Skedco, Inc. v. Strategic Operations, Inc.

Filing 261

OPINION & ORDER: Plaintiff's Motion for Partial Summary Judgment 223 is (1) granted as to literal infringement, (2) denied as moot as to infringement under the doctrine of equivalents, (3) denied as to obviousness; (4) denied as to ine quitable conduct, and (5) granted as to all affirmative defenses other than obviousness and inequitable conduct. Defendant's Amended Motion for Summary Judgment 227 is denied as moot as to infringement under the doctrine of equivalents and denied in all other respects. The parties' evidentiary objections/motions to strike are denied or denied as moot. Signed on 2/12/2018 by Judge Marco A. Hernandez. (jp)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF OREGON
SKEDO, INC., an Oregon corporation,

No. 3:13-cv-00968-HZ

Plaintiff,
v.
STRATEGIC OPERATIONS, INC., a
California corporation,
Defendant.

Nathan C. Brunette
Steven T. Lovett
Elliott J. Williams
STOEL RIVES LLP
760 N.W. Ninth Avenue, Suite 3000
Portland, Oregon 97205
Brian C. Park
STOEL RIVES LLP
600 University Street, Suite 3600
Seattle, Washington 98101
Attorneys for Plaintiff

1 - OPINION & ORDER

OPINION & ORDER

Gary L. Eastman
Kenny Nguyen
EASTMAN & McCARTNEY LLP
401 W. A Street, Suite 1785
San Diego, California 92101
Michael G. Neff
HAGLUND KELLEY LLP
200 S.W. Market Street, Suite 1777
Portland, Oregon 97201
Attorneys for Defendant
HERNANDEZ, District Judge:
Plaintiff Skedco, Inc. brings this action against Defendant Strategic Operations, Inc.,
alleging that Defendant infringes Claims 18, 19, and 20 of United States Patent No. 8,342,652
("the '852 Patent") which discloses a system for simulating hemorrhages in the training of first
responders.1 The United States, through the Secretary of the Army, owns the '852 Patent.
Plaintiff is the sole and exclusive licensee of the '852 Patent under an agreement which also gives
Plaintiff the right to bring this action in its own name.
In 2015, after claim construction disputes were resolved, both parties moved for summary
judgment on the issues of infringement, validity, and unenforceability based on inequitable
conduct. In a December 8, 2015 Opinion, I granted summary judgment to Defendant on the issue
of infringement, denied Plaintiff's motion on that issue, and denied all remaining motions as
moot. Skedco, Inc. v. Strategic Ops., Inc., 154 F. Supp. 3d 1099 (D. Or. 2015). Judgment was
entered that day. ECF 153. Plaintiff appealed. In an April 24, 2017 Opinion, the Court of

1

A copy of the '852 Patent is found at Exhibit A to the Second Amended Complaint,
ECF 17-1. All further references to the '852 Patent will be to this Exhibit and will be denoted
simply by reference to the patent and the column and line number cited as appropriate.
2 - OPINION & ORDER

Appeals for the Federal Circuit (CAFC), reversed the summary judgment determination,
concluding that I erred in construing certain claim elements. Skedco., Inc. v. Strategic Ops., Inc.,
685 F. App'x 956 (Fed. Cir. 2017). The CAFC vacated the underlying judgment and remanded
the case to this Court. Id. The mandate was filed on May 31, 2017. ECF 197.
The parties have now filed new summary judgment motions, again raising issues of
infringement, validity, and unenforceability based on inequitable conduct. I grant Plaintiff's
motion and deny Defendant's motion on the issue of literal infringement. I deny as moot both
parties' motions on infringement under the doctrine of equivalents. I deny both parties' motions
on obviousness and on inequitable conduct. I grant Plaintiff's motion addressed to all of
Defendant's affirmative defenses except for obviousness and inequitable conduct.
Following the recitation of summary judgment standards, this Opinion has four parts: (1)
Infringement; (2) Obviousness; (3) Inequitable Conduct; and (4) Remaining Issues. My
December 8, 2015 Opinion includes an overview of the '852 Patent, the then-operative claim
constructions, and an overview of the allegedly infringing BPS System. 154 F. Supp. 3d at 110103. I do not repeat the overviews here. I do not revisit the claim constructions other than those
addressed by the CAFC in its April 24, 2017 Opinion.
STANDARDS
Summary judgment is appropriate if there is no genuine dispute as to any material fact
and the moving party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(a). The
moving party bears the initial responsibility of informing the court of the basis of its motion, and
identifying those portions of "'the pleadings, depositions, answers to interrogatories, and
admissions on file, together with the affidavits, if any,' which it believes demonstrate the absence
3 - OPINION & ORDER

of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986) (quoting
former Fed. R. Civ. P. 56(c)).
Once the moving party meets its initial burden of demonstrating the absence of a genuine
issue of material fact, the burden then shifts to the nonmoving party to present "specific facts"
showing a "genuine issue for trial." Fed. Trade Comm'n v. Stefanchik, 559 F.3d 924, 927-28 (9th
Cir. 2009) (internal quotation marks omitted). The nonmoving party must go beyond the
pleadings and designate facts showing an issue for trial. Bias v. Moynihan, 508 F.3d 1212, 1218
(9th Cir. 2007) (citing Celotex, 477 U.S. at 324).
The substantive law governing a claim determines whether a fact is material. Suever v.
Connell, 579 F.3d 1047, 1056 (9th Cir. 2009). The court draws inferences from the facts in the
light most favorable to the nonmoving party. Earl v. Nielsen Media Research, Inc., 658 F.3d
1108, 1112 (9th Cir. 2011).
If the factual context makes the nonmoving party's claim as to the existence of a material
issue of fact implausible, that party must come forward with more persuasive evidence to support
his claim than would otherwise be necessary. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,
475 U.S. 574, 587 (1986).
INFRINGEMENT
I. Prior Decision/Claim Construction & CAFC Opinion
Most of the claim constructions from the 2014 Markman hearing and Markman Opinion
which were controlling before the 2015 summary judgment motions, remain unchanged. Of the
six terms or phrases this Court construed, the CAFC expressly rewrote only one. In the
December 8, 2015 Opinion resolving the 2015 summary judgment motions, I added to the
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previous claim constructions. The CAFC concluded that my additional limitations were
unsupported by the patent.
Based on the prior claim constructions, particularly the construction of "valve," "pump,"
and "a controller connected to said pump and said at least one valve," I granted Defendant's
motion for summary judgment on literal infringement. 154 F. Supp. 3d at 1104-1112. The
CAFC's Opinion primarily concerned two claim elements in Claim 18: (1) "at least one valve in
fluid communication with said pump," and (2) "a controller connected to said pump and said at
least one valve." Skedco, 685 F. App'x at 957-58. As the CAFC noted, I construed "at least one
valve in fluid communication with said pump" to require the pump and the valve to be physically
separate structures. Id. at 959 (citing 154 F. Supp. 3d at 1112). The CAFC did not disagree with
the construction of "pump" as a "device that moves or transfers fluid by mechanical action," or
the construction of "valve" as "a device that regulates, directs, or adjusts the flow of fluid through
a passageway by opening, closing, or restricting that passageway." Id. But, the CAFC rejected
my conclusion that the pump and the valve had to be physically separate structures:
[N]othing in the claims requires the pump and the valve to be physically
separated. The claimed valve need only be "in fluid communication with" the
claimed pump. '852 patent, 14:9. Nothing prevents a pump from being "in fluid
communication with" an internal valve.
***
Our construction is also consistent with the district court's construction of
the individual terms "pump" and "valve." To paraphrase the district court, a
"pump" moves fluid and a "valve" regulates fluid flow. See Skedco, 154 F.3d at
1102. . . . We see no reason why a device that moves fluid cannot contain another
device that regulates flow within it. A pump does not cease moving fluid - i.e.,
being a "pump" - just because an internal valve adjusts fluid flow.
***
5 - OPINION & ORDER

We therefore hold that the district court erred in construing the limitation
"at least one valve in fluid communication with said pump" as requiring a
physically separate pump and valve.
685 F. App'x at 959, 960.
The CAFC then addressed the limitation of "a controller connected to said pump and said
at least one valve." Id. at 960-61. Following the Markman hearing, I construed the phrase
"controller connected to" as "an activation mechanism joined, united, or linked to" establishing
the meaning of the entire phrase as "an activation mechanism joined, united, or linked to said
pump and said at least one valve." 154 F. Supp. 3d at 1102. During my 2015 summary judgment
infringement analysis, I further construed the phrase as requiring the controller to have "direct,"
"independent," and "physical" connections to the pump and the valve so that the pump and valve
"were controlled by the controller." Id. at 1105-06. The CAFC concluded that including these
additional limitations into Claim 18 was error.
Instead of requiring a physical connection, the CAFC held that "the term 'connected to' in
the context of the '852 patent contemplates both direct and indirect connections." 685 F. App'x at
961. The CAFC further determined that there was no reason to "import" a "physical" limitation
into Claim 18. Id. The CAFC explained that the claimed "'controller' is merely 'an activation
mechanism'" and "nothing limits this activation to physical channels." Id. (citing embodiments
of the patent where a remote controller activates a valve and noting that "[t]his activation must
occur at least in part through a nonphysical connection."). According to the CAFC, it "was error
to limit the claimed connection to physical connections." Id.
The court agreed that my analysis that the valve and the pump must be "controlled by the
controller" was "essentially correct." Id. The CAFC explained, "[i]n the context of claim 18, the
6 - OPINION & ORDER

controller is 'an activation mechanism' for controlling the components connected to it." Id.
Then, while the CAFC agreed with Plaintiff that Claim 18 "expects interaction between the
controller and the components connected to it," it rejected Skedco's proposed construction of
"connected to" to mean "interacts directly or indirectly with" because the "'852 patent describes
the relationship between the controller and the pump and the valve as being one of control or
activation, not 'interaction' more generally." Id.
Based on this discussion, the CAFC held that the "correct construction of ''a controller
connected to said pump and said at least one valve' is 'an activation mechanism configured to
control a pump and a valve to which it is directly or indirectly joined, united, or linked.'" Id.
According to the CAFC, "[t]his construction reflects the parties' agreement that 'controller' means
'an activation mechanism.'" Id. And, "[i]t is consistent with the plain meaning of 'connected to'
as 'joined, united, or linked to.'" Id.
II. Infringement Standards Generally
A patent holder has the right "to exclude others from making, using, offering for sale, or
selling the invention throughout the United States or importing the invention into the United
States[.]" 35 U.S.C. § 154(a)(1). A party infringes a patent if, "without authority," it "makes,
uses, offers to sell, or sells any patented invention, within the United States or imports into the
United States any patented invention during the term of the patent[.]" 35 U.S.C. § 271(a).
A device can infringe a patent literally or under the doctrine of equivalents. E.g., Energy
Transp. Grp., Inc. v. William Demant Holding A/S, 697 F.3d 1342, 1352 (Fed. Cir. 2012) (noting
that a device that does not literally infringe a claim may still infringe under the doctrine of
equivalents). Infringement analysis involves two steps. Grober v. Mako Prods, Inc., 686 F.3d
7 - OPINION & ORDER

1335, 1344 (Fed. Cir. 2012). First, the court determines the scope and meaning of the patent
claims through the claim construction process and second, the claims as construed are compared
to the allegedly infringing device. Id. (citing Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448,
1454 (Fed. Cir. 1998) (en banc)). The two-step analysis applies to both literal infringement and
infringement under the doctrine of equivalents. Deering Precision Instruments, LLC v. Vector
Distrib. Sys., Inc., 347 F.3d 1314, 1322 (Fed. Cir. 2003). As indicated above, the step one claim
construction occurred in this case in 2014 and was revised by the CAFC in its April 2017
Opinion. As to step two, "[p]atent infringement, whether literal or by equivalence, is an issue of
fact, which the patentee must prove by a preponderance of the evidence." Siemens Med. Sols.
USA, Inc. v. Saint-Gobain Ceramics & Plastics, Inc., 637 F.3d 1269, 1279 (Fed. Cir. 2011).
III. Literal Infringement
To establish literal infringement, "every limitation set forth in a claim must be found in an
accused product, exactly." Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling
USA, Inc., 699 F.3d 1340, 1356 (Fed. Cir. 2012) (internal quotation marks omitted). As in the
2015 summary judgment motions, Defendant focuses its argument on Claim 18 and then asserts
that the allegedly infringing BPS System does not infringe Claims 19 and 20 because those
claims depend from Claim 18. A dependent claim cannot be infringed if the independent claim
is not infringed. Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1552 n.9 (Fed. Cir.
1989).
Defendant does not contest that the BPS System meets Elements 1, 2, or 5 of Claim 18.
As it did previously, Defendant focuses on Elements 3 and 4 of Claim 18 and contends that the
BPS System does not have the requisite valve or that such valve is not "connected to" a
8 - OPINION & ORDER

controller.
A. Element 3: "at least one valve in fluid communication with said pump"
My prior claim construction, confirmed by the CAFC, requires a valve to regulate, direct,
or adjust the flow of fluid through a passageway by opening, closing, or restricting the
passageway. 154 F. Supp. 3d at 1102; 685 F. App'x at 959. Both parties' experts opine that the
internal valves of the three pumps used in the BPS System at any given time (Pump A, Pump B,
and Pump C), regulate, direct, or adjust the flow of fluid through a passageway by opening.
closing, or restricting the passageway and thus meet the claimed element. Stevick Dec. 19, 2014
Infring. Rep. ¶¶ 53-63, ECF 98-3; Guentzler Jan. 2015 Rebuttal Infring. Rep. ¶¶ 47-50 (Pump
A); ¶¶ 53-54 (Pump B); ¶¶ 60-61 (Pump C), ECF 98-10. The same is true for what the parties
refer to as "Pump D" although Pump D is a different type of device. Stevick Dec. 19, 2014
Infring. Rep. ¶¶ 64-66, ECF 98-3; Guentzler July 21, 2015 Dep. 153:17-154:11, ECF 98-15.
Defendant does not seriously contest that the valve components within each of the four
pumps meet the controlling definition of "valve" because the components "regulate[], direct[], or
adjust[] the flow of fluid through a passageway by opening, closing or restricting the
passageway."2 Defendant argues however, that the current claim constructions require that the
valve be a separate and distinct device from the pump, even if it may be physically housed within
the pump, and because the internal valves of Pumps A, B, C, and D are nothing more than
components of the pump that exist solely to allow each pump to function properly, there is no
actual "valve." Thus, Defendant continues, none of the four pumps used in the BPS System meets
2

At the December 12, 2017 oral argument on the motions, Defendant argued that Pump
D did not meet the limitation. Based on the testimony of its expert Dr. William Guentzler cited
above, I reject this argument.
9 - OPINION & ORDER

Element 3 of Claim 18.
In my December 8, 2015 Opinion, I stated that the claim language supported a conclusion
that the pump and the valve were separate devices. 154 F. Supp. 3d at 1108 ("[b]y disclosing a
'pump' in Element 2 and separately disclosing a 'valve' in Element 3, the language in Claim 18
suggests that these are two independent devices"). I also stated that the claim construction
further supported a conclusion that these were separate devices because they perform distinct
functions. Id. ("By defining each of these claim components as a 'device' and by defining each as
performing a distinct function different from the other, the claim construction indicates that the
pump and the valve disclosed in Claim 18 are separate devices").
I recognized the competing expert opinions regarding the independence of the internal
valves that reside within the pumps used in the BPS System. Id. at 1108-09. I noted that
Plaintiff's expert Dr. Glen Stevick asserted that Pumps A-D were "structures that contain internal
components which satisfy both the 'pump' and 'valve' limitations[.]" Id. at 1108. Stevick, I
explained, deconstructed each of the four pumps and asserted, essentially, that each of them had
"valve" components that operated independently from the "pump" components such that the
"pump" components moved fluid by mechanical action and the "valve" components regulated
fluid flow. Id. In contrast, Dr. William Guentzler, Defendant's expert, opined that Pumps A-D
could not function to move fluid and perform as intended with the "valve" components removed.
Id. at 1109. The valve components were not independent of the pump.
For the purposes of the December 8, 2015 Opinion, I accepted Stevick's opinion that
Pumps A-C had valve components that could be separated from the pump components and that
Pump D's gear teeth acted as backflow-preventing valves. Id. I further credited Stevick's opinion
10 - OPINION & ORDER

that even with these valve components removed, the pumps could operate. Id. Nonetheless, I
explained:
The valve components of Pumps A-D "regulate" the fluid only within the
pumps themselves. The valve disclosed in Claim 18 is separate from the pump
because the valve, as discussed above, is separately and independently connected
to the controller/activation mechanism. And, while the components of Pumps
A-D may be disassembled for the purposes of testing the operation of those pumps
absent the "valve" portion, the BPS System does not use Pumps A-D with the
components taken apart. Thus, even though the components can be separated for
testing, the "valve" portions of Pumps A-D actually function as part of the pump.
Each Pump A-D is a single device that has internal components that prevent
backflow into the pump so that the pump will function efficiently to move fluid by
mechanical action. Pumps A-D do not have an independent valve.
Id.; see also id. at 1112 ("Pumps A-D do not satisfy the independent functions of the two devices
(the valve and the pump) because the design of each of those pumps is that the internal valve and
pump work together to make the pump work efficiently to move or transfer the fluid").
The CAFC concluded that I erred in my analysis and determined that nothing in the patent
claims or specification required that the valve be physically separate from the pump. 685 F.
App'x at 959-60. Although the CAFC accepted my claim constructions for "valve" and "pump,"
agreed that each device performed a distinct function ("a 'pump' moves fluid and a 'valve'
regulates fluid flow"), and expressly recognized that "a 'pump' is not a 'valve,'" it nonetheless
found that the claim language contained no limitation on the "structural relationship between the
pump and the valve" other than that the valve be in fluid communication with the pump. Id. at
959-60. Nothing prevented the pump from being "in fluid communication with" an internal
valve and "nothing in the claims or specification prohibits a valve from residing within a pump."
Id. Further, in rejecting Defendant's argument that because the pump and the valve are separately
listed claim elements they are presumptively distinct, the CAFC stated that "nothing in the
11 - OPINION & ORDER

agreed-upon constructions of 'pump' and 'valve' forbids a pump from housing an internal valve."
Id. at 960.
Defendant's argument here poses the question of whether "components" which perform
the function of a valve as defined in the claim construction, but which do so solely as part of the
pump and are integral to the movement of fluid by mechanical action, are nonetheless not
"valves" as defined because, by virtue of their indispensability to pump function, they are not an
independent "device" and they perform no separate function. That is, even though the CAFC
concluded that a "valve" may reside inside a "pump" consistent with the claim language, are
these internal components nonetheless inconsistent with the claim language because they perform
no discrete "valve" function and are not functionally an independent device?
I am constrained by the CAFC's decision to answer the question with a "no," the internal
components are not inconsistent with the claim language. The CAFC's holding is directed to the
physical separation of the pump and valve. But, its discussion reflects a determination that the
"valve" components residing inside each version of the pump meet the Element 3 limitation even
if they are integral to the effective functioning of the pump. This is seen by the fact that this
issue was addressed in my December 8, 2015 Opinion, by the fact that Defendant raised the issue
in its brief to the CAFC, by the questioning of Defendant's counsel during oral argument, and by
statements in the CAFC's opinion.
My December 8, 2015 Opinion, as seen from the discussion above, unambiguously set
forth a discussion regarding how the valve components of Pumps A-D performed no independent
function and instead operated with the pump to make the pump satisfy its required function of
moving or transferring fluid by mechanical action. Defendant raised the issue in its brief on
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appeal. See Skedco, Inc. v. Strategic Ops., Inc., No. 16-1349, ECF 39 (Fed. Cir. July 15, 2016)
(Def.'s Appellee Br.). Beginning in the Introduction, Defendant discussed what it called
Plaintiff's "deconstructed pump theory" and explained why the argument failed. Def.'s Appellee
Br. 5-6. Defendant later explained why Claim 18 required a valve to be a separate device from
the pump and thus could not be something that is part of the "internal, integral structure of the
pump." Id. at 20. Defendant framed the dispute as "not whether a 'valve' can be 'in fluid
communication' with a 'pump' when that valve and pump are housed in the same single structural
element[,]" but "whether each Pump A-D, as used in the BPS, performs the separate and
independent functions of the two separately claimed devices, a 'pump' and a 'valve.'" Id. at 41; see
also id. at 42 (quoting portion of December 8, 2015 Opinion set out above explaining that the
"valve" portions of Pumps A-D function as part of the pump).
During oral argument before the CAFC, Judge Chen and Judge Prost both questioned
Defendant's counsel as to why the valve could not be inside the pump. Stevick Aug. 15, 2017
Supp'l Reb. Infring. Rep. 2-3, ECF 224-4. Judge Chen asked why "can't the valve be inside the
pump?" Id. at 2. Defendant's counsel tried to explain that there was no valve because it was just
a pump device with many components within that device. Id. But, Judge Chen asked directly:
"Is one of the components a valve?" to which Defendant's counsel answered "[y]es." Id.
Defendant's counsel persisted in trying to communicate that the valve component just "functions
in the pump." Id. Judge Chen responded by asking still, why could that valve not meet the claim
limitation for the valves? Id. Citing Powell v. Home Depot U.S.A., Inc., 663 F.3d 1221 (Fed.
Cir. 2011), which I had discussed in my December 8, 2015 Opinion, Judge Chen explained that
although there were two claim limitations in Powell, the CAFC had nonetheless affirmed the
13 - OPINION & ORDER

jury's verdict that the accused product's single box met both limitations. Id. Judge Chen
wondered "why couldn't that also potentially be applicable here, or at least at a minimum, raise a
factual question for a jury or a district court to decide as a factual matter?" Id. at 3. Judge Chen
was not persuaded that Powell was distinguishable, noting that here, there "are two specific
devices[,]" "[j]ust like in Powell." Id. Still, Defendant's counsel pressed in his position that in
Powell, there were specific teachings in the specification envisioning that the two devices could
be integrated into one. Id. At that point, Judge Prost remarked that if the claim language is
broad enough to allow it, then even without teaching in the specification, it would be allowed,
absent a disclaimer. Id.
The CAFC was aware of the issue present here and posed questions to counsel during oral
argument suggesting that despite Defendant's contentions that a valve was not a pump and that
the valve components function only as part of the pump, the valve components still met the
limitation for valves. The CAFC's statements in its decision confirm this. In particular, I note
the court's determination that "Claim 18 contains no other limitation [aside from "in fluid
communication with"] governing the structural relationship between the pump and the valve."
685 F. App'x at 959. Additionally, even in the face of the December 8, 2015 Opinion and
Defendant's arguments on appeal, the court still stated that "nothing in the agreed-upon
constructions of 'pump' and 'valve' forbids a pump from housing an internal valve." Id. at 960.
Then, well aware of how an internal valve functions, the court concluded that the internal valve
components were consistent with the constructions of "pump" and "valve." Finally, the court's
observation that "[a] pump does not cease moving fluid - i.e., being a 'pump' - just because an
internal valve adjusts fluid flow[,]" shows that the court, fully cognizant of the separate functions
14 - OPINION & ORDER

of the valve and the pump, nonetheless held that these functions could be performed by
components housed together in a pump. Id. at 959. With that, the CAFC's opinion requires that I
conclude that as long as the components perform the function as defined, the valve limitation in
Element 3 is satisfied.
Even assuming that Guentzler's opinion is correct, and that the internal valves in Pumps
A-D are not independent from the pumps, that does not mean that they do not satisfy the
limitation of a "valve." Because Guentzler's reports and testimony show that components within
each of Pumps A-D "regulate, direct, or adjust the flow of fluid through a passageway by
opening, closing, or restricting the passageway," there is no dispute that the components meet the
definition of a "valve." Therefore, the "valves" in Pumps A-D of the BPS System meet Element
3 of Claim 18.
B. Element 4: "a controller connected to said pump and said at least one valve"
As noted above, the CAFC revised my claim construction of this phrase to mean "an
activation mechanism configured to control a pump and a valve to which it is directly or
indirectly joined, united, or linked." 685 F. App'x at 961. It contemplates both that the activation
mechanism "control" the pump and the valve and that the activation mechanism be directly or
indirectly joined, united, or linked to the pump and the valve. There is no dispute that the BPS
System activation mechanism controls the pump and that the activation mechanism is directly
joined to the pump via wiring. The issue is whether the internal valves in Pumps A-D meet the
limitation.
Plaintiff argues that Pumps A-D each meet this element because both a wireless key fob
and a wired activation mechanism responsive to the key fob (a) control the pump and the valve
15 - OPINION & ORDER

within the pump, and (b) are indirectly joined, united, or linked to the pump and to the valve
within the pump. Pl.'s Mot. for Sum. J. 12, ECF 223. Plaintiff argues that "[e]ach of Pumps A-D
has a valve component controlled by the action of the pump and thus, [the valve] is indirectly
controlled by and connected to the controller." Id.; see also Pl.'s Reply 6, ECF 238; Pl.'s Opp. 79, ECF 233.
Defendant contends that the BPS controller system is configured to control only the
pump, not the valve. Defendant focuses on the CAFC's rejection of Plaintiff's proposed
construction of "connected to" as "interacts directly or indirectly with." Defendant argues that
Plaintiff's contentions regarding how the BPS System meets Element 4 of Claim 18 describe only
an "indirect interaction" between the controller/activation mechanism and the valve, which the
CAFC rejected. Defendant suggests that a more direct connection is required.
The evidence in the record from both parties' experts establishes that when the controller
turns on electric power to the pump, the pump creates hydraulic pressure that activates the
internal valves in each pump. Plaintiff refers to this as an "electric-over-hydraulic connection."
Pl.'s Reply 6, ECF 238. Stevick opines that the BPS System controller is directly connected to
each pump and indirectly connected to the valve components, and that when activated, the
controller starts the pump which causes the valve to cyclically open and close. Stevick Claim
Chart 15-17, ECF 98-2 (citing to (a) Ex. 1 to Stevick Dec. 19, 2014 Infring. Rep., ECF 98-3
(BPS Product Descrip.); (b) Stevick Dec. 19, 2014 Infring Rep. ¶¶ 67-69, ECF 98-3; and (c)
Guentzler Dep. 158:25-159:9, 163:9-20, ECF 98-15); see also Stevick Aug. 15, 2017 Supp'l Reb.
Infring. Rep. 11, ECF 224-4 ("In each version of the BPS, the controller activates the pump
electrically, and indirectly activates the valve via the pump and the fluid pressure that the pump
16 - OPINION & ORDER

creates"); see also Guentzler July 21, 2015 Dep. 158:25-159:9, 163:9-20, ECF 98-15 (testifying
that when the BPS controller is turned on, it sends 12 volts to the model of the pump and that
when the pump starts to pump, the movement of the plunger controls the valves).
To the extent Defendant suggests that a physical connection between the activation
mechanism and the valve is required, Defendant's contention is foreclosed by the CAFC's
opinion which specifically held that the term "connected to" contemplated both direct and
indirect connections. The court expressly rejected the contention that Claim 18 required a
physical connection. 685 F. App'x at 961. To the extent Defendant argues that the valve must be
activated independently from the pump, nothing in the construction of Element 4 or the CAFC's
opinion suggests that is necessary.
During oral argument at the CAFC, Judge Chen, in asking about an "indirect or direct
connection," stated that "connected to" could be "an indirect connection in the sense that you
have to go through some other component in order to, you know, activate that downstream
component." Stevick Aug. 15, 2017 Supp'l Reb. Infring. Rep. 5, ECF 224-4. And, in the
decision itself, the CAFC explicitly pointed to an indirect connection in the '852 Patent. 685 F.
App'x at 960-61 ("The patent describes activating valve 124 'though [sic] a controller (or remote
control switch) 126' despite a lack of direct connection between the controller and the valve. . . .
Using 'connected to' to cover indirect connections is also more consistent with the term's plain
meaning"; "'controller' is merely 'an activation mechanism,' . . . and nothing limits this activation
to physical channels. Indeed, the '852 patent includes several embodiments where a remote
controller 160 activates a valve. . . . This activation must occur at least in part through a
nonphysical connection.") (emphasis added).
17 - OPINION & ORDER

The CAFC's acknowledgment that indirect connection includes activating a downstream
component by going through another component and its example of indirect control support a
conclusion that going through the "other component" of the pump to activate the valve satisfies
the limitation in Element 4 as construed by the CAFC. Given that the valve is a
subdevice/component of the pump and it is undisputed that the activation mechanism activates
the pump, the valve is also activated by the mechanism, albeit indirectly, and thus the BPS
System and each one of Pumps A-D meets the required limitation of having an activation
mechanism configured to control a pump and a valve to which it is directly or indirectly joined,
united, or linked.
C. Stevick's Opinion
In its Memorandum in Opposition to Plaintiff's Summary Judgment Motion, Defendant
argues that Plaintiff has presented no post-CAFC Opinion expert opinion setting forth an
infringement analysis using the proper construed claim language. Thus, Defendant argues,
Plaintiff cannot sustain its burden of proving infringement. Def.'s Opp. 1, ECF 234. Defendant
objects to any testimony by Stevick related to the post-CAFC Opinion claim constructions
because he provided no expert opinion on those issues. Because Stevick issued no new report
after the CAFC revised the construed claim terms, Defendant argues that Stevick offers no
opinion on these terms on which this Court can rely.
Following the issuance of the CAFC mandate, I set a new case schedule. June 20, 2017
Am. Min. Ord., ECF 203. I denied Defendant's request to reopen fact discovery but I allowed
reopening of expert discovery. Id. I set a schedule for disclosure of initial expert reports as
follows: August 1, 2017 for initial expert reports; August 15, 2017 for supplemental/rebuttal
18 - OPINION & ORDER

reports; and September 1, 2015 for the close of expert discovery. Id.
Plaintiff did not tender a new infringement report to Defendant on August 1, 2017. See
Def.'s Mot. to Strike, ECF 207. Plaintiff did provide a Supplemental Report from Stevick on
August 15, 2017. Id. On September 6, 2017, Defendant moved to strike Stevick's August 15,
2017 Supplemental Report because several of the initial pages were not, in Defendant's opinion,
rebuttal to an August 1, 2017 Supplemental Infringement Report by Guentzler, but were instead
an initial report which was untimely. As a result, Defendant argued it was deprived of the
opportunity to rebut Stevick's infringement opinion. Id.
In a September 8, 2017 Order, I denied Defendant's motion to strike:
ORDER: The Court has reviewed Defendant's Motion to Strike Plaintiff's
"Supplemental Expert Report of Glen Stevick in Rebuttal to Supplemental Expert
Report of William D. Guentzler" 207. The Court has also reviewed Dr. Stevick's
report that is at issue in Defendant's motion. According to Defendant, the first
portion of Dr. Stevick's report (pages 2-6) to which the motion to strike is
addressed is not actually a rebuttal to Dr. Guentzler's report but is an untimely
new expert report on infringement offered by Dr. Stevick. (Defendant's motion
does not address pages 7 - 15 of Dr. Stevick's report which is clearly delineated as
a rebuttal to Dr. Guentzler's report)[.] Based on the Court's reading of this portion
of Dr. Stevick's report, Dr. Stevick opines that the Federal Circuit's decision
clarified the original claim construction this Court rendered in 2014. Dr. Stevick
further states that the "concepts described" by the Federal Circuit are as he
described in earlier reports or are consistent with his understanding of the 2014
claim construction issued by this Court.
I DENY the motion to strike the report 207 because the opinion offered by Dr.
Stevick is not a new opinion regarding infringement but is a reassertion of his
prior infringement opinion based on his conclusion that the Federal Circuit's
decision clarified the claim construction consistent with the claim construction
that Dr. Stevick previously relied on. Dr. Stevick's interpretation of the Federal
Circuit's opinion is not controlling on this Court, however, and Plaintiff may or
may not be successful in defending Dr. Stevick's interpretation going forward. At
this point, because Dr. Stevick does not appear to be offering a new opinion on
infringement, there is no basis to strike his August 15, 2017 report as untimely.

19 - OPINION & ORDER

ECF 208.
Stevick's pre-CAFC infringement opinions are sufficient to sustain Plaintiff's burden of
proof. Stevick's original opinions remain valid unless they are inconsistent with the post-CAFC
Opinion claim constructions. Stevick's opinions were based on the 2014 claim constructions
which are set forth in the December 8, 2015 Opinion. 154 F. Supp. 3d at 1102. As the CAFC
noted, the December 8, 2015 Opinion added claim limitations not previously announced in the
2014 Markman hearing or the Markman Opinion. 685 F. App'x at 960. Before the December 8,
2015 Opinion, nothing in the prior claim constructions suggested that the "in fluid
communication with" limitation required physically separate pump and valve structures. Before
the December 8, 2015 Opinion, nothing in the prior claim constructions suggested that the
"controller connected to" limitation required a direct, physical connection. It was not until the
December 8, 2015 Opinion was issued that these additional limitations were rendered. I even
acknowledged in a footnote in that decision that to the extent the additional limitations were
viewed as changed claim constructions, the law supported my authority to do so. Id. at 1108 n.6.
I read the CAFC decision as addressing and rejecting the additional limitations I provided
in the December 8, 2015 Opinion. I do not read that decision as fundamentally altering the 2014
claim constructions. As a result, Stevick's original infringement opinions are based on claim
constructions which still govern, albeit with some clarification by the CAFC. And, those
clarifications are consistent with the interpretations of the 2014 claim constructions that Plaintiff
and Stevick have had since they were issued in 2014. Defendant's objection to Stevick's
infringement opinions is overruled.
///
20 - OPINION & ORDER

D. Summary re: Literal Infringement
Plaintiff meets its burden of establishing that the BPS System literally infringes all
elements of Claim 18 of the '852 Patent. The record presents no material disputed issues of fact
as to the literal infringement of this claim.
As to Claims 19 and 20, Defendant offers no evidence or argument specifically addressed
to those claims. Claims 19 and 20 depend from Claim 18. Claim 19 discloses a trauma training
system as disclosed in Claim 18 but with two wound sites. Claim 20 discloses a trauma training
system disclosed in Claim 18 with a container housing the reservoir, pump, and at least one
valve. Stevick opines that the BPS System meets all elements of Claims 19 and 20. Stevick
Claim Chart 19-21, 23, ECF 98-2; Stevick Dec. 19, 2014 Infring. Rep. ¶¶ 74-76, 77-78, ECF 983; Ex. D to Stevick Dec. 19, 2014 Infring. Rep. 51-52, ECF 98-3 (BPS Product Description).
Guentzler's opinion is not inconsistent with Stevick's. Guentzler Jan. 2015 Rebuttal Infring. Rep.
¶ 43 (describing four separate blood supply lines), ¶ 73 (describing wound sites), ECF 98-10.
There are no disputed issues of fact regarding the literal infringement of Claims 19 or 20.
I grant summary judgment on literal infringement of Claims 18, 19, and 20 to Plaintiff
and deny Defendant's motion on that issue. By granting summary judgment to Plaintiff on the
issue of literal infringement, I need not address Plaintiff's alternative contention that the BPS
System infringes Claims 18, 19, and 20 of the '852 Patent under the doctrine of equivalents.
Thus, I deny both parties' motions addressed to the doctrine of equivalents, as moot.
OBVIOUSNESS
I. Legal Standards
United States patents are presumed valid by statute. 35 U.S.C. § 282. Defendant bears
21 - OPINION & ORDER

the burden of establishing invalidity by clear and convincing evidence. Microsoft Corp. v. i4i
Ltd. P'ship, 564 U.S. 91, 100-01, 110-13 (2011); Carnegie Mellon Univ. v. Marvell Tech. Grp.,
Ltd., 807 F.3d 1283, 1293 (Fed. Cir. 2015). The presumption mandated by Section 282 applies
to validity challenges based on obviousness. See Senju Pharm. Co. v. Lupin Ltd., 780 F.3d 1337,
1350 (Fed. Cir. 2015). While the clear and convincing burden of proof always applies to the
patent validity challenger, if "a challenger introduces evidence that might lead to a conclusion of
invalidity—what we call a prima facie case," the patentee is "well advised to introduce evidence
sufficient to rebut that of the challenger[.]" Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1360
(Fed. Cir. 2007) (explaining that "the presumption of validity remains intact and the ultimate
burden of proving invalidity remains with the challenger throughout the litigation," and further
that the "trial court has the responsibility to determine whether the challenger has met its burden
by clear and convincing evidence by considering the totality of the evidence, including any
rebuttal evidence presented by the patentee.") (internal quotation marks omitted).
A patent is rendered invalid for being obvious if "the differences between the claimed
invention and the prior art are such that the claimed invention as a whole would have been
obvious before the effective filing date of the claimed invention to a person having ordinary skill
in the art to which the claimed invention pertains." 35 U.S.C. § 103. "Obviousness is a question
of law based on underlying factual findings: (1) the scope and content of the prior art; (2) the
differences between the claims and the prior art; (3) the level of ordinary skill in the art; and (4)
objective considerations of nonobviousness." In re Cyclobenzaprine Hydrochloride
Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1068 (Fed. Cir. 2012). These four
factors are referred to as the "Graham factors" after Graham v. John Deere Co., 383 U.S. 1, 1722 - OPINION & ORDER

18 (1966). E.g., ABT Sys., LLC v. Emerson Elec. Co., 797 F.3d 1350, 1357 (Fed. Cir. 2015).
Additionally, to establish obviousness, there must be evidence of a motive to combine as
well as a reasonable expectation of success in doing so:
Generally, a party seeking to invalidate a patent as obvious must demonstrate by
clear and convincing evidence that a skilled artisan would have had reason to
combine the teaching of the prior art references to achieve the claimed invention,
and that the skilled artisan would have had a reasonable expectation of success
from doing so.
In re Cyclobenzaprine, 676 F.3d at 1068-69 (internal quotation marks omitted). The burden also
includes showing that the skilled artisan would have chosen the particular references asserted in
support of the obviousness argument. WBIP, LLC v. Kohler Co., 829 F.3d 1317, 1337 (Fed. Cir.
2016). As with the four Graham factors, whether there is a reason or motive to combine prior art
references is a question of fact. In re Van Os, 844 F.3d 1359, 1360 (Fed. Cir. 2017).
In 2007, the Supreme Court rejected a "rigid approach" of the CAFC's "teaching,
suggestion, or motivation" (TSM) test. KSR Int'l Co. v. Teleflex, Inc., 550 U.S. 398, 415, 419
(2007). Before KSR, the court required
that a patent challenger show that a person of ordinary skill in the art would have
had motivation to combine the prior art references and would have had a
reasonable expectation of success in doing so [and] that the reason, suggestion, or
motivation to combine may be found explicitly or implicitly: 1) in the prior art
references themselves; 2) in the knowledge of those of ordinary skill in the art that
certain references, or disclosures in those references, are of special interest or
importance in the field; or 3) from the nature of the problem to be solved.
Wyers v. Master Lock Co., 616 F.3d 1231, 1238 (Fed. Cir. 2010) (citations and internal quotation
marks omitted). But, post-KSR, the CAFC, and thus, district courts analyzing obviousness, must
take a more "expansive and flexible approach" in determining whether a patented invention was
obvious at the time it was made. Id.
23 - OPINION & ORDER

Additionally, KSR reiterated the Supreme Court's previous caution in granting patents on
inventions which are combinations of prior art elements:
For over half a century, the Court has held that a patent for a combination which
only unites old elements with no change in their respective functions obviously
withdraws what is already known into the field of its monopoly and diminishes
the resources available to skillful men. This is a principal reason for declining to
allow patents for what is obvious. The combination of familiar elements
according to known methods is likely to be obvious when it does no more than
yield predictable results.
KSR, 550 U.S. at 415-16 (citation, internal quotation marks, and ellipsis omitted). The Court
further explained:
When a work is available in one field of endeavor, design incentives and other
market forces can prompt variations of it, either in the same field or a different
one. If a person of ordinary skill can implement a predictable variation, § 103
likely bars its patentability. For the same reason, if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize that
it would improve similar devices in the same way, using the technique is obvious
unless its actual application is beyond his or her skill. . . . [A] court must ask
whether the improvement is more than the predictable use of prior art elements
according to their established functions.
Id. at 417.
It is clear that post-KSR, "common sense" plays a role in the obviousness analysis. But,
the CAFC has made equally clear that "the mere recitation of the words 'common sense' without
any support adds nothing to the obviousness equation." Mintz v. Dietz & Watson, Inc., 679 F.3d
1372, 1377 (Fed. Cir. 2012). The KSR Court itself acknowledged that even through the lens of
"common sense," it is still important to identify a reason that prompted the inventor to combine
references. KSR, 550 U.S. 418-19. The Court explained:
Although common sense directs one to look with care at a patent application that
claims as innovation the combination of two known devices according to their
established functions, it can be important to identify a reason that would have
24 - OPINION & ORDER

prompted a person of ordinary skill in the relevant field to combine the elements
in the way the claimed new invention does. This is so because inventions in most,
if not all, instances rely upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in some sense, is
already known.
Id.
Recent CAFC cases confirm that evidence of a motivation to combine is part of the
obviousness inquiry. E.g., Metalcraft of Mayville, Inc. v. The Toro Co., 848 F.3d 1358, 1366
(Fed. Cir. 2017) ("In determining whether there would have been a motivation to combine prior
art references to arrive at the claimed invention, it is insufficient to simply conclude the
combination would have been obvious without identifying any reason why a person of skill in the
art would have made the combination"). Nonetheless, according to KSR, in "determining
whether the subject matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under § 103." KSR, 550 U.S. at 419.
Finally, obviousness may not be based on hindsight. The statute requires that
obviousness be assessed at the time the invention was made. 35 U.S.C. § 103 (requiring that the
obviousness determination be made as of the time of the invention's effective filing date); see
also KSR, 550 U.S. at 421 (warning against "the distortion caused by hindsight bias" and
advising caution in the face of "arguments reliant upon ex post reasoning"); Senju Pharm. Co.,
780 F.3d at 1356 ("Obviousness is a matter of foresight, not hindsight.").
II. Graham Factors - Underlying Factual Findings
A. Scope & Content of the Prior Art
Defendant relies on several pieces of prior art in support of its obviousness argument: (1)
25 - OPINION & ORDER

the Simulaids Arterial Blood Action Simulator (SABAS) Device; (2) the Simulaids Humerus Compound Fracture (SH-CF) Device; (3) two patents by Niiranen; (4) the Zelenak Patent; and
(5) the Sirhan Patent. Other than an argument directed at the SABAS Device and noted later in
this Opinion, Plaintiff does not contest that all of the asserted prior references are either patents
or devices which existed or were on the market before the relevant application date of the '852
Patent.3
A prior art reference is analogous and thus available to be used in an obviousness
argument "if it is from the same field of endeavor, regardless of the problem addressed or is
reasonably pertinent to the particular problem with which the inventor is involved, even if it is
not within the inventor's field of endeavor." Tinnus Enters., LLC v. Telebrands Corp., 846 F.3d
1190, 1207 (Fed. Cir. 2017) (internal quotation marks omitted); see also In re GPAC Inc., 57
F.3d 1573, 1577-78 (Fed. Cir. 1995) ("prior art relevant to an obviousness determination
necessarily encompasses not only the field of the inventor's endeavor but also any analogous
arts."). A "reference is reasonably pertinent if it, as a result of its subject matter, logically would
have commended itself to an inventor's attention in considering his problem." K-TEC, Inc. v.
Vita-Mix Corp., 696 F.3d 1364, 1371 (Fed. Cir. 2012) (internal quotation marks omitted). The
scope of prior art is construed broadly. Wyers, 616 F.3d at 1238.
///
3

Defendant asserts that the earliest application in which the limitations of Claims 18, 19,
and 20 of the '852 Patent are fully supported is Provisional Patent Application 60/822,888, filed
on August 18, 2006. Def.'s Am. Mot. for Sum. J. 24, ECF 227; see also Eastman Oct. 2, 2017
Decl., Ex. 8, ECF 211-8 (copy of provisional patent application). Although Plaintiff has
contended that the correct invention and priority dates are earlier, for purposes of these summary
judgment motions, Plaintiff does not appear to dispute that all references (other than the SABAS
Device), are "prior" to Plaintiff's asserted invention/priority date.
26 - OPINION & ORDER

1. Simulaids Products - SABAS and SH-CF Devices
Both of these products are made by Simulaids, a manufacturer of simulation training aids
for healthcare and rescue workers. Guentzler Jan. 2015 Supp'l Inv. Rep. ¶ 16, ECF 210-3. The
SABAS Device has a pump, a reservoir, several moulages, a power supply, a five-gallon rigid
reservoir for simulated blood, multiple supply lines, one by-pass return line, and one main blood
supply line. Eastman Oct. 2, 2017 Decl., Ex. 27, ECF 213-7 (Instructor's Guide); see also id.,
Ex. 28 at 9, ECF 213-8 (photo of device); id., Ex. 29 at 8, ECF 213-9 (photo of device).
Plaintiff does not dispute that the SABAS Device is within the same field of endeavor as the '852
Patent which is teaching aids/simulation devices for hemorrhage control or trauma training
devices. As a matter of law, it is analogous prior art.4
The SH-CF Device includes a collapsible reservoir, a hand pump, a moulage, a main
supply line connecting the collapsible reservoir with the hand pump, a blood supply line
connecting the hand pump to the moulage, and a manual valve attached to the exterior of the
main supply line. Guentzler Jan. 2015 Supp'l Inv. Rep. ¶¶ 45, 46, ECF 210-3; Id., Ex. 3 at 43,
ECF 210-3 at 43 (photo of SH-CF Device).
Defendant argues that like the SABAS device, the SH-CF Device is in the same field of
endeavor as the '852 Patent, meaning teaching aids for injury, hemorrhage, or trauma simulation.
Further, Defendant argues that the SH-CF Device is reasonably pertinent to the particular
problem the '852 Patent was intended to solve, meaning a realistic bleeding simulation that
allows for hands-on practice. Plaintiff contends that the SH-CF Device is non-analogous prior
4

As a result of my conclusion on literal infringement, the fact that the SABAS Device
uses a positive displacement pump with internal valves is no longer relevant to a determination
of its status as prior art for purposes of the obviousness analysis.
27 - OPINION & ORDER

art because it is only a "wound simulator."
As one of the four Graham factors, the scope of the prior art is a fact question for the
jury. Construing the evidence in Defendant's favor, the SH-CF Device is analogous prior art
because it is a teaching aid for the treatment of bleeding wounds and is intended to provide a
realistic simulation of pulsing blood. The realistic wound, supplied by fake blood, activated by a
hand pump, and which is worn by human subjects, all combine to make this device in the same
field of endeavor - trauma training.
Even construing the evidence in Plaintiff's favor, a jury could not reach the opposite
conclusion. Describing this device as being in the field of "wound simulators" is a general
observation, and more importantly, it does not remove the SH-CF Device from being either in the
same field of endeavor of trauma training devices or at least reasonably pertinent to the problem
to be solved. The SH-CF Device allows for hands-on practice of treating a bleeding wound,
appears to be non-fragile in the sense that it does not use software, does not appear to require preprogramming, and given its simplicity, is undoubtedly cost-effective. Plaintiff fails to create a
material issue of fact as to the SH-CF Device. As a matter of law, it is analogous prior art.
2. The Niiranen Patents
Two patents were issued to John V. Niiranen in 1959 and 1960. The first, United States
Patent No. 2,871,579 ("the '579 Niiranen Patent No. 1"), is entitled "Surgical Body-Member
Simulacrum For Teaching First Aid." Brunette Oct. 2, 2017 Decl., Ex. 8, ECF 224-8. The
second, U.S. Patent No. 2,945,304 ("the '304 Niiranen Patent No. 2"), is entitled "Periosomatic
Training Devices." Id., Ex. 7, ECF 224-7.
Defendant contends that both Niiranen patents are within the same field of endeavor as
28 - OPINION & ORDER

the '852 Patent and reasonably pertinent to the particular problem the '852 Patent was intended to
solve because both patents disclose a teaching-aid device designed to provide realistic simulation
of wounds. See '579 Niiranen Patent No. 1, 1:19-28, ECF 224-8 ("The present invention relates
to a surgical body-member simulacrum for teaching first aid and more particularly to an artificial
body-member, such as an abdomen or the like with simulated layers of skin, adipose tissue, and
blood vessels arranged in combination with a motor for simulating 'arterial' and 'venous' pressure
and pulse-beat, and a reservoir for simulated blood, for training advanced first aid students,
doctors, nurses, and medical technicians in the various wound closure and blood vessel clamping
techniques"); '304 Niiranen Patent No. 2, 1:19-22, ECF 224-7 ("This invention relates to a
training means for simulating early emergency casualty care and particularly to moulages which
are fitted around the 'patient' to provide realistic simulation of wounds.").
Plaintiff does not contest that both Niiranen patents are in the same field of endeavor as
the '852 Patent. As a matter of law, they are analogous prior art references.
3. The Zelenak Patent
A patent obtained by John Zelenak in 1997, United States Patent No. 5, 645, 404 ("the
Zelenak Patent"), discloses a "Personal Fluid Dispensing Device." Oct. 2, 2017 Brunette Decl.,
Ex. 6, ECF 224-6. It contains a fluid reservoir, a delivery tube, an electronic pump, a power
supply, and an actuating device. Id. at 1 (abstract description). The invention "relates generally
to personal fluid dispensing devices, and more particularly to an electrically powered handportable dispensing device for potable beverages." Id., 1:5-7. The drawings indicate that it is

29 - OPINION & ORDER

worn as a backpack, similar to what many people refer to as a camelback.5
Defendant asserts that the Zelenak Patent is acceptable prior art because Plaintiff
disclosed it in the '852 Patent prosecution. '852 Patent at 2. However, the relevant federal
regulation indicates that a patent applicant's citation of a reference during prosecution is not an
admission that the reference is prior art. 37 C.F.R. § 1.97(h) ("The filing of an information
disclosure statement shall not be construed to be an admission that the information cited in the
statement is, or is considered to be, material to patentability[.]"). Thus, such disclosure of the
Zelenak Patent does not conclusively establish it as analogous prior art in an obviousness inquiry.
The question remains, however, whether the Zelenak Patent is either in the same field of
endeavor as the '852 Patent or reasonably pertinent to the problem to be solved. Plaintiff argues
that the personal fluid dispensing device in the Zelenak Patent is not in the same field of
endeavor as a trauma training or wound simulation system. According to Plaintiff, trauma
training and the replenishment of personal bodily fluids are completely different fields of
endeavor. I agree with Plaintiff that no reasonable juror could conclude that the Zelenak Patent
and the '852 Patent are devices within the same field of endeavor.
But, analogous prior art includes prior art that is reasonably pertinent to the problem to be
solved. The '852 Patent was trying to overcome problems of previous hemorrhage training
methods which were not dynamic or realistic enough because they were either too limited in
scope of training (such as CPR mannequins), too complex for mass training with attendant
problems of being too costly and fragile for use in the field, or too restricted in the type of wound

5

"Camelbak" is a particular brand but the term "camelback" is often used as a generic
reference to a hydration backpack.
30 - OPINION & ORDER

they could simulate (such as humans with cards). '852 Patent 1:19-67 - 2:1-5; see also Pl.'s Opp.
35-36, ECF 233 (describing problems limiting realism of prior art devices including that they
were too delicate, too expensive, and "too tethered (mobility, and hence realism, limited by cords
or cables attached to training device") (citing ECF 129-7 at 6 (FEBSS ad), 17 (U.S. Army
publication))). Even though Lynn King, the '852 Patent's inventor, knew about the Zelenak
Patent and disclosed it, Plaintiff argues that the Zelenak Patent would not have logically
commended itself to the inventor's attention in considering the problem he was addressing.
Stevick states that individuals in the field of emergency medical and critical care training, and in
particular hemorrhage control simulations and training, would not have thought of beverage
dispensers as potential components of a realistic and robust hemorrhage simulation tool. Stevick
Aug. 15, 2017 Supp'l Reb. Inv. Rep. 18, ECF 224-5.
KSR indicates that relevant prior art is not limited to prior art designed to solve the same
problem as the claimed invention. "Common sense teaches . . . that familiar items may have
obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be
able to fit the teachings of multiple patents together like pieces of a puzzle." KSR, 550 U.S. at
420 ("The second error of the Court of Appeals lay in its assumption that a person of ordinary
skill attempting to solve a problem will be led only to those elements of prior art designed to
solve the same problem"); Wyers, 616 F.3d at 1238 (noting that KSR directs that the scope of
analogous prior art must be construed broadly and quoting KSR in regard to familiar items having
obvious uses beyond their prior purposes). Thus, the fact that the Zelenak Patent is not designed
as a trauma training device is not conclusive as to whether it is analogous prior art.
There are reasonable competing inferences that the Zelenak Patent is reasonably pertinent
31 - OPINION & ORDER

to the problems confronting King, who cited it in his patent application. Because the Zelenak
Patent discloses a portable, lightweight system easily worn by a person as a backpack and which
mechanically pumps fluid from a collapsible reservoir into a tube and then out of a nozzle, it
could be reasonably concluded that it would have logically commended itself to King's attention
in attempting to create a more dynamic and realistic trauma training device. On the other hand,
given that it has no relation to wound simulation or hemorrhage control, a jury could reasonably
conclude that it is not reasonably pertinent to the problems King was attempting to solve. This
issue is to be resolved by a jury.
4. The Sirhan Patent
In 1990, Eddie Sirhan obtained a patent for a "Glove Amusement Device," United States
Patent No. 4, 903, 864 ("the Sirhan Patent"). Brunette Oct. 2, 2017 Decl., Ex. 11, ECF 224-11.
It squirts liquid. Id. at 1. It has a liquid storage apparatus which includes a pump and an
activation mechanism, a glove, and an umbilical cord connecting the two. Id. The field of the
invention "relates to amusement devices and more particularly to amusements [sic] devices for
squirting liquids." Id., 1:5-8.
Plaintiff argues that the Sirhan Patent is not analogous prior art because it is of a
completely different field of endeavor and would not have logically commended itself to the
attention of King, who was concerned with solving problems in realistic trauma training. Stevick
states that individuals working in the field of emergency and critical casualty care training and in
particular hemorrhage control simulations and training, would not have thought of novelty squirt
gun toys as potential components of a realistic and robust hemorrhage simulation tool to train
medical personnel, first responders, or combat medics to deal with life-threatening injuries.
32 - OPINION & ORDER

Stevick Aug. 15, 2017 Supp'l Reb. Inv. Rep. 14, ECF 224-5.
The Sirhan Patent, like the Zelenak Patent, is not in the same field of endeavor as the '852
Patent. But, in contrast to the Zelenak Patent, I agree with Plaintiff that as a matter of law, no
reasonable juror could determine that the Sirhan Patent is reasonably pertinent to the problems
King was solving to solve. The Sirhan Patent does have some features which overlap with the
Zelenak Patent, including a storage container for liquid, a pump, an activation trigger, and a tube
connecting the liquid to a dispensing hole. But, the storage container is not disclosed as being
collapsible, the patent does not disclose a nozzle capable of dispensing fluid but only a pinhole
designed to squirt fluid, and use of the device may require a belt to which the liquid container is
attached as well as velcro straps attached to the tube so the user can strap the tube to his or her
clothes to prevent the tube from becoming an obstacle during water competition. See Sirhan
Patent 3:44-45 (container preferably made of high impact plastic); 3:64-65 ("container 24 is
made from hard, high impact plastic"); 3:65-68 (liquid container unlikely to cause injury to user
or water competition participant because it is attached to the user's belt); 4:22 (end cap has a pin
hole opening); 4:35-39 (use of velcro straps); 5:11-12 (claim element claiming a glove opening
"for squirting liquid"); 5:46-51 (claim element claiming tube with an end cap having a pin hole
opening); 6:20-13 (claim element claiming container made from hard, high impact plastic). All
of these elements combine to create a distinct device, limited in scope, which would not have
commended itself to the problems King was trying to solve.
///
///
///
33 - OPINION & ORDER

B. Differences Between the Claimed Invention & the Prior Art
1. The Simulaids Products
a. The SABAS Device
As described in a 1980 publication by the United States Army, the SABAS Device, which
has the same components as the '852 Patent except for a collapsible reservoir, functions as
follows:
Principal components of the device are the six plastic moulages of a
wounded forearm which is bleeding from the artery. Each of these moulages is
life-size and realistically colored. They may be placed on foam rubber in trays,
which are provided, or strapped onto dummies or human "subjects" during the
first-aid training. The six moulages may be operated separately or simultaneously.
Simulated blood, mixed from a powder provided with the device, is stored
in the 5-gallon reservoir provided. Manifold valves control the blood flow to the
desired moulage(s) so that it flows into the moulage and out of the wound, as it
would on a wounded person.
Control of the simulated blood is accomplished by means of a pump and
power-supply unit, six blood supply lines, a bypass return line, and a main bloodsupply line.
Eastman Oct. 2, 2017 Decl., Ex. 28 at 9, ECF 213-8.
The photos of the SABAS Device show that it is a considerably larger device than the
"Field Expedient Bleeding Simulation System" (FEBSS) product Plaintiff makes and markets as
the patented invention. Compare id., ECF 213-8 (photo of SABAS Device) and id., Ex. 29 at 8,
ECF 213-9 (photo of SABAS Device), with King Aug. 14, 2015 Decl. ¶¶ 6-9, ECF 99
(description of the invention with accompanying photo of Plaintiff's Hydrasim or FEBSS
product), and Ex. 7 to Lovett Sept. 4, 2015 Decl., ECF 129-7 at 6 (photo of FEBSS in
advertisement).
Plaintiff argues that the size difference between the SABAS Device and the patented

34 - OPINION & ORDER

invention renders the SABAS Device irrelevant as prior art. Plaintiff contends that given the size
of the SABAS Device, it is not portable, distinguishing it from the '852 Patent invention. See
Stevick July 25, 2015 Dep. 231-47, ECF 219-2 (stating that a device that is "luggable" can be
moved but is not designed for movement whereas the configuration of the '852 Patent is very
portable).
Although the difference in size is notable, the components and overall function of the
SABAS Device are strikingly similar to the components and practice of the '852 Patent. Thus,
the size discrepancy is essentially a relevance question with an impact on the motivation inquiry.
The weight to be given to the SABAS Device in that determination is an issue for the factfinder.
b The SH-CF Device
The SH-CF Device has similar components to those claimed in the '852 Patent in that it
has a collapsible reservoir, a valve, and a conduit connecting the reservoir to a wound site. It
uses a hand pump, however, and lacks a controller.
2. The Niiranen Patents
Plaintiff argues that there are significant differences between the Niiranen patents and the
'852 Patent claimed invention, including that the Niiranen patents, like the SABAS Device, have
a rigid supply tank. Defendant contends that the Niiranen patents disclose a collapsible reservoir.
a. The '579 Niiranen Patent No. 1.
The '579 Niiranen Patent No. 1 has "four major portions": the body-member simulacrum,
the motor-driven pump system for producing both simulated "arterial" and "venous" pressure, the
supply tank or reservoir for simulated blood, and a supporting base and housing. '579 Niiranen
Patent No. 1, 2:35-39, ECF 224-8. The drawings and description show all components contained
35 - OPINION & ORDER

in a single structure, but with distinct components of the supply tank, the simulacrum, hoses, and
the motor assembly. Id., Figs. 1-3. In the drawings, the simulacrum is made to resemble an
abdomen such that one would practice wound closing directly on that component while it is
housed in the structure with the simulated blood flowing. Id.
As for the supply tank, the '579 Niiranen Patent No. 1 discloses a "closed unit with a
removable air-tight opening" which Defendant argues discloses a collapsible reservoir. Def.'s
Am. Mot. for Sum. J. 42, ECF 227.6 In support, Defendant cites to Exhibit 3 of Guentzler's
August 1, 2017 Third Supplemental Expert Report re: Invalidity. Def.'s Am. Mot. for Sum. J.,
ECF 227. Exhibit 3 is a Claim Chart in which Guentzler asserts that the '579 Niiranen Patent No.
1 has a collapsible reservoir because the disclosed supply tank is a closed unit with removable
air-tight opening. Guentzler Aug. 1, 2017 Supp'l Inv. Rep., Ex. 3, ECF 210-7 at 36.
In opposing Plaintiff's motion, Defendant more clearly states that "[b]ecause the reservoir
described in the Niiranen Patent No. 1 has an 'air-tight opening,' the reservoir must necessarily
flex or fold as the volume of the container of fluid is drawn out." Def.'s Opp. 24, ECF 234. For
support, Defendant cites to Exhibit 6 to Guentzler's January 2015 Invalidity Report which is a
Claim Chart that states that the '304 Niiranen Patent No. 2, not the '579 Niiranen Patent No. 1,
satisfies the "collapsible reservoir" element of Claim 18 of the '852 Patent because it
"[i]ncorporates by reference a description of an air tight supply tank." Guentzler Jan. 2015 Supp'l
Inv. Rep., Ex. 6, ECF 210-3 at 49.

6

Plaintiff notes that in the prior round of summary judgment motions in 2015, Defendant
and its expert admitted that the Niiranen patents lacked a collapsible reservoir. Pl.'s Opp. 23-24,
ECF 233; see Guentzler July 21, 2015 Dep. 182:5-193:1, 185:18-20, ECF 97-6 (testifying that
the Niiranen patents disclosed a rigid tank and neither disclosed a collapsible reservoir).
36 - OPINION & ORDER

The '579 Niiranen Patent No. 1 discloses that the "supply tank 12 is a closed unit with a
removable air-tight opening 45 for replenishing the colored synthetic blood." '579 Niiranen
Patent No. 1, 3:24-26. Earlier, the patent states that the "tank 12 may be supplied with a
continual steady air pressure, through inlet 31 by means of conduit 32 from a small air
compressor 33 driven by electric motor." Id., 3:3-6. The drawings show the supply tank as a
rigid box.
While the claims themselves in the '579 Niiranen Patent No. 1 do not expressly recite a
rigid storage tank or alternatively, a collapsible reservoir, each one of them discloses that the
liquid in the tank is pressurized, thereby forcing the liquid out of the tank for use in the
simulation. '579 Niiranen Patent No. 1, 4:14-75 (claiming a pressurized tank in each of five
separate claims). With these disclosures, no reasonable juror could accept Defendant's argument
that the disclosure of the tank being "air tight" necessitates the disclosure of a collapsible
reservoir when each claim in the '579 Niiranen Patent No. 1 recites a pressurized system for
storage of the liquid. That is, Defendant's argument that the recitation of "air tight" necessarily
discloses a collapsible reservoir is untenable in the presence of a pressurized system. The '579
Niiranen Patent No. 1 does not teach a collapsible reservoir in the context of the pressurized
system disclosed by the claims of that patent.
b. The '304 Niiranen Patent No. 2
Defendant makes the same assertion as to the '304 Niiranen Patent No. 2, contending that
its "closed unit with a removable air-tight opening" discloses a collapsible reservoir. Def's Am.
Mot. for Sum. J. 42, ECF 227. The '304 Niiranen Patent No. 2 is addressed to "a training means
for simulating early emergency casualty care" and particularly to "moulages which are fitted
37 - OPINION & ORDER

around the 'patient' to provide realistic simulation of wounds." '304 Niiranen Patent No. 2, 1:1922, ECF 224-7; see also id., 2:40, 2:45-46 (describing moulages "adapted to be fitted on a
volunteer" which are "connected by rubber tubing to a central fluid supply."). The claims
themselves are primarily directed to the moulages, providing only for "a supply of simulated
blood" without further elaboration. Id., 6:21-47.
The patent description, however, makes clear that the supply tank disclosed in the '579
Niiranen Patent No. 1 is to be used in the '304 Niiranen Patent No. 2. The '304 Niiranen Patent
No. 2 states that the "fluid supply system contains a fluid storage tank 12 which is adapted to
store venous and arterial blood flow." Id., 2:46-48. Figure 1 shows what appears to be a box as
the tank. Later, the '304 Niiranen Patent No. 2 refers to the '579 Niiranen Patent No. 1 when it
states that the "simulated blood supply unit has been more fully described in the co-pending
application, Serial No. 588,584 and will not be further described here." Id., 3:2-5. It also states
that "CO2 supply and solenoid have been substituted for the air compressor in order to make the
pressure producing means portable." Id., 3:5-9.
As with the '579 Niiranen Patent No. 1, the '304 Niiranen Patent No. 2 discloses a
pressurized tank system. Accordingly, Defendant's contention that the recitation of an air-tight
supply tank necessarily discloses a collapsible reservoir is without support in the '304 Niiranen
Patent No. 2. No reasonable juror could conclude otherwise.
3. The Zelenak Patent
Plaintiff contends that in contrast to the '852 Patent, the Zelenak patented device lacks
both a wound site and a valve connected to a controller. Plaintiff also argues that it is not a
"trauma training system." As to the valve, Plaintiff argues that Defendant provides no evidence
38 - OPINION & ORDER

that one exists in the device. There is no dispute that it has a pump, but Stevick states that there
is no evidence that the pump used in that device has an internal valve. Stevick Aug. 15, 2017
Supp'l Reb. Inv. Rep. 17-18, ECF 224-5. Guentzler, however, explains that consistent with
Plaintiff's infringement contentions, if the pump of the Zelenak device includes internal valves,
then the device has a valve in fluid communication with the pump. Guentzler Aug. 1, 2017
Supp'l Inv. Rep., Ex. 3, ECF 210-7 at 36. Plaintiff is correct that there is no affirmative evidence
of the existence of a valve. However, the disclosure of a pump creates a reasonable inference
that the pump possesses an internal valve. Thus, there is an issue of fact as to this component.
During claim construction I construed "wound site," as used in Claim 18, to mean "a
simulated injury having an opening through which fluid can flow to simulate a hemorrhage."
154 F. Supp. 3d at 1102. The parties' experts offer contradictory opinions as to whether the
nozzle in the Zelenak device satisfies the claim limitation of "wound site." Guentzler Aug. 1,
2017 Supp'l Inv. Rep., Ex. 3, ECF 210-7 at 37-38 (stating that the valve or nozzle is "used to
direct a flow fluid, which when inserted into a mouth may simulate a bleeding mouth"); Stevick
Aug. 15, 2017 Supp'l Reb. Inv. Rep. 17, ECF 224-5 (the drinking nozzle of the Zelenak personal
hydration system is not a wound site because the nozzle is not a simulated injury and does not
simulate hemorrhaging).
I agree with Plaintiff that no reasonable juror could conclude that the nozzle used in the
Zelenak device is a "wound site" as defined. It simply lacks a simulated injury. Claim 18 of the
'852 Patent discloses a separate wound site element which means that Claim 18 includes a
component specifically designed to look like an injury. The Zelenak device nozzle is not such a
component.
39 - OPINION & ORDER

Plaintiff also argues that the Zelenak device is not a "trauma training system" as required
by the preamble to Claim 18. Claim 18 recites that it is a "trauma training system for replicating
at least one hemorrhage, said system comprising: [reciting elements]." '852 Patent, 14:3-4.
Plaintiff notes that the '852 Patent consistently describes the invention not as a mere collection of
components such as a pump, valve, and controller, but as a trauma training system. It is the title
of the '852 Patent. It is noted in the abstract to be a "system for simulating one or more
hemorrhages." '852 Patent at 1. The preamble to two of the three independent claims discloses
that it is a "trauma training system for replicating at least one hemorrhage[.]" '852 Patent, 11:4344 (Claim 1), 14:3-4 (Claim 18). All dependent claims also disclose a "trauma training system."
Id., 11:54, 58, 65, 12:1, 4, 16, 19, 31, 39, 41, 44, 54, 65, 13:1, 4, 14:15, 22. Plaintiff argues that
nothing in the Zelenak Patent teaches use of its beverage-supplying personal hydration system as
a trauma training system, and no reasonable factfinder could find otherwise.
Defendant argues that the preamble language is not limiting. Defendant acknowledges
that a preamble can be limiting when it serves as an antecedent basis for limitations in the claim
body. Eaton Corp. v. Rockwell Int'l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003) ("When
limitations in the body of the claim rely upon and derive antecedent basis from the preamble,
then the preamble may act as a necessary component of the claimed invention. On the other
hand, if the body of the claim sets out the complete invention, then the language of the preamble
may be superfluous.") (citation, internal quotation marks, and brackets omitted). Defendant
argues that Claim 18's preamble provides no antecedent element for the asserted claims. Further,
Defendant notes that there is no evidence in the prosecution history where the patent examiner
relied on the preamble to limit a claim element. Defendant argues that the preamble provides
40 - OPINION & ORDER

only a purpose or an intended use for the device, and thus, cannot be limiting.
Plaintiff argues that the "trauma training system" language in the preamble supplies a
fundamental characteristic of the assembled elements and thereby breathes "life, meaning, and
vitality" into the claims. Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1357 (Fed. Cir. 2012)
(internal quotation marks omitted). Plaintiff contends that the express inclusion of "wound site"
in Claim 18 confirms that "trauma training system" is limiting.
Determining whether a preamble is limiting is part of claim construction which is a
matter of law for the court. See Poly-Am., L.P. v. GSE Lining Tech., Inc., 383 F.3d 1303, 1309
(Fed. Cir. 2004) (in reviewing jury's determination on obviousness, district court's determination
regarding limiting nature of language in preamble was analyzed on appeal as a claim construction
issue). The Poly-America court explained that
[w]hether to treat a preamble as a limitation is a determination resolved
only on review of the entire patent to gain an understanding of what the inventors
actually invented and intended to encompass by the claim. No litmus test defines
when a preamble limits claim scope. On the one hand, a preamble is a claim
limitation if it recites essential structure or steps, or if it is necessary to give life,
meaning, and vitality to the claim. On the other hand, a preamble is not limiting
where a patentee defines a structurally complete invention in the claim body and
uses the preamble only to state a purpose or intended use for the invention.
Further, when reciting additional structure or steps underscored as important by
the specification, the preamble may operate as a claim limitation.
Id. at 1309-10 (citations, internal quotation marks, brackets, and ellipsis omitted).
In Poly-America, the court agreed with the district court that the preamble language was
limiting. Id. at 1310. The court noted that (1) the specification is "replete with references to the
invention as a 'blown-film' liner, including the title of the patent itself and the 'Summary of the
Invention'"; (2) the phrase was repeatedly used to describe the preferred embodiments; and (3)

41 - OPINION & ORDER

the entire preamble "blown-film textured liner" was restated in each of the patent's seven claims.
Id. The court concluded that the inventor considered the "blown-film" preamble language to
represent an important characteristic of the claimed invention. Id. Therefore, the court affirmed
the district court's conclusion that, when the entire patent was reviewed, the preamble language
relating to "'blown-film' does not state a purpose or an intended use of the invention, but rather
discloses a fundamental characteristic of the claimed invention that is properly construed as a
limitation of the claim itself." Id.
In addition to Poly-America, other cases cited by Plaintiff support a conclusion that
"trauma training system" is limiting, even if it was not used in the patent's prosecution. In Deere
& Co., the patent at issue disclosed an "easy clean dual wall deck" for a rotary cutter pulled
behind a tractor to cut or mow large swaths of ground. 703 F.3d at 1352. The court considered
whether the recitation of "rotary cutter deck" in the preamble was limiting and concluded it was.
Id. at 1357-58. The court explained that the "recitation of a 'rotary cutter deck' in Claim 1 is
necessary to understand the subject matter encompassed by the claim, which otherwise generally
recites deck walls that 'define a box section having torsional stiffness.'" 703 F.3d at 1358. The
court found that the term did not merely state a name or use for the claimed box section but
described a "characteristic of the claimed invention that informs one of skill in the art as to the
structure required by the claim." Id. (internal quotation marks omitted). As a specific example,
it explained that the limiting effect of the preamble phrase was found because "rotary cutter
deck" informed the meaning of the "torsional stiffness" limitation. Id. That is, the claimed
structure had to possess sufficient stiffness to withstand the torsional loads imposed by the
operation of a rotary cutter. Id.
42 - OPINION & ORDER

Similarly, in a 2013 unpublished case, the CAFC considered claims related to a patent
directed to infant socks with "gripper" surfaces that provided traction for crawling and walking.
Piggy Pushers, LLC v. Skidders Footwear, Inc., 544 F. App'x 984, 988-89 (Fed. Cir. 2013).
There, the district court found that the preamble limited the claims. The CAFC affirmed,
concluding that "[t]he requirement that the combined elements form a 'sock' is a fundamental
characteristic of the claimed invention." Id. at 989 (internal quotation marks omitted). The court
noted that the specification "uniformly describe[d] what results from combining the sock member
with the gripper member as itself remaining a sock." Id. It further noted that the specification
distinguished a sock from a shoe, which could be undesirable or difficult to put on an infant, and
thus, the addition of the gripper could not transform the sock into a shoe. Id.
In Piggy Pushers, Poly America, and Deere & Co., the court found preamble language
limiting even though there was no evidence that the patentee relied on the preamble in the patent
prosecution. Thus, that factor is not determinative. Similar to the torsional stiffness element in
Deere & Co., the presence of the "wound site" element in Claim 18 is informed by the preamble
limitation of "trauma training system." The "wound site" limitation in Claim 18, even with the
claim construction definition of "a simulated injury having an opening through which fluid can
flow to simulate a hemorrhage" has little or no context without the presence of "trauma training
system." Thus, the preamble is essential to understanding the term in the claim body. Further, as
in Poly America, "trauma training system" is the title of the '852 Patent and is recited in the
preamble to every claim but one. The background of the invention establishes that the invention
was conceived as a response to needs for a more dynamic and realistic trauma training system.
Three of the four exemplary embodiments describe the invention as a trauma training system.
43 - OPINION & ORDER

'852 Patent, 2:9-36. The fourth discloses its use for a "simulation." Id., 2:34-36. The
specification thus shows the importance of the additional "structure" recited in the "trauma
training system" preamble language. I agree with Plaintiff that the preamble language "trauma
training system" is limiting because it provides a "fundamental characteristic" of the assembled
elements and thereby "breathes life, meaning, and vitality" into the claims.
In summary in regard to the Zelenak Patent's comparison to Claim 18 of the '852 Patent,
the Zelenak device has a storage reservoir (preferably collapsible), an activation mechanism, and
a pump which moves liquid from the storage reservoir through a tube to the nozzle to be
dispensed. There is a fact issue as to whether it has an internal valve located within the pump. It
does not have a wound site. It is not a trauma training system.
C. Person of Ordinary Skill in the Art (POSA)
As stated in the statute, the obviousness determination is adjudged through the lens of a
"person having ordinary skill in the art to which the claimed invention pertains." 35 U.S.C. §
103. As with the other Graham factors, the level of skill in the art is a factual determination.
Dippin' Dots, Inc. v. Mosey, 476 F.3d 1337, 1343 (Fed. Cir. 2007) (citing Graham, 383 U.S. at
17). "The person of ordinary skill in the art is a hypothetical person who is presumed to know the
relevant prior art." In re GPAC Inc., 57 F.3d at 1579. "In determining this skill level, the court
may consider various factors including" (1) the types of problems encountered in the art; (2) prior
art solutions to those problems; (3) rapidity with which innovations are made; (4) sophistication
of the technology; and (5) educational level of active workers in the field. Id. "In a given case,
every factor may not be present, and one or more factors may predominate." Id.
The parties dispute the level of ordinary skill in the art. Defendant contends that a POSA
44 - OPINION & ORDER

at the relevant time was "a person having familiarity with the appearance and treatment of trauma
conditions, and a basic understanding of electrical and mechanical systems." Guentzler Jan.
2015 Supp'l Inv. Rep. ¶ 34, ECF 210-3. In forming this opinion, Guentzler notes the experience
of "active workers" in the field by stating that Niiranen was a Navy physician who was known in
his era as a pioneer in the field of realistic trauma training and related products and was an
innovator in the field for the United States military and that King was an Army medic. Id. ¶¶ 29,
31. He also relies on what he considers the lack of sophisticated technology of the '852 Patent.
Id. ¶ 34 (stating that the technology claimed in the '852 Patent is "basic, rudimentary technology
already in existence as evidenced by the '304 Niiranen Patent and the Simulaids bleeding injury
simulations products.").
Stevick opines that the appropriate POSA in this case is a person possessing at least an
emergency medical technician (EMT) certificate and high school degree (or similar educational
background) and with a year of hands on experience in EMT training or similar work history.
Stevick Dec. 19, 2014 Infring. Rep.¶ 41, ECF 98-3. Stevick explains that he formed his opinion
by considering factors such as the educational level and years of experience not only of the
person who developed the products that are the subject of the '852 Patent but also of others
working in the field of training front-line medical personnel and other first responders, the types
of problems encountered in the art and publications of other persons or companies, and the
sophistication of the technology. Id. ¶ 39, ECF 98-3. He states that the "art" at issue here, as
implicated by the '852 Patent, is equipment and techniques for training front-line medical
personnel and other first responders. Id. ¶ 40. Given that, he opines that a POSA would be "an
individual possessing at least an emergency medical technician (EMT) certificate and a high
45 - OPINION & ORDER

school degree (or similar educational background) and with a year of hands-on experience in
EMT training or a similar work history." Id. ¶ 41.
Under Federal Rule of Evidence 702, Plaintiff seeks to strike certain portions of
Guentzler's testimony, including his opinions related to the level of skill in the art. Specifically,
Plaintiff seeks to strike all portions of Guentzler's reports "in which Dr. Guentzler purports to
assert what a person of ordinary skill in the art of trauma training would know, think, or
understand." Pl.'s Opp. 45, ECF 233; see also Pl.'s Reply 38-39, ECF 238 (seeking to strike
Guentzler's testimony that "consists of speculation by extending beyond his area of relevant
technical expertise, including his speculation as to what would have been known, understood, or
thought by a person of ordinary skill in the field of trauma training[.]").
The basis for Plaintiff's objection is that Guentzler admittedly is not an expert in trauma
training devices. E.g., Guentzler July 21, 2015 Dep. 56, ECF 235-2 (testifying that he had no
expertise in trauma training). Plaintiff contends that because Guentzler is not an expert in the
pertinent art, he may not testify as to what a POSA would know, think, or understand. As a
result, Plaintiff objects to more than two dozen paragraphs scattered throughout Guentzler's
various expert reports on infringement and invalidity. Pl.'s Opp. 48, ECF 233. Included in those
objections are certain statements and opinions contained in Guentzler's January 2015
Supplemental Invalidity Report pertaining to the level of ordinary skill in the art. Id.7

7

The challenged testimony includes Guentzler's opinion as to the proper POSA even
though the argument is directed to testimony regarding what the proper POSA would know or
understand. The argument does not appear to include Guentzler's underlying opinion as to who
the proper POSA is in the first place. Nonetheless, because Guentzler's opinion regarding the
proper POSA is included in the challenged paragraphs, I address the argument.
46 - OPINION & ORDER

(challenging ¶¶ 28-34 of Guentzler's Jan. 2015 Supp'l Inv. Report).8
The CAFC has explained that
it is an abuse of discretion to permit a witness to testify as an expert on the issues
of noninfringement or invalidity unless that witness is qualified as an expert in the
pertinent art. Testimony proffered by a witness lacking the relevant technical
expertise fails the standard of admissibility under Fed. R. Evid. 702. Indeed,
where an issue calls for consideration of evidence from the perspective of one of
ordinary skill in the art, it is contradictory to Rule 702 to allow a witness to testify
on the issue who is not qualified as a technical expert in that art.
Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363 (Fed. Cir. 2008). In
Sundance, the court considered the admissibility of expert testimony by a patent attorney on
noninfringement and invalidity, among other issues. The court observed that the defendant,
proponent of the testimony, failed to explain how the attorney was an expert in the pertinent art
of tarps or covers. Id. at 1362. Nor did the defendant establish that the attorney's experience was
"sufficiently related" to the pertinent art. Id. Thus, he was unqualified to offer expert testimony
on the topic of invalidity. Id.
Sundance offers two ways an expert may testify on issues of invalidity under Rule 702.
First, the witness is qualified if he or she has expertise in the precise pertinent art at issue.
Alternatively, the witness's testimony may still be admissible if the expertise possessed by the
witness is "sufficiently related" to the pertinent art. See Sport Dimension, Inc. v. The Coleman
Co., Inc., No. CV1400438BROMRWX, 2015 WL 12732710, at *5 (C.D. Cal. Jan. 29, 2015)
(concluding that under Sundance, "an expert need not have an expertise in the specific pertinent
art to be qualified as an expert [under Rule 702], but the expert must nevertheless demonstrate

8

Plaintiff submits a version of this expert report in which the challenged testimony is
highlighted in blue. See ECF 235-9.
47 - OPINION & ORDER

that his or her technical background is sufficiently related to that pertinent art"), aff'd, 820 F.3d
1316 (Fed. Cir. 2016). While Guentzler is admittedly not an expert in trauma training,
hemorrhage control, or wound simulation systems, his testimony may still be admissible if his
knowledge and expertise is sufficiently related to such systems. Plaintiff does not address this
issue, focusing instead only on the lack of actual expertise in the pertinent art. Therefore,
because Guentzler's industrial technology and engineering education and experience, including
experience with pumps and valves, could be sufficiently related to the pertinent art, Plaintiff's
motion to strike is denied.9 See Ex. 1 to Def.'s Exp. Designation, ECF 210-1 at 5-24 (Guentzler
curriculum vitae).
Defendant argues that a specific finding on the level of ordinary skill in the art is
unnecessary in this case because the technology is easily understandable and the prior art
provides all that is required for determining the appropriate POSA. E.g., Litton Indus. Prods.,
Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163-64 (Fed. Cir. 1985) ("A specific finding on the
level of skill in the art is not . . . . required where the prior art itself reflects an appropriate level

9

I resolve this motion to strike based only on the summary judgment record and only in
the context of resolving the summary judgment motions. I note that although Defendant does not
expressly challenge Stevick's opinions under Rule 702, Stevick's background suggests that he is
not a trauma training device expert either. While he has some experience with medical devices,
none of that experience is related to trauma training systems. Thus, similar to Guentzler, the
summary judgment record does not qualify Stevick as a trauma training device expert. See
Stevick Aug. 15, 2015 Decl. ¶ 1, ECF 98 (reciting that his "areas of technical expertise
include the design, performance, and analysis of mechanical, fluid, and dynamic systems
common to a wide variety of products and industries, including medical devices, construction,
and oil and gas" including "extensive work with the engineering and analysis of medical devices
(including arterial stent, heart valve components, pacemaker leads, spinal implants, surgical
tools), blood pressure and flow, and pump and valve systems"); Id., Ex. 1 (Stevick curriculum
vitae). Whether Stevick's experience is "sufficiently related" to the pertinent art to qualify him as
an expert under Rule 702 is not at issue in these motions.
48 - OPINION & ORDER

and a need for testimony is not shown.").
Defendant argues that based on the parties' proposed definitions of a POSA, both agree
that the scientific and engineering principles applicable to the pertinent art are not difficult and
are easily understandable. I agree with Defendant that both parties' proposed POSA definitions
suggest that the scientific and engineering principles are not complex. But, even with that
consensus, I reject Defendant's argument that no expert testimony is needed on the issue.
Plaintiff's proposed definition focuses on the EMT experience both in terms of having an
EMT certificate and having provided EMT training or the equivalent. It includes a basic high
school education or equivalent which supports a conclusion that the scientific and engineering
principles are not difficult. Defendant's proposed definition includes a person who has "a basic
understanding of electrical and mechanical systems." The reference to "basic" suggests that the
skill level is not high, but, because the proposal singles out electrical and mechanical systems, it
suggests a greater skill level than Plaintiff's proposal which more generally requires a high school
or equivalent education without mentioning anything about electrical or mechanical processes.
And, in contrast to Plaintiff's proposed definition emphasizing trauma treatment skills,
Defendant's proposal requires only that the person have familiarity with the appearance and
treatment of trauma conditions. Overall, Plaintiff's proposed POSA has more experience in
trauma training than Defendant's proposed POSA and Defendant's proposed POSA has more
specific requirements for mechanical and electrical systems knowledge than Plaintiff's proposed
POSA.
Defendant suggests that no specific POSA finding is required because "the prior art
discloses all of the elements of the asserted claims and teaches how the components work
49 - OPINION & ORDER

together to create a training device." Def.'s Am. Reply 29, ECF 240. I disagree. While the prior
art informs the finding, the prior art does not resolve the dispute between the parties regarding
how much experience in EMT training or in mechanical and electrical knowledge the POSA
must have. The prior art references indicate that a POSA is someone with some trauma training
experience. The prior art references also indicate a need for a basic understanding of mechanical
and electrical systems. But, the prior art references do not dictate the precise level of experience
in trauma training or the precise level of knowledge of the scientific principles. Thus, the dispute
between the parties about the proper POSA is material and is unresolved on summary judgment
because a reasonable juror examining the evidence in a light most favorable to the non-moving
party could credit either party's proposed POSA.
D. Secondary/Objective Considerations of Nonobviousness
Objective considerations of nonobviousness constitute "independent evidence" which
"may often be the most probative and cogent evidence of nonobviousness in the record." Mintz,
679 F.3d at 1378 (internal quotation marks omitted). The objective criteria "help innoculate the
obviousness analysis against hindsight." Id. As the Mintz court explained:
These objective criteria thus help turn back the clock and place the claims
in the context that led to their invention. Technical advance, like much of human
endeavor, often occurs through incremental steps toward greater goals. These
marginal advances in retrospect may seem deceptively simple, particularly when
retracing the path already blazed by the inventor. For these reasons, this court
requires consideration of these objective indicia because they provide objective
evidence of how the patented device is viewed in the marketplace, by those
directly interested in the product.
Id. (internal quotation marks omitted). Relevant considerations include unexpected results,
expert skepticism, copying, commercial success, praise by others, failure by others, and long-felt

50 - OPINION & ORDER

need. Id. at 1379.
Plaintiff contends that commercial success, industry praise, long-felt need, the failure of
others, and copying by others establish nonobviousness, or at least create an issue of fact
precluding summary judgment for Defendant on obviousness.
1. Commercial Success
To establish nonobviousness, commercial success must relate to the claimed invention.
Tokai Corp. v. Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011) ("nexus must exist
between the commercial success and the claimed invention"). A "prima facie case of nexus is
made when the patentee shows both that there is commercial success, and that the product that is
commercially successful is the invention disclosed and claimed in the patent." Crocs, Inc. v. Int'l
Trade Comm'n, 598 F.3d 1294, 1310–11 (Fed. Cir. 2010).
Plaintiff relies on sales data for its FEBSS products (basic and deluxe models) to support
its commercial success argument. The FEBSS is a commercial embodiment of the '852 Patent.
King Aug. 14, 2015 Decl. ¶¶ 6-9, ECF 99. For the period of January 2013 - August 2014,
Plaintiff sold 173 "units" for a total price of $424,801.55. Serena Morones Aug. 27, 2015 Decl.,
¶18 & Ex. 1 (Morones Exp. Rep.) at Sch. 2, ECF 122 & 122-1. Defendant characterizes these
sales figures as minimal given that since January 2013, Plaintiff has sold only 173 units
amounting to less than $500,000 in sales revenue. Defendant also notes that there is no evidence
of the total sales in the relevant market, rendering the sales data for this product alone not
especially probative of commercial success. See, e.g., In re Huang, 100 F.3d 135, 140 (Fed. Cir.
1996) ("bare sales numbers" are a "weak showing" of commercial success) (citing Cable Elec.
Prods., Inc. v. Genmark, Inc., 770 F.2d 1015, 1026-27 (Fed. Cir. 1983) (sales of five million
51 - OPINION & ORDER

units was a minimal showing of commercial success because without additional economic
evidence, it is "improper to infer that the reported sales represent a substantial share of any
definable market"), overruled on other grounds, Midwest Indus., Inc. v. Karavan Trailers, Inc.,
175 F.3d 1356 (Fed. Cir. 1999)).
Plaintiff responds by noting that these sales figures include data for only the first one and
one-half years of sales, not the entirety of sales to date. But, the record does not appear to
include any updated sales figures. Plaintiff also suggests that its sales figures must be viewed in
the context of Defendant's "copying" and infringing sales. Pl.'s Reply 35, ECF 238 (noting
Defendant's "nearly immediate copying of the invention, resulting in [Defendant] offering the
invention in direct competition with Skedco."); see also Bud Calkin Jan. 21, 2016 Decl. ¶ 3, ECF
183 (stating that Plaintiff and Defendant communicated between October 2007 and January 2011
to discuss Plaintiff's supplying its FEBSS product to Defendant but failed to reach agreement).
Plaintiff's argument is that having obtained information about its product from Calkin in the
process of attempting to negotiate an agreement, Defendant then used that information to unfairly
compete against Plaintiff in the marketplace, diminishing Plaintiff's sales figures. While this is
essentially a damages argument, I accept for the purposes of the summary judgment motions that
Plaintiff's sales figures would have been higher but for Defendant's competition.10
10

Morones opines that Defendant sold 27 BPS units from January 1, 2013 through
August 2014 and an additional 53 BPS units that were components in Defendant's "Cut Suit"
product during that same period, for a total of 80 units. Morones Ex. Rep. ¶¶ 13-17 & Ex. 1,
Schs. 1b, 1a, ECF 122-1. Assuming that Plaintiff had made those sales, Plaintiff would have
seen an additional $155,934 is sales revenue. This figure assumes that 69 basic FEBSS units
were sold (based on Morones's opinion that Defendant sold 16 BPS basic units, 11 BPS deluxe
units, and sold 53 unidentified BPS units as components in the Cut Suit; without additional
evidence, I assume the 53 unidentified units were the basic model for a total of 69 basic units
sold). Given that during the period, Plaintiff's FEBSS basic unit sold for $1,664 and its deluxe
52 - OPINION & ORDER

Defendant also argues that Plaintiff fails to show that any commercial success it has had
is related to the claimed invention. Defendant first contends that Plaintiff has sold its FEBSS as
a common hydration backpack, which is no different from the system disclosed in the Zelenak
Patent. Thus, Defendant argues, any success from selling the FEBSS is not related to the claimed
invention but only to a prior art device. In support, Defendant relies on an advertisement for the
FEBSS which asserts that the FEBSS
recreates active bleeding on real people while doubling as a common hydration
backpack. [The FEBSS] can be worn on the outside of the uniform while the
simulated drink tube is routed underneath the uniform. The entire system is self
contained and allows for independent wireless control of two venous and two
arterial bleeds.
Eastman Oct. 23, 2017 Decl., Ex. 4 at 3, ECF 231-4.
This advertisement does not market the system as only a common hydration pack. It
markets a device that simulates bleeding but which can be worn like a common hydration
backpack. It indicates that the bleeding apparatus is disguised as a common hydration backpack.
While commercial success, as one of the secondary considerations, is a factual issue, no
reasonable juror would construe the advertisement as one for a common hydration pack.
Defendant still more generally argues that to the extent Plaintiff shows commercial
success, such commercial success is attributable only to the non-patented portable and
concealable nature of the product. That is, any commercial success is not related to the claimed
invention because Claims 18, 19, and 20 do not disclose any limitation regarding size,

unit sold for $3,738, Plaintiff would have sold $114,816 in basic units and $41,118 in deluxe
units had it made the sales Morones claims were made by Defendant. Thus, the total sales figure
assumed for the purposes of the summary judgment motions is $580,735.55 based on the sale of
253 units.
53 - OPINION & ORDER

concealability, or portability. See Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed.
Cir. 2006) ("if the commercial success is due to an unclaimed feature of the device, the
commercial success is irrelevant"); Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1377
(Fed. Cir. 2000) (explaining that to counter obviousness, the party must show that "commercial
success of the product results from the claimed invention"; indicating that sales related to feature
not actually claimed would not meet that standard) (internal quotation marks omitted).
Plaintiff responds that first, the objective evidence identifies that the trauma training
system as a whole is commercially desirable, and second, portability is one of the merits of the
claimed invention contemplated in the specification which results from practicing the invention
as a whole. Thus, Plaintiff contends, commercial success related to sales of the system and
which are related to its portability is relevant evidence. Pl.'s Reply 34, ECF 238.
Plaintiff relies on various publications in support of this argument: (1) an article from
"Technology for Today," ECF 129-7 at 13-14; (2) a 2008 Defense Department Press Release,
ECF 129-7 at 18; (3) the June 2009 issue of the Journal of Emergency Medical Services, ECF
129-7 at 15; (4) a May 14, 2009 article from the "News Leader," ECF 129-7 at 16; and (5) a
publication from the United States Army Medical Research and Material Command's Office of
Research and Technology Applications, ECF 129-7 at 17.
Most of the evidence cited supports Plaintiff's position that the system as a whole has
received industry praise and is commercially desirable. The Defense Department press release
notes that the FEBSS system has had "great value in preparing medics to treat combat
casualties." ECF 129-7 at 18. The Journal of Emergency Medical Services recognized the
FEBSS as one of the top thirty "Hot Products" for 2009. ECF 129-7 at 15 (describing the FEBSS
54 - OPINION & ORDER

as an "extremely effective simulator that can be used with any simulation mannikin" with each
bleed capable of simulating any combination of capillary, venous, or arterial bleeds to create the
chaos of a major trauma bleed at the touch of a button). The "News Leader" article contains
remarks from the former director of Emergency Medical Training for the United States Army
regarding the FEBSS, noting that compared to the prior art, the FEBSS is "very inexpensive," is
"relatively indestructible," and "adds a realism that even the higher fidelity mannequin cannot
offer." ECF 129-7 at 16. The Office of Research and Technology Applications publication
describes the FEBSS, mentions King, and notes that a high percentage of fatalities occurs from
delayed hemorrhage treatment in the field. ECF 129-7 at 17. It discusses that prior trauma
training tools to address that issue had been unable to recreate the stress and difficulty of real life
hemorrhage control in the field. Id. It notes that mannequins hooked up to a laptop were
cumbersome and impractical for training. Id. In contrast, the FEBSS can simulate several
concurrent wounds, from mild to severe, suited for mannequins or worn by personnel in a roleplaying exercise. Id.
Even if the system as a whole is commercially desirable, commercial success related to an
unclaimed feature or "external" or "extraneous" factor does not assist a party attempting to show
nonobviousness. Success, however, may be "linked to an individual element or, in other
circumstances, it could be linked to the inventive combination of known elements." WBIP, 829
F.3d at 1332. The issue in an obviousness inquiry is "whether the 'claimed invention as a whole'
would have been obvious." Id. at 1331-32 (quoting 35 U.S.C. § 103) (emphasis in WBIP). As
discussed above, "trauma training system" is limiting on Claim 18. This system, based on
reading the '852 Patent in its entirety, is one that must be adaptable to several uses and practices,
55 - OPINION & ORDER

including mass casualty training. While there is no express reference to "portability" in Claims
18, 19, or 20, the '852 Patent's recitation of the limitations of the prior art and the patent's
discussion of several different embodiments support a conclusion that "portability" is not an
"extraneous factor."
The '852 Patent recites that it was intended to provide a more realistic and dynamic
bleeding simulation and thus a more realistic and dynamic training experience. E.g., '852 Patent
at 1 (abstract), 1:18-21, 2:3-5. The patent discloses the problems in the prior art as (1) specificpurpose mannequins which cannot be used to simulate other types of medical situations; (2)
complex devices reliant on software which are not suited for large training exercises because of
the need to "train the trainers" on the system, are fragile because of the software components, and
are expensive; and (3) human actors who can provide only static injuries. Id., 1:28-67.
The '852 Patent indicates that it was intended to solve these problems because it is easy to
use, requires minimal training, and provides flexibility. Id., 2:34-36 (noting these features in at
least one embodiment). Demonstrating the flexibility of the system, various embodiments are
disclosed including mannequins, body suits, bag enclosures, and backpacks for housing part or
all of the system. Id., 4:12-14; see also id., 6:63-67 (reciting that the system "may be utilized in
many embodiments, including cooperating with, housed in, or integrated with, for example, a
mannequin, a bag or backpack, a belt, or a bodysuit. The system can be retrofitted into an
existing mannequin or other housing."). Discussion of the mannequin embodiment expressly
refers to the portability of the system, even with a mannequin Id., 7:52-54. Such portability is
achieved through the use of a rechargeable battery which "lacks power cords and provides a more
realistic simulation." Id., 7: 57-60. Another exemplary embodiment is placement of the system
56 - OPINION & ORDER

in a "portable container" which may be a backpack, shoulder bag, or the like, allowing live
participants to attach the system to their bodies and locate the simulated wounds at a variety of
locations. Id., 9:48-60. This "allows for a more realistic simulation of a live casualty by
enabling the live participant to provide more meaningful feedback to the trainee." Id., 9:61-63.
Defendant is correct that neither size nor portability is expressly claimed in Claims 18,
19, or 20 of the '852 Patent. Nonetheless, when the '852 Patent is read as a whole, the claimed
"trauma training system," in order to provide a "more realistic and dynamic" training experience,
is a system that is flexible and adaptable to many different uses. Portability is achieved when the
invention as a whole is considered and practiced. As a result, portability is not "an extraneous
factor" and commercial success related to that feature is relevant to nonobviousness.
Plaintiff has established a prima facie case of nexus by virtue of the FEBSS sales figures,
which, while minimal absent market share context, are for sales of the claimed invention. There
is also evidence of commercial desirability of the entire system. Defendant fails to rebut the
prima facie presumption of nexus.
2. Long-Felt Need
Evidence of a long-felt but unresolved need shows nonobviousness because it is
reasonable to infer the need would not have persisted had the solution been obvious. Plaintiff
argues that while prior art devices addressed the need for more realistic hemorrhage control
training, no prior trauma training system allowed a hemorrhage in a live action training scenario
as is possible with the patented device's particular arrangement of components including the
controller, pump, valve, and wound site(s). Stevick opines that there was a long-felt need for a
powered bleeding simulation system that was portable and concealable and which could be worn
57 - OPINION & ORDER

by a trainer patient to simulate traumatic hemorrhage on demand in a live action environment.
Stevick June 2015 Inv. Rep. ¶ 27, ECF 98-5.11
Stevick's opinion creates an issue of fact as to the long-felt but unresolved need satisfied
by the '852 Patent. Even without Stevick's testimony, however, the long-felt need for more
realistic trauma training is found in the prior art. E.g. '304 Niiranen Patent No. 2, 1:23-38, ECF
224-7 (stating that "[t]he existing methods for teaching early emergency casualty care, or first
aid, are unsatisfactory in the realism obtained by the simulation" and reciting problems with
existing methods as unsatisfactory in the realism obtained because (1) tags on subjects describing
wound type provided only minimal realism; (2) painted wound on subject increased realism but
provided inadequate simulation; and (3) moulages painted with wounds improved realism but
complete realism unobtainable without a flow of blood through open wounds). The prior art
attempted to address that need. E.g., id., 1:57-59 ("[a]n object of the invention is to provide
realistic simulation of injury whereby training in first aid is provided under conditions closely
analogous to actual injury"). Thus, the '304 Niiranen Patent No. 2, issued in 1960, along with the
'579 Niiranen Patent No.1, issued in 1959, provided for a simulacrum containing an artificial
body member with simulated layers of skin and blood vessels along with a simulated blood
supply reservoir. Id., 1:39-42.

11

In a footnote, Defendant objects to Stevick's opinion on this issue, contending that
Stevick "lacks personal knowledge of the industry, is not qualified to make such a statement, and
is incompetent to testify as an expert in this regard." Def.'s Opp. 41 n.12, ECF 234. I do not
consider this objection because it is conclusory and not developed enough for consideration.
Additionally, as noted previously, a witness may testify as an expert on invalidity issues under
Rule 702 if the witness's experience is "sufficiently related" to the pertinent art. No "sufficiently
related" argument about either party's expert has been made in connection with the summary
judgment motions.
58 - OPINION & ORDER

Defendant is correct that the prior art resolved the need for more realistic training
systems. E.g., the Niiranen patents, the SABAS Device. However, the record also lacks a prior
art device that increased the realism through use of a collection of components as disclosed in
Claim 18 of the '852 Patent which allows, as Plaintiff notes, for on-demand hemorrhage
simulation in a live action environment using backpacks, mannequins, etc. Accordingly, Plaintiff
produces evidence of long-felt but unmet need.
3. Failure of Others
Failure of others to find a solution to the problem is objective evidence of
nonobviousness. E.g., In re Cyclobenzaprine, 676 F.3d at 1080 ("evidence of a longfelt need for
an extended-release formulation and the failure of others to formulate one strongly support a
conclusion of nonobviousness"); see also Reiner v. I. Leon Co., 285 F.2d 501, 504 (2d. Cir.
1960) (Hand, J.) (The failure of others to create an invention while having the means to do so and
knowing of a need is evidence that the invention "demanded more intuition than was possessed
by the ordinary workers in the field.").
Guentzler contends that Kevin Sweeney, Simulaids's former president, was one of
ordinary skill in the art of trauma training devices and probably highly skilled in that art.
Guentzler July 21, 2015 Dep. 224:19, ECF 97-6. Given that Simulaids is in the business of
making simulation training aids for medical workers, it is reasonable to infer that Simulaids and
Sweeney would have recognized the need for increasingly realistic training systems and would be
motivated to improve upon their products. See Pro-Mold & Tool Co. v. Great Lake Plastics,
Inc., 75 F.3d 1568, 1573 (Fed. Cir. 1996) (court recognized "self-evident proposition that
mankind, in particular, inventors, strive to improve that which already exists"). Yet, even though
59 - OPINION & ORDER

Simulaids already made the SABAS and SH-CF Devices, it did not manufacture a device
equivalent to that disclosed in Claim 18 of the '852 Patent. This supports a finding of
nonobviousness.
4. Copying
Copying of the invention is evidence of nonobviousness. E.g., Crocs, Inc., 598 F.3d at
1311. Plaintiff notes that Defendant released its BPS in late 2011, after learning about King's
invention in 2010. Kit Lavell Sept 24, 2014 Dep.76:8-23, 80:17-18, ECF 129-11. This creates
an inference of copying.
5. Summary re: Objective Factors of Nonobviousness
Plaintiff has evidence of industry praise. It has minimal evidence of commercial success.
Plaintiff's evidence supports a finding of nexus. Defendant fails to rebut that finding. Plaintiff
has evidence of a failure of others, namely Simulaids, to create the device. Plaintiff raises an
inference of copying with the timing of Defendant learning of Plaintiff's device before releasing
its own. A juror, however, could reasonably conclude that the timing does not establish copying.
The record, when construed in Defendant's favor, suggests that prior art did address the
long-felt need to provide more realistic trauma training. However, when construed in Plaintiff's
favor, the record is capable of suggesting that the use and particular arrangement of the
components satisfied an unmet need for a more realistic hemorrhage simulator used to train first
responders that was sturdier, less expensive, and more flexible in its uses than previously existed
Overall, when viewed in Plaintiff's favor, the objective, secondary considerations of
nonobviousness support Plaintiff. But, when viewed in Defendant's favor, some of these
considerations do not show nonobviousness.
60 - OPINION & ORDER

E. Summary of Graham Factors
There are issues of fact as to whether the Zelenak Patent is analogous prior art, as to
whether the Zelenak Patent discloses a valve, as to the proper POSA, and as to some of the
secondary considerations of nonobviousness. These are to be resolved by the factfinder.
F. Motive to Combine
While motive to combine is not one of the four Graham factors, it is a relevant inquiry.
Though KSR held that "neither the particular motivation nor the avowed purpose of the patentee
controls," it also held that when determining whether there is an "apparent reason to combine the
known elements in the fashion claimed by the patent in suit[,]" a court should look at the
"interrelated teachings of multiple patents; the effects of demands known to the design
community or present in the marketplace; and the background knowledge possessed by a person
having ordinary skill in the art[.]" KSR, 550 U.S. at 418, 419.
As noted previously, the motivation inquiry is directed to the motive to select the
particular references, the motive to combine, and a reasonable expectation of success. WBIP,
829 F.3d at 1337 ("[w]hether a skilled artisan would be motivated to make a combination
includes whether he would select particular references in order to combine their elements"); In re
Cyclobenzaprine, 676 F.3d at 1068 ("party seeking to invalidate a patent as obvious must
demonstrate by clear and convincing evidence that a skilled artisan would have had reason to
combine the teaching of the prior art references to achieve the claimed invention and that the
skilled artisan would have had a reasonable expectation of success from doing so") (internal
quotation marks omitted). And, whether there is a reason or motive to combine prior art
references is a question of fact. In re Van Os, 844 F.3d at 1360.
61 - OPINION & ORDER

In its motion, Defendant posits three possible combinations of prior art references which
it argues invalidate Claim 18 of the '852 Patent as obvious. Def.'s Am. Mot. for Sum. J. 36-39,
42-43, ECF 227. In opposing Plaintiff's motion, Defendant adds four more. Def.'s Opp. 35-39,
ECF 234. Defendant's primary argument is that the combination of the SABAS and SH-CF
Devices would have been obvious to a POSA. Def.'s Am. Mot. for Sum. J. 36-39, ECF 227;
Def's Opp. 18-22, ECF 234. It also relies on the combination of either Niiranen Patent with the
SH-CF Device, the Zelenak Patent with the SH-CF Device, the combination of the SABAS and
SH-CF Devices with the '304 Niiranen Patent No. 2, and either Niiranen Patent combined with
the Zelenak Device. Def.'s Am. Mot. for Sum. J. 42-43, ECF 227; Def.'s Opp. 36-39, ECF 234.12
1. SABAS and SH-CF Devices
In support of the SABAS and SH-CF Device combination, Defendant argues that it was
"simple" and that the replacement of the storage tank of the SABAS Device with the collapsible
reservoir of the SH-CF Device was just a "simpl[e] . . . rearrangement of the old elements to
achieve the functions already known and achieved by these prior art devices." Def.'s Am. Mot.
for Sum. J. 36, ECF 227. Because the technical expertise required is minimal, there are no
engineering challenges. It is, Defendant suggests, as simple as cutting the tube from the rigid
tank in the SABAS Device and replacing it with the tube from the collapsible reservoir of the
SH-CF Device. Id. at 37 (citing to screen shot of Stevick's videotaped deposition when he
inserted the SH-CF Device reservoir tube into the SABAS Device pump inlet tube).
Guentzler opines that the combination of the SABAS and SH-CF Devices is
12

A fourth combination offered in opposition to Plaintiff's motion relies on the Sirhan
Patent. Def.'s Opp. 35-36, ECF 234. Given my conclusion that the Sirhan Patent is nonanalogous prior art, I do not consider that combination.
62 - OPINION & ORDER

"rudimentary." Guentzler Jan. 2015 Supp'l Inv. Rep. ¶ 37, ECF 210-3. He reviews the
components of each device, id. ¶¶ 38-46, and then offers this opinion:
The combination of the [SABAS Device] and the collapsible reservoir from the
[SH-CF Device] is shown in Exhibit 4 (with the collapsible reservoir filled with
simulated blood for contrast). The combination replaces the reservoir for
simulated blood of the [SABAS Device] with the collapsible reservoir of the [SHCF Device]. Simply, this combination would have been obvious to a person of
ordinary skill in the art.
Id. ¶ 47. He also provides a claim chart showing the elements of Claim 18 and each device's
corresponding structure for each element. Id. ¶ 48 & Ex. 5.
I agree with Plaintiff that Guentzler's testimony is conclusory and thus insufficient to
create an issue of fact regarding motive. But, the law does not require expert testimony to
establish obviousness. See Wyers, 616 F.3d at 1239 (Fed. Cir. 2010) ("KSR and our later cases
establish that the legal determination of obviousness may include recourse to logic, judgment,
and common sense, in lieu of expert testimony"). Defendant offers several rationales which it
contends support its motivation contention without expert testimony.
Defendant argues that motive is demonstrated because with all of the claimed elements
known in the prior art, one skilled in the art could have combined the elements by known
methods with no change in their respective functions, and the combination yielded nothing more
than predictable results to one of ordinary skill in the art. See KSR, 550 U.S. at 416 ("[W]hen a
patent claims a structure already known in the prior art that is altered by the mere substitution of
one element for another known in the field, the combination must do more than yield a
predictable result"). A reasonable juror could determine that at the time of the invention, a
POSA would have been motivated to make this combination by a desire to improve similar

63 - OPINION & ORDER

devices to satisfy the design and market need for more realistic, durable, cost effective trauma
training devices which could be used in the field for mass casualty live training simulations. See
KSR, 550 U.S. at 420 ("any need or problem known in the field of endeavor at the time of
invention and addressed by the patent can provide a reason for combining the elements in the
manner claimed"); at 421 (explaining that when there is a design need or market pressure to solve
a problem, and there are a finite number of identified, predictable solutions, a POSA has
motivation to "pursue the known options within his or her technical grasp" and if this leads to
anticipated success, it is likely not the product of innovation but of ordinary skill and common
sense); Tokai Corp., 632 F.3d at 1371 ("We have consistently stated that courts may find a
motivation to combine prior art references in the nature of the problem to be solved and this form
of motivation to combine evidence is particularly relevant with simpler mechanical
technologies") (internal quotation marks and brackets omitted).
The SABAS Device contains all of the components of the '852 Patent as claimed in Claim
18 except for a collapsible reservoir. The SH-CF Device contains all of the components of the
'852 Patent as claimed in Claim 18 except for a controller/activation mechanism. Both devices
are in the same field of endeavor as the '852 Patent. A reasonable juror could conclude that to
create more realistic trauma or hemorrhage control training simulations and to overcome the
problems in the prior art (e.g., motive created by design need and/or nature of the problem to be
solved), a POSA would have looked at devices in the same field of endeavor including those
with mechanical blood pumping systems, collapsible reservoirs, and moulages/wound sites.
Thus, a reasonable juror could find, even without expert testimony, a motive to choose these two
prior art devices and combine them.
64 - OPINION & ORDER

Plaintiff argues that a skilled artisan would not have relied on the SABAS Device as a
prior art reference because it had a five-gallon supply tank, a car battery, and a desk-sized
wooden crate housing the entire device. And, Plaintiff contends that given these features of the
SABAS Device, a skilled artisan would not have expected success in achieving an adaptable,
flexible, or portable training device simply by substituting the collapsible reservoir of the SH-CF
Device for the rigid tank of the SABAS Device. Plaintiff also argues that a POSA at the time of
the invention would not have been motivated to combine the SABAS and SH-CF Devices
because the combination would compromise the functionality of the SABAS Device. That
device has lengthy hoses and multiple moulages used to train up to six people simultaneously.
According to Stevick, the combination would provide an inadequate supply of simulated blood to
fill the hoses in the SABAS Device needed to function as a trauma training device for teaching
hemorrhage control. Stevick Aug. 2017 Supp'l Reb. Inv. Rep. 7, ECF 224-5. According to
Plaintiff, there is no evidence or logical explanation to show why a POSA would abandon the
SABAS Device's functionality in order to combine it with the tiny reservoir of the SH-CF to
arrive at an inoperable device.
The CAFC has affirmed a determination of nonobviousness when the alleged
combination would have destroyed a basic objective of how the prior art reference would have
functioned. E.g., Trivascular, Inc. v. Samuels, 812 F.3d 1056, 1068 (Fed. Cir. 2016). The court
has recognized, however, that although "[t]he fact that features of one reference cannot be
substituted into the structure of a second reference may indicate that the claims were nonobvious
in view of the combined teachings of the two references," that is not necessarily always the case.
Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1013 (Fed. Cir. 1983). There, the court
65 - OPINION & ORDER

explained that "[c]laims may be obvious in view of a combination of references, even if the
features of one reference cannot be substituted physically into the structure of the other
reference." Id. The court recognized the "distinction between trying to physically combine the
two separate apparatus disclosed in two prior art references on the one hand, and on the other
hand trying to learn enough from the disclosures of the two references to render obvious the
claims in suit." Id. (further recognizing that a technological incompatibility that prevented the
combination could be "telling on the issue of nonobviousness" but the lack of economic
feasability resulting from the combination would not).
Other cases have explained that "[t]o justify combining reference teachings in support of
a rejection it is not necessary that a device shown in one reference can be physically inserted into
the device shown in the other." In re Keller, 642 F.2d 413, 425 (C.C.P.A. 1981). Instead, "the
test is what the combined teachings of the references would have suggested to those of ordinary
skill in the art." Id.; see also Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1076 (Fed. Cir. 2015)
("[a] reference must be considered for everything it teaches by way of technology and is not
limited to the particular invention it is describing and attempting to protect") (internal quotation
marks omitted); In re Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983) (rejecting argument that a
prior art reference should not be considered "because it deals with collapsible hose rather than
flexible plastic pipe and teaches that rolling 600 feet of 4 inch, noncollapsible hose into a
transportable bundle is virtually 'an insurmountable task'" because "it is not necessary that the
inventions of the references be physically combinable to render obvious the invention under
review.").
Under the caselaw, the fact that the SH-CF collapsible reservoir may be insufficient to
66 - OPINION & ORDER

supply the blood needed for the SABAS Device does not necessarily undermine a POSA's motive
to combine them. The feasability, or lack thereof, of the proposed combination is not controlling.
The issue is what a POSA would have learned at the time of the invention from each of the
references and what the combination would have suggested. Here, reasonable minds could differ
as to whether a POSA, under either party's proposed definition, would rely on the SABAS
Device as a prior art reference in an effort to address the problem to be solved, or would have
expected a likelihood of success. Reasonable minds could also differ as to whether a POSA
would be motivated to combine the two devices even assuming that the combination may impede
the functioning of the SABAS Device.
As to whether the combination yielded nothing more than a predictable result, Defendant
argues that making a device more "portable" is not "inventive." Defendant relies on a 1952 case
which held that the "elements must cooperate in such a manner as to produce a new, unobvious,
and unexpected result." Application of Lindberg, 194 F.2d 732, 736 (C.C.P.A. 1952). The
combination "must amount to an invention." Id. As part of its discussion, the court indicated
that the portability or movability of a claimed device is not sufficient by itself to patentably
distinguish it over prior art unless there are new or unexpected results. Id. at 735; see also
Gardner v. TEC Sys., Inc., 725 F.2d 1338, 1345-46 (Fed. Cir. 1984) (discussing whether an air
bag with dimensions claimed in the patent performed any differently than an air bag with
different dimensions disclosed in the prior art and holding that absent distinct performance, the
dimensional recitation in the claim limitation did not serve to distinguish the prior art in a
significant way); In re Huang, 100 F.3d at 138, 139 (modification of prior art reference may
result in "great improvement and utility over the prior art, [but] it may still not be patentable if
67 - OPINION & ORDER

the modification was within the capabilities of one skilled in the art," unless the claim produces a
"new and unexpected result which is different in kind and not merely in degree from the results
of the prior art") (internal quotation marks omitted).
Defendant's assertion that portability cannot be an innovative feature overstates the
caselaw. Instead, a combination of prior art elements is patentable even if portability is the
distinguishing feature over the prior art but only if the new combination in the claimed invention
creates a new and unexpected result. Thus, the question is whether the combination of prior art
yields anything more than predictable results to one of ordinary skill in the art. Guentzler opines
that the combination of claim elements in Claim 18 does not produce unexpected results.
Guentzler Jan. 2015 Supp'l Inv. Rep. ¶ 76, ECF 210-3 (stating that the elements, "when
combined, produce exactly the results a person of ordinary skill in the art would expect: a device
that pumps simulated blood to a simulated wound to simulate trauma"). In my review of the
record, I do not find an argument or opinion by Plaintiff directly addressing the "predictable" or
"unexpected result" issue.13 Nonetheless, based on what is in the record, it is arguable that the
"inventive contribution" present in Claim 18 is the flexibility and adaptability of the disclosed
system which a POSA would not have expected from combining the SABAS and SH-CF
Devices.
13

I have spent considerable time reviewing the record, but it is extensive, comprising
nearly 300 pages of briefing in the current cross-motions, numerous expert reports, and dozens of
exhibits. It is possible I overlooked Plaintiff's discussion of this issue. I note that Stevick
challenges Guentzler's opinion that the combination did not produce unexpected results. But,
Stevick states only that Guentzler's opinion is based on circular, and thus unconvincing,
argument. Stevick June 2015 Inv. Rep. ¶ 33, ECF 98-5; Stevick Aug. 2017 Supp'l Reb. Inv. Rep.
at 10 (quoting June 2015 Report), ECF 224-5. Other than this, I do not see that Stevick
affirmatively opines as to why or how the combination of the SABAS and SH-CF Devices
produces a new, unpredictable, or unexpected result.
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There are issues of fact regarding motive to combine the SABAS and SH-CF Devices
given the reasonable but contrary inferences as to whether either party's proposed POSA would
rely on the SABAS Device as a prior art reference, would have expected a likelihood of success,
would have been deterred by the lack of functionality of the combination, and as to whether the
combination yielded a novel, unexpected result.
2. Other Proposed Combinations
All of Defendant's other proposed combinations rely on similar arguments which do not
warrant extensive, separate discussion. Generally, Defendant asserts that any combination of the
SABAS and/or either Niiranen Patent with the SH-CF and/or the Zelenak Patent would have
been obvious for the same reasons discussed above. Plaintiff raises similar arguments, including
that combining either Niiranen patented device with a collapsible reservoir would not have
produced an operational system and that a POSA would not have been motivated to look to the
Zelenak Patent as prior art because it is unrelated to trauma training and it lacks a wound site.
Plaintiff also argues that combining the Zelenak Patent with the SH-CF Device does not create a
trauma training device due to the use of a gravity switch in the Zelenak device. See Stevick Aug.
15, 2017 Supp'l Reb. Inv. Rep. 17-18, ECF 224-5. For the reasons discussed in the previous
section, there are issues of fact regarding the motive to combine.
G. Summary re: Graham Factors & Motivation to Combine
Obviousness is a conclusion of law based on the underlying Graham factors considered
with the motive to combine. In considering Plaintiff's motion for summary judgment, I construe
all inferences of material fact in favor of Defendant. Thus, I assume (1) the Zelenak Patent is
analogous prior art; (2) the Zelenak Patent has a valve; (3) a POSA is "a person having
69 - OPINION & ORDER

familiarity with the appearance and treatment of trauma conditions, and a basic understanding of
electrical and mechanical systems"; (4) combinations of various prior art devices would be
functional; (5) there is no evidence of copying and other evidence of secondary considerations is
present but commercial success sales figures without market share are weak; and (6) given the
resolution of these factual disputes in Defendant's favor, this POSA would have been motivated
to combine the SABAS Device with the SH-CF or the Zelenak Patent by a desire to satisfy the
design and market need for more realistic, cost effective trauma training devices which are
durable and suitable for mass casualty live training simulations.
A person having familiarity with the appearance and treatment of trauma conditions, and
a basic understanding of electrical and mechanical systems (Defendant's proposed POSA), would
have had knowledge of the analogous prior art devices, including the Zelenak Patent, and would
have been motivated to combine the prior art devices because of the design need and pressure
from the military market. In order to improve upon the prior art and create a more dynamic and
realistic trauma training system that was flexible, adaptable, cost-effective, and suited to live
action mass casualty simulations, this POSA would have looked for devices that included a
mechanized liquid supply, moulages or wound sites with multiple lines, a collapsible reservoir,
and were relatively small in size - in other words, the prior art relied on by Defendant. The
combination would not have changed the respective functions of the prior art components. The
combination produced a trauma training device consistent with the limiting preamble to Claim
18. The result was predictable because using a collapsible reservoir with a system that already
disclosed a mechanical blood pumping system (with pump, valve, and controller) and a wound
site, would predictably produce a system that was capable of simulating a more realistic and
70 - OPINION & ORDER

dynamic hemorrhage simulation because it would have been more flexible, adaptable, and
portable. Thus, construing the disputed inferences in Defendant's favor, Plaintiff's motion for
summary judgment on obviousness must be denied.
Considering Defendant's motion, I construe the inferences in Plaintiff's favor. Thus, I
assume: (1) the Zelenak Patent is not analogous prior art; (2) the combination of the SABAS and
SH-CF Devices would not have been functional; (3) the combination of the either of the Niiranen
patents with a collapsible reservoir from the SH-CF device would not have functioned given the
compressed air/gas method disclosed in the Niiranen patents; (4) a POSA is a "person possessing
at least an emergency medical technician (EMT) certificate and high school degree (or similar
educational background) with a year of hands on experience in EMT training or similar work
history"; (5) there is evidence of copying along with evidence of other secondary conditions of
nonobviousness; and (6) given the resolution of these factual disputes in Plaintiff's favor, this
POSA would have had little or no motive to combine the prior art devices because with less
knowledge of mechanical and electrical systems, the relevance of the SABAS Device would have
been diminished due to its size, and the functional obstacles to the combinations would have
deterred consideration of them. This POSA, starting with prior art of the SABAS and SH-CF
Devices and the Niiranen patents, would not have thought to combine them. This POSA would
not have been motivated to choose these particular prior art references and would not have
expected a likelihood of success by combining them. Additionally, given that the Zelenak Patent
is the only prior art reference to teach a portable mechanical fluid supply system, its omission as
analogous prior art would deprive this POSA of a key reference. Thus, even in the presence of
market or design need, this POSA would not have been motivated to combine the prior art
71 - OPINION & ORDER

references in ways suggested by Defendant.
A person possessing at least an emergency medical technician (EMT) certificate and high
school degree (or similar educational background) with a year of hands on experience in EMT
training or similar work history" (Plaintiff's proposed POSA), at the time of the invention would
have had knowledge of the analogous prior art devices but would not have been motivated to
combine the prior art devices given the differences between the claims and the prior art and given
the functional impairments produced by the combinations. Considering the evidence in
Plaintiff's favor, the prior art devices did not teach the particular combination of components that
allowed for the flexible, portable, and adaptable system claimed in Claim 18. In this light, it
could be concluded that the patent claims at issue represent a device beyond this POSA's
technical knowledge and would not have been obvious at the time of the invention. Thus, when
all inferences are construed in Plaintiff's favor and with the recognition of Defendant's burden
being one of clear and convincing evidence, Defendant's motion on the issue of obviousness is
denied.14
UNENFORCEABILTY- INEQUITABLE CONDUCT
Both parties move for summary judgment on Defendant's affirmative defense of
inequitable conduct in which Defendant asserts Plaintiff failed to disclose three material prior art
references to the PTO while prosecuting the '852 Patent. This Court has addressed the issue
previously, but in the distinct context of an attorney's fee motion filed by Defendant after I
granted summary judgment to Defendant in 2015. Skedco, Inc. v. Strategic Ops., Inc., No. 3:13-

14

Given my rulings, I do not separately consider Claims 19 or 20 and I do not consider
Plaintiff's objections to the SABAS Device as prior art at this time.
72 - OPINION & ORDER

cv-00968-HZ, 2016 WL 8678445 (D. Or. Apr. 1, 2016) (denying Defendant's motion for
attorney's fees and granting in part Defendant's request for costs). Neither party has contended
that my previous determination on the issue is binding here. Thus, I consider the issue anew.
I. Facts
In August 2010, the PTO issued a "Final Office Action" regarding the prosecution of
Patent Application No. 11/759,891 ("the '891 Application") which was a continuation-in-part of a
prior patent application, Patent Application No. 11/729,064 filed on April 23, 2007, which
eventually issued as U.S. Patent No. 7, 887,330 ("the '330 Patent") on February 15, 2011. See
Eastman Oct. 2, 2017 Decl., Ex. 14, ECF 212-4 (copy of the '891 Application); Ex. 15, ECF 2125 (prosecution history for the '891 Application); Id., Ex. 9, ECF 211-9 (copy of the '330 Patent).
This Final Office Action rejected several claims of the '891 Application, finding them
anticipated under 35 U.S.C. § 102(e) by Bardsley, one of the three prior art references at issue
here. Id., Ex. 15 at 16-19, ECF 212-5. The "Detailed Action" section of the Final Office Action
does not mention the two other prior art references at issue, which are the two Niiranen patents,
but in the Conclusion section, the patent examiner noted that the two Niiranen patents as well as
other prior art references all disclose mannequin forms having a pump, reservoir, conduit,
controller, and sleeve simulating skin located in a common housing. Id., Ex. 15 at 20, ECF 2125. The '330 Patent, the '852 Patent, and the '891 Application (which was abandoned in December
2011), are in the same family of patent applications with King as the inventor. See Eastman Oct.
2, 2017 Decl., Ex. 9, ECF 211-9; Ex. 14, ECF 212-4; Ex. 15, ECF 212-5; Ex 16, 212-6
(prosecution history for the '852 Patent).
The '852 Patent began with a nonprovisional application on January 19, 2011,
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Application No. 13/009,665. There appears to be no dispute that during the prosecution of the
'665 Application, the three prior art references (Bardsley and the two Niiranen patents) were not
disclosed to the patent examiner.
II. Legal Standards
Relevant regulations impose a duty of candor to the PTO on each named inventor, each
attorney or agent that prepares or prosecutes the application, and every other person who is
substantively involved in the preparation or prosecution of the application and who is associated
with the inventor or assignee. 37 C.F.R. § 1.56. Nondisclosure of information to the PTO can
support a finding of inequitable conduct which in turn can render an entire patent unenforceable.
Therasense, Inc. v. Becton, Dickinson & Co., 649 F.2d 1276, 1287, 1288 (Fed. Cir. 2011) (en
banc) (explaining that the inequitable conduct doctrine evolved to include not only affirmative
acts of misconduct before the PTO and the courts, but also the nondisclosure of information to
the PTO; noting that the remedy for inequitable conduct as to any single claim renders the entire
patent unenforceable and referring to such remedy as the "atomic bomb of patent law.").
"To prevail on a claim of inequitable conduct, the accused infringer must prove that the
patentee acted with the specific intent to deceive the PTO." Id. at 1290. With nondisclosures of
information, "clear and convincing evidence must show that the applicant made a deliberate
decision to withhold a known material reference." Id. (internal quotation marks omitted). That
is, the "accused infringer must prove by clear and convincing evidence that the applicant knew of
the reference, knew that it was material, and made a deliberate decision to withhold it." Id.
Intent and materiality are separate requirements and each must be established by clear and
convincing evidence. Id. The court may not use a "sliding scale" in its analysis. Id.
74 - OPINION & ORDER

A. Intent
In cases of omission, direct evidence of a deliberate intent to deceive is rare and thus,
indirect and circumstantial evidence may be considered. Id. Nonetheless, the evidence "must be
sufficient to require a finding of deceitful intent in the light of all the circumstances." Id.
(internal quotation marks omitted). The court may not infer intent solely from materiality. Id.
And, "[p]roving that the applicant knew of a reference, should have known of its materiality, and
decided not to submit it to the PTO does not prove specific intent to deceive." Id.
Importantly, "to meet the clear and convincing evidence standard, the specific intent to
deceive must be the single most reasonable inference able to be drawn from the evidence." Id.
(internal quotation marks omitted). Thus, "when there are multiple reasonable inferences that
may be drawn, intent to deceive cannot be found." Id. at 1290-91.
B. Materiality
Under Therasense, a "but-for materiality" is required, meaning Defendant has to show by
clear and convincing evidence that the PTO would not have allowed a claim had it been aware of
the undisclosed information. Id. at 1291.15 The relevant question is "whether the PTO would
have allowed the claim if it had been aware of the undisclosed reference." Id. In making this
15

The Therasense court also noted that while ordinarily, "but-for materiality must be
proved to satisfy the materiality prong of inequitable conduct," in cases of affirmative acts of
egregious misconduct, "such as the filing of an unmistakably false affidavit, the misconduct is
material." 649 F.3d at 1292. Defendant suggests that this standard applies here. I reject the
invitation. Defendant cites no cases extending this standard to cases of omission and I find no
basis for applying it to inequitable conduct arguments based solely on omissions. See Everlight
Elecs. Co., Ltd. v. Nichia Corp., 143 F. Supp. 3d 644, 658 (E.D. Mich. 2015) (the "per-se
materiality" standard applies upon the showing of a false affidavit or declaration but the "but-for
materiality" standard is used with withheld information), aff'd, Nos. 2016-1577, 2016-1611, 2018
WL 286119 (Fed. Cir. Jan. 4, 2018) (affirming district court's conclusion of no inequitable
conduct without reaching issue of materiality).
75 - OPINION & ORDER

patentability determination, the court applies the preponderance of the evidence standard and
gives claims their broadest possible construction. Id. at 1291-92; Ohio Willow Wood Co. v. Alps
S., LLC, 735 F.3d 1333, 1345 (Fed. Cir. 2013) ("Because the analysis of this but-for materiality
requirement is from the perspective of the PTO, we apply the preponderance of the evidence
standard in assessing whether the withheld or misrepresented information would have blocked
patentability").15
III. Discussion
A. Intent
As I stated in the April 1, 2016 attorney fee opinion, given the timing of the August 2010
PTO action citing the three prior art references as invalidating prior art on a related patent and the
application of the '852 Patent coming just five months later, "the facts allow for an inference that
King or patent prosecution counsel George Metzenthin had some incentive to deliberately omit
the references in the prosecution of the '852 Patent[.]" Skedco, Inc., 2016 WL 8678445, at *12.
(D. Or. Apr. 1, 2016). In the context of the attorney fee motion, Plaintiff relied on Metzenthin's
Declaration to argue that the failure to include the three references in the '852 Patent application
was oversight. With that, I concluded that Metzenthin's statements raised an inference of
"negligence or even gross negligence, but not a specific intent to deceive." Id. As a result,
15

The parties do not address the preponderance of evidence standard. At least one court
has recently expressed confusion in applying this standard in the context of analyzing an alleged
infringer's allegation of material misrepresentation. Barry v. Medtronic, Inc., 245 F. Supp. 3d
793, 802-03 (E.D. Tex. 2017) (discussing CAFC cases on "but for materiality" and noting that it
was "less clear" "how, and to which aspect of the issue, the different standards of proof are to be
applied when a Defendant alleges that there was a material misrepresentation" and remarking that
"this court must admit to some uncertainty as to exactly which aspects of the inquiry the
preponderance of the evidence standard is to be applied"), appeal filed, No. 17-2463 (Fed. Cir.
Aug. 23, 2017).
76 - OPINION & ORDER

because there were multiple inferences, Defendant could not establish deceptive intent in support
of an attorney's fee award based on inequitable conduct. Id.
Here, Plaintiff again relies on Metzenthin's Declaration in which he recalls being
involved in the prosecution of the '665 Application which became the '852 Patent, and the earlier
'891 Application. Metzenthin Decl. ¶ 4, ECF 128. He states that before the allegations of
inequitable conduct, he was unaware of references in the '891 Application that were not cited in
the '665 Application. Id. ¶ 6. He explains that the omission of references from the '891
Application which were cited in the '665 Application was inadvertent on his part and "certainly
not intentional." Id. ¶ 7. Elizabeth Arwine, the Chief Patent Attorney for the United States
Army Medical Research and Materiel Command, declares that she oversees patent applications
owned by the Army, and oversaw those for the '891 Application and the '665 Application.
Arwine Decl. ¶ 2, ECF 225. She retained outside counsel Cahn & Samuels to prepare and
prosecute both applications. Id. ¶ 3. She makes the same assertions as Metzenthin: before these
allegations, she was unaware of any failure to cross-cite the references between the two
applications and any failure to disclose references in connection with the '665 Application was
inadvertent and not intentional. Id. ¶¶ 5, 6. Finally, Corey Mack, who was an associate at Cahn
& Samuels during the relevant time, was involved in the prosecution of the two applications and
makes the same statements: before these allegations, he was unaware of any failure to cross-cite
the references between the two applications and any such failure to disclose references to the
PTO in connection with the '665 Application was inadvertent and not intentional. Mack Decl. ¶¶
2, 3, 5, 6, ECF 226.
Defendant argues that there is no reasonable explanation to justify the withholding of the
77 - OPINION & ORDER

Niiranen patents and the Bardsley Application from the PTO during the prosecution of the '852
Patent other than to specifically deceive the PTO. Defendant observes that the same family of
patents is involved, King is the inventor, and Cahn & Samuels, LLP was King's representative.
The attorneys knew of the prior art, knew the prior art was material, and yet failed to cite to these
prior art references during the prosecution of the '852 Patent. Defendant characterizes this as
"blatant withholding" resulting in a violation of the duty of candor. Def.'s Am. Mot. for Sum. J.
50, ECF 227.
Defendant contends that the only reasonable inference from the facts is that the omission
of the key references was deliberate. Additionally, Defendant argues that deliberate collusion to
withhold material references is demonstrated by the fact that three separate patent practitioners
failed to cite to the references. Furthermore, Defendant argues that the Court cannot overlook the
clear bias and motivation for patent prosecution counsels' submission of affidavits admitting
negligence.
In support, Defendant cites to a 2014 CAFC case which affirmed a district court finding
of inequitable conduct based on the withholding of a material prior art reference. Am. Calcar,
Inc. v. Am. Honda Motor Co., Inc., 768 F.3d 1185 (Fed. Cir. 2014). There, although the inventor
had provided a limited disclosure of the prior art navigation system, the disclosure excluded
material information and details about the system which, according to the defendant, were those
that were claimed in the patents in suit. Id. at 1188, 1190-91.
In its decision, the district court found that the inventor was "constantly feeding"
information to his patent attorney but did not give the attorney information about the operational
details of the prior art navigation system, did not tell the attorney about his personal experience
78 - OPINION & ORDER

with the system, did not give the attorney a copy of the navigation system manual which he
possessed, and failed to provide the attorney with relevant photos of the navigation system
display screens. Am. Calcar, Inc. v. Am. Honda Motor Co., Inc., No. 06cv2433 DMS (KSC),
2012 WL 1328640, at *10 (S.D. Cal. Apr. 17, 2012). The court found that the only reasonable
inference to be drawn from these facts was that the inventor made a deliberate decision to
withhold that information from his patent attorney and the PTO. Id.
The district court then explained why an inference of negligence was not reasonable. Id.
It rejected the idea that the failure to disclose the navigation system details was a mistake or
accident. That the inventor "disclosed some information about the system and withheld other
information demonstrates a deliberative process, not an accident or a mistake." Id. Finally, the
court found that the inventor's interactions with his counsel refuted an inference of negligence or
gross negligence because the evidence showed that the inventor "had ample time and
opportunity" to provide the information to his patent counsel and "took advantage of both to send
'waves' of information, but he never sent the operational details of the [] navigation system." Id.
Thus, it was not reasonable to infer either negligence or gross negligence. Id. As indicated
above, the CAFC affirmed the district court's conclusion. 768 F.3d at 1190-91.
I agree with Defendant that with an omission, it must rely on circumstantial evidence.
And I agree that affidavits or declarations by patent counsel are fairly characterized as selfserving. Nonetheless, the facts in American Calcar are distinguishable. Here, there is no
evidence that the inventor withheld any information from patent counsel. There is no
information that patent counsel withheld any prior art in other applications or disclosures.
Importantly, the evidence relied on by the district court in American Calcar to support its finding
79 - OPINION & ORDER

that the inventor did not act negligently or recklessly was that the inventor provided the prior art
reference in support of the prosecution of the patent but omitted the key details which formed the
basis of the claimed invention. Here, with a wholesale failure to cite to the prior art reference,
deliberate conduct is not the only inference created.
Deliberate intent to deceive is one reasonable inference. But, another reasonable
inference is that patent counsel acted negligently or recklessly. When the evidence is considered
in a light most favorable to Plaintiff, a reasonable factfinder could conclude that negligence or
recklessness is an equally reasonable explanation for counsel's failure to cite to the prior art
references and thus, because deceitful intent is not the single most reasonable inference,
Defendant does not meet its burden to establish inequitable conduct. Viewing the evidence in a
light most favorable to Defendant, however, I deny Plaintiff's motion on this issue. A reasonable
factfinder could conclude that the single most reasonable inference from the evidence is that
patent counsel acted with a deliberate intent to deceive the PTO. Even though the evidence
allows for an inference of a lesser mens rea, reasonable minds could conclude that deceit is the
single most reasonable inference. As a result, there is an issue of fact regarding intent to deceive.
B. Materiality
Defendant argues that the facts conclusively establish that the PTO would not have
allowed the '852 Patent to issue had it known of the undisclosed Bardsley Application and the
Niiranen patents. As noted above, all three references were noted by the PTO in its Final Office
Action on the '891 Application. Several claims of the '891 Application were rejected as
anticipated by Bardsley. And, the patent examiner stated that the Niiranen patents disclosed
mannequin forms having a pump, reservoir, conduit, controller, and sleeve simulating skin
80 - OPINION & ORDER

located in a common housing. Id. Patent prosecution counsel knew about the references as well.
Guentzler opines that the Bardsley Application discloses all of the limitations of Claim 18 of the
'852 Patent. Guentzler July 13, 2015 Supp'l Inv. Rep. ¶¶ 20-37, ECF 219-5.
Plaintiff argues that but-for materiality is not shown because (1) the government
subsequently disclosed all three references to the PTO in connection with two other related
patent applications and both times the PTO found no grounds to reject the related application
based on those references; and (2) the three references are cumulative of prior art that was
disclosed in the '852 Patent Application and thus, the three references are not material. See
Impax Labs., Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1374 (Fed. Cir. 2006) ("Information is
material to patentability when it is not cumulative to information already of record or being made
of record in the application[.]"); Mentor Graphics Corp. v. EVE-USA, Inc., 13 F. Supp. 3d 1116,
1123 (D. Or. 2014) (party asserting "inequitable conduct must explain why the withheld
information is material and not cumulative and how an examiner would have used this
information in assessing the patentability of the claims.") (internal quotation marks omitted).
Osram Sylvania, Inc. v. Am. Induction Techs., Inc., No. CV 09-8748-R, 2011 WL 5143630, at
*11 (C.D. Cal. Oct. 28, 2011) ("Information is cumulative if it teaches no more than what a
reasonable examiner would consider to be taught by the prior art already of record before the
PTO") (citing Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1574–75 (Fed. Cir.
1997)).
Plaintiff's counsel Nathan Brunette explains that United States Patent Application No.
15/155,312 ("the '312 Application") was filed on May 16, 2016 and is a continuation of United
States Patent Application No. 13/683,348 ("the '348 Application"), which is a continuation of the
81 - OPINION & ORDER

application that led to the '852 Patent. Brunette Oct. 2, 2017 Decl. ¶ 10, ECF 224. The '348
Patent was granted as United States Patent No. 9,342,996 ("the '996 Patent"). Id. The '312
Application is the "grandchild" of the '852 Patent. Id. It has claims similar in scope to the '852
Patent. Id.
In prosecuting the '348 Application, the Army, owner of the '852 Patent, disclosed to the
PTO all patent invalidity and unenforceability arguments asserted by Defendant in its 2015
summary judgment briefs. Oct. 6, 2015 Notice of Supp'l Auth., ECF 134; see also id., Ex. 1 at 8,
9, 19-21 (PTO Office Action regarding the '348 Application, including copies of Information
Disclosure Statements filed in August and September 2015). The Army also disclosed all
references asserted by Defendant in this litigation as prior art, including the two Niiranen patents,
a Bardsley patent, and a Bardsley patent application publication. Id.; see also id. at Exs. 1, 2.
The PTO rejected various claims of the '348 Application "on the ground of nonstatutory double
patenting as being unpatentable over claims 1-20 of [the '852 Patent] in view of claims 1-8 of
[the '330 Patent]." Id., Ex. 1 at 3-6.16
In prosecuting the '312 Application, the three prior art references at issue in the
inequitable conduct affirmative defense were disclosed to the PTO. Brunette Oct. 2, 2017 Decl.
Ex. 9 at 17-18, ECF 224-9. In a June 2017 Office Action, the PTO rejected claims 1-18 "on the
16

"Double patenting" "precludes one person from obtaining more than one valid patent
for either (1) the same invention, or (2) an obvious modification of the same invention." R.
Harmon, et al., Patents & the Fed. Circuit 1350-51 (11th ed. 2013). The doctrine "polices the
proper application of the patent term for each invention." Id. at 1351. Statutory double patenting
is based on statutory language requiring "'a patent' for any new and useful invention." Id. (citing
§ 101 of the Patent Act). "Non-statutory, or 'obviousness-type' double patenting is a judicially
created doctrine adopted to prevent claims in separate applications or patents that do not recite
the 'same' invention, but nonetheless claim inventions so alike that granting both exclusive rights
would effectively extend the life of patent protection." Id.
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ground of nonstatutory double patenting as being unpatentable over claims 1-22 of [the '996
Patent]." Id. at 5.
Plaintiff argues that because it disclosed the three prior art references in the '348
Application and in the '312 Application, and because the PTO did not rely on these prior art
references in subsequently invalidating these applications for a device similar to that in the '852
Patent, Defendant cannot meet its burden of establishing that the PTO would have disallowed the
'852 Patent if the references had been disclosed.
Next, as to its cumulative argument, Plaintiff cited to the following prior art references in
prosecuting the '852 Patent: (1) United States Patent No. 3,027,655 ("Alderson"); (2) United
States Patent No. 6,790,043 ("Aboud"); and (3) an application published under the "Patent
Cooperation Treaty" bearing PCT International Publication No. WO 96/42076 which is titled
"Anatomical Simulator for Videoendoscopic Surgical Training." Brunette Oct. 2, 2017 Decl.,
Ex. 12, ECF 224-12 (Alderson); Ex. 13, ECF 224-13 (Aboud); Ex. 14, ECF 224-14 (PCT
Publication); see also '852 Patent at 1, 2 (citing the three references). Plaintiff argues that these
references are cumulative to the prior art disclosed in prosecuting the '852 Patent because the
three prior references disclose (1) a bleeding simulator including the following: pump, valve,
controller, wound site, and rigid hard-walled reservoir similar to the Niiranen patents and
SABAS Device (Alderson); (2) a cadaveric surgical training system with flexible reservoir,
valve, and compressed air fluid pressurization system similar to Bardsley (Aboud); and (3) a
surgical trainer including pump, valve, wound site, and rigid tray as reservoir, similar to the
Niiranen patents and SABAS Device (PCT Int'l Pub. No. WO 96/42076).
When examining the evidence in a light most favorable to Plaintiff, I cannot determine on
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summary judgment that the Bardsley reference or the two Niiranen patents, considered separately
or collectively, are not material under the but-for materiality standard. First, the PTO's rejection
of the '891 Application due to Bardsley, and its citation to the Niiranen patents, is relevant
information but it may not be dispositive of the references' materiality to the '852 Patent. E.g.,
Dayco Prods., Inc. v. Total Containment, Inc., 329 F.3d 1358, 1362-69 (Fed. Cir. 2003) (prior art
reference was omitted from application for patents-in-suit but was relied on by different
examiner to invalidate family of applications related to application for patents-in-suit; court
noted that the "mere fact" that the examiner of the family of applications relied on the prior art
reference was "informative, but not dispositive" of materiality to the patents-in-suit). Second, a
factfinder could determine that because the PTO did not expressly rely on these three prior art
references in later rejecting related applications in which the references were disclosed, the '852
Patent would also not have been rejected because of them. And third, because the three omitted
prior art references related to devices similar to those disclosed in the prosecution of the '852
Patent, a factfinder could reasonably determine that these three prior art references are
cumulative and therefore not material.
On the other hand, when viewing the evidence in a light most favorable to Defendant, an
inference of but-for materiality is reasonable. All three references were noted by the PTO in its
Final Office Action on the '891 Application, several claims of the '891 Application were rejected
as anticipated by Bardsley, and the '891 Application patent examiner noted that the Niiranen
patents disclosed mannequin forms having a pump, reservoir, conduit, controller, and sleeve
simulating skin located in a common housing. Id. Given that the '891 Patent Application is
similar to the '852 Patent, a factfinder could conclude that, just like the claims in the '891
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Application, the '852 Patent would not have issued if the three prior art references had been
disclosed.
Additionally, although the PTO did not expressly cite to the prior art references when
invalidating the subsequent applications which disclosed the references, without evidence as to
whether the PTO's practice is to set forth all possible bases for rejection (e.g. to multiple,
alternative bases for rejection) or to just one of several, a factfinder could determine that here, the
PTO cited to only one of possibly many bases for invalidating the subsequent patents and thus,
its failure to cite to these prior art references is not, in fact, probative of their lack of materiality
as to the '852 Patent. Based on these inferences, a reasonable factfinder could determine that the
omitted three prior art references meet the but-for materiality standard required to establish
inequitable conduct.
Moreover, while Plaintiff includes copies of the prior art references of Alderson, Aboud,
and the PCT International Publication in support of its cumulative argument, it offers only
conclusory argument and fails to assert particularities. E.g., Pl.'s Mot. for Sum. J. 41, ECF 223
("the three references are all cumulative of prior art that was disclosed in the '852 Patent's
application"; citing to exhibits and listing components); Pl.'s Reply 36, ECF 238 ("the three
references at issue were cumulative to other prior art references cited in the prosecution history of
the '852 Patent"); Pl.'s Opp. 42, ECF 233 ("all three references at issue all are cumulative of prior
art that was disclosed in the '852 patent's application"). Similarly, in support of its argument,
Defendant cites to the '891 Application, the Bardsley Application, and the abstract of the
Bardsley Application which total almost 400 pages, yet Defendant provides no particular page
cite to assist the Court in evaluating the evidence. E.g., Def.'s Am. Mot., ECF 227 45-46 (citing
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to Eastman Oct. 2, 2017 Decl., Exs. 15, 17, 18). Overall, the Court finds the materiality
arguments to be conclusory in nature and not particularly helpful to resolution on summary
judgment. As the Dayco court observed, "[w]hether Wilson [the reference omitted from the
patents-in-suit application but found to invalidate claims in a related family of applications]
meets the threshold level of materiality would require a detailed factual analysis of the relevance
of the teachings of that reference both with respect to the claims of the patents-in-suit and with
respect to the other prior art references that were before the examiner." Id. No such "detailed
factual analysis" is included in the summary judgment briefing.
Because, on the present record, reasonable factfinders could reach contrary conclusions
regarding materiality and intent, I deny both parties' motions as to inequitable conduct.
REMAINING ISSUES
I. Affirmative Defenses Other Than Obviousness & Inequitable Conduct
In its Answer to the Second Amended Complaint, Defendant asserts nineteen separate
affirmative defenses. Def.'s Ans. ¶¶ 26-44, ECF 19. The Ninth Affirmative Defense asserts that
one or more claims of the '852 Patent is invalid or void for failing to comply with one or more of
the conditions for patentability set forth in 35 U.S.C. §§ 101, 102, 103, and 112. Id. ¶ 34. The
only one of those raised in the summary judgment briefing is § 103 addressing obviousness. The
Sixteenth Affirmative Defense asserts that Plaintiff's claims are barred in whole or in part by
fraud on the PTO or by Plaintiff's inequitable conduct. Id. ¶ 41. Only Plaintiff's inequitable
conduct is raised in the summary judgment briefing.
Plaintiff moves for summary judgment on all other affirmative defenses (including those
asserted in the Ninth and Sixteenth Affirmative Defenses, meaning those based on §§ 101, 102,
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112, and fraud on the PTO, but not raised in the summary judgment motions). Defendant did not
move for summary judgment on any of these affirmative defenses and made no argument
supporting these defenses in its brief opposing Plaintiff's motion. During oral argument on the
summary judgment motions, I referred to all of the affirmative defenses, exclusive of
obviousness and inequitable conduct, as no longer being "alive." Tr. of Dec. 12, 2017 Oral Arg.
96, ECF 256. Defendant offered no contrary position to indicate that it was still relying on any
affirmative defense other than obviousness and inequitable conduct.
In view of Plaintiff's legal arguments and uncontested facts related to these affirmative
defenses, and Defendant's implicit concession that it is not asserting any of these affirmative
defenses, I grant Plaintiff's motion for summary judgment as to the following affirmative
defenses: (1) First Affirmative Defense - acquiescence; (2) Second Affirmative Defense - waiver;
(3) Third Affirmative Defense - consent; (4) Fourth Affirmative Defense - laches; (5) Fifth
Affirmative Defense - estoppel; (6) Sixth Affirmative Defense - unclean hands; (7) Seventh
Affirmative Defense - lack of right, title, or interest; (8) Eighth Affirmative Defense noninfringement; (9) portions of the Ninth Affirmative Defense - invalidity based on §§ 101,
102, or 112; (10) Tenth Affirmative Defense - innocent infringement; (11) Eleventh Affirmative
Defense - "no causation"; (12) Twelfth Affirmative Defense - failure to state a claim; (13)
Thirteenth Affirmative Defense - no irreparable harm; (14) Fourteenth Affirmative Defense adequate legal remedy; (15) Fifteenth Affirmative Defense - patent exhaustion, patent misuse,
first sale doctrine; (16) portion of the Sixteenth Affirmative Defense - fraud; (17) Seventeenth
Affirmative Defense - damages limited by §§ 286, 287; (18) Eighteenth Affirmative Defense failure to mitigate; and (19) Nineteenth Affirmative Defense - marking/notice under § 287.
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II. Evidentiary Objections
I have previously addressed Plaintiff's evidentiary objections to Guentzler's testimony
regarding the POSA. I also addressed Defendant's objection to Stevick's lack of post-CAFC
decision infringement opinions and his testimony about long-felt need.
Plaintiff also objects to almost 100 paragraphs17 over seven different expert reports
submitted by Guentzler as well as statements he made in another report. Pl.'s Opp. 45-46, ECF
233. Plaintiff argues that Guentzler inaccurately states the law in each of these paragraphs.
Plaintiff clarifies that it does not seek to strike testimony about how the accused products or prior
art devices function, but only to Guentzler's erroneous legal assertions regarding claim scope and
his conclusory applications of erroneous claim scope to the technical facts. Id. at 46 n.6.
I deny the motion to strike these objections as moot because none of Guentzler's legal
assertions impacted the resolution of the summary judgment motions.
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17

Many of the objections are to the same assertion by Guentzler, but just repeated in a
different report.
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CONCLUSION
Plaintiff's Motion for Partial Summary Judgment [223] is (1) granted as to literal
infringement, (2) denied as moot as to infringement under the doctrine of equivalents, (3) denied
as to obviousness; (4) denied as to inequitable conduct, and (5) granted as to all affirmative
defenses other than obviousness and inequitable conduct. Defendant's Amended Motion for
Summary Judgment [227] is denied as moot as to infringement under the doctrine of equivalents
and denied in all other respects. The parties' evidentiary objections/motions to strike are denied
or denied as moot.
IT IS SO ORDERED.
Dated this

day of

Marco A. Hernandez
United States District Judge

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, 2018