Baxter International, Inc. v. CareFusion Corporation et al
Filing
191
MEMORANDUM Opinion and Order signed by the Honorable Virginia M. Kendall on 4/29/2019. Status hearing set for 5/13/2019 at 9:00 AM. Mailed notice(lk, )
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
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)
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Plaintiff,
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v.
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CAREFUSION CORPORATION, and )
BECTON,
DICKINSON
and
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COMPANY,
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Defendants.
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BAXTER INTERNATIONAL, INC.,
No. 15 C 9986
Judge Virginia M. Kendall
MEMORANDUM OPINION AND ORDER
Plaintiff Baxter International, Inc. (“Baxter”) sued Defendants CareFusion
Corporation and Becton, Dickinson and Company (collectively “CareFusion”) for
infringement of United States Patent Nos. 5,782,805 (the “‘805 Patent’”) and
6,231,560 (the “’560 Patent”). The Court held a claims construction hearing, at which
time it heard evidence and argument regarding the various claims in dispute in the
‘805 and ‘560 Patents. The Court’s construction of these terms is set forth below.
BACKGROUND
The ‘805 and ‘560 Patents at issue are concerned with medical infusion pumps
which deliver medication to patients. The ‘805 Patent generally relates to a medical
infusion pump with a display area to facilitate the display of user interface
information. The ‘560 Patent relates to an infusion pump which collects patient
condition information and adjusts medication doses as needed to optimize treatment.
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Baxter asserts that Defendants have infringed on the Patents by engaging in the
manufacture, use, sale, and/or offer for sale of their own infusion system, the Alaris
System.
LEGAL STANDARD
Claim construction resolves disputed meanings in a patent to clarify and
explain what the claims cover. See Terlep v. Brinkmann Corp., 418 F.3d 1379, 1382
(Fed. Cir. 2005). The construction of the claims at issue is a legal determination to
be made by the court. See id. (citing Markman v. Westview Instruments, Inc., 52 F.3d
967, 970-71 (Fed. Cir. 1995)). Generally, the terms of a claim are given the ordinary
and customary meaning that the terms would have to a person of ordinary skill in
the art at the time of the filing date of the patent application. See Phillips v. AWH
Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005). When interpreting an asserted claim,
the court looks first to intrinsic evidence: the words of the claims, the patent
specification, and the prosecution history. See id. at 1316-18.
The claim language is the starting point for claim construction analysis
because it frames and ultimately resolves all issues of claim interpretation. See
Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Limited, 887 F.3d
1153, 1157-58 (Fed. Cir. 2018); Robotic Vision Sys., Inc. v. View Eng’g Inc., 189 F.3d
1370, 1375 (Fed. Cir. 1997). In some cases, the “ordinary and customary” meaning of
the claim language may be readily apparent, even to lay judges, and the court applies
the widely accepted meaning of the commonly understood words. See Phillips, 415
F.3d at 1314. In such cases, a general-purpose dictionary may be helpful. See id. In
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many cases, however, the court must proceed beyond the bare language of the claims
and examine the patent specification. See id. at 1314-15. “The person of ordinary
skill in the art is deemed to read the claim term not only in the context of the
particular claim in which the disputed term appears, but in the context of the entire
patent, including the specification.”
Id. at 1313.
The specification is usually
dispositive; “’it is the single best guide to the meaning of a disputed term.’” Id. at 1315
(quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996)).
In the specification, the patentee provides a written description of the invention that
allows a person of ordinary skill in the art to make and use the invention. See id. at
1323. At times, the patentee uses the specification to “set forth an explicit definition
for a claim term that could differ in scope from that which would be afforded by its
ordinary meaning.” Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1342 (Fed. Cir.
2001).
The court may also look to the patent’s prosecution history. See Phillips, 415
F.3d at 1317. While the prosecution history often lacks the clarity of and is less useful
than the specification, it may inform the court of the meaning of a claim term by
illustrating how the inventor understood the invention as well as how the inventor
may have limited the scope of the invention. See id. The prosecution history is
generally relevant if a particular interpretation of the claim was considered and
specifically disclaimed during the prosecution of the patent. See Schumer v. Lab.
Comp. Sys., 308 F.3d 1304, 1313 (Fed. Cir. 2002).
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Finally, a court may also consult “extrinsic evidence,” such as dictionaries,
treatises, and expert testimony, to “shed useful light on the relevant art.” Phillips,
415 F.3d at 1317-18.
Generally, extrinsic evidence is “less reliable” than intrinsic
evidence and is “unlikely to result in a reliable interpretation of patent claim scope
unless considered in the context of the intrinsic evidence.” Id. at 1318-19. With
respect to the use of dictionaries, technical or general, a court may consult such
evidence “so long as the dictionary definition does not contradict any definition found
in or ascertained by a reading of the patent documents.” Id. at 1322-23.
DISCUSSION
I. Agreed-Upon Terms
The parties agree upon the construction of certain terms in the disputed
patents. The Court adopts the agreed-upon constructions, as set forth in the Parties’
Joint Claim Construction Chart and supplemental Notice of Agreed-Upon
Construction. (Dkts. 169, 188).
II. The ‘805 Patent
A. Microprocessor Terms
The parties agree that each of the following four terms are means-plus function
claims governed by 35 U.S.C. § 112 ¶ 6, and further agree on the function of each.
•
“microprocessor means contained in the main body portion for
generating user interface information on the display areas” (claim 1)
•
“microprocessor means for generating user interface information on the
display” (claim 24)
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•
“means for generating a plurality of pictoral graphic representations as
user interface information on the main display” (claim 1)
•
“means responsive to the entered values for calculating a dose of the
beneficial agent to be infused into the patient” (claims 3 and 31)
The parties disagree however as to the structure of each term. Baxter presents its
own proposed construction for each while CareFusion argues “[t]here is no algorithm
disclosed in the specification explaining how the microprocessor calculates doses of
medication, and accordingly this element is indefinite.” (Dkt. 169, pgs. 4-5).
§ 112(f) provides:
An element in a claim for a combination may be expressed as a means
or step for performing a specified function without the recital of
structure, material, or acts in support thereof, and such claim shall be
construed to cover the corresponding structure, material, or acts
described in the specification and equivalents thereof.
As a result of permitting such means-plus claiming, “the specification must contain
sufficient descriptive text by which a person of skill in the field of the invention would
‘know and understand what structure corresponds to the means limitation.’”
Typhoon Touch Technologies, Inc. v. Dell, Inc., 659 F.3d 1376, 1383-84 (Fed. Cir.
2011) (quoting Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir.
2008)). In reviewing a means-plus claim, “[t]he court must first identify the claimed
function. … Then, the court must determine what structure, if any, disclosed in the
specification corresponds to the claimed function.” Williamson v. Citrix-Online, LLC,
792 F.3d 1339, 1351 (Fed. Cir. 2015). Further, in cases such as here, where the claim
limitation is implemented using a microprocessor, the specification must disclose the
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algorithm necessary to perform the claimed function. Id. at 1352. “The algorithm
may be expressed as a mathematical formula, in prose, or as a flow chart, or in any
other manner that provides sufficient structure.” Id. “In turn, the amount of detail
that must be included in the specification depends on the subject matter that is
described and its role in the invention as a whole, in view of the existing knowledge
in the field of the invention.” Typhoon, 659 F.3d at 1385. “[T]he patent need only
disclose sufficient structure for a person of skill in the field to provide an operative
software program for the specified function.” Id.
An infringer challenging claims as being indefinite has “the burden of proving
indefiniteness by clear and convincing evidence.” United Access Technologies, LLC v.
AT&T Corp., 2019 WL 326120, at *6 (Fed. Cir. 2019). Generally, “[c]laims are invalid
for indefiniteness if, when viewed in light of the specification and the prosecution
history, they ‘fail to inform, with reasonably certainty, those skilled in the art about
the scope of the invention.’” Id. (quoting Nautilus, Inc. v. Biosig Instruments, Inc.,
572 U.S. 898, 901 (2014).
The crux of the four microprocessor claims listed above is whether Figure 7 of
the ‘805 Patent discloses the algorithm necessary to perform the described function.
The ‘805 Patent refers to Figure 7 as “a user interface navigation flow diagram …
depict[ing] an overview of the user interface routine.” (Dkt. 159, pg. 38). The flow
diagram in Figure 7 displays certain routines such as “power on” (element 302),
“select personality” (element 306), “view personality” (element 308), change occlusion
settings” (element 313), “primary rate-volume programming” (element 339),
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“piggyback rate-volume programming” (element 347), “primary volume-time
programming” (element 341), and “primary ‘dose’ programming” (element 343),
among others. Id. at pgs. 9-10. Baxter concedes that a detailed computer code does
not appear in Figure 7 nor anywhere else in the ‘805 Patent. See (Dkt. 161, pg. 16).
However, providing the computer code is not a necessity to survive an indefiniteness
challenge. Typhoon, 659 F.3d at 1385 (“For computer-implemented procedures, the
computer code is not required to be included in the patent specification.”). Rather,
the patent need only “disclose, at least to the satisfaction of one of ordinary skill in
the art, enough of an algorithm to provide the necessary structure under § 112, ¶6.”
Finisar Corp., 523 F.3d at 1340.
Under this flexible standard, the Court finds that the algorithm at issue here
has been presented in sufficiently understandable terms such that a person of
ordinary skill in the art would understand what structure corresponds to the
limitation. See Finisar, 523 F.3d at 1340. The flow diagram in Figure 7 displays a
step by step process of how the claimed function operates. CareFusion demands more,
but it is difficult to imagine precisely what else could have been disclosed short of the
actual computer code, which, as discussed above, is not necessary. Typhoon, 659 F.3d
at 1385. Accordingly, the Court adopts Baxter’s proposed structure construction in
the Joint Claim Construction Chart (Dkt. 169) with respect to the above listed claim
terms for the ‘805 Patent.
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B. “Means for sensing tube restrictions” (claims 5 and 24)
The parties next dispute the proposed structure of the “means for sensing tube
restrictions” term found in claims 5 and 24. The agreed upon function is “sensing
tube restrictions.” (Dkt. 169, pg. 5). CareFusion argues that the Patent specification
does not disclose any structure and therefore the limitation is indefinite. Baxter
suggests that “a pressure sensor” is the disclosed structure found in the ‘805 Patent.
Again, the question before the Court is “whether the specification discloses sufficient
structure that corresponds to the claimed function.” Williamson, 792 F.3d at 1351.
A claim without adequately disclosed structure will be deemed indefinite. Id. at 1352.
There is no question that the words “pressure sensor” do not appear in the ‘805
Patent. The Patent reads: “The flow check display feature provides the user with a
graphical display of the downstream resistance to flow. … When one triangle is filled,
normal flow conditions are present.
When all of the triangles are filled, the
downstream flow has been occluded.” (Dkt. 159, pgs. 40-41). The specification also
provides that the user can change the display to pounds per square inch or
millimeters of mercury. Id. at pg. 41. Instead, Baxter selects certain phrases and
argues that “[a] person of ordinary skill in the art at the time would have readily
recognized that measuring pressure necessarily involves employing a device to sense
pressure.”
(Dkt. 161, pg. 25).
To overcome this deficit, this contention makes
unsound leaps and inferences from the actual specifications within the Patent to its
conclusion that a pressure sensor is the disclosed structure.
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A structure is considered disclosed “only if the specification or prosecution
history clearly links or associates that structure to the function recited in the claim.”
Default Proof Credit Card Sys., Inc. v. Home Depot U.S.A., Inc. (d/b/a The Home
Depot), 412 F.3d 1292, 1298 (Fed. Cir. 2005). While it is true that the precise term,
“pressure sensor,” need not appear in the specification, a total omission of any
structure is fatal to Baxter’s claim. Id. The specification here is analogous to the
circumstances in Robert Bosch, LLC v. Snap-On Inc. 769 F.3d 1094 (Fed. Cir. 2014).
There, the proposed structure was not explicitly present in the Patent and all cited
specifications served to explain the function, rather than the structure. Id. at 1099100; see also Home Depot, 412 F.3d at 1301. Here, the specifications are focused on
the function of the user interface and the varying displays a medical professional
would observe while engaging with the unit. The mere fact that the unit would
display a value in terms of pounds per square inch or millimeters of mercury is not
sufficient disclosure of structure. Baxter attempts to overcome the shortfall of a
complete lack of structure by relying on expert declarations. However, this practice
is prohibited and the testimony of an expert “cannot create structure where none
otherwise exists.”
Williamson, 792 F.3d at 1354.
Because the ‘805 Patent is
completely lacking in structure for “means for sensing tube restrictions,” the
limitation is indefinite.
C. “Means for applying pumping action to the tube” (claims 1 and 24)
The parties again agree that this claim term is a means-plus function term
governed by § 112 ¶ 6. They further agree that the function is “applying pumping
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action to the tube.” (Dkt. 169, pg. 5). Baxter’s proposed construction is “a mechanism
that imparts propulsion to a fluid” and CareFusion proposes “a peristaltic-type or
valve-type pumping mechanism.”
Id.
The dispute centers on precisely which
pumping mechanisms are disclosed in the ‘805 Patent. The Patent clearly articulates
two types of pumping mechanisms—peristaltic-type and valve-type. (Dkt. 159, pg.
36) (“Such pumps include, for example, peristaltic-type pumps and valve-type
pumps.”). Baxter suggests that a third pumping technology is disclosed in the patent,
which reads: “While the pump modules depicted in the preferred embodiment
described herein are standard IV pump modules, the present invention contemplates
use of alternative pump modules employing alternative pumping technology, such as,
for example, syringe pump modules.” Id. at pg. 37. Reading syringe pumps into the
structure would be impermissibly expansive as “a bare statement that known
techniques or methods can be used does not disclose structure.” Biomedino, LLC v.
Waters Techs. Corp., 490 F.3d 946, 953 (Fed. Cir. 2007). The patent discloses and
describes only peristaltic-type and valve-type pumping mechanisms and the Court
will not read in new structures not described in the ‘805 Patent itself. Accordingly,
the Court adopts CareFusion’s proposed construction of “a peristaltic-type or valvetype pumping mechanism.”
D. “A plurality of sets of configuration parameters…” (claim 1)
The term “a plurality of sets of configuration parameters are included as user
interface information such that a user can select which of the plurality of sets of
configuration parameters to configure the infusion pump” appears in claim 1 of the
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‘805 Patent. Baxter proposes a lengthy construction while CareFusion suggests that
no construction is necessary and that the “phrase has its plain and ordinary English
meaning.”
(Dkt. 169, pg. 6).
Baxter argues that the words “plurality,” “sets,”
“configuration,” and “parameters” are confusing terms to those not of ordinary skill.
(Dkt. 161, pg. 27).
While the Court must be cognizant of the jury’s ability to
understand claim construction rulings, Power-One, Inc. v. Artesyn Techs., Inc., 599
F.3d 1343, 1348 (Fed. Cir. 2010), Baxter’s proposed construction does more to
advocate its case than provide clarification to the jury. Baxter’s construction would
have the Court read in limitations not present in the ‘805 Patent. For example,
instead of “of sets of configuration parameters,” Baxter proposes “collection of drugs’
parameters that determines the overall pump operating characteristics for a given
clinical context.” (Dkt. 169, pg. 6). This construction adds terms and limitations not
previously present in the Patent. When a claim has a facially plain and ordinary
meaning, the Court’s inquiry ends.
Power Integrations, Inc. v. Fairchild
Semiconductor Int’l, Inc., 711 F.3d 1348, 1361 (Fed. Cir. 2013); see also ActiveVideo
Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1326 (Fed. Cir. 2012). Here,
the claim is “comprised of commonly used terms; each [] used in common parlance
and has no special meaning in the art.” Summit 6, LLC v. Samsung Elecs. Co., 802
F.3d 1283, 1291 (Fed. Cir. 2015).
The contested claim requires no further
construction and the terms will be given their plain and ordinary meaning.
III. The ‘560 Patent
A. “Automatically changing the rate and amount…”
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The term “automatically changing the rate and amount of the liquid medicant
to be administered to the patient in accordance with the set of patient specific,
predetermined ranges of medication” appears in claim 9 of the ‘506 Patent. Baxter
asserts that no construction is necessary, and the term should be given its plain and
ordinary meaning.
(Dkt. 169, pg. 6).
To the contrary, CareFusion’s proposed
construction reads: “Automatically increasing or decreasing the amount and duration
of the patient’s ongoing delivery of medication in accordance with a set of patient
specific, predetermined ranges of medication.” Id. Essentially, the dispute between
the parties boils down to whether the claim covers the stopping or pausing of the
infusion of a dose. CareFusion attempts to limit the claim to only increasing or
decreasing the dose, while arguing that it is not broad enough to cover the
stopping/starting of a dose. To do so, CareFusion proposes the addition of the terms
“increasing or decreasing” and “ongoing delivery.”
CareFusion’s proposed
construction would require the Court to impermissibly read terms in to the ‘560
Patent and restrict the plain meaning of the claim. The specifications of the Patent
anticipate that “changing the rate and amount of the liquid medicant” include
increasing and decreasing, but also the stopping and starting. For example, the
specification lists modes of infusion which include “an intermittent mode in which
the pump delivers discrete liquid volumes spaced over relatively long periods of time,
such as a liquid volume every three hours” and “a custom mode in which the pump
can be programmed to deliver a unique infusion rate during each of 25 different time
periods.” See e.g. (Dkt. 159, pg. 61). The specifications further detail that in certain
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scenarios, “the motor is not activated continuously, but is instead turned on
periodically … and then is turned off.” Id. Accepting CareFusion’s proposed language
would restrict the claim in a way inconsistent with the plain wording of the Patent.
CareFusion next proposes to change the term “rate” to “duration,” but
withdrew this specific proposal at the claim construction hearing. (Dkt. 190, pg.
123:14-23). Finally, CareFusion alters “the set of patient specific, predetermined
ranges of medication” to “a set of patient specific, predetermined ranges of
medication.” (Dkt. 169, pgs. 6-7) (emphasis added). Such a change is not justified
here where the specification clearly relates back to the language in Claim 9. See e.g.,
(Dkt. 159, pgs. 63:36-39, 63:65-67, 65:7-32). The claim term for claim 9 is sufficiently
clear and will be given its plain and ordinary meaning with no further construction.
See Power Integrations, 711 F.3d at 1361.
B. “Obtaining information pertaining to the patient’s pain level”
(claim 9)
The final term in dispute, “obtaining information pertaining to the patient’s
pain level,” comes from claim 9 of the ‘560 Patent.
CareFusion’s proposed
construction of the term is: “obtaining data specifically related to the patient’s pain
level, such as by querying the patient directly or by analyzing whether the patient
makes a significant number of bolus requests over the maximum permitted in a short
period of time.” Baxter contends that CareFusion’s construction improperly adds
restrictive limitations to the claim and instead the term should be given its plain and
ordinary meaning. CareFusion’s construction essentially parrots limitations from the
dependent Claims 12 and 13. See (Dkt. 159, pg. 65) (“The infusion pump of claim 11
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wherein data pertaining to the patient’s pain level comprises the number of bolus
requests made by the patient which exceed the maximum number of boluses. … The
infusion pump of claim 11 wherein data pertaining to the patient’s pain level, side
effects and impairment of functionalities comprises data stored in response to
querying the patient…”). This claim contains no technical terms of art and is not
facially confusing. See Power Integrations, 711 F.3d at 1361. A person of ordinary
skill in the art could easily discern the term and therefore no further construction of
the term is needed. CareFusion’s proposed construction serves to impermissibly limit
the claim and CareFusion supplies no convincing reason for doing so. “Obtaining
information pertaining to the patient’s pain level” will be given its plain and ordinary
meaning.
CONCLUSION
For the reasons stated within, the Court construes the disputed terms as set
forth above.
Date: April 29, 2019
____________________________________
Virginia M. Kendall
United States District Judge
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