Biomedical Enterprises, Inc. v. Solana Surgical, LLC
Filing
39
MEMORANDUM OPINION AND ORDER Regarding Claims Construction, ( Scheduling Conference set for 12/22/2014 01:30 PM before Judge Lee Yeakel,). Signed by Judge Lee Yeakel. (dm)
¶lT
IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF TEXAS
AUSTIN DIVISION
BIOMEDICAL ENTERPRISES, INC.,
PLAINTIFF,
281NOV-L
k
P1112:36
§
§
§
V.
§
CAUSE NO.
1: 14-CV-095-LY
§
SOLANA SURGICAL, LLC,
DEFENDANT.
§
§
MEMORANDUM OPINION AND ORDER REGARDING
CLAIMS CONSTRUCTION
Before the court are the parties' Joint Claim Construction Statement filed September 10,
2014 (Clerk's Document No. 25); Plaintiff BioMedical Enterprises, Inc. ("BioMedical") and
Defendant Solana Surgical, LLC's ("Solana") Opening Claims Construction Briefs filed August 29,
2014 (Clerk's Document Nos. 23 & 24); and BioMedical and Solana's Responsive Claim
Construction Briefs filed September 19, 2014 (Clerk's Document Nos. 28 & 29).
The court held a claim-construction hearing on October 14,2014. See Markman v. Westview
Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370 (1996). After
considering the patent and its prosecution history, the parties' claim-construction briefs, the
applicable law regarding claim construction, and argument of counsel, the court now renders its
order with regard to claim construction.
I.
Introduction
The court renders this memorandum opinion and order to construe claims in U.S. Patent
No. 8,584,853 (the "853 Patent"). BioMedical, the holder ofthe '853 Patent, asserts claims against
Solana for infringement of the '853 Patent, which generally relates to a disposable, sterile-packaged
orthopedic-fixation system.
II.
Legal Principles of Claim Construction
Determining infringement is a two-step process. See Markman, 52 F.3d at 976 ("[There are]
two elements of a simple patent case, construing the patent and determining whether infringement
occurred
. .
.
."). First, the meaning and scope
of the relevant claims must be ascertained.
Id.
Second, the properly construed claims must be compared to the accused device. Id. Step one, claim
construction, is the current issue before the court.
The court construes patent claims without the aid ofajury. Id. at 979. The "words of a claim
'are generally given their ordinary and customary meaning." Phillips v. A WHCorp., 415 F .3 d 1303,
1312 (Fed. Cir. 2005) (en banc) (quoting Vitronics Corp.
v.
Conceptronic, Inc., 90 F.3d 1576, 1582
(Fed. Cir. 1996)). The ordinary and customary meaning of a claim term is the meaning that the term
would have to a person of ordinary skill in the art in question at the time of the invention. Id. at
1313. The person of ordinary skill in the art is deemed to have read the claim term in the context
of the entire patent. Id. Therefore, to ascertain the meaning of claims, courts must look to the
claims, the specification, and the patent's prosecution history. Id. at 13 14-17; Markman, 52 F.3d
at 979.
Claim language guides the court's construction of claim terms. Phillips, 415 F.3d at 1314
"[T]he context in which a term is used in the asserted claim can be highly instructive." Id. Other
claims, asserted and unasserted, can provide additional instruction because "terms are normally used
consistently throughout the patent." Id. Differences among claims, such as additional limitations
in dependent claims, can provide further guidance. Id.
Claims must also be read "in view of the specification, of which they are a part." Markman,
52 F.3d at 979. The specification "is always highly relevant to the claim construction analysis.
2
Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Teleflex, Inc.
v.
Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002) (internal citations omitted). In the
specification, a patentee may define a term to have a meaning that differs from the meaning that the
term would otherwise possess.
Phillips, 415 F.3d at 1316.
In such cases, the patentee's
lexicography governs. Id. The specification may also reveal a patentee's intent to disclaim or
disavow claim scope. Id. Such intentions are dispositive for claim construction. Id. Although the
specification may indicate that certain embodiments are preferred, particular embodiments appearing
in the specification will not be read into the claims when the claim language is broader than the
embodiment. Electro Med. Sys., S.A.
v.
Cooper Life Scis., Inc., 34 F.3d 1048, 1054 (Fed. Cir. 1994).
The prosecution history is another tool to supply the proper context for claim construction
because it demonstrates how the inventor understood the invention. Phillips, 415 F.3d at 1317. A
patentee may serve as his own lexicographer and define a disputed term in prosecuting a patent.
Home Diagnostics, Inc.
v.
LfeScan, Inc., 381 F.3d 1352, 1356 (Fed. Cir. 2004).
Similarly,
distinguishing the claimed invention over the prior art during prosecution indicates what the claims
do not cover. Spectrum
Int'l
v.
Sterilite Corp., 164 F.3d 1372, 1378-79 (Fed. Cir. 1988). The
doctrine of prosecution disclaimer precludes patentees from recapturing specific meanings that were
previouslydisclaimedduringprosecution. Omega Eng'g, Inc.
v.
RaytekCorp., 334F.3d 1314, 1323
(Fed. Cir. 2003). Disclaimers of claim scope must be clear and unambiguous. Middleton, Inc.
v.
3M
Co., 311 F.3d 1384, 1388 (Fed. Cir. 2002).
Although "less significant than the intrinsic record in determining the legally operative
meaning of claim language," the court may rely on extrinsic evidence to "shed useful light on the
relevant art." Phillips, 415 F.3d at 1317 (quotation omitted). Technical dictionaries and treatises
may help the court understand the underlying technology and the manner in which one skilled in the
art might use claim terms, but such sources may also provide overly broad definitions or may not be
indicative of how terms are used in the patent. Id. at 1318. Similarly, expert testimony may aid the
court in determining the particular meaning of a term in the pertinent field, but "conclusory,
unsupported assertions by experts as to the definition of a claim term are not useful." Id. Generally,
extrinsic evidence is "less reliable than the patent and its prosecution history in determining how to
read claim terms." Id. Extrinsic evidence may be useful when considered in the context of the
intrinsic evidence, id. at 1319, but it cannot "alter a claim construction dictated by a proper analysis
of the intrinsic evidence." On-Line Techs., Inc.
v.
Bodenseewerk Perkin-Elmer GmbH, 386 F.3d
1133, 1139 (Fed. Cir.2004).
III.
Discussion
The parties submitted two agreed claim terms and five claim terms for construction by their
Joint Claim Construction and Prehearing Statement.
A.
Agreed Terms
Before the claims-construction hearing, the parties agreed to the construction ofthe following
two claim terms:
Claim Term/Phrase
Adopted Agreed Construction1
"stores a compressive force"
(Claim 15)
stores a force that would cause the legs to converge
"releases the compressive force
stored in the implant"
(Claim 15)
releases the force that would cause the legs to
converge
Throughout, the bolded terms indicate the court's adopted construction.
ri
B.
Disputed Terms
The parties dispute the construction of five claim terms. The following table summarizes the
parties' proposed constructions of the disputed terms.
Claim TermlPhrase
BioMedical's Proposed Constructions
Solana's Proposed Constructions
"Orthopedic fixation The preamble is a claim limitation (i) this preamble does not limit the
scope of the claims and
system"
meaning "a fixation system for bones"
(ii) construction is unnecessary.
(Claims 15-21)
However, if court finds preamble a
limitation, then "components that
work in conjunction to fixate bones
together"
1.
2. "Implant kit"
(Claim 15)
"a collection of components, including "a collection of components,
an implant for fixating bones together" including an implant, that are
packaged together and separately
from instruments necessary to use the
collection of components to fixate
bones"
or alternatively,
"a collection of components, that are
packaged together, where the
collection is limited to an implant and
components that match the implant"
"the insertion device "The insertion device by itself keeps the
maintains the legs in their implant legs in the substantially parallel
second substantially position so that a force that would cause
parallel position such that the legs to converge is stored."
the implant stores the
compressive force"
3.
(Claim 15)
construction is urmecessary. However,
if court determines construction
helpful,
"The insertion device holds the implant
legs with its legs in their second
substantially parallel position such that
the implant stores a force that would
cause the legs to converge"
4. "such that the insertion "The insertion device by itself keeps the "The insertion device holds the implant
device maintains the legs in legs in the substantially parallel position" with its legs in their second
their second substantially
parallel position"
substantially parallel position"
(Claim 15)
"Multiple sizes of "Implant kits that contain differently
sized implants"
implant kits"
5.
(Claim 21)
"Multiple implant kits that have
different sizes"
1.
Preamble"Orthopedic fixation system"
The parties dispute whether the court should conclude that "orthopedic fixation system," which
appears in the preamble to independent Claim 15 and dependent Claims 16 through 21, is a limitation
on the scope of the claims. BioMedical argues that the court should construe the phrase as a limitation
on the claims' scope to only bones. Further, BioMedical argues that as reflected by the patent
specification's many references to bones, the preamble phrase is fundamental to the claimed invention.
Solana disagrees, contending that the phrase is not a limitation. Solana argues that the '853
Patent addresses the problem of packaging, delivering, and using implants and complementary
instruments in a sterile formata problem that is not unique to "orthopedic fixation." Solana contends
that the '853 Patent's invention consists of a two-kit, sterile-packaged, delivery system, which consists
of two separate packages: (1) the implant-kit package, with the sterilized implant in a ready-to-use
configuration, together with (2) the instrument-kit package, with the complementary sterilized
instruments needed to use "one or more.
. .
or any combination of implant kits." Providing the two-
kits together, satisfies all of the three objects that define the fundamental features of the "present
invention."
To support its respective position, each party relies on Catalina Marketing International Inc.
v.
Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002). A preamble is construed as a limitation
only "if it recites essential structure or steps, or if it is 'necessary to give life, meaning, and vitality'
to the claim." Id. (quoting Pitney Bowes, Inc.
v.
Hewlett-Packard Co., 182 F.3d 1298, 1309 (Fed. Cir.
1999)). Conversely, 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. Id. (citing Rowe
v.
Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)). Generally, unless the
7
patentee has relied on the preamble in the prosecution history to distinguish the claimed invention from
prior art or the preamble is necessary to provide antecedent basis for the body of the claim, the
preamble is not limiting. Catalina, 289 F.3d at 809. When deciding whether the preamble is limiting,
a court must review the entire patent to gain an understanding of what the inventor actually invented
and intended to encompass by the claim. Id. at 808; see e.g., Applied Materials, Inc.
v.
Advanced
Semiconductor Materials Am., Inc., 98 F.3d 1563, 1572-73 (Fed. Cir. 1996) (holding "cold purge
process" in preamble was limiting because it was essential to particularly point out invention defined
by claims).
In reviewing the entirety of the '853 Patent, although the prosecution history includes some
prior art that is not limited to orthopedics, references to "bones" and "orthopedics" appear throughout
every section of the '853 Patent specification. Indeed, the following are a few representations in the
'853 Patent: (1) the title of the '853 Patent"Method and Apparatus For An Orthopedic Fixation
System"includes the term"orthopedic," which, by its plain and ordinary meaning, relates to bones;
(2) the section, "Background of the Invention" refers to "bone fusion and healing in orthopedics,"
which often involve "implants being attached to bones in some way to fixate them together during the
healing process"; (3) the figures include depictions of the invention solely with drawings of bones; and
(4) the section, "Detailed Description of the Preferred Embodiments" refers repeatedly to bones. With
regard to Claims 15 through 21, the only way these claims have any vitality or structure within the
context of the patent is if the phrase "orthopedic fixation system" is a limitation of the scope of the
patent to fixating bones. Interpreting the preamble phrase "orthopedic fixation system" in view of the
specification's focus on bones and orthopedics, rather than all "fixation systems,"is necessary to make
sense of the claims. See e.g., General Elec. Co.
v.
8
Nintendo Co., 179 F.3d 1350, 1361-62 (Fed. Cir.
1999) (limiting claim scope to "raster scanned display device" rather than all display systems in view
of specification's focus on prior art problem of displaying binary data on raster scan display devices);
Corning Glass Works v. Sumitomo Elec. USA., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989) (limiting
claim scope to "optical wavelengths" rather than all optical fibers in light of specification). The court
finds that the preamble "orthopedic fixation system" limits Claims 15 through 21's scope to fixating
and healing bones, not all fixation systems. See Catalina, 289 F.3d at 808 (citing Pitney Bowes, 182
F.3dat 1306).
Having determined that "orthopedic fixation system" is a claim limitation, the court defines
"orthopedic fixation system" as a fixation system for bones.
2. "Implant kit"
The essential difference between the parties' constructions is that Solana's construction adds
a restriction to Claim
15the implant kit's components must be packaged separately from instruments
that may be used by a surgeon during a bone-implant surgical procedure. Solana argues that this
restriction is aligned with the invention described in the specification ofthe '853 Patent. BioMedical' s
construction has no such restriction, which BioMedical argues is proper in light of the entire patent
and the scope of the invention.
In reviewing the claims of the '853 Patent, only unasserted Claims
1
through 14 refer to a
separate, sterile-packaged instrument kit that accompanies the implant kit. There is no reference to
an instrument kit in the claims at issueindependent Claim 15 and dependent Claims 16 through 21.
Claim 15 addresses the "sterile packaged implant kit, comprising": (1) "at least one surgical implant,"
(2) " an insertion device," and (3) "an implant package." Further, dependent Claim 19 provides that
an "implant kit comprises a drill guide" that, according to the specification, allows a surgeon to drill
parallel holes into bone to match the implant. The term "comprising" means that the claim does not
exclude additional, unrecited elements. See e.g., Vivid Techs., Inc.
v.
American Science & Eng 'r, Inc.,
200 F.3d 795, 811 (Fed. Cir. 1999); Stftung v. Renishaw PLC, 945 F.2d 1173, 1178 (Fed. Cir. 1991).
Nothing in Claim 15, nor in Claims 16 through 21 restricts or limits the implant kit from including
additional components.
Additionally, the section of the '853 Patent "Summary of the Invention" includes, "[I]t should
be understood that the scope of this invention is intended to be broad, and any combination of any
subset of the features, elements, or steps described herein is part of the intended scope of the
invention." Further, the '853 Patent's "Detailed Description ofthe Preferred Embodiments's" closing
paragraph instructs:
Although the present invention has been described in terms of the
foregoing embodiments, such description has been for exemplary
purposes only and, as will be apparent to those of ordinary skill in the
art, many alternatives, equivalents, and variations of varying degrees
will fall within the scope of the present invention. That scope,
accordingly, is not to be limited in any respect by the foregoing detailed
description; rather, it is defined only by the claims that follow.
By the existence of independent Claim 15 and dependent Claims 16 through 21, by the use of
the term "comprising," and the specification's language, (1) that the scope of the invention is intended
to be broad, with any combination of any subsets being within the scope of the invention, and (2) that
the invention's scope is not to be limited to the detailed description and is to be defined by the claims,
the inventor contemplated the possibility that the implant kit could contain other items. To adopt
Solana's construction would require the court to read in a limitation to Claim 15 when lacking is any
language in the patent that makes clear such limitation. See Hill-Rom Servs., Inc.
v.
Stryker Corp., 755
F3d 1367, 1371-72 (Fed. Cir. 2014). The court finds "no clear intention" by the patentee "to limit the
10
claim scope using words or expressions of manifest exclusion or restriction." Id. Further, the court
finds that to adopt Solana' s construction would require the court to find independent Claim 15
superfluous of Claim
1.
The court defines "implant kits" as "a collection of components that includes an implant for
fixating bones together."
3. "maintains"
BioMedical argues that the court should construe the word "maintains"as used twice in Claim
15: (1) "the insertion device maintains the legs in their second substantially parallel position such that
the implant stores the compressive force," and (2) "such that the insertion device maintains the legs
in their second substantially parallel
position".2
BioMedical proposes that in each instance, the claim
language supports its construction that the insertion device "maintains" means the insertion device,
itselfkeeps, or by itself keeps, the implant's legs in their parallel position. BioMedical contends that
if it is not the insertion device itself keeping the legs parallel, the shape-memory-material implant legs
would converge, and the implant would be unuseable. Solana, initially posits that no construction of
"maintains" is necessary. Nevertheless, if the court finds construction appropriate, Solana proposes
a construction that the insertion device holds the implant. Contrary to BioMedical's construction,
Solana argues something else other than the insertion device is responsible for maintaining the implant
legs in the parallel position.
BioMedical argues, that to use the word holds, improperly broadens the claim. BioMedical
argues that based on the specification, the insertion device does not merely hold, passively, the shape-
memory material implant. The difference here, Biomedical argues, is a contrast to prior art, which
At argument, the parties agreed that the use of "second substantially" was of no import to the
construction of "maintains."
2
11
addressed a staple implant, not of shape-memory or superelastic material, that was simply heldthere
was no position other than a parallel position possible for the staple legs. With a staple implant, unlike
an implant made of shape-memory or superelastic materials, no need exists to maintain the two staple
implant legs parallel. BioMedical argues that the by itselfkeeps construction is consistent with other
clauses in the patent and is consistent within the claim because after the term is used, there is reference
to the storage of a compressive force in the implant, which is the result of the insertion device's
"maintaining" work. BioMedical argues that but for the insertion device, the implant legs would not
be kept open, but instead would converge.
Solana argues that BioMedical is asking the court to rewrite the claim so that the insertion
device itself keeps the legs parallel and, thus, is the sole mechanism that retains the legs of the implant
parallel while the implant is mounted on the insertion device.
The Figures 2A and 2B and the corresponding detailed description of the preferred
embodiments depict and describe an insertion device that "holds the implant such that implant legs
are held mechanically in a parallel position for easier insertion into bone." Based on the "such that"
phrase, the specification provides that there is something more going on with the insertion device than
only holding the shape-memory or superelastic implant; specifically, the implant is being "held
mechanically in a parallel position." And further, the description "shows the implant being inserted
into two bones and [i]nsertion device can be twisted off implant, releasing the implant to squeeze [the]
bones [together]."
The court finds no mention of "by itself keeps" anywhere in the patent. Additionally, to use
Solana's construction leaves out aspects of the insertion device working in conjunction with a shapememory or superelastic implant.
12
The court finds no construction is necessary and the term "maintains" will be given its ordinary
and customary meaning as understood by a person of ordinary skill in the art when read in the context
of the specification and prosecution history.
4. "multiple sizes
of implant kits"
The parties' dispute here centers on whether "multiple sizes of implant kits" requires that the
actual, physical implant kits themselves be of different sizes, as Solana proposes, or, that the implants
included within the implant kits are of different sizes, as BioMedical proposes.
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." Epos Techs. Ltd.
v.
Pegasus Techs. Ltd., 766 F.3d 1338, 1341 (Fed. Cir.
2014) (quoting Phillips, 415 F.3d at 1312-13).
Here, the specification resolves any ambiguity about the meaning of this phrase. It is stated
explicitly in the specification, "implant kits are identical, except that the implants may be sized
differently as required by the physician." Thus, the implants within an implant kit can vary in size,
while the implant kits are otherwise identical in size. "When there is more than one ordinary meaning
for a claim term, the patent specification serves to point away from improper meanings and toward the
proper meaning." See RenishawPLCv. MarpossSocieta'perAzioni, 158 F.3d 1243, 1250 (Fed. Cir.
1998). Further, to accept Solana' s proposal would improperly read out the preferred embodiment from
the scope of the claim. See SanDisk Corp.
v.
Memorex Prods., Inc., 415 F.3d 1278, 1285 (Fed. Cir.
2005) ("A claim construction that excludes a preferred embodiment, moreover, is rarely, if ever
correct.")
The court defines "multiple sizes of implant kits" as "implant kits that contain differently
sized implants."
13
A.
Summary Table ofAdoptedAgreed and Disputed Terms
Claim Term/Phrase
Court's Construction
stores a compressive force
stores a force that would cause the legs to converge
releases the compressive force stored
in the implant
releases the force that would cause the legs to
converge
Orthopedic fixation system
(Claims 15-21)
a fixation system for bones
Implant kit
(Claim 15)
a collection of components that includes an implant
the insertion device maintains the
legs in their second substantially
parallel position such that the implant
stores the compressive force
(Claim 15)
no construction necessaryplain
meaning
such that the insertion device
maintains the legs in their second
substantially parallel position
(Claim 15)
no
Multiple sizes of implant kits
(Claim 21)
implant kits that contain differently sized implants
for fixating bones together
and
ordinary
construction necessaryplain and ordinary
meaning
14
IV.
Conclusion
For the above reasons, the court construes the above-listed claim terms as noted and so
ORDERS. No further claim terms require construction.
IT IS FURTHER ORDERED that this case is set for a Scheduling Conference on
December 22, 2014, at 1:30 p.m., in Courtroom 7, Seventh Floor, United States Courthouse, 501 W.
5th Street, Austin, Texas 78701. The parties shall meet and confer in advance of that date in an
attempt to settle this case. If the case is not settled, the parties shall confer in an attempt to reach
agreement on a schedule to follow for the remainder of this case. The court will render a Scheduling
Order as a result of the December 22, 2014 conference.
SIGNED this
day of November, 2014.
IKE
UN ED STAT
15
DIST ICT JUDGE
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?