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Synovis Life Technologies, Inc. v. W.L. Gore & Assocs., Inc.: US District Court : PATENT - Markman construction; various terms regarding surgical staplers

UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
Synovis Life Technologies, Inc., Civil No. 07-1396 (DWF/SRN)
Plaintiff,
v. MEMORANDUM
OPINION AND ORDER
W.L. Gore & Associates, Inc.,
Defendant,
________________________________________________________________________
James R. Mayer, Esq., Laura L. Myers, Esq., Lora Mitchell Friedemann, Esq., Darren B.
Schwiebert, Esq., Fredrickson & Byron, PA, counsel for Plaintiff.
Aslan Baghdadi, Esq., and Lawrence J. Gotts, Esq., Paul, Hastings, Janofsky & Walker;
and Calvin L. Litsey, Esq., Charles F. Knapp, Esq., and Kevin P. Wagner, Esq., Faegre &
Benson LLP; and Jessica L. Copland, Esq., and John T. Gallager, Esq., Morgan &
Finnegan, LLP, counsel for Defendant.
________________________________________________________________________
INTRODUCTION
This matter is before the Court on the issue of patent claim construction pursuant
to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996).
BACKGROUND
This litigation involves allegations by Plaintiff Synovis Life Technologies, Inc.
(Synovis) that Defendant W.L. Gore & Associates, Inc. (W.L. Gore) infringed one or
more of claims 37 through 48 of U.S. Patent No. 7,128,748 (the 748 Patent). The
parties disagree as to the meaning of several terms in the 748 Patent.
2
I. Claim Construction Principles
Patent claim construction, i.e., the interpretation of the patent claims that define
the scope of the patent, is a matter of law for the court. Markman v. Westview
Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir. 1995), affd, 517 U.S. 370 (1999).
Proper claim construction requires an examination of the intrinsic evidence of record,
including the claims of the patent language, the specification, and the prosecution history.
Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). The starting
point for claim construction is a review of the words of the claims themselves. Phillips v.
AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc) (citation omitted), cert.
denied, 126 S. Ct. 1332 (2006); see also Vitronics, 90 F.3d at 1582 (First, we look to the
words of the claims themselves, both asserted and unasserted, to define the scope of the
patented invention.). The words of a claim generally carry the meaning that the term
would have to a person of ordinary skill in the art at the time of the invention. Phillips,
415 F.3d at 1313. Claims must also be read in view of the specification. Id. at 1315.
The specification is the single best guide to the meaning of a disputed term. Id. The
specification may prescribe a special definition given to a claim term, or a disavowal of
claim scope by the inventor. Id. at 1316. In such cases, the inventors intention that is
expressed in the specification is dispositive. Id. The Court may not, however, import
limitations from the specification into the claims. Id. at 1323. The Court should also
consider the patents prosecution history, which provides evidence of how the United
States Patent and Trademark Office (USPTO) and the inventor understood the patent.
Id. at 1317. The Court may, in its discretion, consider extrinsic evidence, though it is less
3
reliable than intrinsic evidence. Id. at 1317-18.1 In most situations, however, intrinsic
evidence will resolve any ambiguity in a disputed term, and when it does so, it is
improper to rely on extrinsic evidence. Vitronics, 90 F.3d at 1583. The court may use a
dictionary or technical treatise to assist in understanding the commonly understood
meaning of a term, so long as any meaning found in such sources does not contradict the
definition that is found in the patent documents. Id. at 1322-23.
II. The 748 Patent
The 748 Patent, entitled Circular Stapler Buttress Combination, was issued on
October 31, 2006. The Patent relates to circular surgical staplers and surgical stapling
procedures that include the use of buttress material that is delivered to a tissue site to
connect previously severed tissue portions. (748 Patent at Abstract; c. 1, ll: 6-10.) More
particularly, the 748 Patent relates to reinforcing staple line seams formed by circular
staplers during surgery to join together two sections of hollow organs (i.e., intestines)
while keeping the interior passageway of the organ open.
1 Gore seeks to rely on the deposition testimony of the co-inventors of the 748
Patent, Drs. Nicholas Oray and Daniel Mooradian. To the extent that such testimony has
been offered to show the subjective intent of the inventors, it is not relevant to the issue
of claim construction. Howmedica Osteonics Corp. v. Wright Medl Tech., Inc., 540 F.3d
1337, 1347 (Fed. Cir. 2008). To the extent that the testimony is relevant, the Court
declines to consider it because the intrinsic evidence resolves any ambiguities in the
disputed claim terms. See Vitronics, 90 F.3d at 1583.
4
The terms that are in presently in dispute appear in claims 37 and 38 of the 748
Patent:2
37. A combination medical device comprising:
a) a circular stapler instrument, comprising a staple cartridge
component and corresponding anvil component, and
b) one or more portions of buttress material adapted to be a) stably
positioned upon the staple cartridge and/or anvil components of the
stapler instrument prior to, or at the time of, use, b) while in position
upon the stapler instrument component(s), to then be delivered to a
tissue site in combination with the stapler instrument components,
c) upon delivery of the components and positioned material
portion(s) to the tissue site, to provide a first region of buttress
material as a staple line buttress seal between joined tissue sections
upon activation of the stapler instrument, and optionally, d) to permit
the removal of one or more portions of a second region of the
buttress material upon activation of a stapler instrument knife
provided by the stapler instrument,
wherein at least one of the buttress material portions comprises two or
more regions, including a first region adapted to serve as the staple
line buttress itself, together with a second region adapted to assist in
positioning and/or retaining the buttress material upon a stapler
component, and wherein one or more portions of the second region
are adapted to be removed from the tissue site upon formation of the
staple seam and activation of a stapler knife, the second region being
generally concentric to the first region, the first and second regions
cooperating to provide a desired three dimensional and/or
topographic structure adapted to position and/or retain the materials
in place upon the respective stapler component.
38. A combination according to claim 37 wherein the first and second
regions are adapted to be separated upon activation of a stapler
knife, in a manner sufficient to permit the separated first region to
provide a buttressed surgical seam between abutting tissue portions
and to permit the separated second region to be removed from the
tissue site.
(748 Patent c. 15, ll: 37-67; c. 16, ll: 1-8.)
2 The Court reproduces claims 37 and 38 as representative examples.
5
A. buttress material
The parties dispute the meaning of the term buttress material as it appears in
claims 37, 41, and 45 of the 748 Patent. Synovis contends that the jury can easily grasp
the meaning of the term and therefore no construction is necessary. Alternatively, if the
Court decides to construe the term, Synovis asserts that that the term buttress material
should be construed as material useful for reinforcing a seam. (Joint Proposed Claim
Construction Statement (Joint Statement) at 4.) Gore, on the other hand, asserts that
the Court should construe buttress material as biomaterial formed from animal tissue
designed to be used in a surgical procedure to reinforce a staple line. (Id.) The parties
dispute therefore centers on whether the term buttress material is limited to
biomaterial formed from animal tissue.
In support of its construction, Synovis points to the specification of the 748
Patent, beginning with the description of the Technical Field, which states:
In one aspect, the invention relates to surgical staplers, including
circular staplers. In another aspect, the invention relates to surgical stapling
procedures that include the use of buttress and reinforcing materials formed
of stabilized tissues and polymeric[3] materials. In yet another aspect, the
invention relates to the preparation and use of preformed heterologous
tissues for implantation within the body.
(748 Patent c. 1, ll: 5-12.) In addition, Synovis points to portions of the specification
that explain, for example, that a variety of references teach the preparation of buttress,
or pledget or reinforcing materials for use in combination with conventional surgical
staplers. (Id., c. 2, ll: 7-10.) Synovis asserts that the specification shows that buttress
3 Polymeric refers to plastic materials.
6
and reinforce have similar meanings. Synovis further maintains that the 748 Patent
uses buttress material to mean material useful for reinforcing a seam. (See 748
Patent c. 6, ll: 11-14 (FIG. 4 shows a cross-section view of the overall process of
creating a reinforced stapled connection for tubular tissue . . .). Finally, Synovis argues
that Gores proposed construction departs from the language of the claim and would
improperly limit the claims to a single disclosed embodiment.
Gore asserts that the term buttress material is explicitly defined in the
specification as being composed of biomaterial formed from animal tissue. Gore
contends that this definition is mandated by the description of the invention which Gore
contends describes only the use of biomaterial. In addition, Gore asserts that the
inventors consistently describe the use of animal tissue in buttress material throughout the
patent, and particularly that the written description focuses exclusively on the use of
animal tissue.
The term buttress material appears in the claim language of claims 37, 41, and
45 simply as buttress material and is not expressly limited to biomaterial formed from
animal tissue. Gore does not dispute that the claim language lacks an express limitation
to biomaterial formed from animal tissue, but instead asserts that the specification
provides an explicit definition of buttress material. In support, Gore points to a portion
of the Detailed Description of the specification, which reads: Circular stapler buttress
material is composed of biomaterial which is typically bovine pericardium sheet fixed
onto a preformed shape using a tanning solution. (748 Patent c. 7, ll: 5-6.) The patent
specification may reveal a special definition given to a claim term by the patentee that
7
differs from the meaning it would otherwise possess. Phillips, 415 F.3d at 1316. Here,
however, when viewing the patent in its entirety, the Court finds that the specification
does not transform the plain meaning of buttress material to be limited to biomaterial
formed from animal tissue. First, the language cited by Gore reveals that bovine
pericardium is only an example of a buttress material and that the patentee contemplated
the use of additional materials. The use of the word typically immediately preceding
bovine pericardium underscores the notion that bovine pericardium was not meant to
be the exclusive material for buttress material. In addition, the Background of the
Invention portion of the specification references three patents that disclose non-woven
polyethylene as a buttress material. (See 748 Patent c. 2, ll: 10-12; Mayer Decl. 2, Ex.
B at c. 2, ll: 41; 3, Ex. C at c. 2, ll: 42-43; 4, Ex. D at c. 3, ll: 29-30.)4
Claim differentiation further suggests that the patentee did not intend to limit
buttress material in claims 37, 41, and 45 to biomaterial formed from animal tissue.
Differences among claims can also be a useful guide in understanding the meaning of
particular claim terms. Phillips, 415 F.3d at 1314. Here, claim 1 of the 748 Patent
contains the term buttress material as it is appears in independent claims 37, 41, and 45.
4 Gore argues that these patents were not incorporated by reference, are not part of
the patents written description, and thus do not aid in claim interpretation. The Court
disagrees. Even if the patents were not incorporated by reference, they are listed on the
first page of the patent under References Cited. The Court concludes that these patents
can shed light on claim interpretation. See, e.g., Arthur A. Collins, Inc. v. N. Telecom
Ltd., 216 F.3d 1042, 1045 (Fed. Cir. 2000) (When prior art that sheds light on the
meaning of a term is cited by the patentee, it can have particular value as a guide to the
proper construction of the term, because it may indicate not only the meaning of the term
to persons skilled in the art, but also that the patentee intended to adopt that meaning.).
8
(748 Patent c. 12, ll: 27.) Claim 2, which is dependent on claim 1, reads in part: A
combination according to claim 1 wherein the buttress material comprises preformed
animal tissue. (Id., c. 12, ll: 49-50.) Thus, it is presumed that the patentee did not
intend for the buttress material in independent claim 1 to be limited to animal tissue.5
See, e.g., Phillips, 415 F.3d at 1315 (noting that the presence of a dependent claim that
adds a particular limitation gives rise to a presumption that the limitation in question is
not present in the independent claim). In addition, because claims 37, 41, and 45 also
lack the preformed animal tissue limitation, it is presumed that the patentee did not
intend for those claims to be so limited.
Based on the intrinsic evidence of the 748 Patent, the Court concludes that the
term buttress material is properly construed as a material useful for reinforcing a
seam.
B. Region Limitations
1. first region of buttress material
The parties dispute the meaning of the term first region of buttress material as it
appears in claims 37 and 45 of the 748 Patent. Synovis contends that no construction is
necessary, but alternatively that if the Court decides to construe the term, it should be
construed as a region of buttress material. (Joint Statement at 15.) Gore, on the other
5 Gore also asserts that the patent differentiates between buttress and other
reinforcing materials, and that reinforcing materials could encompass polymeric
materials, but the buttress material does not. The Court disagrees. A reading of the
patent, which references patents that disclose how to use polymeric materials,
demonstrates that the terms buttress and reinforcing materials are the same.
9
hand, asserts that the Court should construe first region as portion of buttress material
adapted to remain in position within the body. (Id.)
Synovis maintains that the use of the first region and second region is
patent-law convention used to distinguish between repeated instances of an element or a
limitation. Synovis asserts that the use of either no construction or its alternative
construction would convey the meaning of the terms without adding meaning that is not
part of the claim language, creating redundancies, or complicating the language of the
claim. Synovis also asserts that Gore is attempting to impose an improper limitation into
the claim language. Gore asserts that Synovis proposed construction impermissibly
deletes the word first from the term first region and would render the claim
unintelligible. In addition, Gore contends that the term region is generic and must be
understood in terms of the written description.
The use of first and second regions can be a way to distinguish between
repeated instances of an element or limitation. See 3M Innovative Properties Co. v.
Avery Dennison Corp., 350 F.3d 1365, 1371 (Fed. Cir. 2003). Here, the use of first is
used to identify a part of the buttress material (first region of buttress material).
Limitations to this region appear elsewhere in the claim language. Importing those
limitations into the term first region would be redundant and unnecessary. The Court
concludes that the term first region has a meaning that is readily understandable and
construction is not necessary.
10
2. second region of buttress material
The parties also dispute the meaning of the term second region of buttress
material as it appears in claims 37 and 45 of the 748 Patent. Synovis contends that no
construction is necessary, but alternatively that if the Court decides to construe the term,
it should be construed as a region of buttress material. (Joint Statement at 16.) Gore,
on the other hand, asserts that the Court should construe second region as region of
buttress material which forms an integral raised center portion. (Id.; Tr. at 151.)
Synovis makes many of the same arguments that it made in support of its
construction of first region, namely that the use of the first region and second
region is common patent-law convention and that Gores construction would add
meaning that is not part of the claim language, therefore creating redundancies and
complicating the language of the claim.
In addition to the arguments made with respect to the construction of first
region, Gore asserts that its construction is compelled in light of the specification,
Synovis admissions,6 and the prosecution history. Gore asserts that the specification
describes the second region of buttress material as being generally concentric to, and
integral with, the first region, providing a desired three dimensional and/or topographic
structure adapted to position and/or retain the materials in place upon the respective
stapler component. (748 Patent c. 3, ll: 48-56.) Gore also asserts that Synovis agreed
6 Gore cites to Synovis responses to Request for Admissions wherein Synovis
admitted that the second region is within and circumscribed by the interior boundary of
the first region. (Gore Ex. 12 at Nos. 11 & 13.)
11
that the claims are limited to structures in which the second region alone provides the
three-dimensional structure and that Synovis cannot now assert that the first region is part
of that structure. Gore further asserts that the claims must be limited so as to require the
second region of buttress material to have an integral raised center portion to ensure the
claims are supported by the written description and enabled.
First, the Court concludes that Gores acquiescence argument, which is based
primarily on the 748 Patents prosecution history, is unavailing. Gore asserts that the
applicants agreed to incorporate the language of Paragraph 187 of the published
application into newly submitted claims during the patents prosecution. Gore asserts
that in doing so, Synovis implicitly agreed that the new claims (including claims asserted
7 Paragraph 18 of the published application corresponds to the following language
of the 748 Patent:
The buttress material portions preferably provide two or more
regions, including a first region adapted to remain in position within the
body in order to serve as the staple line buttress itself, together with one or
more portions of a second region adapted to assist in positioning and/or
retaining the buttress material upon a stapler component. Preferably, the
one or more portions of the second region are adapted to be removed from
the tissue site upon activation of the stapler knife. The second region is
generally concentric to, and integral with, the first region, providing a
desired three dimensional and/or topographic structure adapted to position
and/or retain the materials in place upon the respective stapler component.
Generally, the second region is internal to the circular seam formed, and
can be removed together with the severed ends of the joined tissue portions
in order to provide an unobstructed lumen for the joined tissue portions.
(748 Patent c. 3, ll: 39-56.)
12
in this action) would be limited to structures in which the second region alone provides
the three-dimensional structure. The Court disagrees.
In a summary of a March 20, 2006 interview between the examiner and the
applicant, the examiner noted that [c]laims will be amended to incorporate the allowable
subject matter of claim 10[8] into claim 1, and in another independent claim, subject
matter from paragraph 0018 of the specification will be combined with the language of
claim 1. (Gore Ex. 8.) In the Remarks section in the applicants April 3, 2006
Amendment to the patent application, the applicants stated with respect to the same
interview:
In the course of the [March 20] interview it was agreed that claims 1 and 11
would be allowable if amended to incorporate the limitations of claims 10
and 20, respectively, and without the need to include original intervening
claims. It was also agreed that new claims would be allowable if added to
incorporate discussion found in paragraph [0018] of the application as
published, which claims are now provided as new claims 41-42, 45-46, 49-
50, and 53-56[9]. . . .
(Gore Ex. 9.)
Thereafter, the applicant added the raised center portion language to claim 1.
The applicant also incorporated language that is supported by Paragraph 18 into new
claims, including the claims asserted here. Gore argues that Paragraph 18 described the
three-dimensional structure as in the second region and therefore that claims 37 and 45
must be construed to contain that limitation. The applicants also, however, added new
8 Claim 10 recited a raised center portion.
9 The new claims encompassed the claims being asserted in this action.
13
language to issued claims 37 and 45; namely, the first and second regions cooperating to
provide a desired three dimensional and/or topographic structure. The addition of the
cooperating to provide language, which was allowed by the examiner, demonstrates
that the applicants did not agree that all of the patent claims would be limited to
structures in which the second region alone provides the three-dimensional structure via a
raised center portion.10
Gores proposed construction seeks to add a limitation by construing second
region in claims 37 and 45 as region of buttress material which forms an integral raised
center portion. There are claims in the 748 Patent that contain that limitation; in
particular, claim 1 expressly contains the raised center portion element. The asserted
claims, however, do not.11 The Court declines to import that limitation into the asserted
10 The Court notes that Paragraph 18 does not contain the raised center portion
language. Therefore, that the applicants acknowledged that the issued claim 37
incorporated discussion from Paragraph 18 does not limit claim 37 to a raised center
portion.
11 Gore also cites to the examiners Reasons for Allowance, which read in part:
None of the prior art of record . . . discloses a kit with a buttress material portion for
each of the cartridge and anvil components of a stapler and a combination medical device
comprising a circular stapler instrument and one or more buttress materials, where each
of the buttress portions or materials comprises, inter alia, a circumferential disc with an
integral raised center portion. (Gore Ex. 10.) This statement, which is part of the
patents prosecution history, is not enough to warrant a departure from the plain language
of the asserted claims. First, the examiner did not indicate that the integral raised center
portion was to become an element in all of the asserted claims. Moreover, in the
applicants Amendment, the raised center portion language was expressly added to
other claims (i.e., claim 1), but not to the language of claims 37 and 45. Thus, the Court
presumes that claims 37 and 45 do not contain that limitation.
14
claims. Moreover, the Court concludes that the term second region of buttress material
has a meaning that is readily understandable and no construction is necessary.
C. The staple line/seal/seam limitations
The parties dispute the meaning of the following terms as they appear in
claims 37, 39, 41, 43, 45, and 47 of the 748 Patent. All of the terms are related to the
seal or seam formed when the stapler is fired.
1. staple seam
Synovis contends that no construction is necessary, but if the Court decides to
construe staple seam, it should be construed as a seam between two joined sections of
tissue. (Joint Statement at 9.)12 Gore, on the other hand, asserts that the Court should
construe this term as seam formed when tissue sections are joined with staples. (Id.)
The Court concludes that the term staple seam is properly construed as a seam formed
when tissue sections are joined with staples.
2. staple line buttress seal between joined tissue sections
Synovis contends that no construction is necessary, but if the Court decides to
construe the term, the term should be construed as a reinforced seal between two joined
sections of tissue, having both tissue and buttress material. (Joint Statement at 6.) Gore,
on the other hand, asserts that the Court should construe this term as seal formed by
buttress material positioned between abutting terminal sections of the first and second
tissue portions. (Id.)
12 Synovis originally proposed using the word joint instead of seam, but
abandoned that proposal during the Markman hearing. (Tr. at 64.)
15
Synovis asserts that its proposed construction captures the notion of reinforcement
inherent in the term staple line buttress and reflects the concept of a buttress seal,
which Synovis maintains is necessarily composed of both buttress and tissue. Gore
argues that its proposed construction is based upon the plain language of the term,
making clear that the seal specifically includes buttress material that is positioned
between abutting sections of tissue.
Both parties constructions provide for a seal between two sections of tissue. The
parties dispute centers on where the buttress material and tissue are located after the seal
is formed. Synovis asserts that the tissue ends up between the two sections of the buttress
material. (Tr. at 66.) Gore maintains that the asserted claims require the buttress material
to be between the abutting terminal portions of the first and second tissue portions.
Gore contends that the specification demonstrates that the buttress material ends
up between portions of tissue. For example, Gore relies on a portion of the Detailed
Description, which explains that in an embodiment, the staple cartridge buttress has a
circumferential flat disc-like portion (26) adapted to be positioned upon the open face
(34) of the staple cartridge component (12), and to ultimately be positioned between the
abutted tissue sections (and adjacent to the anvil buttress disc-like portion (32)) in order
to serve as a staple line buttress. (784 Patent c. 4, ll: 54-65.) The specification further
explains that [t]he buttress materials comprise a generally planar circumferential exterior
region . . . to be positioned between the abutting sections of tissue in order to form a seal
therebetween. (Id., c. 5, ll: 37-41). In addition, Gore points to the portions of the
specification describing the staple cartridge component being adapted to retain and
16
position a terminal section of the first tissue portion, (id., c. 5, ll: 7-8), and the stapler
anvil component as adapted to retain and position a terminal section of the second tissue
portion. (Id., c. 5, ll: 17-20.) Gore maintains that the specification describes the
terminal sections of the tissue portions as being positioned directly on the cartridge and
anvil and, further, that the buttress material is positioned between the abutting sections of
tissue.
Synovis contends that Gores construction would improperly exclude all
embodiments in the 748 Patent and render the claims inoperable. Synovis asserts that
the buttress material in the 748 Patent is always depicted as abutting the stapler and anvil
components. (748 Patent FIGS. 1-3.) In addition, Synovis asserts that the tissue is
always shown over the buttress material. (Id., FIGS. 4a-d.) Synovis further asserts that
the buttress seal is between the sections of tissue to be joined (for example two sections
of intestine), and not between abutting terminal ends of that tissue.
Synovis asserts that the portions of the Detail Description (primarily Column 4 of
the 748 Patent) cited by Gore in support of the notion that the buttress material is in
between the tissue refer only to FIG. 2 of the 748 Patent and that FIG. 2 represents an
embodiment of the buttress material before the tissue in involved. (Tr. at 67.) Synovis
asserts that Column 4 of the 748 Patent therefore describes the orientation of the
components prior to the tissue becoming involved. Synovis argues that the portion of the
specification that refers to the overall process of creating a seal, including the process
when the tissue is involved, demonstrates that the terminal ends of the tissue portions
become sandwiched between the buttress material. For example, Synovis points to the
17
language of Column 6 of the 748 Patent, which refers to Figures 4a-4d. Figures 4a-4d
illustrate the process for creating a seam. (Id., c. 6, ll: 11-14 (FIG. 4 shows a
cross-section view of the overall process of creating a reinforced stapled connection for
tubular tissue in four steps, from top to bottom, using a preferred embodiment of this
invention.).) Figures 4a-4c all show that the buttress material lies on the open face of
both the stapler and the anvil components and that the tissue being sealed ends up in
between portions of buttress material.13
The language of the claim term staple line buttress seal between joined tissue
sections, provides that the seal is between joined tissue sections. This is consistent with
the specification, which explains that buttress material along with joined tissue sections
make up the seal. For example, the Abstract of the 748 Patent explains that [t]he
buttress material is retained and provides an improved seal between the joined tissue
sections. The Summary of the Invention reads in part: to provide a first region of
buttress material as a staple line buttress seal retained between joined tissue sections.
(784 Patent c. 2, ll: 48-51.) According to the claim language and the specification, it is
the seal that remains between the joined tissue sections (i.e., two sections of intestine).
The Court next looks to the specification. It is evident that the language in
Column 6 of the 748 Patent and the illustrations of Figure 4 are most relevant to the
13 Gore asserts that the Court should not rely on Figure 4 because 4d is incorrect.
Gore asserts that Figure 4d must be inaccurate because it depicts buttress material being
removed that is not near the joined tissue sections. The portion of buttress material being
removed, however, is specifically labeled severed material. (748 Patent c. 6, ll: 44.)
That there is not a label for the remaining buttress material does not mean that there is
none or that the severed material is meant to encompass all of the buttress material.
18
construction of this term. As detailed above, this section of the specification
demonstrates an embodiment where the buttress material lies on the open face of both the
stapler and the anvil and that the tissue being sealed ends up between portions of buttress
material. Gores proposed constructionseal formed by buttress material positioned
between abutting terminal sections of the first and second tissue portions
is at odds with this embodiment. Gores proposed construction would require not only
that portions of buttress material lie on the open face of the stapler and anvil components,
but also that the portions of buttress material touch each other when the seal is formed. If
this configuration were required by the claim language, there would be no way for the
tissue to be involved with the seal. Therefore, the Court declines to adopt Gores
proposed construction. Instead, the Court construes the term as a reinforced seal
between two sections of tissue.
3. buttressed surgical seam between abutting tissue portions
Synovis contends that the term should be construed as a reinforced seam between
two joined sections of tissue, having both tissue and buttress material. (Joint Statement
at 11.) Gore, on the other hand, asserts that the Court should construe seam formed by
buttress material positioned between abutting terminal sections of the first and second
tissue portions. (Id.) For the reasons discussed with respect to the construction of
staple line buttress seal between joined tissue sections above, the Court construes this
term as a reinforced seam between abutting tissue portions.
19
4. staple line buttress itself
Synovis contends that no construction is necessary, but if the Court decides to
construe staple line buttress itself, the term should be construed as portion of a first
region of buttress material that is within the reinforced seal, and is the only material that
remains in the body. (Joint Statement at 8; Tr. at 64.) Gore, on the other hand, asserts
that the Court should construe this term as the portion of the buttress material that is
stapled between abutting terminal sections of tissue and remains in position within the
body and forms the staple line buttress seal. (Id.)
Synovis contends that its construction accurately captures the meaning of the term
while keeping the term in context of the claims, which refer to a region adapted to serve
as the staple line buttress itself. Synovis asserts that Gores proposed construction adds
unnecessary language and unsupported limitations. In particular, Synovis asserts that
Gores construction would require that the entirety of the first region stay in the body and
that the buttress material be positioned between abutting terminal sections of tissue.
Gore asserts that staple line buttress is the portion of the buttress material that is
stapled between abutting terminal sections of tissue and remains within the body to form
the staple line buttress seal. In support, Gore cites to the specification. (See 748 Patent
c. 3, ll: 40-42 (including a first region adapted to remain in position within the body in
order to serve as the staple line buttress itself); c. 4, ll: 53-58 (a circumferential flat,
disc-like portion adapted . . . to ultimately be positioned between the abutted tissue
sections . . . to serve as a staple line buttress); c. 5, ll: 37-41 (The buttress materials
comprise a generally planar circumferential exterior region . . . to be positioned between
20
the abutting sections of tissue in order for form a seal therebetween.).) Gore asserts that
Synovis proposed construction is incorrect by stating that only a portion of the first
region remains in the body and that the specification indicates that portions other than the
first region may remain in the body.
For the reasons discussed above with respect to the staple line buttress seal
between joined tissue sections term, the Court does not construe the term staple line
buttress itself to require that the portion of buttress material be stapled between
abutting terminal sections of tissue. Consistent with the ordinary meaning of the claim
terms and the specification, the Court construes the term as portion of the buttress
material that is within the reinforced seal.
D. stably positioned upon the staple cartridge and/or anvil components
of the stapler instrument, adapted to assist in positioning and/or
retaining the buttress material, and adapted to position and/or
retain the materials in place
The Court discusses the above terms together because the parties proposed
constructions are essentially the same for each term and the construction of the first term
will apply to the construction of the second and third. Claim 37 and 45 of the 748 Patent
refer to buttress material adapted to be [] stably positioned upon the staple cartridge
and/or anvil components of the stapler instrument.14 Synovis contends that no
construction is necessary, but if the Court decides to construe the term, it should construe
it as located so as to avoid becoming dislodged, during the course of its normal use,
14 Claims 37, 41, and 45 refer to a region of buttress material that is adapted to
assist in positioning and/or retaining the buttress material. Claims 37, 41, 44, 45, and 48
all reference a structure adapted to position and/or retain the materials in place.
21
from the staple cartridge and/or anvil components. (Joint Statement at 13.) Gore, on the
other hand, asserts that the Court should construe the phrase as positioned in a secure
fashion upon the staple cartridge and/or anvil components of the stapler by virtue of its
physical structure without the need for adhesives or ties. (Id.)
Synovis claims that its proposed construction is consistent with the language of the
claim terms and with the intrinsic evidence. Specifically, Synovis asserts that the claim
terms all discuss positioning and retaining the buttress material on the stapler
components. Synovis points to language in the Summary of the Invention that explains
that the buttress material is designed so as to avoid being dislodged or delaminated from
its position in the course of positioning. (748 Patent c. 2, ll: 62-63.) Synovis asserts
that Gores inclusion of the requirement that the positioning occur by virtue of its
physical structure without the need of adhesives or ties is unjustified. Synovis asserts
that the specification repeatedly refers to adhesives, ties, and gels as optional features for
further enhancing the positioning of the buttress material.
Gore asserts that Synovis proposed substitution of the word located for
positioned would not be helpful to the jury and that the concept of normal use is not
supported by the claims and would add ambiguity. In addition, Gore asserts that
Synovis construction does not capture a critical aspect of the inventionthat the stable
positioning of the buttress materials is attributed to its physical structure. Gore also cites
to portions of the specification that it argues describe the invention in a way that requires
that the buttress material be capable of being stably positioned by virtue of its physical
structure.
22
It is apparent that the parties dispute centers on the inclusion of the language by
virtue of its physical structure without the need for adhesives or ties. With the exception
of this language, there is no significant difference between the parties proposed
constructions. The Court concludes that the intrinsic evidence does not support the
additional language proposed by Gore. First, the Summary of the Invention reads in part:
The preformed tissue portions permit the placement and retention of the
portions upon respective stapler components, preferably without the need
for adhesives, ties, and the like. The preformed tissue portions can be
treated (e.g., chemically treated) and/or manipulated (e.g., sewn) to retain
suitable three dimensional structure and topographic features (e.g.,
raised/indented portions, ridges) that permit them to be positioned in a
secure fashion upon a respective stapler component, e.g., by press or
friction fit onto the corresponding grooves, apertures, ridges and edges of
the stapler device component.
(748 Patent c. 3, ll: 25-35.). The phrase preferably without the need for adhesives, ties,
and the like suggests that the specification describes a desirable, but not mandatory,
embodiment of the patent. See Cordis Corp. v. Medtronic AVE, Inc., 339 F.3d 1352,
1357 (Fed. Cir. 2003). The Summary of the Invention also reads: By virtue of its
physical structure, optionally aided with ancillary materials described herein, the material
retains sufficient properties, including shear resistance, to avoid being dislodged or
delaminated from its position in the court of positioning. (748 Patent c. 2, ll: 59-64.)
In addition, there are several references in the patent specification to the potential use of
adhesives. (748 Patent c. 3, ll: 16-20 (Also optionally, positioning of the material upon
a respective component can be accomplished or facilitated by the use of ancillary
materials, such as gels or ties.); id., c. 10, ll: 33-40 (example 1); id., c. 11, ll: 58-64
(example 2).)
23
The Court concludes that the specification does not support the addition of the
language without the need for adhesives or ties to the otherwise clear and
understandable claim language. In addition, the Court determines that the structure of the
buttress material to be stably positioned is described in the claim language and declines
to construe the claim term so as to add the language by virtue of its physical structure.
Instead, the Court determines that the meaning of the stably positioned terms are
readily understandable and no construction is necessary.
E. being generally concentric to
The parties dispute the meaning of the term being generally concentric to as it
appears in claims 37, 41, and 45 of the 748 Patent. Synovis contends that no
construction is necessary, but if the Court decides to construe the term, it should be
construed as generally sharing a common axis or center. (Joint Statement at 19.) Gore,
on the other hand, asserts that the Court should construe being generally concentric to
as having a common center (as circles one within another). (Id.) The Court concludes
that the term being generally concentric to is properly construed as a having a
common center (as circles one within another).
F. cooperating to provide a desired three dimensional and/or
topographic structure
The parties dispute the meaning of the term cooperating to provide a desired
three dimensional and/or topographic structure as it appears in claims 37, 41, and 45 of
24
the 748 Patent.15 Synovis contends that no construction is necessary, but if the Court
decides to construe the term, that it should be construed as cooperating to provide a
structure that is not flat. (Joint Statement at 10.) Gore, on the other hand, asserts that
the Court should construe this term as forming an integral raised center portion. (Id.)
Synovis asserts that a jury is capable of understanding the term without further
construction. Alternatively, Synovis asserts that its proposed construction is consistent
with the claims and intrinsic evidence, including the file history, and that the term not
flat encompasses the concepts of three dimensional and topographic. Synovis relies
on the specification, which Synovis asserts provides examples of buttress material with a
structure that is three dimensional and/or topographic. Synovis further argues that the
three-dimensional structure of the claimed buttress material contrasts with the prior art
reference U.S. Patent No. 6,656,193, which Synovis asserts disclosed two flat circular
buttress material embodiments. Synovis asserts that the examiner allowed independent
claims 37 and 45 because they explicitly included limitations on the buttress material
structure, specifically that the buttress material must include at least two portions that
cooperate to provide a desired three-dimensional and/or topographic structure. Synovis
claims that Gores proposed construction seeks to introduce a limitation that does not
exist in the claims, lacks support in the intrinsic evidence, and is an attempt to improperly
limit the scope of the claim to a single preferred embodiment.
15 These claims refer to the first and second regions [of buttress material]
cooperating to provide a desired three dimensional and/or topographic structure. (748
Patent c. 15, ll: 65-67.)
25
Gore contends that Synovis proposed construction is too general and that the
patent provides no support for a reinforcement wherein the three-dimensional structure is
not in the central, raised region. Instead, Gore asserts that its proposed construction,
forming an integral raised center portion, is supported by Figure 3 of the patent, which
Gore asserts shows the second region as having an integral raised center portion that is
three-dimensional on its own. Gore asserts that this second region does not need to
cooperate with the first region to provide a three-dimensional structure. Gore further
asserts that written description and the prosecution history of the 748 Patent support its
proposed construction. In particular, Gore asserts that in a January 3, 2006 Office
Action, the USPTO expressly allowed the claims because the examiner concluded that
[n]one of the prior art of record . . . discloses a kit with a buttress material portion . . .,
where each of the portions comprise, inter alia, a circumferential disc with an integral
raised center portion. (Gore Ex. 7 9.) Gore further asserts that Synovis acquiesced to
the inclusion of the subject matter of Paragraph 18 of the published application into all of
the asserted claims. Gore maintains that Paragraph 18 makes clear that the second region
provides the three-dimensional structure.
The Court first looks to the claim language, which expressly provides for the first
and second regions cooperating to provide a desired three dimensional and/or
topographic structure. This language, on its face, contradicts Gores proposed
construction, which does not require the second region to cooperate with the first region
to provide an integral raised center portion that is three-dimensional. Further, the
specification provides examples of buttress material with three dimensional structure.
26
The Summary of the Invention provides that buttress material portions can retain three
dimensional structure and topographic features (e.g., raised/indented portions, ridges) that
permit them to be positioned in a secure fashion upon a restrictive stapler component,
e.g., by press fit or friction fit onto the corresponding grooves, apertures, ridges and
edges of the stapler device component. (See 748 Patent c. 3, ll: 29-35.) The
specification also contains an example of a buttress material structure with a
three-dimensional structure. Figures 2 and 3 both show a buttress material with a
circumferential disc and an integral raised center portion. With respect to Figure 2, the
specification calls the interior circumferential regions of the buttress material
nonplanar. (748 Patent c. 5, ll: 46-47.) The specification also indicates that buttress
structure is defined by the shapes they are adapted to fit onto. The Detailed Description
explains: The actual buttress portions used are defined by the shapes they are adapted to
be positioned upon, which for a circular stapler are typically the staple cartridge and the
anvil components. (748 Patent c. 7, ll: 7-10.)
In addition, differences in the language of other claims suggest that claims 37, 41,
and 45 are not limited to forming an integral raised center portion. As explained
above, claim 1 of the 748 Patent recites a circumferential disc having an integral raised
center portion, while claim 37 does not. Instead, claim 37 requires the first and second
regions to cooperate to provide a three-dimensional or topographic structure.
Gore relies primarily on the prosecution history to limit the claim term. Gores
arguments are similar to those made with respect to the construction of the second
region of buttress material. The Court similarly rejects those arguments here. In
27
addition, the Court concludes that Gores proposed construction (forming an integral
raised center portion) is not supported by the intrinsic evidence. The Court further
concludes that the term has a meaning that is readily understandable and no construction
is necessary.
G. upon activation
The parties dispute the meaning of the term upon activation as it appears in
claims 37, 38, 39, 41, 42, 43, 45, 46, and 47 of the 748 Patent. Synovis contends that no
construction is necessary, but if the Court decides to construe the term, it should be
construed as immediately following or very soon after activation. (Joint Statement at
22.) Gore, on the other hand, asserts that the Court should construe upon activation as
as a result of activation. (Id.) The difference between the parties proposed
construction centers on the requirement in Gores proposed construction of a causal
relationship between the activation of the stapler and the severance of the second region.
Synovis asserts that its construction captures the commonly understood meaning
of the work upon, which connotes a temporal relationship between events. In support
of its proposed construction, Gore cites to portions of the specification, which, it argues,
supports a causal relationship. These include the following: The former region is
severed and discarded upon activation of the stapler to form an anastomoses. (Abstract.)
[T]o permit the removal of one or more portions of a second region of the buttress
material upon activation of a stapler knife provided by the stapler. (748 Patent c. 2,
ll: 52-55); Preferably, the one or more portions of the second region are adapted to be
removed from the tissue site upon activation of the stapler knife. (748 Patent c. 3,
28
ll: 44-47); Simultaneously, or thereafter, the distal end of an annular scalpel (40) is
extended through the sandwiched tissue and buttress material, until it bottoms out in a
recessed annular ring within the anvil, thereby severing an inner ring of the sandwiched
tissue/buttress material. (748 Patent, c. 6, ll: 38-41.) Gore maintains that the
specification makes clear that the second region is severed from the first region as a
result of the activation of the stapler.
The Court concludes that the term upon activation does not require a causal
relationship between two events. For example, claim 37 provides in part: wherein one
or more portions of the second region [of buttress material] are adapted to be removed
from the tissue site upon formation of the staple seam and activation of a stapler knife.
Nothing in the claim language or specification suggests that the use of the term upon
activation requires the activation of the stapler knife to cause the removal of the second
region of buttress material. Therefore, the Court believes that the use of Gores proposed
construction would only add confusion to an otherwise understandable term. Thus, the
Court declines to construe the term.
Therefore, IT IS HEREBY ORDERED that:
1. The claims at issue are construed as set forth in this Order.
Dated: January 23, 2009 s/Donovan W. Frank
DONOVAN W. FRANK
Judge of United States District Court
 

 
 
 

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