Ex Parte Derwin et al

Patent Trial and Appeal Board

Sep 8, 2017

12934791 (P.T.A.B. Sep. 8, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/934,791 09/27/2010 Kathleen Derwin CCF-018284-US-PCT 9807
26294 7590 09/12/2017
TAROLLI, SUNDHEIM, COVELL & TUMMINO L.L.P.
1300 EAST NINTH STREET, SUITE 1700
CLEVELAND, OH 44114
EXAMINER
TEMPLETON, CHRISTOPHER L
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/12/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
rkline @ tarolli. com
docketing@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KATHLEEN DERWIN, AMIT AURORA,
JOSEPH P. IANNOTTI, and JESSE A. McCARRON
Appeal 2016-001791
Application 12/934,791
Technology Center 3700
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON REQUEST FOR REHEARING
Appellants requested rehearing of the Board’s Decision entered July
6, 2017, which affirmed the Examiner’s rejections of claims 1, 6—12, 16—19,
and 33—42 as obvious under 35 U.S.C. § 103(a). Appellants’ request is
denied with respect to making any modifications to the Decision.
Appeal 2016-001791
Application 12/934,791
Appellants contend ‘Tt]lie Board erred because it misapprehended
Appellants’ claim language reciting ‘an extracellular matrix natch’ and ‘a
fascia patch,” as recited by, e.g., claims 1,11, 35, and 42. Req. Reh’g 2.
Appellants argue the Board did not “explicitly articulate logical and rational
reasons for its interpretation of Appellants ’ claim language''’ and “[t]he
Board’s interpretation of the Appellants ’ claim language is inconsistent with
the broadest reasonable interpretation standardId. at 2, 4. The Board did
not misapprehend Appellants’ claim language in rendering its Decision.
For convenience, we reproduce independent claims 1 and 11, which
are representative of the claim language now in dispute:
I. A biocompatible tissue graft comprising:
an extracellular matrix patch -, and
at least one fiber stitched into the patch in a concentric
reinforcement pattern, the at least one stitched fiber mitigating
tearing and/or improving fixation retention of the patch.
II. A biocompatible tissue graft comprising:
a fascia patch ', and
at least one fiber stitched into the patch in a reinforcement
pattern to mitigate tearing and/or improve fixation retention of
the patch, the at least one fiber being formed from at least one of
PLA and PGA.
App. Br. 38, 39 (Claims App’x) (emphasis added).
Appellants’ contentions focus on the following excerpt from the
Board’s Decision: “We find that a reasonable interpretation of the
Appellants’ claim language (‘an extracellular matrix patch’ and ‘a fascia
patch’) includes such subject matter, as an implant of elastomer and
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Application 12/934,791
extracellular matrix or of elastomer and collagen/fascia would satisfy
Appellants’ claim limitations.” Req. Reh’g 2 (citing Decision 11).
We apply the standard of broadest reasonable claim interpretation in
light of the specification. Cuozzo Speed Tech., LLC v. Lee, 136 S. Ct. 2131,
2145 (2016); see also In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000).
“[A] claim must be read in view of the specification of which it is a part,”
but “limitations from the specification are not to be read into the claims.”
Renishawpic v. Marposs Societaper Azioni, 158 F.3d 1243, 1248 (Fed. Cir.
1998); Sjolundv. Musland, 847 F.2d 1573, 1582 (Fed. Cir. 1988). “[T]he
words of a claim ‘are generally given their ordinary and customary
meaning.’” Phillips v. AWHCorp., 415 F.3d 1303, 1312—13 (Fed. Cir.
2005).
The claim language at issue was not expressly interpreted in the
Decision, nor was there any need to do so. It was found that the prior art
reasonably fell within the scope of the claim language under its broadest
reasonable interpretation, attributing the ordinary meaning to the claim
language at issue. As exemplified by the claims reproduced above, the
claims (1) use “comprising” transition language, meaning they are not
exclusive to the expressly-recited elements therein, and (2) merely recite, in
relevant part, “an extracellular matrix patch” and “a fascia patch,”
respectively. Thus, the plain language of the claims themselves does not
require that such patches (useful as tissue grafts) are singularly composed of
EMC or fascia. Thus, we find that the broadest reasonable interpretation of
such claim language would not exclude a patch composed of ECM or fascia,
respectively, and including other materials.
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Application 12/934,791
The Specification is consistent with and supportive of such an
understanding of patch-material non-exclusivity.1 Nowhere does the
Specification indicate that a graft patch must be singularly composed of
ECM or fascia. To the contrary, the Specification describes the invention as
open to combining ECM material with other materials in forming a patch,
describing, “[t]he tissue graft in accordance with the present invention
includes an extracellular matrix (ECM) patch (or ECM) and a reinforcing
means,” and
[t]he reinforcing means can include any structure or material that
is applied to the ECM, is capable of mitigating tearing of the graft
when the graft is fixed to tissue being treated, and/or is capable
of increasing or improving the fixation retention properties of the
tissue graft beyond that which is present in a patch of the ECM
alone.
Spec. 1132, 34.
Further, the Specification describes, “[t]he fixation retention
properties can be tailored to increase the graft’s ability to remain secured to
anatomic structures, such as bone and soft tissues, when used to treat a tissue
defect.” Id. 134. While, “[i]n one aspect of the invention, the reinforcing
means can include a thread or strands of fiber(s) that are stitched in a
reinforcement pattern in the ECM patch,” the invention is not described in
the Specification as limited to just this one aspect of reinforcing and, as the
Specification explains, the patch can include “any structure or material” that
may serve a reinforcing function. Id. H 34, 35. Moreover, the Specification
describes, “[i]n an aspect of the invention, the fibers and/or the ECM can be
1 Our references to the Specification or Spec, herein are to the application as
originally filed.
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Application 12/934,791
mechanically, chemically or biologically modified to enhance adhesion
between the fibers and ECM to further secure the fibers to the ECM. This
modification may occur before or after the fibers are incorporated into the
ECM.” Id. 139. In fact, the dependent claims on appeal (see claims 7, 9,
10, 16, 18, 19) reflect the concept that patches are composed of more than
one material. Therefore, in the Decision, we correctly identified that the
“extracellular matrix patch” and “fascia patch,” as claimed, are not limited to
patches composed singularly of ECM or fascia.
In their original briefing, Appellants did not present, and they do not
now present persuasive argument or evidence that our reading of the claim
language, which did not resort to extrinsic evidence, is incorrect in view of
the claims themselves and the Specification. The Specification does not
contradict, but reinforces that the ordinary meaning of “extracellular matrix
patch” is not limited to something composed of only ECM and the ordinary
meaning of “fascia patch” is not limited to something composed of only
fascia, but that the ECM or fascia may be combined (or mechanically,
chemically, or biologically modified) with any other materials (e.g., to
enhance the ECM or fascia patch’s fixation retention and reinforcing
properties, or for other reasons). This is the broadest reasonable
interpretation of this claim language and would be its ordinary meaning in
view of the Specification.
Furthermore, we note Appellants have consistently and repeatedly
equated ECM, collagen, and fascia. Decision FF15; App. Br. 24, 28 (Table
1), 30, 31, 33 (citing Spec. 132, i.e., published Spec. 133); Req. Reh’g 2
(“an ECM patch or a fascia patch would be understood to mean a dense
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collagen network”), 7 (citing Spec. 132 — “An ECM patch is derived from
mammalian tissues, such as fascia (‘fascia patch’)”). And, as identified in
the Decision, Datta discloses a reinforced patch made of such materials. See
FF1—FF5, and pages 9-11.
Appellants argued that Datta merely teaches “a highly porous,
synthetic elastomeric matrix.” See, e.g., Req. Reh’g 7. However,
Appellants consistently overlook the breadth of Datta’s disclosure. We note
that, of particular relevance in view of Appellants’ current contentions, Datta
discloses that the elastomer matrix component of its tissue
augmentation/repair implant is porous and, further, that the reticulated,
connected porosity of the elastomeric matrix can provide up to 99% of the
volume of the elastomeric matrix, or, essentially all of it. See Datta H 88,
100-101 (“void phase 14 is continuous or substantially continuous
thoroughout elastomeric matrix 10, meaning that there are few if any closed
cell pores,” and “the volume of void phase 14, as just defined, is from about
10% to about 99% of the volume of elastomeric matrix,” that is, “before any
optional interior pore surface coating or layering is applied”).
Further, as noted in the Decision (FF2, FF3) and as explicit in Datta’s
disclosure (see, e.g., Datta Tflf 229-45), Datta’s pores are filled with collagen
or ECM components, thus, the implant can be up to 99% collagen or ECM
components (ECM). Thus, Datta discloses fabricating essentially its entire
implant of collagen/ECM or, as discussed in the Decision, providing a
coating layer over its elastomer matrix that is entirely collagen/ECM. For
these reasons, we find it reasonable to identify Datta’s implant as an ECM or
fascia patch as defined by the claims or, at the very least, that Datta’s
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implant composed of collagen (and/or ECM components) would have
rendered such an ECM or fascia patch obvious.
Further, as ECM, collagen, and fascia are equivalent materials for the
purposes of the invention described in the Specification and the similar
purposes disclosed in the cited prior art, it is not only the implant of Datta
that discloses an ECM or fascia patch (see Datta Tflf 65, 80, 231—32, Til,
244, 253, 267—69), but Badylak’s tissue graft made of an ECM composition
(see, e.g., Badylack || 18, 59) and Bilbo’s tissue engineered prostheses
patch made of collagen / fascia lata and extracellular matrix / extracellular
matrix components (see, e.g., Bilbo Tflf 5—7, 12, 17, 42, 55) would each be
considered an ECM patch or a fascia patch, and/or would have rendered the
claimed patches obvious.
Finally, the Examiner’s rejections are premised on the obviousness of
combining Datta and either Badylak or Bilbo. Appellants contend:
the Board essentially reasoned that each of Datta . . ., Badylak
. . ., and Bilbo . . . disclose[s] an extracellular matrix (ECM) or
fascia patch and, thus, one skilled in the art would have simply
substituted the reinforcement pattern of Datta with the patches of
Badylak and Bilbo because these references disclose “ECM and
fascia patches.”
Req. Reh’g 2. Appellants’ point is not inaccurate, but it is too restrictive of
the prior art combination.
Datta suggests forming an implant essentially entirely of collagen or
ECM components or using such materials as a matrix coating, used for the
purpose of encouraging tissue regeneration, and also reinforcing such an
implant with, inter alia, concentric stitching (Datta illustrates such stitching
at Figs 5a—6d, 9a, 9b, 13, and 14). The ECM and fascia patches of Badylak
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Application 12/934,791
and Bilbo provide these materials for the same tissue regeneration
functionality as the collagen / ECM components of Datta, and all three
references disclose using their implants for similar purposes, e.g., sutured
tissue grafts. FF6—FF14. Therefore, the Examiner was correct that it would
have been obvious to combine these references, either by applying a
stitching pattern, as disclosed by Datta, to the patches disclosed by Badylak
and Bilbo, or by applying the ECM or fascia materials of Badylak and/or
Bilbo to the coating or reticulated pore filling of Datta’s stitched-implant,
and such combinations would have been reasonably expected to be
successful because Datta teaches that reinforcement stitching is useful to
improve pull-out resistance and load bearing for such a device, and each of
Badylak and Bilbo teaches its ECM and/or fascia materials are
suturable/stitchable. FF4, FF5, FF8, FF14.
SUMMARY
For the reasons set forth above, Appellants’ request is denied with
respect to making any modifications to the Decision affirming the
Examiner’s rejections.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv).
DENIED
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