Ex Parte Derwin et al

Patent Trial and Appeal Board

Jul 3, 2017

12934791 (P.T.A.B. Jul. 3, 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 07/06/2017
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
07/06/2017 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. MCCARRON1
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 APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a biocompatible tissue graft. Claims 1, 6—12, 16—19, and
33—42 are on appeal as rejected under 35 U.S.C. § 103(a).2 We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as The Cleveland Clinic
Foundation. App. Br. 3.
2 We understand that a rejection under 35 U.S.C. § 112 is withdrawn. See
Final Action 2, and Advisory Action (Mar. 27, 2015); see also, generally,
Ans. (not addressing said rejection).
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Application 12/934,791
STATEMENT OF THE CASE
The Specification states the “invention relates to a reinforced,
biocompatible tissue graft.” Spec. 14. The Specification further states:
The tissue graft in accordance with the present invention
includes an extracellular matrix (ECM) patch (or ECM) and a
reinforcing means. The ECM can be derived from any
mammalian ECM, such as fascia, and in particular, fascia lata
from humans. . . . The ECM can also be derived, for example,
from other tissues and/or other materials, such as collagen, skin,
bone, articular cartilage, meniscus, myocardium, periosteum,
artery, vein, stomach, large intestine, small intestine, diaphragm,
tendon, ligament, neural tissue, striated muscle, smooth muscle,
bladder, ureter, abdominal wall fascia, and combinations thereof.
Spec. 132.
Claims 1, 11,35, and 42 are the independent claims; claim 1 is
representative and is reproduced below:
1. 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.
App. Br. 38 (Claims App’x).
The following rejections are on appeal:
Claims 1, 6—10, 33, 38, and 39 stand rejected under 35 U.S.C.
§ 103(a) over Badylak3 and Datta.4 Final Action 2—3.
3 U.S. Pat. App. Pub. No. US 2004/0006395 A1 (Jan. 8, 2004) (“Badylak”).
4 U.S. Pat. App. Pub. No. US 2007/0190108 A1 (Aug. 16, 2007) (“Datta”).
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Claims 11, 12, 16—19, 34, 35—37, 40, 41, and 42 stand rejected under
35 U.S.C. § 103(a) over Bilbo5 and Datta. Id. at 4.
FINDINGS OF FACT
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the claims and prior art, and conclusions set out in the Final
Action and Answer. The findings of fact set forth below are provided to
highlight certain evidence.
FF1. Datta discloses “reticulated elastomeric matrices ... for
implantable devices into or for topical treatment of patients, such as
humans and other animals, for surgical devices, tissue augmentation,
[and] tissue repair,” for example, for an “orthopedic application []
relating] to a repair, reconstruction, regeneration, augmentation, gap
interposition, or any mixture thereof of a tendon,” such as “rotator cuff
repair.” Datta, abstract, || 2, 41, 315; see also Final Action 2—17, and
Ans. 2—14 (discussing Datta).
FF2. Datta discloses its “elastomeric material of which
elastomeric matrix 10 is constituted may be a mixture or blend of
multiple materials,” for example polycarbonate and collagen, such that
“the reticulated elastomeric matrix of the invention facilitates tissue
ingrowth by providing a surface for cellular attachment, migration,
proliferation and/or coating (e.g., collagen) deposition,” and may
include “connective tissue” and “biopolymer, such as collagen, [or]
5 U.S. Pat. App. Pub. No. US 2002/0103542 A1 (Aug. 1, 2002) (“Bilbo”).
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elastin.” Datta 80, 65, 73, 232, 268, 317; see also Final Action 2—
17, and Ans. 2—14 (discussing Datta).
FF3. Further to the preceding finding of fact, Datta discloses:
An[] embodiment of the invention employs a collagen-
coated composite elastomeric implantable device, as described
above, configured as a sleeve extending around the implantable
device. The collagen matrix sleeve can be implanted at a tissue
repair and regeneration site, either adjacent to and in contact with
that site. So located, the collagen matrix sleeve can be useful to
help retain the elastomeric matrix 10, facilitate the formation of
a tissue seal and help prevent leakage. The presence of the
collagen in elastomeric matrix 10 can enhance cellular
ingrowth and proliferation and improve mechanical stability,
in one embodiment, by enhancing the attachment of fibroblasts
to the collagen. The presence of collagen can stimulate earlier
and/or more complete infiltration of the interconnected pores
of elastomeric matrix 10.
Datta 1253 (emphasis added); see also Final Action 2—17, and Ans. 2—
14 (discussing Datta).
FF4. Datta discloses:
The reinforced elastomeric matrix and/or compressed
reinforced elastomeric matrix can be made more functional for
specific uses in various implantable devices by including or
incorporating a reinforcement, e.g., fibers, into the reticulated
cross-linked biodurable elastomeric polycarbonate urea-urethane
matrix. The enhanced functionalities that can be imparted by
using a reinforcement include but are not limited to enhancing
the ability of the device to withstand pull out loads associated
with suturing during surgical procedures, the device’s ability to
be positioned at the repair site by suture anchors during a surgical
procedure, and holding the device at the repair site after the
surgery when the tissue healing takes place. In another
embodiment, the enhanced functionalities provide additional
load bearing capacities to the device during surgery in order to
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facilitate the repair or regeneration of tissues. In another
embodiment, the enhanced functionalities provide additional
load bearing capacities to the device, at least through the initial
days following surgery, in order to facilitate the repair or
regeneration of tissues. In another embodiment, the enhanced
functionalities provide additional load bearing capacities to the
device following surgery in order to facilitate the repair or
regeneration of tissues.
One way of obtaining enhanced functionalities is by
incorporating a reinforcement, e.g., fibers, fiber meshes, wires
and/or sutures, into the elastomeric matrix. Another exemplary
way of obtaining enhanced functionalities is by reinforcing the
matrix with at least one reinforcement. The incorporation of the
reinforcement into the matrix can be achieved by various ways,
including but not limited to stitching, sewing, weaving and
knitting. In one embodiment, the attachment of the
reinforcement to the matrix can be through a sewing stitch.
Datta H299-300; and see id. H 301—307; see also Final Action 2—17,
and Ans. 2—14 (discussing Datta).
FF5. Further to the preceding finding of fact, Datta discloses
that such “reinforcement can be incorporated into the reticulated
elastomeric matrix in different patterns,” such as stitching “along the
border,” and/or “along the perimeter” and/or “in geometrically-shaped
patterns” or lines, so as to improve the implant’s strength as exhibited
by enhanced suture pullout strength, break strength, and ball burst
strength. Datta H 308—322; see also Final Action 2—17, and Ans. 2—14
(discussing Datta).
FF6. Badylak discloses “[a] tissue graft construct for use in
repairing diseased or damaged tissues,” which “comprises a matrix
composition,” e.g., “in sheet form,” that “is preferably prepared from
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an extracellular matrix composition.” Badylack, abstract, || 6, 18, 41;
see also Final Action 2—4, 9-12, 14—16, and Ans. 2—14 (discussing
Badylak).
FF7. Badylak discloses that such a matrix “provides a unique
cell growth substrate that promotes the attachment and proliferation
of cells in vitro and induces tissue remodeling when the graft
constructs are implanted in vivo,” and “advantageously provides a
physiological environment that supports the proliferation and
differentiation of cells cultured in vitro on the matrix composition.”
Badylak || 4, 31 (emphasis added); see also Final Action 2—4, 9—12,
14—16, and Ans. 2—14 (discussing Badylak).
FF8. Badylak discloses its tissue graft may take the “form [of]
multilayer sheets of submucosa, multiple layers of submucosa can be
overlapped with each other” and “fixed to one another using standard
techniques known to those skilled in the art, including the use of sutures
and biocompatible adhesives such as collagen binder pastes.” Badylak
159; see also Final Action 2-4,9-12,14—16, and Ans. 2—14 (discussing
Badylak).
FF9. Bilbo discloses a “tissue engineered prostheses made from
processed tissue matrices derived from native tissues that are
biocompatible,” such as collagen derived from fascia lata, which can be
in the form laminate sheets and “can serve as a functioning repair,
augmentation, or replacement body part or tissue structure,” and “when
implanted on the damaged or diseased soft tissue, undergoes controlled
biodegradation occurring with adequate living cell replacement such
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Application 12/934,791
that the original implanted prosthesis is remodeled by the patient’s
living cells’'’ Bilbo, abstract, || 5, 7, 12 (emphasis added); see also
Final Action 4, 6—9, 11—14, 17, and Ans. 2—3, 10, 13—14 (discussing
Bilbo).
FF10. Bilbo discloses the “[intrinsic and functional properties of
the implant, such as the modulus of elasticity, suture retention and
ultimate tensile strength are important parameters which can be
manipulated for specific requirements.” Bilbo 1 5; see also Final
Action 4, 6—9, 11—14, 17, and Ans. 2—3, 10, 13—14 (discussing Bilbo).
FF11. Bilbo discloses making a collagen matrix construct by
“spread[ing an intestinal collagen layer (ICL)] mucosal side down onto
a smooth polycarbonate sheet.” Bilbo 135; see also Final Action 4, 6—
9, 11—14, 17, and Ans. 2—3, 10, 13—14 (discussing Bilbo).
FF12. Bilbo discloses “[t]he multilayer construct is useful for
treating connective tissue such as in rotator cuff or capsule repair.”
Bilbo 142, 118; see also Final Action 4, 6—9, 11—14, 17, and Ans. 2—3,
10, 13—14 (discussing Bilbo).
FF13. Bilbo discloses its implant “may be populated with cells
to form a cellular tissue construct comprising bonded layers of ICL and
cultured cells,” e.g., progenitor cells, and the “[cjells may also be
genetically engineered to express proteins or different types of
extracellular matrix components which are either ‘normal’ but
expressed at high levels or modified in some way to make a graft device
comprising extracellular matrix.” Bilbo 51, 53, 55; see also Final
Action 4, 6—9, 11—14, 17, and Ans. 2—3, 10, 13—14 (discussing Bilbo).
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FF14. Bilbo discloses its implant is “‘suturable’ meaning] that
the mechanical properties of the layer include suture retention which
permits needles and suture materials to pass through the prosthesis
material at the time of suturing of the prosthesis to sections of native
tissue.” Bilbo 64, 118; see also Final Action 4, 6—9, 11—14, 17, and
Ans. 2—3, 10, 13—14 (discussing Bilbo).
FF15. Appellants and their declaration state, “ECM
[extracellular matrix] ... is a discontinuous collagen network.” App.
Br. 28; Badylak Deck 117.6
DISCUSSION
Only those arguments made by Appellants in the Briefs have been
considered in this Decision. Arguments not presented in the Briefs are
waived. See 37 C.F.R. § 41.37(c)(l)(iv) (2015). Because Appellants present
essentially the same arguments and evidence in support of the patentability
of the claims over each rejection, we address both rejections together.
“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v.
Adams, 383 U.S. 39, 50-51 (1966). “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” Id. As to motivation to combine separately
6 Stephen F. Badylak Declaration Under 37 C.F.R. § 1.132 (Nov. 5, 2014)
(“Badylak Deck”).
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disclosed subject matter, “the question is whether there is something in the
prior art as a whole to suggest the desirability, and thus the obviousness, of
making the combination, not whether there is something in the prior art as a
whole to suggest that the combination is the most desirable combination
available.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation
omitted).
It is prima facie obvious to combine two [things] each of which
is taught by the prior art to be useful for the same purpose, in
order to form a third [thing] which is to be used for the very same
purpose. . . . [T]he idea of combining them flows logically from
their having been individually taught in the prior art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
Reviewing the Examiner’s rationale for the obviousness rejections and
the cited prior art combinations, we find that under the above-cited
precedent the Examiner has established that Appellants’ claims would have
been obvious. In agreement with the Examiner, we find that the prior art
combination teaches an implantable, biocompatible tissue graft or patch that
includes a combination of elastomeric polymer and extracellular matrix,
collagen, or fascia, where the patch is strengthened by a stitched
reinforcement, which may take the form of a concentric pattern and may use
stitching fibers of polylactic or polyglycolic acid. FF1—FF14. Further, we
find that the skilled artisan would have combined Datta with either Badylak
or Bilbo because each reference is directed to the same field of endeavor,
because Datta teaches that it would be advantageous to incorporate a layer of
bio-material, such as collagen, with its polymer matrix to encourage tissue
repair at the implant on a cellular level, and because each of Badylak and
Bilbo teaches using either extracellular matrix or collagen (closely related
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materials) in such an implant, either alone or in combination with other
materials, for the very same purpose. FF3, FF7, FF9. Further, the skilled
artisan would have reasonably expected such a combination to succeed
because Datta teaches an elastomeric polymer and collagen are combinable
and also reinforceable by stitching (FF2—FF4), because, as acknowledged by
Appellants, extracellular matrix is composed of collagen (FF15), and
because collagen can be derived from fascia (FF9).
Appellants have not produced evidence showing, or persuasively
argued, that the Examiner’s determinations are incorrect. We address
Appellants’ arguments below.
Appellants’ arguments are focused, generally, on the contention that
Badylak and Datta, as well as Bilbo and Datta, would not have been
combined by the skilled artisan because there would be no motivation to do
so and no reasonable expectation of successfully doing so. App. Br. 14, 33.
Appellants argue that there would be no reason to add a reinforcing stitch
pattern, much less a specifically concentric one as taught by Datta as applied
to a polymer matrix, to an extracellular matrix patch as taught by Badylak,
or to a collagen/fascia patch as taught by Bilbo, because the bio-materials of
Badylak and Bilbo are different from the polymer of Datta and, at the time
of invention, there was at least uncertainty as to how stitching affected
various materials in terms of reinforcement or weakening thereof. App. Br.
15—17, 23 (citing Badylak Deck Tflf 8—10, 17). This is not persuasive.
Appellants also argue that there would have been no reasonable expectation
of success in the prospect of reinforcing an extracellular matrix patch as
taught by Badylak (or Bilbo’s collagen patch) with a concentric stitch
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pattern as taught by Datta because their disclosed materials have very
different mechanical properties. App. Br. 19-20, 23 (citing Badylak Decl.
16, 17). Appellants contend the Examiner’s rationale for such an
expectation, that is, that the patches of the references (Badylak and Datta)
are each used to repair tissue, is not sufficient because it is too general. Id.
at 18. These arguments are also not persuasive.
As we have found that it would be obvious to combine the polymer
material of Datta with the extracellular matrix material or collagen fascia
material of Badylak and Bilbo, respectively, as suggested by the references,
the Appellants’ argument that the differences between these materials would
not allow one to transfer understanding of reinforcing stitching from one
reference to the other is irrelevant. The stitching that is taught to be
reinforcing in Datta would likewise be reinforcing if one of skill were to use
Badylak’s extracellular matrix or Bilbo’s fascia as Datta’s bio-material-
coating, as the references suggest. 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
extracellular matrix or of elastomer and collagen/fascia would satisfy
Appellants’ claim limitations.
For the above reasons, we affirm the rejections over Datta and
Badylak or Bilbo.
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SUMMARY
The rejections of the claims as obvious are each affirmed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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