Ex Parte Derwin et al

Patent Trial and Appeal Board

Sep 25, 2017

13663938 (P.T.A.B. Sep. 25, 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.
13/663,938 10/30/2012 Kathleen A. Derwin CCF-018284US CIP-1 9123
26294 7590 09/27/2017
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
09/27/2017 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 A. DERWIN, JOSEPH P. IANNOTTI, and
SAMBIT SAHOO1
Appeal 2016-005057
Application 13/663,93 82
Technology Center 3700
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
RYAN H. FLAX, and 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—3, 5—7, 11—15, 33,
34, and 39 are on appeal as rejected under 35 U.S.C. § 103(a).3 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 Appellants identify that U.S. Patent Application No. 12/934,791 (Appeal
2016-001791) is related to the application on appeal. App. Br. 4.
3 We understand that a rejection under 35 U.S.C. § 112 is withdrawn. See
Final Action 2, and Advisory Action (July 10, 2015); see also, generally,
Ans. (not addressing said rejection).
Appeal 2016-005057
Application 13/663,938
STATEMENT OF THE CASE
The Specification states the “invention relates to a reinforced,
biocompatible tissue graft.” Spec. 14. The Specification further states
“[t]he 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.” Id. 147. The Specification further
states:
The 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,
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, and/or can limit the cyclic stretching of
the graft and substantially maintain these properties following
partial enzymatic degradation of the graft while it remodels.
Id. 149. “In one aspect of the invention, the reinforcing means can include a
thread or strands of fiber(s).” Id. 1 50. The Specification further states, “[i]n
an aspect of the invention, the fibers and/or the ECM can be 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. | 55.
Claims 1 and 39 are the independent claims and are reproduced
below:
1. A biocompatible tissue graft comprising:
an extracellular matrix patch having a peripheral surface; and
at least one fiber stitched in a reinforcing pattern to mitigate
tearing of the graft and/or improve the fixation retention of the
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graft, the at least one fiber having at least one free end extending
beyond the peripheral surface of the extracellular matrix for
securing the patch to a host tissue.
39. A biocompatible tissue graft comprising:
a fascia lata patch having a peripheral surface; and
at least one fiber stitched into the patch in a reinforcing pattern
to mitigate tearing of the graft, improve the fixation retention of
the graft, and limit cyclic stretching of the graft, the at least one
fiber having at least one free end extending beyond the peripheral
surface of the patch for securing the patch to a host tissue;
wherein the at least one fiber comprises an ultra-high-molecular-
weight polyethylene braid.
App. Br. 40, 46 (Claims App’x).
The following rejections are on appeal:
Claims 1—3, 5—7, 11—13, 33 and 34 stand rejected under 35 U.S.C.
§ 103(a) over Badylak,4 Datta,5 and Leung.6 Final Action 3.
Claim 15 stands rejected under 35 U.S.C. § 103(a) over Badylak,
Datta, Leung, and Neisz.7 Id. at 4—5.
Claims 1—3, 5—7, 11—14, 33, 34, and 39 stand rejected under 35 U.S.C.
§ 103(a) over Bilbo,8 Datta, and Leung. Id. at 5.
4 US 2004/0006395 A1 (Jan. 8, 2004) (“Badylak”).
5 US 2007/0190108 A1 (Aug. 16, 2007) (“Datta”).
6 US 2009/0228021 A1 (Sept. 10, 2009) (“Leung”).
7 US 6,652,450 B2 (Nov. 25, 2003) (“Neisz”)
8 US 2002/0103542 A1 (Aug. 1, 2002) (“Bilbo”).
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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. Appellants and their declarant (Dr. Badylak) equate
ECM, fascia, and collagen (as well as submucosa) as synonymous
terms. App. Br. 22 (“ECM, which is a discontinuous collagen
network), 30 (Table 1 indicates ECM is collagen, “ECM, which is a
discontinuous collagen network”), 31 (“collagen (ECM)”), 32
(“collagen-rich ECM”), 35 (“fascia, which is one type of ECM (see
Paragraph [0047] of Appellants’ published U.S. patent application)
. . . discussion of the ECM patch of Badylak in the Declaration is
equally applicable to the fascia patch of Bilbo.”); Badylak Decl.9
8—9 (discussing Badylak’s disclosure of ECM/submucosa patch),
1115, 17 (“ECM [extracellular matrix] ... is a discontinuous collagen
network”), 123 (“collagenous sources, such as fascia”).
FF2. The Specification describes the invention as open to
combining ECM (e.g., collagen, fascia, submucosa) 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
9 Stephen F. Badylak Declaration Under 37 C.F.R. § 1.132 (Jan. 23, 2015)
(“Badylak Deck”).
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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. 32, 34. The Specification further describes, “[i]n an aspect of
the invention, the fibers and/or the ECM can be 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.
FF3. 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, H 2, 41, 315; see also Final Action 3—
15, and Ans. 2—15 (discussing Datta).
FF4. 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] elastin” and “extracellular matrix components.” Datta
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65, 73, 80, 232, 267, 268, 317; see also Final Action 3—15, and
Ans. 2—15 (discussing Datta).
FF5. 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 3—15, and Ans. 2—
15 (discussing Datta).
FF6. Datta discloses, “[t]he cells of elastomeric matrix 10 are
formed from clusters or groups of pores 20, which would form the
walls of a cell except that the cell walls 22 of most of the pores 20 are
absent or substantially absent owing to reticulation,” and “[i]n certain
embodiments, void phase 14 is continuous or substantially continuous
throughout elastomeric matrix 10, meaning that there are few if any
closed cell pores,” where “[i]n one embodiment, the volume of void
phase 14, as just defined, is from about 10% to about 99% of the
volume of elastomeric matrix 10.” Datta Tflf 84, 88, 101; see also
Final Action 3—15, and Ans. 2—15 (discussing Datta).
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FF7. Further to the preceding finding of fact, Datta discloses,
“some or all of the pores 20 of elastomeric matrix 10 are coated or
filled with a cellular ingrowth promoter,” where cellular ingrowth
“[promoters include naturally occurring materials that can be
enzymatically degraded in the human body or are hydrolytically
unstable in the human body, such as fibrin, fibrinogen, collagen,
elastin, hyaluronic acid and absorbable biocompatible
polysaccharides.” Datta 1237; see also Final Action 3—15, and Ans.
2—15 (discussing Datta). Thus, Datta teaches that its reinforced
elastomeric matrix can be composed of up to 99% collagen.
FF8. 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
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
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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 299-300; and see id. H 301—307; see also Final Action 3—
15, and Ans. 2—15 (discussing Datta).
FF9. 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 3—15, and Ans. 2—
15 (discussing Datta).
FF10. Further to the preceding finding of fact, Datta illustrates
such a stitching reinforcement at Figs. 5a—6d, 9a, 9b, 13, and 14; Figs.
5a, 5b, and 5c are reproduced below:
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fig. Sa Fig. 5b Fig. Sc
These figures are described by Datta as “illustrat[ing] several different
exemplary reticulated elastomeric matrix reinforcement grids.” “FIG.
5a illustrates an eliptical reinforcement element superimposed on a
rectangular grid reinforcement element,” where the implantable
device is stitched around its perimeter and in a grid pattern across and
to the peripheral edges of the device, where the eliptical pattern
stitching overlaps the grid pattern. Datta 1309. “FIG. 5b illustrates
two [overlapping] eliptical reinforcement elements superimposed on a
rectangular grid reinforcement element,” similar to the perimeter and
grid stitching patterns of Fig. 5a. Id. “FIG. 5c illustrates a rectangular
grid reinforcement element,” similar to Fig. 5a, but having a denser
grid pattern. Id.
FF11. Datta discloses “[t]he reinforcement can comprise mono­
filament, multi-filament yam, [and] braided multi-filament yams” and
“can be made from absorbable or non-absorbable materials,”
including “polyolefins []such as polyethylene.” Datta ^fl[ 302-03; see
also Final Action 3—15, and Ans. 2—15 (discussing Datta).
FF12. In view of the preceding findings of fact, Datta teaches a
collagen / ECM tissue repair implant having fiber(s) stitched in a
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reinforcing pattern to improve the strength, durability, and anchoring
of the implant.
FF13. 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
an extracellular matrix composition.” Badylak Abstract, || 6, 18, 41;
see also Final Action 3—5, 7—10, 12—14, and Ans. 2—11, 13—15
(discussing Badylak). Thus, Badylak teaches an extracellular matrix
patch.
FF14. 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 3—5, 7—10,
12— 14, and Ans. 2—11, 13—15 (discussing Badylak).
FF15. 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 | 59; see also Final Action 3—5, 7—10, 12—14, and Ans. 2—11,
13— 15 (discussing Badylak).
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FF16. In view of the preceding findings of fact, Badylak
teaches a suturable, ECM, tissue graft.
FF17. 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 that the original implanted prosthesis is
remodeled by the patient’s living cells.’ '’ Bilbo Abstract, H 5, 7, 12
(emphasis added); see also Final Action 5—7, 10-11, 14—15, and Ans.
2, 8, 10, 13—15 (discussing Bilbo).
FF 18. Bilbo discloses its “processed tissue matrices may be
treated or modified” by “chemical modifications such as binding . . .
extracellular matrix components.” Bilbo 117; see also Final Action
5—7, 10-11, 14—15, and Ans. 2, 8, 10, 13—15 (discussing Bilbo).
FF19. 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 5—7, 10-11, 14—15, and Ans. 2, 8, 10, 13—15 (discussing
Bilbo).
FF20. Bilbo discloses making a collagen matrix construct by
“spread[ing an intestinal collagen layer (ICL)] mucosal side down
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onto a smooth polycarbonate sheet.” Bilbo 135; see also Final Action
5—7, 10-11, 14—15, and Ans. 2, 8, 10, 13—15 (discussing Bilbo).
FF21. Bilbo discloses “[t]he multilayer construct is useful for
treating connective tissue such as in rotator cuff or capsule repair.”
Bilbo 1142, 118; see also Final Action 5—7, 10-11, 14—15, and Ans.
2, 8, 10, 13—15 (discussing Bilbo).
FF22. 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 5—7, 10-11, 14—15, and Ans. 2, 8, 10, 13—15 (discussing
Bilbo).
FF23. Bilbo discloses its implant is “‘suturable’ mean[ing] 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,” where “[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,” and
“the prosthesis resists creep during bioremodeling, and additionally is
pliable and suturable.” Bilbo Tflf 5, 23, 38, 40, 63, 64, 118; see also
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Final Action 5—7, 10-11, 14—15, and Ans. 2, 8, 10, 13—15 (discussing
Bilbo).
FF24. In view of the preceding findings of fact, Bilbo teaches a
suturable, fascia lata / ECM implant.
FF25. The Oxford Dictionary defines “suture” as follows: “A
stitch or row of stitches holding together the edges of a wound or
surgical incision.” Oxford Dictionary, suture, https://en.oxford-
dictionaries.com/defmition/suture, Sept. 8, 2017 (emphasis added);
see also Ans. 7—8, and Advisory Action (July 10, 2015) (discussing
the meaning of stitching and suturing).
FF26. Leung discloses, “[a] matrix material is provided for
implanting in tissue in surgical applications. The matrix material
includes a body portion and at least one suture attached to the body
portion so that the suture extends outwardly from the body portion,”
where such a structure is useful to “eliminate the need for tying knots
in the suture to hold the matrix material in tissue.” Leung Abstract,
Fig. 1, || 13, 14, 39; see also Final Action 3—8, 12, 14, and Ans. 2, 8
(discussing Leung).
FF27. Neisz is directed to “[a]n implantable article ... to treat
urological disorders” where a “filament 66 [is] attached] to the sling
42” and “the [filament] is coated with a radiopaque substance,
retaining the member [filament] 66 allows the practitioner to track
post-operative changes to the position of the sling 42.” Neisz
Abstract, 33:48—55; see also Final Action 4—5 (discussing Neisz), and
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Datta 377—38 (disclosing advantages to making a radio-opaque
implantable device).
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).
“[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. The obviousness analysis “can take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418. “A person of ordinary skill is also a
person of ordinary creativity, not an automaton.” Id. at 421.
As to motivation to combine separately 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
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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).
Obviousness Over Badylah, Datta, and Leung
Reviewing the Examiner’s rationale for the obviousness rejection and
the cited prior art combination, we find that, in view of the findings of fact
and 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
extracellular matrix patch with a reinforcing stitched fiber (e.g., a fiber-
stitching-reinforced, tissue graft or patch composed of a reticulated porous
elastomer and up to 99% ECM / collagen or having an ECM / collagen
coating or sleeve). FF1—FF16, FF25. The prior art combination also teaches
that the stitching fiber can have at least one free end extending from the
peripheral surface of the patch. FF26.
Further, we find that the skilled artisan would have combined Datta
with Badylak because each reference is directed to the same field of
endeavor, because Datta teaches that it would be advantageous to
incorporate a layer or coating or pore-filling of bio-material, such as
collagen, with its elastomer matrix to encourage tissue repair at the implant
on a cellular level, and because Badylak teaches using ECM / collagen in
such an implant, either alone or in combination with other materials, for the
very same purpose. FF3, FF5—FF7, FF13, FF14. 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 (FF3—FF12) (and, Badylack teaches an ECM
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patch is suturable (FF15)), and because, as acknowledged by Appellants an
ECM is collagen (FF1).
Appellants have not produced persuasive evidence showing, or
persuasively argued, that the Examiner’s determinations are incorrect. We
address Appellants’ arguments below.
Appellants have repeatedly argued that the materials used by Datta
and by Badylak (or Bilbo)10 are different and have fundamentally different
properties, but, in conflict with this position, have repeatedly relied on the
common properties of collagen, ECM, and fascia, equating these terms, in
arguing that the properties of elastomers cannot be attributed to such
material. Compare App. Br. 18, 22—23, 27, 29, 30—31, 33, 35, and Reply Br.
3, 8, with FF1. Appellants rely on their contention of material differences, in
view of the Badylak Declaration, as the basis for the argument that the
skilled artisan would not combine Datta’s reinforcement stitching with an
ECM (and/or fascia) patch as taught by Badylak (and Bilbo) and also for the
argument that making such a combination would not reasonably be expected
to be successful. This is the over-arching theme of Appellants’ case;
however, Appellants’ arguments wholly ignore that Datta teaches a patch or
implant that is up to 99% collagen / ECM (FF3—FF7, FF12) and includes
reinforcement stitching (FF8—FF12) that improves the load bearing,
10 Although Bilbo is combined with Datta in a separate obviousness
rejection, we discuss the reference here because Appellants make the same
arguments over each rejection, contending that the ECM of Badylak and the
fascia material of Bilbo are so similar to one another and so different from
the elastomer material of Datta that claims 1 and 39 warrant the same
rationale for the patentability. See, e.g., App. Br. 35.
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positioning, and pullout resistance of such a patch / implant. Appellants also
ignore or dismiss that Badylak teaches an ECM patch that can be sutured /
stitched (FF13—FF16; FF25), that Bilbo teaches an ECM / fascia patch that
is suturable / stitchable to native tissue and resists tearing (FF17—FF21,
FF23—FF25), and that each of these combined references teaches using
ECM / collagen / fascia in a patch as support for tissue regeneration (see,
e.g., FF5, FF14, FF17).
Appellants acknowledge several facts:
(1) “Badylak teaches multilayer sheets of the Badylak
submucosa [ECM] can be formed by overlapping a single
submucosa [ECM] sheet and fixing the sheets to one another
using sutures ... to provide a means for holding the sheets
together” (App. Br. 15, 20);
(2) Badylak and Datta can be combined and “can be used for
tissue repair” (id. at 17);
(3) “Datta and Badylak [are] in the same field of endeavor” (id.
at 18);
(4) “[i]t is true that ECM grafts are commonly sutured during
surgery” (id. at 19);
(5) “stitching can be done to enhance the strength of a reticulated
elastomer (as taught by Datta [as being 99% collagen])” (id. at
21, 22 (acknowledging Datta’s disclosed “void volume of 10-
99%,” which is filled with collagen)); and
(6) “fascia ... is one type of ECM . . . [t]hus, discussion of the
ECM patch of Badylak in the Declaration is equally applicable
to the fascia patch of Bilbo.” (id. at 35).
We agree with the Examiner that it would be obvious to combine the
matrix of Datta with the ECM material of Badylak or the collagen / fascia
material of Bilbo, and also find that Datta itself teaches and suggests a patch
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composed of up to 99% collagen, which Appellants equate to ECM and
fascia, which suggests that if a collagen-based implant can be reinforced by
stitching, an ECM-based and/or fascia-based patch can, similarly, be
reinforced by such stitching. In view of the Appellants’ acknowledged facts
and the findings of fact set forth above, it is apparent that the cited prior art
combination would reasonably have been made by the skilled artisan and
reasonably would have been expected to be made successfully.
Appellants’ arguments that differences between the materials of Datta
and the other references would not allow one to transfer understanding of
reinforcing stitching from one reference to the other are not persuasive. The
stitching disclosed to be reinforcing in Datta would likewise be reinforcing if
one of skill were to use Badylak’s extracellular matrix or Bilbo’s fascia lata
as Datta’s bio-material-coating or pore-filling, as the references suggest.
Datta itself discloses that its implant, taught as reinforced by stitching, is up
to 99% collagen (once again, Appellants identify that ECM is collagen at,
inter alia, Table 1 of their brief, and that fascia is ECM at page 35 of their
brief — see FF1). Thus, Appellants’ contentions that Datta does not teach
and suggest that such stitching would improve the fixation retention of an
ECM or fascia patch are not persuasive.
The Examiner cited Leung in combination with Datta and Badylak for
its teaching that a patch can include a fiber having at least one free end
extending beyond the peripheral surface of the patch. Final Action 4.
Appellants do not contest that Leung teaches this or the propriety of its
inclusion in the prior art combination.
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For the above reasons, we affirm the rejection over Datta, Badylak
and Leung.
Obviousness Over Badylak, Datta, Leung, and Niesz
Reviewing the Examiner’s rationale for the obviousness rejection and
the cited prior art combination, we find that, under the above-cited
precedent, the Examiner has established that Appellants’ claim 15 would
have been obvious. As discussed above, in agreement with the Examiner,
we find that the prior art combination teaches an implantable extracellular
matrix patch with a reinforcing stitched fiber (e.g., a fiber-stitching-
reinforced, tissue graft or patch composed of up to 99% collagen / ECM).
FF1—FF16, FF25. The prior art combination also teaches that the stitching
fiber can have at least one free end extending from the peripheral surface of
the patch. FF26. Further, the prior art teaches that the fibers can be radio­
opaque to allow locating the implanted device. FF27.
Regarding claim 15, Appellants state:
claim 15, which depends directly from claim 1, [and] is
patentable over Badylak in view of Datta and Leung, and further
in view of Neisz for at least the reasons that claim 1 is patentable
over Badylak in view of Datta and Leung (discussed above), and
for the specific features recited therein.
App. Br. 35. Therefore, for the same reasons discussed above, we find
Appellants’ arguments not persuasive and affirm the obviousness rejection
of claim 15.
Obviousness Over Bilbo, Datta, and Leung
Reviewing the Examiner’s rationale for the obviousness rejection and
the cited prior art combination, we find that, in view of the findings of fact
and under the above-cited precedent, the Examiner has established that
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Appellants’ claims would have been obvious. As discussed above, in
agreement with the Examiner, we find that the prior art combination teaches
an implantable fascia lata patch with a reinforcing stitched fiber (e.g., a
fiber-stitching-reinforced, tissue graft or patch composed of up to 99%
collagen / ECM). FF1—FF12, FF17—FF25. The prior art combination also
teaches that the stitching fiber can have at least one free end extending from
the peripheral surface of the patch. FF26. The prior art combination also
teaches that the stitching fiber can be made of polyolefins such as
polyethylene. FF11.
With respect to this rejection, Appellants argue:
It is therefore respectfully submitted that one of ordinary skill in
the art at the time of the claimed invention would have realized,
for at least the reasons discussed above [regarding the rejection
over Badylak, Datta, and Leung], that the Examiner’s proposed
combination of Bilbo with Datta and Leung would fail to fulfill
a prima facie rejection of claims 1 and 39 under 35 U.S.C.
§ 103(a). In view of the foregoing [arguments over combining
Badylak and Datta], it is respectfully submitted that claims 1 and
39 are not obvious in view of the prior art references of record
and are allowable.
App. Br. 36. Thus, Appellants do not present any arguments over this
rejection different from those presented with respect to the first obviousness
rejection.
Therefore, we affirm this rejection for the same reasons set forth
above regarding the affirmance of the first obviousness rejection.
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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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