THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

Patent Trials and Appeals Board

Oct 29, 2020

13891562 - (D) (P.T.A.B. Oct. 29, 2020)

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.
13/891,562 05/10/2013 Karen Christman 24978-0213 1030
29052 7590 10/29/2020
EVERSHEDS SUTHERLAND (US) LLP
999 PEACHTREE STREET, N.E.
SUITE 2300
ATLANTA, GA 30309
EXAMINER
KIM, TAEYOON
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
10/29/2020 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):
patentdocket@eversheds-sutherland.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte KAREN CHRISTMAN,
JENNIFER SINGELYN, and JESSICA DEQUACH
__________

Appeal 2020-002061
Application 13/891,562
Technology Center 1600
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to a
catheter based administration method for cardiac tissue repair or
regeneration. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as the Regents
of the University of California (see Appeal Br. 2).
2 We have considered the Specification of May 10, 2013 (“Spec.”); Non-
Final Office Action of Aug. 10, 2018 (“Non-Final Action”); Appeal Brief of
Sept. 11, 2019 (“Appeal Br.”); and Examiner’s Answer of Nov. 19, 2019
(“Ans.”).
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Statement of the Case
Background
“The most common cause of cardiovascular disease is myocardial
infarction (Ml), which occurs when a coronary artery is occluded. MI
results in the death of cardiomyocytes and extracellular matrix (ECM)
degradation, followed by scar tissue deposition. Eventually heart failure is
onset” (Spec. ¶ 4). “Current efforts to prevent heart failure after myocardial
infarction have focused on cellular transplantation to replace necrotic
cardiomyocytes, prevent negative left ventricular remodeling, and regenerate
heart tissue. However, without the proper matrix, cardiomyocyte growth in
vitro and survival in vivo have been poor” (id. ¶ 7). The Specification
teaches “a composition comprising decellularized extracellular matrix
derived from cardiac tissue” (id. ¶ 8).
The Claims
Claims 21, 27–32, 34, 35, 37–39, 44, 45, and 47–52 are on appeal.
Claim 21 is representative and reads as follows:
21. A catheter based administration method for cardiac tissue
repair or regeneration in a subject in need thereof, comprising
delivering 2–8 mg/mL of decellularized extracellular matrix
derived from cardiac muscle tissue to ischemic cardiac tissue
within said subject through a catheter and catheter needle
having a gauge 27G, 28G, 29G, or 30G, wherein the
decellularized extracellular matrix transitions to a gel form in
vivo after delivery through the catheter and catheter needle to
the ischemic cardiac tissue.

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The Rejection
The Examiner rejected claims 21, 27–32, 34, 35, 37–39, 44, 45, and
47–52 under U.S.C. § 103(a) as obvious over Badylak,3 Freyman,4
Kornowski,5 PuraMatrix,6 and Klein7 (Ans. 3–8).
The Examiner finds Badylak teaches “administering a solubilized
extracellular matrix (ECM) composition to a patient in an un-gelled form
prior to gelation where the composition gels in situ . . . and the ECM is
decellularized after isolation from the tissue of interest” (Ans. 4). The
Examiner finds Badylak teaches “(urinary bladder matrix) concentration is
around 3–6 mg/ml” (id. at 5).
The Examiner acknowledges that Badylak does not “teach the method
for cardiac tissue repair or the ECM being delivered to an ischemic cardiac
tissue of a subject” or “the concentration of decellularized ECM from
cardiac muscle tissue” (id. at 4, 5).
The Examiner finds Freyman teaches “the use of decellularized ECM
for treating diseased, defected, damaged or ischemic tissue or organ
including heart valves, myocardium, pericardium” and also teaches “cardiac

3 Badylak et al., US 2008/0260831 A1, published Oct. 23, 2008.
4 Freyman et al., US 2005/0181016 A1, published Aug. 18, 2005.
5 Kornowski et al., Electromagnetic Guidance for Catheter-Based
Transendocardial Injection: A Platform for Intramyocardial Angiogenesis
Therapy, 35 J. Am. College Cardiology 1031–9 (2000).
6 PuraMatrix, 3DM Inc., WWW.Puramatrix.com, 1–3 (2005). The
Examiner refers to this reference as “PuraMatrix” and Appellant refers to the
reference as 3DM (see, e.g., Ans. 4, Appeal Br. 3). We will refer to this
reference as “PuraMatrix.”
7 Klein et al., Injectible Collagen in Tissue Augmentation in Clinical
Practice 63–82 (Taylor & Francis 2006, first edition).
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muscle tissue is a source of decellularized ECM” (id.). The Examiner finds
Kornowski teaches “the use of a catheter-based needle (27G) for
intramyocardial injection for treating an ischemic heart” (id. at 5–6). The
Examiner finds PuraMatrix teaches “hydrogel can be injected into a tissue
using 30G needle” (id. at 6). Finally, the Examiner finds that Klein teaches
“Zyderm collagen (ZC) can be injected using a 30- or 32-gauge needle when
it is stored at 4°C” (id. at 6).
The Examiner finds it obvious to “combine the teachings of Badylak
et al. with the teachings of Freyman et al. because since both teachings are
directed to the use of decellularized ECM isolated from cardiac tissue” (Ans.
4–5). The Examiner further finds it obvious to “determine a suitable
concentration of a decellularized ECM derived from cardiac muscle tissue
that can be gelled in vivo” (id. at 5). The Examiner also finds Kornowski
renders it obvious “to use a catheter-based transendocardial injection using a
27G needle” as a known equivalent (id. at 5–6).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Badylak,
Freyman, Kornowski, PuraMatrix, and Klein render the claims obvious?
Findings of Fact
1. Badylak teaches “methods for preparing gelled, solubilized
extracellular matrix (ECM) compositions useful as cell growth scaffolds”
that can be “administered to a patient in an un-gelled form prior to gelation
where the composition gels in situ” (Badylak ¶ 12).
2. Badylak teaches a process for preparation of cardiac ECM (see
Badylak ¶ 91).
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3. Badylak teaches that after “isolation of the tissue of interest,
decellularization is performed by various methods” (Badylak ¶ 50).
4. Badylak teaches
the composition is injected as a pre-gel into a patient. The
composition is injected at a locus in the patient where the
matrix is needed for cell growth. For example and without
limitation, where a patient has had tissue removed due to
trauma . . . [T]he composition can be injected at the site of
tissue removal to facilitate in-growth of tissue. The viscosity of
the pre-gel can be controlled by varying the amounts of water
(e.g., by varying the amounts of water, acid, base, buffer (such
as PBS) or other diluents) used to prepare the pre-gel. In
applications in which a small gauge needle is used, such as in
endoscopy, a less viscous pre-gel would be needed, which
typically results in a less viscous gel, once the pre-gel is gelled.
In applications in which a larger gauge needle is available, a
more viscous gel, with higher strength when gelled, can be
used.
(Badylak ¶ 70).
5. Badylak teaches exemplary ECM concentrations, specifically
“[c]ollagen type I gels at a concentration of 3 mg/ml became more turbid
following gelation than UBM-gel at a concentration of 3 mg/ml and 6
mg/ml” (Badylak ¶ 119). Badylak teaches that:
ECM powder suspended in saline and UBM gels were tested
side by side to see if they could successfully pass through
injection needles frequently used in medical procedures such as
vocal cord augmentation. These needles had 1 cm long, 25
gauge caliber tips that are attached to 25 cm long, 16 gauge
needle shafts. UBM gels easily and consistently passed through
these needles. The UBM powder suspension had an upper limit
concentration of 10 mg/ml above which the needle would be
frequently occluded, making it difficult to determine the actual
amount of ECM delivered. This trial showed the feasibility of
using the [UBM] gel as an injectable material.
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(Badylak ¶ 123).
6. Freyman teaches “decellularized extracellular matrix may be
used to promote angiogenesis and/or repair, replace or regenerate cells,
tissues or organs, such as but not limited to lymph vessels, blood vessels,
heart valves, myocardium, pericardium, pericardial sac” (Freyman ¶ 21).
7. Freyman teaches “[b]one marrow extracellular matrix has
potential therapeutic value in treating myocardial infarction” (Freyman
¶ 200).
8. Freyman teaches “[s]uitable animal body tissue from which the
decellularized extracellular matrix material of the present invention is
produced includes” “internal organs, such as the heart” and “[e]xamples of
muscle tissue include, but are not limited to, myocardium (heart muscle)”
(Freyman ¶¶ 46, 48).
9. Kornowski teaches “an injecting catheter having a 27G needle
for intramyocardial delivery of potentially therapeutic agents” (Kornowski
1032, col. 1).
10. Kornowski teaches “this system should permit the routine safe
transendocardial delivery of therapeutic agents into the LV myocardium. If
the biologic and clinical importance of angiogenic treatment is ultimately
demonstrated, the system we describe in this report may constitute an
important new strategy of treating patients with myocardial ischemic
syndromes” (Kornowski 1038, col. 2).
11. Klein teaches treatment with zyderm collagen (ZC) where
ZC contains 95% to 98% type I collagen; the remainder is type
III collagen. The collagen is suspended in phosphate-buffered
physiologic saline with 0.3% lidocaine. It is provided in
prefilled syringes, which are stored at a low temperature (4°C),
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so that the dispersed fibrils remain fluid and small. This allows
passage of the product through a 30- or 32-gauge needle. Once
implanted, the human body temperature (37°C) causes the
product to undergo consolidation into a solid gel.
(Klein 64).
12. PuraMatrix teaches in vivo delivery using a “needle to 26 or
30G and inject in tissue of choice” (PuraMatrix 1).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007).
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Ans. 3–8, FF 1–12) and agree that Badylak, Freyman, Kornowski,
PuraMatrix, and Klein render claim 1 obvious. We particularly agree with
and adopt the Examiner’s response to arguments and to the Christman
Declaration.8 We address Appellant’s arguments below.
Appellant contends:
There is no reason to combine Kornowski with Badylak
or Freyman. The Applicant respectfully disagrees that the
Examiner demonstrates that these references would be obvious
to combine. In particular, the Examiner states, “Badylak et. al.
do not particularly teach the method for cardiac tissue repair of
the ECM being delivered to an ischemic cardiac tissue of a

8 Declaration of Dr. Karen Christman, dated Nov. 20, 2017.
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subject.” (See Office Action at p. 3, para. 4). The Examiner
later states “Kornowski does not teach a ‘viscous’ solution”
(See Office Action at p. 8, para. 3). Therefore, how could it be
obvious to one skilled in the art to combine these references
when they are in completely different fields of study (ECM
manufacturing, and stem cell delivery)?
(Appeal Br. 4).
We find this argument unpersuasive because in an obviousness
analysis, “[i]f a person of ordinary skill can implement a predictable
variation, § 103 likely bars its patentability.” KSR, 550 U.S. at 417). Here,
Badylak teaches methods of preparing decellularized ECM compositions,
including cardiac ECM, in un-gelled form that are delivered to the location
where cell growth is needed and then gel in situ (FF 1–3). Freyman also
teaches preparing ECM from heart tissue (FF 8) and explains “decellularized
extracellular matrix may be used to promote angiogenesis and/or repair,
replace or regenerate cells, tissues or organs, such as but not limited to . . .
heart valves, myocardium, pericardium” (FF 6). Thus, the ordinary artisan
would have had reason to apply Badylak’s cardiac ECM to treatment of
cardiac tissues in order to promote blood vessel growth (angiogenesis) or to
replace damaged cardiac tissues (FF 1–3, 6–8).
Badylak also teaches that “the composition is injected as a pre-gel into
a patient. The composition is injected at a locus in the patient where the
matrix is needed for cell growth” and that this injection may be performed
using either a small gauge or large gauge needle depending upon the
optimized gel viscosity (FF 4) including a 25G needle (FF 5). Kornowski
evidences that one particular gauge of needle, 27G gauge needles, may be
used for intramyocardial delivery (FF 9). Kornowski specifically teaches the
“routine safe transendocardial delivery of therapeutic agents into the LV
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myocardium” (FF 10). Thus, an ordinary artisan interested in delivery of the
cardiac ECM of Badylak or Freyman using various gauge needles as taught
by Badylak would have had reason to select the 27G gauge needle of
Kornowski because it would be routine and safe (FF 1–4, 6, 9, 10).
Appellant contends “there is no clear rationale for combining the
references with Korn[o]kowski considering the physical differences and the
completely different research fields as compared to the Badylak and
Freyman references” (Appeal Br. 45).
We interpret this argument as asserting that Kornowski is non-
analogous art to Badylak and Freyman and find the argument unpersuasive.
“Prior art is analogous if it is from the same field of endeavor or if it is
reasonably pertinent to the particular problem the inventor is trying to
solve.” Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331, 1335 (Fed. Cir.
2015). Under either test, Kornowski is reasonably understood as analogous
to Badylak and Freyman. All three references are in the field of endeavor of
delivering pharmaceutical materials to heart tissue for therapeutic purposes
(FF 4, 6, 9, 10). Even if these references were not in the same field of
endeavor, Kornowski’s teaching that 27G needles are a safe and routine way
to deliver un-gelled treatment materials to the heart would have been directly
pertinent to Freyman who teaches treatment of cardiac tissue with ECM (FF
6) and to Badylak who teaches delivery of un-gelled ECM using various
gauge needles to trauma locations (FF 4). An ordinary artisan, considering
which specific gauges of needles to use based on Badylak’s treatment would
have reasonably looked to Kornowski’s teaching as a guide for needles
useful in treatment of cardiac tissue.
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Appellant contends:
It is erroneous to find that one skilled in the art would
have been motivated to combine the method of Badylak with
the catheter-based injection of Kornowski and a 30G needle of
3DM. In particular, the 3DM reference has no bearing on this
application, as it does not describe an ECM hydrogel.
Hydrogel is a generic scientific term for a gel-like substance
that contains water. As described above, biomaterial
compositions vary widely and to assume that one hydrogel with
completely different components would behave the same as an
ECM hydrogel is flatly erroneous.
(Appeal Br. 5).
We find this argument unpersuasive because the Examiner has already
demonstrated that Badylak teaches the use of a variety of different needles
for delivery of the un-gelled ECM (FF 4) and Kornowski teaches that 27G
needles may be used for delivery of therapeutics to cardiac tissue (FF 9).
PuraMatrix is simply further evidence showing that un-gelled materials may
be administered through 30 or 32 gauge needles prior to forming gels in the
human body (FF 11). As KSR explains, “if a technique has been used to
improve one device, and a person of ordinary skill in the art would recognize
that it would improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.” KSR, 550
U.S. at 417. Here, PuraMatrix supports the Examiner’s position by
providing further support for Badylak’s teaching that un-gelled materials
such as un-gelled ECM may be administered through smaller needle gauges
such as 30G needles (FF 4, 11).
Appellant contends a
person of ordinary skill looking to modify the method disclosed
in Badylak for delivery of hydrogels would look to methods of
delivering viscous solutions. In contrast, Kornowski relates to
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delivering adenoviral vectors in a 3% sucrose solution, which is
a low viscosity solution having a viscosity of 1.081 relative to
water, using a catheter-based transendocardial injection using a
27G needle. (Kornowski, p. 1033, col. 2, para. 2.) Cardiac
catheters, as used in Kornowski, typically are ~1 m in length.
(See “Christman Declaration” filed on November 27, 2017,
Appendix 2C.)
(Appeal Br. 6). Appellant therefore contends the ordinary artisan would
expect Badylak’s “catheter and/or needle would become occluded with the
ECM when pushing concentrations of ECM needed to form a gel in vivo
through the length of the catheter, and as such the ECM of Badylak could
not reasonably be expected to travel through a long cardiac catheter without
significant dilution” (id.).
We are not persuaded for several reasons. First, none of the claims
impose any specific length requirement on the catheter or needle, and
Appellant provides no evidence showing that only meter long needles
function to reach the heart. “[A]ppellant’s arguments fail from the outset
because . . . they are not based on limitations appearing in the claims.”). In
re Self, 671 F.2d 1344, 1348 (CCPA 1982). Indeed, Badylak teaches the use
of 25 cm long needles (FF 5), and Appellant provides no explanation why
that length would be insufficient to administer the obvious ECM
composition to a human heart.
Second, we have considered the inventor Declaration of Dr.
Christman, but she also asserts the requirement for longer catheters that is
not recited in any of the pending claims (see, e.g., Christman Decl. ¶ 7). We
are also unpersuaded by Dr. Christman’s assertion that “there is no
reasonable expectation that a decellularized cardiac ECM at a concentration
of 2-8 mg/ml would pass through a cardiac catheter with a 27G needle and
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form a gel in vivo” (Christman Decl. ¶ 8). The evidence of record does not
support Dr. Christman’s statement. Badylak specifically teaches that UBM
“easily and consistently passed through” 25G needles in concentrations of 3
mg/ml and 6 mg/ml that fall within the claimed range (FF 5). Badylak
teaches that only at concentrations above 10 mg/ml was occlusion a problem
(FF 5). Moreover, Klein evidences that smaller 30G and 32G needles
functioned to allow passage of un-gelled Zyderm II material that is up to
6.5% gelling material (FF 11; Klein 64). Similarly, Appellant provides no
persuasive evidence that the other concerns of higher pressure or issues
would impede the use of Badylak’s material at 3 mg/ml using 27G needles.
We note that Appellant provides no comparative evidence showing
that the prior art Badylak composition would not pass through a 27G needle,
instead rebutting the evidence of record with the calculation that “the
difference in pressure change through a 27G needle versus a 25G needle is
greater than 50%” (Christman Decl. ¶ 6). However, the more than 50%
reduction in viscosity from the highest claimed 8 mg/ml value to the 3
mg/ml value disclosed by Badylak reasonably supports an understanding
that Badylak’s un-gelled 3 mg/ml ECM composition would be expected to
pass through a 27G needle (FF 4).
Appellant contends a
person skilled in the art, starting with Badylak, would not look
to Kornowski or 3DM or Klein to modify the method of
delivery of the ECM to ischemic tissue of a subject for cardiac
tissue repair of Badylak, because Badylak provides no teaching
or motivation to do so. In fact, Badylak discloses concerns
regarding the limitations arising as a result of the viscosity of
the ECM, and as such teaches away from modifying the method
in ways that would adversely affect these limitations (i.e.
increase length and decrease bore size of needle). There are
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countless possible ways of delivery and numerous needle bore
sizes and lengths. The Appellant asserts that all of these
choices are not all equivalent. The surprising technical success
of combining a smaller needle bore size and using a catheter for
delivery, while maintaining control and precision of delivery,
provides a method that can advantageously be used over prior
methods for cardiac tissue repair or regeneration.
(Appeal Br. 7).
We find these arguments unpersuasive for several reasons. “We start
from the self-evident proposition that mankind, in particular, inventors,
strive to improve that which already exists.” Pro–Mold & Tool Co., Inc. v.
Great Lakes Plastics, Inc., 75 F.3d 1568, 1573 (Fed. Cir. 1996). As
discussed above, Badylak suggests the use of un-gelled decellularized
cardiac ECM for treatment of damaged tissue (FF 1–4) using concentrations
as low as 3 mg/ml and needles as small as 25G (FF 5). Freyman explains
that ECM may have “therapeutic value in treating myocardial infarction”
(FF 7) and the ordinary artisan would have therefore found it obvious to
apply Badylak’s un-gelled decellularized cardiac ECM to repair organs
including heart valves, myocardium and pericardium (FF 6) for the expected
therapeutic improvement in these tissues due to cell repair. As also noted,
the ordinary artisan, interested in delivering the cells using smaller needles
because Kornowski teaches that 27G needles are suitable for intramyocardial
delivery of agents (FF 9).
We are not persuaded by Appellant’s argument that Badylak teaches
away from the use of a 27G needle. Badylak does not criticize, discredit, or
otherwise discourage the use of a 27G needle (FF 5). “The prior art’s mere
disclosure of more than one alternative does not constitute a teaching away
from any of these alternatives because such disclosure does not criticize,
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discredit, or otherwise discourage the solution claimed.” In re Fulton, 391
F.3d 1195, 1201 (Fed. Cir. 2004). As to Badylak’s teaching that amounts of
10 mg/ml or larger occlude the 25G needle, Badylak also teaches that 3
mg/ml and 6 mg/ml “easily and consistently passed through these needles”
(FF 5). Because the claims encompass these lower values and not the less
effective 10 mg/ml concentrations, there is no teaching away from the
concentrations recited in the claims. And to the extent that viscosity is an
issue, Badylak teaches the viscosity can be controlled by a variety of
measures (FF 4) and Klein teaches that using reduced temperatures also
allows improved fluidity (FF 11). Thus, the ordinary artisan, concerned with
gel fluidity, would have had a number of optimizable parameters available to
achieve administration as required by the claims.
Lastly, to the extent that Appellant is asserting “surprising technical
success” as a secondary consideration, Appellant has not demonstrated that
i. the result is unexpected, because it is only in the Attorney’s
arguments that the results are identified as unexpected (“[I]t is not enough to
show that results are obtained which differ from those obtained in the prior
art: that difference must be shown to be an unexpected difference” In re
Klosak, 455 F.2d 1077, 1080 (CCPA 1972));
ii. that a comparison of the claims to the closest prior art of Badylak
shows any differences (“[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991));
iii. and has not shown a result commensurate in scope with the claims
(Unexpected results must be “commensurate in scope with the degree of
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protection sought by the claimed subject matter.” In re Harris, 409 F.3d
1339, 1344 (Fed. Cir. 2005)).
Appellant contends
Without the blueprint drawn by Appellant, there is no reason
for a skilled artisan to look to Kornowski and 3DM and Klein,
and bootstrapping the teachings of a secondary reference as
justification for using the secondary reference does not explain
why a skilled artisan would know to look at the secondary
reference in the first instance.
(Appeal Br. 8).
We are not persuaded. While we are aware that hindsight bias may
plague determinations of obviousness, Graham v. John Deere Co., 383 U.S.
1, 36 (1966), we are also mindful that the Supreme Court has clearly stated
that the “combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.”
KSR, 550 U.S. at 416. We, and the Examiner, have provided extensive
reasoning explaining why the ordinary artisan, motivated by Freyman to
apply Badylak’s un-gelled cardiac ECM to treatment of cardiac tissue,
would have used needle sizes known by Klein and Kornowski to be
functional in administering active agents to cardiac tissue that were also
known to function in administering un-gelled materials that gel inside the
human body, as also evidenced by PuraMatrix (FF 1–12). The combination
of these known elements predictably allows administration of Badylak’s un-
gelled cardiac ECM to cardiac tissue using 27G needles.
Conclusion of Law
A preponderance of the evidence of record support the Examiner’s
conclusion that Badylak, Freyman, Kornowski, PuraMatrix, and Klein
render the claims obvious.
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SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
21, 27–32, 34,
35, 37–39, 44,
45, 47–52
103 Badylak, Freyman,
Kornowski,
PuraMatrix, Klein
21, 27–32,
34, 35, 37–
39, 44, 45,
47–52

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