Wook Chun et al.

Patent Trials and Appeals Board

Aug 10, 2020

13392596 - (D) (P.T.A.B. Aug. 10, 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.
13/392,596 04/13/2012 Wook Chun HI-2 US (044284.0003) 1387
27104 7590 08/10/2020
FENNEMORE CRAIG, P.C.
1700 Lincoln Street Suite 2400
DENVER, CO 80203
EXAMINER
MCNEIL, STEPHANIE A N
ART UNIT PAPER NUMBER
1653
MAIL DATE DELIVERY MODE
08/10/2020 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WOOK CHUN, WEON IK CHOI, MAN SEONG PARK, GEUN
HYUNG KIM, and JAE DEUK JUNG
____________

Appeal 2019-006119
Application 13/392,596
Technology Center 1600
____________

Before FRANCISCO C. PRATS, ULRIKE W. JENKS, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to a method for preparing a cryopreserved acellular dermal matrix.
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 Industry Academic Cooperation
Foundation of Hallym University of Gangwon-do, Korea as the real party in
interest. Appeal Br. 2. Herein, we refer to the Final Action mailed October
11, 2018 (“Final Act.”); Appellant’s Appeal Brief filed March 7, 2019
(“Appeal Br.”); Examiner’s Answer mailed June 24, 2019 (“Ans.”); and
Appellant’s Reply Brief filed August 14, 2019 (“Reply Br.”).
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STATEMENT OF THE CASE
The Specification explains:
The present invention relates to a method for preparing a
cryopreserved acellular dermal matrix and a cryopreserved
acellular dermal matrix prepared therefrom. More specifically,
the present invention relates to a method in which a
cryoprotectant is prepared by adding sucrose to basic
constituents comprising glycerol and a basic solution, and then
the resulting solution is used to subject skin tissue in which
epidermis and cells in dermis are removed to a cryopreservation
process and a cryopreserved acellular dermal matrix prepared
therefrom.
Spec. ¶ 1. According to the Specification, the method it describes “can
efficiently increase stability of tissue and maintain extracellular matrix
structure without impairment as compared with the conventional methods,
when skin tissue for transplantation is processed.” Id. ¶ 5.
Claims 1 and 3–7 are on appeal and can be found in the Claims
Appendix of the Appeal Brief. See Appeal Br. 5–15. Claims 1 is the only
independent claim and illustrative of the claims on appeal. It reads as
follows:
1. A method for preparing a cryopreserved acellular dermal
matrix consisting essentially of:
i) removing epidermis of an isolated allogeneic skin;
ii) removing cells in dermis of the epidermis-removed
skin;
iii) mixing glycerol, sucrose and a basic solution selected
from a buffer solution and an animal cell culture medium to
obtain a cryoprotectant which consists essentially of the glycerol,
the sucrose and the basic solution, wherein the mixing ration of
glycerol and the basic solution is 0.8-2 : 9 based on weight, and
the sucrose has a concentration of 25% to 40% by weight;
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iv) penetrating the cryoprotectant into the skin from which
epidermis and cells in dermis are removed, for a penetration
interval ranging from 6 to 24 hours; and
v) freezing the cryoprotectant-penetrated skin in a
controlled rate freezer at a freezing rate of from -0.1 to -5°C per
minute to obtain a cryopreserved acellular dermal matrix.
Id. at 16.
Appellant seeks review of the following rejections:
I. Claims 1, 3, and 5 under 35 U.S.C. § 103 as unpatentable over
Livesey,2 in view of Taylor,3 Mansbridge,4 and Brockbank;5
II. Claims 4, 6, and 7 under 35 U.S.C. § 103 as unpatentable over
Livesey in view of Taylor, Mansbridge, Brockbank, and Wang;6
III. Claims 1 and 3–7 for obviousness-type double patenting (“ODP”)
over claims 1–5 of the U.S. Patent No. 9,623,149 (“the ’149 patent”);
and
IV. Claims 1 and 3–7 as provisionally rejected for ODP over claims 1, 3,
and 5–7 of U.S. Patent Application No. 13/386,111 (the “’111
application”) in view of Livesey and Mansbridge.

2 US 2006/0210960 A1, published Sept. 21, 2006 (“Livesey”).
3 US 6,492,103 B1, issued Dec. 10, 2002 (“Taylor”).
4 US 6,291,240 B1, issued Sept. 18, 2001 (“Mansbridge”).
5 US 2004/0067480 A1, published April 8, 2004 (“Brockbank”).
6 X. Wang et al., The Cryopreservation of a Tissue Engineered Dermal
Replacement by Programmed Freezing, Proceeding of the 2005 IEEE, Eng’g
in Medicine and Biology 27th Annual Conf. (2005) (“Wang”).
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I. OBVIOUSNESS REJECTIONS
Issue
Both of Examiner’s obviousness rejections are premised on the same
combination of Livesey, Taylor, Mansbridge, and Brockbank as to
independent claim 1. Final Act. 6 (rejecting claims 4, 6, and 7 as obvious
over these references “as applied to claims 1, 3, and 5 above, and further in
view of Wang”). Appellant presents the same arguments for each rejection
and does not argue the claims separately. See generally Appeal Br. 5–14.
Accordingly, we consider the obviousness rejections together, focusing on
claim 1 as representative of the claims on appeal. The issue is whether a
preponderance of the evidence supports Examiner’s conclusion that cited
prior art renders the method of claim 1 obvious.
Analysis
Examiner finds that Livesey teaches a method for cryopreserving
acellular dermis comprising the steps recited in claim 1. Final Act. 2–3.
Regarding claim step iii), Examiner determines that Livesey teaches the use
of solutions comprising both “penetrating” cryoprotectants, such as glycerol,
and “nonpenetrating” cryoprotectants, such as sucrose. Id. at 3. Examiner
acknowledges that “Livesey does not teach the claimed ratios of ingredients
in the c[ry]oprotectant solution,” but determines Livesey teaches
cryoprotectant solutions “contain[ing] between 6% and 12% sucrose” that
also “comprise a mixture of other sugars/nonpenetrating c[ry]oprotectants,
and that the total amount of these compounds is up to 46% of the solutions.”
Id. (referring to amounts of “dextran, raffinose, PVP, trehalose, and sucrose”
in “formulations VS2 – VS4” in Livesey ¶¶ 88–90, 145). Examiner further
determines that Taylor teaches a cryoprotectant solution containing a range
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of sucrose (i.e., “1% to 30%”) and Mansbridge teaches a cryoprotectant
solution containing a range of glycerol (i.e., “5-10%) that, when combined,
overlap with the ranges recited in claim 1. Id. at 3–4.
Based on these teachings, Examiner concludes it would have been
obvious to apply “Mansbridge’s and Taylor’s guidance on amounts of
glycerol and sucrose to include in Livesey’s c[ry]oprotectant solution”
because “Mansbridge and Taylor teach[] details of levels of cryoprotectants
that Livesey teaches are useful in [its] method” and “Livesey teaches that
several nonpenetrating compounds, including sucrose, have the same
functions, and therefore they are obvious to substitute for each other.” Id. at
4. Examiner further concludes that it would have been obvious to combine
Brockbank’s teaching regarding the penetration time for a cryoprotectant
solution with Livesey’s method. Id. at 4–5.
Appellant disputes Examiner’s obviousness rejections in several
respects. Among other things, Appellant contends that “Livesey merely
recites glycerol and sucrose in a longer list of cryoprotectants” and
“[n]othing in Livesey suggests the benefits of combining the respective
cryoprotectants when used as is presently claimed.” Appeal Br. 6. In
particular, Appellant relies on data in the Specification and Declaration of
Weon Ik Choi dated March 19, 2014 (“Choi Declaration”) showing “the
benefits of using sucrose in the amounts claimed,” namely that “the
[claimed] cryoprotectants containing 25% to 40% by weight of sucrose were
exceptionally stable in comparison to” a solution comprising “7% dextran,
6% sucrose and 6% raffinose” as taught in Livesey. Id. at 6–8. Appellant
further disputes Examiner’s reliance on the sucrose and glycerol ranges
taught in Taylor and Mansbridge respectively, urging that Examiner’s
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rationale for combining these references with Livesey is “logically
defective” because Examiner has not sufficiently explained why it would be
“necessary or desirable to optimize the constituents of [Livesey’s]
cryoprotectant solution” according to the ranges taught in those references.
For such reasons, Appellant urges that Examiner’s rejection is premised on
impermissible “hindsight” and a “mix-and-match approach” that, inter alia,
“equates methods of preserving cells [as taught in Taylor and Mansbridge]
to a method [of] preserving acellular dermal matrix,” as recited in claim 1.
See id. at 9–10, 14.
Based on the current record, we determine that Appellant has the
better position. Examiner’s obviousness rejections are premised on the
conclusion that it would have been obvious for a skilled artisan to select two
particular cryoprotectants (i.e., sucrose and glycerol) from the much longer
list of cryoprotectants set forth in Livesey, choose to combine them, and
then adjust the amounts of those components to the recited ranges. The
evidence Examiner cites to support that conclusion are teachings in Taylor
and Mansbridge regarding different solutions comprising an array of other
ingredients in a wide range of amounts. See, e.g., Taylor 11:54–13:57
(describing various “exemplary” base solutions comprising a multitude of
ingredients other than sucrose); Mansbridge 16:60–17:28 (describing
solutions comprising an array of ingredients “with or without 5–10%
glycerol”). Appellant does not dispute that at least some of the solutions
taught in Taylor contain sucrose, and at least some of the solutions taught in
Mansbridge contain glycerol, in amounts that overlap to some extent with
the ranges recited in claim 1. However, Examiner has not sufficiently
explained why it would have been obvious for one of ordinary skill to select
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Taylor and Mansbridge’s teachings regarding these ranges from the much
broader array of solutions and ingredients described in these references for
the purpose of modifying Livesey’s method.7
In addition, we are persuaded by Appellant’s argument that the results
in the Choi Declaration demonstrate “unexpectedly good” results for
solutions containing “25–40% by weight” sucrose, as recited in claim 1.
The Choi Declaration reports “degradability by collagenase”8 data for
solutions containing glycerol and phosphate buffered saline in a 1:9 weight
ratio with sucrose added in 5% increments from 10–40% by weight. Choi
Decl. 2. The data show “considerably increased stability” for solutions
“containing 25, 30, 35 and 40% by weight sucrose . . . as compared with
those prepared with . . . 10, 15 and 20% by weight of sucrose.” Id. at 4.
Moreover, the Choi Declaration compares these results to the “Reagan”
solution, i.e., a solution containing “7% dextran, 6% sucrose and 6%
raffinose . . . added to a solution in which glycerol and phosphate buffered
saline were mixed in the weight ratio of 1 : 9.” Id. at 2. Again, the data
show that the Reagan solution has significantly “less stability” than the same

7 We are not persuaded by Appellant’s argument that Taylor, Mansbridge
and Brockbank are “non-analogous art” to Livesey. See Appeal Br. 12–13.
All of the cited references are concerned with the preservation of biological
materials for subsequent transplantation and are, therefore, within the same
“field of endeavor.” See Airbus S.A.S. v. Firepass Corp., 941 F.3d 1374,
1379 (Fed. Cir. 2019).
8 “Because the main structural component of the dermis is collagen, the
stability of the acellular dermal matrix can be measured by using a
collagenase” and then quantifying the amount of “release L-leucine
equivalent” with a lower amount of released L-leucine indicating increased
stability of the acellular dermal matrix. Choi Decl. 4.
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mixture of glycerol and phosphate buffered saline, but containing 25–40%
sucrose. Id. at 5.
Examiner determines that “the Declaration does not establish
unexpected results” because the Reagan solution tested therein is not
comparable to the ones taught in Livesey. Ans. 12. We disagree.
Examiner’s rejection is primarily based on the method taught in Livesey
Example 1. Final Act. 3 (citing Livesey ¶¶ 140–145). The method in that
example employs a cryoprotectant solution with the same sugars in the same
amount as the Reagan solution, but without glycerol. Livesey ¶ 145.
Indeed, Livesey exemplifies several solutions comprising various of the
ingredients it lists, but none of those exemplary solutions contain glycerol or
an amount of sucrose above 12% by weight. See id. ¶¶ 87–90, 145.
Accordingly, the Reagan solution and the 20% sucrose described in the Choi
Declaration are actually closer prior art to the cryoprotectant solution recited
in claim 1, step iii) than the exemplary solutions taught in Livesey. For this
reason, the data in the Choi Declaration showing that samples prepared with
the cryoprotectant solution of claim 1 exhibited increased stability over
those prepared with the Reagan and 20% sucrose solutions is probative of
unexpected results. See MPEP § 716.02(e)(I) (“Applicants may compare the
claimed invention with prior art that is more closely related to the invention
than the prior art relied upon by the examiner.”). To the extent Examiner
discounted the Choi Declaration because it did not compare the claimed
invention to a solution based on “Livesey’s teachings as a whole, in view of
the secondary references,” i.e., a solution with the same ingredients in the
same amounts as those in the claim based on Examiner’s combination of the
references (see Ans. 12), that was in error because that “would amount to
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requiring comparison of the results of the invention with the results of the
invention.” In re Chapman, 357 F.2d 418, 422 (CCPA 1966); see also
MPEP § 716.02(e)(III) (“Although evidence of unexpected results must
compare the claimed invention with the closest prior art, applicant is not
required to compare the claimed invention with subject matter that does not
exist in the prior art.”).
For these reasons, we determine that Examiner’s rejection of claim 1
as obvious over the cited prior art is not supported by the preponderance of
the evidence and, therefore, reverse. We reverse the obviousness rejections
of claims 3–7 for the same reasons.
II. ODP REJECTION OVER CLAIMS OF THE ’149 PATENT
The issue for this rejection is whether the preponderance of evidence
of record supports Examiner’s conclusion that claims 1 and 3–7 are obvious
over claims 1–5 of the ’149 patent. Appellant does not argue any claim
separately. We select claim 1 as representative for our analysis; the other
claims stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
Examiner’s ODP rejection is substantially based on claim 1 of the
’149 patent, which teaches as follows:
1. A method for preparing an acellular dermal matrix
comprising the steps of:
i) removing epidermis of an isolated allogenic skin;
ii) removing cells in dermis of the epidermis-removed
skin;
iii) mixing a cryoprotectant to include glycerol,
propylene glycol, sucrose and a basic solvent or solution,
wherein the mixing ratio of glycerol, propylene glycol and the
basic solvent or solution is 0.8-1.5:0.8-1.5:7-9 based on weight,
and the cryoprotectant contains sucrose in an amount ranging
from 25% to 40% by weight of the cryoprotectant;
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iv) penetrating the cryoprotectant into the skin from
which epidermis and cells in the dermis are removed; and
v) freeze-drying the cryoprotectant-penetrated skin at a
freezing rate of from –0.1 to –5° C. per minute to obtain an
acellular dermal matrix.
’149 patent 8:30–46.
Examiner finds “[c]laim 1 of the instant application is identical in
scope to claim 1 of patent ‘149, with the exception of step (iii)” because
claim 1 of the ’149 patent teaches that the cryoprotectant in its method
includes propylene glycol in addition to the other ingredients recited in
Appellant’s present claim 1. Final Act. 10. Examiner determines that
propylene glycol is not excluded by the “consisting essentially of” transition
phrase in present claim 1 and, therefore, the claims of the ’149 patent “recite
all the limitations of the instant claims.” Ans. 16.
We determine that Examiner’s ODP rejection is supported by the
preponderance of the evidence. We agree with and adopt Examiner’s
findings and conclusion of obviousness, as articulated by Examiner. See
Final Act. 10; Ans. 8–9, 16. As explained below, Appellant’s arguments to
the contrary are not persuasive.
Appellant argues that the claims of the ’149 patent are distinguishable
from present claim 1 in two respects: (1) the patented claims’ use of
propylene glycol in addition to the sucrose, glycerol and a basic solution in
the cryoprotectant of step iii) of present claim 1; and (2) the claims of the
’149 patent teach that the “cryoprotectant-penetrated skin is freeze dried,”
whereas the last step of present claim 1 recites that it is frozen in “a
controlled rate freezer.” See Appeal Br. 14–15.
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With respect to Appellant’s first argument, we are unpersuaded
because Appellant has not demonstrated that propylene glycol is excluded
by the “consisting essentially of” transition phrase in claim 1. “If an
applicant contends that additional steps or materials in the prior art are
excluded by the recitation of ‘consisting essentially of,’ applicant has the
burden of showing that the introduction of additional steps or components
would materially change the characteristics of applicant’s invention.”
MPEP § 2111.03(III). The Specification indicates that the basic and novel
feature of the invention is an improvement to “the stability of tissue of the
cryopreserved acellular dermal matrix,” resulting, at least in part, from the
addition of sucrose in the recited amount to the cryoprotectant solution.
Spec. ¶¶ 5, 11. Appellant does not dispute that the Specification identifies
improved tissue stability as the basic and novel feature of the claimed
method. See Reply Br. 2 (“Essentially, practicing what is claimed has the
benefit of improved structure in the acellular dermal matrix and results in
less damage to the matrix thereof.”). However, Appellant has not met its
burden to show that the addition of propylene glycol to that solution, as
taught in claim 1 of the ’149 patent, would materially change that feature.
Indeed, Appellant fails to point to any evidence of such in its Appeal Brief.
See Appeal Br. 14–15.
If anything, the ’149 patent evidences that the use of propylene glycol,
in addition to ingredients recited in present claim 1, does not materially
affect the increased stability observed from the addition of sucrose in the
recited amounts. Figure 4 of the ’149 patent shows increased stability for a
cryoprotectant solution containing glycerol, propylene glycol, buffer and
30% by weight sucrose relative to certain comparative examples in an assay
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similar to the one described in the Choi Declaration. ’149 patent, 8:13–18,
Fig. 4. Moreover, based on the “Histological Examination” in Experimental
Example 1, the ’149 patent concludes that “it can be known that in the
acellular dermal matrix treated with a cryoprotectant containing 20% by
weight or more of sucrose [in a solution containing glycerol, propylene
glycol, and phosphate-buffered saline in a 1:1:8 ratio] the destruction of
tissue that occurred in the course of freeze-drying is remarkably reduced”
and has “much better stability of tissue” as compared to samples frozen with
solutions containing no or less sucrose. Id. at 7:30–57.
For these reasons, we interpret the “consisting essentially of”
transition phrase in present claim 1 such that it does not exclude the presence
of propylene glycol as recited in claims 1–5 of the ’149 patent. Accordingly,
Appellant’s present claims are not distinguished from the claims of the ’149
patent on this basis.
We are similarly unpersuaded by Appellant’s argument regarding the
freezing step of present claim 1. As Examiner points out, the claims of the
’149 patent recite the same “active step of freezing, at the same rate as the
instant claims.” Ans. 16; compare ’149 patent claim 5, with present claim 7
(both reciting a “freezing rate of -1°C per minute”). Appellant’s argument
that freezing and freeze-drying “affect the skin tissue in very different ways
and require different protocols” is unsupported attorney argument and,
therefore, unpersuasive. See In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir.
1984) (explaining that arguments and conclusions unsupported by factual
evidence carry no evidentiary weight). For these reasons, we agree with
Examiner the freezing step of Appellant’s present claims would have been
obvious over the teachings in claims 1–5 of the ’149 patent.
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For all these reasons, we affirm the rejection.
III. PROVISIONAL ODP REJECTION
The issue for this rejection is whether the preponderance of evidence
of record supports Examiner’s conclusion that claims 1 and 3–7 are obvious
over claims 1, 3, and 5–7 of the ’111 application in view of Livesey and
Mansbridge. As before, Appellant does not argue any claim separately. We
select claim 1 as representative for our analysis; the other claims stand or fall
with claim 1. See 37 C.F.R. § 41.37(c)(iv).
Examiner determines that claim 1 of the ’111 application
“encompasses all the limitations [of the claims] of the instant application
except for the steps of removing the epidermis and the inclusion of glycerol”
in the cryoprotectant of step iii). Final Act. 11. Examiner finds that these
steps are taught by Livesey and that Mansbridge would additionally
motivate one of ordinary skill in the art to include glycerol in the
cryoprotectant solution. See id. at 11–12.
Appellant does not specifically dispute these findings, nor Examiner’s
conclusion of obviousness based on them, in its Appeal Brief. 9 Instead,
Appellant merely asserts that
[t]his rejection is provisional in nature, and so it should have no
bearing upon this appeal. The inclusion of Mansbridge is,
however, made in error because following Mansbridge leads

9 We note that only those arguments timely presented in the Appeal Brief
have been considered; arguments not so presented are waived. See 37
C.F.R. § 41.37(c)(1)(iv) (2015); see also Ex parte Borden, 93 USPQ2d
1473, 1474 (BPAI 2010) (informative) (“Any bases for asserting error,
whether factual or legal, that are not raised in the principal brief are
waived.”).
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also to the use of DMSO in the cryoprotectant as discussed
supra. Mansbridge is nonanalogous art as explained supra.
Appeal Br. 15. These arguments are unpersuasive.
Appellant’s DMSO argument is not clearly presented in the Appeal
Brief. As we understand it, Appellant contends Mansbridge teaches that
DMSO should be included in the cryoprotectant (in addition to the
ingredients recited in claim 1), but that the “consisting essentially of”
transition phrase excludes DMSO and, therefore, claim 1 would not be
obvious over the articulated combination of the ’111 application claims with
Livesey and Mansbridge.
We are not persuaded because, even if the articulated combination of
references would lead to the inclusion of DMSO, Appellant has not shown
that DMSO “would materially change the characteristics of applicant’s
invention.” See MPEP § 2111.03(III). The only evidence Appellant cites
for such a proposition is Example 2 and Figures 15 and 16 of Taylor.
Appeal Br. 11. According to Appellant, this example and the results in the
figures show that “[c]ell viability is enhanced” by the addition of “0.5% to
3% DMSO” to the cryoprotectant media taught in Taylor. Id. However,
Appellant has not explained how such evidence demonstrates a material
change to the basic and novel properties of claim 1, i.e., improved stability
of tissue of the cryopreserved acellular dermal matrix. Thus, Appellant has
not sufficiently shown that the addition of DMSO is excluded by the
“consisting essentially of” transition phrase in present claim 1.
We are likewise unpersuaded by Appellant’s non-analogous art
argument. Mansbridge, Livesey, and the claims of the ’111 application all
describe methods for preserving biological materials for subsequent
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transplantation and, therefore, are within the “same field of endeavor” as the
present claims. See Airbus, 941 F.3d at 1380. Accordingly, Mansbridge is
analogous art.
For these reasons, we affirm the provisional ODP rejection.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 5 103 Livesey, Taylor,
Mansbridge,
Brockbank
1, 3, 5
4, 6, 7 103 Livesey, Taylor,
Mansbridge,
Brockbank, Wang
4, 6, 7
1, 3–7 Obviousness-type
Double Patenting
1, 3–7
1, 3–7 Provisional
Obviousness-type
Double Patenting
1, 3–7
Overall
Outcome
1, 3–7

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED