Anthony Kihm et al.

Patent Trials and Appeals Board

May 13, 2021

2020002809 (P.T.A.B. May. 13, 2021)

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.
10/876,998 06/25/2004 Anthony J. Kihm JNJ207PTUS(001705.001268) 2537
93358 7590 05/13/2021
BakerHostetler/ Johnson & Johnson
Washington Square, Suite 1100
1050 Connecticut Avenue, NW
Washington, DC 20036-5304
EXAMINER
WILSON, MICHAEL C
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
05/13/2021 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):
eofficemonitor@bakerlaw.com
jnjuspatent@corus.jnj.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_________________

Ex parte ANTHONY J. KIHM, AGNIESZKA SEYDA,
SRIDEVI DHANARAJ, ZIWEI WANG, ALEXANDER M. HARMON,
IAN ROSS HARRIS, DARIN J. MESSINA, SANJAY MISTRY,
ANNA GOSIEWSKA, and CHIN-FENG YI
_________________

Appeal 2020-002809
Application 10/876,998
Technology Center 1600
_________________

Before JASON V. MORGAN, DEBORAH KATZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appellant1 seeks our review2, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 68, 74, 76–78, 109, 110, 112, 114, 116,
117, 119, 120, 122, and 123. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party-in-interest as DePuy Synthes Products, Inc. (Appeal
Br. 3.)
2 We consider the Final Office Action issued May 14, 2019 (“Final Act.”),
the Appeal Brief filed October 22, 2019 (“Appeal Br.”), the Examiner’s
Answer issued on January 2, 2020 (“Ans.”), the Reply Brief filed March 2,
2020 (“Reply Br.”).
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Application 10/876,998
2
The Examiner rejects all of Appellant’s pending claims under four
grounds:
(1) under 35 U.S.C. § 102(b) as being anticipated by Purchio,3 as
supported by Aston4 and Ciavarella5 (see Ans. 3–13);
(2) under 35 U.S.C. § 103(a) as being obvious over Purchio,
Mansbridge,6 Aston, Ciavarella, Liddiard,7 and Ronnett8 (see Ans. 13–27);
(3) under the doctrine of obviousness-type double-patenting over the
claims of U.S. Patent 9,579,351 (“the ’351 patent”) (see Ans. 27–33); and
(4) provisionally under the doctrine of obviousness-type double-
patenting over the claims of application 11/321,863 (see Ans. 31–33.)
Appellant’s Specification is directed to cells derived from postpartum
tissue that have the potential to differentiate into chondrogenic and
osteogenic lineages. (Spec. ¶ 2.)
Appellant’s claim 68 recites:
A method of forming cartilage in a patient,
said method comprising administering to said patient a matrix
comprising a homogeneous population of undifferentiated umbilical
cord tissue-derived cells,

3 Purchio et al., U.S. Patent 5,902,741, issued May 11, 1999.
4 Aston and Bentley, “Repair Of Articular Surfaces By Allografts Of
Articular And Growth-Plate Cartilage,” J. BONE AND JOINT SURGERY vol.
68-B, pp.29–35 (1986).
5 Ciavarella et al., “Umbilical Cord Mesenchymal Stem Cells: Role of
Regulatory Genes in Their Differentiation to Osteoblasts,” STEM CELLS AND
DEVELOPMENT, vol. 18, pp. 1211–20 (2009).
6 Mansbridge and Liu, U.S. Patent 6,291,240 B1, issued September 18,
2001.
7 Liddiard, et al., “An Improved Method for Preparation of Human Fetal and
Adult Hepatocytes,” ARC. TOXICOLOGY, vol. 44, pp. 107–12 (1980).
8 Ronnett et al., U.S. Patent 5,308,763, issued May 3, 1994.
Appeal 2020-002809
Application 10/876,998
3
wherein the homogeneous population of cells is obtained from
human postpartum umbilical cord substantially free of blood, and
wherein said homogeneous population of cells:
i) exhibits increased expression, relative to a human cell that is
a fibroblast, a mesenchymal stem cell, or an iliac crest bone marrow
cell, of an endogenous gene encoding interleukin 8 and an
endogenous gene encoding reticulon 1;
ii) secretes MCP-1, IL-6, IL-8, GCP-2, HGF, KGF, FGF, HB-
EGF, BDNF, TPO, MIPlb, RANTES and TIMP 1;
iii) produces CD10, CD13, CD44, CD73, CD90, PDGFr-alpha,
and HLA-A,B,C; and
iv) lacks production of CD31, CD34, CD117, CD141, and
HLA-DR,DP,DQ,
whereby cartilage is formed in the matrix.

(Appeal Br. 31 (indentations added).) In general, claim 68 recites a method
of forming cartilage by administering a matrix comprising undifferentiated
umbilical cord tissue-derived cells to a patient, wherein the population of
cells exhibit certain characteristics of expression, secretion, and production.
Independent claims 119 and 120 recite methods of forming cartilage
in a patient comprising administering a matrix of a homogeneous population
of undifferentiated umbilical cord tissue-derived cells, wherein said
homogenous population of cells is deposited with ATCC under Accession
No. PTA-6067 or PTA-6068, respectively, whereby cartilage is formed in
the matrix. (See Appeal Br. 32–33.) Thus, independent claims 119 and 120
are limited methods of forming cartilage by administering specifically
recited homogenous populations of cells.
35 U.S.C. § 102(b)
The Examiner rejects all of Appellant’s currently pending claims as
being anticipated by Purchio. (See Ans. 3–13.) Purchio is directed to a
method of stimulating the proliferation and maturation of a variety of
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different cells and tissues in three-dimensional cultures, in vitro, for example
by using TGF-β in the culture medium. (Purchio Abstract.) Purchio teaches
that the three-dimensional cultures and biological replacement cartilage
tissue constructs of the invention have a range of applications, including
transplantation or implantation in vivo. (See id. 2:20–23, 15:40–45, 16:4–7.)
The Examiner finds that Appellant’s Specification provides a broad
disclosure of the methods used to obtain a homogeneous population of
undifferentiated umbilical cord cells for use in the claimed method. (See
Ans. 3–4.) The Examiner also finds that Purchio teaches using umbilical
cords as a source of stromal cells in an in vitro method of make cartilage by
culturing the cells on a 3D matrix. (See Ans. 4, citing Purchio 2:8–10, 9:4–
8, 11:43, 12:1–5.)
According to the Examiner, the teachings of Purchio are equivalent to
“forming cartilage in a patient, said method comprising administering to said
patient a matrix comprising a homogenous population of undifferentiated
umbilical cord tissue-derived cells” as required in Appellant’s claim 68.
(See Ans. 4.) The Examiner reasons that the 3D culture and framework
seeded with cells taught in Purchio are “a matrix” comprising cells as
required in claim 68. (See id.) The Examiner also reasons that the “fetal
cells” isolated from umbilical cord in Purchio are “undifferentiated” and
“homogenous” as required in claim 68. (See id. 5.)
Furthermore, the Examiner finds that because Appellant’s
Specification does not teach a specific method of disaggregation or enzyme
technique for obtaining umbilical cord cells to be used in the method of
claim 68, and the methods that are taught in the Specification are the
equivalent of the methods taught in Purchio, the cell characteristics recited
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in claim 68 would be inherent to the cells taught in Purchio. (See Ans. 6–8.)
To support this finding, the Examiner cites to Ciavarella, which teaches that
mesenchymal cells derived from umbilical cords expand and produce large
amounts of undifferentiated cells expressing CD13, CD44, CD73, CD90 and
HLA class I (HLA A, B,C), but not CD31, CD34, CD117 and HLA class II
(HLA-DR,DP,DQ). (See Ans. 9–10, citing Ciavarella 1213–1214.)
Although the Examiner’s specific findings are supported by the
record, we are not persuaded Purchio anticipates the method of claim 68
because the claim requires “administering to said patient a matrix
comprising a homogeneous population of undifferentiated umbilical cord
tissue-derived cells . . . .” (Appeal Br. 31.) The Examiner does not find that
Purchio teaches administering a matrix with undifferentiated cells to a
patient. Instead, as Appellant argues, Purchio teaches three-dimensional
cartilage cultures generated by inoculating and growing stromal cells on a
matrix in the presence in vitro of TGF-β, a known chondrogenic
differentiation agent. (See Appeal Br. 21, citing Purchio 15:27–28.) Purchio
teaches that even if TGF-β is not added, growth factors are elaborated from
the stromal support matrix. (See Purchio 9:36–37.) A teaching that of a
homogeneous population of undifferentiated cells is not a teaching to
administer those cells to the patient. (Contra 6–8.)
“Anticipation requires a showing that each limitation of a claim is
found in a single reference, either expressly or inherently.” Atofina v. Great
Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006). Although Purchio
teaches obtaining and culturing umbilical cord cells within the scope of
claim 68, and such cells would inherently have the characteristics recited in
claim 68, the Examiner has not directed us to a teaching in Purchio of
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implanting undifferentiated cells in a patient where they can differentiated in
vivo.
Accordingly, we are not persuaded that Purchio teaches Appellant’s
claimed method either expressly or inherently.
35 U.S.C. § 103(a)
The Examiner rejects all of Appellant’s claims as being obvious over
Purchio, Mansbridge, Aston, Ciavarella, Liddiard, and Ronnett. (See Ans.
13–27.) As discussed above, the Examiner finds that Purchio teaches
transplanting cells in vivo to form cartilage and teaches that umbilical cords
are a source of stromal cells to make cartilage tissue in vitro. (See Ans. 14,
citing Purchio 15:50, 9:4–8.) According to the Examiner, the teachings of
Purchio are equivalent to “forming cartilage in a patient, said method
comprising administering to said patient a matrix comprising a homogenous
population of undifferentiated umbilical cord tissue-derived cells” as
required in claim 68. (See Ans. 14.)
As discussed above, we are not persuaded that Purchio teaches
administering undifferentiated cells to a patient as required in Appellant’s
claim 68 because Purchio teaches differentiating the cells in a 3D scaffold in
vitro, using agents such as TGF-β. The Examiner does not explain why the
cells that Purchio teaches to administering to a patient would be
undifferentiated.
The Examiner cites to Mansbridge to show that methods of isolating
cells from an umbilical cord were well-known in the art. (See Ans. 16.) But
the Examiner does not cite to a reference that would have rendered it
obvious to administer undifferentiated cells to a patient. Although the
Examiner finds that the starting materials, disaggregation/enzyme
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techniques, and culture techniques of claim 68 are equivalent to the starting
materials described in Purchio and Mansbridge, we are not persuaded that
their teachings would have rendered it obvious to one of ordinary skill in the
art to using a homogenous population of undifferentiated umbilical cord
cells for administration because we have not been directed to a teaching in
either reference to use undifferentiated umbilical cord cells for
transplantation. (See Ans. 19–21.) The Examiner finds that the phrase
“whereby cartilage is formed in the matrix” is rendered obvious by the
combined teachings of Purchio and Mansbridge because they teach making
“living cartilage tissue” in vitro, but Appellant’s claim 68 is directed to
making cartilage tissue in vivo. (See Ans. 23.)
Because we are not persuaded that the cited prior art would have
rendered obvious a method of administering undifferentiated cells to a
patient, as required in claim 68, we are not persuaded that the cited prior art
would render claim 68 obvious.
Obviousness-type Double-patenting
The Examiner rejects all of the pending claims as being obvious over
the claims of the ’351 patent, which is co-owned by the Appellant. (See
Ans. 27–31.) Claim 1, the only independent claim of the ’351 patent is
directed to a cell culture comprising an isolated homogeneous cell
population and a culture medium, wherein said isolated cell population is
obtained from human postpartum placenta. (See ’351 patent, 127:18–38.)
The Examiner cites to Example 29 of the ’351 patent for its teaching
of administering a matrix and a homogenous population of undifferentiated
placenta- or umbilical cord-derived cells to create cartilage in patients. (See
Ans. 27–28, citing ’351 patent, 115:14–20.) The Examiner also cites to
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Examples 15 and 16 of the ’351 patent for its teaching of using cells to
create cartilage in vitro that has the morphology of cartilage tissue. (See
Ans. 28.) The Examiner finds that the ’351 patent discloses using placenta-
or umbilical cord derived cells to create cartilage. (Ans. 28.) The Examiner
concludes:
the cells obtained from the placenta in ’351 and the method of
using cells obtained from umbilical cord in the instant application
are linked as product and method of using the product. In this
case, the inventions are not independent or distinct from each
other because the process for using the product as claimed can be
practiced with another materially different product, i.e. the
product of ’351. See MPEP § 806.05(h). The cells in claim 1 of
’351 are obvious variants of the cells used in the method of claim
68, and the method of using the cells in claim 1 of the instant
application is an obvious process for using the cells in light of
Example 29 disclosed in ’351 and in Examples 16 and 17 in ’351
(Examples 15 and 16) and could have been claimed in ’351.

(Ans. 30–31.) Thus, according to the Examiner, because the claims of the
’351 patent and the currently pending claims have a product and process
relationship, the claims of the ’351 patent render the currently pending
claims obvious.
We are not persuaded by the Examiner’s reasoning because it does not
explain why one of ordinary skill in the art would have considered it obvious
to form cartilage in a patient by administering a population of
undifferentiated umbilical cord tissue-derived cells in light of claims to an
isolated cell population obtained from placenta. Even though the ’351
patent teaches using cells derived from both the placenta and umbilical cord,
it claims only placenta-derived cells. The Examiner does not explain why
placenta-derived cells render umbilical cord-derived cells obvious. We
agree with Appellant that placenta and umbilical cord are different sources
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of cells and are not necessarily obvious over each other. (See Appeal Br. 9–
14.) Thus, we are not persuaded that the claims of the ’351 patent render the
claims obvious.
The Examiner also rejects the currently pending claims under the
doctrine of obviousness-type double-patenting over the claims of application
11/321,863. (See Ans. 31–33.) This is a provisional rejection because the
claims of the 11/321,863 application have not yet been allowed. Because
the claims of the 11/321,863 application might not be issued in their current
form, reaching this rejection would be premature. See Ex parte Moncla,
Appeal No. 2009-006448 (PTAB June 22, 2010) (holding that it is
premature to address a provisional rejection that is the only remaining
rejection) (designated precedential).
Conclusion
Upon consideration of the record and for the reasons given, we
reverse the Examiner’s rejections.
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
120, 122,
123
102(b) Purchio, as
supported by
Aston, Ciavarella
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
120, 122,
123
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
103(a) Purchio,
Mansbridge,
Aston, Ciavarella,
Liddiard, Ronnett
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
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120, 122,
123
120, 122,
123
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
120, 122,
123
Obviousness-Type
Double-Patenting
over the all claims
of U.S. Patent
9,579,351
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
120, 122,
123
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
120, 122,
123
Provisional
Obviousness-type
Double-Patenting
over application
11/321,8639

Overall
Outcome
68, 74, 76–
78, 109,
110, 112,
114, 116,
117, 119,
120, 122,
123

REVERSED

9 As explained above, we do not reach this rejection per Ex parte Moncla,
Appeal No. 2009-006448 (PTAB June 22, 2010) (holding that it is
premature to address a provisional rejection) (designated precedential).