Ex Parte Mandalam et al

Patent Trial and Appeal Board

Jan 31, 2017

13323567 (P.T.A.B. Jan. 31, 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.
13/323,567 12/12/2011 Ramkumar Mandalam 091/040C 1164
144527 7590 02/01/2017
Astp.rias R i nth eranen tips; Tnn
EXAMINER
c/o Krista Kauppinen
6300 Dumbarton Circle
CROUCH, DEBORAH
Fremont, CA 94555 ART UNIT PAPER NUMBER
1632
MAIL DATE DELIVERY MODE
02/01/2017 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 RAMKUMAR MANDALAM, CHUNHUI XU,
JOSEPH D. GOLD, and MELISSA K. CARPENTER1
Appeal 2015-001292
Application 13/323,567
Technology Center 1600
Before CHRISTOPHER G. PAULRAJ, TAWEN CHANG, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
screening a factor for its effect on a pPS cell. The Examiner entered final
rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify the Real Party in Interest as Asterias Biotherapeutics,
Inc. App. Br. 3.
Appeal 2015-001292
Application 13/323,567
STATEMENT OF THE CASE
According to the Specification:
Prototype “primate Pluripotent Stem cells” (pPS cells) are
pluripotent cells derived from pre-embryonic, embryonic, or
fetal tissue at any time after fertilization, and have the
characteristic of being capable under the right conditions of
producing progeny of several different cell types.
Spec. 138.
Previous technology for culturing primate pluripotent stem (pPS)
cells has required that the cell culture environment contain feeder
cells in order to prevent them from differentiating. In particular,
the standard feeder cells used for culturing human embryonic
stem cell are irradiated mouse embryonic fibroblasts.
Unfortunately, using feeder cells increases production costs,
impairs scale-up, and produces mixed cell populations that
complicate quality control and regulatory approval for use in
human therapy.
[]This disclosure provides a system for rapidly expanding
primate pluripotent stem (pPS) cells in vitro without requiring a
layer of feeder cells to support the culture and inhibit
differentiation.
Spec. 1131-32.
Claims 30-37 are on appeal. Claim 30, the sole independent claim, is
illustrative and reads as follows:
30. A method of screening a factor for its effect on a pPS
cell, comprising: a) obtaining an undifferentiated pPS cell
cultured essentially feeder free on an extracellular matrix in a
non-conditioned nutrient media comprising fibroblast growth
factor (FGF); b) contacting the pPS cell with the factor; c)
observing any change in the pPS cell; and d) correlating the
observed change with the factor.
App. Br. 13 (Claims App’x).
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Appeal 2015-001292
Application 13/323,567
The following rejections are on appeal:
Claims 30-37 are rejected under 35 U.S.C. 102(b) as
anticipated by Thomson.2 Ans. 2.
Claims 30-37 are rejected under 35 U.S.C. § 103(a) as obvious
over Thomson. Ans. 2.
I
The Examiner has rejected all of the claims on appeal as obvious
based on Thomson. The Examiner finds that Thomson teaches “determining
or screening for the effect of [leukemia inhibitory factor] LIF on
undifferentiated rhesus monkey embryonic stem cells, R278.5, cultured in
the absence of fibroblasts on gelatin coated tissue culture ware in medium
comprising DMEM, FBS, glutamine, 2-mercaptoethanol, [and] non-essential
amino acids.” Ans. 2 (citations omitted). The Examiner also finds that LIF
is a “differentiation factor” and “exhibited no effect on the differentiation of
rES cells.” Id. at 2—3. The Examiner concluded that Thomson disclosed the
method of claim 30 because “[a] difference cannot be discerned between the
claimed cells, ‘cultured essentially feeder free on an extracellular matrix’
and those of Thomson, grown on a gelatin (extracellular matrix).” Id. at 3.
The Examiner states:
The limitation cultured essentially feeder free on an
extracellular matrix in a nonconditioned nutrient media
comprising fibroblast growth factor (FGF) does not affect the
structure or function of the pPS cell. The limitation, further, can
be considered as a process limitation for the pPS cell... Absent
results to the contrary, the method for culturing pPS cells does
2 James A. Thomson et al, Isolation of a primate embryonic stem cell line,
92 PNAS, 7844—888 (1995).
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Appeal 2015-001292
Application 13/323,567
not affect either the cells or the method of screening. Therefore,
Thomson need not teach this limitation as the method of
culturing the pPS cells is not viewed as relevant to the claims. A
pPS cell cultured by another method would function the same as
a pPS cells cultured under feeder-free conditions on an
extracellular matrix in a medium comprising FGF. Thomson
teaches such a method.
Id. at 5—6 (emphasis in original). The Examiner states “[t]he
patentability of the claimed method of screening does not depend
upon the method for culturing pPS cells” (Ans. 7), and cites In re
Thorpe: “If the product in the product-by-process claim is the same as
or obvious from a product of the prior art, the claim is unpatentable
even though the prior product was made by a different process.” 777
F.2d 695, 698 (Fed. Cir. 1985).
Appellants argue “[t]he Examiner mistakenly applies a product-by­
process analysis to element a) of claim 30” and argue the Examiner was
incorrect in reading out the limitation “cultured essentially feeder free on an
extracellular matrix in a nonconditioned nutrient media comprising
fibroblast growth factor (FGF)” from claim 30. Reply Br. 2. Rather,
Appellants argue, “‘every limitation in the claim must be considered.’” Id.
at 2—3 (citing MPEP 2103(I)(C)). Appellants argue the Examiner has not
established a prima facie case of obviousness because “Thomson does not
teach obtaining an undifferentiated pPS cell cultured essentially feeder free
on an extracellular matrix in a non-conditioned nutrient media comprising
fibroblast growth factor (FGF).” App. Br. 9. Instead, Appellants argue,
“Thomson states explicitly that the rES cells die or differentiate when they
are removed from their embryonic feeder layer.” Id. Appellants further
argue “the examiner has pointed to nothing in the record to suggest that the
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Application 13/323,567
cells in Thomson were cultured in a non-conditioned media or that the non-
conditioned media comprised FGF.” App. Br. 10.
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the claims are
anticipated by Thomson.
Principles of Law
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently. See
Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047 (Fed. Cir. 1995). The
obviousness of a method claim must be determined on a case-by-case basis,
and the PTO must take into account the novelty of materials used in or made
by process. In re Ochiai, 71 F.3d 1565, 1570-71 (Fed. Cir. 1995).
Analysis
We agree with Appellants that the evidence does not support the
Examiner’s finding that Thomson teaches all of the limitations of
independent claim 30. The Examiner’s application of a product-by-process
methodology to claim 30, a method claim, is incorrect under established
precedent. In re Ochai, 71 F.3d at 1570-71. The Examiner has
acknowledged that Thomson does not teach the limitation “cultured
essentially feeder free on an extracellular matrix in a nonconditioned
nutrient media comprising fibroblast growth factor (FGF).” Ans. 6. The
Examiner has not pointed to any evidence to show that such a limitation
would not affect the structure or properties of an undifferentiated pPS cell
obtained in accordance with method step a). No other references are cited to
show this limitation. Because the Examiner has not provided evidence
sufficient to support a prima facie case of obviousness, we reverse the
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Application 13/323,567
rejection of claims 30-37 as obvious based on Thomson. See In re
Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (“In rejecting claims under 35
U.S.C. § 103, the examiner bears the initial burden of presenting a prima
facie case of obviousness. Only if that burden is met, does the burden of
coming forward with evidence or argument shift to the applicant.”).
II
The Examiner has rejected claims 30—37 as anticipated by Thomson.
As discussed above, however, the Examiner has not shown that Thomson
teaches all of the limitations of independent claim 30. We therefore reverse
the rejection under 35 U.S.C. § 102(b).
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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