Geeta Shroff

Patent Trials and Appeals Board

Aug 30, 2019

12224839 - (D) (P.T.A.B. Aug. 30, 2019)

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.
12/224,839 09/08/2008 Geeta Shroff 2515.0020001/RWE/SLE 3169
26111 7590 08/30/2019
STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
1100 NEW YORK AVENUE, N.W.
WASHINGTON, DC 20005
EXAMINER
LANKFORD JR, LEON B
ART UNIT PAPER NUMBER
1657
NOTIFICATION DATE DELIVERY MODE
08/30/2019 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):
e-office@sternekessler.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte GEETA SHROFF1
__________

Appeal 2018-006771
Application 12/224,839
Technology Center 1600
__________

Before ERIC B. GRIMES, DEBORAH KATZ, and RYAN H. FLAX,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition, which have been rejected as being directed to
patent-ineligible subject matter. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The “invention relates to pharmaceutical compositions comprising
human embryonic stem (hES) cells or their derivatives . . . for use in the
treatment of presently incurable, terminal and medical diseases, conditions.”

1 Appellant identifies the Real Party in Interest as Geeta Shroff. Appeal
Br. 3.
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Spec. ¶ 1. The Specification states that one risk of hES cell administration
“is that components of the cell culture medium, retained in the
pharmaceutical product for administration to human subjects, are
administered and therefore represent a risk to the patient through as yet
unanticipated side effects.” Id. ¶ 24. Residues of cell culture “supplements
are viewed as unnecessary risks to the safety of patients.” Id. ¶ 30. However,
“trace amounts of progestin and βhCG [β-human chorionic gonadotrophin]
agonist . . . may be present in the pharmaceutical composition as a result of
the culturing methods of the present invention.” Id. ¶ 116.
Claims 1–27 and 118–123 are on appeal. Claim 1 is illustrative and
reads as follows (formatting and emphasis added):
1. A pharmaceutical composition for the treatment of
diseases, disorders, or conditions comprising a therapeutic
effective amount of human embryonic stem (hES) cells,
derivatives of hES cells, or combinations thereof,
wherein said hES cells, derivatives of hES cells, or
combinations thereof are free from feeder cells, animal
products, growth factors, leukemia inhibiting factor, fibroblast
growth factor, vitamin supplements, membrane associated steel
factor, soluble steel factor, and conditioned media,
wherein the hES cells, derivatives of hES cells, or
combinations thereof do not give rise to teratomas upon
administration,
wherein said hES cells, derivatives of hES cells, or
combinations thereof are suspended in a pharmaceutically
acceptable biocompatible solution,
wherein said derivatives of hES cells are selected from
the group consisting of hematopoietic stem cell progenitors,
neuronal stem cell progenitors, a combination of hematopoietic
stem cell progenitors and neuronal stem cell progenitors,
mesenchymal stem cell progenitors, insulin producing stem cell
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progenitors, hepatocytic stem cell progenitors, cardiac stem cell
progenitors, and epithelial stem cell progenitors, and
wherein the composition contains trace amounts of a
progestin and a β-human chorionic gonadotrophin (βhCG)
agonist.

Claim 22 is also independent and is directed to a composition similar
to that of claim 1, except that the hES cells (and/or derivatives) are
“entrapped in a biocompatible structure or matrix,” rather than “suspended
in a pharmaceutically acceptable biocompatible solution” as in claim 1. Like
claim 1, claim 22 requires that “the composition contains trace amounts of a
progestin and a β-human chorionic gonadotrophin (βhCG) agonist.”
DISCUSSION
The Examiner has rejected claims 1–27 and 118–123 under 35 U.S.C.
§ 101 on the basis that “[t]he claims are . . . drawn to a natural phenomenon,
namely the occurrence of the claimed cells in nature and are thus are [sic] a
judicial exception.” Ans. 3. The Examiner finds that “[t]he cells, hES cells in
particular, do not differ significantly from those found in nature. Since the
cells have not undergone any transformations, and have been extracted from
a human, these cells fit under a judicial exception for patent eligible claims.”
Id.
The Examiner also finds that “[t]he additional components in the
cellular composition, i.e. progestin and a βhCG agonist are products of
nature as are the biocompatible matrix materials.” Id. The Examiner also
reasons:
The claims require only a “trace” amounts of progestin and
βhCG and as there is no definition of “trace” within the
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specification that has [been] interpreted as a negligible amount.
As such, there is no evidence that the claimed composition has
any characteristics (structural, functional, or otherwise) that are
different from the naturally occurring cells and molecules.
Id. at 4.
The Examiner concludes that “the composition of matter claimed (a
mixture) does not appear to have markedly different characteristics from
what occurs in nature and is a ‘product of nature’ exception to the statute”
that “does not include any additional features that could add significantly
more to the exception.” Id.
Appellant argues that “[a]s discussed in the Declaration of Dr. Geeta
Shroff (‘the Shroff 2014 Declaration’[2]) . . . , human embryonic stem cells
prepared using conditions disclosed in the Specification differ from isolated
inner cell mass (ICM) clusters of pluripotent cells.” Appeal Br. 14.
Appellant argues that, for example, the hES cells of the invention were
negative for teratoma formation while ICM clusters of pluripotent cells were
positive. Id. at 14–15.
Appellant argues that “[t]he Shroff 2017 Declaration[3] discusses
additional markers that were not expressed in the hES cells of the present
invention, including HLA-G, which may contribute to their ability to be
administered without the formation of teratomas.” Id. at 15. Appellant
concludes that, “[b]ased on the Specification and the results shown in the
Shroff Declarations, the cultured human embryonic stem cells of the present

2 Declaration under 37 C.F.R. § 1.132 of Geeta Shroff, signed July 16, 2014.
3 Declaration under 37 C.F.R. § 1.132 of Geeta Shroff, signed Jan. 13, 2017.
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invention are markedly different from ICM clusters of pluripotent cells
found in nature.” Id.
Appellant also argues “the claims require that compositions contain
trace amounts of a progestin and a βhCG agonist — confirmed by the test
results for the cultured cells of the present invention — whereas, isolated
ICM clusters of pluripotent cells showed negative expression for βhCG.”
Reply Br. 3. Appellant argues that “the hES cells of claims 1 and 22 are not
those present in the human body but rather, are hES cells that are part of a
pharmaceutical composition or a composition of matter and thus, have been
subjected to culture conditions. This is further supported by the requirement
that the composition contains trace amounts of a progestin and a βhCG
agonist.” Id. at 4.
“In the prosecution of a patent, the initial burden falls on the PTO to
set forth the basis for any rejection; i.e., a prima facie case.” Hyatt v. Dudas,
492 F.3d 1365, 1369 (Fed. Cir. 2007). Here, this means that the initial
burden is on the Examiner to show that a naturally occurring composition
has all of the properties required for the claimed composition.
Whether two products are the same is a factual determination. See,
e.g., In re King, 801 F.2d 1324, 1326 (Fed. Cir. 1986) (“It is axiomatic that
anticipation of a claim under § 102 can be found only if the prior art
reference discloses every element of the claim, and that anticipation is a fact
question.”). “In rejecting an application, factual determinations by the PTO
must be based on a preponderance of the evidence.” In re Oetiker, 977 F.2d
1443, 1449 (Fed. Cir. 1992) (J. Plager, concurring). See also In re Warner,
379 F.2d 1011, 1017 (CCPA 1967) (“The Patent Office has the initial duty
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of supplying the factual basis for its rejection. It may not . . . resort to
speculation, unfounded assumptions or hindsight reconstruction to supply
deficiencies in its factual basis.”).
We conclude that the Examiner has not carried the initial burden in
this case of showing, by a preponderance of the evidence, that the
composition defined by the claims on appeal is identical to a product of
nature. Both of the independent claims require, among other things, that “the
composition contains trace amounts of a progestin and a β-human chorionic
gonadotrophin (βhCG) agonist.” Claims 1 and 22.
The Specification states that “[a] ‘progestin’ is any natural or
synthetic hormone having progesterone-like activity”; examples include
progesterone. Spec. ¶ 98. The Specification states that “‘β-human chorionic
gonadotrophin (βhCG) agonists’ are defined as any naturally occurring or
synthetic βhCG or fragment or derivative thereof having at least 25% of the
activity of natural βhCG in one of any known assay for biological activity”;
examples include βhCG. Id. ¶ 99.
The Specification states that “trace amounts of progestin and βhCG
agonist . . . may be present in the pharmaceutical composition as a result of
the culturing methods of the present invention.” Id. ¶ 116. The Specification
also states that “[t]he hES cells used as the starting material for the cell lines
developed under the present invention are derived from a 2 to 7 day old
embryo.” Id. ¶ 329. “The embryo is suspended in a small amount of minimal
essential medium . . . and the hES cells are isolated from the embryo by
mechanical means . . . . Additional medium is added to the isolated cells
along with a progestin and a βhCG agonist.” Id. ¶ 331. The hES cells are
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incubated under substantially anaerobic conditions. Id. ¶ 332. Cells are
passaged or re-cultured using medium comprising progesterone and βhCG.
Id. ¶ 335. “hES cells cultured under such conditions remain in a largely
undifferentiated form.” Id. ¶ 336.
Thus, the Specification provides evidence that the claimed
composition contains trace amounts of a progestin and a βhCG agonist as a
result of the conditions under which the hES cells were cultured in vitro, not
because the naturally occurring embryonic cells used as starting material
occurred in combination with a progestin and a βhCG agonist. That is, the
combination of hES cells, a progestin, and a βhCG agonist was a result of
human manipulation of culture conditions, not because the combination of
hES cells, a progestin, and a βhCG agonist is naturally occurring.
The Examiner does not cite any evidence showing that hES cells
occur naturally in combination with a progestin and a βhCG agonist. Rather,
the only compositions in the record that comprise hES cells in combination
with a progestin and a βhCG agonist appear to be those described in the
Specification, resulting from culturing embryonic cells under certain
conditions.
The Examiner reasons that “[t]he claims are . . . drawn to a natural
phenomenon, namely the occurrence of the claimed cells in nature and are
thus are [sic] a judicial exception.” Ans. 3. The Examiner finds that “[t]he
cells, hES cells in particular, do not differ significantly from those found in
nature.” Id. “The claims require only a ‘trace’ amounts [sic] of progestin and
βhCG and as there is no definition of ‘trace’ within the specification that has
[been] interpreted as a negligible amount.” Id. at 4. “[T]here is no evidence
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of record that trace amounts of progestin and a βhCG agonist have any effect
on hES cells or specifically impart the ‘differences’ alleged.” Id. at 5–6.
We disagree with the Examiner’s reasoning. The claims are not
directed to hES cells per se, but to a composition comprising hES cells in
combination with trace amounts of a progestin and a βhCG agonist. The
issue, therefore, is not whether the hES cells in the composition are naturally
occurring, but whether the claimed composition, including all of the
elements recited in the claims, is naturally occurring. We conclude that the
Examiner’s position—that a composition comprising hES cells that have the
properties recited in claims 1 and 22, combined with trace amounts of a
progestin and a βhCG agonist, is naturally occurring—is not supported by a
preponderance of the evidence. We therefore reverse the rejection of claims
1–27 and 118–123 under 35 U.S.C. § 101.

REVERSED