Ex Parte Rao et al

Patent Trial and Appeal Board

Apr 19, 2017

14008195 (P.T.A.B. Apr. 19, 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.
14/008,195 09/27/2013 Min Rao 153717-00016 3455
84346 7590 04/19/2017
MILLER, CANFIELD, PADDOCK AND STONE
277 SOUTH ROSE STREET
SUITE 5000
KALAMAZOO, MI 49007
EXAMINER
COFFA, SERGIO
ART UNIT PAPER NUMBER
1675
MAIL DATE DELIVERY MODE
04/19/2017 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 MIN RAO,
MEI GE, MINYU LUO, LIJUN RUAN, XING XIA,
LI ZHU, LINGAO RUAN, HUAIXIA KANG, TIAN YANG,
TIANJIAO WANG, QIUSHUANG LI, and HANYAN JIANG1
Appeal 2016-006726
Application 14/008,195
Technology Center 1600
Before ERIC B. GRIMES, ROBERT A. POLLOCK, and RYAN H. FLAX,
Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 11, 22, and 34. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
According to the Specification, “[t]he inventors obtained a microbial
strain, identified as Streptomyces parvus, from a natural soil sample, which
1 Appellants identify the real party-in-interest as Shanghai Laiyi Center
for Biopharmaceutical R & D. App. Br. 2.
Appeal 2016-006726
Application 14/008,195
was deposited at China General Microbiological Collection Center
(CGMCC) on July 20, 2010, with a code of CGMCC No.4027.” Spec. 12.
A stock culture of CGMCC No. 4027 was used to inoculate a fermentation
culture, and a compound in the supernatant was purified. See id. 131. The
compound, designated 3-amino-2-hydroxy-4-phenylbutanoyl-valyl-
isoleucine {id. 19), is set forth in claim 11, which recites:
11. A compound having the following formula:
The Examiner rejects claims 11, 22, and 34 under 35U.S.C. § 101 as
directed to non-patentable subject matter. Ans. 2.
Appellants do not argue the claims separately.
We have reviewed Appellants’ contentions that the Examiner erred in
rejecting claims 11, 22, and 34 as patent ineligible under 35U.S.C. § 101.
App. Br. 7—11; Reply Br. 4—8. We disagree with Appellants’ contentions
and adopt the factual findings and analysis set forth in the Examiner’s
Answer. For emphasis, we highlight and address the following:
Upon weighing factors for and against eligibility, the Examiner finds
that the claimed subject matter is an unpatentable natural product “not
markedly different from what exists in nature.” Ans. 5—7. In response,
Appellants contend that the Examiner has failed to satisfy the initial burden
of presenting a prima facie case that the appealed claims are directed to
STATEMENT OF THE REJECTION
ANALYSIS
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Application 14/008,195
unpatentable natural products. See App. Br. 10-11; see also Reply Br. 4
(asserting that “the only real question to be addressed on this appeal is
whether the instantly claimed compounds are natural products or not”).
According to the Specification, the compound set forth in claim 11
was derived from the fermentation of a stock culture of microbial strain
CGMCC No. 4027 isolated from a natural soil sample. See Spec. Tflf 2, 9,
31. We discern nothing in the Specification indicating that either the
microbial strain or the compound was specifically modified in any way—a
point Appellants do not contest. See App. Br. 8. Accordingly, we find
reasonable the Examiner’s implicit conclusion that the CGMCC No. 4027 is
a naturally occurring microorganism, and that it produces the naturally
occurring secondary metabolite set forth in claim 11. See, e.g., Ans. 5 (“the
compound claimed is not structurally different than the natural product”).
See In re Jung, 637 F.3d 1356, 1363 (Fed. Cir. 2011) (“[A]ll that is required
of the office to meet its prima facie burden of production is to set forth the
statutory basis of the rejection and the reference or references relied upon in
a sufficiently articulate and informative manner as to meet the notice
requirement of § 132.”) (quoting 35 U.S.C. § 132, alterations by the Jung
court).
Relying on the declaration testimony of Dr. Ge2 and references cited
therein, Appellants respond that because the presence and level of secondary
metabolites are affected by the external environment, the laboratory
culturing conditions set forth in the Specification might have induced
2 Declaration under 37 C.F.R. § 1.132 of Mei Ge, Ph.D., dated Dec. 17, 2014
(“Ge Declaration”).
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Application 14/008,195
CGMCC No. 4027 to produce a compound not otherwise found in nature—
and in particular, the compound of claim 11. See App. Br. 9-10; Reply Br.
5; Ge Declaration 17. The Board evaluates a declaration submitted pursuant
to 37 C.F.R.§ 1.132 on its merits, considering the evidence relied upon in
light of the arguments explaining why the evidence is sufficient. In the
present case, we agree with the Examiner that Appellants have not provided
sufficient objective evidence to support their speculative assertion and
accord it little weight in our analysis. See Ans. 9.
Appellants similarly argue that CGMCC No. 4027 “may have mutated
and is no longer the same as it existed in nature.” Reply Br. 5. In particular,
Appellants assert that the “lengthy culturing under artificial conditions has
likely caused the isolate to undergo genetic mutation, such as spontaneous
mutations at the chromosomal level or spontaneous loss of plasmids.” App.
Br. 9 (citing Ge Declaration | 6). As above, we do not find Appellants’
arguments persuasive.
Appellants provide no objective evidence that the original isolate of
CGMCC No. 4027 is in any way genetically different from that used to
produce the claimed compound by fermentation. Lacking such evidence,
Appellants cannot show that any such genetic differences result in the
production of a non-naturally occurring small molecule, and most
particularly, the compound recited in claim 11. Further, Appellants provide
no explanation or theory for why the theoretical loss of a plasmid would
result in the appearance of a compound heretofore unknown in the natural
world. Accordingly, we find Appellants’ argument speculative and
unsupported by sufficient evidentiary basis. See In re Am. Acad, of Sci. Tech
Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004). “Although there is no reason
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Application 14/008,195
why opinion evidence relating to a fact issue should not be considered by an
examiner, the Board is entitled to weigh the declarations and conclude that
the lack of factual corroboration warrants discounting the opinions expressed
in the declarations.” (internal citations omitted).
In sum, the Examiner provides a logical rationale for finding that the
compound of claim 11 is a natural product and patent ineligible under § 101.
Because Appellants’ arguments fail to rebut the Examiner’s position, we
affirm.
SUMMARY
We affirm the rejection of claims 11, 22, and 34 under 35 U.S.C.
§ 101 as directed to non-patentable subject matter.
TIME PERIOD FOR RESPONSE
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
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