Ex Parte Sung et al

Patent Trials and Appeals Board

Apr 25, 2019

12646839 - (D) (P.T.A.B. Apr. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/646,839 12/23/2009
20350 7590 04/29/2019
KILPATRICK TOWNSEND & STOCKTONLLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
Joseph Jao Yiu Sung
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
80015-000200US-780481 1846
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
04/29/2019 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):
ipefiling@kilpatricktownsend.com
KTSDocketing2@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH HAO YIU SUNG, JUN YU, and KIN F AI CHEUNG
Appeal2018-001721
Application 12/646,839 1
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
ELIZABETH A. LA VIER, Administrative Patent Judges.
LA VIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner's rejections of claims 1, 6, 7, 12, and 21-24. We have jurisdiction
under 35 U.S.C. § 6(b).
For the reasons set forth below, we AFFIRM.
1 Appellants identify the real party in interest as The Chinese University of
Hong Kong. Appeal Br. 3.
Appeal2018-001721
Application 12/646,839
BACKGROUND
The Specification describes "markers for gastric cancer, and methods
for the inhibition of gastric cancer." Spec. 1. Claim 1, the only independent
claim on appeal, is illustrative:
1. A method for assessing likelihood of mortality from gastric
cancer, the method comprising the steps of:
(a) treating genomic DNA isolated from a gastric cancer sample
with a bisulfite, wherein the gastric cancer sample is taken from
a human patient diagnosed with stage I-III gastric cancer;
(b) performing a polymerase chain reaction (PCR) to amplify
the treated genomic DNA following step (a) with primers
consisting of the nucleotide sequences of SEQ ID N0:43 and
SEQ ID N0:44;
( c) determining nucleotide sequence of the amplified DNA
from step (b) to detect DNA that has been amplified from a
methylated version of the genomic DNA; and
( d) determining, based on the presence of the amplified
methylated genomic DNA from step ( c ), a higher likelihood of
mortality for the patient compared with another stage I-III
gastric cancer human patient whose gastric cancer sample
shows absence of amplified methylated genomic DNA after
being processed through steps (a) to (c).
Appeal Br. 13 (Claim Appendix) (emphasis added).
REJECTIONS MAINTAINED ON APPEAL
1. Claims 1, 6, 7, 12, and 21-24 stand rejected under 35 U.S.C.
§ 112(a) as failing to comply with the written description requirement for
containing subject matter not described in the specification. Ans. 2.
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Application 12/646,839
2. Claims 1, 6, 7, and 242 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Cheung, 3 Freije, 4 Dieffenbach, 5 and Roux. 6 Ans. 5, 7.
3. Claims 12, 21, and 22 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Cheung, Freije, Dieffenbach, Roux, and Hogan. 7 Ans.
10.
4. Claim 23 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Cheung, Freije, Dieffenbach, Roux, Hogan, and Yao. 8
Ans. 11.
2 The Answer at page 5 includes claim 23 (not claim 24) in the list of
rejected claims for Rejection 2. This appears to be a typographical error, as
the Answer goes on to address claim 24 (not claim 23) in the substantive
discussion of Rejection 2. See Ans. 7-8. Accordingly, we treat Rejection 2
as encompassing claim 24 (not claim 23). As discussed below, Appellants
argue the§ 103 rejections (and claims) together, so there is no prejudice to
Appellants in treating Rejection 2 as encompassing claim 24 (not claim 23).
3 Cheung et al., Epigenetic Characterization of a Novel Tumor Suppressor
Gene, Rnfl 80, in Gastric Cancer and Its Application in Noninvasive Cancer
Detection, 134 GASTROENTEROLOGY A-382 (2008).
4 Frije et al., WO 2007/102891 A2, published Sept. 13, 2007.
5 Dieffenbach et al., General Concepts for PCR Primer Design, 3 PCR
METHODS APPL. 30-37 (1993).
6 Roux, Optimization and Troubleshooting in PCR, 4 PCR METHODS APPL.
185-194 (1995).
7 Hogan et al., US 5,541,308, issued July 30, 1996.
8 Yao et al., Evaluation of Minor Groove Binding Probe and Taqman Probe
PCR Assays: Influence of Mismatches and Template Complexity on
Quantification, 20 MOLECULAR & CELLULAR PROBES 311-316 (2006).
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Appeal2018-001721
Application 12/646,839
A. Rejection 1
DISCUSSION
The Examiner finds that the amendment of claim 1 to recite step ( d)
( emphasized above) constitutes new matter. See Final Action 3-9.
Specifically, the Examiner states that Appellants have "failed to identify
where the specification supports [the] combination of steps together," and
instead "demonstrated the claims have merely combined different limitations
from wide ranging parts of the specification and asserted all the limitations
are taught." Ans. 15.
Having reviewed the portions of the Specification cited by Appellants
as supporting step (d) (see Appeal Br. 6 (citing Spec. 30, 37-39, 41, Figs.
17, 18, 20) ), we cannot agree with the Examiner's assessment. The test for
determining whether a specification is sufficient to support a particular claim
"is whether the disclosure of the application relied upon 'reasonably conveys
to the artisan that the inventor had possession at that time of the later
claimed subject matter."' Ralston Purina Co. v. Far-Mar-Co, Inc., 772 F.2d
1570, 1575 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375
(Fed. Cir. 1983)). Notably, this is not an in haec verba requirement. Purdue
Pharma L.P. v. Faulding, Inc., 230 F.3d 1320, 1323 (Fed. Cir. 2000). The
cited portions of the Specification are not disparate embodiments cherry-
picked by Appellants in an attempt to respond to this rejection. Instead, the
discussion and data in the Specification on which Appellants rely flow
naturally with the rest of the disclosure and are not separate from it. The
various examples, including Examples 6 and 7 (see Spec. 39--41) present
different tests and analyses of RNF 180 expression and promoter
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Application 12/646,839
methylation. Examples 6 and 7 specifically consider effects on tumor
growth and patient survival. These exemplary disclosures dovetail with the
earlier description of embodiments in which:
the levels of expression of RNF 180 RNA, or protein, or levels
of promoter methylation, may alternatively or in combination
be used to predict the likely mortality of a subject or to
determine the degree of progress of gastric cancer in the
subject. In embodiments patient samples may be analysed to
determine levels of any of these variables and the results
compared with standard curves to make predictions.
Spec. 30.
Accordingly, we conclude that the Specification, as originally filed,
would have reasonably conveyed to the ordinarily skilled artisan that the
inventors had possession of the subject matter of claim 1 as currently
amended. We reverse Rejection 1.
B. Rejections 2--4
Appellants discuss Rejections 2--4 together, focusing their arguments
entirely on step (d) of claim 1. See Appeal Br. 10-12; Reply Br. 4--7.
Appellants first argue that the Examiner has disregarded step ( d) as a
limitation of claim 1 as "merely instructions or a mental step." Appeal Br.
10 (quoting Final Action 14). We agree with Appellants that step (d) cannot
be disregarded on this basis, but the Examiner also found:
Frieje further teaches "The invention also provides methods of
prognosticating cancer by assaying for the methylation of one
or more genes that are indicative of the grade or stage of the
cancer, and/or the length of disease-free survival following
treatment for cancer."
Final Action 16. Although not specifically labeled as referring to step ( d) of
claim 1, and sandwiched between findings related to claims 6 and 24, this
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Application 12/646,839
analysis nonetheless supports the rejection of claim 1. 9 Appellants also
argue it as such:
the alleged relevant statements in Freije at best should be
considered to provide a motivation for one of skill in the art to
consider experimenting with predicting cancer survival based
gene methylation status. Nothing in Freije shows that the
proposed prognostic method actually works. The nature of the
claimed invention is such that, unless and until actual
experimentation has been performed and proven effective a
proposed method for cancer survival prognosis, there can be no
reasonable expectation of success prior to experimentation.
Appeal Br. 11-12; see also Reply Br. 6.
We are not persuaded. Appellants cite no support, legal or otherwise,
for their assertion that "actual experimentation" to "prove[] effective a
proposed method for cancer survival prognosis" (Appeal Br. 11-12) is
required to support a prima facie case of obviousness. To the contrary, the
law is long-settled that "[ o ]bviousness does not require absolute
predictability," but rather "[o]nly a reasonable expectation that the beneficial
result will be achieved." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir.
1986) (citations omitted); see also In re Kubin, 561 F.3d 1351, 1360 (Fed.
Cir. 2009).
The Examiner did not err in relying on Frieje as explained above. Nor
are we persuaded by Appellants' related argument, that the Examiner's
findings regarding Frieje as applied to step ( d) are in isolation, noting "it is
9 Obviating any potential prejudice or lack of notice to Appellants regarding
the relevance of this finding regarding Frieje to claim 1, however, is the
Notice of Decision from Post-Prosecution Pilot Program (P3) Conference,
dated February 15, 2017 ("P3 Decision"). The P3 Decision specifically
refers to this finding by the Examiner as addressing step ( d) of claim 1.
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Application 12/646,839
the entire claim that should be assessed for obviousness, not a single element
such as step (d)." Appeal Br. 11. Indeed, Frieje as a whole explores the
correlation between methylation of certain genes and cancer, as indicated by
its title: "Materials and Methods for Assaying for Methylation of CpG
Islands Associated with Genes in the Evaluation of Cancer." Further, as the
Examiner explains, addressing both Frieje and Cheung:
the prior art of Cheung specifically teaches RNF 180 is a tumor
suppressor in gastric cancer and implicates the methylation of
the RNF 180 core promoter ( sequence amplified by claimed
primers) as a biomarker, while Freije teach SEQ ID NO 183
which comprises the RN F 180 core promoter and the sequences
or complement of SEQ ID NO 43 and SEQ ID NO 44. Further
Frieje teaches, "The invention also provides methods of
prognosticating cancer by assaying for the methylation of one
or more genes that are indicative of the grade or stage of the
cancer, and/or the length of disease-free survival following
treatment for cancer" (0025, page 10 of Frieje ).
Ans. 16. Thus, the combination of references relied upon by the Examiner
provides a reasonable expectation of successfully predicting the likelihood
of patient mortality relative to another stage I-III gastric cancer human
patient based on methylation state of the amplified genomic DNA.
Appellants have not persuaded us of any reversible error in the
Examiner's rejection of claim 1. Accordingly, we affirm the rejection of
claim 1. As noted above, Appellants address the § 103 rejections (i.e.,
Rejections 2--4) together, and do not argue any of the other claims separately
from claim 1. As such, claims 6, 7, and 24 (Rejection 2) fall with claim 1.
See 37 C.F.R. § 4I.37(c)(l)(iv). For the same reasons, we affirm the
Examiner's§ 103 rejections of claims 12, 21, and 22 (Rejection 3) and 23
(Rejection 4).
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Application 12/646,839
CONCLUSION
We reverse Rejection 1. We affirm Rejections 2, 3, and 4. No time
period for taking any subsequent action in connection with this appeal may
be extended under 37 C.F.R. § 1.I36(a)(l)(iv).
AFFIRMED
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