Ex Parte Nistico et al

Patent Trial and Appeal Board

Nov 6, 2018

12997795 (P.T.A.B. Nov. 6, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/997,795 08/12/2011
23117 7590 11/08/2018
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Paola Nistico
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.
GRT/4161-59 9080
EXAMINER
MOSELEY II, NELSON B
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
11/08/2018 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PAOLA NISTICO, FRANCESCA DI MODUGNO,
and MARIA SIMONA PINO
Appeal2017-010301
Application 12/997, 795 1
Technology Center 1600
Before ULRIKE W. JENKS, JOHN G. NEW,
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 1-5, 10, 20-24, and 29. 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 Istituti Fisioterapici
Ospitalieri (IFO)-Istituto Regina Elena Per Lo Studio E La Cura Dei
Tumori. Br. 3.
Appeal2017-0010301
Application 12/997,795
BACKGROUND
The Specification relates to a method for determining whether a tumor
is sensitive or resistant to EGFR2 inhibitor drugs by testing for expression of
the hMena+lla splicing variant of hMena. Spec. 4:5-8.
Claim 1 is illustrative, and recites:
1. A method for discriminating between sensitive and resistant
tumours to a treatment with EGFR inhibitor drugs comprising:
- in vitro testing whether tumour material expresses the
hMena+lla splicing variant of hMena, a tumour comprising the
tumour material positive for said testing being sensitive to the
treatment, wherein said testing is carried out by detecting
hMena+lla isoform protein with an antibody or fragment thereof
that specifically recognises the hMena+lla isoform without cross
reacting with other hMena isoforms.
Br. 21 (Claims Appendix).
REJECTIONS MAINTAINED ON APPEAL
1. Claims 1-5, 20, and 29 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over Di Modugno3' 4 and Adolf. 5 Ans. 3.
2 Epidermal growth factor receptor (EFGR) "is commonly over expressed in
a number of epithelial malignancies and its up regulation is often associated
with an aggressive phenotype of the tumour," and thus represents a promising
target for cancer treatment. Spec. 1 :5-8; see also id. at 1: 14--20.
3 Di Modugno et al., Molecular Cloning of hMena (ENAH) and Its Splice
Variant hMena+11a: Epidermal Growth Factor Increases Their Expression
and Stimulates hMena+JJa Phosphorylation in Breast Cancer Cell Lines, 67
CANCER RES. 2657 (2007).
4 Di Modugno is sometimes referred to in the record as "Di Modugno II." We
have left unaltered such references in the passages quoted herein.
5 Adolf et al., US 6,972,324 B2, issued Dec. 6, 2005.
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Application 12/997,795
2. Claims 10 and 21-24 stand rejected under 35 U.S.C. § I03(a)
as unpatentable over Di Modugno, Adolf, and Baker. 6 Ans. 7.
DISCUSSION
Upon consideration of the evidence on this record and each of
Appellants' contentions, we find that the preponderance of evidence on this
record supports the Examiner's conclusions that the appealed claims are
unpatentable over the cited prior art. Accordingly, we sustain Rejections 1
and 2 for the reasons set forth in the Answer at pages 3-8 and 10-15, which
we incorporate herein by reference. We offer the following discussion for
emphasis only.
A. Re} ection 1
Di Modugno reports the cloning ofhMena and hMena+lla from a
breast carcinoma cell line, and reports that EGF treatment in breast cancer
cell lines promotes upregulation of hMena and hMena+ 11a, "resulting in an
increase of the fraction of phosphorylated hMena+lla isoform only." Di
Modugno Abstract. hMena and hMena+lla differ from one another insofar as
hMena+lla contains an additional exon corresponding to 21 amino acids. Id.;
see also id. at Figs. IC, ID. Di Modugno teaches using an anti-hMena
antibody, CKLKI, which recognizes both isoforms, for Western blot
analysis to study protein expression in tumor cell lines. See id. at 2660. Di
Modugno notes that "[t]he hMena and hMena+lla isoforms are not clearly
distinguishable by Western blot because they comigrate (88-90 kDa)." Id.
6 Baker et al., US 2007/0128636 Al, published June 7, 2007.
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Appeal2017-0010301
Application 12/997,795
The Examiner relies on Di Modugno as teaching the elements of
claim 1 with the exception that "Di Modugno II does not teach
discriminating between tumors that are sensitive or resistant to treatment
with EGFR inhibitor drugs via the detection of the hMena+lla variant using
an antibody that is specific for the hMena+lla variant and does not cross-react
with other isoforms." Non-Final Action 8. 7 To remedy this deficiency, the
Examiner turns to Adolf, which teaches "the production of two CD44v6
antibodies with different properties." Non-Final Action 9 (citing Adolf 3:1-
13). The Examiner finds that "[b ]y substituting the hMena+lla variant that
was disclosed and sequenced by Di Modugno II for the CD44v6 variant of
Adolf et al., one could produce an antibody that is specific for the hMena+l la
variant and does not cross-react with other isoforms," and that it would have
been obvious to do so in part8 because "Di Modugno II teaches that
detecting the hMena+l la variant would provide a method for discriminating
between tumors that are sensitive or resistant to treatment with EGFR
inhibitor drugs." Id.
Appellants argue the rejection of claim 1 is the product of hindsight
and unsupported opinions. See Br. 11-12. Specifically, Appellants assert
that Di Modugno "is completely silent on whether tumors are resistant ( or
not) to EGFR inhibitor drugs," and further that "[ n ]owhere does Di
Modugno suggest or otherwise make obvious the conclusion that detection
ofhMena+lla would allow discrimination between tumors that are sensitive
or resistant to treatment with EGFR inhibitor!" Id. at 12.
7 Non-Final Action dated May 5, 2014.
8 A full description of the Examiner's rationale for combining the references
as claimed can be found at pages 9-10 of the Non-Final Action.
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Application 12/997,795
We are not persuaded. The "discriminat[ion] between sensitive and
resistant tumours to a treatment with EGFR inhibitor drugs" recited in claim
1 amounts to an intended purpose, not a claim limitation. 9 As the Examiner
points out, "the only meaningful limitation of claim 1 comprises detecting
the hMena+lla isoform ofhMena using an antibody that specifically
recognizes the hMena+lla isoform without cross reacting with other hMena
isoforms." Ans. 13. We discern no error in the Examiner's conclusion that
this step would have been obvious to the ordinarily skilled artisan at the time
of the invention, because ( 1) Di Modugno provides the 21-amino acid
sequence of the exon unique to the hMena+lla isoform (see Ans. 11), and (2)
"[i]n view of the teachings of Di Modugno et al. and Adolf et al., one of
ordinary skill in the art would reason that detecting the hMena+lla variant of
hMena could be carried out by using antibodies that are hMena+lla variant-
specific" (id.). 10 Accordingly, for these reasons and those already of record,
we affirm the rejection of claim 1.
With respect to Appellants' allegation that the Examiner
impermissibly relied upon hindsight in performing the obviousness analysis:
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and
does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
9 Our analysis likewise applies to the similar (but not identical) intended use
language in the preambles of claims 10 and 29.
10 Even if we were to construe the preamble of claim 1 as limiting, we would
still affirm the Examiner's rejection for claim 1, for the reasons articulated by
the Examiner on pages 14--15 of the Answer.
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Application 12/997,795
In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). Appellants point to
no knowledge that the Examiner relied upon which could have been gleaned
only from Appellants' Specification. The Examiner, relying solely upon the
teachings of the cited prior art, concluded that a skilled artisan would have
had a reasonable expectation of success in combining the references for the
reasons we set forth supra, and additionally based upon the teachings of
Baker. Final Act. 6. Appellants have, for the reasons we have explained,
not persuaded us to the contrary; indeed, Appellants do not address the
Examiner's latter conclusion in this respect.
Appellants group claims 2-5 and 20 along with claim 1 (see Br. 9)
and do not separately argue these claims. Thus, claims 2-5 and 20 fall with
claim 1. See 37 C.F.R. § 4I.37(c)(l)(iv). Although Appellants state that
claim 29 forms a separate group (see Br. 9), Appellants do not argue it
separately from claim 1. See generally Br. 10-14. As such, we affirm the
rejection of claim 29 for substantially the same reasons as claim 1.
B. Re} ection 2
Appellants' arguments in favor of the patentability of claims 10 and
21-24 largely retrace their arguments with respect to claim 1. Compare Br.
14--16 with id. at 10-14. In regard to Baker, the additional reference unique
to Rejection 2, Appellants state:
At best, Baker shows it would have been desirable to identify a
specific marker for circulating tumor-cells in the blood. There is
no evidence or reasoning, however, that it would have been
obvious to make an antibody or fragment thereof that specifically
recognizes the hMena+JJa isoform without cross reacting with
other hMena isoforms. Thus, even the broadest claim is not
made obvious by the combination of Di Modugno and Adolf,
further in view of Baker.
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Application 12/997,795
Br. 15-16 ( emphasis added). As is apparent from the emphasized sentence,
the essence of this argument is about Di Modugno, not Baker. For the
reasons discussed above with respect to Rejection 1 and those already of
record, we are not persuaded of any reversible error in the Examiner's
reliance on Di Modugno, nor in the combination of Di Modugno with Adolf.
As such, Appellants have not demonstrated any reversible error by the
Examiner in rejecting claim 10. Appellants group claims 21-24 with claim
10 (see Br. 9) and argue them only by virtue of their dependency on claim
10 (see id. at 16). Accordingly, claims 21-24 fall with claim 10.
CONCLUSION
The rejections of claims 1-5, 10, 20-24, and 29 are affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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