Ex Parte Biggerstaff et al

Patent Trial and Appeal Board

Mar 20, 2017

11508815 (P.T.A.B. Mar. 20, 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.
11/508,815 08/23/2006 John Biggerstaff Ension-1202 5646
36787 7590
BLYNN L. SHIDELER
THE BLK LAW GROUP
3500 BROKKTREE ROAD
SUITE 200
WEXFORD, PA 15090
EXAMINER
NIEBAUER, RONALD T
ART UNIT PAPER NUMBER
1676
NOTIFICATION DATE DELIVERY MODE
03/22/2017 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):
patents @ BLKLawGroup.com
cbelleci @ BLKLawGroup .com
blynn @ BLKLawGroup. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN BIGGERSTAFF and BRANDY WEIDOW
Appeal 2016-000087
Application H/508,8151
Technology Center 1600
Before ELIZABETH A. LaVIER, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants seek review of the
Examiner’s rejections of claims 15, 17—19, 22, 30, and 31. We have
jurisdiction under 35 U.S.C. § 6(b). For the reasons of record and those set
forth below, we REVERSE.
1 Appellants state the real parties in interest are the University of Tennessee
Research Foundation, John Biggerstaff, and Enison, Inc. Br. 3.
Appeal 2016-000087
Application 11/508,815
BACKGROUND
The Specification “discloses peptide sequences that inhibit soluble
fibrin (sFn) binding to blood monocytes and melanoma cells and their use in
a wide variety of diseases such as cancer . . . Spec. 1:16—18.
Claim 15, the only independent claim on appeal, is illustrative:
15. A method of treating an individual diagnosed with a
cancer, comprising:
administering to the individual an anticancer agent; and
administering to the individual pharmacologically effective
amounts of a pharmaceutical composition comprising a mixture
of isolated peptides selected from one of
i) a combination of SEQ ID NO: 5 or a recombinant
peptide thereof and SEQ ID NO: 6 or a recombinant peptide
thereof, or
ii) a combination of SEQ ID NO: 3 or a recombinant
peptide thereof and SEQ ID NO: 7 or a recombinant peptide
thereof,
said pharmaceutical composition effective to reduce inhibition
of cell adherence due to the soluble fibrin, restore immune
response, inhibit progression of a solid tumor, inhibit
enhancement of metastasis of the cancer or a combination
thereof in the individual, thereby treating the individual
diagnosed with the cancer.
Br. 16 (Claims Appendix).
REJECTIONS MAINTAINED ON APPEAL
1. Claims 15, 17—19, 22, and 31 stand rejected under 35 U.S.C.
§ 112, second paragraph, as indefinite. Ans. 2.
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Application 11/508,815
2. Claims 15, 17—19, 22, and 31 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Altieri,2 Simpson-Haidaris,3 Young,4
and Ugarova.5 Ans. 5—6.
DISCUSSION
A. Rejection 1
The Examiner finds that claim 15 and its dependents are indefinite
because the meaning of “SEQ ID NO: 6,” as recited in claim 15, is unclear.
See Final Action 3^4. The amino acid sequence recited for SEQ ID NO: 6
in the Specification is YKSMKKTTMKIIPFNRLTIF. Spec. Table 1;
Sequence Listing. However, the Examiner observes that the narrative
description in the Specification “states that SEQ ID NO:6 is from soluble
fibrin and is called P2” (Final Action 3 (citing Spec. Table 1)), and “Figure 9
shows that P2 is residues 377—395 of soluble fibrin gamma chain” (id. ). The
problem, according to the Examiner, is that the relevant portion of the
fibrinogen gamma sequence is known in the art to be
YSMKKTTMKIIPFRNLTIG (starting at residue 376). Id. (citing NCBI
BLAST search results); see also Ans. 15. This sequence is thus different
from SEQ ID NO:6, as set forth in the Specification. See Final Action 3;
Ans. 13. As such, the Examiner finds that “the information provided by
2 Altieri et al., 5,919,754, issued July 6, 1999.
3 Simpson-Haidaris & Rybarczyk, Tumors & Fibrinogen: The Role of
Fibrinogen as an Extracellular Matrix Protein, 936 Annals NY Acad. Sci.
406 (2001).
4 Young, US 2004/0101511 Al, published May 27, 2004.
5 Ugarova et al., Identification of a Novel Recognition Sequence for Integrin
aMf2 within the y-chain of Fibrinogen, 273 J. Bio. Chem. 22519 (1998).
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Appeal 2016-000087
Application 11/508,815
applicant is contradictory and there is more than one reasonable
interpretation of the claims. It is unclear how SEQ ID NO: 6 can be the
‘peptide comprising the cell-binding domain in soluble fibrin’ yet comprise
other than the sequence of fibrin.” Final Action 3^4.
Appellants assert that the confusion is the result of a “minor
typographical error,” and that the ordinarily skilled artisan would “know
exactly the metes and bounds of the claim.” Br. 10. But, as the Examiner
notes, Appellants do not specify whether “the proper correction is to change
the description of the sequence (for example Table I column 3; figure 9) to
refer to SEQ ID NO:6 as a modified soluble fibrin fragment, or if the proper
correction is to change SEQ ID NO:6.” Ans. 14.
We appreciate the Examiner’s point that the Specification’s narrative
description of SEQ ID NO:6 could be read to suggest a different sequence
than the one the Specification expressly as SEQ ID NO:6, and that there is
evidence for both interpretations. See Ans. 14. However, the Specification
clearly states, in two places, that SEQ ID NO:6 comprises
YKSMKKTTMKIIPFNRLTIF. Spec. Table 1; Sequence Listing (using
three-letter amino acid abbreviations). To interpret SEQ ID NO:6 as
meaning a different sequence than the one expressly recited in Table 1 and
the Sequence Listing of the Specification would require resorting to extrinsic
evidence whilst ignoring the clear intrinsic evidence, as no other candidate
sequence for SEQ ID NO:6 is provided expressly in the Specification. This
would contravene bedrock principles of claim construction. See Phillips v.
AWHCorp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (enbanc) (“[T]he
specification may reveal a special definition given to a claim term by the
patentee that differs from the meaning it would otherwise possess. In such
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Appeal 2016-000087
Application 11/508,815
cases, the inventor’s lexicography governs.”); see also id. at 1315
(explaining that extrinsic sources are “less significant than the intrinsic
record in determining the legally operative meaning of claim language”)
(quotations and citations omitted). Thus, we find that Appellants have acted
as their own lexicographers in defining SEQ ID NO:6 to comprise the
sequence recited in Table 1 and the Sequence Listing, i.e.,
YKSMKKTTMKIIPFNRLTIF.
For these reasons, we find that the meaning of “SEQ ID NO:6” in
claim 15 is not unclear, and claim 15 itself it not unclear. Cf. In re Packard,
751 F.3d 1307, 1310, 1315 (Fed. Cir. 2014) (approving the Board’s
application of MPEP § 2173.05(e) standard of indefmiteness, i.e., that “[a]
claim is indefinite when it contains words or phrases whose meaning is
unclear”). Accordingly, we reverse the rejection under 35U.S.C. § 112,
second paragraph, of claim 15; claims 17—19, 22, and 31 stand together with
claim 15.
B. Rejection 2
The obviousness rejection is based in part on the Examiner’s finding
that Ugarova teaches “fibrinogen gamma chain residues 377—395” (Final
Action 9), i.e., the native fibrinogen sequence, not the one expressly defined
in the Specification as SEQ ID NO:6. Because it is clear that SEQ ID NO:6
comprises YKSMKKTTMKIIPFNRLTIF (see discussion, supra), and
because the Examiner does not find that Ugarova (or another reference)
teaches or suggests this sequence, the Examiner has not established a prima
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Application 11/508,815
facie case of obviousness for claim 15.6 Accordingly, we reverse the
rejection under § 103(a) of claim 15; claims 17—19, 22, and 31 stand
together with claim 15.
CONCLUSION
The rejections of claims 15, 17—19, 22, and 31 are reversed.
REVERSED
6 As the rejection focuses on option (i) listed in claim 15 (i.e., involving SEQ
ID NOS: 5 and 6), not option (ii) (i.e., involving SEQ ID NOS: 3 and 7), the
Examiner has not made out a prima facie case of obviousness independent of
SEQ ID NO:6, either.
6