Ex Parte Urbaniak et al

Patent Trial and Appeal Board

Jun 10, 2016

10563204 (P.T.A.B. Jun. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
10/563,204 07/10/2006 Stanislaw Joseph Urbaniak
26259 7590 06/14/2016
LICATA & TYRRELL P.C.
66 E. MAIN STREET
MARLTON, NJ 08053
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.
ABLE0032US.NP 6475
EXAMINER
SZPERKA, MICHAEL EDWARD
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
06/14/2016 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):
PTOactions@licataandtyrrell.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STANISLAW JOSEPH URBANIAK,
ROBERT NORMAN BARKER, and
HOSEA SUKATI
Appeal2013-009142
Application 10/563,204
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
r-T"I .. • • .. 1 .. ,..... ,_ TT r'1 I'\ l\ -1,..... Al • "1 • "1 • , ,.. .. ims 1s an appear unaer j) u.~.L. s U4 mvo1vmg crnm1s to a memoa
for managing or reducing the likelihood of a condition caused by exposure
to an antithetical allele of a platelet by transfusion or during pregnancy. The
Examiner rejected the claims as failing to comply with the written
description requirement and for obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b). We reverse the written description
rejection but affirm the double-patenting rejection.
1 Appellants identify the Real Parties in Interest as Aberdeen
University and the Common Services Agent for the Scottish Health
Service (see App. Br. 1 ).
Appeal2013-009142
Application 10/563,204
Statement of the Case
Background
"Platelet blood group antigens are present on the surface
glycoproteins and are expressed as pairs of alleles ... Individuals that are
negative for a particular allele, may be immunised if exposed to the
antithetical allele (by pregnancy or blood transfusion) and produce
alloantibody responses" (Spec. 1:8-14). "These antibodies are clinically
important and may cause fetomatemal alloimmune thrombocytopenia
(FMAIT), or reactions and resistance to platelet transfusions given to
prevent bleeding" (Spec. 1:15-18).
The Claims
Claims 11, 12, 14--17, 19, and 20 are on appeal. Independent claim 11
is representative and reads as follows:
11. A method for managing or reducing the likelihood of a
condition caused by exposure to an antithetical allele of a
platelet by transfhsion or during pregnancy, the method
comprising administering to a patient a linear peptide fragment
of a human platelet antigen (HP A) recognized by T-cells.
The Issues2
A. The Examiner rejected claims 11, 12, 14, 15, 17, and 19 under 35
U.S.C. § 112, first paragraph as failing to comply with the written
description requirement (Final Act. 2--4).
B. The Examiner provisionally rejected claims 11, 12, 14--17, 19, and 20
on the ground of nonstatutory obviousness-type double patenting as being
2 The Examiner states that the written description rejection "as set
forth in section four of the office action mailed December 30, 2011
has been withdrawn" (Ans. 2; cf. Final Act. 5-7).
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Appeal2013-009142
Application 10/563,204
unpatentable over claims 14--32 of copending Application No. 12/523,549
(now Urbaniak et al., US 8,398,987 B2, issued Mar. 19, 2013).
A. 3 5 U.S. C. § 112, first paragraph, written description
Claim 11 has a step of administering "a linear peptide fragment of a
human platelet antigen (HPA)" to a patient. The Examiner finds that "the
context for the phrase 'linear peptide' is limited to sequences of 15 amino
acids. In contrast, the instant claims comprise no such length limitation"
(Final Act. 2-3). The Examiner finds that "it is not clear where in the 16
pages of the instant specification guidance or working examples concerning
peptides of any length other than 15 consecutive amino acids is to be found"
(Final Act. 3--4). The Examiner finds that "[g]iven this discrepancy in scope
between what is disclosed in the specification and what has been claimed,
applicant's claim amendments appear to have introduced new matter into the
presently claimed invention" (Final Act. 3).
The issue with respect to these rejection is: Does the evidence of
record support the Examiner's conclusion that the limitation in claim 11 to
"a linear peptide fragment of a human platelet antigen" represents new
matter?
Findings of Fact
1. Original claim 1 of the Specification recites: "A pharmaceutical
composition for the prevention or management of a condition caused by
exposure to an antithetical allele of a platelet by transfusion or during
pregnancy by tolerisation, the composition comprising an immunologically
effective platelet protein or peptide fragment thereof' (Spec. 16, claim 1 ).
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Appeal2013-009142
Application 10/563,204
2. The Specification teaches the "use of an immunologically
effective platelet protein or peptide fragment thereof in the manufacture of a
medicament for the prevention or management of a condition caused by
exposure to an antithetical allele of a platelet by tolerisation" (Spec. 3, 11.
29-33).
3. The Specification teaches that if "a women is HP A-1b1 b then
immunologically effective fragments of the HP A-1 a antigen can be
administered to her by a tolerogenic route" (Spec. 4, 11. 20-22).
4. The Specification teaches that "a set of linear peptides with the
polymorphism at every possible position in 15 mer peptides ... was derived,
and this was successful in identifying Leu-33-peptide specific responses"
(Spec. 7, 1. 31 to 8, 1. 1 ).
5. The Specification teaches that "[s]ynthetic peptides containing
these epitopes can be used to prepare a tolerogenic composition to prevent or
reverse the alloantibody response to HPA-la in susceptible individuals in
vivo" (Spec. 8, 11. 4--7).
Principles of Law
"[I]t is the specification itself that must demonstrate possession. And
while the description requirement does not demand any particular form of
disclosure, ... or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement" Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (Fed. Cir. 2010).
Analysis
Appellants contend that "peptides of lengths other than 15 mer and
derived from other HP As were clearly contemplated by the inventors for use
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Application 10/563,204
in the present invention as evidenced by teachings in the as-filed
specification" (Br. 9). Appellants contend that "Dr. Mark Peakman, 3 has
also acknowledged that the patent application sets out identifying additional
useful peptides to the 15 mer peptides of the initial experiments" (Br. 10).
The Examiner responds that the "specification does not appear to
teach anywhere that the terms 'protein', 'peptide', and 'peptide fragment'
are indeed synonymous (which is what reasonably is required if the terms
are to be used interchangeably)" (Ans. 3).
Appellants' argument is supported by a preponderance of the
evidence. The originally filed claim 1 uses the terms "protein" and "peptide
fragment" as synonyms (FF 1) as does the Specification (FF 2-3). The
Specification teaches examples of 15-mer linear peptides (FF 4) and teaches
generically that peptides with platelet epitopes can be used (FF 2, FF 5). It
is these teachings in the Specification that provide descriptive support for a
limitation to a "linear peptide fragment of a human platelet antigen" in claim
11.
Conclusion of Law
The evidence of record does not support the Examiner's conclusion
that the limitation in claim 11 to "a linear peptide fragment of a human
platelet antigen" represents new matter.
B. Obviousness-type double patenting
We summarily affirm the obviousness-type double patenting
rejections since no arguments were presented. See Manual of Patent
Examining Procedure§ 1205.02 ("If a ground of rejection stated by the
3 Declaration of Dr. Mark Peakman, dated Feb. 7, 2010.
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Appeal2013-009142
Application 10/563,204
examiner is not addressed in the appellant's brief~ that ground of rejection
will be summarily sustained by the Board.").
SUMMARY
In summary, we reverse the rejection of claims 11, 12, 14, 15, 17, and
19 under 35 U.S.C. § 112, first paragraph as failing to comply with the
written description requirement.
We affirm the rejection of claims 11, 12, 14--17, 19, and 20 on the
ground of nonstatutory obviousness-type double patenting as being
unpatentable over claims 14--32 of copending Application No. 12/523,549
(now Urbaniak et al., US 8,398,987 B2, issued Mar. 19, 2013).
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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