Ex Parte Aricò et al

Patent Trials and Appeals Board

Apr 17, 2019

13806743 - (D) (P.T.A.B. Apr. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/806,743 03/05/2013
20462 7590 04/19/2019
GlaxoSmithKline
Global Patents UP4110
1250 South Collegeville Road
Collegeville, PA 19426
FIRST NAMED INVENTOR
Maria Arico
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.
VN54179US 3259
EXAMINER
OGUNBIYI, OLUW ATOSIN A
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
04/19/2019 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):
US_cipkop@gsk.com
laura.m.mccullen@gsk.com
eofficeaction@appcoll.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARIA ARICO, BRUNELLA BRUNELLI,
MAURIZIO COMANDUCCI, MARIAGRAZIA PIZZA,
SILVANA SA VINO, and MARIA SCARSELLI
Appeal2017-009471
Application 13/806,743 1
Technology Center 1600
Before TA WEN CHANG, DEVON ZASTROW NEWMAN and
DAVID COTTA, Administrative Patent Judges.
COTT A, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
immunogenic composition. The Examiner rejected the claims on appeal
under 35 U.S.C. § 102(b) as anticipated.
We reverse.
1 According to Appellants, the real party in interest is GlaxoSmithKline
Biologicals SA.
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Application 13/806,743
STATEMENT OF THE CASE
The Specification discloses that "Neisseria meningitidis
(meningococcus) is a Gram-negative spherical bacterium" and that while
there are vaccines based on capsular saccharides for serogroups A, C, W135,
and Y, "[t]here is currently no useful vaccine authorised for general use
against serogroup B ('MenB')." Spec. 1. "One antigen which has been
proposed for use in immunising against MenB is the factor H binding
protein ('fHbp')" which has been "well studied." Id. The Specification
discloses that "[c]ompositions of the invention include at least two different
meningococcal factor H binding proteins ( fHbp) to generate distinct immune
responses which are not fully cross-reactive and which provide a broader
spectrum of strain coverage against meningococci that the single fHbps
alone." Id. at 2.
Claims 1-9, and 14 are on appeal. 2 Claims 1 and 2, the only
independent claims, are illustrative and read as follows:
1. An immunogenic composition which comprises an
immunologically effective amount of an adjuvant, an
immunologically effective amount of a first isolated factor H
binding protein (fHbp) antigen and an immunologically
effective amount of a second isolated fHbp antigen, wherein:
the first isolated fHbp antigen comprises a first amino acid
sequence which has at least 7 5% sequence identity to both of
SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino acid
sequence has a higher sequence identity to SEQ ID NO: 1 than
to SEQ ID NO: 23, when aligned using the same algorithm and
parameters; and the second isolated fHbp antigen comprises a
second amino acid sequence which has at least 7 5% sequence
identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the
2 Appellants cancelled claims 10-13 and 15-20 in an after-final amendment.
The Examiner entered this amendment in a June 16, 2016, Advisory Office
Action. Accordingly, these claims are no longer part of this appeal.
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Application 13/806,743
second amino acid sequence has a higher sequence identity to
SEQ ID NO: 23 than to SEQ ID NO: 1, when aligned using the
same algorithm and parameters.
2. An immunogenic composition which comprises an
immunologically effective amount of an adjuvant, an
immunologically effective amount of a first isolated ffibp
antigen and an immunologically effective amount of a second
isolated ffibp antigen, wherein: the first isolated ffibp antigen
comprises a first amino acid sequence which has at least 7 5%
sequence identity to both of SEQ ID NO: 1 and SEQ ID NO:
23, but the first amino acid sequence has a higher sequence
identity to SEQ ID NO: 1 than to SEQ ID NO: 23, when
aligned using the same algorithm and parameters; and the
second isolated ffibp antigen comprises a second amino acid
sequence (i) having at least 94% sequence identity to SEQ ID
NO: 25 and/or (ii) consisting of a fragment of at least 50
contiguous amino acids from SEQ ID NO: 25.
App. Br. 14 (Claim App.).
The Examiner rejected claims 1-9, and 14 under 35 U.S.C. § 102(b)
as anticipated by Zlotnick. 3, 4
ANALYSIS
Zlotnick discloses "proteins that can be isolated from native neisserial
strains, including strains of Neisseria meningitidis (serogroups A, B, C, D,
W-135, X, Y, Zand 29E), Neisseria gonorrhoeae, and Neisseria lactamica."
Zlotnick 4. Zlotnick also discloses 329 amino and nucleic acid sequences
relating to such proteins. Id. at 7-30. The Examiner found that several of
3 Zlotnick et al., WO 03/063766 A2, published Aug. 7, 2003 ("Zlotnick").
4 In the Examiner's Answer, the Examiner withdrew the rejection of claims
1-10, 13, 17, and 18 under 35 U.S.C. 101 § as directed to patent ineligible
subject matter and the rejection of claims 1-20 under 35 U.S.C. 103(a) as
obvious over the combination of Zlotnick and Comanducci (WO 04/048404
A2). Ans. 12. These rejections are thus not a part of this appeal.
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Application 13/806,743
the sequences disclosed in Zlotnick were 100% identical to sequences
recited in the pending claims. Ans. 4. This correspondence between
Zlotnick' s sequences and the sequences of the present application is
summarized in the below table.
Id.
SEQ ID NO: 198 SEQIDNO: 1
SEQ ID NO: 248 SEQ ID NO: 23
SEQ ID NO: 56 SEQ ID NO: 25
Claims 1, 6, and 7 of Zlotnick are reproduced below.
1. A composition comprising:
(a) at least one protein encoded by an open reading frame
of Neisseria species (ORF2086), said open reading frame
encoding a crossreactive immunogenic antigen, and said
crossreactive immunogenic antigen providing immunogenicity
against infection by Neisseria meningitidis serogroup Bin a
subject; or
(b) at least one immunogenic portion of at least one
protein described in (a); or
( c) at least one biological equivalent of at least one
protein described in (a) or immunogenic fragment described in
(b).
6. The composition of claim 1, wherein the at least one
protein comprises the amino acid sequence of any of even
numbered SEQ ID NOS:2-174.
7. The composition of claim 6, additionally comprising at
least one protein comprising the amino acid sequence of any of
even numbered SEQ ID NOS: 176-252.
Zlotnick 128.
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Application 13/806,743
In finding that Zlotnick anticipates claim 1, the Examiner reasoned
that the language "at least one protein" in Zlotnick' s claim 7 encompassed
more than one protein selected from the recited sequences. Ans. 10. Since
the amino acid sequences recited in Zlotnick's claim 7 include sequences
corresponding to SEQ ID NOS:1 and 23 of pending claim 1, the Examiner
concluded that Zlotnick disclosed the limitations of pending claim 1
requiring "a first amino acid sequence which has at least 7 5% sequence
identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the first amino
acid sequence has a higher sequence identity to SEQ ID NO: 1 than to SEQ
ID NO: 23" and "a second amino acid sequence which has at least 75%
sequence identity to both of SEQ ID NO: 1 and SEQ ID NO: 23, but the
second amino acid sequence has a higher sequence identity to SEQ ID NO:
23 than to SEQ ID NO: 1. Id.
The Examiner employed similar logic in finding claim 2 anticipated,
reasoning that the amino acid sequences recited in Zlotnick' s claim 7
included sequences corresponding to SEQ ID NOS:1 and 25 of pending
claim 2. Id. The Examiner thus concluded that Zlotnick disclosed the
limitations of pending claim 2 requiring "a first amino acid sequence which
has at least 75% sequence identity to both of SEQ ID NO: 1 and SEQ ID
NO: 23, but the first amino acid sequence has a higher sequence identity to
SEQ ID NO: 1 than to SEQ ID NO: 23" and "a second amino acid sequence
(i) having at least 94% sequence identity to SEQ ID NO: 25 and/or (ii)
consisting of a fragment of at least 50 contiguous amino acids from SEQ ID
NO: 25." Id.
Appellants argue that claim 6 of Zlotnick recites 87 specific sequences
and claim 7 of Zlotnick recites 39 specific sequences. App. Br. 4.
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According to Appellants, when claims 6 and 7 are considered together, they
"recite[] 3,393 (87*39) different sequence combinations." Id. Appellants
argue that the Examiner has "not cited to any section of Zlotnick et al. that
teaches or suggests the specific combination of sequences as recited in the
pending claims." Id. Appellants contend that Zlotnick does not anticipate
the claims because it "does not teach each element arranged together as
claimed without picking and choosing." Id.
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
"[T]he examiner bears the initial burden ... of presenting a prima facie case
ofunpatentability." Appellants have persuaded us that the Examiner has not
carried the burden of establishing that the claimed invention was anticipated
by Zlotnick.
In order for a reference to anticipate a claim, it must:
clearly and unequivocally disclose the claimed [composition] or
direct those skilled in the art to the [composition] without any
need for picking, choosing, and combining various disclosures
not directly related to each other by the teachings of the cited
reference. Such picking and choosing may be entirely proper in
the making of a 103, obviousness rejection, where the applicant
must be afforded an opportunity to rebut with objective
evidence any inference of obviousness which may arise from
the similarity of the subject matter which he claims to the prior
art, but it has no place in the making of a 102, anticipation
rejection.
In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972).
Here, in order to have arrived at the composition of pending claim 1,
based on the disclosure of Zlotnick' s claim 7, the ordinary artisan must have
first selected Zlotnick's SEQ ID N0:198 from among the 39 sequences
disclosed in claim 7. The ordinary artisan would then have needed to select
SEQ ID N0:248 from among the 38 remaining sequence disclosed in claim
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7. Accordingly, the composition of pending claim 1 requires picking the
recited combination from 1482 possible sequence combinations. 5 Similarly,
in order to arrive at the composition of pending claim 2, the ordinary artisan
would first have needed to select Zlotnick's SEQ ID N0:56 from among the
87 sequences recited in claim 6 and then have selected SEQ ID N0:198
from among the 39 sequences disclosed in claim 7. The composition of
pending claim 2 thus requires picking from among 3,393 possible sequence
combinations.
We acknowledge that the claimed combination of sequences is
encompassed within claim 7 of Zlotnick. However, the Examiner does not
explain how or why the ordinary artisan would have known to select the
combination of SEQ ID NO: 198 and SEQ ID N0:248 from among 1,482
potential combinations to arrive at the combination recited in pending claim
1. Nor does the Examiner explain how or why the combination of SEQ ID
N0:56 and SEQ ID NO: 198 would have been selected from among the
3,393 possible combinations to arrive at the combination recited in pending
claim 2. On this record, the general teaching of a composition that may
include the recited sequences does not "unequivocally disclose" the specific
combination of sequences recited in the pending claims without the need for
"picking and choosing." Accordingly, we reverse the Examiner's rejection
of claims 1-9 and 14 as anticipated by Zlotnick.
5 With respect to pending claim 1, we do not factor in the 87 sequences
recited in Zlotnick's claim 6 because any one of those 87 sequences in
combination with SEQ ID NOS 198 and 248 would anticipate claim 1.
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SUMMARY
For the reasons discussed herein, we reverse the Examiner's rejection
of claims 1-9 and 14 under 35 U.S.C. § 102(b) as anticipated by Zlotnick.
REVERSED
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