Ex Parte Masignani et al

Patent Trial and Appeal Board

Apr 6, 2017

13375759 (P.T.A.B. Apr. 6, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/375,759 12/01/2011 Vega Masignani 529552004430 7809
20872 7590 04/10/2017
MORRISON & FOERSTER LLP
425 MARKET STREET
SAN FRANCISCO, CA 94105-2482
EXAMINER
OGUNBIYI, OLUWATOSIN A
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
04/10/2017 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VEGA MASIGNANI, MICHELE ANNE BAROCCHI,
MONICA MOSCHIONI, and PAOLO RUGGIERO
Appeal 2014-004949
Application 13/375,759
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
of raising an immune response. The Examiner rejected the claims as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“S. pneumoniae has a pilus known as pilus-1 encoded by a 14-kb islet
(PI-I) having seven genes encoding: the RlrA transcriptional regulator, three
pilus subunits with LPXTG-type cell wall sorting signals, and three sortase
enzymes involved in synthesis of the pilus polymer and in the incorporation
1 Appellants identify the Real Party in Interest as Novartis AG (see App. Br.
2).
Appeal 2014-004949
Application 13/375,759
of ancillary pilus components” (Spec. 1:5—8). “RrgB is the major subunit
that forms the backbone of the structure, while the other two pilins (RrgA,
RrgC) are ancillary structural proteins” (Spec. 1:8—9).
It has been found that serum raised against a given RrgB clade
is active against pneumococci which express that clade, but is
not active against strains which express one of the other two
clades i.e. there is intra-clade cross-protection, but not inter-
clade cross-protection. According to the invention, therefore,
an immunogenic composition includes at least two different
clades of RrgB.
(Spec. 6:10-13).
The Claims
Claims 7 and 9—11 are on appeal. Claim 7 is representative and reads
as follows:
7. A method of raising an immune response in a mammal
comprising administering to the mammal an effective amount
of an immunogenic composition comprising at least two of:
(a) a first polypeptide comprising a first amino acid
sequence, where the first amino acid sequence comprises an
amino acid sequence (i) having at least 90% sequence identity
to SEQ ID NO: 1 and/or (ii) consisting of a fragment of at least
7 contiguous amino acids from SEQ ID NO: 1;
(b) a second polypeptide, comprising a second amino
acid sequence, where the second amino acid sequence
comprises an amino acid sequence (i) having at least 90%
sequence identity to SEQ ID NO: 2 and/or (ii) consisting of a
fragment of at least 50 contiguous amino acids from SEQ ID
NO: 2; and/or
(c) a third polypeptide, comprising a third amino acid
sequence, where the third amino acid sequence comprises an
amino acid sequence (i) having at least 90% sequence identity
to SEQ ID NO: 3 and/or (ii) consisting of a fragment of at least
29 contiguous amino acids from SEQ ID NO: 3.
2
Appeal 2014-004949
Application 13/375,759
The issue
The Examiner rejected claims 7 and 9-11 under 35 U.S.C. § 102(b) as
anticipated by Telford2 (Ans. 3—4).
The Examiner finds Telford teaches
a method of raising an immune response in a mammal. . .
comprising administering combinations of two or more proteins
selected from a group of proteins which comprises at least two
of the proteins of instant claim 1 wherein the at least two
proteins which are identical to those listed in instant claim 7 are
SP0463 (SEQ ID NO: 85), ORF4_6BF (SEQ ID NO: 196),
ORF4-6BSP (SEQ ID NO: 203), ORF4-670 (SEQ Id NO: 174),
ORF4-14CSR (SEQ ID NO: 217), ORF4_23FTW (SEQ ID
NO: 231).
(Ans. 3—4).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Telford anticipates the
claims?
Findings of Fact
1. Telford teaches the “GBS AI proteins of the invention may be
used in immunogenic compositions for prophylactic or therapeutic
immunization against GBS infection” (Telford 120).
2. Telford teaches the “immunogenic compositions may also be
selected to provide protection against an increased range of GBS serotypes
and strain isolates. For example, the immunogenic composition may
comprise a first and second GBS AI protein” (Telford 121).
2 Telford et ah, US 2006/0165716 AI, published July 27, 2006 (“Telford”).
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Appeal 2014-004949
Application 13/375,759
3. The Examiner finds:
SP0463 (SEQ ID NO: 85) is 100% identical to SEQ ID NO: 1
and/or consists of a fragment of at least 7 contiguous amino acids
from SEQ ID NO: 1. See appendix A.
ORF4_6BF (SEQ ID NO: 196) is 100% identical to SEQ
ID NO: 2 and/or consists of a fragment of at least 50 contiguous
amino acids from SEQ ID NO: 2. See appendix B
ORF4-6BSP (SEQ ID NO: 203) is 100% identical to
SEQ ID NO: 2 and/or consists of a fragment of at least 50
contiguous amino acids from SEQ ID NO: 2. See appendix C
ORF4-670 (SEQ Id NO: 174) is 100% identical to SEQ
ID NO: 2 and/or consists of a fragment of at least 50 contiguous
amino acids from SEQ ID NO: 2. See appendix D
ORF4_23FTW (SEQ ID NO: 231) is 100% identical to
SEQ ID NO: 3 and/or consists of a fragment of at least 29
contiguous amino acids from SEQ ID NO: 3. See appendix E.
(Ans. 4).
4. Telford teaches:
5. pneumoniae AI surface proteins are preferred proteins for use
in the immunogenic compositions of the invention. In one
embodiment, the compositions of the invention comprise
combinations of two or more S pneumoniae AI surface
proteins. Preferably such combinations are selected from two
or more of the group consisting of SP0462, SP0463, SP0464,
orf3_670, orf4 670. orf5_670, ORF3_14CSR, ORF4_14CSR,
ORF5_14CSR, ORF3_19AH, ORF4_19AH, ORF5_19AH,
ORF3_19FTW, ORF4_19FTW, ORF5_l gFTW, ORF3_23FP,
ORF4_23FP, ORF5_23FP, ORF3_23FTW, ORF4 23FTW.
ORF5_23FTW, ORF3_6BF, ORF4 6BF. ORF5_6BF,
ORF3_6BSP, ORF4 6BSP. ORF5_6BSP, ORF3_9VSP,
ORF4_9VSP, and ORF5_9VSP.
(Telford till; emphasis added to identify proteins listed as meeting
requirements of claim 7 by Examiner; cf. Ans. 8).
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Application 13/375,759
Principles of Law
For the purposes of whether they are anticipatory, lists and
genera are often treated differently under our case law.
Compare Perricone v. Medicis Pharm. Corp., 432 F.3d 1368,
1376 (Fed.Cir.2005) (rejecting “the notion that [a compound]
cannot anticipate because it appears without special emphasis in
a longer list”) with Atofina v. Great Lakes Chem. Corp., 441
F.3d 991, 999 (Fed.Cir. 2006) (“It is well established that the
disclosure of a genus in the prior art is not necessarily a
disclosure of every species that is a member of that genus.”).
In re Cleave, 560 F.3d 1331, 1337 (Fed. Cir. 2009).
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3^4; FF 1 4) and agree that the
claims are anticipated by Telford. We address Appellants’ arguments
below.
Appellants contend “Telford et al. in fact disclose a group of 30
preferred proteins, from among which two or more proteins are to be
selected to form immunogenic compositions” (App. Br. 4). Appellants
contend
Thus, the paragraphs cited by the Examiner at best disclose a
broad genus of protein combinations. Even the smallest genus
of just the pairwise combinations (870) is too large to envision
one of the small number of pair-wise combinations that are
relevant to the claims. Based upon the examiner's assertion,
there are only seven possible pair-wise combinations that meet
the limitations of the claims . . . The Examiner has provided no
reason for why a person of skill would have selected one of
these specific combinations from among the 870 possible pair
wise compositions disclosed by Telford et al.
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Application 13/375,759
(App. Br. 5). Appellants contend “that, in this case, the class of possible
protein combinations disclosed by Telford et al. is not as limited as the class
of about 20 compounds in In re Petering and that a person of ordinary skill
could not at once envisage the exact combinations suggested by the
Examiner” (App. Br. 6).
We do not find these arguments persuasive because Telford teaches
that every combination of two proteins selected from the listed group (FF 4)
would have been expected to function as an immunogen (FF 2). This
reasoning is consistent with Blue Calypso and Kennametal, where
The party challenging the claim’s patentability argued, and the
Board accepted, that the reference anticipated each of the
numerous possibilities that resulted from the permutations of
the options disclosed in the reference. ... In affirming the
Board’s anticipation finding, we noted that a reference need not
always include an express discussion of the actual combination
to anticipate. . . . Instead, a reference may still anticipate if that
reference teaches that the disclosed components or
functionalities may be combined and one of skill in the art
would be able to implement the combination.
Blue Calypso, LLCv. Groupon, Inc., 815 F.3d 1331, 1343—44 (Fed. Cir.
2016) {analyzing Kennametal, Inc. v. Ingersol Cutting Tool Co., 780 F.3d
1376 (Fed. Cir. 2015). Here, Telford clearly teaches the disclosed
immunogenic components, requires that the immunogenic components be
combined, and evidences that the skilled artisan would be able to implement
the combination (FF 1—4).
Appellants contend
the present facts, where there are hundreds of pairwise
combinations, are much more akin to the facts in Impax
Laboratories, Inc., v. Aventis Pharmaceuticals Inc., 468 F.3d
1366, 81 U.S.P.Q.2D (BNA) 1001 (Fed. Cir. 2006).. . .
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Telford et al. does not anticipate the pending claims as one of
skill in the art because one of skill in the art could not “at once
envisage” a combination that is relevant to the pending method
claims given the hundreds of pairwise combinations.
(Reply Br. 5—6).
We do not find this argument persuasive because in Impax, there were
other issues besides the combination concerns. Indeed, as discussed in
Wrigley, the “issue in Impax was whether the use of the drug riluzole for
treating amyotrophic lateral sclerosis (“ALS”) was anticipated . . . there are
important distinctions between that case and this one. . . . the only mention
of riluzole in the prior art reference in Impax was to disclaim it from the
disclosed invention.” Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC,
683 F.3d 1356, 1361—62 (Fed. Cir. 2012). Thus, unlike the instant case or
Wrigley, Impax disclaimed the drug from the disclosed invention, as well as
not providing dosage information.
Wrigley itself also supports the Examiner’s anticipation rejection. In
Wrigley, the Shahidi patent disclosed “several categories of components that
can be included in the compositions” including “WS—3 and WS—23 as two
of three “particularly preferred cooling agents’” and “menthol as one of 23
listed flavoring agents.” Wrigley found the “question for purposes of
anticipation is therefore whether the number of categories and components
in Shahidi was so large that the combination of WS—23 and menthol would
not be immediately apparent to one of ordinary skill in the art.” Id. at 1361.
Wrigley concluded that “the Shahidi reference clearly identifies the
combination.” Id. at 1362.
The same reasoning applies here. Where the list of flavoring agents
included 23 members in Wrigley, Telford lists 30 different specific surface
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Application 13/375,759
proteins, and specifically teaches combinations of “two or more of the
group” (FF 4). Because Telford teaches all of the selections in a single list
in a single paragraph, rather than having to combine teachings from different
parts of the patent reference as in Wrigley, Telford provides a stronger
anticipation fact pattern than Wrigley. Thus, the specific combinations from
Telford’s list anticipate the claims.
Appellants also contend the “claimed methods produce a surprisingly
superior result which are not taught or even suggested by Telford et al.”
(App. Br. 7).
We find this argument unpersuasive because unexpected results, a
type of secondary consideration, are not an element of an anticipation
analysis. See Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364
(Fed. Cir. 2008) (“[Secondary considerations are not an element of a claim
of anticipation”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Telford anticipates the claims.
SUMMARY
In summary, we affirm the rejection of claim 7 under 35 U.S.C.
§ 102(b) as anticipated by Telford. Claims 9-11 fall with claim 7.
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
8