Robinson, Margaret

Patent Trials and Appeals Board

Nov 27, 2020

2020002083 (P.T.A.B. Nov. 27, 2020)

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.
12/758,315 04/12/2010 Andrew Robinson MSQ01-020-CIP3-US 4684
43320 7590 11/27/2020
EVAN LAW GROUP LLC
PO Box 802919
CHICAGO, IL 60680
EXAMINER
DEVI, SARVAMANGALA J N
ART UNIT PAPER NUMBER
1645
MAIL DATE DELIVERY MODE
11/27/2020 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANDREW ROBINSON, ANDREW RICHARD GORRINGE,
MICHAEL JOHN HUDSON, and KAREN MARGARET REDDIN1
Appeal 2020-002083
Application 12/758,315
Technology Center 1600
Before ERIC B. GRIMES, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
meningitis vaccine composition, which have been rejected as anticipated.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as “Secretary of State for
Health, which is an agency of the United Kingdom government.” Appeal
Br. 4. We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42.
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STATEMENT OF THE CASE
The Specification states that “[m]eningococcal meningitis is a major
problem worldwide. . . . Neisseria meningitidis is the causative agent of the
disease.” Spec. ¶ 3. The Specification states that “combining Neisseria
meningitidis outer membrane vesicles (OMVs) and an antigenic component
isolated from Neisseria meningitidis increases the cross-protective capability
of a meningococcal disease vaccine against a range of meningococcal
strains.” Id. ¶ 33.
Claims 62, 63, 65–69, 75–79, 83, and 86–89 are on appeal. Claim 62,
reproduced below, is illustrative:
62. A composition comprising:
(i) isolated N. meningitidis outer membrane vesicles;
and
(ii) at least one isolated N. meningitidis antigenic
protein, wherein said at least one isolated N. meningitidis
antigenic protein
(a) has been extracted from an outer membrane
of an N. meningitidis bacterium; or
(b) is a recombinant N. meningitidis antigenic
protein; and
(iii) alum in an amount effective as an adjuvant;
wherein said isolated N. meningitidis outer membrane
vesicles are from a first strain of N. meningitidis and said at
least one isolated N. meningitidis antigenic protein is from a
second strain of N. meningitidis different from the first,
said at least one isolated N. meningitidis antigenic protein
is not transferrin binding protein A (TbpA) nor transferrin
binding protein B (TbpB), and
the N. meningitidis outer membrane vesicles are isolated
by desoxycholate treatment.
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Each of claims 68 and 86, the other independent claims, is directed to
a “vaccine composition” comprising the same components as claim 62.
OPINION
Claims 62, 63, 65–69, 75–79, 83, and 86–89 stand rejected under
35 U.S.C. § 102(b) as anticipated by Seid.2 Ans. 3. The Examiner finds that
Seid discloses “the obtaining of and the use of isolated meningococcal
OMVs and genetically fused fusion proteins of recombinant meningococcal
class 1 OMP (i.e., non-TbpA and/or non-TbpB PorA surface antigenic
proteins) or their epitopes from different meningococcal serotypes or wild
strains in multivalent subunit vaccines.” Id.
The Examiner also finds that “[t]he isolated recombinant class 1
proteins of different epidemiologically relevant strains or serotypes of N.
meningitidis . . . were used in combination with N. meningitidis outer
membrane vesicles (OMVs) of another serotype (different strain) of N.
meningitidis by mixing together.” Id. The Examiner also finds that Seid
teaches “vaccine formulations in pharmaceutically acceptable vehicles and an
adjuvant such as aluminum hydroxide or aluminum phosphate [i.e., alum].”
Id. Finally, the Examiner finds that Seid’s “OMVs were isolated . . . as per
Beuvery et al. Infect. lmmun. 40: 369-380, 1983, i.e., by desoxycholate
treatment.” Id. at 3–4.
Appellant argues, among other things, that Seid does not anticipate
because “the selection of the OMVs from the list of sources of Class 1
OMPs, and the selection of alum from the list of adjuvants, requires picking

2 Seid et al., WO 90/06696, published June 28, 1990.
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and choosing.” Appeal Br. 13–14. Appellant argues that Seid describes
“many different sources of Meningococcal Class 1 outer-membrane protein”
and thus “there are many different vaccine combinations which do not
include OMVs.” Id. at 14. Appellant also argues that Seid “fails to describe
the specific combination of isolated N. meningitidis OMVs as the source of
Class 1 OMP and an isolated N. meningitidis antigenic protein, each from
different strains of N. meningitidis.” Id. at 16–17.
We agree with Appellant that the Examiner has not shown that Seid
anticipates the instant claims. “Anticipation requires that all of the claim
elements and their limitations are shown in a single prior art reference.”
In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009). “[I]t is not enough that
the prior art reference . . . includes multiple, distinct teachings that the
artisan might somehow combine to achieve the claimed invention.” Net
MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).
Rather,
unless a reference discloses within the four corners of the
document not only all of the limitations claimed but also all of
the limitations arranged or combined in the same way as recited
in the claim, it cannot be said to prove prior invention of the
thing claimed and, thus, cannot anticipate under 35 U.S.C.
§ 102.
Id.
Here, the Examiner points to various passages on Seid’s pages 3–5, 7–
12, 22–24, and 34, and its Examples 1B and 2 as support for the rejection.
Ans. 4. The Examiner reasons that Seid’s “disclosure is simply a
representation of a list that contains a multielement species, which reads on
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Applicants’ claimed invention and which may appear ‘without special
emphasis.’” Id. at 5.
We disagree with the Examiner’s reasoning. Seid states that its
invention pertains to isolated outer membrane vesicles
(OMV’s), to substantially purified Class 1 outer membrane
protein (OMP) of Neisseria meningitidis, to fragments of the
Class 1 OMP and to oligopeptides derived from the Class 1
OMP . . . and to the use of isolated OMV’s, the meningococcal
Class 1 OMP, fragments or oligopeptides for vaccination
against N. meningitidis.
Seid 3–4.
Seid states that the above components “can be used in univalent or
multivalent subunit vaccines alone, in mixtures, or as chemical conjugates or
genetic fusions. In preferred vaccines, epitopes from different . . . strains are
used.” Id. at 4. Seid states that the components “can be produced by
recombinant DNA techniques, chemical synthesis or chemical or enzymatic
cleavage.” Id. at 5. Seid also states that the components “can be formulated
in pharmaceutically acceptable vehicles with optional additives such as
adjuvants.” Id.
In formulating the vaccine compositions with the peptide
or protein, alone or in the various combinations described, the
immunogen is adjusted to an appropriate concentration and
formulated with any suitable vaccine adjuvant. Suitable
adjuvants include, but are not limited to: surface active
substances, e.g., hexadecylamine, octadecylamine, octadecyl
amino acid esters, lysolecithin, dimethyl-dioctadecylammonium
bromide[], methoxyhexadecylgylcerol [sic], and pluronic
polyols; polyamines, e.g.; pyran, dextransulfate, poly IC,
carbopol; peptides, e.g., muramyl dipeptide and derivatives,
dimethylglycine, tuftsin; oil emulsions; and mineral gels, e.g.,
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aluminum hydroxide, aluminum phosphate, etc., lymphokines
and immune stimulating complexes (ISCOMS).
Id. at 25.
We have reviewed all of the passages of Seid cited by the Examiner,
but do not find that Seid discloses the claimed invention with the specificity
required by § 102. Rather, Seid discloses various products derived from N.
meningitidis—OMV’s, Class 1 outer membrane protein (OMP), and
fragments or oligopeptides derived from OMP—that can be used alone or
together, possibly in combination with an adjuvant, which can be alum. But
Seid does not disclose a composition comprising the three components
required by the instant claims, “arranged or combined in the same way as
recited in the claim.” Net MoneyIN, 545 F.3d at 1371. Therefore, Seid does
not anticipate the instant claims.3
In response to Appellant’s argument, the Examiner points to Seid’s
claim 6, which “is drawn to a meningococcal vaccine comprising a
combination of both meningococcal outer membrane vesicles and various
(i.e., different) group B meningococcal class I outer membrane proteins
(PorA proteins).” Ans. 12. The Examiner finds that “Seid’s (’696) vaccine
further comprised aluminum hydroxide or aluminum phosphate, i.e. alum.
See claim 16 of Seid.” Id.
Again, however, achieving a composition that includes all three
components of the claimed composition at a minimum requires combining

3 Appellant argues that the instant claims would not have been obvious in
view of Seid, even though “[t]he Examiner has not rejected the claims as
obvious.” Appeal Br. 19. Because no obviousness rejection is on appeal, we
have not considered the arguments presented on that issue.
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the compositions defined by Seid’s claims 6 and 16. Seid’s claim 1 is
directed to a vaccine “comprising an effective amount of an outer-membrane
vesicle . . . or at least one meningococcal class 1 outer-membrane protein or
a fragment or oligopeptide containing an epitope thereof.” Seid 94. The
composition of Seid’s claim 1 thus comprises either element (i) or element
(ii) of the instant claims.
Seid’s claim 6 adds the limitation that the vaccine also comprises “5–
10 various group B meningococci class I outer-membrane proteins,
fragments or oligopeptides.” Id. at 95. It therefore combines elements (i) and
(ii) of the instant claims, but lacks element (iii).
Seid’s claim 16 depends from claim 1, and adds the limitation of “an
adsorbent selected from group consisting of aluminium phosphate,
aluminium hydroxide and calcium phosphate.” Seid 96. It therefore
combines elements (i) and (iii) of the instant claims, but lacks element (ii).
Thus, Seid’s claims 6 and 16 are not sufficient to support a rejection for
anticipation.
The above discussion applies to each of the independent claims on
appeal. We therefore reverse the rejection of claims 62, 63, 65–69, 75–79,
83, and 86–89 under 35 U.S.C. § 102(b) based on Seid.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
62, 63, 65–
69, 75–79,
83, 86–89
102(b) Seid 62, 63, 65–69,
75–79, 83,
86–89

REVERSED