Ex Parte Costantino

Patent Trial and Appeal Board

Oct 9, 2018

10543455 (P.T.A.B. Oct. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
10/543,455 11/06/2006
20462 7590 10/11/2018
GlaxoSmithKline
Global Patents UP4110
1250 South Collegeville Road
Collegeville, PA 19426
FIRST NAMED INVENTOR
Paolo Costantino
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.
VN51926 3687
EXAMINER
DEVI, SARY AMANGALA J N
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
10/11/2018 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 PAOLO COSTANTINO 1
Appeal2017---001496
Application 10/543,455
Technology Center 1600
Before TONI R. SCHEINER, DEMETRA J. MILLS, and
JOHN G. NEW, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant states that the real party-in-interest is GlaxoSmithKline
Biologicals SA. App. Br. 2.
Appeal2017---001496
Application 10/543,455
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 26-38, 40, 42, 43, and 56-59.
Specifically, claims 26-37 and 56-59 stand rejected as unpatentable under
the judicially-created doctrine of obviousness-type double patenting over
claims 1-3, 5, 7, 9, 11, and 29-32 of Appellant's US 8,889,152 (November
18, 2014) (the "'152 patent").
Claims 38, 40, 42 and 43 stand rejected as unpatentable under the
judicially created doctrine of obviousness-type double patenting over the
claims 1-3, 5, 7, 9, 11, and 29-32 of the '152 patent in view of Blake et al.
(US 6,451,317 B 1, September 17, 2002) ("Blake").
We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM-IN-PART.
NATURE OF THE CLAIMED INVENTION
Appellant's invention is directed to an injectable immunogenic
composition comprising capsular saccharides from at least two of serogroups
A, C, W135, and Y of Neisseria meningitidis. Abstr.
REPRESENTATIVE CLAIM
Claim 26 is representative of the claims on appeal and recites:
An injectable immunogenic compos1t10n compnsmg
capsular saccharides from N. meningitidis serogroups A, C,
Wl35 and wherein: (i) each of said capsular saccharides is
conjugated to a carrier protein to give separate conjugates for
each of the four serogroups; (ii) the total of the capsular
saccharides from theN. meningitidis serogroups A, C, W135 and
Y per dose of the composition is between about 10 µg and 25 µg;
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and (iii) the capsular saccharides from the N. meningitidis
serogroups A, C, WI35 and Y are present at a 2: 1: 1: 1 capsular
saccharide weight ratio.
App. Br. 13.
ISSUES AND ANALYSES
We are persuaded by, and expressly adopt, the Examiner's findings
and conclusions establishing that Appellant's claims are primafacie obvious
under the nonstatutory doctrine of double patenting. We address the
arguments raised by Appellant below.
A. Rejection of claims 26-37 and 56-59 over the '152 patent
Issue 1
Appellant argues that the Examiner erred in finding that the '152
patent teaches or suggests the limitation of claim 26 reciting: "the total of
the capsular saccharides from the N. meningitidis serogroups A, C, WI 3 5
and Y per dose of the composition is between about 10 µg and 25 µg." App.
Br. 3.
Analysis
Appellant disputes the Examiner's finding that it would have been
prima facie obvious to one of ordinary skill in the art to combine
components (a) and (b) of the kit of the '152 patent to produce the
composition of the instant invention. App. Br. 4 ( citing Final Act. 4).
According to Appellant, the Examiner provides no evidence or reasoning
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with respect to how combining components (a) and (b) of the kit of the '152
patent would result in a composition in which: "the total of the capsular
saccharides from the N. meningitidis serogroups A, C, W135 and Y per dose
of the composition is between about 10 µg and 25 µg," as recited in claim
26. Id. Nor, Appellant argues, does the Examiner provide any reasoning as
to why one of skill in the art would modify the alleged combination of
components to arrive at the disputed limitation. Id.
Furthermore, Appellant argues, and more importantly, combining the
components of (a) and (b) into an injectable immunogenic composition
would not result in a composition that anticipates the pending claims. App.
4--5. According to Appellant, the only claims of the '152 patent that
mention the amount of the capsular saccharide are claims 26 and 27. Id. at
4. Those claims of the '152 patent recite: the "dose is between 5 µg and 20
µg per saccharide per dose." Id. Therefore, Appellant argues, the recited
dose range in the claims of the '152 patent for a tetravalent saccharide
vaccine would be 20 µg to 80 µg. Id. Appellant asserts that this small
overlap of the ranges is not anticipatory of the limitation of Appellant's
claim 26 reciting: "between about 10 µg and 25 µg." Id.
We do not find Appellant's argument persuasive. We agree with
Appellant that claims 26 and 27 of the '152 patent recite a range of dosages
that only partially overlap the range recited in claim 26. We further agree
with Appellant that claims 26 and 27 of the '152 patent therefore likely do
not anticipate Appellant's claims on appeal.
But we are not performing an anticipation analysis of the claims.
Indeed, if the claims of the ' 15 2 patent anticipated Appellant's claims on
appeal, we would have no need to resort to an analysis under the doctrine of
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obviousness-type double patenting because the claims would be statutorily
unpatentable under Sections 101 and 102, which prohibit double patenting.
We therefore tum our analysis to whether Appellant's claims are
obvious over the claims of the '152 patent. We conclude that they are. As
Appellant states, claims 26 and 27 of the '152 patent recite a range of 20 µg
to 80 µg total saccharide, whereas Appellant's claim 26 recites a range of
"between about 10 µg and 25 µg" total saccharide. However, our reviewing
court has consistently held that, in cases involving overlapping ranges, even
a slight overlap in range establishes a prima facie case of obviousness. In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Moreover, a primafacie
case of obviousness exists even when the claimed range and the prior art
range do not overlap but are close enough such that one skilled in the art
would have expected them to have the same properties. Id.
Finally, Appellant argues that the Examiner has not established that
one of skill in the art would have a reasonable expectation of success in
using a much lower range. App. Br. 5. According to Appellant, there is an
eight-fold difference between the high end of the '152 patent's range and the
low end as claimed. Id. Appellant asserts that a person of ordinary skill in
the art would not have had a reasonable expectation that dropping the total
antigen concentration in a vaccine eight-fold would result in an efficacious
vaccine. Id.
We are not persuaded by Appellant's reasoning. As an initial matter,
Appellant's claims, and the claims of the '152 patent, are drawn to
compositions of matter and not to a method of use of the claimed
composition. Appellant points to no evidence of record to support the
contention that a person of ordinary skill would have had no reasonable
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expectation of success in synthesizing the claimed compositions or using
them. Furthermore, Appellant points to no evidence of record to support the
conjecture that a person of ordinary skill would have had no expectation of
success in using a range of dosages that, at least in part, overlap the range
recited in the claims of the '152 patent. Consequently, Appellant's
conclusory statements are no more than attorney argument, to which we
assign little probative value. In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir.
1997).
Appellant's claims and the claims of the '152 patent overlap in the
20-25 µg dosage range. We conclude that, under the Federal Circuit's
holding in Peterson, that is sufficient to establish prima facie obviousness
and we consequently affirm the Examiner's rejection of the claims.
Issue 2 Claims 28 and 29
Analysis
Appellant separately argues these claims together. App. Br. 6. Claim
28 is representative and recites: "wherein each dose contains about 5 µg of
each of the capsular saccharides from the N. meningitidis serogroups C,
Wl3 5 and Y and about 10 µg of the capsular saccharide from the N.
meningitidis serogroup A." Id. at 13. Appellant argues that the Examiner
has not provided an explanation as to how one of skill in the art would
modify the claims. Id. at 6.
Appellant argues further that the claimed tetravalent meningococcal
ACWY conjugate vaccine, MENVEOâ„¢, with the claimed amounts of each
capsular saccharide, produces statistically superior bactericidal immune
responses against all four serogroups of meningococcus when compared to
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the other approved tetravalent meningococcal ACWY conjugate vaccine,
MENACTRAâ„¢.
We are not persuaded by Appellant's arguments. We have explained
supra that Appellant's claims are primafacie obvious over the prior art
because they recite the same composition of matter and overlapping ranges
of dosages. See Peterson, 315 F.3d at 1329.
With respect to Appellant's arguments concerning the allegedly
superior results of the formulation recited in claims 28 and 29 over another
approved ACWY conjugate vaccine, in the Appeal Brief, Appellant adduces
no evidence in support of this contention beyond a bare conclusory
statement that this is so. As such, it constitutes no more than attorney
argument, to which we accord little probative value. See In re Geisler, 116
F.3d 1465, 1470 (Fed. Cir. 1997) (Attorney arguments and conclusory
statements that are unsupported by factual evidence are entitled to little
probative value).
Appellant, however, adduces some evidence in the Reply Brief in
support of this contention. See Reply Br. 15-16. We are not persuaded that
the use of a merely conclusory statement in the Appeal Brief necessarily
permits Appellant to make a more extensive argument, supported by
evidence, in the Reply Brief. See Ex parte Borden, 93 USPQ2d 14 73, 14 7 4
(BP AI 2010) (Informative) ("[T]he reply brief [is not] an opportunity to
make arguments that could have been made in the principal brief on appeal
to rebut the Examiner's rejections, but were not"); see also 37 C.F.R.
§ 4I.67(c)(vii) ("Any arguments or authorities not included in the [Appeal]
brief ... will be refused consideration by the Board") ( emphasis added); and
37 C.F.R. § 41.41(b) (A reply brief shall not include any new or non-
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admitted amendment, or any new or non-admitted affidavit or other
Evidence) (emphasis added).
Furthermore, even supposing, arguendo, that Appellant's assertion is
true, and that the results obtained by Appellant's claimed composition are
statistically significantly better than those obtained by the similar
composition disclosed by the '152 patent, Appellant provides no evidence of
record that the statistically significant results obtained by using different
dosage ranges of the same vaccine produce results that would have been
unexpected to a person of ordinary skill in the art. Unexpected results that
are probative of nonobviousness are those that are "different in kind and not
merely in degree from the results of the prior art." Iron Grip Barbell Co. v.
USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (citation omitted).
Appellant proffers no evidence that the alleged superior results obtained by
use of their claimed composition are qualitatively unexpectedly superior and
not just statistically significantly superior, i.e., "in degree," to the
composition disclosed by the '152 patent. Absent any such evidence, we
affirm the Examiner's rejection of claims 29 and 29.
Issue 3 Claims 3 6 and 3 7
Issue
Appellant separately argues these claims together. App. Br. 6. Claim
36 is representative and recites: "wherein the capsular saccharide from the
N. meningitidis serogroup A is modified so that one or more hydroxyl
groups of the capsular saccharide have been replaced with blocking groups."
Id. at 14. Appellant argues that the Examiner erred in finding that the claims
of the '152 patent teach or suggest this limitation. Id. at 6.
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Analysis
Appellant argues that the Examiner erred in finding that the
Specification of the '152 patent teaches that the serogroup A saccharide
conjugate defines the serogroup A saccharide in the conjugate as being
modified to replace one or more hydroxyl groups with blocking groups.
App. Br. 6. Appellant asserts that, in fact, the relevant passage of the '152
patent teaches that: "The polysaccharide may be chemically modified. For
instance, it may be modified to replace one or more hydroxyl groups with
blocking groups. This is particularly useful for MenA." Id. at 6-7 (quoting
'152 patent Spec. col. 3, 11. 32-35 (internal citation omitted)). Appellant
characterizes this passage, not as a definition, but rather as an indication that
the capsular saccharide from serogroup A can be modified by blocking
groups. Id. at 7. As such, Appellant argues, the Examiner has
impermissibly relied upon the Specification of the '152 patent as prior art in
an obviousness-type, double-patenting rejection. Id. ( citing, e.g., MPEP
§ 804(Il)(B)(2)(a)). Appellant argues that the quoted language in the '152
patent's Specification is not a definition of the ordinary meaning of capsular
saccharide such that it must include blocking groups replacing hydroxyl
groups, but rather an optional teaching that is not available to the Examiner
as prior art. Id.
We are not persuaded by Appellant's arguments. As an initial matter,
claim 1 of the '152 patent, cited by the Examiner, recites, in relevant part:
"A kit comprising: (a) conjugated capsular saccharide from Neisseria
meningitidis (N. meningitidis) serogroup A, in lyophilized form; and (b)
capsular saccharides from one or 30 more of N. meningitidis serogroups C,
W135 and Y, in liquid form." (Emphasis added). Claim 2 limits claim 1,
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reciting: "The kit of claim 1, wherein one or more of the saccharides of (b)
is conjugated to a carrier protein." Claim 2 requires that one or more of the
saccharides from group bis conjugated to a carrier protein, but neither claim
1 nor claim 2 sets any restriction on what is meant by the claim term:
"conjugated capsular saccharide ... serogroup A" in group (a). Finally claim
11 recites: "The kit of claim 1 or 2 or 3 or 4 or 5, wherein one or more of
the saccharides is an oligosaccharide."
The Specification states that:
The polysaccharide may be chemically modified. For instance,
it may be modified to replace one or more hydroxyl groups with
blocking groups. This is particularly useful for MenA.
Polysaccharides from serogroup B may be N-propionylated.
The ( optionally modified) polysaccharide will typically be
hydrolysed to form oligosaccharides.. .. chromatography.
Oligosaccharides with a degree of polymerisation of less than or
equal to about 6 are preferably removed for serogroup A, and
those less than around 4 are preferably removed for serogroups
W135 and Y.
'152 patent Spec. col. 3, 11. 32-53 (internal references omitted).
We agree with the Examiner that the quoted passage of the
Specification of the '152 patent defines both the claim term "conjugated
saccharide" and "oligosaccharide," as recited in the claims because the
passage defines the scope of the claim term. The passage discloses to a
person of ordinary skill in the art that the claim term "conjugated
saccharide" of group (a) in claims 1 and 2 can mean one in which hydroxyl
groups of the saccharide are substituted with blocking groups. Further, it
discloses that the oligosaccharides of claim 11 are derived from
polysaccharides in which, optionally, the hydroxyl groups have been
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substituted with blocking groups. We therefore find that the quoted passage
of the Specification of the '152 patent defines the scope of the claim terms
"conjugated saccharide" and 'oligosaccharide" and conclude that the
Examiner did not improperly rely upon the Specification as prior art for the
purpose of this rejection.
Moreover, we do not agree with Appellant's contention that the
Specification may be used by the Examiner only as a dictionary for the
exclusive purpose of defining claim terms per se. The predecessor to our
reviewing court has held that the Specification may also be used as required
to answer the question of whether Appellant's claims on appeal define
merely an obvious variation of an invention disclosed and claimed in the
reference (i.e., the '152) patent. In re Vogel, 422 F.2d 438, 441--42
(C.C.P.A. 1970). The court in Vogel noted that, in general, the
Specification: "sets forth at least one tangible embodiment within the claim,
and it is less difficult and more meaningful to judge whether that thing has
been modified in an obvious manner." Vogel, 422 F.2d at 442. The court
further stated that: "use of the [Specification] is not in contravention of the
cases forbidding its use as prior art, nor is it applying the patent as a
reference under 35 U.S.C. § 103, since only the disclosure of the invention
claimed in the patent may be examined." Id.
In this instance, the Specification of the '152 patent discloses that, in
at least one tangible embodiment, the "polysaccharides may be modified to
replace one or more hydroxyl groups with blocking groups." '152 patent
col. 3, 11. 33-34. As such, this passage discloses that the scope of the claim
term "conjugated saccharides" and "oligosaccharides" includes saccharides
in which hydroxyl groups have been substituted with blocking groups.
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Because the '152 patent expressly discloses that the disputed limitation is
within the scope of the '152 patent's claims, we conclude that claims 36 and
37 are obvious over the cited claims of the '152 patent and we consequently
affirm the Examiner's rejection of the claims.
B. Rejection of claims 3 8, 40, 42 and 43 over the '152 patent and Blake
Issue 1
Appellant repeats the arguments presented supra with respect to
claims 26-37 and 56-59, i.e., that combining components (a) and (b) of the
kit of the '152 patent would not result in a composition where the total of the
capsular saccharides from the N. meningitidis serogroups A, C, W135 and Y
per dose of the composition is between about 10 µg and 25 µg, and that the
claimed range of dosages is not anticipated by the '152 patent. We have
explained our reasoning as to why we do not find Appellant's arguments
persuasive and, for the same reasons, we similarly do not find them
persuasive with respect to these claims.
Issue 2 Claim 43
Appellant argues claim 43 separately. App. Br. 10. Claim 43 recites:
"wherein the one or more antigen( s) can induce, after administration to a
subject, an antibody response in that subject that is bactericidal against two
or more ofhypervirulent lineages A4, ET 5 and lineage 3 of N. meningitidis
serogroup B." Id. at 15. Appellant argues that neither of the cited references
teach this limitation. Id. at 10.
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Analysis
The Examiner finds that, although the conflicting claims are not
identical, they are not patentably distinct from each other because the
addition of group B meningococcal OMV or OMP to the composition of the
'152 patent would have been obvious to one of ordinary skill in the art since
it was known in the art as having adjuvant functions. Final Act. 5.
Appellant argues that the Examiner has failed to provide the required
articulated reasoning with some rational underpinning as to how a person of
ordinary skill in the art would modify the claims of the '152 patent in
combination with Blake to arrive at a composition with the properties recited
in the limitation. App. Br. 11. Appellant asserts that Blake teaches that an
outer membrane vesicle ("OMV") vaccine from serogroup Bis only
effective against homologous serogroup B strains. Id. (citing, e.g., M.
Comanducci et al., NadA, a Novel Vaccine Candidate of Neisseria
meningitides, 195(11) J. EXP. MED. 1445, 1446 (2002)). According to
Appellant, serogroup B OMV vaccine by itself or in combination with
meningococcal capsular saccharide vaccines from other serogroups would
be very unlikely to provide protection against two or more heterologous
strains of serogroup B such as the hypervirulent lineages A4, ET 5 and
lineage 3. Id.
The Examiner responds that Blake teaches the use of meningococcal
OMV or OMP as an adjuvant capable of direct T cell stimulation or
immunopotentiation. Ans. 13. The Examiner finds that a person of ordinary
skill in the art would have been motivated to add the meningococcal OMV
or OMP to the composition of the claims of the '152 patent for the expected
benefit of immunopotentiation to produce the claimed composition. Id. The
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Examiner finds that the resultant combination composition comprising both
the multiantigen serogroup B OMV vaccine and the tetravalent serogroup
ACW135Y meningococcal capsular saccharide conjugates could induce an
antibody response in a subject that is bactericidal against two or more of
hypervirulent lineages A4, ET 5 and lineage 3 of N. meningitidis serogroup
B, is implicit and self-evident. Id. The Examiner finds that it was well
known in the art that meningococcal OMV-based vaccines, such as those
taught by Blake are complex mixtures of multiple protein antigens that also
contain low amounts of the group B meningococcal lipooligosaccharide
(LOS or LPS) immunogen. Id. (see Blake col. 7, 11. 6-40). The Examiner
finds these protein and LOS antigens meet the claim limitation "one or more
antigen(s) that protect against N. meningitidis serogroup B," recited in claim
42 and that they can induce an antibody response as recited in claim 43. Id.
The Examiner finds further that it was well known in the art that the
protein antigens present in OMV s include multiple major outer membrane
proteins and minor outer membrane proteins as well as conserved and non-
conserved protein antigens that are strain-specific and strain-nonspecific.
Ans. 13-14. The Examiner points to J. Gil et al., Proteomic Study via a
Non-gel Based Approach of Meningococcal Outer Membrane Vesicle
Obtained from Strain CU-385, 5 HUMAN VACCINES 347-56 (2009) ("Gil")
as identifying 31 outer membrane proteins and three conserved proteins in a
classical meningococcal OMV. Id. ( citing Gil 34 7). The Examiner next
points to C. Vipond et al., Proteomic Analysis of a Meningococcal Outer
Membrane Vesicle Vaccine Prepared from the Group B Strain IMZ38/254, 6
PROTEOMICS 3400-413 (2006) ("Vipond 2006"), which the Examiner finds
identifies more than 70 membrane proteins representative of strain-specific
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and strain-nonspecific antigens in meningococcal OMV vaccine samples.
Id. (citing Vipond 3.2 and 3.2.1); see also C. Vipond et al., Characterization
of the Protein Content of a Meningococcal Outer Membrane Vesicle
Vaccine by Polyacrylamide Gel Electrophoresis and Mass Spectrometry, I
HUMAN VACCINES 80-84, (2005) ("Vipond 2005"). The Examiner also
finds that it was well known in the art that group B meningococcal
lipooligosaccharide present in the OMV vaccines comprises, in addition to
the lipid A, the inner core antigen that is commonly shared among different
serogroups, serotypes, homologous and heterologous strains of
meningococci, and that the lipooligosaccharide induces bactericidal
antibodies to homologous and heterologous group B meningococci. Id. The
Examiner finds that art-known meningococcal OMV-based vaccines elicit at
least modest cross-protective or cross-bactericidal response likely by
conserved antigens present in the antigen mixture of the OMV s. Id. ( citing,
e.g., J. Poolman et al., Serogroup B Neisseria meningitidis Vaccine
Development, Abstracts of 15th International Pathogenic Neisseria
Conference 45 (2006)) ("Poolman"). The Examiner finds that Poolman
teaches that the serogroup B meningococcal OMVs do induce cross-
protection due to some minor and well conserved outer membrane proteins
(OMPs) and lipooligosaccharides. Id.
The Examiner summarizes that, by finding that a composition
resulting from combining the group B meningococcal OMV with the
tetravalent serogroup ACWI35Y meningococcal capsular saccharide
conjugate composition of the claims of the '152 patent, as taught by Blake,
can induce in a generic subject an antibody response that is bactericidal
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against two or more ofhypervirulent lineages A4, ET 5 and lineage 3 of N.
meningitidis serogroup B. Ans. 14.
Appellant replies that the references cited by the Examiner in the
Answer confirm that OMVs such as those mentioned in Blake are only
useful against the strain from which the OMV s are obtained. Reply Br. 18.
Appellant points out that Vipond 2005 teaches that:
The development and evaluation of outer membrane vesicles as
vaccines against meningococcal disease has been carried out for
more than two decades. Although such vaccines have limitations
and are not widely licensed, they continue to be used to disrupt
clonal outbreaks caused by group B meningococci and a wealth
of information is now available from large-scale clinical trials.
Id. (quoting Vipond 2005 Abstr.). Appellant argues further that Vipond
2005 teaches that OMV s are only useful against the strains from which the
OMVs are obtained (i.e., clonal strains). Id. (citing Vipond 2005 80-81).
Appellant also points to Gil, which teaches that:
Although the use of OMV-based vaccines in single-strain
epidemic scenarios is generally accepted, it is also understood
that this approach is likely to be of limited benefit for endemic
serogroup B disease, due to the rapid evolution of antigenic
variants among meningococcal populations. Still, the presence
of a modest cross-protective response during an efficacy study of
VA-MENGOC-BC® in elder Brazilian children suggested the
existence of conserved antigens that can induce functionally
cross-reactive antibodies, and has stimulated further works
towards a more comprehensive characterization of the OMV
components of the vaccine.
Reply Br. 18-19 (quoting Gil 347). According to Appellant, Gil, like
Vipond 2005, teaches the limited utility of OMV vaccines and speculate
about other antigens in the OMV s providing broader protection. Id. at 19.
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Finally, Appellant asserts that Poohnan teaches that:
Due to the dominant immune response mediated by PorA, outer
membrane vesicles (OMVs) derived from serogroup B
meningococcal wild-type strains of Neisseria meningitidis
(MenB) confer only limited crossprotection against circulating
PorA heterologous wild-type strains. The partial cross-
protection induced by wild-type OMV appears to be due to some
minor and well conserved outer membrane proteins (OMPs) and
lipooligosaccharide (LOS).
App. Br. 19. Appellant contends that the object of Poolman was to eliminate
the two immunodominant, but highly variable antigens, PorA and FrpB, in
order to assess whether the minor proteins and LOS could be "unmasked"
and able to induce broadly protective immune responses. Id. Appellant
therefore argues that nothing in Poolman suggests the OMVs taught by
Blake could have induced "an antibody response in that subject that is
bactericidal against two or more of hypervirulent lineages A4, ET 5 and
lineage 3 ofN meningitides serogroup B" as recited in claim 43.
We are persuaded by Appellant's arguments. Only a single claim
(claim 32) of the '152 patent recite a serogroup B antigen as part of the
saccharide mixture in the claimed composition, and that is from a saccharide
antigen from Haemophilus influenzae B, and not from a N. meningitidis
serogroup. We agree with Appellant that the prior art teaches that OMVs
derived from Neisseria serogroup B, when used as antigens by themselves,
may confer only limited cross-protection against other (non-clonal) B
serogroup strains. However, although Blake teaches that Neisseria OMVs
may be useful as adjuvants, we can discern no teaching or suggestion in
Blake that the inclusion of N. meningitidis OMV s will possess the claimed
ability of being able to induce: "an antibody response in that subject that is
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bactericidal against two or more of hypervirulent lineages A4, ET 5 and
lineage 3 of N meningitidis serogroup B," as required by claim 43. Indeed,
Blake expressly teaches that: "The immune stimulatory effect of adjuvants
is not antigen specific, as they boost immune responses towards many
different types of antigens." Blake col. 2, 11. 35-37. Blake further teaches
that:
The major outer membrane proteins of the pathogenic Neisseria
(Neisseria gonorrhoeae and Neisseria meningitidis) have been
investigated for adjuvant potential and for the mechanism behind
their immunopotentiating ability... . They all function as porins
... and are considered to be part of the gram negative porin
superfamily ....
Neisserial porins, when complexed non-covalently with
malarial peptides, were shown to enhance the antibody response
to these peptides as compared to when the peptides were used as
an immunogen alone or covalently linked to other proteins.
Id. at 11. 45-46. Blake thus discloses that N. meningitidis OMVs can act as
non-specific enhancers of immune responses, but the Examiner points to no
teaching or suggestion of Blake, nor can we discern one, that discloses the
abilities of Neisseria OMVs to act as antigens that will induce the precise
antibody response recited in claim 43. We therefore reverse the Examiner's
rejection of claim 43.
DECISION
The Examiner's rejection of claims 26-38, 40, 42 and 56-59 under 35
U.S.C. § 103(a) is affirmed.
The Examiner's rejection of claim 43 under 35 U.S.C. § 103(a) is
reversed.
18
Appeal2017---001496
Application 10/543,455
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED-IN-PART
19