Ex Parte O

Patent Trial and Appeal Board

Oct 25, 2016

13041042 (P.T.A.B. Oct. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/041,042 03/04/2011
27476 7590 10/27/2016
NOV ARTIS VACCINES
atGSK
709 Swedeland Road
UW2220
KING OF PRUSSIA, PA 19406-0939
FIRST NAMED INVENTOR
Derek O'Hagan
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.
P ATOS 1223-US-CNT 4163
EXAMINER
TONGUE, LAKIA J
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
10/27/2016 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):
us_cipkop@gsk.com
arlene.e.cannon@gsk.com
laura.m.mccullen@gsk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DEREK O'HAGAN
Appeal2014-002707
Application 13/041,042
Technology Center 1600
Before DEMETRA J. MILLS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF CASE
The following claim is representative.
1. A composition for mucosal delivery, comprising a mucosal
adjuvant and two or more of the following: (a) an antigen which induces an
immune response against Haemophilus injluenzae; (b) an antigen which
induces an immune response against Neisseria meningitidis; and ( c) an
antigen which induces an immune response against Streptococcus
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Application 13/041,042
pneumonia, wherein the mucosal adjuvant comprises a detoxified cholera or
E. coli heat labile toxin.
Examiner Cited References
Lian et al. US 2011/0045017 Al
Capiau et al. WO 00/56359
Rappuoli et al. WO 01/22993 A2
Appellant Cited References (see Br. 9--10)
Feb. 24, 2011
("Lian")
Sept. 28, 2000
("Capiau")
Apr. 5, 2001
("Rappuoli")
Aucouturier et al., Adjuvants designed for veterinary and human
vaccines, 19 VACCINE 2666-2672 (2001) ("Aucouturier").
Robert Edelman, The Development and Use of Vaccine Adjuvants, 21
MOLECULAR BIOTECHNOLOGY 129--148 (2002).
Wuorimaa et al., Avidity and Subclasses of IgG after Immunization of
Infants with an I I-Valent Pneumococcal Conjugate Vaccine with or without
Aluminum Adjuvant, 184 I.INFECTIOUS DISEASES 1211-1215 (2001)
("Wuorimaa").
Grounds of Rejection
1. Claims 1-15 and 17 are rejected under 35 U.S.C. § 102(e) as being
anticipated by Lian.
Claims 1-15 and 17 are rejected under 35 U.S.C. § 103(a) as
beingobvious over Capiau and further in view of Rappuoli.
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PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F .2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant." In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
,,_T?_ej ection 1
We vacate the Examiner's anticipation in favor of a new ground of
rejection for obviousness in view of Lian alone or in combination with
Capiau.
NEW GROUNDS OF REJECTION
Claims 1-15 and 17 are newly rejected under 35 U.S.C. § 103(e) as
obvious in view of Lian.
FINDINGS OF FACT
1. Lian disclosed HIV vaccine compositions for mucosal delivery
comprising antigens which may advantageously include saccharide
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antigens from N. meningitidis serogroup A, C, W135 and/or Y,
such as the oligosaccharide; a saccharide antigen from
Streptococcus pneumonia; and a saccharide antigen from
Haemophilus influenzae (see paragraphs 49--53 and 60).
2. Lian disclosed that its vaccine composition can be administered by
an intranasal route; the vaccine of the invention may be in the form
of a nasal spray, nasal drops, gel, or powder (see paragraph 80).
3. Lian disclosed mucosal adjuvants suitable for use in the invention
include, but are not limited to, heat-labile enterotoxins or
detoxified mutants thereof, such as the L TK63 or L TR 72 mutants
(see paragraphs 13 and 82).
4. Lian disclosed where a saccharide or carbohydrate antigen is
included; it is conjugated to a carrier protein, which is bacterial
toxins or toxoids, such as diphtheria (CRM197), cholera or tetanus
toxoids (see paragraph 74).
5. In Lian, preferred carrier proteins are bacterial toxins or toxoids,
such as diphtheria, cholera, E. coli heat labile or tetanus toxoids.
The CRM197 diphtheria toxoid is particularly preferred. (See
paragraph 74).
6. Capiau disclosed that it was well known in the art to prepare
combination vaccines which provide protection against a range of
different pathogens. P. 7, 1. 29-p. 8, 1. 4; p. 25, 11. 5-6.
ANALYSIS
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The composition of claim 1 includes the transitional phrase
"comprising," which opens the claim up to additional elements or
ingredients. Therefore, it is of no consequence that the composition of Lian
is primarily directed to an HIV vaccine for mucosal delivery [i-f 13], but
which also includes additional antigens. Lian's vaccine can include
additional [i-f 49] (any or all) antigens including: (a) Haemophilus influenza
[i-f 60]; (b) an antigen which induces an immune response against Neisseria
meningitidis [i-f 52]; and (c) an antigen which induces an immune response
against Streptococcus pneumonia [i-f 53]; wherein the mucosal adjuvant
comprises a detoxified cholera or E. coli heat labile toxin [i-f 14]; [i-f 74].
With respect to the anticipation rejection, Appellant argued that there
was a substantial amount of picking and choosing from a laundry list of 24
disclosed additional antigens in Lian. Reply Br. 6. As explained in Arkley,
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). Furthermore, picking
one of a finite number of known solutions to a known problem is obvious.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007), states:
When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a
person of ordinary skill has good reason to pursue the known options
within his or her technical grasp. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill
and common sense. In that instance the fact that a combination was
obvious to try might show that it was obvious under§ 103.
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Finally, "[ d]isclos[ ure of] a multitude of effective combinations does not
render any particular formulation less obvious." Merck & Co. Inc. v.
Biocraft Laboratories Inc., 874 F.2d 804, 807, 10 USPQ2d 1843, 1846
(Fed. Cir. 1989). Here, Lian would reasonably appear to disclose multiple
effective vaccine combinations, in that Lian discloses that additional
antigens (plural) may be present in the disclosed HIV mucosal vaccine.
[i-f49 and i-f 50-7 4.] Moreover, this list of optional antigen components is not
excessively long, but is limited to just over twenty. [Id.] Conceivably,
while unlikely, nothing would prevent the skilled artisan from including
several or all of them in a single composition. In addition, Capiau
discloses that it is well known in the art to prepare combination vaccines
which provide protection against a range of different pathogens. P. 7, 1. 29-
p. 8, 1. 4; p. 25, 11. 5-6.
It would have been obvious to one of ordinary skill in the art at the time of
the invention to prepare a vaccine composition comprising a mucosal
adjuvant and any or all of the following: (a) an antigen which induces an
immune response against Haemophilus injluenzae; (b) an antigen which
induces an immune response against Neisseria meningitidis; and ( c) an
antigen which induces an immune response against Streptococcus
pneumonia, wherein the mucosal adjuvant comprises a detoxified cholera or
E. coli heat labile toxin, in view of Lian. Lian discloses a vaccine having a
mucosal adjuvant, an antigen which induces an immune response against
Haemophilus influenzae; and an antigen which induces an immune response
against Neisseria meningitides, in conjunction with a detoxified cholera or
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E. coli heat labile toxin. Alternatively, Capiau motivates one of ordinary
skill in the art to include multiple antigens in combination vaccines.
Rejection 2
Claims 1-15 and 17 are rejected under 35 U.S.C. § 103(a) as being obvious
over Capiau and further in view of Rappuoli.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
2-14. The following facts are highlighted.
7. Capiau disclosed vaccine compositions comprising at least one
Streptococcus pneumoniae polysaccharide antigen (preferably conjugated)
and a Streptococcus pneumoniae protein antigen or immunologically
functional equivalent thereof, optionally with an adjuvant (see page 8, lines
15-20).
8. The polysaccharides of Capiau may be conjugated to protein
carriers, such as; diphtheria and tetanus toxoids (DT, CRM197 and TT) (see
page 14, lines 13-18).
9. Capiau disclosed that polysaccharides to be conjugated and
contemplated by this invention, include, but are not limited to
meningococcal polysaccharides (including type A, C, W135 and Y) and the
capsular polysaccharide from Haemophilus injluenzae (see page 23, lines 5-
15).
10. In one Capiau embodiment, the combination includes a vaccine
that affords protection against Neisseria meningitidis C and Y infection
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wherein the polysaccharide antigen from one or more serotypes Y and Care
linked to a protein.
11. Additionally, Haemophilus injluenzae polysaccharide based
vaccine conjugated with TT, OT, or CRM197, may be formulated with the
above combination vaccine. Page 23. Capiau disclosed that many vaccines
are now given as a combination vaccine so as to reduce the number of
injections a subject has to receive. Thus, for Capiau's vaccines, other
antigens may be formulated with the vaccines of the current invention (see
page 25, lines 17-29; page 26, lines 21-30; and page 27, lines 1-2).
12. Capiau disclosed that the vaccine composition preparation is
administered via a mucosal route and include intranasal administration (see
page 18, lines 1-8), which necessarily encompasses the form of a nasal
spray, nasal drops, a gel or a powder.
13. Lastly, Capiau disclosed that suitable adjuvant systems include,
but are not limited to, monophosphoP;l lipid i\., saponin and CPG (see page
15, line 27 and page 16, lines 8-14). Since Capiau used the entire capsular
polysaccharide and in light of Appellant's definition of oligosaccharide (a
fragment of capsular polysaccharide ), the capsular saccharide antigen of the
prior art necessarily encompasses an oligosaccharide.
14. Capiau disclosed vaccine
polysaccharides may be conjugated to protein carriers, which
provide bystander T-cell help. It is preferred, therefore, that the
polysaccharides utilised in the invention are linked to such a
protein carrier. Examples of such carriers which are currently
commonly used for the production of polysaccharide
immunogens include the Diphtheria and Tetanus toxoids (DT,
DT CRMl 97 and TT respectively), Keyhole Limpet
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Haemocyanin (KLH), OMPC from N. meningitidis, and the
purified protein derivative of Tuberculin (PPD).
Page 14.
15. Rappuoli discloses
Rappuoli et al. disclose that mucosal vaccine compositions
where cholera toxin and E. coli heat labile toxin (L T-K63 or
LT-R72) act as a mucosal adjuvant, both of which have been
found to enhance antigen specific serum lgG, sigA and local
and systemic T cell responses. L T-K63 is preferred, as it has
been found reliable in animal models to result in a high level of
protection. Lastly, both are homologous and are
interchangeable (see page 1, lines 56-27 and page 2, lines 1-7)
Ans. 4.
16. The vaccines of Rappuoli include Bordetella pertussis, diphtheria
antigen (D), a tetanus antigen, and are for mucosal delivery. Page 1.
17. Rappuoli discloses that the detoxified form of cholera toxin (CT)
or E.coli heat labile toxin (LT) acts as a mucosal adjuvant. CT and LT are
homologous and are typically interchangeable. Page 1.
ANALYSIS
We agree with the Examiner's fact finding, statement of the rejection
and responses to Appellant's arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner's argument set forth in the Final Rejection and Answer. We agree
with the Examiner that
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Application 13/041,042
It would have been prima facie obvious to one of
ordinary skill in the art at the time the invention was made to
modify the invention of Capiau et al. with the cholera toxin and
E.coli heat labile toxin (LT-K63 or LT-R72) ofRappuoli et al.
because they act as a mucosal adjuvants that are homologous
and are interchangeable. Both have enhanced antigen specific
serum lgG, slgA and local and systemic T cell responses, and
result in a high level of protection. One would have had a
reasonable expectation, barring evidence to the contrary, that
the composition, which is intended for mucosal delivery would
be effective for inducing an immune response against the
claimed bacterial antigens.
Ans. 4.
Appellant argues that, Capiau "never suggest[ ed] that they be used
together in a single composition." App. Br. 8. Appellant argues that the art
of selecting adjuvants in order to enhance immune responses to specific
antigens is unpredictable as noted in the three adjuvant review articles of
i~ .. ucouturier, Edelman, and \Vuorimaa. i~ .. pp. Br. 9.
We are not persuaded. As articulated in KSR, "[ t ]he combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results." KSR, 550 U.S. at 416. We
agree with the Examiner that, it would have been prima facie obvious to one
of ordinary skill in the art at the time the invention was made to modify the
invention of Capiau with the cholera toxin and E. coli heat labile toxin (LT-
K63 or LT-R72) ofRappuoli because they act as a mucosal adjuvants that
are homologous and are interchangeable.
Although Appellant argues that there is lack of predictability with
respect to adjuvant selection, Appellant's lack of predictabile data from
Aucouturier, Edelman, and Wuorimaa primarily relate to the unpredictability
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associated with the use of alum adjuvant. Br. 10. The cholera toxin or
E.coli heat labile toxin mucosal adjuvants of Rappuoli are appropriate for
use with Bordetella pertussis, diphtheria antigen (D), a tetanus antigen.
FF15. Similarly, the polysaccharide vaccines of Capiau include the
Diphtheria and Tetanus toxoids. FF13. Therefore, Rappuoli establishes the
appropriateness of the use of cholera toxin or E.coli heat labile toxin
mucosal adjuvants with vaccines such as that of Capiau which may also
include similar antigens. Appellant has provided no contrary evidence or
further evidence of unexpected results.
Capiau disclosed that it is well known in the art to prepare
combination vaccines which provide protection against a range of different
pathogens. P. 7, 1. 29-p. 8, 1. 4; p. 25, 11. 5-6. Capiau disclosed vaccine
compositions comprising at least one Streptococcus pneumoniae
polysaccharide antigen (preferably conjugated) and a Streptococcus
pneitmoniae protein antigen or immunologically fi1nctional equivalent
thereof, optionally with an adjuvant (see page 8, lines 3-20). It would have
been obvious to one of ordinary skill in the art aware of Capiau and
Rappuoli to include multiple antigens in a vaccine to form a combination
vaccine with an expectation of success. Appellant has provided no evidence
that one of ordinary skill in the art would be unsuccessful in combining the
specific antigens disclosed in Capiau.
Rejection 2 is affirmed for the reasons of record.
CONCLUSION OF LAW
The anticipation rejection 1 is vacated in favor of a new ground of
rejection for obviousness in view of Lian. The cited references support the
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Examiner's obviousness rejection 2, which is affirmed. All pending,
rejected claims fall.
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b), which provides that a "new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review."
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner ....
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record ....
Should the Appellant elect to prosecute further before the Examiner
pursuant to 37 C.F.R. § 41.50(b)(l), to preserve the right to seek review
under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection(s), the
effective date of the affirmance is deferred until conclusion of the
prosecution before the Examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If the Appellant elects prosecution before the Examiner and this does
not result in allowance of the application, abandonment, or a second appeal,
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this case should be returned to the Patent Trial and Appeal Board for final
action on the affirmed rejection, including any timely request for rehearing
thereof.
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; NEW GROUND UNDER 37 C.F.R. § 41.50(b)
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