Ex Parte Wheeler et al

Patent Trial and Appeal Board

Oct 25, 2012

10181684 (P.T.A.B. Oct. 25, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ALAN W. WHEELER, GARY ELLIOTT,
and CHRISTOPHER CLUFF
____________

Appeal 2011-010822
Application 10/181,684
Technology Center 1600
____________

Before TONI R. SCHEINER, DONALD E. ADAMS, and STEPHEN
WALSH, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 1, 4-6, 13, 37, and
42 (App. Br. 3).
1
We have jurisdiction under 35 U.S.C. § 6(b).
STATEMENT OF THE CASE
The claims are directed to a method for producing a (1) mucosal and
systemic (claims 1, 5, 6, and 13) or (2) IgA (claims 4, 37, and 42) immune

1
Pending claims 8, 11, 34-36, 38, 41, and 43-45 stand withdrawn from
consideration (App. Br. 3 and 14; Fin. Rej. 2: ¶ 1).
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response in a human or animal. Claim 1 is representative and is reproduced
in the Claims Appendix of Appellants’ Brief.
Claims 1, 4-6, 13, 37, and 42 stand rejected under 35 U.S.C. § 102(b)
as being anticipated by Blaser.
2

Claims 1, 4-6, 13, 37, and 42 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Blaser and Hauser.
3

We reverse.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Blaser teaches Appellants’ claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Blaser teaches “a vaccine composition comprising a polypeptide
antigen PEB1A from Campylobacter jejuni” (Ans. 4; Blaser 24: 1-4).
FF 2. Blaser teaches that “[a]n adjuvant can … be a part of the carrier of
the vaccine, in which case it can be selected by standard criteria based on the
antigen used, the mode of administration and the subject” (Blaser 24: 20-23;
see generally Ans. 4).
FF 3. Blaser identifies six groups and a variety of sub-groups of
“preferred” adjuvants, including
(2) oil-in-water emulsion formulations (with or without other
specific immunostimulating agents such as … bacterial cell
wall components), such as for example … (c) Ribi
TM
adjuvant
system (RAS) … containing 2% Squalene, 0.2% Tween 80, and

2
Blaser et al., WO 95/05850, published March 2, 1995.
3
Hauser et al., US 5,776,468, issued July 7, 1998.

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one or more bacterial cell wall components from the group
consisting of[, inter alia,] monophosphorylipid A (MPL).

(Blaser 25: 17 - 26: 3; see Ans. 4 and 8.)
FF 4. Appellants’ disclose that “MPL adjuvant is [a] TH-1 inducing
adjuvant” (Ans. 5; see Spec. 8: 10-12).
FF 5. Blaser teaches that “administration can be by oral or sublingual
means, or by injection, depending on the particular vaccine used and the
subject to whom it is administered” (Blaser 24: 24-26; see Ans. 4 and 5).
ANALYSIS
Based on Blaser, Examiner finds that Appellants’ “claimed
composition and the referenced composition are identical and both
compositions are being administered to the identical population, inducing an
IgA mucosal response and a serum IgG systemic response and induction of
IgA response distal from [the] sublingual site are inherently achieved” (Ans.
5). Examiner also finds that Blaser “teaches a small genus (6 species for
adjuvants and 3 species for route of administration)” (Ans. 8). We are not
persuaded.
Notwithstanding Examiner’s contention to the contrary, Blaser
teaches more than 6 species of adjuvant (FF 3; App. Br. 7; Reply Br. 2).
Further, as Appellants point out, Blaser teaches “that the choice of adjuvant
for the PEB1A vaccine depends not only on the antigen, but also on the
mode of administration of the vaccine” (App. Br. 7; Reply Br. 2; FF 2).
Therefore, while Examiner is correct in that Blaser mentions the words
adjuvant, MPL, and sublingual, Examiner failed to establish an evidentiary
basis on this record to support a finding that a person of ordinary skill in this
art would have reasonably selected MPL as a component of a vaccine that is
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administered sublingually as required by Appellants’ claimed invention (see,
e.g., claim 1; Cf. FF 2; App. Br. 7; Reply Br. 2). In re Wilder, 429 F.2d 447,
450 (CCPA 1970) (“[I]n an ex parte proceeding to obtain a patent, ... the
Patent Office has the initial burden of coming forward with some sort of
evidence tending to disprove novelty.”).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner’s finding that Blaser teaches Appellants’ claimed invention. The
rejection of claims 1, 4-6, 13, 37, and 42 under 35 U.S.C. § 102(b) as being
anticipated by Blaser is reversed.

Obviousness:
ISSUE
Does the preponderance of evidence on this record support a
conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 6. Examiner relies on Blaser as discussed above (see Ans. 5).
FF 7. Examiner finds that Blaser fails to suggest “antigens that are derived
from virus, prion, neoplasm, autoantigen, animal, or plant” (id. at 6).
FF 8. Examiner relies on Hauser to suggest a “vaccine composition
comprising a MPL and an antigen from various sources including bacteria,
virus, tumor, animal pathogen, or fungus” (id.).
FF 9. Appellants’ Evidence Appendix contains a number of references
relied upon by Appellants to establish that: (1) MPL is a glycolipid adjuvant
that contains ester and amidic bonds and (2) the buccal mucosa and saliva
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contain enzymes that degrade compounds comprising ester and amidic
bonds (App. Br. 9-10).
ANALYSIS
Based on the combination of Blaser and Hauser, Examiner concludes
that, at the time Appellants’ invention was made, it would have been prima
facie obvious to “substitute and/or add other antigenic materials,” as
suggested by Hauser, in Blaser’s composition and method of using the
composition (Ans. 6). Appellants contend that Hauser fails to suggest the
sublingual administration of a composition comprising MPL and therefore
fails to make up for the deficiency in Blaser (see generally App. Br. 8). The
weight of the evidence falls in favor of Appellants. Examiner failed to
establish an evidentiary basis on this record to support a conclusion that a
person of ordinary skill in this art would have reasonably selected MPL as a
component of a vaccine that is administered sublingually as required by
Appellants’ claimed invention.
In this regard, we recognize Appellants’ contention that the state of
the art at the time of their invention suggested that enzymes present in the
buccal mucosa and saliva would have degraded a MPL adjuvant
administered sublingually; therefore, a person of ordinary skill in this art
would not have had a reasonable expectation “that the antigen/glycolipid
adjuvant combination could be delivered to the blood stream and produce
the systemic IgG and mucosal IgA-mediated response of the claimed
invention” when administered sublingually (App. Br. 9-11; see also Reply
Br. 3-4 (“based upon what was known in the art at the time of the invention,
one of skill in the art would not be led to apply MPL sublingually because
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they would appreciate that salivary enzymes would disrupt the ester-amidic
bonds of the MPL molecule”)).
Absent an evidentiary basis to support a conclusion that differs from
Appellants’ contentions, we are not persuaded by Examiner’s assertion that
“none of the references [relied upon by Appellants] specifically teach that
the sublingual route is not suitable for MPL” (Ans. 9). For the same reasons,
we are not persuaded by Examiner’s assertion that “[j]ust because the MPL
has esters, it does not mean that the esterases would digest MPL” (id. at 10).
Lastly, Examiner’s rejection is based on the combination of Blaser and
Hauser, therefore we are not persuaded by Examiner’s assertion that other
prior art, not relied upon, “suggests the way to overcome the problems
associated with [administration via an] oral route” (Ans. 10).
Obviousness requires more than a mere showing that the
prior art includes separate references covering each separate
limitation in a claim under examination. KSR Int'l Co. v.
Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d
705 (2007). Rather, obviousness requires the additional
showing that a person of ordinary skill at the time of the
invention would have selected and combined those prior art
elements in the normal course of research and development to
yield the claimed invention. Id. at 421, 127 S.Ct. 1727.

Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir.
2011).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support a
conclusion of obviousness. The rejection of claims 1, 4-6, 13, 37, and 42
under 35 U.S.C. § 103(a) as unpatentable over the combination of Blaser and
Hauser is reversed.
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REVERSED

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