Ex Parte Schenk

Board of Patent Appeals and Interferences

Nov 30, 2010

10777792 (B.P.A.I. Nov. 30, 2010)

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.
10/777,792 02/11/2004 Dale B. Schenk 057437-391791 3041
826 7590 11/30/2010
ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000
EXAMINER
KOLKER, DANIEL E
ART UNIT PAPER NUMBER
1649
MAIL DATE DELIVERY MODE
11/30/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte DALE B. SCHENK
__________

Appeal 2010-004495
Application 10/777,792
Technology Center 1600
__________

Before ERIC GRIMES, JEFFREY N. FREDMAN, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON REQUEST FOR RECONSIDERATION1
Dale B. Schenk (Appellant) requests reconsideration of the Decision
on Appeal mailed August 30, 2010, which affirmed obviousness rejections
of all the pending claims.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-004495
Application 10/777,792

2
ANALYSIS
The background of this request is, briefly, that Appellant claims a
composition comprising the first seven amino acids of the known β amyloid
peptide (aka Aβ), linked to a toxoid. The Examiner concluded that the
composition would have been obvious because Selkoe taught making
antibodies against Aβ by using a peptide of about 8 amino acids as the
antigen, Wong taught linking the first ten amino acids of Aβ as an antigen to
a carrier to increase antibody production against Aβ, and Penney taught
using a toxoid as a carrier for antigens. We affirmed.
The first ground for reconsideration concerns the meaning of Selkoe’s
teaching to use an Aβ fragment of “about 8 or more residues.” (Req. Reh’g2
2-3.) The Decision agreed with the Examiner’s interpretation that “about 8”
included 7. (Dec. 7, citing Ans. 3.)
Appellant views “about 8” as a teaching that “the minimum length
cannot be defined with absolute certainty,” and “suggest[s] there is some
risk of failure in an Aβ1-7 fragment or a need to expend more effort to
generate a suitable antibody.” (Req. Reh’g 2.) According to Appellant, “the
claimed invention involves the additional complexity presented by a possible
risk of failure or additional effort without any compensating advantages,”
and “no or insufficient reason has been provided for specific selection of an
Aβ1-7 fragment rather than Aβ1-10 or many other possible alternative Aβ
fragments whose lengths would not present any concerns with respect to
generating a suitable antibody.” (Id. at 3.)

2 Citations are to Appellant’s “Corrected Request For Rehearing Under
37 C.F.R. 41.50(b)(2)” filed with a Communication dated Nov. 12, 2010.
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Application 10/777,792

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We are not persuaded that these arguments establish a ground for
reversal. Selkoe’s teaching that “about 8” Aβ amino acids are sufficient is
presumed enabled. See Amgen Inc. v. Hoechst Marion Roussel, Inc., 314
F.3d 1313, 1355 (Fed. Cir. 2003) (a patent’s disclosure is presumed
enabled). Further, “[o]bviousness does not require absolute predictability.
Only a reasonable expectation that the beneficial result will be achieved is
necessary to show obviousness.” In re Merck & Co., Inc., 800 F.2d 1091,
1097 (Fed. Cir. 1986) (citations omitted). Appellant’s vague references to
“added features or steps” (Req. Reh’g 3) are not evidence that actual features
or steps beyond those described in the references would have been needed.
Similarly, Appellant’s “assumption of unnecessary complications” (id.), is
not evidence that a person having ordinary skill in the art could not have
combined the Selkoe, Wong, and Penney teachings with a reasonable
expectation of success.
Appellant’s second point is that there is “evidence that the Aβ1-7
moiety of the claimed conjugate has an unexpected advantage relative to the
Aβ1-10 fragment used by Selkoe.” (Id.) According to Appellant,
[i]n the aggregate, these reports provide evidence that an Aβ1-7
fragment is likely to be equally effective as an Aβ1-10 fragment
in inducing three classes of antibodies primarily responsible for
plaque clearing but even less likely to have T-cell mediated side
effects because of its smaller size relative to the approximate
minimum size of T-cell epitopes reported by Rammensee.

(Id. at 4.)
The “evidence” consists of hypotheses, not results obtained from
using the claimed conjugates. Appellant agrees that the “evidence” is
actually an inference based on combining information in the art, in the
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Application 10/777,792

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Specification, and in post-filing date publications: “Appellant has never
contended that the underlying evidence was generated using a conjugate as
claimed. Nevertheless, the evidence inferentially supports a conclusion that
the Aβ1-7 moiety of the claimed conjugates has an unexpected property of
practical importance vis a vis the Aβ1-10 fragment of Selkoe.” (Id.)
To reiterate, appellant is not arguing about the
advantages of different products, but instead is using the data in
the specification defining the location of epitopes responsible
for plaque clearing and postfiling data regarding side effects to
support an inferential conclusion of unexpected results of
practical significance of the Aβ1-7 moiety of the claimed
product vis a vis Wong’s Aβ1-10 fragment.

(Id. at 5.) We do not agree that the inferences constitute evidence of a
suitable side-by-side comparison with the closest prior art as is necessary to
demonstrate unexpected results.
Appellant argues that the Board overlooked that replacing KLH with a
toxoid “confers an unexpected result that the claimed conjugates are
rendered more suitable for human therapeutic use.” (Id. at 7.) The
Examiner found that Appellant did not provide evidence to support the
assertion (Ans. 9), and we agreed (Decision 9). We did not overlook that
argument. When the references relied on explicitly describe a toxoid for
improved vaccine compositions for human use, e.g., Penney, col. 2, it was
reasonable for the Examiner to require evidence of unexpected results.
Appellant similarly argues that the Board misapprehended the nature
of the unexpected result relating to QS-21 (replacing Freund’s adjuvant with
QS-21) (Req. Reh’g 7), but we are again unpersuaded. The Examiner
carefully explained how Hancock disclosed advantages associated with QS-
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Application 10/777,792

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21 and why QS-21 would have been an obvious choice. (Ans. 5-6.)
Appellant recognizes that the art taught the unsuitability of Freund’s
adjuvant for use in humans, but maintains that “replacing Freund’s adjuvant
with QS-21 conferred an unexpected result of suitability for human use.”
(Req. Reh’g 7.) We continue to disagree that the result was unexpected. It
is undisputed that Hancock taught QS-21 for use in humans, and its
suitability would therefore not have been unexpected.
SUMMARY
We have considered Appellant’s request for reconsideration but deny
the requested relief.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

DENIED

cdc

ALSTON & BIRD LLP
BANK OF AMERICA PLAZA
101 SOUTH TRYON STREET, SUITE 4000
CHARLOTTE, NC 28280-4000