Ex Parte Norman et al

Patent Trial and Appeal Board

Jul 28, 2016

11788808 (P.T.A.B. Jul. 28, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111788,808 0412012007 Andrew B. Norman
24256 7590 07/29/2016
DINSMORE & SHOHL LLP
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.
10738-90 5708
EXAMINER
255 East Fifth Street, Suite 1900 DUTT, ADITI
CINCINNATI, OH 45202
ART UNIT PAPER NUMBER
1649
MAILDATE DELIVERY MODE
07/29/2016 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 B. NORMAN and WILLIAM J. BALL
JR.1
Appeal2013-005634
Application 11/788,808
Technology Center 1600
Before JEFFREYN. FREDMAN, RICHARD J. SMITH, and
TA WEN CHANG, Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) involving claims to a
monoclonal antibody, which have been rejected as anticipated. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
"Cocaine is a powerful addictive stimulant that directly affects the
brain." (Spec. i-f 3.) According to the Specification,
1 Appellants identify the Real Party in Interest as the University of
Cincinnati. (Appeal Br. 1.)
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Application 11/788,808
[a]s the site of action of cocaine is in the brain, decreasing the
concentrations [of cocaine] reaching the brain would be expected to
decrease the probability of [cocaine] dependence, addiction, overdose,
and relapse. Antibodies with high affinity and specificity for cocaine
would be expected to act as pharmacokinetic antagonists by
sequestering cocaine in the peripheral circulation and preventing its
entry to the brain.
(Id. at iT 18.)
Further according to the Specification, antibodies may be obtained
from hybridomas, which are hybrid cells generated by fusing mouse tumor
cells with spleenocytes of transgenic mice immunized with the appropriate
antigens. (Id. at iT 41.) The Specification explains that "the present
invention is directed toward a monoclonal [anti-cocaine] antibody
comprising a human gamma heavy chain and a murine [lambda] light
chain." (Id. at iT 8.)
Claims 16-18, 23, and 24 are on appeal. Claim 16 is representative
and reproduced belov,r:
16. A monoclonal antibody compnsmg a human gamma
heavy chain and a murine lambda light chain, wherein the
antibody specifically binds cocaine and is generated by
immunizing a HCo7 /Ko5 mouse with an antigen comprising a
conjugate of benzoylecgonine and an immunogenic carrier
protein, wherein the murine lambda light chain comprises SEQ
ID NO: 4, SEQ ID NO: 5, and SEQ ID NO: 6 and wherein the
human gamma heavy chain comprises SEQ ID NO: 7, SEQ ID
NO: 8, and SEQ ID NO: 9.
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Application 11/788,808
Issue
DISCUSSION
The Examiner rejected claims 16-18, 23, and 24 under 35 U.S.C.
§ 102(b) as being anticipated by Paula.2 (Ans. 3.) The Examiner finds that
Paula teaches a monoclonal antibody 2E2, "[which] is the same antibody
that is generated from the same hybridoma cell line obtained from the same
mouse strain HCo7 /Ko5, by immunizing with the same antigen as recited in
the instant claim 16, and described in the instant specification." (Id. 4.) The
Examiner further finds that, "[a]lthough the prior art reference does not
teach sequences of the heavy and light chains, these would be inherent, as a
consequence of corresponding to an identical monoclonal antibody and an
identical hybridoma." (Id.)
Appellants do not dispute that they are co-authors of Paula or that
Paula is directed to the monoclonal antibody of the instant claims. (Appeal
Br. 6.) However, Appellants contend that, because Paula does not disclose
the actual sequences of the variable regions of the antibody or any
distinguishing details of the hybridoma other than an arbitrary lab-assigned
name, Paula does not provide sufficient disclosure to be enabling reference
for the claims on appeal. (Id. at 6-10.)
In particular, Appellants contend that, while Paula discloses how the
monoclonal antibody E2E was made, the process for making antibodies is so
variable that "it is virtually a statistical impossibility that one of ordinary
2 Stefan Paula et al., Three-Dimensional Quantitative Structure-Activity
Relationship Modeling of Cocaine Binding by a Novel Human Monoclonal
Antibody, 47 J. Medicinal Chemistry 133 (2004).
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Application 11/788,808
skill in the art, following the process exactly as outlined in Paula, would
spontaneously generate the same hybridoma/monoclonal antibody as that
produced by the Paula authors/Appellants." (Id. at 7-8.) Appellants further
contend that the preliminary research published in Paula mischaracterized
the E2E antibody as containing a human rather than murine lambda light
chain. (Id. at 8.) Thus, Appellants argue that, if a skilled artisan tried to
screen for the E2E antibody by following Paula's disclosure, such efforts
would have been unsuccessful because Paula's mischaracterization of the
E2E antibody would have led the skilled artisan to screen incorrectly for an
antibody having a human lambda light chain. (Id. at 9.)
The Examiner counters that neither the variability of the antibody
production process nor Paula's mischaracterization of the antibody obviates
the anticipation rejection, because Paula's publication placed both the
claimed antibody and the antibody-producing hybridoma in the public
domain. (Ans. 8.) In making this argument, the Examiner relies on ACS
Publications' "Ethical Guidelines to Publication of Chemical Research"
("Ethical Guidelines"), which states in part that,
[ w ]hen requested, the authors should make every reasonable effort to
provide ... samples of unusual materials unavailable elsewhere, such
as ... antibodies, etc. to other researchers.
(Reply Br. 3.) Appellants dispute the Examiner's interpretation of Paula
authors' obligation to share materials under the Ethical Guidelines, and
further state that Appellants have never provided another investigator access
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Application 11/788,808
to either the hybridoma or the monoclonal antibody discussed in Paula.
(Ball/Norman Decl.3 i-f 7 .)
The issues with respect to this rejection are whether Paula's
publication placed the 2E2 antibody and/or the hybridoma producing the
antibody in the public domain in view of the Ethical Guidelines, and, if not,
whether the Paula reference itself is nonetheless enabling prior art.
Principles of Law
"A prior art reference cannot anticipate a claimed invention 'if the
allegedly anticipatory disclosures cited as prior art are not enabled."' In re
Antor Media Corp., 689 F.3d 1282, 1287 (Fed. Cir. 2012 (citation omitted)).
"Enablement of prior art requires that the reference teach a skilled artisan to
make or carry out what it discloses in relation to the claimed invention." Id.
at 1290.
[D]uring patent prosecution, an examiner is entitled to reject claims as
anticipated by a prior art publication or patent without conducting an
inquiry into whether or not that prior art reference is enabling. As long
as an examiner makes a proper prima facie case of anticipation by
giving adequate notice under§ 132, the burden shifts to the applicant
to submit rebuttal evidence of nonenablement.
Id. at 1289. "Once an applicant makes a non-frivolous argument that cited
prior art is not enabling, however, the examiner must address that
challenge." In re Morsa, 713 F.3d at 104, 110 (Fed. Cir. 2013).
Analysis
On balance, we agree with the Appellants that ACS' s Ethical
Guidelines does not require Appellants to place the Paula antibody and
3 Declaration of William J. Ball, Jr. and Andrew B. Norman Under 37
C.F.R. § 1.132 (Jan. 27, 2012).
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Application 11/788,808
hybridoma in the public domain as a condition of publishing the Paula paper.
As Appellants point out, the Ethical Guidelines state that authors of papers
should make "reasonable" efforts to provide materials unavailable
elsewhere, such as antibodies, but also takes into account "the legitimate
interests of the authors." (Reply Br. 3.) Thus, we do not find that the
Appellants agreed to place Paula antibody and hybridoma in the public
domain through publication of the Paula reference.
Given our conclusion above, and given Appellants' declaration that
they have not otherwise publicly shared either the Paula hybridoma or the
antibody it produces (Ball/Normal Deel. i-fi-17, 9; Reply Br. 3), we next tum
to the issue of whether the Paula reference itself anticipates the claims on
appeal. We agree with Appellants that it does not.
"A prior art reference cannot anticipate a claimed invention 'if the
allegedly anticipatory disclosures cited as prior art are not enabled."' In re
Antor Media Corp., 689 F.3d at 1287. Although prior art publications cited
by an Examiner are presumed enabling during prosecution, in this case we
find that Appellants have submitted persuasive evidence that Paula does not
teach a skilled artisan to make an antibody with the claimed sequences. Id.
at 1290 (holding that to be enabling the prior art reference must "teach a
skilled artisan to make or carry out what it discloses in relation to the
claimed invention").
In particular, Appellants have explained in a declaration why it is
"extremely unlikely" for a skilled artisan to generate a monoclonal antibody
that is identical to E2E based on Paula's disclosures. (Ball/Norman Deel. i-fi-1
5, 6, 8, 9.) Neither has the Examiner disputed the variable nature of making
monoclonal antibodies or provided other evidence that disclosures contained
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within the Paula reference itself enables a skilled artisan to generate an
antibody with the claimed sequences. (Ans. 7-8.) Accordingly, we find that
the evidence of record does not support the Examiner's conclusion that
Paula anticipates the claims on appeal.
SUMMARY
For the reasons above, we reverse the Examiner's decision rejecting
claims 16-18, 23, and 24.
REVERSED
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