Ex Parte Gorlach

Patent Trial and Appeal Board

Sep 1, 2016

13253366 (P.T.A.B. Sep. 1, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/253,366 10/05/2011 Jorn Gorlach
26259 7590 09/06/2016
LICATA & TYRRELL P.C.
66 E. MAIN STREET
MARLTON, NJ 08053
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.
ALA0005US.Cl 9196
EXAMINER
BRISTOL, LYNN ANNE
ART UNIT PAPER NUMBER
1643
NOTIFICATION DATE DELIVERY MODE
09/06/2016 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):
PTOactions@licataandtyrrell.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JORN GORLACH
Appeal2015-000643
Application 13/253,3661
Technology Center 1600
Before ERIC B. GRIMES, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving a
claim directed to a method for producing a plurality of isolated antibodies
for profiling antigen expression. Claim 5 is on appeal as rejected under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 The Real Party in Interest is Montecito Bio-Sciences, Ltd. App. Br. 1.
Appeal2015-000643
Application 13/253,366
STATEMENT OF THE CASE
The Specification states that the invention meets the "need in the art
for a high-throughput approach [for] producing antibodies with a high
affinity and [that] are antigen-specific" where the "antibodies [are] rapidly
produced with minimal or no selection to eliminate the time-consuming
processes of panning or screening." Spec. i-f 6. The Specification also states
that a first exposure to an antigen results in production of IgM
immunoglobulins and that "subsequent exposure provides a selection
process among B-cells whereby a genetic rearrangement occurs within the
antibody gene of the corresponding B-cell," which results in "a higher
binding affinity antibody of a non-IgM class of immunoglobulin such as
IgG, IgA, or IgE." Spec. i-f 4. Further, the Specification explains, "[t]his in
vivo response is critical for obtaining high quality antibodies with a high
binding affinity and has yet to be routinely replicated in vitro." Id.
The Specification describes a method of making an array of
antibodies. See, e.g., Spec. i-fi-1 7, 11, 16. The arrays are disclosed as suitable
for, inter alia, profiling antigens derived from patient tissue samples. Spec.
,-r 53.
The appealed claim can be found in the Claims Appendix of the
Appeal Brief and reads as follows:
5. A method for producing a plurality of isolated antibodies for
profiling antigen expression comprising
(a) binding, in vitro, an isolated plurality of antibody-producing
B-cells to an isolated plurality of cognate antigens from a
mammal;
(b) isolating each cognate antigen-bound antibody-producing B-
cell;
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Appeal2015-000643
Application 13/253,366
( c) amplifying each nucleic acid sequence encoding each
antibody, or fragment thereof, from each B-cell;
( d) introducing each amplified nucleic acid sequence encoding
each antibody, or fragment thereof, into an expression system;
( e) expressing and purifying each antibody, or fragment thereof;
and
(f) preparing an array consisting of each purified antibody, or
fragment thereof, from step ( e) on a substrate for profiling
antigen expression.
App. Br. 12 (Claims App'x).
DISCUSSION
The Examiner rejected claim 5 under 35 U.S.C. § 103(a) over
Wagner.2 Final Action 4. The Examiner determined Wagner disclosed an
array of protein-capture agents, arranged in a plurality of patches across a
substrate, where the protein-capture agents can be a variety of antibodies (or
fragments). Final Action 4--5. The Examiner determined that Wagner
disclosed the antibodies can be expressed from recombinant DNA in vivo or
in vitro. Final Action 5. The Examiner determined "Wagner teaches using a
cell and its expression product and the cognate ligand in order to screen and
select the partners in the pairing using an array format to screen the pairs."
Final Action 6.
Appellant contends the Examiner did not establish that Wagner taught
or suggested all the limitations of claim 5. App. Br. 7. Specifically,
Appellant argues the Examiner did not identify where or how Wagner
2 U.S. Patent No. US 6,365,418 Bl to Wagner et al. (issued Apr. 2. 2002)
(hereinafter "Wagner").
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Appeal2015-000643
Application 13/253,366
disclosed "binding and isolating cognate antigen-bound antibody-producing
B cells; [and] amplifying and expressing nucleic acids encoding each
antibody or antibody fragment from the B-cells," as these steps are recited
by claim 5. Id. Appellant's argument is persuasive.
A proper § 103 analysis requires "a searching comparison of the
claimed invention-including all its limitations-with the teachings of the
prior art." In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995). Here, the
Examiner did not explain where the first 3 steps of claim 5 are disclosed in
or suggested by Wagner.
The Examiner's rejection focuses on the results of the claimed
process, not the recited steps of the method claim, which are the limitations
of the method-invention. The Examiner responds to Appellant's arguments
by urging that steps "a" and "b" recited by claim 5 are to the product
produced and are, thus, product-by-process limitations (Ans. 11 ), but this is
not so---these limitations are composed as steps in a method.
Wagner presents no discussion of combining B-cells with antigens,
then isolating B-cells, and then amplifying the antibodies. Appellant argues
(App. Br. 7-8) portions of Wagner directed to using lymphoid cells for
expression and cloning to produce antibodies or fragments for an array (e.g.,
col. 25, 11. 42--45) do not teach or suggest binding B-cells with cognate
antigens, isolating those bound pairs, and deriving nucleic acid sequences
from the cells for amplification, per claim 5. Appellant's argument is
persuasive and the Examiner has offered no persuasive evidence to the
contrary.
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Appeal2015-000643
Application 13/253,366
For the reasons presented above, we find the preponderance of the
evidence of record does not support the Examiner's determination that the
claim would have been obvious over Wagner. Therefore, we reverse.
SUMMARY
The rejection of claim 5 under 35 U.S.C. § 103(a) over Wagner is
reversed.
REVERSED
5