Ex Parte Jevnikar et al

Patent Trial and Appeal Board

Mar 29, 2016

11815359 (P.T.A.B. Mar. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111815,359 06/23/2008 Anthony Jevnikar
26294 7590 03/31/2016
TAROLLI, SUNDHEIM, COVELL & TUMMINO LLP,
1300EASTNINTH STREET, SUITE 1700
CLEVELAND, OH 44114
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.
SMB-8757 6747
EXAMINER
EWOLDT, GERALD R
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
03/31/2016 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):
rkline@tarolli.com
dkinder@tarolli.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY JEVNIKAR, SHENGWU MA,
WILLIAM MICHAEL AINLEY, DONALD JOSEPH MERLO,
SEAN MICHAEL RUSSELL, and JANNA M. ARMSTRONG1
Appeal2013-006233
Application 11/815,359
Technology Center 1600
Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to a method of treating new onset type- I diabetes in a mammal comprising
administering anti-T cell therapy in conjunction with an autoantigen and a
mucosal adjuvant. The Examiner rejects the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 According to Appellants, the Real Parties in Interest are Plantigen Inc. and
Dow Agrosciences, LLC. (App. Br. 3.)
Appeal2013-006233
Application 11/815,359
STATEMENT OF THE CASE
Claims 1, 11, 13-15, 18, 19, 21-32, 34, 40, 46, 47, and 51-55 are on
appeal, 2 and can be found in the Supplemental Claims Appendix to the
Appeal Brief, submitted Nov. 19, 2012. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. A method for the treatment of new onset Type I diabetes in a
mammal or pre-Type I diabetic mammal, the method
compnsmg:
(a) administering an anti CD3 monoclonal antibody as anti-T
cell therapy to said mammal; and
(b) orally administering a composition comprising an
autoantigen selected from the group consisting of GAD65,
GAD67 and mixtures thereof, and a mucosal adjuvant selected
from the group consisting ofIL-1, lL-2, IL-3, IL-4, IL-5, IL-6,
IL-7, IL-8, IL-9, IL-10, IL-12, IL-13, lL-15, IL-18 and mixtures
thereof,
wherein (b) is provided within a transgenic plant material, and
wherein (a) and (b) are administered concurrently or
sequentially.
Appellants request review of the Examiner's rejection of claims 1, 11,
13-15, 18, 19, 21-32, 34, 40, 46, 47, and 51-55 under 35 U.S.C. § 103(a)
over Brandle3 and Herold4 (App. Br. 19-23).
2 Claims 2-10, 16, 17, 20, 33, 36-39, 41--43, 45, and 48-50 are canceled,
and claims 12, 35, 44, and 56-70 are withdrawn from consideration (App.
Br. 5).
3 Brandle et al., CA 2 427 574 Al, published Nov. 3, 2003.
4 Herold et al., US 2007/0190045 Al, published Aug. 16, 2007.
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Application 11/815,359
As Appellants do not argue the claims separately, we focus our
analysis on claim 1, and claims 11, 13-15, 18, 19, 21-32, 34, 40, 46, 47, and
51-55 stand or fall with that claim. 37 C.F.R. § 41.37 (c)(l)(iv).
The issue is: Does the preponderance of evidence of record support
the Examiner's conclusion that the combination of Brandle and Herold
renders the treatment of new onset type- I diabetes using a combination of an
anti-CD3 antibody, GAD autoantigen, and a mucosal adjuvant obvious?
Findings of Fact
We adopt the Examiner's findings and analysis concerning the scope
and content of the prior art (see Final Act. 2--4; Ans. 3---6). The following
facts are repeated for reference convenience.
FF 1. Brandle teaches the production of proteins of interest for oral
consumption. (Brandle Abstract.) Specifically teaching that
"cytokine and autoantigen may be produced in the same plant or in
different plants." (Id. at 12: 14--15.)
FF2. Brandle teaches combining Il-4 and GAD (glutamic acid
decarboxylase) from the same or different species (see Brandle 11:
27-32). GAD includes GAD65 or GAD67, or fragments thereof (see
id. at 11: 32 to 12:10).
FF3. Brandle teaches feeding animals GAD and IL-4 transgenic plants.
To examine whether the protection from diabetes in
NOD mice fed both GAD and IL-4 transgenic plants may be
associated with the induction of GAD-specific regulatory T
cells, the ability of T cells from treated mice to inhibit the
adoptive transfer of diabetes was tested .... 50% of the mice
receiving a mixture of splenic mononuclear cells from
GAD+IL-4 treated, diabetic mice developed diabetes (IDDM
[insulin-dependent diabetes mellitus]) at the end of 8 weeks
post transfer, while 100% of the mice receiving only diabetic
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Application I 1/8I5,359
splenic cells developed IDDM. These data demonstrate that
regulatory cells are only increased in those mice in which GAD
and IL-4 are used concurrently. These regulatory cells can
prevent the full diabetogenic effect of spleen cells taken from
mice with new onset diabetes. These results also suggest that
oral administration of plant produced GAD with interleukin-4
or other cytokines could possibly induce regulatory T cells in
those not yet having overt diabetes, and in this pre-diabetic
condition, regulatory cells may prevent the full onset of disease
by blocking an activated effector T cell population.
(Id. at 39:I-I8.)
FF4. Herold teaches that T-cell mediated autoimmune diseases, such as
type-I diabetes, can be targeted by the coadminstration of anti-CD3
antibodies and self-antigen (Herold 1: i-f 8, see also 8: i-fi-165-73).
"[E]xamples of antigens that can be coadministered with anti -CD3
for the treatment of diabetes (reestablishing tolerance in TID [type-I
diabetes] patients) include, for example, insulin, proinsulin, GAD65,
ICASI2/ IA-2 and HSP60." (Id. at 8: i-f 69 (emphasis added).)
FF5. Herold exemplifies the coadministration of "[a]nti-CD3 and islet self-
antigens (either proinsulin or GAD[65] self-antigens) ... to NOD
mice with recent-onset TID .... The coadministration of anti-CD3
and proinsulin provided a IOO% protection (n=4), and the
coadministration of anti-CD3 and GAD[65] provided a 75%
protection (n=4)." (Id. at 3: 24; see i-fi-180-85, Example I, and also
Fig. 2.)
Principle of Law
"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, 4I6 (2007).
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Application 11/815,359
Analysis
After considering the evidence and the arguments, we conclude the
evidence favors the Examiner's conclusion of obviousness. Accordingly, we
adopt the Examiner's reasoning (see Final Office Action 2--4), and agree that
the Examiner properly found Appellants' arguments unpersuasive (see
Response to Argument, Ans. 3---6). We provide the following points for
emphasis.
We are not persuaded by Appellants' position that the Examiner's
combination of Brandle and Herold lacks a reasonable expectation of
success (see App. Br. 23). Kubin stated that, "[r]esponding to concerns
about uncertainty in the prior art influencing the purported success of the
claimed combination, this court [in 0 'Farr ell] stated: ' [ o ]bviousness does
not require absolute predictability of success ... all that is required is a
reasonable expectation of success."' In re Kubin, 561F.3d1351, 1360 (Fed.
Cir. 2009) (citing Jn re O'Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988)).
Appellants have not established, with sufficient evidence, that the
combination would have been unreasonable.
We are not persuaded by Appellants' contention "that combination
immunotherapy treatment as ... presently claimed are generally
unpredictable, and neither of the references suggests or implies that a
successful combination of the three claimed reagents, in the manner
claimed." (App. Br. 20.)
[The] case law is clear that obviousness cannot be avoided
simply by a showing of some degree of unpredictability in the
art so long as there was a reasonable probability of success ....
Indeed, a rule of law equating unpredictability to patentability
... would mean that any new salt-including those specifically
listed in the [prior art patent] itself-would be separately
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Application 11/815,359
patentable, simply because the formation and properties of each
salt must be verified through testing. This cannot be the proper
standard since the expectation of success need only be
reasonable, not absolute.
Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007).
We are not persuaded by Appellants' contention "that immunotherapy
is unpredictable and detrimental effects can be devastating to a subject.
Thus, making haphazard combinations is completely undesirable and would
require much experimentation and clinical evaluation" (App. Br. 23). We
agree with the Examiner that this argument is also unsupported by evidence
(see Ans. 5), in particular, unsupported by any evidence of unpredictability
specific to the disclosures of the cited references. "An assertion of what
seems to follow from common experience is just attorney argument and not
the kind of factual evidence that is required to rebut a prima facie case of
obviousness." In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
\Ve are not persuaded by Appellants' contention that the Examiner has
not provided sound scientific reasoning or a sufficient rationale for the
combination as proposed (App. Br. 19). Here the Examiner relies the
rationale as set out in Kerkhoven for concluding that the claims are obvious.
It is prima facie obvious to combine two compositions each of
which is taught by the prior art to be useful for the same
purpose, in order to form a third composition which is to be
used for the very same purpose .... [T]he idea of combining
them flows logically from their having been individually taught
in the prior art.
In re Kerkhoven, 626 F .2d 846, 850 (CCP A 1980)( citations omitted). The
Examiner explains that both Brandle and Herold each teach treating
diabetes, however, each uses a different composition (see Final Act. 3; Ans.
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Application 11/815,359
see also FF1-FF5). We agree with the Examiner's position that given the
teachings in Brandle and Herold with respect to the treatment of new onset
diabetes it would have been obvious to combine the anti-CD3 and GAD
treatment of Herold (FF4 and FF5) with the edible GAD and IL-4 containing
plants of Brandle (FF1-FF3). We agree with the Examiner that it would
have been obvious to apply this combination product using the disclosed
methods to the same patient population as taught by Brandle and Herold (see
Final Act. 3, see also FF1-FF5).
We are not persuaded by Appellants' contention that the Examiner is
relying on impermissible hindsight. (App. Br. 19.)
Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant's
disclosure, such a reconstruction is proper.
In re McLaughlin, 443 F.2d 1392, 1395, (CCPA 1971). Here, Appellants
have not explained what knowledge needed to be gleaned by the Examiner
from the Specification that is not found in either of the references in order to
arrive at the claimed method. Here, the Examiner's rejection has made
specific reference to disclosures and motivations in the prior art cited
references.
We are not persuaded by Appellants' contention that "[t]here is no
teaching with respect to the use of an anti-CD3 monoclonal antibody in"
Brandle (App. Br. 21 ). Appellants err in attacking the references
individually, as the rejection is based on a combination of references. See In
re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The references
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Application 11/815,359
cannot be read in isolation, but for what they teach in combination with the
prior art as a whole. See id.
We are not persuaded by Appellants' contention that it is
impermissible in a 103 analysis "to pick and choose from any one reference
only so much of it as will support a given position" (App. Br. 23). Although
picking and choosing is not permissible in the context of an anticipatory
rejection -the instant rejection is based on the grounds of obviousness. 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). Although both Brandle
and Herold disclose multiple compositions and multiple disease targets, as
explained by the Examiner the list of compositions and disease targets is
small. Specifically, the Examiner finds that Brandle teaches 'just 3 diseases
[that] are specifically recited in the claims, [and] 2 of the 3 being the
diseases of the instant claims" (Final Act. 3).
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1, and Appellants have not
provided sufficient rebuttal evidence or evidence of secondary
considerations that outweighs the evidence supporting the prima facie case.
As Appellants do not argue the claims separately, claims 11, 13-15, 18, 19,
21-32, 34, 40, 46, 47, and 51-55 fall with claim 1. 37 C.F.R. § 41.37
( c )(1 )(iv).
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Application 11/815,359
SUMMARY
We affirm the rejection of claim 1under35 U.S.C. § 103(a) over
Brandle and Herold. Claims 11, 13-15, 18, 19, 21-32, 34, 40, 46, 47, and
51-5 5 fall with claim 1.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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