Ex Parte Podack et al

Board of Patent Appeals and Interferences

Jun 22, 2012

10923373 (B.P.A.I. Jun. 22, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ECKHARD R. PODACK and LEI FANG
__________

Appeal 2011-001847
Application 10/923,373
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a process of
treating asthma. The Examiner entered a rejection for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

STATEMENT OF THE CASE
Claim 1, the only claim pending, stands rejected and appealed (App.
Br. 4), and reads as follows:
Claim 1: A method of treating an animal subject suffering from
asthma characterized by a large number of eosinophils infiltrating the
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subject’s lungs, the method comprising the step of administering to
the animal subject an anti-TL1A antibody in an amount effective to
reduce the number of eosinophils in the lungs of the animal subject.

The sole rejection before us for review is the Examiner’s rejection of
claim 1 under 35 U.S.C. § 103(a) as obvious Yu ‘5341 or Yu ‘1892 combined
with Hubbell3 and Migone4 (Ans. 3-8).
DISCUSSION
The Examiner initially noted that the protein described in the prior art
as “TNF-gamma-beta . . . is the claimed TL1A” (Ans. 3). Appellants did not
dispute this fact.
The Examiner cited Yu ‘534 and Yu ‘189 as describing a process of
administering anti-TNF-gamma-beta antibodies to treat asthma, including
describing dosages, as recited in claim 1 (id. at 4-5). The Examiner noted
that the Yu publications experimentally characterized TNF-gamma-beta in a
number of ways, including its interaction with DR3 and TR6 receptors, as
well as its activity as a T-cell costimulator, and its exacerbation of an in vivo
mixed lymphocyte reaction (id.).
The Examiner found that the Yu publications differed from claim 1
“only by not having a working example of the claimed method and the
recitation of anti-TLIA antibody in claim 1” (id. at 5). The Examiner found,
however, that Hubbell taught that it was known in the art that antibodies

1 U.S. Patent App. Pub. No. 2002/0150534 Al (published October 17, 2002).
2 U.S. Patent App. Pub. No. 2003/0129189 A1 (published July 10, 2003).
3 U.S. Patent No. 5,567,440 (issued October 22, 1996).
4 Thi-Sau Migone et al., TL1A Is a TNF-like Ligand for DR3 and TR6/DcR3
and Functions as a T Cell Costimulator, 16 IMMUNITY 479-492 (March
2002).
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could be used therapeutically by disrupting receptor-ligand interactions (id.).
The Examiner also found that Migone taught, among other properties, that
TL1A was a ligand for the DR3 and TR6 receptors, and also described a
monoclonal antibody against TL1A (id. at 6).
Based on the references’ teachings, the Examiner concluded that an
ordinary artisan would have considered it obvious to “to substitute the anti-
TLIA antibody taught by . . . Migone with anti-DR3 antibody, DR3-Fc or
TR6-Fc taught by [the Yu publications] . . . in a method of treating asthma in
a subject” (id. at 7). The Examiner reasoned that the artisan would have
“had reason to use the anti-TL1A antibody of . . . Migone as a substitute for
the treatment [of] . . . T-cell mediate disease, asthma taught in [the Yu] . . .
publication[s] because, like the compounds taught in . . . [the] publication[s],
anti-TL1A antibodies inhibit[ ] the interaction of DR3 and it[s] ligand,
TL1A” (id. at 6-7).
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

Appellants’ arguments do not persuade us that a preponderance of the
evidence fails to support the Examiner’s conclusion that claim 1 would have
been prima facie obvious to an ordinary artisan.
Claim 1 recites a method of treating asthma characterized by a large
number of eosinophils infiltrating the subject’s lungs. The sole step
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required by the claimed process is administering to the subject an amount of
anti-TL1A antibody effective to reduce the number of eosinophils in the
subject’s lungs.
As the Examiner points out, the Yu publications both disclose treating
the claimed disease, asthma, with antibodies to TNF-gamma-beta (Yu ‘534
[0364]; Yu ‘189 [0376]), a protein that is undisputedly the same protein as
the claimed TL1A. As the Examiner also points out, and Appellants do not
dispute, therapeutic methods in which antibodies were used to disrupt
receptor-ligand interactions were known in the art, as was an antibody to
TNF-gamma-beta/TL1A that blocked interaction of that protein to its
receptor (see Ans. 6-7). Given these teachings, we are not persuaded that
the Examiner failed to make out a prima facie case that it would have been
obvious to treat asthma with an anti-TL1A antibody.
Appellants initially argue that the cited references fail to teach or
suggest treating asthma “in an enabling manner” (App. Br. 8). That
argument is unavailing, however, since, “[u]nder § 103, . . . a reference need
not be enabled; it qualifies as a prior art, regardless, for whatever is
disclosed therein.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d
1313, 1357 (Fed. Cir. 2003). Here, both Yu publications explicitly teach
“treating, preventing or ameliorating allergy or asthma comprising
administering to an animal, preferably a human, in which such treatment,
prevention or amelioration is desired[,] an antibody that specifically binds
TNF-gamma-alpha and/or TNF-gamma-beta” (Yu ‘534 [0364]; Yu [0376]
(language identical)).
Appellants also urge that, despite the Yu publications’ direct teaching
to treat asthma with antibodies to the TNF-gamma-beta/TL1A protein, an
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ordinary artisan would not have had a reasonable expectation of success in
such treatment because none of the cited references provides a working
example of treating asthma in animals, and because “none of the actual
experiments described in the [Yu] publications directly demonstrate a role
for TL1A or its receptor DR3 in asthma” (App. Br. 9). Moreover,
Appellants argue, given the variety of treatable diseases and useful
therapeutic agents described by the Yu publications, and the absence of
administration of any agent to an animal subject, the Yu publications’
disclosure of treating asthma with anti-TNF-gamma-beta/TL1A antibodies
“is clearly mere speculation” (id.; see also id. at 10 (“[W]hether anti-TL1A
antibodies would work to treat asthma in actual animal subjects could in no
way have been predicted from any of the references relied upon by the
examiner for this rejection.”)).
It is well settled, however, that “[o]bviousness does not require
absolute predictability of success. . . . For obviousness under § 103, all that
is required is a reasonable expectation of success.” In re O’Farrell,
853 F.2d 894, 903-04 (Fed. Cir. 1988); accord, In re Kubin, 561 F.3d 1351,
1359-61 (Fed. Cir. 2009).
Here, as the Examiner has pointed out (Ans. 4-5), the Yu publications
provide cell culture experiments elucidating the biological properties of the
TNF-gamma-beta/TL1A protein (see Yu ‘534 [0942]-[0951] (Examples 35-
37)); also Yu ‘189 [1027]-[1039] (Examples 35-37)), and those experiments
led to a conclusion that administering antibodies against that protein to an
animal patient would treat asthma (see Yu ‘534 [0364]; also Yu ‘189
[0376]). Appellants do not advance any clear or specific evidence to support
the premise that, in this art, a reasonable expectation of success in treating
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asthma in animals would not have been premised on the experiments
described by the Yu publications and Migone. That is, Appellants provide
no evidence-based explanation as to why an ordinary artisan would have
found the experimental evidence presented in the cited references to be
insufficient to give an ordinary artisan a reasonable expectation of success of
treating asthma in animals.
Thus, because Appellants have not advanced any clear or specific
evidence showing that an ordinary artisan would have viewed the
experimental evidence in the cited references as being insufficient to support
a reasonable expectation of success in the asthma treatment described in the
Yu publications, we are not persuaded that Appellants have shown that an
ordinary artisan would have failed to follow the Yu publications’ direct
teachings to treat asthma in an animal. It is well settled that argument by
counsel is no substitute for actual evidence. See In re Geisler, 116 F.3d
1465, 1471 (Fed. Cir. 1997).
As to claim 1’s requirement of reducing the number of eosinophils in
the subject’s lungs, we note, as did the Examiner, that the only positive step
required in the claim is administering the antibody which, as discussed
above, the prior art fairly teaches, or at least suggests. While it might be true
that Appellants’ purpose for administering the therapeutic agent is different
than the reason supplied by the prior art, that fact does not demonstrate that
claim 1 would have been unobvious to an ordinary artisan. See KSR Int’l v.
Teleflex Inc., 550 U.S. 398, 419 (2007) (“In determining whether the subject
matter of a patent claim is obvious, neither the particular motivation nor the
avowed purpose of the patentee controls. What matters is the objective
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reach of the claim. If the claim extends to what is obvious, it is invalid
under § 103.”);
Moreover, “[m]ere recognition of latent properties in the prior art does
not render nonobvious an otherwise known invention.” In re Baxter-
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); see also, In re
Woodruff, 919 F.2d 1575, 1577-78 (Fed. Cir. 1990) (obviousness rejection
affirmed where using claimed elements in the manner suggested by the prior
art necessarily resulted in claim-recited effect).
In sum, for the reasons discussed, Appellants’ arguments do not
persuade us that the Examiner erred in maintaining the obviousness rejection
of claim 1 over the Yu publications combined with Hubbell and Migone.
We therefore affirm that rejection.
SUMMARY
We affirm the Examiner’s rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious Yu ‘534 or Yu ‘189 combined with Hubbell and
Migone.

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

clj