Ex Parte Lee

Patent Trial and Appeal Board

Apr 10, 2013

10850072 (P.T.A.B. Apr. 10, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte FRANCIS Y.F. LEE
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Appeal 2011-002616
Application 10/850,072
Technology Center 1600
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Before DEMETRA J. MILLS, ERIC GRIMES, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating cancer, which the Examiner rejected for obviousness and
obviousness-type double patenting. In a previous decision, we reversed the
rejection for obviousness but affirmed the double-patenting rejection. This
application returns to us following a remand from the U.S. Court of Appeals
for the Federal Circuit, so that we can consider the effect of Otsuka Pharm.
Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012). In light of that
decision, we reverse the rejection for obviousness-type double patenting.
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STATEMENT OF THE CASE
Claims 121-127 and 141-143 are on appeal. The Examiner rejected
the claims under 35 U.S.C. § 103(a) as obvious based on Danishefsky1 and
Chen,2 or based on Vite3 and Chen. The Examiner also rejected the claims
for obviousness-type double patenting based on the claims of Lee4 in view
of Chen.
In our previous decision, mailed Dec. 16, 2011 (“Decision”), we
reversed the rejections under 35 U.S.C. § 103(a) because, even though the
cited references supported a prima facie case of obviousness (Decision at 4-
5), Appellant had provided evidence of unexpectedly superior results that
was sufficient to outweigh the evidence supporting a conclusion of
obviousness (id. at 8-9).
However, we affirmed the rejection for obviousness-type double
patenting, on the basis that evidence of unexpected results could not be
relied on to overcome that type of rejection (id. at 12). We rested our
conclusion on the following statement in Geneva Pharms., Inc. v.
GlaxoSmithKline PLC, 349 F.3d 1373, 1378 n.1 (Fed. Cir. 2003): “The
distinctions between obviousness under 35 U.S.C. § 103 and nonstatutory
double patenting include: . . . Obviousness requires inquiry into objective
criteria suggesting non-obviousness; nonstatutory double patenting does
not.” (Decision 12.)

1 Danishefsky et al., US 6,867,305 B2, Mar. 15, 2005.
2 Chen et al., US 2002/0147198 A1, Oct. 10, 2002.
3 Vite et al., WO 99/02514, Jan. 21, 1999.
4 Lee, U.S. RE41,393 E, reissued June 22, 2010.
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Subsequent to our decision, the Federal Circuit decided the case of
Otsuka Pharm. Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012); the
Otsuka decision casts doubt on the reading of the case law that we relied on
in the Decision. In Otsuka, the accused infringers asserted that the patented
claims were invalid for obviousness and obviousness-type double patenting.
678 F.3d at 1287. The district court concluded that the defendants had not
shown that the claims were invalid based on either obviousness or
obviousness-type double patenting. Id. at 1289-1290.
The Federal Circuit affirmed those rulings. With regard to
obviousness-type double patenting, the court noted that the “Defendants rely
on Geneva Pharm., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1377 n. 1
(Fed. Cir. 2003), which states in a footnote that ‘[o]bviousness requires
inquiry into a motivation to modify the prior art; nonstatutory double
patenting does not.’” Id. at 1297.
The court held that Geneva was distinguishable, however, because it
“involved nonstatutory double patenting based on anticipation, not
obviousness. . . . For anticipation, of course, motivation in the prior art is
unimportant.” Id. The Otsuka court held that the repetition of Geneva’s
statement in Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989
(Fed. Cir. 2009), was dictum, and that “neither Geneva nor Procter &
Gamble stands for the proposition that, in considering whether one
compound is an obvious variant of another for purposes of nonstatutory
double patenting, analyzing the compound of the prior claim for a reason or
motivation to modify is irrelevant.” 678 F.3d at 1298. The Otsuka court
held that, like an analysis under § 103, “an analysis of nonstatutory
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obviousness-type double patenting . . . entails determining, inter alia,
whether one of ordinary skill in the art would have had reason or motivation
to modify the earlier claimed compound to make the compound of the
asserted claim with a reasonable expectation of success.” Id.
Although the above discussion in Otsuka specifically concerned
Geneva’s statement regarding motivation to combine, the court stated with
regard to secondary considerations that “[b]ecause we agree with the district
court that the prior art would not have provided one of ordinary skill with a
reason or motivation to make aripiprazole from the unsubstituted butoxy
compound, we need not examine Otsuka’s evidence of secondary
considerations of nonobviousness.” Id. at 1299. The clear implication of
this statement, of course, is that if the evidence had provided a reason to
make the claimed compound, the court would have gone on to consider
whether the evidence of secondary considerations showed that the claimed
compound would have been nonobvious as a matter of law.
Based on the Otsuka decision, therefore, we conclude that the
statements in Geneva and Procter & Gamble should not be taken at face
value, and should be understood to apply only to instances where the
rejection for obviousness-type double patenting is based on anticipation;
e.g., a broader claim to a genus being anticipated by an earlier claim to a
species within the genus.
That is not the case here, because the Examiner’s rejection relies on
“the same reasoning as set forth in the 103(a) rejection” (Office action
mailed July 8, 2009, page 3). Thus, under Otsuka, the evidence of
unexpected results should be considered with regard to the obviousness-type
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double patenting rejection. For the reasons thoroughly discussed in the
Decision (pages 5-9), Appellant’s “evidence of unexpected results . . .
outweighs the evidence supporting the prima facie case of obviousness.” Id.
at 10. For the same reason, the evidence of secondary considerations also
outweighs the evidence supporting the obviousness-type double patenting
rejection.
SUMMARY
We reverse the rejection of claims 121-127 and 141-143 for
obviousness-type double patenting. The rejection of claims 121-127 and
141-143 under 35 U.S.C. § 103(a) remains reversed for the reasons
discussed in our decision of Dec. 16, 2011.

REVERSED

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