Ex Parte Aoki et al

Board of Patent Appeals and Interferences

Mar 24, 2010

11293217 (B.P.A.I. Mar. 24, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte TARO AOKI, JUNJI YAMAGUCHI, and YUSUKE SASAKI
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Appeal 2009-009502
Application 11/293,217
Technology Center 1600
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Decided: March 24, 2010
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Before TONI R. SCHEINER, DONALD E. ADAMS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims 7-11, the only
claims pending in this application. We have jurisdiction under 35 U.S.C. §
6(b).

Appeal 2009-009502
Application 11/293,217

STATEMENT OF THE CASE
The claims are directed to a hypertriglyceridemia therapeutic agent.
Claim 7 is illustrative:
7. A hypertriglyceridemia therapeutic agent comprising a
synergistically effective blood-triglyceride decreasing amount of a
combination of a pitavastatin and eicosapentaenoic acid (EPA) or an ester
thereof.

The Examiner relies on the following evidence1:
Fujikawa et al. US 5,856,336 Jan. 5, 1999

N. Nakamura et al., Joint effects of HMG-CoA reductase inhibitors and
eicosapentaenoic acids on serum lipid profile and plasma fatty acid
concentrations in patients with hyperlipidemia, 29 INT J CLIN LAB RES 22-25
(1999).

Appellants rely on the following evidence:
Taro Aoki Declaration, executed June 4, 2007.

The rejection presented by the Examiner follows:
Claims 7-13 stand rejected under 35 U.S.C § 103(a) as unpatentable
over the combination of Nakamura and Fujikawa2.
We reverse.

1 The Examiner withdrew his reliance on Zhu et al., US 2004/0106556 A1,
Jun. 3, 2004 and Horrobin, US 6,331,568 B1, Dec. 18, 2001 (see Supp. Ex.
Ans. 3; see also Supp. Reply Br. 1).
2 The Examiner’s statement of the rejection is set forth in the Examiner’s
Supplemental Answer (Supp. Ans. 3). In addition, since the Examiner relies
on Appellants’ Specification to teach that pitavastatin compounds were
known in the art we find the citation to the Specification to be cumulative to
Fujikawa (see Ans. 4).
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Appeal 2009-009502
Application 11/293,217

ISSUE

Does the evidence of record suggest a composition comprising the
combination of pitavastatin and EPA, and if so, does Appellants’ evidence of
unexpected results overcome the Examiner’s prima facie case of
obviousness?

FINDINGS OF FACT
FF 1. Nakamura studied the effect HMG-CoA reductase inhibitors
(pravastatin or simvastatin) in combination with EPA had on hyperlipidemia
(Nakamura 22: col. 1, ll. 10-13; Ans. 4).
FF 2. Nakamura exemplifies the combined administration of 900 mg or
1,800 mg of EPA ethyl ester with either 5, 10, 15 or 20 mg of pravastatin or
5 mg of simvastatin decreases serum triglyceride concentrations in patients
(Nakamura 23: col. 1, ll. 13-18 and 24: col. 1, ll. 2-8).
FF 3. Nakamura concludes that the “results suggest that the addition of
EPA to HMG-CoA reductase inhibitor therapy may be more effective for the
prevention of coronary heart disease than HMG-CoA reductase inhibitor
therapy alone” (Nakamura 24: col. 2, ll. 13-17).
FF 4. The Examiner finds that Nakamura fails to teach “the claimed
pitavastatin compounds and ‘a synergistically effective blood-triglyceride
decreasing amount’ of . . . a combination” of pitavastatin and EPA (Ans. 4).
FF 5. The Examiner finds that Fujikawa teaches the administration of 0.05
mg to 500 mg of pitavastatin for the treatment of hyperlipoproteinemia or
hyperlipidemia (Ans. 5).
FF 6. Aoki studied the effect of EPA in combination with either
pitavastatin, atorvastatin, simvastatin, or pravastatin on lowering triglyceride
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Appeal 2009-009502
Application 11/293,217

blood levels and concludes that while “all of the combinations of a statin and
EPA exhibited some synergistic effect . . . the combination of Pitavastatin +
EPA exhibited a remarkably strong hyperlipemia therapeutic effect
compared to all other combinations of a statin + EPA” (Aoki Dec. 3: 3-10).
FF 7. In addition, Aoki declares that the therapeutic effect of Pitavastatin +
EPA “was surprising and unexpected [because] . . . the individual compound
triglyceride lowering data, as individually, Atorvastatin was best at
triglyceride lowering, and thus, the combination of Atorvastatin and EPA
would have been expected to produce the lowest triglyceride levels” (Aoki
Dec. 3: 13 - 4: 2).

PRINCIPLES OF LAW
“[T]he [E]xaminer bears the initial burden, on review of the prior art
or on any other ground, of presenting a prima facie case of unpatentability.”
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“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’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). It is proper to “take
account of the inferences and creative steps that a person of ordinary skill in
the art would employ.” Id. at 418. See also id. at 421 (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”). In
sum, the “suggestion test is in actuality quite flexible and not only permits,
but requires, consideration of common knowledge and common sense.”
DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1367 (Fed. Cir. 2006).
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Application 11/293,217

A conclusion of prima facie obviousness, does not end a patentability
determination under 35 U.S.C. § 103. “When prima facie obviousness is
established and evidence is submitted in rebuttal, the decision-maker must
start over.” In re Rinehart, 531 F.2d 1048, 1052 (CCPA 1976); In re
Hedges, 783 F.2d 1038, 1039 (Fed. Cir. 1986) (“If a prima facie case is
made in the first instance, and if the applicant comes forward with
reasonable rebuttal, whether buttressed by experiment, prior art references,
or argument, the entire merits of the matter are to be reweighed”).
“Evidence that a compound is unexpectedly superior in one of a
spectrum of common properties . . . can be enough to rebut a prima facie
case of obviousness.” In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).

ANALYSIS
Nakamura teaches that the combination of a HMG-CoA reductase
inhibitor and EPA may be more effective for the prevention of coronary
heart disease than HMG-CoA reductase inhibitor alone (FF 3). Fujikawa
teaches the HMG-CoA reductase inhibitor pitavastatin (FF 4). Accordingly,
we find no error in the Examiner’s prima facie case of obviousness. This
does not, however, end our analysis. “When prima facie obviousness is
established and evidence is submitted in rebuttal, the decision-maker must
start over.” Rinehart, 531 F.2d at 1052.
On this record, Appellants submit declaratory evidence in support of
the synergistic activity of their specific combination of active agents.
Specifically, Aoki provides evidence that the combination of Pitavastatin +
EPA exhibited a remarkably strong hyperlipemia therapeutic effect
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Appeal 2009-009502
Application 11/293,217

compared to all other combinations of a statin + EPA and that this
therapeutic effect was unexpected and surprising because the individual
compound triglyceride lowering data identified Atorvastatin as the best
triglyceride lowering statin, therefore “the combination of Atorvastatin and
EPA would have been expected to produce the lowest triglyceride levels”
(FF 7).
Accordingly, the declaratory evidence supports Appellants’
contention that “pitavastatin has an effect different from other statins, such
as the pravastatin and simvastatin disclosed by Nakamura” (Supp. Reply Br.
3 (emphasis removed)). “Evidence that a compound is unexpectedly
superior in one of a spectrum of common properties . . . can be enough to
rebut a prima facie case of obviousness.” Chupp, 816 F.2d at 646. The
Examiner failed to rebut Appellants’ showing of unexpected results.

CONCLUSION OF LAW
The evidence of record suggests a composition comprising the
combination of pitavastatin and EPA. However, Appellants’ evidence of
unexpected results overcomes the Examiner’s prima facie case of
obviousness.

REVERSED

cdc
OBLON, SPIVAK, MCCLELLAND MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA VA 22314
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