Ex Parte Doisaki et al

Board of Patent Appeals and Interferences

Sep 27, 2010

10535413 (B.P.A.I. Sep. 27, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte NOBUSHIGI DOISAKI, TSUYOSHI KORIYAMA,
JUN OKANO, and SHUJI JINNO,
Appellants1
____________________

Appeal 2010-001942
Application 10/535,413
Technology Center 1600
____________________

Before CAROL A. SPIEGEL, DONALD E. ADAMS, and
FRANCISCO C. PRATS, Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL2

1 The real party in interest is NIPPON SUISAN KAISHA, LTD. (Brief on
Appeal filed 8 July 2008 ("App. Br.") at 2 (supplemented 25 July 2008)).
This decision also cites the Examiner's Answer mailed 11 December 2008
("Ans."), the Communication mailed 11 August 2009 ("Communication"),
the Reply Brief for Appellants filed 22 January 2009 ("Reply Br."), and the
Specification ("Spec.") of Application 10/285,810 ("the 810 Application").
2 The two-month period for filing an appeal or commencing a civil action, as
recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited
in 37 C.F.R. § 41.52, begins to run from the "MAIL DATE" (paper delivery
mode) or the "NOTIFICATION DATE" (electronic delivery mode) shown
on the PTOL-90A cover letter attached to this decision.
Appeal 2010-001942
Application 10/535,413

2
Appellants appeal under 35 U.S.C. § 134(a) from an Examiner's final
rejection of claims 1 and 5-20 (App. Br. 2; Ans. 2). Claim 4, the only other
pending claim, is withdrawn from consideration (Advisory Action mailed
June 19, 2008). We have jurisdiction under 35 U.S.C. § 134. We AFFIRM.
I. Statement of the Case
Claim 1 is illustrative of the subject matter on appeal and reads (App.
Br. Claims App'x 2):
1. A composition having oxidative stability comprising:
polyunsaturated fatty acid or its salt or ester,
an antioxidative sesame component which is purified
from sesame or synthesized, and
ascorbic acid or an ascorbyl fatty acid ester.

In response to an election requirement, Appellants elected to prosecute
sesamol as the antioxidative sesame component (Response to Election of
Species Requirement filed May 22, 2007). Therefore, only compositions
comprising sesamol as the antioxidative sesame component are before us.
The Examiner rejected claims 1 and 5-10 as unpatentable under 35
U.S.C. § 103(a) over Kataoka3 and/or Granata4 in view of Chavali I5 and/or

3 US Patent 6,235,331 B1, Modified Fish Oil Type Material Containing
Highly Unsaturated Fatty Acid and/or Esters Thereof and a Composition
Containing Said Material, issued 22 May 2001 to Kataoka et al. ("Kataoka").
4 International Patent Publication WO 02/058793 A1, Essential N-3 Fatty
Acids in Cardiac Insufficiency and Heart Failure Therapy, published 1
August 2002, Granata et al. ("Granata").
5 Chavali et al., Composition Useful for Treating a Disorder Such as Adult
Respiratory Distress Syndrome in a Mammal Comprises Sesamol or Its
Metabolite, Derwent World Patent Index Accession No. 2002-040630
(2002) ("Chavali I").
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Application 10/535,413

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II,6 Maguire,7 Chen I8 and/or II,9 and Wechter10 (Ans. 3-6; Communication
1). The Examiner found that both Kataoka and Granata teach treating
cardiovascular disease with polyunsaturated fatty acids or esters, e.g.,
eicosapentaenoic acid ethyl ester ("EPA") or docosahexaenoic acid ("DHA")
(id. at. 4). The Examiner found that Chavali, Maguire, Chen, and Wechter
teach treating cardiovascular disorders with sesamol, ascorbyl palmitate,
ascorbic acid, and tocopherol, respectively (id. at 4-5). The Examiner
concluded that it would have been obvious to one of ordinary skill in the art
to combine sesamol, ascorbyl palmitate, ascorbic acid, and tocopherol with
the polyunsaturated fatty acid esters of Kataoka and/or Granata to form a
composition for treating cardiovascular disorders in view of Chavali's,
Maguire's, Chen's, and Wechter's teachings that these ingredients are useful
for the same purpose (id. at 5).

6 US Patent Application Publication 2001/0031275 A1, Sesamol Inhibitors of
Delta-5-Desaturase Activity and Uses Thereof, published 18 October 2001,
Forse et al. ("Chavali II").
7 Maguire et al., Preparation of Edible Water-in-Oil Emulsions Containing
Fish Oil and Ascorbyl Palmitate, Derwent World Patent Index Accession No.
1995-054394 (1995) ("Maguire").
8 Chen et al., New Phytosterol and/or Phytostanol and Ascorbic Acid
Containing Derivatives Useful in Treating, e.g., Cardiovascular Disease,
Derwent World Patent Index Accession No. 2003-219905 (2003) ("Chen I").
9 US Patent Application Publication 2002/0156051 A1, Novel Structures
Comprising Phytosterol and/or Phytostanol and Ascorbic Acid and Use
Thereof in Treating Cardiovascular Disease, Its Underlying Conditions and
Other Disorders, published 24 October 2002, Kutney et al. ("Chen II").
10 US Patent 6,242,479 B1, Use of γ-Tocopherol and Its Oxidative Metabolite
LLU-α in the Treatment of Disease, issued 5 June 2001 to William J.
Wechter ("Wechter").
Appeal 2010-001942
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The Examiner also relied on Tallarida11 as rebuttal evidence.
Appellants argue that sesamol and ascorbic acid/ascorbyl fatty acid
esters are added to the composition of Kataoka or Granata for a different
purpose, i.e., to form a third composition with dramatically improved
oxidative stability (App. Br. 5). Appellants further argue that the synergistic
effect shown by the examples in the Specification, and illustrated in Figures
1, 5, 10-12, and 14, are effective to rebut any prima facie case of
obviousness (id. at 6-8; Reply Br. 4-6).
Appellants have not separately argued the patentability of dependent
claims 5-20 (App. Br. 9). Therefore, we decide this appeal on the basis of
claim 1. 37 C.F.R. § 41.37(c)(1)(vii). At issue is whether it would have
been prima facie obvious to combine a polyunsaturated fatty acid or its salt
or ester with sesamol and ascorbic acid or an ascorbyl fatty acid ester to
form a composition based upon the combined disclosures of the applied
prior art; and, if so, whether Appellants have provided evidence that, when
weighed with the evidence of obviousness, is sufficient to overcome the
prima facie conclusion of obviousness.
II. Findings of Fact
The following findings of fact ("FF") are supported by a
preponderance of the evidence of record.
[1] Katakoa teaches that highly unsaturated fatty acids and esters thereof,
such as EPA, contained in fish oil are known to be effective in the
prevention and treatment of cardiac infarction and arteriosclerosis
(Katakoa 1:23-30).

11 R. Tallarida, DRUG SYNERGISM AND DOSE-EFFECT DATA ANALYSIS,
Chapman & Hall/CRC publishers, Boca Raton (2000), pp. 8-10 ("Tallarida").
Appeal 2010-001942
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[2] Granata teaches using a composition containing a mixture of EPA and
DHA for the prevention and treatment of heart disease, specifically,
cardiac insufficiency and/or heart failure (Granata abstract; 3:19-23).
[3] Chavali teaches that a composition comprising sesamol is useful for
treating disorders including cardiovascular disease (Chavali I 1-2;
Chavali II ¶ 35, claim 29).
[4] Maguire teaches preparing an edible water-in-oil emulsion comprising
fish oil containing ascorbyl palmitate for protection against heart
disease (Maguire 1-2).
[5] Chen teaches chemical structures comprising (a) phytosterol or
phytostanol and (b) ascorbic acid useful in the treatment or
preventionof cardiovascular disease (Chen I, 1-2; Chen II 3, ¶¶ 12-15).
[6] Wechter teaches using γ-tocopherol and derivatives thereof to treat
and prevent cardiovascular disease (Wechter abstract; 2:27-34).
[7] Figure 1 of the 413 Application illustrates the amount of oxygen
absorbed by samples of (a) refined fish oil containing 0.5 %12 δ-
tocopherol ("refined fish oil"), (b) refined fish oil plus 1.0% sesamol
and 0.01% ascorbyl palmitate, (c) refined fish oil plus 1.0% sesamol,
and (d) refined fish oil plus 0.01% ascorbyl palmitate after storage at
60oC for two days (Spec. 25:1-22). Figure 1 is reproduced below.

12 Percentages are given as weight %.
Appeal 2010-001942
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{Figure 1 of the 413 Application shows the amounts
of oxygen absorbed by oil in Example 1.}

[8] Figure 5 of the 413 Application illustrates the amount of oxygen
absorbed by samples of (a) refined fish oil, (b) refined fish oil plus
2.0% sesame oil extract and 0.1 % ascorbyl palmitate, (c) refined fish
oil plus 0.1% ascorbyl palmitate, and (d) refined fish oil plus 2.0%
sesame oil extract after storage at 60oC for 4 days (Spec. 27:16-28:16).
Figure 5 is reproduced below.

{Figure 5 of the 413 Application shows the amounts
of oxygen absorbed by oil in Example 5.}

[9] In Example 11 of the 413 Application, preparations of (i) 0.5%
sesamol and 0.1% ascorbyl palmitate or (ii) 1.0% sesamol and 0.1%
ascorbyl palmitate were added to refined fish oil to provide test
samples that were sealed and stored at 60oC. The concentration of
oxygen in the samples as well as the concentrations of sesamol,
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ascorbyl palmitate, and δ-tocopherol were measured over time (Spec.
33:21-34:17.) Figures 10 and 11 show the results from samples made
with preparations (i) and (ii), respectively, and are reproduced below.

{Figures 10 and 11 of the 413 Application shows changes in the
amount of oxygen absorbed by sample over time,
and the remaining amounts of antioxidants.}

[10] Figure 12 of 413 Application shows the effect of adding 0.1%
ascorbyl palmitate to the same system as in Figure 11 on day four.
Figure 12 is reproduced below.

{Figure 12 of the 413 Application shows the effect of adding
ascorbyl palmitate to the system of Figure 11 on day 4.}
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III. Discussion
A. Legal principles
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and, (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
"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). Indeed, "[i]t 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." In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Also, it is well settled that it is
not necessary for a finding of obviousness that all the advantages of a
claimed invention are recognized by the prior art, and it is not necessary for
such finding that the motivation of one of ordinary skill in the art be the
same as the applicant's motivation. See In re Kemps, 97 F.3d 1427, 1430
(Fed. Cir. 1996); In re Dillon, 919 F.2d 688, 693 (Fed. Cir. 1990).
The burden of demonstrating unexpected results rests on the party
asserting them, and "it is not enough to show that results are obtained which
differ from those obtained in the prior art: that difference must be shown to
be an unexpected difference." In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972). Moreover, a showing of unexpected results must be commensurate in
scope with the breadth of the claims. In re Grasselli, 713 F.2d 731, 743
(Fed. Cir. 1983).
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Application 10/535,413

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B. Analysis
"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."
Kerkhoven, 626 F.2d at 850. Therefore, we agree with the Examiner that it
would have been prima facie obvious to combine sesamol and ascorbyl
palmitate/ascorbic acid with a polyunsaturated fatty acid/ester to obtain a
composition useful for treating cardiovascular disorders since all three of
these agents are taught or suggested to be useful for treating cardiovascular
disorders by Katakoa (FF1 (polyunsaturated fatty acid/ester)), Granata (FF 2
(polyunsaturated fatty acid/ester)), Chavali (FF 3 (sesamol)), Maguire (FF 4
(ascorbyl palmitate)), and Chen (FF 5 (ascorbic acid)). It is not necessary
that the motivation of one of ordinary skill in the art to make the
combination be the same as Appellants' motivation. Dillon, 919 F.2d at 693.
Nor is it necessary that all of the advantages of the claimed composition, e.g.,
improved stability, are recognized by the prior art. Kemps, 97 F.3d at 1430.
The question then becomes whether Appellants have provided evidence
sufficient to overcome the prima facie conclusion of obviousness in this case.
We think not.
A showing of unexpected results must be commensurate in scope with
the breadth of the claims. Grasselli, 713 F.2d at 743. Here, Appellants
argue that the claimed composition has dramatically improved oxidative
stability. However, claim 1 does not require any particular improvement in
stability, e.g., in terms of degree, duration, storage conditions, etc. Similarly,
the composition of claim 1 is not limited to any particular concentration,
ratio, etc. of its components. For example, claim 1 encompasses the
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Application 10/535,413

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compositions existing at day 4 in Figures 10-12 of the 413 Application (see
FF 9-10). Therefore, we agree with the Examiner that Appellants' showing
of unexpected results is not commensurate in scope with the claimed
invention.
Furthermore, it is not enough show that the results are different when
sesamol and ascorbyl palmitate are used together, as opposed to separately.
Appellants must show that the results are unexpectedly different. Klosak,
455 F.2d at 1080. Here, Appellants have merely demonstrated a difference
and, therefore, have not met their burden of persuasion. In this regard, we
note that Appellants' own Background Section states that "[i]n order to
enhance the oxidative stability of oils and fats, various types of antioxidants
have been used … in combination, or a synergist, such as … ascorbic acid, is
added to the antioxidant to enhance the antioxidant properties" (Spec. 3:24-
4:4).
C. Conclusion
We sustain the rejection of claims 1 and 5-20 under § 103 over
Kataoka and/or Granata in view of Chavali I and/or II, Maguire, Chen I
and/or II, and Wechter. It would have been prima facie obvious to combine
a polyunsaturated fatty acid or its salt or ester with sesamol and ascorbic
acid or an ascorbyl fatty acid ester to form a composition based upon the
combined disclosures of the applied prior art; and, Appellants have not
provided evidence that, when weighed with the evidence of obviousness, is
sufficient to overcome the prima facie conclusion of obviousness.
IV. Order
Upon consideration of the record, and for the reasons given, it is
Appeal 2010-001942
Application 10/535,413

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ORDERED that the decision of the Examiner to reject claims 1 and 5-
20 as unpatentable under 35 U.S.C. § 103(a) over Kataoka and/or Granata in
view of Chavali I/II, Maguire, Chen I/II, and Wechter is AFFIRMED; and,
FURTHER ORDERED that no time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

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