Ex Parte Hase et al

Board of Patent Appeals and Interferences

Nov 24, 2008

10131188 (B.P.A.I. Nov. 24, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte TADASHI HASE, TAKATOSHI MURASE, HIROYUKI
WATANABE, and HIDEHIKO KONDO
____________

Appeal 2008-3944
Application 10/131,188
Technology Center 1600
____________

Decided: November 24, 2008
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 321-42, the only
claims pending in this application. We have jurisdiction under 35 U.S.C.
§ 6(b).

1 While the Examiner has included claim 31 in the grounds of rejection we
note that claim 31 was canceled in Appellants December 12, 2004
Amendment and Request for Reconsideration (see also App. Br. 2 (“Claims
1-31 have been canceled”)).
Appeal 2008-3944
Application 10/131,188

STATEMENT OF THE CASE
The claims are directed to a method for promoting the burning of
dietary lipids. Claim 32 is illustrative:
32. A method for promoting the burning of dietary lipids, which
comprises:
a) consuming a triglyceride intended to be metabolized;
b) in advance of consuming said triglyceride, consuming a fat/oil
composition to effect accumulation of fatty acids in the small intestine,
wherein said fat/oil composition comprises 80-95 wt% of diglyceride having
55 to 90 wt.% of 1,3 diglyceride and less than 10 wt % of free fatty acid.

The Examiner relies on the following prior art references to show
unpatentability:
Koike et al. US 6,844,021 B2 Jan. 18, 2005
Masui et al. WO 01/13733 A1 Mar. 1, 2001
Katsuragi et al. JP 2001-064169 Mar. 13, 2001
(PTO Translation 07-4753)2

The rejections as presented by the Examiner are as follows:
1. Claims 32-42 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 19 and
20 of Koike.

2 We recognize the differences between e.g., the title and name of the
reference Appellants refer to as Katsuragi and the Examiner’s translation of
this document. However, Appellants do not dispute that the Examiner’s
translation is not an accurate translation of the Katsuragi reference.
Accordingly, we refer to the Examiner’s translation as Katsuragi.
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2. Claims 32-42 stand rejected under 35 U.S.C § 103(a) as unpatentable
over the combination of Katsuragi and Masui.
We affirm.

Claim Interpretation:
Claim 32 is drawn to a method for promoting the burning of dietary
lipids. The claimed method comprises two steps:
Step 1) (referred to as step “b)” in the claim) consume a fat or oil
composition that comprises
1. 80-95 wt.% diglyceride, wherein 55-90 wt.% of the
digylceride is 1,3 diglyceride, and

2. less than 10 wt.% free fatty acid.
Step 2) after step (1) (referred to as step “a)” in the claim) consume “a
triglyceride intended to be metabolized”.
Appellants’ Specification provides no definition for the phrase
“intended to be metabolized.” Accordingly, we interpret this phrase to read
on any triglyceride that is consumed e.g., with a meal.
According to claim 32 the fat or oil composition effects the
accumulation of fatty acids in the small intestine.

Obviousness-type Double Patenting:
ISSUE
The Examiner finds that claims 19 and 20 of Koike are “directed to a
method of administering to a subject a[n] oil or fat composition comprising
5-100% of monoglycolceride and/or diglyceride, phytosterol, and
antioxidants” (Ans. 3). The Examiner concedes that claims 19 and 20 of
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Koike do not teach the administration of a triglyceride after the
administration of the oil or fat composition (Ans. 4-5). Nevertheless, the
Examiner finds that since a triglyceride is a common food ingredient one
“would inevitably take triglycerides . . . later with his (or her) next meal”
(Ans. 8).
Appellants contend that claims 19 and 20 of Koike do not recite a step
of consuming a triglyceride and that “[t]he examiner has failed to establish
that the claimed step of consuming a triglyceride intended to be metabolized
followed [by] the consumption of diglyceride [is] in the prior art” (App. Br.
7).
Did the Examiner err in finding that a triglyceride would be present,
as a common food ingredient, in a meal ingested by a person after taking
Koike’s composition?

FINDINGS OF FACT
1. Koike’s claim 1 is directed to
An oil or fact composition comprising 5-100 wt. % of a
monoglyceride and/or a diglyceride and at least one anti-
oxidant selected from the group consisting of vitamin A,
vitamin C, vitamin E, polyphenols and a mixture thereof and
which exhibits an index of stability against oxidation (induction
time as measured through a Rancimat test conducted at 100 ºC.)
of 7 or higher, wherein said monoglyceride and/or the
diglyceride contains, as fatty acid constituents, ω3 unsaturated
fatty acids in amounts of 15-90 wt. %.

(Koike, col. 13, ll. 17-26.)
2. Koike’s claim 2 is directed to
The oil or fat composition according to claim 1, wherein said
fatty acid constituents are comprised of cis-ω3 unsaturated fatty
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acids, cis-ω6 unsaturated fatty acids, saturated fatty acids and
trans-unsaturated fatty acids in a weight ratio of cis-ω3
unsaturated fatty acids/(cis-ω6 unsaturated fatty acids+saturated
fatty acids+trans-unsaturated fatty acids of 1-6, based on the
fatty acid constituents of said monoglyceride and/or
diglyceride.

(Koike, col. 13, ll. 27-34.)
3. Koike’s claim 3 is directed to “[t]he oil or fat composition according
to claim 1, which further comprises a phytosterol in an amount of 0.05 wt. %
or more” (Koike, col. 13, ll. 35-37).
4. Koike’s claim 19 is directed to “[a] method for reducing or preventing
accumulation of visceral fat, which comprises ingesting the oil or fat
composition of any of claim[s] 1, 2 or 3” (Koike, col. 14, ll. 41-43).
5. Koike’s claim 20 is directed to “[a] method for preventing or treating
obesity, which comprises ingesting the oil or fat composition of any one of
claim[s] 1, 2 or 3” (Koike, col. 14, ll. 44-46).
6. Appellants disclose
In general, lipids (triglycerides) ingested as a meal are degraded
by lipase into fatty acids and 2-monoglyceride in the small
intestine, and subsequently, most of the fatty acids and 2-
monoglycerides are usually resynthesized into the triglycerides
in the small intestine epithelium, followed by a move into
blood. A portion of the fatty acids so formed, on the other hand,
is subjected to catabolism in the small intestine epithelium and
is converted into energy.

(Spec. 2: 16-23.)

7. Appellants disclose
Ingestion of diglycerides results in the accumulation of fatty
acids in the small intestine. The fatty acids so accumulated
promote induction of a β-oxidation enzyme to activate lipid
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catabolism at the small intestine, so that energy consumption is
promoted and the fatty acids are hardly resynthesized into
triglycerides. Further, ingestion of diglycerides over an
extended time promotes burning of not only the diglycerides
but also triglycerides ingested through other meals, and
therefore, accumulation of body fat is suppressed.

(Spec. 7: 10-18 (emphasis added).)

PRINCIPLES OF LAW
The analyses for obviousness under 35 U.S.C. § 103 and obviousness-
type double patenting are not identical; for one thing, “[t]he objects of
comparison are very different: Obviousness compares claimed subject
matter to the prior art; nonstatutory double patenting compares claims in an
earlier patent to claims in a later patent or application.” Geneva Pharms.,
Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1378 n.1 (Fed. Cir. 2003).
The purpose of an obviousness-type double patenting rejection is “to prevent
an unjustified extension of the term of the right to exclude granted by a
patent by allowing a second patent claiming an obvious variant of the same
invention to issue to the same owner later.” In re Berg, 140 F.3d 1428, 1431
Fed. Cir. 1998).
It is proper to “take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex
Inc., 127 S.Ct. 1727, 1741 (2007). See also id. at 1742 (“A person of
ordinary skill is also a person of ordinary creativity, not an automaton.”).
TThe “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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It is well settled that argument by counsel cannot take the place of
evidence. In re Cole, 326 F.2d 769, 773 (CCPA 1964); In re Geisler, 116
F.3d 1465, 1471 (Fed. Cir. 1997).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii)
(“Any arguments or authorities not included in the brief or a reply brief . . .
will be refused consideration by the Board, unless good cause is shown.”).

ANALYSIS
The claims have not been argued separately and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(vii). Therefore, we limit our discussion to
representative claim 32.
Appellants do not dispute that Koike claims a method wherein an
individual consumes a fat/oil composition, wherein the fat/oil composition
comprises 80-95 wt.% of diglyceride having 55 to 90 wt.% of 1,3
diglyceride and less than 10 wt. % of free fatty acid (see FF 1-5).
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii).
Instead, Appellants dispute the Examiner’s finding that a triglyceride
is a common food ingredient one would inevitably ingest with a subsequent
meal (Reply Br. 1). However, Appellants themselves appreciate that
triglycerides are ingested with meals (FF 6 and 7). Accordingly, we are not
persuaded by Appellants’ contention regarding the Examiner’s burden to
provide evidence well known to those of ordinary skill in the art (Reply Br.
2). It is proper to “take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” KSR, 127 S.Ct. at 1741.
See also id. at 1742 (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”).
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As to Appellants contention that “[t]he prior art relied upon by the
examiner must be either explicit in its teaching or inherent in its disclosure”
(Reply Br. 2), we note that the “suggestion test is in actuality quite flexible
and not only permits, but requires, consideration of common knowledge and
common sense.” DyStar, 464 F.3d at 1367.
We recognize Appellants’ contentions regarding the “growing obesity
problem,” however, there is no evidence on this record to support
Appellant’s assertions (Reply Br. 2). It is well settled that argument by
counsel cannot take the place of evidence. In re Cole, 326 F.2d at 773; In re
Geisler, 116 F.3d at 1471. Therefore, we find no error in the Examiner’s
finding that an individual’s consumption of a triglyceride with a meal after
ingesting Koike’s composition would be the consumption of a triglyceride
intended to be metabolized (Ans. 8; Cf. FF 7). There is no persuasive
evidence on this record to support a contrary conclusion.

CONCLUSION OF LAW
The preponderance of the evidence on this record supports the
Examiner’s conclusion that a triglyceride would be present, as a common
food ingredient, in a meal ingested by a person after taking Koike’s
composition.
Accordingly, we affirm the rejection of claim 32 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 19 and 20 of Koike. Claims 33-42 fall together with claim 32.

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Obviousness:
ISSUE
The Examiner finds that Katsuragi teaches a composition for
lowering plasminogen activator inhibitor, wherein 70% or more of the
composition comprises diacylglycerol as the active ingredient (Ans. 4).
While the Examiner recognizes that Katsuragi fails to teach 1,3-diglyceride,
the Examiner finds that Katsuragi encompasses 1,3-diaglyceride because
“diglyceride [is] present only in to [sic] forms, 1,2-diglyceride, and 1,3-
diglyceride” (Ans. 5). The Examiner finds that Masui teach fat or oil
compositions comprising a diglyceride (preferably a 1,3-diacylglycerol) for
reducing arteriosclerotic factors in blood by reducing plasminogen activator
inhibitor.
Based on these findings, the Examiner concludes that a person of
ordinary skill in the art would combine the teachings of Katsuragi and Masui
to achieve “the most effective product for reducing PAI-1, thereby
effectively protecting one from arteriosclerosis” (Ans. 5). While the
Examiner recognizes that the “specific percentage of 1,3-diglyceride is not
taught” the Examiner finds that the discovery of the optimal working range
would involve only routine skill in the art (Ans. 5-6).
Appellants contend that Katsuragi “fails to disclose or suggest a
method for promoting metabolism of dietary lipids in which a diglyceride
composition is consumed in advance of consuming a triglyceride intended to
be metabolized” (App. Br. 4). According to Appellants, Masaui “fails to
cure the basic deficiencies of the primary reference” (App. Br. 6).
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Did the Examiner err in finding that a triglyceride would be present,
as a common food ingredient, in a meal ingested by a person after taking a
composition taught by the combination of Katsuragi and Masui?

FINDINGS OF FACT
8. Katsuragi teaches that if the activity of plasminogen activator
inhibitor type 1 (PAI-1) is accelerated, production of plasmin is suppressed
so that a thrombus is easily formed. Therefore, Katsuragi teach that “the
development of a PAI-1 repressor as an agent for preventing the formation
of the thrombus is in demand” (Katsuragi 2-3: ¶ 0002).
9. Katsuragi teaches a “PAI-1 repressor having a diacylglycerol as an
active ingredient” (Katsuragi 3: ¶ 0004).
10. Katsuragi teaches an oil and fat composition wherein the
diacylglycerol is “especially preferably 80% or more” (Katsuragi 5: ¶ 0007).
11. Katsuragi fails to teach 1,3-diglyceride (Ans. 5).
12. Masui teaches a fat or oil composition which comprises at least 35
wt.% of a diacylglycerol, “with at least 80% being particularly preferred”
(Masui, Abstract and 4: 16-17).
13. Masui teaches a PAI-1-activity lowering agent that comprises a
diacylglycerol (Masui 3: 14-15).
14. Masui teaches that a particularly preferred diacylglycerol is 1,3-
diacylglycerol (Masui 5: 21-24).

PRINCIPLES OF LAW
In proceedings before the Patent and Trademark Office, the Examiner
bears the burden of establishing a prima facie case of obviousness based
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upon the prior art. On appeal to this Board, Appellants must show that the
Examiner has not sustained the required burden.3
“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., 127 S. Ct. 1727, 1740 (2007).
When there is a design need or market pressure to solve a
problem and there are a finite number of identified, predictable
solutions, a person of ordinary skill has good reason to pursue
the known options within his or her technical grasp. If this
leads to the anticipated success, it is likely the product not of
innovation but of ordinary skill and common sense. In that
instance the fact that a combination was obvious to try might
show that is was obvious under § 103.

Id. at 1742. It is proper to “take account of the inferences and creative steps
that a person of ordinary skill in the art would employ.” KSR, 127 S.Ct. at
1741. See also id. at 1742 (“A person of ordinary skill is also a person of
ordinary creativity, not an automaton.”). “In determining whether
obviousness is established by combining the teachings of the prior art, ‘the
test is what the combined teachings of the references would have suggested
to those of ordinary skill in the art.’ ” In re GPAC Inc., 57 F.3d 1573, 1581
(Fed. Cir. 1995) (internal quotations omitted).

3 See (1) Ex parte Yamaguchi, Appeal 2007-4412, slip op. at 5 and 23 (Bd.
Pat. App. & Int. Aug. 29, 2008); (2) Ex parte Fu, Appeal 2008-0601, slip op.
at 5 and 20 (Bd. Pat. App. & Int. Mr. 31, 2008); (3) Ex parte Catan, Appeal
2007-0820, slip op. at 3 and 21 (Bd. Pat. App. & Int. Jul. 3, 2007) and (4) Ex
parte Smith, Appeal 2007-1925, slip op. at 4, 9 and 23 (Bd. Pat. App. & Int.
Jun. 25, 2007). Opinions in support of the decisions in these four appeals
are (a) precedential opinions of the Board and (b) available on the USPTO
website.
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The law is replete with cases in which the difference between the
claimed invention and the prior art is some range or other variable within the
claims. See, e.g., Gardner v. TEC Sys., Inc., 725 F.2d 1338, 220 USPQ 777
(Fed. Cir.), cert. denied, 469 U.S. 830 [ 225 USPQ 232 ] (1984); In re
Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980); In re Ornitz, 351 F.2d
1013, 147 USPQ 283 (CCPA 1965); In re Aller, 220 F.2d 454, 105 USPQ
233 (CCPA 1955). These cases have consistently held that in such a
situation, the applicant must show that the particular range is critical,
generally by showing that the claimed range achieves unexpected results
relative to the prior art range. In re Woodruff, 919 F.2d 1575, 1578 (Fed.
Cir. 1990). In re Geisler, 116 F.3d 1465, 1470, (Fed. Cir. 1997) (“‘[I]t is not
inventive to discover the optimum or workable ranges by routine
experimentation.’”) (quoting In re Aller, 220 F.2d 454, 456 (CCPA 1955)).
It is a general rule that merely discovering and claiming a
new benefit of an old process cannot render the process again
patentable. Verdegaal Bros., Inc. v. Union Oil Co. of Calif., 814
F.2d 628, 632-33 (Fed. Cir.), cert. denied, 484 U.S. 827 (1987);
Bird Provision Co. v. Owens Country Sausage, Inc., 568 F.2d
369, 375 (5th Cir. 1978).

In re Woodruff, 919 F.2d at 1578.

ANALYSIS
The claims have not been argued separately and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(vii). Therefore, we limit our discussion to
representative claim 32.
Appellants do not dispute that the combination of Katsuragi and
Masui teach a method wherein an individual consumes a fat/oil composition,
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wherein the fat/oil composition comprises 80-95 wt.% of diglyceride having
55 to 90 wt.% of 1,3 diglyceride and less than 10 wt. % of free fatty acid
(see FF 8-14). Arguments not made are waived. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Instead, Appellants dispute the Examiner’s finding that a triglyceride
is a common food ingredient one would inevitably ingest with a subsequent
meal (App. Br. 4 and 6). However, Appellants themselves appreciate that
triglycerides are ingested with meals (FF 6 and 7). Accordingly, we are not
persuaded by Appellants’ contention regarding the Examiner’s burden to
provide evidence well known to those of ordinary skill in the art (App. Br.
6). It is proper to “take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.” KSR, 127 S.Ct. at 1741.
See also id. at 1742 (“A person of ordinary skill is also a person of ordinary
creativity, not an automaton.”).
While Appellants content that neither Katsuragi nor Masaui teach the
“consumption of a triglyceride intended to be metabolized” (App. Br. 4 and
6), Appellants’ Specification offers no definition of the phrase “intended to
be metabolized”. Accordingly, as set forth above, we interpret this phrase to
read on any triglyceride that is consumed.
There is no evidence on this record to suggest that the method of
lowering or repressing the activity of PAI-1 taught by the combination of
Katsuragi and Masaui would not also promote the burning of dietary lipids
consumed in a meal following the consumption of the composition taught by
the combination of Katsuragi and Masaui. In re Woodruff, 919 F.2d at 1578.
Therefore, we find no error in the Examiner’s finding that an
individual’s consumption of a triglyceride with a meal after ingesting
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Koike’s composition would be the consumption of a triglyceride intended to
be metabolized (Ans. 6-7; Cf. FF 7). There is no persuasive evidence on this
record to support a contrary conclusion.

CONCLUSION OF LAW
The preponderance of the evidence on this record supports the
Examiner’s conclusion that a triglyceride would be present, as a common
food ingredient, in a meal ingested by a person after taking a composition
taught by the combination of Katsuragi and Masui.
We affirm the rejection of claim 32 under 35 U.S.C § 103(a) as
unpatentable over the combination of Katsuragi and Masui. Claims 33-42
fall together with claim 32.

SUMMARY
In summary, we affirm the rejections of record.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 CFR § 1.136(a).

AFFIRMED

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