Ex Parte Krotkiewski

Patent Trial and Appeal Board

Nov 5, 2014

10585546 (P.T.A.B. Nov. 5, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MARCIN KROTKIEWSKI1
__________

Appeal 2012-005454
Application 10/585,546
Technology Center 1600
__________

Before DEMETRA J. MILLS, ERIC B. GRIMES, and ULRIKE W. JENKS,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
composition for treating obesity, which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 According to Appellant, the Real Party in Interest is Scandinavian Clinical
Nutrition I Sverige AB (Appeal Br. 3).
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STATEMENT OF THE CASE
Claims 1–3, 5–8, and 17 are on appeal. Claim 1 is illustrative and
reads as follows:
1. A formulation of plant matter extracts for treating obesity and low
metabolic rate, said formulation comprising:
a) 20-90% by wt. of Green tea extract, containing more than 70 % by
wt. of catechins,
b) 2-30 % by wt. of Coleus forskohlii extract, containing at least 10 %
by wt. of diterpene forskolin,
c) 5-58% by wt. of Yerba Maté extract, containing 2-4% by wt. of
caffeine and caffeoylquinic acids (CGA), and
d) 7.5-45 % by wt. of Betula alba extract containing at most 3% by
wt. of flavonoids.

DISCUSSION
Issue
The Examiner has rejected claims 1, 3, 5–8, and 17 under 35 U.S.C.
§ 103(a) as obvious based on Liao,2 Majeed,3 Gow,4 de la Harpe,5 and
Schorpion6 (Ans. 5). The Examiner has rejected claim 2 under 35 U.S.C.
§ 103(a) as obvious based on Liao, Majeed, Gow, de la Harpe, Schorpion,
and Chokshi7 (Ans. 7). Because Appellant has waived arguments based on
Chokshi, the same issue is dispositive for both rejections.
The Examiner finds that “Liao teaches using isolated EGCG, a
catechin, extracted from green tea to reduce body weight” (id. at 5), “Majeed

2 Liao et al., US 6,610,749 B2, issued Aug. 26, 2003.
3 Majeed et al., US 5,804,596, issued Sept. 8, 1998.
4 Gow et al., US 7,279,184 B2, issued Oct. 9, 2007.
5 de la Harpe et al., US 6,251,888 B1, issued June 26, 2001.
6 Schorpion, BE 1009545, issued Mar. 1997.
7 Chokshi, US 2003/0059403 A1, published Mar. 27, 2003.
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teaches using a composition comprising 1 to 40% forskohlin extracted from
Coleus forskohlii to promote lean body mass” (id.), “Gow teaches using Ilex
paraguariensis (yerba mate) extract to induce weight loss” (id.), and “De la
Harpe teaches using Betula pubescens to increase lean body mass and reduce
body fat” (id. at 6).8
The Examiner concludes that each of the ingredients of the claimed
formulation was known for treating obesity, and it would have been obvious
“to combine two or more ingredients 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 useful for the same purpose” (id.). The Examiner also reasons that “[t]he
amount of a specific ingredient in a composition is clearly a result effective
parameter that a person of ordinary skill in the art would routinely optimize”
and “absent some demonstration of unexpected results from the claimed
parameters, this optimization of ingredient amount would have been obvious
at the time of the appellant’s invention” (id. at 7).
Appellant contends that “[t]he presence of five different constituents,
each of which is mentioned in a different reference, would require a virtually
limitless number of optimization trials . . . and would therefore not even be
attempted by one of ordinary skill in the art” (Br. 18). Appellant also
contends that the Specification’s Figures 1, 2A, and 2B show that the
claimed combination provides unexpected results (id. at 16–17, 20–22).
The issues presented are (1) whether the cited references support a
prima facie case of obviousness, and (2) whether Appellant has provided

8 The Examiner provided a reference to show that Betula alba is also known
as Betula pendula (Ans. 6), a fact that Appellant does not dispute.
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evidence of unexpected results that, when weighed with the evidence
supporting the prima facie case, shows that the claimed formulation would
not have been obvious.
Findings of Fact
1. Liao discloses “a method of reducing food intake in a subject . . .
compris[ing] administering to a subject in need thereof an effective amount
of a compound of formula (I)” (Liao 1:38–41).
2. Liao discloses that “[c]ompounds of formula (I) can be obtained
from natural sources. For example, (-)epigallocatechin-3-gallate (EGCG)
. . . can be isolated from green tea.” (Id. at 5:24–27.)
3. Liao discloses that “EGCG and other catechins (>98% pure) were
isolated from green tea. . . . Catechins were dissolved in water for oral
administration.” (Id. at 14:9–13).
4. Majeed discloses “a method of promoting lean body mass in an
individual, comprising administering to the individual a lean body mass
promoting effective amount of forskohlin” (Majeed 2:66 to 3:2).
5. Majeed discloses that its purification process normally yields “a
product containing about 15 to about 20% forskohlin . . . although higher
purities are certainly well within the skill of an ordinary worker” (id. at
6:17–21).
6. Majeed discloses that “[t]he product preferably contains from
about 15 to about 40% forskohlin, although the process of the invention is
unique in that it can provide 100% pure forskohlin” (id. at 6:21–24).
7. Gow states that “[t]he genus Ilex is member of the holly family. . . .
I. paraguariensis [is] referred to as maté or yerba maté.” (Gow 1:20–23.)
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8. Gow discloses a “SFE CO2 decaffeinated mate extract material
(see Table 2)” that contains 0.8% caffeine and 2.8% chlorogenic acid (id. at
13:43–44, 13:66). The Examiner finds, and Appellant does not dispute, that
chlorogenic acid is also called 3-caffeoylquinic acid (Ans. 5).
9. Gow discloses that “[t]he maté compositions of the present
invention are also useful for the treatments of obesity and as an aid to weight
loss” (id. at 23:3–5).
10. De la Harpe discloses “compositions comprising chromic
tripicolinate or chromic polynicotinate in combination with . . . [a] salicin-
containing herb, and uses of these compositions in lowering blood glucose
levels [and] increasing lean body mass” (de la Harpe 1:15-20).
11. De la Harpe states that “Boswellia serrata (frankincense), Betula
lenta (sweet birch), Betula pubescens (white birch) . . . are all salicin-
containing plants” (id. at 5:22–27).
12. Schorpion discloses that a food supplement comprising an extract
from birch leaves is useful for slimming (Schorpion 1).
13. The Specification states that “[b]irch leaves contain approx. 2-3
% of flavonoid glycosides” (Spec. 3:21–22).
Principles of Law
“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. . . . [T]he
idea of combining them flows logically from their having been individually
taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
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“[D]iscovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art.” In re Boesch, 617
F.2d 272, 276 (CCPA 1980).
“[I]t is well settled that unexpected results must be established by
factual evidence. ‘Mere argument or conclusory statements in the
specification does not suffice.’” In re Geisler, 116 F.3d 1465, 1470 (Fed.
Cir. 1997).
“[T]he burden of showing unexpected results rests on he who asserts
them. Thus 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).
Analysis
Liao, Majeed, Gow, and de la Harpe disclose that each of the extracts
of the claimed formulation was known for aiding in weight loss or
promoting lean body mass (FF1, FF2, FF4, FF9, FF10, FF11). The
references also disclose that the extracts have the same active agents in the
amounts recited in claim 1 (FF3, FF5, FF8, FF12, FF13). We agree with the
Examiner that, since each extract was known for use in aiding weight loss or
promoting lean body mass, it would have been obvious to combine them in
order to produce a composition for accomplishing these same effects. And,
although the references do not expressly disclose the recited amounts of each
extract in the claimed formulation, we agree with the Examiner that the
relative amount of each extract was a result-affecting variable (since each
was disclosed in the prior art to produce an effect), and therefore it would
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have been obvious to vary the relative amount of each extract in the
combined formulation in order to optimize the resulting effects.
Appellant argues, however, that
[t]he presence of five different constituents, each of which is
mentioned in a different reference, would require a virtually
limitless number of optimization trials. . . . Clearly, such a
testing program would be a hopelessly complex task, one that
would be impractical from both a financial and a time
standpoint, and would therefore not even be attempted by one
of ordinary skill in the art.
(Br. 18.)
We are not persuaded by this argument. Claim 1 encompasses
compositions with a broad range of each component: 20-90% Green tea
extract, 2-30% Coleus forskohlii extract, 5-58% Yerbe Maté extract, and
7.5-45% Betula alba extract. Appellant has pointed to no evidence showing
that undue experimentation would have been required for a skilled artisan to
arrive at a composition within these broad ranges based on the teachings of
the cited references.
Appellant also argues that “[t]he present application provides ample
evidence of an unexpected effect of the claimed invention by virtue of the
examples and the tables that are included in the specification, along with
Figs. 2A and 2B of the drawings” (Br. 17). Appellant also argues that
further evidence of unexpected results is found in the Specification’s Figure
1, which shows “a comparison of the present combination against Xenical
with respect to lipase activity” (id. at 21). Finally, Appellant argues that the
Specification’s Figure 3 shows that “the mean food intake in the tested rats
is lowest in the group treated with the formulation of the invention and that
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this effect is sufficiently significant to conclude that synergism was achieved
by the invention formulation” (id.).
We are not persuaded that the evidence relied on shows the
nonobviousness of the claimed formulation, for several reasons. First,
although the Appeal Brief characterizes the evidence as showing unexpected
results, the Specification does not. At best, the Specification characterizes
the results as showing synergism (Spec. 4:13–15, 13:11–13). However, the
Specification uses the term “synergistically” to include effects that are
simply additive, and therefore would have been expected.
The Specification states that “it has been found that a certain
combination of different herbs and extracts of plant origin acts more
effective[ly] than each of the components alone. The components are acting
in concert (synergistically).” (Id. at 4:13–15.) Similarly, the Specification
states that the examples show that the “[f]ormulation of the invention
contains active components which effects are synergistically strengthening
each other, so that effect of their mixture is significantly greater them [sic]
the effect of any separate component alone” (id. at 13:11–13).
Neither of these statements acknowledges that agents that act
independently are expected to show improved overall effect when used in
combination. The Specification provides no calculations demonstrating
what effect would have been expected when combining four active agents,
which were all known in the prior art to aid in weight loss or to promote lean
body mass, and how that expected effect compares to the effect actually
observed in the Specification’s working examples.
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The second problem with Appellant’s evidence is that it is unclear
whether the data shown in Figures 2A and 2B represent a true apples-to-
apples comparison. The Specification discloses that the components of the
claimed formulation were administered separately at the following daily
dosages: EGCG (green tea extract), 5.33 mg; Coleus forskohlii extract, 0.17
mg; Yerbe Maté extract, 0.5 mg; and Betula alba extract, 0.5 mg (Spec. 10,
Table 2). Thus, the components administered separately amount to a total
of 6.5 mg/day. But the formulation of the invention that was compared to
the individual components was administered at a dosage of 6.95 mg/day.
The Specification does not explain why the inventive formulation was
administered in a dosage greater than the total of the administered
components. Since a larger dose of each component was administered in the
combined formulation of the Specification’s Example 4, it would seem
logical to expect a larger effect compared to any of the components
administered separately.
The third problem with the Specification’s Example 4 is that it does
not include any negative control, showing body weight increase in animals
that were not administered any active agent. In the absence of a negative
control—a baseline—there is no way to determine what effect any of the
components had on slowing the body weight increase that would have been
seen otherwise. In the absence of evidence showing what would have been
expected, the effect of the combined formulation cannot be said to be
unexpected.
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The data shown in the Specification’s Figure 3 suffer from the same
deficiencies discussed above, because they are derived from the same
experiment. See Spec. 11:8–10.
With respect to the data shown in the Specification’s Figure 1, we
agree with the Examiner (Ans. 12) that it does not show unexpected results
because the drug Xenical is not the closest prior art. See In re Baxter-
Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.”). While the data shown
in Figure 1 might show that the claimed formulation has a property that was
not described in the prior art, the discovery of a new property for one or
more of the components of the claimed formulation does not make that
formulation patentable. See In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990)
(“The discovery of a new property or use of a previously known
composition, even when that property and use are unobvious from the prior
art, can not impart patentability to claims to the known composition.”).
Conclusion of Law
The cited references support a prima facie case of obviousness.
Appellant has not provided evidence of unexpected results that, when
weighed with the evidence supporting the prima facie case, shows that the
claimed formulation would not have been obvious.
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Claims 3, 5–8, and 17 have not been argued separately and therefore
fall with claim 1.9 37 C.F.R. § 41.37(c)(1)(vii). As previously noted,
Appellant has waived arguments directed to the separate rejection of claim
2, and so we affirm that rejection as well. See Hyatt v. Dudas, 551 F.3d
1307, 1314 (Fed. Cir. 2008).
SUMMARY
We affirm both of the rejections on appeal.
TIME PERIOD FOR RESPONSE
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

lp

9 Although Appellant states that “the dependent claims contain further
recitations . . . that distinguish the claimed invention from the references
cited” (Br. 19), Appellant provides no substantive arguments that would
satisfy 37 C.F.R. § 41.37(c)(1)(vii). See In re Kao, 639 F.3d 1057, 1065
(Fed. Cir. 2011) (Statements in a brief that “merely mention [a] claim . . .
and lack any type of separate, substantive argument concerning the claim”
are not sufficient to constitute separate argument).