Ex Parte Tsygankov

Board of Patent Appeals and Interferences

Jan 5, 2012

10907749 (B.P.A.I. Jan. 5, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte VLADIMIR VLADIMIROVICH TSYGANKOV
__________

Appeal 2011-009317
Application 10/907,749
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical antidiabetic composition. The Examiner rejected the claims
as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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Application 10/907,749

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Statement of the Case
Background
“It is the object of the present invention to use the prior art preparation
of hardened antlers for a novel purpose as a medicament for treatment and
prophylaxis of diabetes by means of revelation of its hypoglycemic effect”
(Spec. 2 ¶ 12).
The Claims
Claim 20 is on appeal. Claim 20 reads as follows:
20. A pharmaceutical antidiabetic composition,
comprising:
about .4 to .8 grams of a powder extracted from
hardened antlers;
about 0.5ng of insulin per gram of powder
extracted from hardened antlers; and
about 18ng of insulin-like growth factor-I per gram
of powder extracted from hardened antlers.

The issue

The Examiner rejected claim 20 under 35 U.S.C. § 103(a) as obvious
over Tsygankov
1
(Ans. 3-6).
The Examiner finds that
based on the appellant‟s own admissions and in the lack of
any evidence to the contrary, it is logical and reasonable to
conclude that the hardened antler preparation of
[Tsygankov] contains insulin and insulin-like growth factor I
in the amounts claimed by the appellant because this is the
prior art product referred to in paragraph 16 [of the
Specification]

1
Tsygankov, V., CA 2201768, published Oct. 11, 1997.
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(Ans. 4). The Examiner finds that Tsygankov “does not specifically teach a
composition of 0.4 to 0.8 grams of the hardened antler powder extract. The
amount of a composition is clearly a result effective parameter that a person
of ordinary skill in the art would routinely optimize” (id.).
The Examiner finds that “by teaching a broad range of dosages, the
prior art acknowledges that dosage amounts can be varied to suit the purpose
of the artisan” (id. at 5). The Examiner finds that the “broad range of
dosages taught in the reference overlaps with the dosages claimed by the
appellant. It is not considered to be inventive to optimize dosages within the
range of dosages taught in the prior art” (id.).
Appellant contends that “there is no teaching what so ever relating to
dosage of the composition which is effective for use as an antidiabetic
compound” (App. Br. 9). Appellant contends that:
Optimization, however, inherently entails the improvement
of given parameter. The Office even states that one of
ordinary skill “would routinely modify the amount of the
powder extract.” What lacks from this assertion is something
in the prior art that is being modified. There is no prior art of
record giving a disclosed set of parameters (dosage) for an
antidiabetic compound which the current application has
“optimized”.

(Id. at 10.) Appellant contends that “[a]bsent some teaching of any dosage
for an antidiabetic compound comprising powdered deer antler, the Office
does not set forth a prima facie case of obviousness” (id.).
Appellant contends that “Applicant‟s express reliance on the
preamble reciting an antidiabetic composition transforms the preamble into a
claim feature not taught or suggested in [Tsygankov]” (id. at 11).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner‟s conclusion that Tsygankov renders claim 20
obvious?
Findings of Fact
1. The Specification teaches that it “is the object of the present
invention to use the prior art preparation of hardened antlers for a novel
purpose as a medicament for treatment and prophylaxis of diabetes by means
of revelation of its hypoglycemic effect” (Spec. 2 ¶ 12).
2. The Specification teaches that “400 to 800 mg of the inventive
preparation administered per day produce a hypoglycemic effect on the
insulin-independent diabetic patients so that they are able to reduce the dose
of administered insulin.” (Spec. 8 ¶ 52.)
3. The Specification teaches that a “powder-like biogenic
preparation of hardened antlers is known from RU 2077887 A, which
contains a complex of biologically active components” (Spec. 1 ¶ 9).
4. The Examiner finds that Tsygankov “is an English language
equivalent of RU 2077877” (Ans. 4).
5. Tsygankov teaches “a powdery biogenic preparation from
ossified deer antlers and a food additive based on said biogenic preparation”
(Tsygankov 1, ll. 5-7).
6. Tsygankov teaches that the “novel biogenic preparation appears
as a grey-colored loose powder having inclusions of light-brown particles,
has a specific nonputrescent odor, and is virtually insoluble in water and
organic solvents” (Tsygankov 11, ll. 7-11).
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7. Tsygankov teaches “daily doses of the preparation, according to
the invention, in an amount of 225 mg/kg and 1225 mg/kg . . . . In addition,
the preparation is not cytogenetically active when administered in doses of
1300 and 7800 mg/kg” (Tsygankov 17, ll. 2-16).
Principles of Law
The Supreme Court has emphasized that “the [obviousness] analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” KSR
Int’l v. Teleflex Inc., 550 U.S. 398, 418 (2007). As noted by the Court in
KSR, “[a] person of ordinary skill is also a person of ordinary creativity, not
an automaton.” Id. at 421. “The combination of familiar elements according
to known methods is likely to be obvious when it does no more than yield
predictable results.” Id. at 416.
“[A] preamble limits the invention if it recites essential structure or
steps, or if it is „necessary to give life, meaning, and vitality‟ to the claim.”
Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed.
Cir. 2002)(quoting Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d
1298, 1305 (Fed. Cir. 1999)). A preamble is not limiting, however, “„where
a patentee defines a structurally complete invention in the claim body and
uses the preamble only to state a purpose or intended use for the invention.”‟
Id. (quoting Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997)).
[W]here the Patent Office has reason to believe that a
functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the
authority to require the applicant to prove that the subject
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matter shown to be in the prior art does not possess the
characteristic relied on. … Whether the rejection is based on
“inherency” under 35 U.S.C. § 102, on “prima facie
obviousness” under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced
by the PTO‟s inability to manufacture products or to obtain
and compare prior art products.

In re Best, 562 F.2d 1252, 1254-55 (CCPA 1977).
Analysis
Tsygankov teaches a composition which is composed of a powder
extracted from hardened antlers (FF 5-6). The Specification acknowledges
that a “powder-like biogenic preparation of hardened antlers is known from
RU 2077887 A, which contains a complex of biologically active
components” (Spec. 1 ¶ 9; FF 3), where Tsygankov is the English language
equivalent of RU 2077887 (FF 4). Tsygankov teaches a range of doses (FF
7). The Examiner reasonably finds that the powder of Tsygankov is
inherently identical to the instant powder claimed. Best, 562 F.2d at 1255.
Applying the KSR standard of obviousness to the findings of fact,
selecting a particular amount of powder from a range disclosed in the prior
art represents routine optimization. See In re Aller, 220 F.2d 454, 456
(CCPA 1955) (“[W]here the general conditions of a claim are disclosed in
the prior art, it is not inventive to discover the optimum or workable ranges
by routine experimentation.”)
In this case, Appellant contends that Aller does not apply because
“there is no teaching what so ever relating to dosage of the composition
which is effective for use as an antidiabetic compound” (App. Br. 9).
Appellant contends that:
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Optimization, however, inherently entails the improvement
of given parameter. The Office even states that one of
ordinary skill “would routinely modify the amount of the
powder extract.” What lacks from this assertion is something
in the prior art that is being modified. There is no prior art of
record giving a disclosed set of parameters (dosage) for an
antidiabetic compound which the current application has
“optimized”.

(App. Br. 10.) Appellant contends that “[a]bsent some teaching of any
dosage for an antidiabetic compound comprising powdered deer antler, the
Office does not set forth a prima facie case of obviousness” (id.).
We are not persuaded. The claim is to a composition, not a method of
treating diabetes. In this case, the composition of claim 20, requiring
powder extracted from hardened antlers, represents a situation where the
claim body defines a structurally complete invention. The preamble is not
necessary to give life or meaning to the claimed composition and functions
solely to provide an intended use for the composition as an “antidiabetic.”
Appellant contends that “Applicant‟s express reliance on the preamble
reciting an antidiabetic composition transforms the preamble into a claim
feature not taught or suggested in [Tsygankov]” (App. Br. 11).
We are not persuaded. An intended use that merely states the purpose
of the claimed subject matter, without adding additional structure to it, is
generally not treating as limiting the scope of the claim. See Boehringer
Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345
(Fed. Cir. 2003); Rowe v. Dror, 112 F.3d at 478.
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Simply because Appellant wishes to rely upon the preamble does not
convert the preamble into a limitation. The hypothetical presented in
Catalina explains this concept, noting that
a hypothetical best illustrates these principles: Inventor A
invents a shoe polish for shining shoes (which, for the sake
of example, is novel, useful, and nonobvious). Inventor A
receives a patent having composition claims for shoe polish.
Indeed, the preamble of these hypothetical claims recites “a
composition for polishing shoes.” Clearly, Inventor B could
not later secure a patent with composition claims on the
same composition because it would not be novel . . . .
Suppose Inventor B discovers that the polish also
repels water when rubbed onto shoes. Inventor B could not
likely claim a method of using the polish to repel water on
shoes because repelling water is inherent in the normal use
of the polish to shine shoes. . . .
Upon discovering, however, that the polish composition
grows hair when rubbed on bare human skin, Inventor B can
likely obtain method claims directed to the new use of the
composition to grow hair. . . . Hence, while Inventor B may
obtain a blocking patent on the use of Inventor A‟s
composition to grow hair, this method patent does not
bestow on Inventor B any right with respect to the patented
composition. Even though Inventor A‟s claim recites “a
composition for polishing shoes,” Inventor B cannot invoke
this use limitation to limit Inventor A‟s composition claim
because that preamble phrase states a use or purpose of the
composition and does not impose a limit on Inventor A‟s
claim.

Catalina, 289 F.3d at 809-810. Applying this example to the instant
situation, the prior art Tsygankov patent has already invented a composition
composed of a powder extracted from hardened antlers and would be
Inventor A (FF 1-4). Whether we analogize Appellant‟s invention as
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“Inventor B” as the polish which repels water or which grows hair, in either
case Appellant is not entitled to a composition patent. Catalina, 289 F.3d at
809-810. These situations differ only where method claims are under
review.
Conclusion of Law
The evidence of record supports the Examiner‟s conclusion that
Tsygankov renders claim 20 obvious.
SUMMARY
In summary, we affirm the rejection of claim 20 under 35 U.S.C. §
103(a) as obvious over Tsygankov.

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

cdc