Ex Parte Cavazza et al

Board of Patent Appeals and Interferences

Mar 3, 2011

11407351 (B.P.A.I. Mar. 3, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CLAUDIO CAVAZZA, CLAUDIO PISANO,
LOREDANA VESCI, and FRANCO MANDELLI
__________

Appeal 2010-012194
Application 11/407,351
Technology Center 1600
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Before TONI R. SCHEINER, ERIC GRIMES, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
composition and kit comprising acetyl L-carnitine or a pharmaceutically

1 The two-month time 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.

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Application 11/407,351

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acceptable salt thereof, and thalidomide. The Patent Examiner rejected the
claims as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

STATEMENT OF THE CASE
The invention concerns “the use of acetyl L-carnitine … for the
preparation of a medicament for preventing and/or treating peripheral
neuropathies induced by the administration of a peripheral neuropathy-
inducing anticancer drug,” i.e., thalidomide. (Spec. 16, ll. 5-9.)
Claims 31-33 are on appeal. The claims read as follows:
31. A composition which in combination comprises:
a) acetyl L-carnitine or a pharmaceutically acceptable salt thereof;
and
b) thalidomide.

32. The composition according to claim 31, wherein said
pharmacologically acceptable salt of acetyl L-carnitine is selected from the
group consisting of chloride, bromide, orotate, acid aspartate, acid citrate,
acid phosphate, fumarate and acid fumarate, maleate and acid maleate, acid
oxalate, acid sulphate, glucose phosphate, tartrate and acid tartrate.

33. A kit comprising:
a) a pharmaceutical composition comprising a therapeutically
effective amount of a thalidomide; and
b) a pharmaceutical composition comprising acetyl L-carnitine or a
pharmaceutically acceptable salt thereof in an amount suitable for
producing a substantially protective action against peripheral
neuropathies induced by the administration of thalidomide.

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The Examiner rejected all of the claims under 35 U.S.C. §102(b) as
anticipated by Cavazza.2
ANTICIPATION
The Issue
The Examiner’s position is that Cavazza disclosed a composition and
kit comprising thalidomide and a pharmaceutically acceptable salt of acetyl-
L-carnitine, including its chloride salt. (Ans. 4.) The Examiner found that
Cavazza also taught that the acetyl-L-carnitine is in an amount suitable for
producing a protective action against peripheral neuropathy induced by the
administration of the thalidomide. (Id.)
Appellants contend that “Cavazza does not contain an enabling
disclosure with regard to the combination of acetyl-L-carnitine with
thalidomide to produce a protective action against thalidomide-induced
peripheral neuropathies.” (App. Br. 12.) In particular, Appellants assert that
Cavazza disclosed “working examples [that] demonstrate the ability of
acetyl-L-carnitine to reduce neurotoxicity when administered in combination
with oxaliplatin, vinorelbine and vincristine only.” (Id. at 9.) According to
Appellants, “Cavazza is enabling only for oxaliplatin, vinorelbine and
vincristine.” (Id. at 13.) Appellants assert that these anticancer agents act
through different mechanisms than thalidomide. (Id. at 10.) Additionally,
Appellants assert that several mechanisms are involved in causing
neuropathic pain. (Id.) Therefore, according to Appellants, “a person
skilled in the art would not be able to extrapolate how acetyl-L-carnitine
would interact with the mechanism of action of thalidomide” without

2 Patent Application Publication No. WO 2004/043454 A1 by Claudio
Cavazza et al., published May 27, 2004.
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Application 11/407,351

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performing undue experimentation because oxaliplatin, vinorelbine and
vincristine “do not share any features with thalidomide.” (Id. at 11-12.)
The issues with respect to this rejection are:
whether Cavazza disclosed a kit and composition comprising a
combination of thalidomide and acetyl-L-carnitine in an amount to produce
a protective action against thalidomide-induced peripheral neuropathies; and
if so,
whether undue experimentation would have been required to practice
Cavazza’s teachings.

Findings of Fact
1. We agree with the Examiner’s specific findings regarding the scope
and content of the prior art reference. (See Ans. 4.)
2. Cavazza disclosed that a “preferred daily dosing of acetyl-L-carnitine
for clinical use is a composition comprising an amount of acetyl-L-carnitine
from 0.1 to 3g, and preferably 0.5 to 3 g, or an equivalent amount of a
pharmaceutically acceptable salt.” (Cavazza 12.)
3. The instant Specification disclosed that “preferred daily dosing of
acetyl-L-carnitine for clinical use is a composition comprising an amount of
acetyl-L-carnitine from 0.1 to 3g, and preferably 0.5 to 3 g, or an equivalent
amount of a pharmaceutically acceptable salt.” (Spec. 20, ll. 12-15.)
4. The instant Specification's working example demonstrating the
protective effect of acetyl-L-carnitine on peripheral nerve from thalidomide-
induced damage used a 3g dose of acetyl-L-carnitine. (Id. at 45, ll. 1-11.)

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Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987). Prior art under § 102(b) must sufficiently
describe a claimed invention to have placed the public in possession of that
invention. In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985).

Analysis
We are not persuaded by Appellants’ argument that “Cavazza does
not contain an enabling disclosure with regard to the combination of acetyl-
L-carnitine with thalidomide to produce a protective action against
thalidomide-induced peripheral neuropathies.” (See App. Br. 12.) In
particular, Appellants have not provided objective evidence that a person of
ordinary skill in the art at the time the invention was made would have
required more guidance than disclosed in Cavazza to practice the claimed
invention. Cavazza disclosed the preferred amount of acetyl-L-carnitine
suitable for producing a protective action against peripheral neuropathy
induced by the administration of anticancer agents including thalidomide,
oxaliplatin, vinorelbine and vincristine. (Ans. 4; FF-2.) The working
examples in Cavazza demonstrated the effectiveness of this dosing in
combination with oxaliplatin, vinorelbine and vincristine. (See App. Br. 9.)
The working example in the instant Specification demonstrating the
effectiveness of acetyl-L-carnitine in combination with thalidomide merely
follows the guidance set forth in Cavazza, i.e., administering a dose of
acetyl-L-carnitine within the preferred range disclosed in Cavazza.
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(Compare FF-2 and 4.) Simply following the prior art’s instructions, thereby
showing their precise correctness, does not evidence undue experimentation.
We find that Cavazza placed the public in possession of the invention
Appellants now claim, and we reject Appellants’ undue experimentation
argument.
Further, to the extent Appellants assert that the claimed invention was
not described by Cavazza because “a person skilled in the art would not be
able to extrapolate how acetyl-L-carnitine would interact with the
mechanism of action of thalidomide” (see App. Br. 11, emphasis added), the
argument is misdirected. Anticipation does not require a description of how
the elements of the claimed composition interact, rather a claim is
anticipated “if each and every element as set forth in the claim is found,
either expressly or inherently described, in a single prior art reference.”
Verdegaal Bros., 814 F.2d at 631. We agree with the Examiner (Ans. 4) that
Cavazza expressly disclosed each of the claimed elements.

CONCLUSIONS OF LAW
Cavazza disclosed a kit and composition comprising a combination of
thalidomide and acetyl-L-carnitine in an amount to produce a protective
action against thalidomide-induced peripheral neuropathies. Undue
experimentation would not have been required to practice Cavazza’s
teachings.

SUMMARY
We affirm the rejection of claims 31-33 under 35 U.S.C. §102(b) as
anticipated by Cavazza.
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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

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