Ex Parte Sagman et al

Board of Patent Appeals and Interferences

Dec 11, 2009

10623110 (B.P.A.I. Dec. 11, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte URI SAGMAN, MICHAEL ROSENBLUM, and
LON WILSON
__________

Appeal 2009-007942
Application 10/623,110
Technology Center 1600
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Decided: December 12, 2009
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Before ERIC GRIMES, RICHARD M. LEBOVITZ, and STEPHEN
WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
composition comprising an antigen-binding moiety covalently linked to a
fullerene or nanotube, and to a method of treating a disease. The Patent
Examiner rejected the claims for obviousness. We have jurisdiction under
35 U.S.C. § 6(b). We reverse.
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Application 10/623,110

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STATEMENT OF THE CASE
Claims 1, 3, 4, 6-10 and 12-19, which are all the pending claims, are
on appeal. Claim 1 is representative and reads as follows:
1. A composition, comprising:

(i) a Cn-Ab, wherein Cn is a fullerene or nanotube comprising n carbon
atoms, and Ab is a moiety comprising an antigen-binding site and is
covalently linked to the Cn, wherein the antigen-binding site
recognizes an antigen associated with a medical condition; and
(ii) a pharmaceutically-acceptable carrier.

The Examiner rejected claims 1, 3, 4, 6-10 and 12-19 under 35 U.S.C.
§ 103(a) as unpatentable over Erlanger,1 Haberzettl,2 and Williams.3

OBVIOUSNESS
The Issue
The Examiner’s position is that Erlanger disclosed the possibility of
covalent linkage between fullerenes and a specific monoclonal antibody and
how to test for the linkage. (Fin. Rej. 3.) The Examiner found that
Haberzettl taught fullerenes for drug delivery, and “successful drug delivery
architectures will be enhanced by allowing them to target a particular tissue
or organ.” (Id.) The Examiner concluded it would have been obvious “to
produce a fullerene tube attached to an antibody that recognizes an antigen

1 U.S. Patent No. 6,593,137 B1, issued to Bernard F. Erlanger et al., Jul. 15,
2003.
2 C A Haberzettl, Nanomedicine: destination or journey?,
13 NANOTECHNOLOGY R9-R13 (2002).
3 JA Williams et al., Targeting and therapy of human glioma xenografts in
vivo using radiolabeled antibodies, 19 INT. J. RADIAT. ONCOL. BIOL. PHYS.
633-42 (1990).
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Application 10/623,110

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and add a drug such as doxorubicin to enhance treatment of a disease as
disclosed by Haberzettl.” (Id. at 3-4.) To Appellants’ argument that
Haberzettl’s disclosure lacked a grounding in chemistry for making the
claimed compositions, the Examiner responded that “[t]he claims do not
require a method of making or loading” (Ans. 6), and gave no explanation
that the prior art disclosed or suggested a way to make the claimed
compositions. The Examiner found Haberzettl’s disclosure at R10-R11 of
nanobot targeting mechanisms and payloads “sufficient to reject the instant
claims.” (Id.) The Examiner found Haberzettl’s suggestion of enhancing
disease treatment and reducing drug side effects sufficient motivation for
combining the Erlanger and Haberzettl teachings. (Id. at 7.)
Appellants contend that “Haberzettl is directed to a hypothetical
device that neither he nor any other worker has constructed or even shown
how to construct.” (App. Br. 4.) Appellants further argue that Haberzettl’s
“speculative and hypothetical” teachings give no motivation to combine
them with Erlanger or Williams, and even if they did, there would have been
no obvious modifications that would have had a reasonable expectation of
success. (Id. at 5.)
The issue in this appeal is whether Appellants have shown that
Haberzettl’s teachings were insufficient to support finding a reasonable
expectation of success in combining them with Erlanger or Williams.

Findings of Fact
1. Erlanger raised “the possibility of covalent linkage between fullerenes
and a [fullerene-] specific monoclonal antibody.” (Erlanger, col. 20,
ll. 4-5.)
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2. Haberzettl taught that for targeting drug delivery fullerenes, “[t]he
most likely mechanisms to be employed are based on
antigen/antibody interactions.” (Haberzettl, R10.)

Principles of Law
(I)f the prior art of record fails to disclose or render obvious a
method for making a claimed compound, at the time the
invention was made, it may not be legally concluded that the
compound itself is in the possession of the public. In this
context, we say that the absence of a known or obvious process
for making the claimed compounds overcomes a presumption
that the compounds are obvious.

In re Hoeksema, 399 F.2d 269, 274 (CCPA 1968) (footnote omitted).
“Obviousness does not require absolute predictability of success . . .
[A]ll that is required is a reasonable expectation of success.” In re
O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988). “[T]he expectation of
success must be founded in the prior art, not in the applicant's disclosure.”
In re Dow Chemical Co., 837 F.2d 469, 473 (Fed. Cir. 1988).

Analysis
Erlanger disclosed the possibility that a fullerene and its cognate
antibody might become covalently linked after incubation. (FF1.) The
Examiner found that because “Erlanger used a fullerene specific antibody,
however, [Erlanger] does not disclose an antibody which recognizes an
antigen.” Thus, it was necessary to examine other prior art to learn if a
covalently linked composition of fullerene and antibody that recognized an
antigen associated with a medical condition (as Appellants claim) was
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suggested in the prior art. The Examiner found that Haberzettl provided the
suggestion. (FF2.)
Appellants argued that Haberzettl and Erlanger could not have made
the claimed composition obvious because Haberzettl and Erlanger did not
disclose the chemistry needed to make the suggested covalently linked
composition. The Examiner was unpersuaded because “[t]he claims do not
require a method of making. . . .” (Ans. 6.) That was a mistake: “the
absence of a known or obvious process for making the claimed compounds
overcomes a presumption that the compounds are obvious.” Hoeksema,
399 F.2d at 274. The Examiner did not explain why a fullerene would have
reasonably been expected to covalently link to an antibody associated with a
medical condition. Erlanger’s statement of the “possibility of covalent
linkage” referred to fullerene’s cognate antibody, not the antibody
referenced in Appellants’ claim. In the absence of evidence that there was a
known or obvious process for covalently linking a fullerene and a moiety
comprising an “antigen-binding site [that] recognizes an antigen associated
with a medical condition,” we conclude that the rejection did not state a
prima facie case of obviousness.

CONCLUSIONS OF LAW
Appellants have shown that the combined Erlanger and Haberzettl
teachings were insufficient to support finding a reasonable expectation for
making the claimed composition.

Appeal 2009-007942
Application 10/623,110

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SUMMARY
We reverse the rejection of claims 1, 3, 4, 6-10 and 12-19 under 35
U.S.C. § 103(a) as unpatentable over Erlanger, Haberzettl, and Williams.

REVERSED

dm

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