Ex Parte Kawasaki

Board of Patent Appeals and Interferences

Feb 12, 2008

09971475 (B.P.A.I. Feb. 12, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte TOSHISUKE KAWASAKI
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Appeal 2007-3119
Application 09/971,475
Technology Center 1600
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Decided: February 12, 2008
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Before TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a gene
therapy method of treating cancer, which the Examiner has rejected as
nonenabled. We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
BACKGROUND
The Specification discloses that “mannan-binding protein (MBP)” is a
known “type C lectin which binds to mannose (Man) or N-acetylglucosamine
(GlcNAc) in a calcium-dependent manner” (Spec. 1). The Specification also
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Application 09/971,475

discloses that “the growing ability of cancer cells in . . . tumor bearing
animals administered with the gene coding for MBP is clearly suppressed”
(id. at 2-3).
The Specification provides a working example in which nude mice
were inoculated with human colon cancer cells and treated with saline, wild-
type vaccinia virus, or a recombinant vaccinia virus encoding MBP
(administered either into the tumor or “subcutaneously to non-diseased
part”) (id. at 14). The Specification reports that
when the MBP recombinant vaccinia virus of the present
invention is administered into tumors of the diseased part, the
tumors clearly became smaller and that, even when it was
subcutaneously administered to the non-diseased part, a
significant suppression of growth of cancer cells was observed
as compared with the controls where vaccinia virus WR strain
of a wild type and physiological saline solution were
administered.
(Id. at 15.)
DISCUSSION
1. CLAIMS
Claims 12, 14, and 19 are pending and on appeal. Claim 12 is
representative and reads as follows:
12. A method of treating human cancer comprising administering a
gene for a mannan-binding protein having an amino acid sequence
represented by SEQ ID NO:1, where administering said gene includes
injecting said gene directly into a tumor of the diseased part, wherein said
gene is integrated in a virus vector.

2. ENABLEMENT
Claims 12, 14, and 19 stand rejected under 35 U.S.C. § 112, first
paragraph, on the basis that the “specification does not teach how to
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overcome problems with in vivo delivery and expression with respect to the
administration of the claimed nucleic acids or viral vectors comprising said
nucleic acids” (Answer 3). The Examiner cites several references to support
his position that gene therapy generally was highly unpredictable as of this
application’s effective filing date (id. at 3-4).1 The Examiner concludes that
the “specification does not remedy any of the deficiencies [of] the prior art
with regard to gene therapy. Given the lack of any guidance from the
specification on any of the above issues pointed out by Verma or Eck or
Orkin[, o]ne of skill in the art would be subject to undue experimentation
without reasonable expectation of success in order to practice the methods of
[the] claims” (id. at 5).
Appellant argues that a “specific working example describing the
preparation of a recombinant vaccinia virus vector for administering a gene
coding for MBP is provided . . . at Example 1 of the specification.
Administration of the recombinant vaccinia virus vector is described in
Example 2 of the specification.” (App. Br. 4.) Appellant also argues that
the state of the art of gene therapy supports the position that the claimed
method is enabled (id. at 5-6). Appellant concludes that “[i]n view of the
guidance provided . . . for performing the claimed method, in combination
with experimental evidence showing anti-cancer activity in human colon

1 The Examiner cites Verma et al., “Gene therapy – promises, problems and
prospects,” Nature, Vol. 389, pp. 239-242 (1997); Eck et al., “Gene-based
therapy,” in Goodman & Gilman’s The Pharmacological Basis of
Therapeutics, 9th edition, pp. 77-101, McGraw Hill (1996); and Orkin et al.,
“Report and Recommendations of the Panel to Assess the NIH Investment in
Research on Gene Therapy,” Nat’l Insts. of Health (1995).
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cancer cells, and the skill and knowledge available to an artisan of ordinary
skill,” the claims should be considered enabled (id. at 8).
We agree with Appellant that the Examiner has applied an overly
stringent standard for enablement in this case. “[T]o be enabling, the
specification of a patent must teach those skilled in the art how to make and
use the full scope of the claimed invention without ‘undue experimentation.’”
In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). “That some
experimentation may be required is not fatal; the issue is whether the amount
of experimentation required is ‘undue.’” In re Vaeck, 947 F.2d 488, 495
(Fed. Cir. 1991) (emphasis in original). Some experimentation, even a
considerable amount, is not “undue” if, for example, it is merely routine, or if
the specification provides a reasonable amount of guidance as to the direction
in which the experimentation should proceed. In re Wands, 858 F.2d 731,
737 (Fed. Cir. 1988).
In this case, the claims are relatively narrow, in that they require
administration of a gene encoding a known protein with a specific amino
acid sequence, and require “injecting said gene directly into a tumor.”
Importantly, the Specification provides a working example of one viral
vector comprising the gene recited in the claims (Spec. 12-13), and another
working example that describes practice of the claimed method to treat
tumors in experimental mice (id. at 14-15). In the Specification’s working
example, the claimed method caused tumors to shrink from >35 mm in
control mice (treated with saline or wild-type virus) to <5 mm in mice
treated by the claimed method (id. at 15; Fig. 3).
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We conclude that, in view of the significant guidance provided by the
Specification and the prior art of record, and the working example in the
Specification, the Examiner has not adequately established that undue
experimentation would have been required to practice the claimed method.
We disagree with the Examiner’s apparent position that a therapeutic
method must be clinically proven to be safe and effective in order to be
enabled. When Appellant cited clinical trials showing gene therapy for
different diseases, the Examiner responded that those treatments were
“under the guise of clinical trials. A treatment is administered by a clinical
trial when the result is uncertain, and therefore the method was not enabled,
because there was no reasonable expectation of success. Even in the year
2006, . . . an individual suffering from cancer does not go [to] a physician
and expect to receive gene therapy for cancer.” (Answer 12-13.)
The Examiner’s position “confuses the requirements under the law for
obtaining a patent with the requirements for obtaining government approval
to market a particular drug for human consumption.” In re Brana, 51 F.3d
1560, 1567 (Fed. Cir. 1995). The Brana court held that “[u]sefulness in
patent law, and in particular in the context of pharmaceutical inventions,
necessarily includes the expectation of further research and development.
The stage at which an invention in this field becomes useful is well before it
is ready to be administered to humans.” Id. at 1568. (The court’s reference
to “usefulness” was in the context of the how-to-use prong of 35 U.S.C.
§ 112, first paragraph; the rejection on appeal was for nonenablement. See
id. at 1564.)
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The Brana court’s holding is consistent with that of CFMT, Inc. v.
Yieldup Int’l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003) (“Enablement
does not require an inventor to meet lofty standards for success in the
commercial marketplace. Title 35 does not require that a patent disclosure
enable one of ordinary skill in the art to make and use a perfected,
commercially viable embodiment absent a claim limitation to that effect.”).
See also In re Cortright, 165 F.3d 1353, 1359 (Fed. Cir. 1999) (claims to
method of “restoring hair growth” encompassed achieving full head of hair
but did not require it).
SUMMARY
The Examiner’s conclusion that the pending claims are not enabled is
based on an overly stringent application of the enablement requirement of 35
U.S.C. § 112, first paragraph. We therefore reverse the rejection of claims
12, 14, and 19 for nonenablement.

REVERSED

Ssc:

KOLISCH HARTWELL, P.C.
520 SW YAMHILL STREET, SUITE 200
PORTLAND, OR 97204

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