Ex parte Panetta et al.

Board of Patent Appeals and Interferences

Sep 26, 2000

08213873 (B.P.A.I. Sep. 26, 2000)

The opinion in support of the decision being entered today was not written for
publication in a law journal and is not binding precedent of the Board.

Paper No. 18

UNITED STATES PATENT AND TRADEMARK OFFICE

__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JILL A. PANETTA,
MICHAEL L. PHILLIPS, JON K. REEL,
JOHN K. SHADLE, SANDRA K. SIGMUND,
RICHARD L. SIMON and CELIA A. WHITESITT
__________

Appeal No. 1997-2741
Application 08/213,873
__________

ON BRIEF
__________

Before WINTERS, ROBINSON, and GRIMES, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1 -8. Claim 9, the other pending claim in the application,1
is not subject to any outstanding rejection.

1 Originally, the application contained claims 1-24, all of which were rejected by the examiner. An
amendment after the final rejection, canceling claims 10-24, was received on September 4, 1996,
and approved for entry by the examiner. The amendment, however, was never entered. Upon
return of this case, the examiner should see to it that this amendment is properly entered.
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Application 08/213,873

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The claims are drawn to a method of treating conditions associated with
ß-amyloid peptide, including Alzheimer’s disease and Down’s syndrome, by
administering one of a class of benzylidene rhodanine compounds. The
examiner has rejected the claims under 35 U.S.C. § 112, first paragraph, on the
basis that the specification does not enable practice of the full scope of the
claimed invention without undue experimentation.
We reverse.

Background
As stated in Appellants’ specification, aberrant production of ß-amyloid
peptide is associated with various disorders, including Alzheimer’s disease,
Down’s syndrome, and advanced aging of the brain. See pages 1-2 and 99.
The specification also states that the protease cathepsin D appears to be
involved in the processing of ß-amyloid peptide and the formation of associated
plaques, and that inhibition of cathepsin D reduces ß-amyloid plaques. Pages
3-4. Accordingly, Appellants claim a method of treating a disease associated
with ß-amyloid peptide by administering to a patient a benzylidene rhodanine
compound which is disclosed to inhibit cathepsin D.

Discussion
As understood, the examiner rejected the claims because the specification
provides insufficient guidance to enable a person of ordinary skill in the art to
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practice the full scope of the claimed invention without undue experimentation.2
The examiner has conceded that the specification enables inhibition of ß-amyloid
peptide production in the brain (Examiner’s Answer, page 3). However, he notes
that the specification contains “no discussion or guidelines at all of any other
organ system which is associated with ß-amyloid. Nor is there any evidence that
aspartyl protease (cathepsin D) is present in any system other than the brain.”
Id. The examiner argues that the specification is not enabling for the full scope of
the claims because its guidance “is limited to the brain system.” Examiner’s
Answer, page 4.
Appellants state that “there are conditions in organs other than the brain
which are associated with ß-amyloid peptide,” although they fail to identify any
such disorders. Appellants argue that the full scope of the claims is enabled by
the specification. In particular, Appellants point out that the level of ordinary skill
in the art (of clinical medicine, presumably) is very high and that skilled artisans
would be familiar with dosing schedules and regimens for the disclosed
compounds. Appellants also argue that assays to test the cathepsin D-inhibiting
activity of the subject compounds are disclosed, and that the scope of the claims

2 The basis of the examiner’s rejection is not as clear as it could be because of a pronounced
change in emphasis between the final rejection and the Examiner’s Answer. In the final rejection,
the Examiner rejected the claims “under 35 U.S.C. § 112, first and second paragraphs.” The
explanation given was that “[t]he specification teaches the use of the compounds in the brain.
However, there are other conditions ‘associated with ß-amyloid peptide’ in other organ systems A
[sic] which specification does not teach.” The final rejection did not state with any clarity that it
was on the basis of non-enablement. The Examiner’s Answer explains, for the first time, that the
rejection is based on non-enablement.
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is “relatively modest.” Based on these factors, Appellants argue that the claims
are enabled by the specification.
It is well-settled that enablement under 35 U.S.C. § 112, first paragraph,
requires that a person of skill in the art be able to practice the full scope of the
claimed invention without undue experimentation. Before considering the
enablement issue, however, the claims must be construed to determine their
proper scope. See, e.g., In re Cortright, 165 F.3d 1353, 1357, 49 USPQ2d 1464,
1466-67 (Fed. Cir. 1999). “[A]s an initial matter, the PTO applies to the verbiage
of the proposed claims the broadest reasonable meaning of the words in their
ordinary usage as they would be understood by one of ordinary skill in the art,
taking into account whatever enlightenment by way of definitions or otherwise
that may be afforded by the written description contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed.
Cir. 1997).
Here, the claims are drawn to a method of treating “a condition associated
with ß-amyloid peptide.” As the examiner notes, the specification contains no
discussion of conditions associated with ß-amyloid peptide in organ systems
other than the brain. Notably, the title of the application at issue is “Treatment of
Alzheimer’s Disease Employing Inhibitors of Cathepsin D.” In fact, the
specification’s discussion of ß-amyloid-associated disorders is almost entirely
limited to Alzheimer’s disease. See, e.g., page 1, lines 13-15 (“it was proposed
early on that ß-amyloid peptide is invo lved in . . . Alzheimer’s disease”); page 3,
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lines 29-30 (“elevated activity of cathepsin D has been observed in the brains of
Alzheimer’s patients”); and page 4, lines 8-9 (“This invention provides methods
for the treatment of Alzheimer’s disease in mammals.”).
In the only place the specification refers to any ß-amyloid-associated
disorders other than Alzheimer’s disease, it merely mentions two other brain
disorders as subject to treatment with the disclosed compounds. See page 99,
lines 9-13 (“The compounds of the present invention can be administered for
prophylactic and/or therapeutic treatment of diseases related to the deposition of
ß-amyloid peptide, such as Alzheimer’s disease, Down’s syndrome, and
advanced aging of the brain.”).
Thus, the specification and the prior art cited therein are focused entirely
on disorders of the brain, and almost entirely on Alzheimer’s disease. The
specification does not identify a single disorder associated with ß-amyloid peptide
that occurs in an organ other than the brain. The only indication in the record
that ß-amyloid peptide is associated with any disorders outside of the brain is in
the Appeal Brief, where Appellants state that “there are conditions in organs
other than the brain which are associated with ß-amyloid protein.” Page 5.
Appellants characterize such conditions as “well known to those of ordinary skill
in the art,” but do not cite any evidence in the record that either supports this
assertion or identifies such a condition.
While attorney argument can in some circumstances limit the scope of
patent claims by means of prosecution history estoppel, see Haynes Int'l, Inc. v.
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Jessop Steel Co., 8 F.3d 1573, 1579, 28 USPQ2d 1652, 1657 (Fed. Cir. 1993),
we are aware of no authority saying that claims can be broadened beyond the
scope defined by the specification merely through attorney argument. We
therefore decline to accept Appellants’ unsupported assertion that a person of
ordinary skill in the art would know that ß-amyloid peptide is associated with
conditions in organs other than the brain.
Thus, when we read the claims in light of the specification, we conclude
that the scope of the properly construed claims is limited to a method of treating
a condition of the brain that is associated with ß-amyloid peptide. This is the
broadest reasonable meaning of the words in the claim, as they would be
understood by one of ordinary skill in the art, taking into account the
enlightenment that is afforded by Appellants’ specification. See In re Morris,
127 F.3d at 1054, 44 USPQ2d at 1027.
Having construed the claims, we can now turn to the issue of enablement.
When we do so, we conclude that proper interpretation of the claims has
effectively disposed of the enablement issue. The examiner has conceded that
the specification is enabling for inhibiting ß-amyloid peptide production in the
brain, and we have concluded that the scope of the claims is limited to treatment
of disorders of the brain. Therefore, the examiner’s position would appear to be
that the claims as we have construed them are enabled throughout their scope.

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Application 08/213,873

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Other Issues
We note that the application file contains an Information Disclosure
Statement that was submitted on August 5, 1994, before the first Office action.
The IDS was never initialed by the examiner to show that he considered the cited
references. We also note that only the first two of the cited references are
currently in the application file. (Whether the other references cited were also
present at one time, we cannot tell.) Upon return of the case, the examiner
should treat the IDS as appropriate under 37 CFR §§ 1.97 and 1.98.

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Summary
We reverse the rejection for lack of enablement because the claims,
properly construed, are limited to treatment of brain disorders and the examiner
has conceded that the specification enables such treatments.

REVERSED

Sherman D. Winters )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Douglas W. Robinson )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Eric Grimes )
Administrative Patent Judge )

EG/cam
Appeal No. 1997-2741
Application 08/213,873

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Paul J. Gaylo
Eli Lilly and Company
Patent Division/PJG
Lilly Corporate Center
Indianapolis, IN 46285