Ex Parte Jackowski et al

Board of Patent Appeals and Interferences

Feb 2, 2009

09994909 (B.P.A.I. Feb. 2, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte GEORGE JACKOWSKI and JOHN MARSHALL
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Appeal 2008-5147
Application 09/994,909
Technology Center 1600
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Decided:1 February 2, 2009
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Before DONALD E. ADAMS, DEMETRA J. MILLS, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 CFR § 1.304, begins to run from the
decided date shown on this page of the decision. The time period
does not run from the Mail Date (paper delivery) or Notification
Date (electronic delivery).

Appeal 2008-5147
Application 09/994,909

This is an appeal under 35 U.S.C. § 134 involving a claim to
an isolated biopolymer marker linked to Alzheimer’s disease. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.

Statement of the Case
The Claim
Claims 1 is on appeal.2 Claim 1 reads as follows:

1. An isolated biopolymer marker consisting of amino acid
residues 2-14 of SEQ ID NO: 1 which evidences a link to Alzheimer's
disease.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Robert F. Clark and Alison M. Goate, Molecular Genetics of
Alzheimer’s Disease, 50 ARCHIVES NEUROLOGY 1164-1172 (1993).

R. Motter et al., Reduction of β-Amyloid Peptide42 in the
Cerebrospinal Fluid of Patients with Alzheimer’s Disease, 38 ANNALS OF
NEUROLOGY 643-647 (1995).

The issue
The Examiner rejected claim 1 under 35 U.S.C. § 101 and 35 U.S.C. §
112, first paragraph as lacking utility (Ans. 3, 8).
The Examiner finds that the sole utility claimed for the biopolymer
marker in claim 1 is that the marker “evidences a link to Alzheimer's

2 Claims 39-46 were withdrawn based upon the restriction
requirement in the May 28, 2004 Final Rejection.
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Application 09/994,909

disease” (Claim 1; Ans. 6). While the Examiner does not doubt that a
marker that is diagnostic of Alzheimer’s disease represents a specific utility,
the Examiner challenges whether the Specification has demonstrated that the
peptide 2-14 of SEQ ID NO: 1 will serve as a diagnostic for Alzheimer’s
disease under the low utility requirement threshold (Ans. 3-8).
Appellants contend that the “application discloses an invention having
specific, substantial, well-established and credible utility by showing an
invention that is useful to the public as disclosed in its current form, rather
than at some future date after further research, as a peptide marker linked to
Alzheimer's disease” (App. Br. 10). Appellants further contend that
“Applicants . . . elucidated and identified amino acid residues 2-14 of SEQ
ID NO: 1 as a fragment of complement component 3 precursor protein found
in healthy, control patients but found to be down-regulated in patients
having Alzheimer's disease” (App. Br. 13).
Appellants also contend that “the Examiner has similarly erred by
improperly questioning the operability of the invention, in that she states
what one of skill in the art would believe without providing evidence to
support her conclusion” (App. Br. 21).
In view of these conflicting positions, we frame the utility and
enablement issues before us as follows:
Did the Examiner err in finding that the relationship of SEQ ID NO: 1
and Alzheimer’s disease failed to satisfy the enablement and utility
requirements?
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Findings of Fact (FF)
Teachings in the Specification regarding utility and
enablement of Biopolymer markers
1. The Specification states that
The present inventors do not attempt to develop a
reference “normal”, but rather strive to specify
particular markers whose presence, absence or relative
strength/concentration in disease vs. normal is
diagnostic of at least one specific disease state or
whose up-regulation or down-regulation is predictive
of at least one specific disease state, whereby the
presence of said marker serves as a positive indicator
useful in distinguishing disease state.

(Spec. 5:12-20.)
2. The Specification teaches that in analyzing the composition of
peptides in human blood, “over 20,000 molecular masses were detected
representing an estimated 5,000 different peptides” (Spec. 6:9-10).
3. The Specification teaches that “[b]iopolymer markers which are
present in both disease and normal states are indicative/predictive based
upon their relative strengths in disease vs. normal, along with the
observation regarding when their signal strengthens/weakens relative to
disease manifestation or progression” (Spec. 11:16-20). No specific disease
states are specified.
4. The Specification teaches that “[f]igures 1 and 4 are
photographs of a gel which is indicative of the presence/absence of the
marker in [Alzheimer’s] disease vs. control and, in cases where the marker is
always present, the relative strength, e.g. the up or down regulation of the
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Application 09/994,909

marker relative to categorization of disease state is deduced” (Spec. 46:20-
47:2).

5. The Specification discloses Figure 1 which is reproduced
below:

“Figure 1 is a photograph of a tricine gel DEAE 3 (Elution) comparing
Alzheimer’s disease versus Age Matched Control” (Spec. 37:3-4).
Examiner’s findings on utility and enablement
6. The Examiner found that the Specification did not disclose “if
the fragment 2-14 was present, not present or present at different levels in
samples identified as obtained from AD patients” (Ans. 5).
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7. The Examiner found that “the instant specification fails to
explain the relationship between a peptide 2-14 of SEQ ID NO: 1 and
Alzheimer’s disease” (Ans. 6).
8. The Examiner found that the Specification fails to teach
“experimentation [that] would include determination if a peptide 2-14 of
SEQ ID NO: 1 is absent or present or present at particular levels in a specific
tissue or body fluid sample of persons suffering from Alzheimer’s disease or
who are at risk of developing AD versus other forms of neurological
conditions and normal individuals” (Ans. 7).
Principles of Law
“Congress intended that no patent be granted on a chemical compound
whose sole ‘utility’ consists of its potential role as an object of use-testing.”
Brenner v. Manson, 86 S. Ct. 1033, 1042 (1966). “[A] patent is not a
hunting license. It is not a reward for the search, but compensation for its
successful conclusion.” Id.
“Tossing out the mere germ of an idea does not constitute enabling
disclosure . . . reasonable detail must be provided in order to enable
members of the public to understand and carry out the invention.”
Genentech, Inc. v. Novo Nordisk, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
We do not believe that it was the intention of
the statutes to require the Patent Office, the courts, or
the public to play the sort of guessing game that might
be involved if an applicant could satisfy the
requirements of the statutes by indicating the
usefulness of a claimed compound in terms of
possible use so general as to be meaningless and then,
after his research or that of his competitors has
definitely ascertained an actual use for the compound,
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adducing evidence intended to show that a particular
specific use would have been obvious to men skilled
in the particular art to which this use relates.

In re Fisher, 421 F.3d 1365, 1375 (Fed. Cir. 2005).
[T]he PTO has the initial burden of challenging
a presumptively correct assertion of utility in the
disclosure…. Only after the PTO provides evidence
showing that one of ordinary skill in the art would
reasonably doubt the asserted utility does the burden
shift to the applicant to provide rebuttal evidence
sufficient to convince such a person of the invention's
asserted utility. See In re Bundy, 642 F.2d 430, 433,
209 USPQ 48, 51 (CCPA 1981).

In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995).
Analysis
The sole utility claimed for the biopolymer marker in claim 1 is that
the marker “evidences a link to Alzheimer's disease” (Claim 1). While there
is no doubt that a marker that is diagnostic of Alzheimer’s disease represents
a specific utility, the Examiner challenges whether the Specification has
demonstrated that the peptide 2-14 of SEQ ID NO: 1 will serve as a
diagnostic for Alzheimer’s disease under the low utility requirement
threshold (Ans. 3-8).
The Specification teaches what biopolymer markers are generically
(FF 1-3). The Specification fails to explain how peptide 2-14 of SEQ ID
NO: 1 “evidences a link to Alzheimer’s disease” as required by claim 1.
The Examiner found that the Specification does not disclose “if the
fragment 2-14 was present, not present or present at different levels in
samples identified as obtained from AD patients” (Ans. 5; FF 6). Further,
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the Examiner found that “the instant specification fails to explain the
relationship between a peptide 2-14 of SEQ ID NO: 1 and Alzheimer’s
disease” (Ans. 6; FF 7). At best, Appellants’ Specification discloses that
Figures 1 and 4 are photographs of a gel which
is indicative of the presence/absence of the marker in
disease vs. control and, in cases where the marker is
always present, the relative strength, e.g., the up or
down regulation of the marker relative to
categorization of disease state is deduced.

(Spec. 46: 20 - 47: 2.) Essentially, the Specification establishes that the
alleged marker can either be present or absent; and if always present then
one looks at the whether the alleged marker is up or down regulated.
Appellants’ Specification fails to establish whether the marker is present or
absence in Alzheimer’s disease, or whether the marker is up or down
regulated in Alzheimer’s disease. Stated differently, the Specification
identifies a peptide, alleges the peptide is a marker of Alzheimer’s disease,
and leaves it to those of ordinary skill in the art to figure out how to use the
peptide as a marker for Alzheimer’s disease.
Appellants have not satisfied the basic quid pro quo embodied by the
utility requirement of 35 U.S.C. § 101, which is to teach how to use the
invention so that the ordinary practitioner can make use of that knowledge.
See Brenner, 86 S. Ct. at 1042. (“[A] patent is not a hunting license. It is not
a reward for the search, but compensation for its successful conclusion.”)
Without specific knowledge of how the peptide of SEQ ID NO: 1 is
associated with Alzheimer’s disease, the Specification does not provide the
ordinary practitioner with a real world, specific, and substantial utility. It
was insufficient in Brenner and Fisher to simply provide potential utilities
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without providing the connecting link that allows the ordinary practitioner to
use the invention.
In the Jackowski Declaration, the Declarant correctly notes that the
comparison between diseased and normal patients would permit
identification of potential markers (Jackowski Declaration ¶ 4). However,
the Jackowski Declaration does not identify any part of the Specification or
drawings in which an actual identification of a marker is made. Further, the
Declaration does not address the issues of reproducibility and accuracy in
complex and genetically diverse patient populations (FF 8).
The Lander Declaration contends that “decreased expression of the
claimed peptide in Alzheimer’s disease is also clearly shown” (Lander
Declaration ¶ 4). However, neither the photographs of the gels presented in
Appellant’s Specification nor the photograph of the gel attached to the
Lander Declaration, “clearly” shows anything whatsoever. The Examiner
found that the photograph of the gels, as originally filed in the Specification,
did not clearly show the change in the abundance of the claimed peptide (FF
6) and we find, upon our careful review, that the photograph of the gel cited
in the Lander Declaration also does not show any clear change in the
abundance of the claimed peptide.
In the instant case, Appellants compound has been identified, but
without information in the Specification on how the abundance, presence or
other property of the peptide differs between normal and Alzheimer’s
disease patients, the mere disclosure of a “link” and the polypeptide does not
satisfy the utility requirement. The Fisher court held that disclosing a
substantial utility means “show[ing] that an invention is useful to the public
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as disclosed in its current form, not that it may prove useful at some future
date after further research. Simply put, to satisfy the ‘substantial’ utility
requirement, an asserted use must show that that claimed invention has a
significant and presently available benefit to the public.” Fisher, 421 F.3d at
1371.
Even though the threshold of utility is low, the Specification must
provide more than a compound that requires further use testing in order to
determine the actual utility. Appellants contention that the “‘link to
Alzheimer’s disease’ . . . was elucidated under real-world conditions” is not
found persuasive. (App. Br. 12.) The Specification never describes how the
resultant peptides are linked to Alzheimer’s disease, which is the central
element necessary to satisfy the utility requirement. Just as in Fisher, where
ESTs were identified, some of which would surely have been useful in
analyzing traits of corn or functioning as promoter sequences, the mere
identification of the physical molecule was not sufficient. Without the
further step of correlating some function of that physical molecule to an
actual utility, the compounds failed to satisfy the utility requirement.
We do not find Appellants comparison of research tools to the instant
invention an apt comparison (App. Br. 15). Unlike research tools such as
gas chromatographs, whose use is instantly evident, the ordinary practitioner
would have to do inventive experimentation to determine the use of the
claimed marker. Appellants invention is one “whose asserted utility requires
further research to identify or reasonably confirm.” Fisher, 421 F.3d at 1372.
We are not persuaded by Appellants’ argument relying upon
Gunnersen that “detection of glutamine synthetase in the cerebrospinal fluid
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Application 09/994,909

of Alzheimer’s disease patients lead to the suggestion of glutamine
synthetase as a potential diagnostic marker for Alzheimer’s disease” (App.
Br. 22). As noted by the Examiner, the current fact pattern differs from
Gunnersen because no correlation is shown, since the “specification only
presents a photograph of a gel containing bands of [a] mixture of
unidentified proteins isolated from different subjects with no clear
explanation” as to why any one of these bands would be a diagnostic marker
for Alzheimer’s disease (Ans. 17).
We also are not persuaded by Appellants reliance upon Emmerling
and Cooper, which are cited to show that it is reasonable to link the claimed
peptide to Alzheimer’s disease (see App. Br. 23). The issue is not whether it
is reasonable to link the peptide but whether there is a link based upon the
evidence presented and what the link is. As discussed above, without
information in the Specification on how the abundance, presence or other
property of the peptide differs between normal and Alzheimer’s disease
patients, the mere disclosure of a “link” does not satisfy the utility
requirement.

Conclusion of Law
The Examiner did not err in finding that the disclosure of SEQ ID
NO: 1 in the Specification and the relationship of SEQ ID NO: 1 and
Alzheimer’s disease failed to satisfy the utility and enablement
requirements.
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SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 101
and 35 U.S.C. § 112, first paragraph.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

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