Ex Parte Belanoff

Board of Patent Appeals and Interferences

Jun 29, 2007

10230575 (B.P.A.I. Jun. 29, 2007)

The opinion in support of the decision being entered today is not binding
precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte JOSEPH K. BELANOFF
____________

Appeal 2007-11551
Application 10/230,575
Technology Center 1600
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Decided: June 29, 2007
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Before TONI R. SCHEINER, DONALD E. ADAMS, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 1-15, the only
claims pending in this application. We have jurisdiction under 35 U.S.C.
§ 6(b).

1 Heard May 17, 2007.
Appeal 2007-1155
Application 10/230,575

INTRODUCTION
The claims are directed to a method of inhibiting cognitive
deterioration in an adult patient with Down’s syndrome but without
dementia. Claim 1 is illustrative:

1. A method of inhibiting cognitive deterioration in an adult patent
with Down’s syndrome but without dementia, the method comprising the
step of administering to the patient an amount of a glucocorticoid receptor
antagonist effective to inhibit cognitive deterioration, with the proviso that
the patient be not otherwise in need of treatment with a glucocorticoid
receptor antagonist.

The Examiner relies on the following prior art references to show
unpatentability:
Schatzberg (‘596) WO 9959596 Nov. 25, 1999.
Schatzberg (‘046) US 6,369,046 B1 Apr. 9, 2002.
Schatzberg (‘802) US 6,620,802 B1 Sep. 16, 2003.
Yoshiki Sekijima et al., “Prevalence of Dementia of Alzheimer Type and
Apolipoprotein E Phenotypes in Aged Patients with Down’s Syndrome,”
European Neurology, Vol. 39, No. 4, pp. 234-237 (1998).

The rejections as presented by the Examiner are as follows:
1. Claims 1-15 stand rejected under 35 U.S.C § 103(a) as unpatentable over
the combination of Schatzberg ‘596 and Sekijima.
2. Claims 1-15 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-13 of
Schatzberg‘802.
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3. Claims 1-15 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-20 of
Schatzberg‘046.
We reverse.

DISCUSSION
Down’s syndrome (DS) is a genetic trait that “arises from one of three
chromosomal abnormalities” (Specification 1: ¶ 03). In most cases “DS is
the result of trisomy 21, or the presence of an extra chromosome 21 in
otherwise diploid cells” (id.). However, about 2-4% of DS cases are the
result of a translocation event, “occurring when a fragment of chromosome
21 becomes attached to another chromosome, most typically chromosome
14” (id.). “The rarest form of DS[ ](about 1-4% of cases) results from
nondisjunction of chromosome 21 during early embryogenesis. Such
individuals are mosaic, with both normal and trisomic cells being present”
(id.).”
“DS individuals are almost invariably cognitively impaired . . .”
(Specification 1: ¶ 04). “Generally, significant developmental delays are
apparent in DS child[ren] in infancy and early childhood. . .” (id.).
“Superimposed on this early cognitive impairment, however, is a more
serious deterioration of cognition that begins to appear as individuals with
DS age” (Specification 1: ¶ 05). “No effective treatment for the cognitive
impairment and decline of DS individuals is known” (id. at 2: ¶ 06).
Appellant asserts that “[t]he present invention therefore fulfills the need for
an effective preventive measure for cognitive deterioration in DS patients by
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providing methods of administering glucocorticoid receptor antagonists to
improve cognitive function in DS patients” (Specification 4: ¶ 10).

OBVIOUSNESS:
Claims 1-15 stand rejected under 35 U.S.C § 103(a) as unpatentable
over the combination of Schatzberg ‘596 and Sekijima. Claim 1 is directed
to a method of inhibiting cognitive deterioration in an adult patient with
Down’s syndrome but without dementia. Claims 2-15 ultimately depend
from claim 1. The claimed method comprises the single step of
administering a glucocorticoid receptor antagonist to an adult patient with
Down’s syndrome, but without dementia, in an amount that is effective to
inhibit cognitive deterioration. According to Appellant’s Specification,
“dementia was previously known to be treated by glucocorticoid
antagonists” (Specification 12: ¶ 43). Therefore, “Down syndrome patients
with dementia are outside the scope of this invention” (id.). In this regard,
we recognize that the claim method requires that the patient must not
otherwise be in need of treatment with a glucocorticoid receptor antagonist.
Appellant’s Specification defines the term “dementia” according to
the “American Psychiatric Association: Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition [(DSM-IV)] . . . as characterized by
multiple cognitive deficits that include impairments in memory . . .”
(Specification 6: ¶ 22). In contrast, “[t]he term ‘cognitive deterioration’
refers to a loss of ability to remember concrete facts (names or objects) or to
solve logical problems” (Specification 6: ¶ 21). According to Appellant’s
Specification, “[w]here cognitive deterioration in adults with DS is severe,
patients may meet the criteria for clinical dementia, as set forth in the DSM-
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IV-TR” (Specification 12: ¶ 43). Therefore, as we understand it, while
cognitive deterioration may lead to dementia, cognitive deterioration and
dementia (including dementia of the Alzheimer’s type) represent two
separately definable ailments. Accordingly, the claimed method intends to
treat a DS patient exhibiting cognitive deterioration before the deterioration
reaches the dementia stage.
The Examiner relies on Schatzber ‘596 to teach a method for treating
dementia or Alzheimer’s disease in an adult patient by administering an
effective amount of a glucocorticoid receptor antagonist (Answer 3-4). The
Examiner recognizes, however, that Schatzberg ‘596 does not teach the
treatment of “cognitive deterioration in an adult patient with Down’s
syndrome” (Answer 4). To make up for this deficiency in Schatzberg ‘596,
the Examiner relies on Sekijima to teach the prevalence of dementia of the
Alzheimer’s type in DS patients (Answer 4).
Based on this evidence, the Examiner finds that “[i]t would have been
obvious to a person of ordinary skill in the art at the time the invention was
made to employ the same active compounds in the same effective amount in
a method of inhibiting cognitive deterioration in an adult [p]atient with
Down’s syndrome” (Answer 4-5).
In response, Appellant asserts that both Schatzberg ‘596 and Sekijima
address “dementia, such as dementia of [the] Alzheimer type (DAT)” and
therefore provide no motivation or reasonable expectation of success in
treating cognitive deterioration in DS patients (Br. 7). We agree.
Schatzberg ‘596 is directed to “a method of treating dementia in an
individual diagnosed as having symptoms of dementia. . .” (Schatzberg ‘596
3). In addition, Schatzber ‘596 states that “[d]ementia associated with
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Alzheimer’s disease is treated by the methods of the invention” (Schatzberg
‘596 11). Schatzberg ‘596’s definition of dementia is the same as
Appellants (Schatzberg ‘596; Specification 6: ¶ 22). However, Appellant’s
expert Dr. Ranga Ram Krishnan explains, “cognitive deterioration from
Down’s syndrome, dementia of the Alzheimer’s type, and mild cognitive
impairment are regarded as distinct conditions in the medical community,
even though some overlapping may exist in the symptoms” (Krishnan
Declaration 4: ¶ 10). Accordingly, Dr. Krishnan declares that “a person of
skill in the art would not reasonably expect one common treatment method .
. . for cognitive deterioration in Down’s syndrome, for dementia of the
Alzheimer’s type, and for mild cognitive impairment” (id.).
In response, the Examiner asserts that Schatzberg ‘596 uses
descriptive terms that apply to both dementia and cognitive deterioration
(Answer 8). We agree and note that there does not appear to be any dispute
on this record that dementia and cognitive deterioration from Down’s
syndrome have overlapping symptoms (see, e.g., Krishnan Declaration 4:
¶ 10). However, without evidence to the contrary, an overlap in symptoms
does not lead to a conclusion that the impairments are equivalent or that the
treatment of one condition will work for another (id.).
We recognize the Examiner’s assertions regarding Sekijima (Answer
8-9). We note, however, that the Examiner uses the terms Alzheimer’s
disease, cognitive decline, cognitive deterioration, and dementia as if they all
relate to the same impairment. While cognitive decline may be a symptom
of Alzheimer’s disease, cognitive deterioration, and dementia, the evidence
on this record supports the finding that these impairments represent distinct
medical conditions. Accordingly, we disagree with the Examiner’s assertion
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that “it would be obvious to use a known compound for the treatment of
dementia (and cognitive decline), specifically for use with Alzheimer’s
disease, in patients with Down’s syndrome as there is a known increase in
cognitive impairment and specifically of Alzheimer’s disease pathogenesis
in Down’s syndrome patients” (Answer 9). To the contrary, the evidence of
record points the other way. Specifically, Krishnan declares that
[i]t is particularly true that therapeutic regiments suitable for
normal patients are not predictably effective or necessarily
recommended for patients with genetic abnormalities, such as a
patient with Down’s syndrome. This is because patients with
genetic defects (e.g., Down’s syndrome) differ from genetically
normal patients in multiple physiological/biochemical
parameters, which can be immediately relevant to the
effectiveness and possible side effects of any given treatment
modality.

(Krishnan Declaration 5: ¶ 11.)
We remind the Examiner that a claim “composed of several elements
is not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art. Although common sense directs one
to look with care at a patent application that claims as innovation the
combination of two known devices according to their established functions,
it can be important to identify a reason that would have prompted a person
of ordinary skill in the relevant field to combine the elements in the way the
claimed new invention does.” KSR Int’l v. Teleflex Inc., 127 S. Ct. 1727,
1741, 82 USPQ2d 1385, 1396 (2007).
On reflection, we find that Schatzber ‘596 fails to teach or suggest a
method of inhibiting cognitive deterioration in an adult patient with Down’s
syndrome, but without dementia. In our opinion, Sekijima fails to make up
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for the deficiency in Schatzber ‘596. Accordingly, we reverse the rejection
of claims 1-15 under 35 U.S.C § 103(a) as unpatentable over the
combination of Schatzber ‘596 and Sekijima.

OBVIOUSNESS-TYPE DOUBLE PATENTING:
Claims 1-15 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-13 of
Schatzberg ‘802. The claims in Schatzberg ‘802 are directed to a method of
treating mild cognitive impairment. In the Examiner’s opinion, since the
same active agent is administered the method of Schatzberg ‘802 and
Appellants’ claimed methods overlap. We disagree. As discussed above,
mild cognitive impairment and cognitive deterioration in Down’s syndrome
are distinct impairments. For the reasons set forth above, we find no
evidence on this record to suggest that a method of treating mild cognitive
impairment would be effective to inhibit cognitive deterioration in an adult
patient with Down’s syndrome but without dementia. Accordingly, we
reverse the rejection of claims 1-15 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-13 of
Schatzberg ‘802.

Claims 1-15 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-20 of
Schatzberg ‘046. The Examiner finds that Schatzberg ‘046 is “drawn to a
method of inhibiting progression toward dementia in a patient therein
administering the same glucocorticoid receptor antagonist as the instantly
claimed” (Answer 7-8). According to the Examiner, the patient population
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in Schatzberg ‘046 overlaps the patient population in Appellant’s claimed
method.
There can be no doubt that Schatzberg ‘046’s invention is directed to
a method of inhibiting progression toward dementia by administering a
glucocorticoid receptor antagonist in an amount that is effective to treat
dementia. However, Schatzberg ‘046 requires that the patient being treated
is determined to have a score of between 21 and 29 on the Folstein Mini
Mental Status Exam. The Examiner makes no findings on this record to
establish a nexus between the patient treated in Schatzberg ‘046 and the
patient treated in Appellant’s claims. Instead, the Examiner simply asserts
that the patient population is the same. In our opinion, the factual evidence
before us is insufficient to sustain the rejection. Conclusions of obviousness
must be based upon facts, not generality. In re Warner, 379 F.2d 1011,
1017, 154 USPQ 173, 178 (CCPA 1967); In re Freed, 425 F.2d 785, 787,
165 USPQ 570, 571 (CCPA 1970).
Accordingly, we reverse the rejection of claims 1-15 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1-20 of Schatzberg ‘046.

CONCLUSION
In summary, we reverse all rejections of record.

REVERSED

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ssc

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