Ex Parte Lapuerta et al

Board of Patent Appeals and Interferences

Nov 25, 2003

09859614 (B.P.A.I. Nov. 25, 2003)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
Paper No. 14
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte
Pablo Lapuerta
and Michael Gold
___________
Appeal No. 2003-1745
Application No. 09/859,614
ON BRIEF

____________________________
Before WILLIAM F. SMITH, LIEBERMAN, and SCHEINER, Administrative Patent Judges.
LIEBERMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the decision of the examiner
refusing to allow claims 13 through 16, which are all the claims pending in this application.

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Application No. 09/859,614
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THE INVENTION
According to the appellants, the invention is directed to the use of a vasopeptidase
inhibitor to treat or slow the progression of cognitive dysfunction and treat and/or prevent
dementia. Additional limitations are described in the following illustrative claim.

THE CLAIMS
Claim 13 is illustrative of appellants’ invention and is reproduced below.
13. A method of treating and/or slowing the progression of the condition cognitive
dysfunction and treating and/or preventing the condition dementia consisting essentially of
administering to a patent an effective amount of the vasopeptidase inhibitor omapatrilat, a
pharmaceutically acceptable salt of omapatrilat, gemopatrilat, a pharmaceutically
acceptable salt of gemopatrilat, or an effective amount of the combination of a diuretic and
the vasopeptidase inhibitor omapatrilat, a pharmaceutically acceptable salt of omapatrilat,
gemopatrilat, or a pharmaceutically acceptable salt of gemopatrilat.
THE REFERENCES OF RECORD
As evidence of obviousness, the examiner relies upon the following references:
Robl 5,508,272 Apr. 16, 1996
Lis et al. (Lis) Vascular dementia, hypertension and the brain, “Neurological Research”,
Oct. 1997; 19:471-480
Wyss et al. (Wyss) Neurologic consequences of hypertension and antihypertensive drug
therapy, “Current Opinion in Nephrology and Hypertension, 1994; 3:228-235

THE REJECTION
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Claims 13 through 16 stand rejected under 35 U.S.C. §103(a) as being
unpatentable over Robl in view of Lis and Wyss.
OPINION
We have carefully considered all of the arguments advanced by the appellants and
the examiner and agree with the examiner for the reasons stated in the Answer and those
set forth herein that the rejection of claims 13 through 16 under 35 U.S.C. § 103(a) is
well founded. Accordingly, we affirm the rejection.
As an initial matter, it is the appellants’ position that, “[a]ll of claims 13 to 16
stand together.” See Brief, page 2. Accordingly, we select claim 13, the sole independent
claim as representative of the claimed subject matter and limit our consideration thereto.
See 37 CFR §1.192(c)(7)(2002).
The Rejection under § 103(a)
There is no dispute that the primary reference to Robl discloses omapatrilat which is
both an angiotensin converting enzyme, ACE inhibitor, and an inhibitor of neutral
endopeptidase for the treatment of hypertension. See Brief, page 3 and the Office action
of June 19, 2002, page 3. The examiner thereafter relies upon the secondary references
to Lis and Wyss for their disclosure of a correlation between hypertension and cognitive
impairment to show that it would have been obvious to the person having ordinary skill in
the art to have utilized omapatrilat for the treatment or prevention of vascular dementia
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and preventing cognitive dysfunctions. See Office action of June 19, 2002, at page 4.
We agree.
Lis is directed to a discussion of the relationship between both vascular dementia,
cognitive impairment and hypertension. Indeed, treating both elements of cognitive
dysfunction and dementia separately required by the claimed subject matter fall within the
scope of the teachings of Lis. In the abstract Lis states that, “[h]ypertension is thought to
be directly associated with vascular dementia and preliminary evidence suggests an
association between blood pressure and impairments in cognitive functioning.” In a
discussion of the risk factors for dementia, Lis reports on the conclusion reached in another
study that, “[h]ypertension is one of the major risk factors for stroke and vascular
dementia . . . .” See page 475, left-hand column. Indeed Lis reports that, “[m]ost
current literature suggest that hypertension and diabetes seem to be directly associated with
vascular dementia . . . .” See page 475, right-hand column. Furthermore, Lis states that,
“hypertensives are more susceptible to cerebral ischemia and possibly stroke even during
small reductions in cerebral perfusion pressure.” See page 476, right-hand column. We
further find that in a discussion of hypertension and cognitive function Lis reports that,
“higher blood pressures were reliable predictors of poor performance on tests of memory
and abstract reasoning . . . .” See page 477, left-hand column. We find that in discussing
the impact of hypertension on both cognitive impairment and vascular dementia Lis states
that, “sustained hypertension is inversely related to cognitive functioning and is thought to
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be a major risk factor of vascular dementia.” Id. Indeed, we find that, “[h]ypertension is
a well established and potentially remediable risk factor for vascular disease.” See page
477, right-hand column. We further find in a discussion of the prevention of vascular
dementia that, “[p]reliminary research suggests that if we control and/or prevent the risk
factors for stroke, particularly hypertension, we may be able to reduce the incidence of
vascular dementia.” Id. Lis further reports on a study by Meyer that, “published results
from a longitudinal study suggesting that vascular dementia is preventable by control of
hypertension.” Id. We find that, “prevention of hypertension offers promise in terms of
reducing the incidence of vascular dementia and related disorders.” Id. Based upon the
above findings we conclude that it would have been obvious to the person having ordinary
skill in the art to treat and prevent the onset of both dementia and cognitive dysfunction by
using one or more pharmaceutical compositions for the treatment of hypertension.
While we acknowledge that Lis is not directed to any specific anti hypertensive
pharmaceutical composition, Wyss specifically teaches that, “the angiotensin-converting
enzyme inhibitors most consistently lead to cognitive improvement in the overall
hypertensive population.” See Abstract. Furthermore, Wyss in reporting on ACE
inhibitors states that, “reports suggest that antihypertensive drugs that act by inhibiting
ACE may have no adverse effect on cognitive function and may actually improve cognitive
performance in some hypertensive individuals.” See the paragraph bridging pages 230 and
231. Based upon the above findings, we conclude that it would have been obvious to the
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person having ordinary skill in the art to have preferably utilized ACE inhibitors in the
treatment of both elements of cognitive dysfunction and dementia separately required by
the claimed subject matter. Accordingly, the use of a specific ACE inhibitor, such as
omapatrilat, for the treatment or slowing the progression of dementia, would have been
obvious to the person having ordinary skill in the art.
Based upon the above findings and analysis we sustain each of the rejections of
claims 13 through 16.
DECISION
The rejection of claims 13 through 16 under 35 U.S.C. §103(a) as being
unpatentable over Robl in view of Lis and Wyss is affirmed.
The decision of the examiner is affirmed.
No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).

AFFIRMED
WILLIAM F. SMITH )
Administrative Patent Judge )
)
)
)
)
) BOARD OF PATENT
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Application No. 09/859,614
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PAUL LIEBERMAN ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
)
TONI R. SCHEINER )
Administrative Patent Judge )
PL/lp
STEPHEN B. DAVIS
BRISTOL-MYERS SQUIBB COMPANY
PATENT DEPARTMENT
P O BOX 4000
PRINCETON, NJ 08543-4000
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