Ex Parte Caruso

Board of Patent Appeals and Interferences

Apr 30, 2002

08734738 (B.P.A.I. Apr. 30, 2002)

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for publication and is not binding precedent of the Board.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.19

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte FRANK S. CARUSO
__________

Appeal No. 2001-1043
Application No. 08/734,738
__________

ON BRIEF
__________

Before WILLIAM F. SMITH, ADAMS, and GREEN, Administrative Patent
Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
An oral hearing in this case was scheduled for April 23, 2002. Upon
reviewing the case, however, we have determined that an oral hearing will not be
necessary and we render the following decision based on the record. See 37
CFR § 1.194(c).
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 24-33. Claim 24 is representative of the subject matter
on appeal, and reads as follows:
24. A composition comprising at least one morphinan selected from the
group consisting of dextromethorphan, dextrophan and the pharmaceutically
Appeal No. 2001-1043 Page 2
Application No. 08/734,738

acceptable salts thereof and at least one pharmacologically active agent
selected from the group consisting of anticholinergics, tricyclic antidepressants,
antispasmodics, direct-acting bladder smooth muscle relaxants, estrogens,
compounds having estrogen-like activity, and any combination of the forgoing.

The specification states that the claimed compositions are useful for
treating urinary incontinence. See Specification, page 3. The specification also
teaches that morphinans, such as dextromethorphan and dextrophan, are non-
competitive NMDA receptor antagonists. See id. at 2. Claims 25, 28, 29 and 30
further define the anticholinergic, the antidepressant, the antispasmodic and the
compound having estrogen-like activity, respectively. Claims 26, 27 and 31
through 33 all specify that the claimed composition be in sustained release
dosage form.
The examiner relies on the following references:
Thor 5,192,751 March 9, 1993
Mayer et al. (Mayer) 5,321,012 June 14, 1994

In addition, we refer to the following references, copies of which are
attached to this opinion:
Nelson 4,316,888 February 23, 1982
Musacchio et al. (Musacchio) 4,898,860 February 6, 1990

The claims stand rejected under 35 U.S.C. § 103 over the combination of
Thor, Mayer, and alleged admissions in the specification. After careful review of
the record and arguments before us, we reverse. However, we raise other prior
art issues relating to the patentability of the claimed compositions
Appeal No. 2001-1043 Page 3
Application No. 08/734,738

DISCUSSION
The claims stand rejected under 35 U.S.C. § 103 as being obvious over
Thor, Mayer and the admission in the specification, particularly at page 1. The
pertinent part of the rejection is reproduced below.
Thor teaches that NMDA antagonists broadly, possess
activity which may be useful in the treatment of disorders of urinary
incontinence. See particularly column 2, lines 42-58 therein. The
claims differ in that they are drawn to compositions containing
particular NMDA antagonizing compounds in combination with at
least one more pharmacologically active agent which compositions
may be in a sustained release dosage form.
One of ordinary skill would have found it obvious to employ
dextromethorphan or dextrophan in a composition for the treatment
of urinary incontinence since these compounds were known to
have NMDA antagonizing activity. See Meyer et al. particularly the
abstract. Any NMDA antagonizing compound would be reasonably
expected to be similarly useful in the treatment of urinary disorders
herein.

Answer, pages 3-4.
Appellant argues that Thor is drawn to the use of competitive NMDA
receptor antagonists, and that the one example of a non-competitive receptor
antagonist disclosed in the Thor patent, MK-801, was discussed as increasing
the frequency of micturition (urination). Thus, appellant argues that the
disclosure of Thor in fact teaches away from the claimed compositions. In
response, the examiner asserts that “the overwhelming weight of the evidence in
Thor would teach towards the employment of a compound which blocks an
NMDA receptor by any means in the treatment of urinary incontinence,” and that
“[t]he criticality of the particular mechanism of NMDA receptor antagonism or
blockade to the treatment of urinary incontinence is not seen.” Answer, pages
Appeal No. 2001-1043 Page 4
Application No. 08/734,738

5-6 (emphasis in original).
The burden is on the examiner to set forth a prima facie case of
obviousness. See In re Alton, 76 F.3d 1168, 1175, 37 USPQ2d 1578, 1581
(Fed. Cir. 1996). In assessing the prior art, each prior art reference must be
considered in its entirety in an obviousness determination. In re Wesslau,
353 F.2d 238, 241, 147 USPQ 391, 393 (CCPA 1965). As stated in Panduit
Corp., F.2d at 1093, 227 USPQ at 344 “[t]he well established rule of law is that
each prior art reference must be evaluated as an entirety, and that all of the prior
art must be evaluated as a whole.” See W.L. Gore & Assocs., Inc. v. Garlock,
Inc., 727 F.2d 1540, 1550, 220 USPQ 303, 311 (Fed. Cir. 1983), cert. denied,
469 U.S. 851 (1984); In re Kuderna, 426 F.2d 385, 390, 165 USPQ 575, 578-79
(CCPA 1970). In assessing the teachings of the prior art reference as a whole,
the examiner must also consider those disclosures that may teach away from the
invention. See In re Fine, 837 F.3d 1071, 1074, 5 USPQ2d 1596, 1598 (1988).
Thor, when considered in its entirety, teaches the use of competitive
NMDA antagonists in the treatment of urinary incontinence. There is only a
single disclosure of the use of a non-competitive NMDA antagonist in the
Background of the Invention section of the patent, which states:
In humans, it has been shown that the highest density of NMDA
receptors in the spinal cord are located at the sacral level, including
those areas that putatively contain bladder parasympathetic
preganglionic neurons. Because NMDA receptors are excitatory in
nature, pharmacological blockade of these receptors would
suppress bladder activity. Recent studies have shown that MK-
801, a non-competitive NMDA antagonist, increases the volume
necessary to elicit micturation (urination) and decreases the
amplitude of the micturation contraction. However, these studies
Appeal No. 2001-1043 Page 5
Application No. 08/734,738

have shown that the inhibitory effects of MK-801 are not
stereospecific, suggesting that non-specific effects of MK-801
mediated the bladder inhibition. Also, these studies have shown
that MK-801 produces endocrine effects that are dissociated from
its NMDA antagonism. A separate study has shown that the
administration of MK-801 to conscious, freely moving rats produces
an increase in the frequency of micturation.

Thor, col. 2, lines 44-68 (citations omitted).
One of ordinary skill in the art would read this passage, in the context of
the overall disclosure of the use of competitive NMDA antagonists in the
treatment of urinary incontinence, to signify that the inventors have overcome the
problems associated with the use of noncompetitive NMDA receptor antagonists
by using competitive NMDA receptor antagonists. Thus, the ordinary artisan
would read Thor as teaching away from the use of noncompetitive NMDA
receptor antagonists, such as dextromethorphan and dextrophan, in
compositions for the treatment of urinary incontinence. Mayer discloses that
morphinans blocks NMDA receptor activation, but does not remedy the
deficiencies of Thor because Mayer does not speak to the use of morphinans in
treating urinary incontinence. Because one of ordinary skill in the art would read
Thor as teaching away from the use of noncompetitive NMDA receptor
antagonists in the treatment of urinary incontinence, and as neither Meyer nor
the portion of the specification relied upon by the examiner remedy that
deficiency, the rejection does not set forth a prima facie case of obviousness,
and is thus reversed.
Appeal No. 2001-1043 Page 6
Application No. 08/734,738

OTHER MATTERS
We note that the rejection of the composition claims on appeal was made
in the context of the use of the composition disclosed in the specification—the
treatment of urinary incontinence. But the treatment of urinary incontinence is
intended use, and does not serve to limit the claimed compositions.
The panel has discovered several references pertinent to the patentability
of the claimed compositions in a brief search of only the patent literature. The
first reference is U.S. Patent No. 4,898,860, to Musacchio et al. That reference
discloses that an agent such as atropine, one of the claimed anticholinergics, is
not a potent competitor of [3H]dextromethorphan binding. See Musacchio,
column 13, line 67-column 14, line 3. The competition study would read on the
composition of claim 24 because the composition is not limited to any particular
form, the competition study would require the atropine and the
dextromethorphan to be present in the same solution, and the use of
“comprising” allows the presence of other components in the composition. The
second reference, U.S. Patent No. 4,316,888, to Nelson, specifically discloses a
pharmaceutical composition comprising dextromethorphan in combination with
an anticholinergic, such as atropine. See, e.g., Column 1, line 61-column 2, line
6.
Upon receipt of this application, the examiner may want to address the
patentability issues raised in this section, as well as searching for addressing the
composition per se, and not in the context of its intended use.
Appeal No. 2001-1043 Page 7
Application No. 08/734,738

CONCLUSION
The rejection under 35 U.S.C. § 103 before us on appeal is reversed.
The panel has, however, raised other issues for the examiner’s attention.
REVERSED

William F. Smith )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Donald E. Adams )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )
Appeal No. 2001-1043 Page 8
Application No. 08/734,738

Peter G Dilworth
Dilworth & Barrese
333 Earle Ovington Blvd
Uniondale NY 11553