Ex parte Graham

Board of Patent Appeals and Interferences

Jul 11, 2000

08211352 (B.P.A.I. Jul. 11, 2000)

1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1)
was not written for publication in a law journal and (2) is
not binding precedent of the Board.
Paper No. 26
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte HERBERT K. GRAHAM
__________
Appeal No. 1997-1705
Application 08/211,352
___________
ON BRIEF
___________
Before OWENS, LIEBERMAN, and DELMENDO, Administrative Patent
Judges.
OWENS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the examiner’s final rejection of
claims 6, 7, 10 and 13-17, and refusal to allow claims 1-4, 11
and 12 as amended after final rejection. These are all of the
Appeal No. 1997-1705
Application 08/211,352
In the event of further prosecution, appellant and the1
examiner should address on the record whether the antecedent
basis in claim 17 for “the presynaptic neurotoxin” is
sufficiently clear.
2
claims remaining in the application.
THE INVENTION
Appellant’s claimed invention is directed toward a method
for treating a juvenile patient up to six years in age who
suffers from muscle contractures due to cerebral palsy.
Claims 1 and 17 are illustrative and read as follows:
1. A method for treating a juvenile patient, said method
comprising formulating a solution containing a presynaptic
neurotoxin for the promotion of normal muscle growth in a
juvenile patient of up to six years in age, suffering from
dynamic contractures due to cerebral palsy, said promotion
having a duration greater than a clinical activity of said
presynaptic neurotoxin, and administering said formulation to
said juvenile patient.
17. A method for causing relief of muscle contractures
due to cerebral palsy in juvenile patients, said method
comprising the administering to a juvenile patient of up to
six years in age an effective amount of botulinum toxin A
having clinical activity for blocking the release of synaptic
vesicles containing acetylcholine, the relief from arrested
muscle growth having a duration greater than the clinical
activity of the presynaptic neurotoxin.[1]
THE REFERENCES
T.K. Das & D.M. Park (Das), “Effect of treatment with
botulinum toxin on spasticity”, 65 Postgrad. Med. J. 208-10
Appeal No. 1997-1705
Application 08/211,352
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(1989).
Barry J. Snow et al. (Snow), “Treatment of Spasticity with
Botulinum Toxin: A Double-Blind Study”, 28 Ann. Neurol. 512-15
(1990).
Joseph Jankovic & Mitchell F. Brin (Jankovic), “Therapeutic
Uses of Botulinum Toxin”, 324 New Eng. J. Med. 1186-94 (1991).
THE REJECTIONS
Claims 1-4, 6, 7 and 10-17 stand rejected under 35 U.S.C.
§ 103 as obvious over Jankovic in view of Snow or Das, and
under 35 U.S.C. § 112, first paragraph, on the ground that the
original specification does not provide adequate written
descriptive support for the invention as now claimed.
OPINION
We have carefully considered all of the arguments
advanced by appellant and the examiner and agree with the
examiner that the claimed invention would have been obvious to
one of ordinary skill in the art at the time of appellant’s
invention over the applied references. Accordingly, we affirm
the rejection under 35 U.S.C. § 103. We also affirm the
rejection of claims 1-4, 7, 10-12, 15 and 16 under 35 U.S.C.
§ 112, first paragraph, but reverse the rejection under 35
U.S.C. § 112, first paragraph, of claims 6, 13, 14 and 17.
Appeal No. 1997-1705
Application 08/211,352
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Rejection under 35 U.S.C. § 103
Appellant states that no claim is made for separate
patentability (brief, page 4). Thus, the claims stand or fall
together and we limit our discussion to one claim, i.e.,
claim 17. See In re Ochiai, 71 F.3d 1565, 1566 n.2, 37 USPQ2d
1127, 1129 n.2 (Fed. Cir. 1995); 37 CFR § 1.192(c)(7)(1995).
In order for a prima facie case of obviousness to be
established, the applied prior art must have provided one of
ordinary skill in the art with both a motivation to carry out
appellant’s claimed method and a reasonable expectation of
success in doing so. See In re Vaeck, 947 F.2d 488, 493, 20
USPQ2d 1438, 1442 (Fed. Cir. 1991); In re O’Farrell, 853 F.2d
894, 902, 7 USPQ2d 1673, 1680 (Fed. Cir. 1988).
Jankovic discloses under “Other Potential Indications”
(page 1191) that “[t]he effects of botulinum toxin on
spasticity in children with cerebral palsy are also being
studied” and, under “Strabismus and Other Disorders of Ocular
Motility” (page 1187), that “children under seven years of age
may require light ketamine anesthesia and restraint” when
treated with botulinum toxin. Jankovic states that he refers
Appeal No. 1997-1705
Application 08/211,352
The clinical activity for blocking the release of2
synaptic vesicles containing acetylcholine recited in
appellant’s claim 17 is an inherent characteristic of
botulinum toxin A as indicated by Jankovic (page 1186).
5
to botulinum toxin A as botulinum toxin (page 1186), and
teaches that “[t]he therapeutic scope of botulinum toxin has
continued to expand, and it now includes a variety of
neurologic disorders associated with
inappropriate muscular contractions or spasms” (page 1187). 2
These teachings, taken together, would have provided one of
ordinary skill in the art with motivation to administer
botulinum toxin A to a child who is less than seven years old
to treat the child for muscle contractures due to cerebral
palsy.
The remaining question is whether one of ordinary skill
in the art would have had a reasonable expectation of success
in carrying out such treatment, i.e., whether there would have
been a reasonable expectation of the absence of detrimental
side effects which would have prevented the treatment from
being useful. Under “Other Potential Indications” (page
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Application 08/211,352
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1191), which includes the statement cited above regarding the
effect of botulinum toxin on spasticity in children with
cerebral palsy being studied, Jankovic states that “[f]urther
studies are needed to establish the efficacy and safety of
botulinum toxin in these and other disorders associated with
muscular spasms”. However, in this section Jankovic also
states that “[t]here are no absolute contraindications to
injections of botulinum toxin except a history of
hypersensitivity to the toxin (none yet reported) and
infection at the site of injection. Thus far, no
teratogenicity has been attributed to botulinum toxin, even
though several women have been injected during pregnancy.
Because botulinum toxin acts on the final common pathway,
spasms of any cause could be temporarily relieved by this
treatment.” This teaching would have provided one of ordinary
skill in the art with a reasonable expectation that
administering botulinum toxin A to a child less than seven
years old would not be accompanied by any side effects which
would render such treatment inadvisable. Consequently, we
conclude that such an administration of botulinum toxin A
Appeal No. 1997-1705
Application 08/211,352
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would have been prima facie obvious to one of ordinary skill
in the art. The recitation in appellant’s claim 17 regarding
“the relief from arrested muscle growth having a duration
greater than the clinical activity of the presynaptic
neurotoxin” is merely an inherent characteristic of the above-
discussed administration of botulinum toxin A, and reciting an
inherent characteristic of the prior art does not render
appellant’s invention patentable. See In re Woodruff, 919
F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990).
Appellant argues that he has discovered that botulinum
toxin A is effective in promoting normal growth and not just
the alleviation of spasticity (reply brief, page 2).
Appellant’s claim 17, however, is directed toward a method for
causing relief of muscle contractures. As discussed above,
Jankovic would have fairly suggested, to one of ordinary skill
in the art, administering botulinum toxin A to a child under
seven years of age to relieve muscle contractures.
Appellant argues that the claimed invention produces
unexpected results (reply brief, page 6). In support of this
argument appellant relies upon Case Study 1 and Example 2 of
Appeal No. 1997-1705
Application 08/211,352
See In re Baxter Travenol Labs., 952 F.2d 388, 392, 213
USPQ2d 1281, 1285 (Fed. Cir. 1991); In re De Blauwe, 736 F.2d
699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
See In re Freeman, 474 F.2d 1318, 1324, 177 USPQ 139,4
143 (CCPA 1973); In re Klosak, 455 F.2d 1077, 1080, 173 USPQ
14, 16 (CCPA 1972).
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the specification.
Regarding Case Study 1, appellant argues that it was
unexpected that in a gait analysis taken at four months after
a five year old girl was injected with botulinum toxin A,
which was after the effects of the toxin had clinically worn
off, her knee flexed to the same extent in swing that it did
prior to injection (reply brief, page 6). This argument is
not persuasive because appellants have not provided a
comparison with the closest prior art, explained why the3
results would have been unexpected by one
of ordinary skill in the art, or provided evidence which is4
commensurate in scope with claim 17 which encompasses relief
from arrested muscle growth which has a duration which is
greater than the clinical activity of the botulinum toxin A by
Appeal No. 1997-1705
Application 08/211,352
See In re Grasselli, 713 F.2d 731, 743, 218 USPQ 769,5
778 (Fed. Cir. 1983); In re Clemens, 622 F.2d 1029, 1035, 206
USPQ 289, 296 (CCPA 1980).
When we give appellant’s claim 17 its broadest6
reasonable interpretation in view of the specification and the
prior art, see In re Kroekel, 504 F.2d 1143, 1146, 183 USPQ
610, 612 (CCPA 1974); In re Moore, 439 F.2d 1232, 1235, 169
USPQ 236, 238-39 (CCPA 1971), we conclude that “juvenile
patients” refers to human juvenile patients.
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as little as a fraction of a second.5
As for Example 2, appellant argues that it was unexpected
that injection of intermuscular botulinum toxin A during the
growth period of the hereditary spastic mouse allowed normal
longitudinal muscle growth to take place (reply brief, page
6). This argument is not persuasive for the reasons given
regarding Case Study 1 and also because appellant has not
established that results for mice are indicative of results
for a human. 6
For the above reasons we conclude, based upon the
preponderance of the evidence, that the method recited in
appellant’s claim 17 would have been obvious to one of
ordinary skill in the art within the meaning of 35 U.S.C.
§ 103. Consequently, we affirm the rejection under this
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Application 08/211,352
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section of the statute.
Rejection under 35 U.S.C. § 112, first paragraph
The examiner argues that there is inadequate written
descriptive support in appellant’s original specification for
“having a duration greater than a clinical activity of said
presynaptic neurotoxin” in claims 1, 6 and 17, “having a
duration greater than a clinical activity of said botulinum
toxin” in claim 7, and “having a clinical activity of about
four months” in claim 10.
We do not find in appellant’s briefs a challenge to the
rejection based on the language in claim 10. We therefore
affirm the rejection under 35 U.S.C. § 112, first paragraph,
of claim 10 and claims 11 and 12 which depend therefrom.
Claims 1 and 7 require that the promotion of normal
muscle growth has a duration greater than the clinical
activity of the presynaptic neurotoxin or botulinum toxin.
Appellant argues (brief, page 12; reply brief, page 8) that
this language is supported by the statements in the
specification that “such functional improvements persist when
the tone reducing effects of the toxin have worn off” (page 4)
Appeal No. 1997-1705
Application 08/211,352
The article relied upon by appellant on page 14 of the7
brief is not part of the specification and is not prior art.
Thus, we give it no weight in our determination of whether the
specification complies with 35 U.S.C. § 112, first paragraph.
11
and “[a]t this stage the effects of the toxin had clinically
worn off and it was found that the knee flexed to the same
extent in swing that it did prior to injection” (page 10). 7
These statements, however, pertain to functional improvements
and knee flexure, whereas claims 1 and 7 require that normal
muscle growth continues to be promoted after the clinical
activity of the toxin ends. Appellant has not pointed out,
and we do not find, written descriptive support in the
original specification for this claim requirement.
Accordingly, we affirm the rejection under 35 U.S.C. § 112,
first paragraph, of claim 1 and claims 2-4 which depend
therefrom, and claim 7 and claims 15 and 16 which depend
therefrom. Also, this is an additional reason for affirming
the rejection under 35 U.S.C. § 112, first paragraph, of claim
10 which depends from claim 7.
Claims 6 and 17 require that the relief from arrested
muscle growth has a duration which is greater than the
clinical activity of the presynaptic neurotoxin. This
Appeal No. 1997-1705
Application 08/211,352
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language appears to have adequate written descriptive support
in the portions of the specification cited above, and the
examiner’s argued distinction between normal muscle growth and
normal range of movement (answer, pages 14-15) is not a
convincing argument to the contrary. We therefore reverse the
rejection under 35 U.S.C. § 112, first paragraph, of claims 6
and claims 13 and 14 which depend therefrom, and claim 17.
DECISION
The rejection of claims 1-4, 6, 7 and 10-17 under 35
U.S.C. § 103 over Jankovic in view of Snow or Das is affirmed.
The rejection under 35 U.S.C. § 112, first paragraph, is
affirmed as to claims 1-4, 7, 10-12, 15 and 16, and reversed
as to claims 6, 13, 14 and 17.
Appeal No. 1997-1705
Application 08/211,352
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No time period for taking any subsequent action in
connection with this appeal may be extended under 37 CFR
§ 1.136(a).
AFFIRMED
TERRY J. OWENS )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
PAUL LIEBERMAN )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
ROMULO H. DELMENDO )
Administrative Patent Judge )
Appeal No. 1997-1705
Application 08/211,352
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TJO:pgg
Walter A. Hecker
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