Ex Parte Hanin et al

Patent Trial and Appeal Board

Nov 19, 2013

11552411 (P.T.A.B. Nov. 19, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte LISA D. HANIN and GREGORY F. BROOKS1
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Appeal 2011-010454
Application 11/552,411
Technology Center 3700
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Before MELANIE L. McCOLLUM, ERICA A. FRANKLIN, and
ULRIKE W. JENKS, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
botulinum neurotoxin comparison method. The Examiner has rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 19-35 are on appeal (App. Br. 3). Claims 19 and 27 are
representative and read as follows:

1 Appellants identify the real party in interest as Allergan, Inc. (App. Br. 3).
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19. A method for comparing botulinum neurotoxins, comprising the
steps of:
(a) making a first impression of a skin surface region of an individual
in proximity to a first muscle and a second muscle into or in the vicinity of
which a first botulinum neurotoxin and a second botulinum neurotoxin,
respectively are to be administered, the impression being made while the
first and second muscles are at a first maximum voluntary contraction;
(b) administering the first and second botulinum toxins to the first and
second muscles, respectively;
(c) making a second impression of the skin surface region in
proximity to the first and second muscles, the impression being made while
the first and second muscles are at a second maximum voluntary contraction;
(d) examining the first and second impressions;
(e) obtaining from the impressions mean depth of a skin wrinkle, and;
(f) comparing the mean depth of the skin wrinkle for the first and
second botulinum neurotoxins.
27. The method of claim 19, wherein the first botulinum neurotoxin is
selected from the group consisting of botulinum neurotoxin types A, B, C,
D, E, F and G, and the second botulinum neurotoxin is of a serotype other
than the first botulinum neurotoxin.
Claims 19-26 and 35 stand rejected under 35 U.S.C. § 103(a) as
obvious over Blitzer2 in view of Bazin3 (Ans. 4).
Claims 27-34 stand rejected under 35 U.S.C. § 103(a) as obvious over
Blitzer in view of Bazin and Donovan4 (Ans. 6).
I
The Examiner relies on Blitzer for teaching “a method of comparing
and determining the optimum dose and efficacy of botulinum toxin

2 Andrew Blitzer et al., The Management of Hyperfunctional Facial Lines
with Botulinum Toxin, 123 ARCHIVES OF OTOLARYNGOLOGY – HEAD & NECK
SURGERY 389-92 (1997).
3 Bazin et al., US 4,758,730, Jul. 19, 1988.
4 Donovan, US 6,265,379 B1, Jul. 24, 2001.
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injections in the management of hyperfunctional facial lines and the degree,
onset and duration of the muscle paralysis (at contraction) by using
photography” (Ans. 4). The Examiner relies on Bazin for teaching “a
method of using skin impressions . . . , illumination . . . and photography . . .
to evaluate the efficacy of a skin treatment for managing facial lines
including lengths and depths of wrinkles” (id.).
The Examiner also finds that it “is admitted prior art in product
teaching to compare products side by side for the purpose of direct
comparison” (id.). In addition, the Examiner indicates that Dow5 “was
provided as evidentiary support for the Official Notice position . . . that it is
well known to compare products side by side for the purpose of direct
comparison” (id.).
The Examiner concludes:
It would have been obvious to one of ordinary skill in the art of
skin testing at the time the invention was made to test the
effects of botulinum toxin injections on the skin and underlying
tissue by additionally using skin impressions, illumination and
photography, as taught by Bazin et al, to test[] for lines or
wrinkles and depth (which includes mean depth since statistical
analysis is used in comparison) and to test treatments side by
side for direct comparison.
(Id. at 4-5.)
Analysis
We conclude that the Examiner has set forth a prima facie case, as
summarized above, that representative claim 19 would have been obvious.

5 Dow et al., US 7,368,122 B1, May 6, 2008.
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Appellants argue, however, that Blitzer “includes no discussion of the
use of more than one botulinum toxin” (App. Br. 9). We are not persuaded.
Instead, we agree with the Examiner “that the broadest reasonable
interpretation of ‘a first botulinum neurotoxin and a second botulinum
neurotoxin’ includes two separate doses of a botulinum neurotoxin”
(Ans. 8). In particular, as noted by the Examiner, “dependent claim 26 adds
the additional requirement that the neurotoxins are different (which implies
an acceptable alternative for the independent claim could be ‘are the same’)”
(id.). “Where some claims are broad and others narrow, the narrow claim
limitations cannot be read into the broad.” D.M.I., Inc. v. Deere & Co., 755
F.2d 1570, 1574 (1985).
Appellants also argue that Bazin “disparage[s] previous
methodologies of analyzing impressions made of skin surfaces and
[discusses] the problems associated with cast shadows resulting from
utilizing a single light source” (App. Br. 10). Thus, Appellants argue that
“Bazin teaches away from the methods of the present invention” (id.). We
are not persuaded. Instead, as noted by the Examiner, representative
claim 19 is “not limited to single or multiple light sources, or any particular
technique of obtaining measurements from the impression” (Ans. 9). Thus,
even if we conclude that Bazin teaches away from using a single light
source, we do not agree with Appellants that Bazin teaches away from the
method of claim 19.
In addition, Appellants argue that “the cited art fails to teach the side-
by-side comparison of test results” (App. Br. 11). We are not persuaded.
First, it is proper for an Examiner to rely on “common knowledge” in
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making a rejection (see MPEP ¶ 2144.03). As stated by the Supreme Court,
obviousness analysis “need not seek out precise teachings directed to the
specific subject matter of the challenged claim.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007). Instead, it proper to “take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ.” Id.
It is also proper for the Examiner to later provide evidentiary support
for an assertion of official notice. In fact, the MPEP states that, “[i]f
applicant adequately traverses the examiner’s assertion of official notice, the
examiner must provide documentary evidence in the next Office action if the
rejection is to be maintained (MPEP ¶ 2144.03(C) (emphasis added)). Thus,
we do not agree with Appellants that it is improper for us to consider Dow in
the present appeal. In addition, we agree with the Examiner that Dow
supports the Examiner’s position that it was “well known in the art . . . to
compare products side by side for the purpose of direct comparison” (Final
Rej. 2).
Conclusion
The evidence supports the Examiner’s conclusion that claim 19 would
have been obvious. We therefore affirm the obviousness rejection of
claim 19. Claims 20-26 and 35 have not been argued separately and
therefore fall with claim 19. 37 C.F.R. § 41.37(c)(1)(vii).
II
In rejecting representative claim 27, the Examiner additionally relies
on Donovan for disclosing “many botulinum toxins (serotype A, B, C, D, E,
F and G) for use on humans” (Ans. 6). The Examiner concludes that it
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would have been obvious “to use the many serotype[s] of botulinum toxins
(A, B, C, D, E, F and G) usable on humans, as disclosed in Don[o]van, in the
testing of Blitzer et al. as modified by Bazin et al. in order to do side by side
comparisons of the different toxins effectiveness” (id. at 6-7).
Analysis
We conclude that the Examiner has set forth a prima facie case, as
summarized above, that representative claim 27 would have been obvious.
Appellants argue:
The addition of Donovan to the combination of Blitzer and
Bazin fails to remedy the deficiencies of these two references,
and neither teaches or suggests the claimed method steps.
Appellants note that Donovan is not related to the subject
matter of Blitzer (optimizing the management of hyper-
functional facial lines) nor to that of Bazin (a method for
analyzing a sample made from a skin surface [by] utilizing a
plurality [of] illumination sources), but rather is directed to
methods for treating otic disorders. Otic disorders have nothing
to do with hyperfunctional facial lines, nor methods for
analyzing a sample made from a patient’s skin surface.
(App. Br. 14.) We are not persuaded.
Donovan discloses:
Botulinum toxin type A is the most lethal natural biological
agent known to man. . . . Seven immunologically distinct
botulinum neurotoxins have been characterized, these being
respectively botulinum neurotoxin serotypes A, B, C1, D, E, F
and G each of which is distinguished by neutralization with
type-specific antibodies. The different serotypes of botulinum
toxin vary in the animal species that they affect and in the
severity and duration of the paralysis they evoke.
(Donovan, col. 3, ll. 34-46.) As noted by Appellants, Donovan discloses
administrating these different serotypes for treating an otic disorder (id. at
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col. 5, l. 63, to col. 6, l. 28). However, we agree with Examiner that
Donovan supports the conclusion that that it would have been obvious “to
use the many serotype[s] of botulinum toxins (A, B, C, D, E, F and G)
usable on humans, as disclosed in Don[o]van, in the testing of Blitzer et al.
as modified by Bazin et al. in order to do side by side comparisons of the
different toxins effectiveness” (Ans. 6-7).
Conclusion
The evidence supports the Examiner’s conclusion that claim 27 would
have been obvious. We therefore affirm the obviousness rejection of
claim 27. Claims 28-34 have not been argued separately and therefore fall
with claim 27. 37 C.F.R. § 41.37(c)(1)(vii).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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