Ex Parte First et al

Patent Trial and Appeal Board

May 9, 2016

11566859 (P.T.A.B. May. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111566,859 12/05/2006
51957 7590 05/11/2016
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
Eric R. First
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
17893 (BOT) 6706
EXAMINER
BAEK, BONG-SOOK
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
05/11/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
patents_ip@allergan.com
pair_allergan@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC R. FIRST and RY ANS. IRVINE
Appeal2014-006087
Application 11/566,859 1
Technology Center 1600
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
KRISTI L. R. SA WERT Administrative Patent Judges.
SA WERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the rejection of claims 1
and 9. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appellants identify Allergan, Inc. as the real party in interest. Br. 3.
Appeal2014-006087
Application 11/566,859
STATEMENT OF THE CASE
The claimed invention relates to a method of "enhancing a facial skin
treatment" by administering to a patient a dermatologic agent and botulinum
neurotoxin. As claimed, the botulinum neurotoxin is administered after the
administration of the dermatologic agent. Claims 1 and 9 stand rejected
under 35 U.S.C. § 103(a) for obviousness over Carruthers2 in view of
Eckardt3 and further in view of de Maio. 4 This rejection is before us on
appeal.
Claims 1 and 9 are on appeal. Appellants do not separately argue
claim 9. See Br. 7, 9-12. Thus, we choose independent claim 1 as
representative of claims 1 and 9, and limit our analysis to independent claim
1. See 37 C.F.R. § 41.37(c)(l)(iv).
2 Jean Carruthers and Alastair Carruthers, A Prospective, Randomized,
Parallel Group Study Analyzing the Effect of BTX-A (Botox) and Nonanimal
Sourced Hyaluronic Acid (NASHA, Restylane) in Combination Compared
with NASHA (Restylane) Alone in Severe Glabellar Rhytides in Adult
Female Subjects: Treatment of Severe Glabellar Rhytides with a Hyaluronic
Acid Derivative Compared with the Derivative and BTX-A, 29 Dermatol.
Surg. 802---09 (2003).
3 Andre Eckardt and Christian Kuettner, Treatment of Gustatory
Sweating (Frey's Syndrome) with Botulinum Toxin A, 25 Head & Neck 624--
28 (2003).
4 Mauricio de Maio, The Minimal Approach: An Innovation in Facial
Cosmetic Procedures, 28 Aesth. Plast. Surg. 295-300 (2004).
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Application 11/566,859
Claim 1 provides:
1. A method for enhancing a facial skin treatment for a human
patient in need thereof, the method comprising the step of administering a
botulinum neurotoxin to a skin area designated for skin treatment after the
skin treatment, wherein a dose of neurotoxin administered is determined by
(a) selecting a surface area of the skin, and
(b) multiplying the surface area by a unit of neurotoxin that is
equivalent to about 1-5 units ofbotulinum toxin type A per square
centimeter,
wherein the skin treatment comprises administering a dermatologic
agent selected from the group consisting of hyaluronic acid, crossed linked
hyaluronic acid, and combinations thereof
wherein the result of the skin treatment at the selected skin area is
prolonged relative to the duration of the same treatment result without the
botulinum neurotoxin enhancement.
Appeal Br. 14.
DISCUSSION
Obviousness
A claimed invention is unpatentable if the differences between it and
the prior art are "such that the subject matter as a whole would have been
obvious at the time the invention was made to a person having ordinary skill
in the art." 35 U.S.C. § 103(a) (pre-AIA). To assess whether the subject
matter would have been obvious, the Board follows guidance in Graham v.
John Deere Co., 383 U.S. 1 (1966) andKSRint'l Co. v. Teleflex, Inc., 550
U.S. 398 (2007). The obviousness "analysis need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
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Application 11/566,859
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ." KSR, 550 U.S. at 418.
Applying this standard, we conclude that the Examiner did not err in
determining that representative claim 1 would have been obvious to an
ordinarily-skilled artisan over Carruthers in view of Eckardt and further in
view of de Maio.
The Prior Art
Carruthers discloses the treatment of dynamic glabellar furrowing
("frown lines" between the eyebrows) in adult female patients with
botulinum toxin A ("BTX-A") and hyaluronic acid-based filling agents.
Carruthers 802; Answer 4. Carruthers specifically compared the results
observed in patients treated with hyaluronic acid alone with the results
observed in patients treated with both BTX-A and hyaluronic acid.
Carruthers 803; Answer 4. All patients in the combination-therapy group
received BTX-A treatment one week before hyaluronic acid treatment.
Carruthers 806. Carruthers found that patients treated with a combination of
BTX-A and hyaluronic acid showed a better response both at rest and on full
activated frowning, and experienced a longer duration of response compared
to treatment with hyaluronic acid alone. Carruthers 804--808 (Results &
Discussion), 809 (Summary); Answer 4. Based on these results, Carruthers
observed that "BTX-A may ... play a protective role in the longevity of
filler response in combined use in the glabella." Carruthers 806. Carruthers
hypothesized that "repeated muscular activity can contribute to the breakup
of the hyaluronan molecule," but that "the muscular relaxation provided by
the BTX-A prevented deformation of the filler residing in the dermis." Id.
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The Examiner acknowledges that Carruthers does not explicitly teach
two limitations of claim 1 : ( 1) determining a dose of a botulinum neurotoxin
by selecting a surface area of the skin and multiplying the skin surface area
by a unit of neurotoxin that is equivalent to about 1-5 units of BTX-A per
square centimeter; and (2) administering botulinum neurotoxin after
treatment with hyaluronic acid. Answer 5.
Eckardt discloses the treatment of gustatory sweating (Frey's
syndrome) with BTX-A. Eckardt 624 (Abstract). Eckardt teaches that the
affected skin areas were detected and divided into fields of 1.5 x 1.5 cm, and
that 1 unit of BTX-A was injected per 1 square centimeter skin field.
Eckardt 625; Answer 5.
De Maio describes a "minimal approach" to facial cosmetic
procedures involving the combined administration of hyaluronic acid-based
dermal fillers and botulinum toxin. de Maio 295 (Abstract). de Maio
explains that the hyaluronic acid-based dermal fillers are "influenced by the
movement of muscles in the area to which they are injected," and that
mimetic movement may break down the fillers and lead to reduced effects.
Id. at 296. But because botulinum toxin reduces muscle movement, "[t]he
use of these products in combination can provide better and longer-lasting
results than those seen with product used individually." Id. de Maio states
that when using combination therapy, "it is preferable to inject the
botulinum toxin into the muscle first." Id. de Maio further teaches that
hyaluronic acid may be "injected later or during the same session" as
botulinum neurotoxin administration. de Maio 297.
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Representative Claim 1
On appeal, the Board "reviews the obviousness rejection for error
based upon the issues identified by appellant, and in light of the arguments
and evidence produced thereon." Ex parte Frye, 94 USPQ2d 1072, 1075-76
(BP AI 2010) (Precedential). The issues Appellants raise on appeal are: (1)
whether the prior art discloses or suggests all the limitations of the claim,
and (2) whether the Examiner provided an adequate reason "as to why one
skilled in the art would have combined and modified the cited references to
produce the claimed method." Br. 9. "The presence or absence of a
motivation to combine references in an obviousness determination is a pure
question of fact." In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000).
"What a reference teaches and whether it teaches toward or away from the
claimed invention are questions of fact." Winner Int'! Royalty Corp. v.
Wang, 202 F.3d 1340, 1349 (Fed. Cir. 2000) (quotation omitted).
For the reasons stated below, we find that a preponderance of the
evidence supports the Examiner's rationale for finding that an ordinarily-
skilled artisan would have been motivated to combine the prior art
references. Answer 6-8. We also agree with the Examiner that, although
the prior art does not explicitly teach the administration of botulinum
neurotoxin after treatment with hyaluronic acid, modifying the prior art to
administer first hyaluronic acid and then botulinum neurotoxin would have
been obvious to a person of ordinary skill in the art. Answer 7-8.
As to the first issue, Appellants argue that the prior art references,
even if combined, do not "disclose all of the elements of the claimed
method." Br. 10. As noted above, although both Carruthers and de Maio
disclose combined treatment with botulinum neurotoxin and hyaluronic acid,
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neither reference specifically teaches the administration of botulinum
neurotoxin after treatment with hyaluronic acid. Supra at 5---6. In
Carruthers' study, for example, all combined-therapy patients received
BTX-A treatment one week before hyaluronic acid treatment. Carruthers
806.
Nevertheless, we find that Appellants' argument is not persuasive of
Examiner error. The obviousness analysis may "take account of the
inferences and creative steps that a person of ordinary skill in the art would
employ." KSR, 550 U.S. at 418. For example, the analysis may "include
recourse to logic, judgment, and common sense available to the person of
ordinary skill that do not necessarily require explication in any reference or
expert opinion." Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324,
1329 (Fed. Cir. 2009). Here, the Examiner reasonably employed such
"logic, judgment, and common sense available to the person of ordinary
skill'' when finding that the skilled artisan would have recognized that
administering botulinum neurotoxin after skin treatment with hyaluronic
acid would reduce the movement of muscles in the treated area and thereby
prolong the effect of the hyaluronic acid treatment. Answer 7-8. Thus,
because a precise teaching in the prior art is not necessary for a conclusion
of obviousness, we reject Appellants' assertion of error. See In re Baird, 16
F.3d 380, 383 (Fed. Cir. 1994) (stating that a "reference must be considered
not only for what it expressly teaches, but also for what it fairly suggests")
(quotation omitted).
Appellants also appear to argue that de Maio teaches away from the
claimed order of treatment because de Maio explicitly teaches that "'it is
preferable to inject the botulinum toxin into the muscle first."' Br. 10
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(quoting de Maio at 296). We disagree. "The prior art's mere disclosure of
more than one alternative does not constitute a teaching away from any of
these alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed .... " In re Fulton, 391 F.3d
1195, 1201 (Fed. Cir. 2004). Here, de Maio states that it is "preferable" to
inject botulinum toxin first but does not state or suggest that botulinum
neurotoxin "should not" or "cannot" be injected after treatment with
hyaluronic acid. In re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012). Indeed, de
Maio states that "dermal fillers can be injected ... during the same session"
as the botulinum toxin. de Maio 297. Thus, to the extent that Appellants
argue otherwise, de Maio does not teach away.
As to the second issue, Appellants argue that the Examiner "has failed
to identify a reason as to why a skilled artisan would have selectively
disregarded both Carruthers and [de Maio's] explicit teachings to inject the
botulinum toxin prior to the skin treatment and instead would have
arbitrarily injected the botulinum toxin after the skin treatment." Br. 11.
Appellants point out that both Carruthers and de Maio explicitly teach
injecting botulinum neurotoxin before treatment with hyaluronic acid, and
"provide scientific rationale as to why injecting the toxin prior to the skin
treatment ... would enhance the long-term performance of biodegradable
fillers." Id. (quotation omitted). For these reasons, Appellants argue, the
skilled artisan would not have been motivated to modify the sequence of
injections explicitly described in the prior art. Id. at 11-12.
We find that the preponderance of the evidence supports the
Examiner's reasoning as to the motivation to modify the prior art methods.
Specifically, both Carruthers and de Maio support the Examiner's finding
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that "it was well known in the art to use botulinum toxin A (BTX-A) in
combination with hyaluronic acid for providing more effective skin
treatment with longer duration of response," and that "botulinum toxin
reduces muscular traction and has been shown to enhance the long-term
performance of biodegradable fillers." Answer 7; see also Carruthers 804--
09; de Maio 295-96. de Maio also supports the Examiner's findings that
"biodegradable dermal fillers such as hyaluronic acid are influenced by the
movement of muscles in the area to which they are injected" and that
"mimetic action may break down the polymers of fillers and lead to quicker
absorption." Answer 7; see also de Maio 295-96.
Based on these factual findings, the Examiner provided an adequate
rationale for modifying the prior art. Specifically, as the Examiner
articulated, the skilled artisan would understand that "the use of the
botulinum neurotoxin after or prior to the skin treatment with hyaluronic
acid would provide similar enhancement since the botulinum toxin would
reduce muscular traction, thereby inhibiting breaking down the
biodegradable filler and maintaining the dermal fillers in the designated skin
area longer regardless of the treatment order." Answer 8 (emphases added).
Thus, the skilled artisan would recognize that, although the references may
describe treatment with botulinum neurotoxin before treatment with
hyaluronic acid as preferable, treatment with botulinum neurotoxin after
treatment with hyaluronic acid would also provide the same benefit, absent
evidence to the contrary. "A person of ordinary skill has good reason to
pursue the known options within his or her technical grasp." KSR, 550 U.S.
at 421. And here, the skilled artisan would have been motivated to
administer botulinum neurotoxin to a patient after treatment with hyaluronic
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acid because the botulinum neurotoxin would inhibit breakdown of the
hyaluronic acid and provide for longer-lasting results. Answer 8. For these
reasons, we reject Appellants' argument that the Examiner did not provide a
credible reason for modifying the prior art. KSR, 550 U.S. at 421.
Moreover, the limited number of orders in which botulinum
neurotoxin and hyaluronic acid could be administered to a patient supports
the Examiner's conclusion of obviousness. As the Examiner explained, "the
skilled artisan would have reasonably recognized a finite number of
identified, predictable ways of providing two skin treatments," including the
options of administrating botulinum neurotoxin and hyaluronic acid
simultaneously, administering botulinum neurotoxin before treatment with
hyaluronic acid, and administering botulinum neurotoxin after treatment
with hyaluronic acid. Answer 7-8. As the Federal Circuit has explained,
"[ w ]here a skilled artisan merely pursues 'known options' from 'a finite
number of identified, predictable solutions,; the resulting invention is
obvious under Section 103." In re Cyclobenzaprine Hydrochloride
Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1070 (Fed. Cir.
2012) (quotingKSR, 550 U.S. at 421). Appellants have provided
insufficient evidence or argument of unpredictability or that administration
of botulinum neurotoxin after treatment with hyaluronic acid is outside the
ordinarily-skilled artisan's technical abilities. KSR, 550 U.S. at 421. Thus,
we agree with the Examiner that a skilled artisan would have been motivated
to pursue the option of administering botulinum neurotoxin to a patient after
treatment with hyaluronic acid with the expectation that the botulinum
neurotoxin would inhibit breakdown of the hyaluronic acid and provide for
longer-lasting results. Answer 8.
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Finally, we address Appellants' statement that the Examiner erred by
relying "on Applicant's specification to establish obviousness." Br. 11
(citing Advisory Action at 2). We disagree that the Examiner relied on the
written description to provide a rationale for modifying the prior art. In the
Advisory Action, the Examiner noted that Appellants provided no evidence
of unexpected results from changing the order of treatment found in the prior
art. Adv. Action 2. The Examiner also observed that the written description
makes no distinction between the administration of botulinum neurotoxin
during, before, or after treatment with hyaluronic acid. Spec. 37. Thus, the
Examiner appropriately looked to the written description for evidence of
unexpected results-not to provide a reason for modifying the prior art. Cf
In re Kao, 639 F.3d 1057, 1067 (Fed. Cir. 2011) (stating that an examiner
must consider evidence of secondary considerations when present).
SUMMARY
We affirm the rejection of claims 1 and 9 under 35 U.S.C. § 103(a) on
appeal.
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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