Ex Parte Abel et al

Patent Trial and Appeal Board

Mar 6, 2017

13495605 (P.T.A.B. Mar. 6, 2017)

United States Patent and Trademark Office
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/495,605 06/13/2012 Kenton B. Abel 18911 (NTB) 5105
51957 7590 03/15/2017
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
EXAMINER
MINNIFIELD, NITA M
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
03/15/2017 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 KENTON B. ABEL and ANDREW M. BLUMENFELD
Appeal 2016-003521
Application 13/495,6051
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and DAVID
COTTA, Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating at least one symptom of post-traumatic stress disorder. The
Examiner rejected the claims on appeal under 35 U.S.C. § 112(a) as failing
to comply with the written description requirement and as failing to comply
with the enablement requirement.
We reverse.
1 According to Appellants, the real parties in interest is Allergan, Inc. Br. 3.
Appeal 2016-003521
Application 13/495,605
STATEMENT OF THE CASE
Claims 1 and 5 are on appeal. Claim 1 is illustrative and reads as
follows:
1. A method of treating at least one symptom of post-
traumatic stress disorder in a patient in need thereof, the
method comprising the step of administering to the patient a
therapeutically effective amount of a composition including
a botulinum neurotoxin serotype A (BoNT/A), wherein
administration is to the glabellar complex; wherein
administration of the composition decreases the at least one
symptom of the post-traumatic stress disorder; and wherein
the at least one symptom of post-traumatic stress disorder
comprises total or partial amnesia of a traumatic event,
flashbacks or nightmares wherein the patient re-experiences
the traumatic event, avoidance of stimuli associated with the
traumatic event, increased arousal including difficulty
falling or staying asleep, anger, hyper-vigilance, or
combinations thereof.
The claims stand rejected as follows:
Claims 1 and 5 under 35 U.S.C. § 112(a) as failing to comply with the
written description requirement;
Claims 1 and 5 under 35 U.S.C. § 112(a) as failing to comply with the
enablement requirement.
FINDINGS OF FACT
1. The Specification discloses: “Post-traumatic stress disorder
(PTSD) is a severe anxiety disorder that can develop after exposure to any
event that results in psychological trauma.” Spec. 13.
2. The Specification discloses:
A post-traumatic stress disorder (PTSD) refers to a
disorder where an individual has one or more symptoms
due to an over-reactive adrenaline response to a triggering
traumatic event, which creates neurological patterns in the
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brain and biochemical changes in the brain and body that
persist long after the triggering event is over. As a result,
an individual affected with a PTSD is hyper-responsive to
future fearful or stressful events.
Id. at 190.
3. The Specification discloses: “Symptoms for PTSD include re­
experiencing the original trauma(s) through flashbacks or nightmares,
avoidance of stimuli associated with the trauma, and increased arousal —
such as difficulty falling or staying asleep, anger, and hyper-vigilance.” Id.
at 13.
4. The Specification discloses:
Symptoms of a PTSD can include, without limitation:
amnesia regarding parts or all of the event; anger;
avoidance of people, places or things that may serve as
reminders of the event; flashbacks, dreams or other
memories that cause the sufferer to re-experience the
traumatic event; hypervigilance; insomnia; lack of
concentration; emotional numbing of or complete inability
to feel certain feelings; an intensely negative response,
either psychological or physiological or both, to reminders
of the event; reduction in ability to participate in
significant life activities; and, a significant impairment of
major areas of life activity, such as social relations, work,
etc. Additionally, alcohol and drug abuse can commonly
co-occur with a PTSD, and other psychological disorders
(such as an anxiety disorder) can be exacerbated or
worsened[]. In some cases a PTSD can become chronic.
Id. at 191.
5. The Specification discloses: “methods for treating an individual
suffering from physiological trauma disorders. This is accomplished by
administering a therapeutically effective amount of a composition
comprising a Botulinum toxin (BoNT) and/or a TEM to an individual in
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need thereof. The disclosed methods provide a safe outpatient-based
treatment.” Id. at| 16.
6. The Specification discloses: “As used herein ‘treating’ or ‘to
treat’ means to alleviate, modulate, or eliminate either a symptom of a
condition or disorder or the condition or disorder itself.” Spec. 126.
7. The Specification discloses:
As used herein ‘therapeutically effective’ means an
amount of toxin administered that will reduce or
ameliorate a condition or symptom (in frequency and/or
intensity) in a subject. The therapeutically effective
amount of toxin, such as a botulinum neurotoxin,
delivered to a subject, is an amount that achieves a desired
effect yet does not result in undesirable systemic side
effects associated with systemic neurotoxin poisoning, as
known by those of ordinary skill in the art.
Id. at 128.
8. The Specification discloses multiple prophetic examples in
which subjects are administered botulinum neurotoxin serotype A (“BoNT/A”
or “Botox®”) and/or a targeted exocytosis modulator. The examples
describe the subjects as suffering from symptoms including symptoms
associated with PTSD. In each of the examples, following treatment the
patient reports a decrease in his symptoms. Id. at || 119-31.
9. The Specification discloses: “a therapeutically effective amount
of a Clostridial toxin generally is in the range of about 1 fg to about 30.0
pg.” Id. at 1103; see also, 103—05.
10. The Specification discloses: “Variations in these dosage levels
can be adjusted using standard empirical routines of optimization, which are
well-known to a person of ordinary skill in the art.” Id. at 198.
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11. Gaffney2 discloses:
Botox (nabotulinumtoxin A): Also a technique with no
research evidence at this point, Botox is being used in a
limited trial to assess if injections into facial nerves will
have a positive side effect of decreasing negative affect
associated with PTSD. This work is proceeding due to
an[ec]dotal reports that Botox injections ha[ve] sometimes
decreased depressive emotions in those diagnosed with
Major Depressive Disorder.
Gaffney at p. 4.
12. Rosenthal3 discloses “[a] retrospective cohort study was
conducted among 270 consecutive U.S. Army soldiers diagnosed with post-
traumatic headache at a single Army neurology clinic.” Rosenthal 1564.
The objective of Rosenthal’s study was to “determine the impact of post-
traumatic stress disorder (PTSD) on headache characteristics and headache
prognosis in U.S. soldiers with post-traumatic headache.” Id.
2 Gaffney, Established and Emerging PTSD Treatments, 2(7) Ment.
Health Clin. 35 (2013), available at: http://cpnp.Org/resource/mhc/2013/0
1/established-and-emerging-ptsd-treatments (“Gaffney”). Gaffney post-dates
the filing of the present application and was cited by the Examiner as
evidence that “[t]he state of the art teaches that there is no evidence that
Botox can be used to successfully treat PTSD.” Final Act. 5.
3 Rosenthal et al., Post-Traumatic Stress Disorder in U.S. Soldiers With
Post-Traumatic Headache, 53 Headache 1564—72 (2013) (“Rosenthal”).
Rosenthal post-dates the filing of the present application and, like Gaffney,
was cited by the Examiner as evidence that “[t]he state of the art teaches that
there is no evidence that Botox can be used to successfully treat PTSD.”
Final Act. 5.
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WRITTEN DESCRIPTION
A description adequate to satisfy 35 U.S.C. § 112, first paragraph,
must ‘“clearly allow persons of ordinary skill in the art to recognize that [the
inventor] invented what is claimed.’” AriadPharms., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (enbanc) (citation omitted, alteration
in original). “[T]he test for sufficiency is whether the disclosure of the
application relied upon reasonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as of the filing date.”
Id. “If. . . the specification contains a description of the claimed invention,
albeit not in ipsis verbis (in the identical words), then the examiner . . . , in
order to meet the burden of proof, must provide reasons why one of ordinary
skill in the art would not consider the description sufficient.” In re Alton, 76
F.3d 1168, 1175 (Fed. Cir. 1996)
Here, the Specification describes PTSD and specifically identifies the
symptoms thereof. See FF1—FF4. All of the symptoms recited in claim 1
are taught to be symptoms of PTSD. See FF3 and FF4. The Specification
further teaches a method of treatment that involves administering an
effective amount of BoNT/A. See, e.g., FF5 and FF8. The terms
“treatment” and “effective amount” are specifically defined to involve
ameliorating or reducing symptoms of a condition. FF6 and FF7. In
addition, the examples in the Specification provide written description
support for reducing at least one of the claimed symptoms of PTSD by
administering BoNT/A. For instance, Example 2 (a prophetic example)
describes a patient having flashbacks, having difficulty sleeping,
experiencing anger outbursts, having difficulty concentrating, and feeling
hypervigilant. Spec. 1121. In Example 2, following administration of 100
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units of Botox®, “within days, the patient reports a decrease in his
symptoms” and the patient is “evaluated at three months to determine
whether another round of administrations is necessary.” Id. at 1122. We
find that these teachings show Appellants to be in possession of a method of
treating PTSD that “decreases the at least one symptom” recited in claim 1.
The Examiner found that the claimed invention did not satisfy the
written description requirement because “[t]he state of the art teaches that
there is no evidence that Botox can be used to successfully treat PTSD.”
Final Act. 5. As support, the Examiner cites Gaffney and Rosenthal. Id.
(quoting FF11). We are not persuaded.
Neither Gaffney nor Rosenthal provides evidence that counters the
teaching of the Specification that Botox can be used to treat PTSD. See FF5
and FF8. Gaffney simply points to an absence of evidence that Botox can be
used to treat PTSD. FF11. Indeed, rather than call the Specification’s
teachings into doubt, Gaffney’s reference to anecdotal reports that Botox
“decreased depressive emotions” lends credibility to the statements in the
Specification that Botox can be used to treat PTSD. Id. Rosenthal relates to
an attempt to correlate PTSD and headaches. FF12. The Examiner does not
identify, and we do not find, any teaching in Rosenthal regarding the
treatment of PTSD with botulinum neurotoxin serotype A. Accordingly,
Gaffney and Rosenthal do not help to meet the Examiner’s burden of
providing a reason “why one of ordinary skill in the art would not consider
the description sufficient.” In re Alton, 76 F.3d at 1175.
The Examiner also found that the claims were not supported by the
Specification because the examples in the Specification do not make clear
“that the specifically claimed symptoms were reduced as a result of
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botulinum neurotoxin administration.” Ans. 5. We disagree with the
Examiner’s finding that it is not clear from the examples which of the
claimed symptoms is reduced by administration of Botox. For instance, in
Example 2, paragraph 121 recites symptoms experienced by a prophetic
patient. Spec. 1121. Paragraph 122 states that “within days, the patient
reports a decrease in his symptoms.” Id. at 1122. A fair reading of
Example 2 is that the decrease in symptoms reported in paragraph 122 of the
Specification refers to all of the symptoms identified in paragraph 121.
Other examples, which include similar language regarding a decrease in
previously identified symptoms, are reasonably interpreted similarly. See, id.
at 11 122-30.
We acknowledge the Examiner’s position that Example 2 indicates
that in addition to treatment with BoNT/A, a patient could alternatively be
treated with a composition comprising TEM or with a composition
comprising TEM and BoNT/A. Ans. 5. The existence of alternative
treatments, however, is of little relevance because Example 2 (and the other
examples in the Specification) clearly supports treatment with just BoNT/A,
and because the claims do not exclude the use of treatments in addition to
BoNT/A.
We also acknowledge the Examiner’s position that it is not clear from
the examples whether “subsequent treatments [were] necessary in view of
the knowledge that the effects of botulinum neurotoxin wear off after a few
months.” Ans. 5. Examples 2—6, however, make clear that a single
treatment was administered and, three months later, the patient was
evaluated to determine whether additional treatments were necessary. Spec.
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122, 124, 126, 128, 130. Moreover, the claims do not require that the
reduction in at least one symptom have any particular duration.
With respect to claim 5, which requires that the composition be
additionally administered to specific muscles and injection sites, the
Examiner states: “it is noted that only Examples 4 and 5 recite any of the
specific muscles and number of injection sites as set forth in claim 5.” Ans.
5. There is no requirement, however, that the claim elements be recited
more than once in order to find sufficient written description support in the
Specification.
Accordingly, we reverse the Examiner’s decision to reject claims 1
and 5 under 35 U.S.C. § 112(a) for failure to comply with the written
description requirement.
ENABLEMENT
A description adequate to satisfy the enablement requirement of 35
U.S.C. § 112(a) requires, inter alia, that the specification enable the person
of ordinary skill in the art to make and use the claimed invention. “Although
the statute does not say so, enablement requires that the specification teach
those in the art to make and use the invention without ‘undue
experimentation. ’ . . . That some experimentation may be required is not
fatal; the issue is whether the amount of experimentation required is
‘undue.’” In re Vaeck, 947 F.2d 488, 495 (Fed. Cir. 1991) (internal citation
omitted). The Examiner bears the burden of explaining why the scope of
protection claimed is not adequately enabled by the description of the
invention provided in the specification including, “providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement.” In re Wright, 999 F.2d 1557, 1561—62 (Fed. Cir. 1993).
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As discussed supra, the Specification describes PTSD, identifies the
symptoms thereof, and provides prophetic examples and general teachings
reflecting the reduction in PTSD symptoms through the administration of
BoTN/A.4 See FF1—FF8. In addition the Specification provides information
regarding dosing and teaches that “Variations in these dosage levels can be
adjusted using standard empirical routines of optimization, which are well-
known to a person of ordinary skill in the art.” FF9 and FF10; see also,
Spec. 119, 122, 124, 126, 128, and 130. We find that these teachings
would have enabled the person of ordinary skill to practice the claimed
invention without undue experimentation.
The Examiner found that the claims did not comply with the
enablement requirement for reasons similar to those underlying the
Examiner’s written description rejection. The Examiner thus found that the
“state of the art teaches that there is no evidence that Botox can be used to
successfully treat PTSD” (Final Act. 19—20 (citing Gaffney and Rosenthal)),
and that “insufficient direction or guidance is presented in the specification
with respect to determining which symptoms were reduced as a result of
Botox administration to the patient.” Id. at 20. In addition, the Examiner
found that “no declaration under 37 C.F.R. 1.132 or other relevant evidence
has been made of record establishing the amount of experimentation
4 While the examples in the Specification are not actual working examples,
we note that “a patentee is not required to provide actual working
examples.” Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1189
(Fed. Cir. 2014) (“we have rejected enablement challenges based on the
theory that there can be no guarantee that prophetic examples actually
work”).
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necessary” and concluded that “[o]ne of skill in the art would require
guidance, in order to make or use the method as claimed.” Id.
As discussed above, neither Gaffney nor Rosenthal provides evidence
that counters the teaching of the Specification that Botox can be used to treat
PTSD. See FF5 and FF8. Neither provides “sufficient reasons for doubting
any assertions in the specification as to the scope of enablement.” In re
Wright, 999 F.2d at 1561—62. As also discussed above, we disagree with the
Examiner that the Specification does not teach which of the symptoms
identified in claim 1 are reduced by treatment with BoTN/A. As the
Examiner has not provided sufficient reasons to doubt the assertions made in
the Specification, the burden of proof did not shift to the Appellants to
demonstrate that the claimed invention would have required undue
experimentation. Accordingly, Appellants had no obligation to come
forward with a “declaration under 37 C.F.R. 1.132 or other relevant evidence
has been made of record establishing the amount of experimentation
necessary.” See id. (discussing burden shifting).
Accordingly, we reverse the Examiner’s decision to reject claims 1
and 5 under 35 U.S.C. § 112(a) for failure to comply with the enablement
requirement.
SUMMARY
For the reasons set forth herein the Examiner’s decision to reject
claims 1 and 5 is reversed.
REVERSED
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