Ex Parte Abel et alDownload PDFPatent Trial and Appeal BoardMar 6, 201713495605 (P.T.A.B. Mar. 6, 2017) Copy Citation 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 2 Appeal 2016-003521 Application 13/495,605 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 3 Appeal 2016-003521 Application 13/495,605 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. 4 Appeal 2016-003521 Application 13/495,605 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. 5 Appeal 2016-003521 Application 13/495,605 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 6 Appeal 2016-003521 Application 13/495,605 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 7 Appeal 2016-003521 Application 13/495,605 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. 8 Appeal 2016-003521 Application 13/495,605 122, 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). 9 Appeal 2016-003521 Application 13/495,605 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”). 10 Appeal 2016-003521 Application 13/495,605 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 11 Copy with citationCopy as parenthetical citation