Finzi, Eric et al.

Patent Trials and Appeals Board

Feb 17, 2022

2021002122 (P.T.A.B. Feb. 17, 2022)

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. 14/443,359 05/15/2015 Eric Finzi 6863-89339-04 8574 24197 7590 02/17/2022 KLARQUIST SPARKMAN, LLP 121 SW SALMON STREET SUITE 1600 PORTLAND, OR 97204 EXAMINER YAMASAKI, ROBERT J ART UNIT PAPER NUMBER 1657 NOTIFICATION DATE DELIVERY MODE 02/17/2022 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): docketing@klarquist.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ERIC FINZI and NORMAN E. ROSENTHAL __________ Appeal 2021-002122 Application 14/443,359 Technology Center 1600 __________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and RACHEL H. TOWNSEND, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims to a method for treating post-traumatic stress disorder. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the Real Party in Interest as the inventors, Eric Finzi and Norman E. Rosenthal (see Appeal Br. 2). We have considered the Specification filed May 15, 2015 (“Spec.”); Final Rejection of Nov. 22, 2019 (“Final Act.”); Appeal Brief filed April 15, 2020 (“Appeal Br.”); Examiner’s Answer filed Dec. 14, 2020 (“Ans.”); and Reply Brief filed Feb. 3, 2021 (“Reply Br.”). Appeal 2021-002122 Application 14/443,359 2 Statement of the Case Background “Post-traumatic stress disorder (PTSD) is a severe psychological disorder that can develop after exposure to an event that results in psychological trauma” (Spec. 1:14-15). “Diagnostic symptoms for PTSD include re-experiencing the original trauma(s) through flashbacks or nightmares, avoidance of stimuli associated with the trauma, and increased arousal” (id. at 1:17-20). A “number of psychotropic agents . . . have been proposed to be of use to treat PTSD. However, most of these agents treat a subset of symptoms of PTSD, and many are not particularly efficacious or have unwanted side-effects” (id. at 2:2-8). The Claims Claims 1, 3, 6-9, 11-16, and 18-23 are on appeal. Claim 1 is an independent claim, is representative, and reads as follows: 1. A method for treating post traumatic stress disorder (PTSD) in a subject, comprising administering a therapeutically effective amount of a Botulinum toxin to a corrugator supercilii and a procerus muscle of the subject to cause paralysis of the corrugator supercilii and the procerus muscle, thereby treating the PTSD in the subject. The Rejections A. The Examiner rejected claims 1, 3, 6-9, 11-16, 18-21, and 23 under 35 U.S.C. § 103 as obvious over Finzi ’0362 and Borodic3 (Ans. 3-6). 2 Finzi, E., US 2010/0249036 A1, published Sept. 30, 2010. 3 Borodic, G., US 2007/0009555 A1, published Jan. 11, 2007. Appeal 2021-002122 Application 14/443,359 3 B. The Examiner rejected claim 22 under 35 U.S.C. § 103 as obvious over Finzi ’036, Borodic, and Forbes4 (Ans. 6-7). A. 35 U.S.C. § 103 over Finzi ’036 and Borodic The Examiner finds Finzi ’036 teaches method for treating a subject diagnosed with a disorder consisting of major depression, dsythymia or depression with an accompanying anxiety disorder by identifying . . . . a subject with major depression, dsythymia or depression with an accompanying anxiety disorder and administering 30 to 50 unit equivalents of a Botulinum toxin to the corrugator supercilii muscle and a procerus muscle. (Ans. 3). The Examiner acknowledges that Finzi ’036 “does not teach treating PTSD in the subject” (id.). The Examiner finds that “Borodic teaches a method of treating depression and anxiety comprising administering an effective amount of a composition comprising a botulinum toxin” (Ans. 3). The Examiner finds that, although “Borodic teaches Post-traumatic Stress Disorder is classed as an anxiety disorder [as does paragraph [0022] of the instant specification], Borodic also teaches a symptom of Post-Traumatic Stress Disorder can be depression” (id. at 4, alteration in original). The Examiner finds it would have been obvious to modify the method comprising the step of administering the Botulinum toxin to the corrugator supercilii muscle and a procerus muscle as taught by Finzi [’036] by administering the Botulinum toxin to the corrugator supercilii muscle and a procerus muscle of a subject with post-traumatic headaches 4 Forbes et al., The validity of the PTSD checklist as a measure of symptomatic change in combat-related PTSD, 39 Behaviour Res. Therapy 977-86 (2001). Appeal 2021-002122 Application 14/443,359 4 and/or PTSD with depression . . . in order to treat the post- traumatic headaches, PTSD with depression, PTSD caused by a traumatic event and/or PTSD as an anxiety disorder as taught by Borodic. (Ans. 4). Appellant contends there is no prima facie case of obvious[ness], as there is no predictability in the art. Further, the Applicants have demonstrated an unexpected superior result that could not be predicted in view of the combination of Finzi [’036] and Borodic. Furthermore, there is significant evidence of record that the claimed methods are non-obvious, which has been discounted by the Examiner. (Appeal Br. 3). The issue with respect to this rejection is: Does a preponderance of the evidence of record support the Examiner’s conclusion that Finzi ’036 and Borodic would have rendered treatment of PTSD by administration of Botulinum toxin to a corrugator supercilii and a procerus muscle of a subject obvious? Findings of Fact 1. Finzi ’036 teaches a method “for treating depression” where “a therapeutically effective amount of Botulinum toxin A can be injected into one or more of the frontalis, procerus, the corrugator supercilii, orbicularis oculi, or the depressor anguli oris (trianglaris muscle).” (Finzi ’036 ¶ 13). 2. Finzi ’036 teaches “[a]ny form of depression can be treated herein, including mild depression, dysthymia and major depression. The depression can be the result of a mood disorder, and may be accompanied by an anxiety disorder” (Finzi ’036 ¶ 51). Appeal 2021-002122 Application 14/443,359 5 3. Borodic teaches “treatment of primary disorders of mood and affect with a neurotoxin, including depressive, anxiety and sleep disorders as well as other CNS disorders” (Borodic ¶ 2). 4. Borodic teaches methods of selecting a subject for the treatment of pain with botulinum toxin, comprising the step of identifying a subject suffering from a pain syndrome and a condition selected from the group consisting of a depressive disorder, an anxiety disorder and a sleep disorder . . . In a preferred embodiment, the pain syndrome is any one or a combination of the pain syndromes selected from the group consisting of: . . . post- traumatic headaches. (Borodic ¶ 26). 5. Borodic teaches “[p]ost-traumatic Stress Disorder is also classed as an anxiety disorder, and can be triggered by anyone experiencing or witnessing a deeply traumatic event. Some symptoms of Post-Traumatic Stress Disorder can be anger, depression, emotional numbness, flashbacks, nightmares and a tendency to startle easily” (Borodic ¶ 64). 6. Borodic claims 10. A method of treating anxiety comprising the steps of: a) identifying a subject with an anxiety disorder or identifying a subject with at least one symptom of an anxiety disorder; and b) administering an effective amount of a composition comprising a botulinum toxin and a pharmaceutically acceptable carrier to said subject thereby reducing at least one symptom of anxiety. (Borodic 10, claim 10). Appeal 2021-002122 Application 14/443,359 6 7. The Ross Declaration5 teaches: To my knowledge, no treatments applied to the facial musculature, such as those disclosed in the above-referenced patent application (e.g., paralysis of any muscle, let alone the corrugator supercilii and a procerus muscle), were previously known (or suggested) to be of use in treating PTSD. The finding that PTSD could be treated by injecting a drug into the corrugator supercilii and a procerus muscle was a surprise and a very welcome one at that. (Ross Decl. ¶ 4). 8. The Finzi Declaration6 states it is not predictable that the route of administration disclosed in Finzi [’036] would be effective against any particular disorder mentioned in Borodic. We have documented that administration of botulinum toxin to the orbicularis oculi, another route disclosed in Finzi [’036], is ineffective for the treatment of PTSD. We have also documented that administration of botulinum toxin to the corrugator supercilii and the procerus muscle was ineffective for treating two other disorders (sleep disorder and attention deficit disorder) both specified in Borodic. . . . The effectiveness of the claimed method is not predictable in view of Finzi [’036]and Borodic. (Finzi Decl. ¶ 6). 9. The Liebowitz Declaration7 teaches: It is well known in psychiatry that the effectiveness of a drug for treating one disorder, such as PTSD, simply cannot be predicted based on the efficacy of that drug for treating a completely different disorder, such as depression or anxiety. Thus, one of skill in the art cannot simply read Finzi [’036], and 5 Declaration of Dr. Richard Ross, dated April 28, 2018. 6 Declaration of Dr. Eric Finzi, dated Sept. 1, 2019. 7 Declaration of Dr. Michael Liebowitz, dated Sept. 1, 2019. Appeal 2021-002122 Application 14/443,359 7 Borodic, and understand that botulinum toxin administration into particular facial muscles could be used for treating PTSD. (Liebowitz Decl. ¶ 3). Principles of Law A prima facie case for obviousness “requires a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). To differentiate between proper and improper applications of “obvious to try,” this court outlined two classes of situations where “obvious to try” is erroneously equated with obviousness under § 103. In the first class of cases, what would have been “obvious to try” would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. In re Kubin, 561 F.3d 1351, 1359 (Fed. Cir. 2009) (citing In re O’Farrell, 853 F.2d 894, 903 (Fed.Cir.1988)). Analysis We agree with Appellant that the evidence of record supports a finding that there would not have been a reasonable expectation of success in treating a patient population with PTSD using injections of botulinum toxin into the corrugator supercilii and a procerus muscle as required by claim 1 (see Appeal Br. 4, and generally). In particular, we are not persuaded that Finzi ’036’s treatment of Appeal 2021-002122 Application 14/443,359 8 depression by injection of botulinum toxin into the corrugator supercilii and a procerus muscle, muscles that interfere with the ability of the facial muscles to assume a depressed facies (Finzi ’036 ¶ 13), suggests that PTSD would be treated by injections into those muscles. And Borodic does not suggest botulinum toxin injection into those particular muscles for treatment of either anxiety or PTSD (see, e.g.. Borodic ¶ 33.) Borodic also does not suggest how to select a specific treatment location for anxiety or PTSD. Moreover, the evidence of record supports Appellant’s position that an ordinary artisan would not have had a reasonable expectation of success in treating PTSD by selecting to inject botulinim toxin in the specific facial muscles claimed based on the teachings of Finzi ’036 and Borodic or randomly selecting locations on a patient’s face, head, or body for injection of botulinum toxin. The Finzi Declaration explains that some treatment routes worked for some diseases and some did not (FF 8). Consistent with Kubin, this supports Appellant’s position that this is an improper obvious to try situation because the prior art of Finzi ’036 and Borodic gave no indication of which injection parameters were critical for PTSD treatment. Moreover, Finzi ’036 and Borodic gave minimal, if any, direction as to which of many possible choices of injection sites would have had a reasonable likelihood to be successful for treatment of PTSD. The Liebowitz Declaration directly supports this position, noting “[i]t is well known in psychiatry that the effectiveness of a drug for treating one disorder, such as PTSD, simply cannot be predicted based on the efficacy of that drug for treating a completely different disorder, such as depression or anxiety” (FF 9). The Ross Declaration explains the “finding that PTSD could be Appeal 2021-002122 Application 14/443,359 9 treated by injecting a drug into the corrugator supercilii and a procerus muscle was a surprise” (FF 7). We need not address whether the claimed PTSD treatment is an unexpected result to agree with Appellant that Finzi ’036 and Borodic do not reasonably suggest that the ordinary artisan modify a treatment for depression into a treatment for PTSD. And the unrebutted Declaration evidence supports the position that there was not a reasonable expectation of success in treating PTSD by administering botulinum toxin to the two specific muscles, the corrugator supercilii and procerus. Conclusion of Law A preponderance of the evidence of record does not support the Examiner’s conclusion that Finzi ’036 and Borodic render treatment of PTSD by administration of Botulinum toxin to a corrugator supercilii and a procerus muscle of a subject obvious. B. 35 U.S.C. § 103 over Finzi ’036, Borodic, and Forbes Having reversed the obviousness rejection of claim 1 over Finzi ’036 and Borodic for the reasons given above, we also find that the further combination with Forbes does not provide persuasive reasons addressing the absence of a reasonable expectation of success. Indeed, to the extent that Forbes relates to the rejection, Forbes teaches “there is, as yet, no definitive method for confirming a diagnosis of PTSD or assessing the symptom severity” (Forbes 984). Forbes does not support the obviousness rejection of the claims over Finzi ’036 and Borodic. If the patient population itself is difficult to identify, this supports a finding that there would not have been a reasonable expectation of success in the treatment of that patient population. We reverse this rejection for the same reasons as given above. Appeal 2021-002122 Application 14/443,359 10 DECISION SUMMARY In summary: In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 6-9, 11-16, 18- 21, 23 103 Finzi ’036, Borodic 1, 3, 6-9, 11-16, 18- 21, 23 22 103 Finzi ’036, Borodic, Forbes 22 Overall Outcome 1, 3, 6-9, 11-16, 18- 23 REVERSED