Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Examiner is faced with thirty five claims 98-132 and overwhelming number of Information Disclosure Statements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 98-132 are rejected under 35 U.S.C. 103 as being unpatentable over Barsuclia, ", PROGRESS IN BRAIN RESEARCH, vol. 242, 2018, pages 121-158; Vollenweider NATURE REVIEWS. NEUROSCIENCE, vol. 21, no. 11, 14 September 2020 (2020-09-14), pages 611-624; Balaet, FRONTIERS IN NEUROSCIENCE, vol. 16, 15 March 2022 (2022-03-15); Uthaug, JOURNAL OF PSYCHEDELIC STUDIES, vol. 4, no. 2, 26 March 2020 (2020-03-26), pages 104-113; Machsoud, WO2021216489; Terwey1 WO2020169851; Terwey2 WO2020169850; and Davis, American Journal of Drug and Alcohol Abuse vol. 45, no. 2, 1 March 2019 (2019-03-01), pages 161-169.
Barsuclia titled : "A comparison of reactivation experiences following vaporization and intramuscular injection (IM) of synthetic 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting" teaches (paragraph bridging pages 127-128; page 129, paragraph 2; page 130, paragraph 2) discloses a case report of a patient who presented for treatment of alcohol use disorder. Barsuclia reported currently drinking in order to 'feel stable' and cope with social isolation, homelessness, and poverty. The subject was treated with a 4-day program that included administration of ibogaine HCI and 5-MeO-DMT. 5-MeO-DMT was administered in inhaled form. The patient noted feeling surprised by a lasting improved ability to manage and control his anger and respond less reactively in social situations.
Vollenweider titled "Psychedelic drugs: neurobiology and potential for treatment of psychiatric disorders" teaches that page 619, column 2, paragraph 2 - page 620, column 1, paragraph 1) teaches that psychedelic agents increase emotional empathy (that is, the capacity to feel 'with' other people). Furthermore, it mentions that psilocybin has been shown to reduce the feeling of social exclusion and social rejection processing in the anterior cingulate cortex. These effects may reduce social withdrawal behavior and improve the patient-therapist relationship during psychedelic-assisted treatment.
Vollenweider discloses this agent as a psychedelic (page 611, column 2, last paragraph).
Also, Terwey2 (page 1, last two paragraphs - page 2, paragraph 6; page 13, paragraph 3; example 2; claims) discloses that 5-MeO-DMT is a psychedelic agent.
With respect to route of administration, Vollenweider teaches the administration of 5-MeO-DMT via the i.v., i.m., s.c. route (p. 13, par. 3).
Uthaug (abstract; page 105, column 1, paragraph 1) suggests that compared to vaporization, the i.m. route of administering 5-MeO-DMT is associated with lower and less doses, lower frequencies of reporting reactivation, a higher frequency of physical tension release, and a slower onset of acute effects.
Balaet titled "Psychedelic Cognition-The Unreached Frontier of Psychedelic Science" (page 5, column 2, paragraph 2 - page 6, column 1, paragraph 2) mentions that psychedelics minimize the feelings of social exclusion and make people more empathic, i.e. with less emotional detachment.
Machsoud discloses the use of various psychedelic agents for use in treating symptoms of PTSD including social withdrawal and detachment ("withdrawal from others" and "emotional numbing" in claim 2 of Terwey1). The agent used can be DMT (see claim 9 of Machsoud).
Terwey1 teaches a practitioner to administer 5-MeO-DMT to patients suffering from moderate or severe major depressive disorder as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or more; or by a Hamilton Depression Rating Scale (HAM-D) score of 17 or more. (p. 1, last ¶; p.2, first ¶). The dosage of 5-MeO-DMT is in a range that causes a patient to experience a peak psychedelic experience and is the range from 1 mg to about 10 mg (p.2, 4th ¶).
Terwey1 teaches 5-MeO-DMT may be administered in a first dosage for a first administration and then administered in zero to six subsequent administrations. Terwey1 further teaches the subsequent administrations are at higher dosages than the previous administrations, unless the patient experiences a peak psychedelic experience. The interval time between two administrations is not less than 1 hour and not more than 24 hours, including a range of about 2 to 4 hours (p.2, 6th ¶). The interval time range taught by Terwey1 overlaps with the range instantly claimed range.
Terwey1 teaches, in Example 3, Table 4, a patient in Part B received up to three administrations of 5-MeO-DMT in a single day wherein the first administration was at a dose of 6 mg, the second administration was at a dose of 12 mg, and the third administration was at a dose of 18 mg. The dosage amounts overlap with ranges of instantly claim.
Terwey1 teaches after a first administration and subsequent administrations, which were at higher doses than the previous administrations, unless the patient receives a peak psychedelic experience. The peak psychedelic experience is identified through at least 60% of four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30). The peak psychedelic experience can also be identified through at least 60% of the maximum possible score of the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire (pp. 90-91, Embodiment 37). Similarly, the peak psychedelic experience can be identified through achievement of a Peak Psychedelic Experience Questionnaire (PPEQ) Total Score of at least 75 (p. 91, Embodiment 38). According to the instant specification the PPEQ and the PES tests are equivalent.
Terwey1 teaches most common routes of administration of 5-MeO-DMT are inhalation of smoke or vapor or intranasal insufflation (p. 14, 3rd ¶). Example 1 also describes administration of 5-MeO-DMT via inhalation (p. 92).
Terwey1 teaches that administration of 5-MeO-DMT leads to a clinical response reflecting at least 50% improvement in the MADRS or HAM-D score compared to the respective score prior treatment, not later than about 2 hours after the last administration of 5-MeO-DMT (p. 88, Embodiment 20). Terwey1 teaches the same improvement should be observed, compared to the respective score prior to treatment, persists at least 6 days after the last administration of 5-MeO-DMT. The improvement persistence for 6 days overlaps with range claimed in instant claims.
Terwey1 teaches that after administration of 5-MeO-DMT, improvements in general psychiatric symptoms, such as anxiety, guilt, improved (p. 99)
A person skilled in the art would consider 5-MeO-DMT to be an obvious alternative to DMT and would replace DMT in Terwey1 with 5-MeO-DMT because both act on serotonin receptors, N, N-dimethyltryptamine (DMT) and 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) are structurally related tryptamine psychedelic
Davis teaches that 5-MeO-DMT used in a naturalistic group setting is associated with unintended improvements in depression and anxiety.
Terwey1, Terwey2 and Davis all disclose the use of 5-MeO-DMT to treat various disorders, including depression and anxiety. One of the symptoms of depression mentioned in example 2 of Terwey1 is emotional detachment.
Therefore, the person skilled in the art would expect that the i.v., i.m. or s.c. administration of 5-MeO-DMT also achieves the effects reported in Terwey1 teaches a practitioner to administer 5-MeO-DMT to patients suffering from moderate or severe major depressive disorder as indicated by a Montgomery-Åsberg Depression Rating Scale (MADRS) score of 20 or more; or by a Hamilton Depression Rating Scale (HAM-D) score of 17 or more. (p. 1, last ¶; p.2, first ¶). The dosage of 5-MeO-DMT is in a range that causes a patient to experience a peak psychedelic experience and is the range from 1 mg to about 10 mg (p.2, 4th ¶).
Terwey1 teaches 5-MeO-DMT may be administered in a first dosage for a first administration and then administered in zero to six subsequent administrations. Terwey1 further teaches the subsequent administrations are at higher dosages than the previous administrations, unless the patient experiences a peak psychedelic experience. The interval time between two administrations is not less than 1 hour and not more than 24 hours, including a range of about 2 to 4 hours (p.2, 6th ¶). The interval time range taught by Terwey1 overlaps with the range instantly claimed range.
Terwey1 teaches, in Example 3, Table 4, a patient in Part B received up to three administrations of 5-MeO-DMT in a single day wherein the first administration was at a dose of 6 mg, the second administration was at a dose of 12 mg, and the third administration was at a dose of 18 mg. The dosage amounts overlap with ranges of instantly claim.
Terwey1 teaches after a first administration and subsequent administrations, which were at higher doses than the previous administrations, unless the patient receives a peak psychedelic experience. The peak psychedelic experience is identified through at least 60% of four subscales (mystical, positive mood, transcendence of time and space, and ineffability) of the 30-item revised Mystical Experience Questionnaire (MEQ30). The peak psychedelic experience can also be identified through at least 60% of the maximum possible score of the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) questionnaire (pp. 90-91, Embodiment 37). Similarly, the peak psychedelic experience can be identified through achievement of a Peak Psychedelic Experience Questionnaire (PPEQ) Total Score of at least 75 (p. 91, Embodiment 38). According to the instant specification the PPEQ and the PES tests are equivalent.
Terwey1 teaches most common routes of administration of 5-MeO-DMT are inhalation of smoke or vapor or intranasal insufflation (p. 14, 3rd ¶). Example 1 also describes administration of 5-MeO-DMT via inhalation (p. 92).
Terwey1 teaches that administration of 5-MeO-DMT leads to a clinical response reflecting at least 50% improvement in the MADRS or HAM-D score compared to the respective score prior treatment, not later than about 2 hours after the last administration of 5-MeO-DMT (p. 88, Embodiment 20). Terwey1 teaches the same improvement should be observed, compared to the respective score prior to treatment, persists at least 6 days after the last administration of 5-MeO-DMT. The improvement persistence for 6 days overlaps with range claimed in instant claims.
Terwey1 teaches that after administration of 5-MeO-DMT, improvements in general psychiatric symptoms, such as anxiety, guilt, improved (p. 99)
Consequently, the subject-matter of claim 1 is considered obvious in the light of Barsuclia in combination with Terwey2 or Uthaug. Further a person skilled in the art would know from any of Terwey1, Terwey2 and Davis that depression can be treated by administration of 5-MeO-DMT. These documents suggest that all symptoms of said depression will be treated. A person skilled in the art, reading Terwey1, Terwey2 and Davis would apply 5-MeO-DMT to treat all the symptoms of the disorders mentioned therein, including social/emotional withdrawal.
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 98-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-68 of copending Application No. 18850394 (reference application) further in view of Barsuclia, ", PROGRESS IN BRAIN RESEARCH, vol. 242, 2018, pages 121-158; Vollenweider NATURE REVIEWS. NEUROSCIENCE, vol. 21, no. 11, 14 September 2020 (2020-09-14), pages 611-624; Balaet, FRONTIERS IN NEUROSCIENCE, vol. 16, 15 March 2022 (2022-03-15); Uthaug, JOURNAL OF PSYCHEDELIC STUDIES, vol. 4, no. 2, 26 March 2020 (2020-03-26), pages 104-113; Machsoud, WO2021216489; Terwey1 WO2020169851; Terwey2 WO2020169850; and Davis, American Journal of Drug and Alcohol Abuse vol. 45, no. 2, 1 March 2019 (2019-03-01), pages 161-169.. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
Discussions under Claim Rejections - 35 USC § 103 for the secondary references here is invoked here in the obviousness analysis.
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The active ingredient and the treatment results of the claimed methods are the same in both cases.
Further note that reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Likewise (likewise means for the same reasonings discussed above),
Claim(s) 98-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97-124 of copending Application No. 18851301 (reference application) further in view of Barsuclia, ", PROGRESS IN BRAIN RESEARCH, vol. 242, 2018, pages 121-158; Vollenweider NATURE REVIEWS. NEUROSCIENCE, vol. 21, no. 11, 14 September 2020 (2020-09-14), pages 611-624; Balaet, FRONTIERS IN NEUROSCIENCE, vol. 16, 15 March 2022 (2022-03-15); Uthaug, JOURNAL OF PSYCHEDELIC STUDIES, vol. 4, no. 2, 26 March 2020 (2020-03-26), pages 104-113; Machsoud, WO2021216489; Terwey1 WO2020169851; Terwey2 WO2020169850; and Davis, American Journal of Drug and Alcohol Abuse vol. 45, no. 2, 1 March 2019 (2019-03-01), pages 161-169.. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
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Claim(s) 98-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 97-124 of copending Application No. 18851336 (reference application) further in view of Barsuclia, ", PROGRESS IN BRAIN RESEARCH, vol. 242, 2018, pages 121-158; Vollenweider NATURE REVIEWS. NEUROSCIENCE, vol. 21, no. 11, 14 September 2020 (2020-09-14), pages 611-624; Balaet, FRONTIERS IN NEUROSCIENCE, vol. 16, 15 March 2022 (2022-03-15); Uthaug, JOURNAL OF PSYCHEDELIC STUDIES, vol. 4, no. 2, 26 March 2020 (2020-03-26), pages 104-113; Machsoud, WO2021216489; Terwey1 WO2020169851; Terwey2 WO2020169850; and Davis, American Journal of Drug and Alcohol Abuse vol. 45, no. 2, 1 March 2019 (2019-03-01), pages 161-169.. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
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Claim(s) 98-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 284 of copending Application No. 18851343 (reference application) further in view of Barsuclia, ", PROGRESS IN BRAIN RESEARCH, vol. 242, 2018, pages 121-158; Vollenweider NATURE REVIEWS. NEUROSCIENCE, vol. 21, no. 11, 14 September 2020 (2020-09-14), pages 611-624; Balaet, FRONTIERS IN NEUROSCIENCE, vol. 16, 15 March 2022 (2022-03-15); Uthaug, JOURNAL OF PSYCHEDELIC STUDIES, vol. 4, no. 2, 26 March 2020 (2020-03-26), pages 104-113; Machsoud, WO2021216489; Terwey1 WO2020169851; Terwey2 WO2020169850; and Davis, American Journal of Drug and Alcohol Abuse vol. 45, no. 2, 1 March 2019 (2019-03-01), pages 161-169.. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
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Claim(s) 98-132 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12685721 in view of Although the claims at issue are not identical, they are not patentably distinct from each other because further in view of Barsuclia, ", PROGRESS IN BRAIN RESEARCH, vol. 242, 2018, pages 121-158; Vollenweider NATURE REVIEWS. NEUROSCIENCE, vol. 21, no. 11, 14 September 2020 (2020-09-14), pages 611-624; Balaet, FRONTIERS IN NEUROSCIENCE, vol. 16, 15 March 2022 (2022-03-15); Uthaug, JOURNAL OF PSYCHEDELIC STUDIES, vol. 4, no. 2, 26 March 2020 (2020-03-26), pages 104-113; Machsoud, WO2021216489; Terwey1 WO2020169851; Terwey2 WO2020169850; and Davis, American Journal of Drug and Alcohol Abuse vol. 45, no. 2, 1 March 2019 (2019-03-01), pages 161-169.. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter.
.Base claim 1 of 12685721
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Discussions under Claim Rejections - 35 USC § 103 for the secondary references here is invoked here in the obviousness analysis. As recited in the instant dependent claims 108 and 109, the patient getting treatment is same in both cases.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
