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 .
DETAILED ACTION
Election/Restriction
Applicant elected, without traverse, 1) Group I invention, drawn to a method for treating a subject undergoing a psychotherapeutic intervention; and species: A. 5-MAPB; B. post-traumatic stress disorder; C. cognitive therapy and D. improved stability in the work/home environment, in the reply filed on 07/27/2026.
Claims 40-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 22-39, 43, and 44 read on the elected invention and species.
Status of Claims
Claims 22-44 are pending in the instant application.
Claims 40-42 are withdrawn.
Claims 22-39, 43, and 44 are currently under examination.
Priority
The instant application 18/699,185 filed on 07/18/2023 is 371 of PCT/IB2022/059561 filed on 10/06/2022 which claims benefit of U.S. provisional application No. 63/253,443 filed on 10/07/2021.
Information Disclosure Statement
The information disclosure statements filed 04/05/2024 and third-party submission on 06/12/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the reference listed in IDS are being considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities:
page 21, Table 2, It’s not clear what link/info is “see above” referring back to.
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Claim Interpretation
Independent claims are directed to a method of treating a subject undergoing a psychotherapeutic intervention comprising administering to the subject 1-(benzofuran-5-yl)-N-methylpropan-2- amine (5-MAPB).
According to PubChem database, 1-(benzofuran-5-yl)-N-methylpropan-2-amine ( 5-MAPB) is benzofuran analog structurally related to MDMA.
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Regarding the limitation of intended treatment outcome recited in instant claims 31-34 and 38-39, e.g. reduce the stress in the subject, reducing mental health symptoms, reducing addiction behaviors, or reducing chemical dependencies, etc., these recitations are construed as intended results of active method step of administering 1-(benzofuran-5-yl)-N-methylpropan-2- amine (5-MAPB) in any amount to a patient in need thereof , which do not materially limit the claimed method since such limitations do not result in manipulative difference in method steps of the claims. It’s noted the biological activity of compound is the property of active compound and products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. If the prior art teaches and/or suggests the same or similar method step as instantly claimed (i.e. administering 5-MAPB to a subject in need thereof), the method of the prior art would have achieved the intended results recited in instant claims and read on instant claimed methods. The burden of proof is shifted to the Applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 22-39 and 43-44 are rejected under 35 U.S.C. 112 (a), first paragraph, as failing to comply with the written description requirement. Claims 22-39, 43, and 44 contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor, at the time the application was filed, had possession of the full scope of method genus for treating a subject undergoing a psychotherapeutic intervention comprising administering to the subject 1-(Benzofuran-5-yl)-N-methylpropan-2- amine (5-MAPB) wherein the subject is resistant to treatment with 3,4-Methylenedioxymethamphetamine (MDMA). This is a written description rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant is directed to the MPEP 2163 and Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
MPEP 2163.02 states “ Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed.”
Instant claims are drawn to method for treating a subject undergoing a psychotherapeutic intervention comprising administering to the subject 1-(Benzofuran-5-yl)-N-methylpropan-2- amine (5-MAPB), wherein the subject is resistant to treatment with 3,4-Methylenedioxymethamphetamine (MDMA). Instant claims further recite variety of psychotherapeutic intervention for treating variety of distress related disorders/conditions, e.g. bipolar disorder, anxiety disorders, etc. and intended treatment outcome, e.g. reducing the distress, improving stability in the work/home environment, improving behaviors, etc.. Applicant is required to provide adequate written description and evidence of possession of instantly claimed method genus as of the effective filing date of instant application.
Instant specification does not disclose any working example wherein 5-MAPB is administered to any subject, let alone to a subject who is undergoing a psychotherapeutic intervention and resistant to treatment with MDMA. Instant specification does not disclose any assay where a subject under psychotherapeutic intervention is administered 5-MAPB before, during or after a psychotherapeutic intervention as recited in claims 23-26. Instant specification does not disclose any working example or assay wherein 5-MAPB is administered at the recited dosage range in claims 27-30 and 43-44. Instant specification does not disclose any subject is administered 5-MAPB and evaluated for the distress level. Instant specification does not disclose how to quantitively measure/evaluate the distress from parent-child relational problem, personal history (past history) of neglect in childhood... phase of life problem. etc. and how the method of administering 5-MAPB reduces the stress and to what extent, comprising improving stability in the work/home environment, improving behaviors, improving employment functioning,..., improving the subject's sense of meaning to life, improving the subject's sense of purpose to life,..., reducing chemical dependencies. Instant specification does not disclose any assay and efficacy data for 5-MAPB. Instant specification does not disclose any efficacy data of 5-MAPB to support instantly alleged treatment outcome. Due to lack of working example by insistent disclosure and high unpredictability of treating psychological disorder, an ordinary skilled in the art would not know if 5-MAPB is effective and safe for treating a subject who is resistant to MDMA treatment with alleged treatment outcome . As such, instant specification in absence of any working example/efficacy data of 5-MAPB as of the effective filing date of instant application does not provide sufficient written description /support for instantly claimed method.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-39 and 43-44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites a method of treating a subject undergoing a psychotherapeutic intervention comprising administering to the subject 1-(benzofuran-5-yl)-N-methylpropan-2- amine (5-MAPB) wherein the subject is resistant to treatment with 3,4-Methylenedioxymethamphetamine (MDMA). It’s not clear what disease/disorder is being treated by 5-MAPB and what’s the dosage regimen of 5-MAPB to be administered to the subject. One of ordinary skill in the art cannot determine the metes and bounds of claim 22 due to lack of disease/disorder/medical condition and administration regimen.
Dependent claims 23-39 and 43-44 are rejected due to dependency on claim 22.
Claims 31-34 and 38-39 reciting intended treatment outcome, e.g. reduce the stress in the subject, reducing mental health symptoms, etc. are indefinite because they merely define the invention in terms of results to be achieved and do not provide any further restraints on the method steps of administrating 5-MAPB to the subject in need thereof. Further, these recitation of intended treatment outcome are generally narrative, ambiguous in subjective and relative terms and instant specification does not provide a standard for ascertaining the requisite degree. Instant specification does not disclose how to quantitively measure/evaluate the distress from parent-child relational problem, personal history (past history) of neglect in childhood... phase of life problem. etc. and how the method of administering 5-MAPB reduces the stress and to what extent, comprising improving stability in the work/home environment, improving behaviors, improving employment functioning,... improving the subject's sense of meaning to life, improving the subject's sense of purpose to life... reducing chemical dependencies. One of ordinary skill in the art cannot determine the metes and bounds of these claims because it is unknown how the treatment outcome is further limiting to instant claimed methods.
Claim 35 recites stress-sensitive disorder selected from the group consisting of Post-traumatic Stress Disorder (PTSD); Bipolar Disorder; Acute Stress Disorder; anxiety disorders such as Generalized Anxiety Disorder, Obsessive-Compulsive Disorder, social anxiety disorders, Panic Disorders, phobias, obsessive compulsive disorders, and Trichotillomania. The term “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claims 36-37 recite psychotherapeutic intervention is selected from the group consisting of psychoanalytic and psychodynamic therapy; behavioral therapy; cognitive therapy; humanistic therapy; and integrative therapy or holistic therapy. Instant specification (See [0035]-[0042]) provides definition for these recited psychotherapeutic intervention. However, these psychotherapeutic intervention are not mutually exclusive and may substantially overlap. For example, integrative therapy may incorporate cognitive, behavioral and /or humanistic therapeutic techniques. Accordingly, instant claims fail to provide reasonable clear boundaries as to the scope of the recited psychotherapeutic intervention.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 22, 27-35, 38, 39 and 43 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Oeri (Journal o/Psychopharmacology. 2021, Vol. 35(5) 512- 536, Applicant’s IDS dated 04/05/2024, "Beyond ecstasy: Alternative entactogens to 3,4-methylenedioxymethamphetamine with potential applications in psychotherapy").
Oeri reviews entactogenic drugs as alternatives to 3,4-methylenedioxy-N-methylamphetamine MDMA as adjunct to psychotherapy (See whole article). Oeri discloses pharmacology and subjective effects of entactogen MDMA as an adjunct to psychotherapy, particularly for the treatment of post-traumatic stress disorder, but patients who have a long history of MDMA use may not respond adequately to typical clinical dose and may require larger and potentially dangerously high, doses of MDMA (See abstract, Introduction, page 513, left column). Oeri further reviews alternative of MDMA that share the entactogenic qualitative effects of MDMA for psychotherapy while also possessing a safety profile that is equal or superior to that of MDMA, so that patients could receive alternative treatment that do not produce cross tolerance with MDMA (See page 513, left column; Table 1).
Oeri explicitly teaches benzofurans, e.g. 5-(2-methylaminopropyl)benzofuran (5-MAPB), having intriguing pharmacological and qualitative effects that make them substitutes for MDMA (See page 522, right column; page 523; Fig 3, Table 1 and 2). Oeri and incorporated reference teach 5-MAPB greatly increased extracellular concentrations of dopamine (DA), norepinephrine
(NE) and 5-HT, and that 5-MAPB was significantly more potent at eliciting this response than MDMA (See page 523, left column). Oeri and incorporated reference also teach 5-MAPB is purely entactogenic, not psychedelic, and its effect lasts about twice as long as those of MDMA, eliminating the need to administer a second dose during prolonged therapy sessions as is usually done with MDMA (See page 523, right column, first para).
Regarding claims 27 and 43, Oeri teaches oral dose amount of 5-MAPB at 30-70 mg(See Table 2; page 523, right column, first para).
Oeri collectively teaches 5-(2-methylaminopropyl)benzofuran (5-MAPB) as alternative of MDMA in psychotherapy ( e.g. PTSD) for patient who is not responsive to MDMA, Thus, Oeri anticipates instant claimed invention.
Oeri is silent about the intended treatment outcome as recited in instant claims 31-34 and 38-39, e.g. reduce the stress in the subject, reducing mental health symptoms, reducing addiction behaviors, etc. It’s noted the biological activity of compound is the property of active compound and product of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. If the prior art teaches and/or suggests the same or similar method step as instantly claimed (i.e. administering an effective amount of a 5-MAPB to a subject in need thereof), the method of prior art would have achieved the intended results as recited in instant claims.
In the alternative, it would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to explore use of 5-MAPB for treating mental disorder (e.g. PTSD) in a subject who is resistant to MDMA, based on combined beneficial teachings of Oeri and exploration/optimization base on general knowledge of treatment for mental disorder and psychotherapy. Oeri teaches 5-MAPB is more efficacious than MDMA at increasing serotonin level with long lasting effect. A skilled artisan would be motivated to explore use of 5-MAPB in subjects who is resistant to MDMA and reasonably expect 5-MAPB provide an alternative treatment in psychotherapy without cross-resistance to MDMA . Thus, instant claimed methods would have been obvious to those of ordinary skilled in the art within the meaning of USC 103. The burden of proof is shifted to the Applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 22-39 and 43-44 are rejected under 35 U.S.C.103 as being unpatentable over Baggott et al. (WO2021252538A2 ).
Baggott discloses a method of modulating central nervous system activity for treatment of central nervous system disorders, mental disorders (e.g. Post-Traumatic Stress Disorder PTSD, etc. ), or for mental enhancement /psychotherapeutics comprising administering an effective amount of benzofuran compounds (e.g. 5-MAPB) (See abstract, page 1, lines 13-26; page 6, lines 10-28; page 18, lines 15-28; Examples 3-30; claims 1-215). Baggott explicitly discloses 5-MAPB, salt thereof and effects of 5-MAPB on neurotransmitters, e.g. dopamine/DAT and serotonin/SERT in variety of assays (See page 5, lines 6-26 ; page 9, lines 1-6; Examples 3-19, 23 and 26-28; Tables 1-24; claims 1-2, 141 and 207). Baggott teaches embodiments wherein 5-MAPB is efficacious at rapidly increasing extracellular serotonin compared with MDMA (See Example 9, Table 5), which enhances therapeutic effect for treating CNS disorders including mental disorders (See page 13, lines 1-9). Baggott also teaches 5-MAPB embodiment as selective agonist of 5-HT1B receptor over 5-HT2A (See Example 6, Table 1), which is an unexpected discovery that has not been observed in an entactogen, including MDMA, wherein 5-HT1B related to the pro-social effects of entactogens allows more relaxed and therapeutically productive experience for the patient undergoing treatment (See page 13, lines 10-22).
Regarding claims 23-26, Baggott discloses embodiments wherein benzofuran compounds administered to a human patient in conjunction with psychotherapy, cognitive enhancement, or life coaching (pharmacotherapy)(See page 17, lines 16-19; page 151, lines 28-31; page 152, lines 1-30). Baggott teaches benzofuran compounds administered shortly before or during a scheduled psychotherapy session, e.g. about 40 to about 120 mg of non-racemic 5-MAPB could be taken once, two or three times in a single therapeutic session (See page 152, lines 18-20; page 247, lines 5-25; claims 155, 200). Baggott teaches different sessions with one, two, or rarely three or more administrations of an entactogen per session wherein these sessions can be as frequent as weekly, monthly or even less frequently (See page 150, lines 20-31). Baggott also teaches combination therapy comprising benzofuran compounds and other active agent , e.g. MDMA, serotonin receptor agonists, etc. wherein benzofuran compound is administered concurrently or sequentially, before or after other pharmacological agent (See page 224, lines 8-30; page 225, lines 1-9).
Regarding claims 27-30 and 43-44 , Baggott discloses variety of dosage forms comprising various amount of active ingredient, e.g. from 100mg to 800mg, or at the range of at least about 0.2 to about 3 mg/kg or less, administered through various route, e.g. oral administration, intravenously, etc.(See page 157, lines 5-31; page 158, lines 1-26; page 159, lines 18-27; page 248, lines 9-12; page 315, lines 7-24; Figure 2, Example 28, etc.).
Regarding claims 31-38, Baggott teaches embodiments wherein CNS disorder is a psychiatric condition/ mental disorders typically treated by a psychiatrist, which are primarily abnormalities of thought, feeling or behavior that cause significant distress or impairment of personal functioning, wherein benzofuran compounds can improve neurological or psychiatric
functioning in a patient in need thereof, by reduction in signs and symptoms of mental distress, by improvement in functioning in some domain of life, or by increased feelings of closeness to and understanding of some other person, etc. (See page 76, lines 28-31; page 135, lines 6-8; page 150, lines 26-31). Baggott teaches variety of CNS disorder, e.g. post-traumatic stress disorder/PTSD, anxiety, generalized anxiety, social anxiety, etc. (See page 11, lines 3-15; page 134, lines 13-32; claim 141-152, 184-197, and 207-215). Baggott teaches improving psychiatric function in various situations including mental health and life conditions treated by psychiatrists or psychotherapists, for example, couples discussing difficulties in their relationship, etc. (See page 76, lines 28-31; page 77, lines 1-5).
Baggott is silent about the subject is resistant to treatment with MDMA. Baggott teaches MDMA is currently in human clinical trial (NCT03537014) for use in psychotherapy sessions for severe PTSD and for aiding social cognition, and MDMA has a number of features that potentially make it contraindicated for some patients, e.g. acute euphoria, acute hypertensive effects, risk of hyponatremia, and oxidative stress (See page 5 lines 27-31; page 6, line 1-5).
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to further explore use of benzofuran compounds (e.g. 5-MAPB) for treating mental disorder (e.g. PTSD) in a subject who is resistant to MDMA, based on combined beneficial teachings of prior art and general knowledge of treatment for mental disorder and psychotherapy. Baggott already teaches benzofuran (e.g. 5-MAPB) for treating CNS disorder/mental disorder (e.g. PTSD, anxiety, etc.). Baggott teaches embodiments wherein 5-MAPB is more efficacious than MDMA at increasing extracellular serotonin level (See Example 9, Table 5). Baggott also teaches 5-MAPB embodiment as selective agonist of 5-HT1B receptor over 5-HT2A (See Example 6, Table 1), which is an unexpected discovery that has not been observed in an entactogen, including MDMA. In seeking for treatment for a subject who is resistant to MDMA, a skilled artisan would be motivated to explore use of 5-MAPB and reasonably expect 5-MAPB provide an alternative treatment for MDMA resistant subject based on the advantageous properties of 5-MAPB taught by Baggott.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and exploration/optimization based on general knowledge of treatment for mental disorder and psychotherapy. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 22-39 and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Oeri (Journal o/Psychopharmacology. 2021, Vol. 35(5) 512- 536, Applicant’s IDS dated 04/05/2024, "Beyond ecstasy: Alternative entactogens to 3,4-methylenedioxymethamphetamine with potential applications in psychotherapy"), in view of Baggott et al. (WO2021252538A2 ) .
The collective teachings of Oeri and Baggott are elaborated in preceding 102/103 and 103 rejection and applied as before. Oeri collectively teaches 5-(2-methylaminopropyl)benzofuran (5-MAPB) as alternative of MDMA in psychotherapy.
Oeri is silent about 5-MAPB administered before, during or after the psychotherapy.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to further explore use of 5-MAPB for treating mental disorder (e.g. PTSD) in a subject who is resistant to MDMA, based on combined beneficial teachings of prior art and general knowledge of treatment for mental disorder and psychotherapy. Both Oeri and Baggott teach 5-MAPB is more efficacious than MDMA at increasing extracellular serotonin level. Baggott already teaches benzofuran (e.g. 5-MAPB) for treating CNS disorder/mental disorder (e.g. PTSD, anxiety, etc.). Baggott also teaches 5-MAPB embodiment as selective agonist of 5-HT1B receptor over 5-HT2A which is an unexpected discovery that has not been observed in an entactogen, including MDMA. In seeking for treatment for a subject who is resistant to MDMA, a skilled artisan would be motivated to explore use of 5-MAPB and reasonably expect 5-MAPB provide an alternative treatment for MDMA based on the advantageous properties of 5-MAPB taught by Oeri and Baggott.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and exploration/optimization based on general knowledge of treatment for mental disorder and psychotherapy. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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/LIYUAN MOU/ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
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