DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 97-124 are pending.
Priority
This application is filed 09/26/2024, and claims the benefit of domestic priority as below:
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Note: Certified Copy of Foreign Priority Document(s) is/are missing in the file wrapper.
Information Disclosure Statements
47 IDS(s) received on 1/17/2025, 2/27/2025, 3/28/2025, 4/30/2025, 5/30/2025, 6/30/2025, 7/31/2025, 8/29/2025, 9/26/2025, 10/31/2025, 12/15/2025, 01/21/2026 and 02/23/2026 have been considered unless marked with a strikethrough.
Claim interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard
consistent with the specification (See MPEP 2111).
With respect to claim 97, the phrase “treating social/emotional withdrawal or detachment” is interpreted, consistent with the specification, as encompassing symptoms including anhedonia, emotional withdrawal, affective flattening, and reduced social engagement (1st paragraph in page 2, 3rd paragraph in page 3, and 2nd paragraph in page 9). In addition, the term “treating” is interpreted, consistent with the specification, as including alleviation or reduction of the signs or symptoms of social/emotional withdrawal or detachment (2nd-3rd paragraphs in page 6). Thus, complete elimination is not required.
Claim Rejections - 35 USC § 112
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 112, 117, and 124 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.
Regarding claim 112, the phrase "leads to an improvement in the associated mental disorder.” renders the claim indefinite because the claim does not recite an objective criterion for determining what degree of change constitutes the claimed “improvement.” Although the specification describes various rating scales for addressing mental disorders and states that a clinical response may include improvements on rating scales (3rd paragraph in page 6 – 1st paragraph in page 7), the claim does not identify a particular scale, threshold, or other objective standard for determining whether the claimed improvement has occurred.
Regarding claim 117, the phrase "unless the patient experiences a peak psychedelic experience” renders the claim indefinite because the claim does not specify which criterion is used to determine whether the claimed peak psychedelic experience has occurred. The specification provides multiple potentially alternative criteria for identifying a peak psychedelic experience, including the MEQ-30 criterion, the OBN criterion, and the PES criterion (5th paragraph in page 33 – 2nd paragraph in page 34). Accordingly, it is unclear whether satisfaction with any one of these criteria is sufficient to satisfy the limitation or whether a particular criterion is required, although dependent claims 118 and 119 provide the specific criterion.
Regarding claim 124, the phrase " a dose or in a dosage regimen sufficient to result in the patient having a peak psychedelic experience” renders the claim indefinite because the claim does not specify which of the different criteria disclosed in the specification is used to determine whether the required peak psychedelic experience has occurred. The specification identifies a peak psychedelic experience using at least the MEQ-30, OBN, and PES criteria (5th paragraph in page 33 – 2nd paragraph in page 34). Because the claim does not specify what criteria define the functional limitation "sufficient to produce a result," the measurement range of the claimed dose or administration regimen may be uncertain.
Claim Rejections - 35 USC § 102
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 97, 106-110, 112-115, 117-119, 123, and 124 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Terwey (WO 2020/169851 A1, pub'd 08/27/2020, made of record in the IDS).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Terwey teaches treating patients suffering from mental disorders, including major depressive disorder (MDD) and treatment resistant major depressive disorder (TRD), by administering an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof via intravenous, intramuscular, or subcutaneous administration, as required in claim 97 (claim 1). Although, Terwey fails to teach the treatment as “treating social/emotional withdrawal or detachment”, the therapeutic effect is inherent in the disclosed treatment. As discussed in the claim interpretation, the instant specification identifies emotional withdrawal, anhedonia, and affective flattening as symptoms encompassed by “social/emotional withdrawal or detachment” (1st paragraph in page 2, 3rd paragraph in page 3, and 2nd paragraph in page 9), and states that “social/emotional withdrawal or detachment in a patient suffering from a mental or nervous system disorder, such as disorders characterized by depressive episodes, for example Major Depressive Disorder (MDD)” (3rd paragraph in page 3). The instant specification further states, based on clinical data obtained following 5-MeO-DMT treatment, reductions in rating scale items corresponding to emotional withdrawal and related symptoms (5th paragraph in page 33 – 2nd paragraph in page 34, and examples 1-8). Thus, the subsequently recognized reduction of these symptoms does not distinguish the claimed method where such reduction necessarily results from the same treatment disclosed by Terwey.
Terwey further teaches:
1) treating a patient suffering from a mental disorder, including MDD and other psychiatric disorders including persistent depressive disorder, anxiety disorder, posttraumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse (technical field section), as required in claim 106;
2) treatment-resistant forms of such disorders including TRD (3rd paragraph in page 18), as required in claims 107 and 110;
3) a disorder characterized by depressive episodes, including MDD (4th paragraph in page 16), as required in claims 108 and 109;
4) improvement of the associated mental disorder following administration of 5-MeO-DMT, including rapid and sustained improvement in patients with a clinical response (1st paragraph in page 23), as required in claim 112;
5) multiple administration of 5-MeO-DMT within a treatment block, including specific regimens involving three administrations within the same treatment day (paragraphs 4th-6th in page 19), as required in claim 113;
6) administering progressively higher doses, including exemplary regimens of 2 mg, 5 mg, and 8 mg (claim 11), as required in claim 114;
7) administering successive doses at approximately 3 hour intervales (2nd paragraph in page 24), as required in claim 115;
8) administering a subsequent higher dose unless the patient experiences a peak psychedelic experience (claim 12), as required in claim 117;
9) identifying a peak psychedelic experience by achievement of at least 60% of the maximum possibles score in each of the mystical, positive mood, transcendence of time and space, and ineffability subscales of the MEQ30 (claim 16), as required in claim 118;
10) identifying a peak psychedelic experience by a peak psychedelic experience questionnaire (PPEQ) total score of least 75 (claims 16-17), and the instant specification identifies the claimed peak experience scale (PES) with this same peak experience assessment (instant specification 2nd paragraph in page 34), thus, Terwey discloses the limitation required in claim 119;
11) intravenous administration of 5-MeO-DMT (2nd paragraph in page 24, and example 7), as required in claim 123; and
12) administering 5-MeO-DMT at a dose or according to an individualized up-titration regimen provides a higher chance of achieving peak psychedelic experiences (2nd paragraph in page 108), as required in claim 124.
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 (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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 97, 106-110, 112-115, 117-119, 123, and 124 have been rejected above under 35 U.S.C. 102 as being anticipated by Terwey. Even if the treatment of social/emotional withdrawal or detachment is not found to be inherently disclosed by Terwey, that limitation would nevertheless have been obvious for the reasons set forth below.
Claims 97-119, 123 and 124 is/are rejected under 35 U.S.C. 103 as being obvious over Terwey (WO 2020/169851 A1, pub'd 08/27/2020, made of record in the IDS), in view of Nakonezny (J. Psychiatr. Res., 65, 124-30, pub'd 03/21/2015).
The applied reference (i.e., WO 2020/169851 A1) has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
With respect to independent claim 97, the claim recites that a method for treating social/emotional withdrawal or detachment in a patient suffering from social/emotional withdrawal or detachment comprising administering an effective amount of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route.
Terwey teaches treating patients suffering from mental disorders, including major depressive disorder (MDD) and treatment resistant major depressive disorder (TRD), by administering an effective amount of 5-MeO-DMT or a pharmaceutically acceptable salt thereof via intravenous, intramuscular, or subcutaneous administration (claim 1).
Terwey fails to explicitly state the words “social/emotional withdrawal or detachment” or to explicitly disclose treatment of symptoms encompassed by that limitation, such as anhedonia. Further, if the treatment of “social/emotional withdrawal or detachment” is not found to be inherent, as state above, Terwey fails to teach the claim limitation.
Nakonezny teaches that anhedonia is a core symptom of MDD and that SHAPS is a reliable and valid instrument for assessing hedonic experience in adult patients with MDD, including treatment resistant patients (abstract, and study and participants section).
It would have been obvious to a PHOSITA at the time of the invention to evaluate and treat anhedonia in the MDD/TRD patients receiving the 5-MeO-DMT treatment of Terwey because Nakonezny teaches that anhedonia is a core symptom of MDD and provides SHAPS as a validated instrument for assessing hedonic experience or positive valence. A PHOSITA would have been motivated to use the combination of Terwey and Nakonezny because the combination would advantageously allow the practitioner to obtain the rapid antidepressant response taught by Terwey while assessing improvement in an important symptom domain of MDD. A PHOSITA would have had a reasonable expectation of successfully making the combination because Terwey reports major improvement in depressive symptoms as early as two hours after 5-MeO-DMT administration and continued improvement through follow-up (example 2 section), while Nakonezny provides a validated measure directed to hedonic function.
With respect to claims 98-101, the claims recite that the treatment reduces or eliminates social/emotional withdrawal or detachment in claim 98; the treatment reduces or eliminates anhedonia, emotional withdrawal, affective flattening and/or reduced social engagement in claim 99; the treatment reduces or eliminates anhedonia in claim 100; and the anhedonia is measured by the Snaith-Hamiliton Pleasure Scale (SHAPS) in claim 101.
Terwey teaches rapid and sustained improvement of depressive symptoms after 5-MeO-DMT treatment (example 2 section section).
Terwey fails to teach that improvement as reduction or elimination of anhedonia.
Nakonezny teaches that anhedonia is a core symptom of MDD (abstract and introduction), and use of the 14 item SHAPS to measure hedonic experience in MDD patients (Hedonic experience section). Thus, it would have been obvious to evaluate reduction or elimination of anhedonia as part of the therapeutic response in claims 98-101 for the same reason with respect to claim 97.
With respect to claim 102, the claim recites that the treatment reduces or eliminates affective flattening.
The combination of Terwey and Nakonezny fails to teach the treatment reduces or eliminates affective flattening directly.
However, Terwey teaches to assessing “emotional withdrawal”, and “blunted affect” among the 18 individual psychiatric symptoms assessed by the BPRS and reports improvement in psychiatric symptoms following 5-MeO-DMT treatment (Example 2 section). In view of the reported psychiatric improvement, evaluating reduction of blunted affect/affective flattening would have been obvious.
With respect to claims 103-105, the claims recite that the reduction or elimination of social/emotional withdrawal or detachment is observed 2 hours after a last administration of 5-MeO-DMT or the pharmaceutically acceptable salt thereof in claim 103; observation on day 1 after a last administration in claim 104; and observation on day 7 after a last administration in claim 105.
Terwey teaches that the clinical response within about two hours after 5-MeO-EMT administration and continued improvement through Day 7. Example 2 section evaluates patients at baseline, 2 hours, Day 1, and Day 7. (Example 2 section) Thus, claims 103-105 would have been obvious for the same reason with respect to claim 97.
With respect to claims 106-110, the claims recite that the patient is suffering from a mental or nervous system disorder associated with the social/emotional withdrawal or detachment in claim 106; the patient suffers from a treatment resistant form of the disorder in claim 107; patient is suffering from a disorder characterized by depressive episodes in claim 108; the patient is suffering from major depressive disorder (MDD) associated with the social/emotional withdrawal or detachment in claim 109; and the patient suffers from a treatment resistant form of the disorder in claim 110.
Terwey teaches 1) treating a patient suffering from a mental disorder, including MDD and other psychiatric disorders including persistent depressive disorder, anxiety disorder, posttraumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder and psychoactive substance abuse (technical field section), as required in claim 106; 2) treatment-resistant forms of such disorders including TRD (3rd paragraph in page 18), as required in claims 107 and 110; and 3) a disorder characterized by depressive episodes, including MDD (4th paragraph in page 16), as required in claims 108 and 109. Thus, claims 106-110 would have been obvious for the same reasons with respect to claim 97.
With respect to claim 111, the claim recites that the patient suffers from a current major depressive episode.
The combination of Terwey and Nakonezny fails to teach the patient suffers from a current major depressive episode directly.
However, Terwey teaches that MDD patients who “had not shown adequate improvement to at least two adequate courses of pharmacological therapy in the current episode of depression”. (Example 2 section, and clinical study inclusion criteria section). Terwey teaches that “"treatment-resistant" is defined for major depressive disorder and persistent depressive disorder as no adequate improvement to at least two adequate courses of pharmacological therapy in the current episode of depression (4th paragraph in page 17). Thus, selection of a patient suffering from a current major depressive episode would have been obvious.
With respect to claims 112-115, the claims recite that the treatment leads to an improvement in the associated mental disorder in claim 112; the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered in one to six administrations within 24 hours in claim 113; each subsequent administration after the first administration uses a dosage amount higher than the previous administration in claim 114; and the interval between two administrations is 1 to 4 hours.
Terwey teaches 1) improvement of the associated mental disorder following administration of 5-MeO-DMT, including rapid and sustained improvement in patients with a clinical response (1st paragraph in page 23), as required in claim 112; 2) multiple administration of 5-MeO-DMT within a treatment block, including specific regimens involving three administrations within the same treatment day (paragraphs 4th-6th in page 19), as required in claim 113; 3) administering progressively higher doses, including exemplary regimens of 2 mg, 5 mg, and 8 mg, as required in claim 114; and 4) administering successive doses at approximately 3 hour intervales (2nd paragraph in page 24), as required in claim 115. Thus, claims 112-115 would have been obvious for the same reasons with respect to claim 97.
With respect to claim 116, the claim recites that the interval between two administrations is 1 to 2 hours.
The combination of Terwey and Nakonezny fails to teach the interval between two administrations is 1 to 2 hours.
However, Terwey teaches that an interval between administrations of not less than one hour and not more than 24 hours, including 2 to 4 hours (claim 15). Selection of an interval within the claimed 1 to 2 hour ranges would have been an obvious optimization of the disclosed dosing interval for repeated dosing of 5-MeO-DMT. See MPEP 2144.05.
With respect to claims 117-119, the claims recite that the patient receives a subsequent administration unless the patient experiences a peak psychedelic experience in claim 117; the occurrence of a peak psychedelic experience is identified through achievement of at least 60% of the maximum possible score in each of the mystical, positive mood, transcendence of time and space, and ineffability sub scales of the 30-item revised Mystical Experience Questionnaire (MEQ30) in claim 118; and the occurrence of a peak psychedelic experience is identified through achievement of a Peak Experience Scale (PES) Total Score of at least 75 in claim 119.
Terwey teaches 1) administering a subsequent higher dose unless the patient experiences a peak psychedelic experience (claim 12), as required in claim 117; 2) identifying a peak psychedelic experience by achievement of at least 60% of the maximum possibles score in each of the mystical, positive mood, transcendence of time and space, and ineffability subscales of the MEQ30 (claim 16), as required in claim 118; and 3) identifying a peak psychedelic experience by a peak psychedelic experience questionnaire (PPEQ) total score of least 75 (claims 16-17), and the instant specification identifies the claimed peak experience scale (PES) with this same peak experience assessment (instant specification 2nd paragraph in page 34), thus, Terwey discloses the limitation required in claim 119. Thus, claims 117-119 would have been obvious for the same reasons with respect to claim 97.
With respect to claims 123-124, the claims recite that the 5-MeO-DMT or the pharmaceutically
acceptable salt thereof is administered via intravenous injection in claim 123; and the 5-MeO-DMT or the pharmaceutically acceptable salt thereof is administered at a dose or in a dosage regimen sufficient to result in the patient having a peak psychedelic experience in claim 124.
Terwey teaches 1) intravenous administration of 5-MeO-DMT (2nd paragraph in page 24, and example 7), as required in claim 123; and 2) administering 5-MeO-DMT at a dose or according to an individualized up-titration regimen provides a higher chance to achieve peak psychedelic experiences (2nd paragraph in page 108), as required in claim 124. Thus, claims 123-124 would have been obvious for the same reasons with respect to claim 97.
Claim(s) 120-122 is/are rejected under 35 U.S.C. 103 as being unpatentable over Terwey (WO 2020/169851 A1, pub'd 08/27/2020, made of record in the IDS) and Nakonezny et al. (J. Psychiatr. Res., 65, 124-30, pub'd 03/21/2015) as applied to claim 97 above, and further in view of Jiang et al. (Ann. Gen. Psychiatry,. 8, 4, pub'd 01/23/2009) .
With respect to claims 120-122, the claims recite that a clinical response, as reflected by a reduction in the Clinical Global Impression -Severity (CGI-S) score, is observed 2 hours after last administration of 5-MeO-DMT or the pharmaceutically acceptable salt thereof in claim 120; the clinical response, as reflected by the reduction in the CGI-S score, is observed on day 1 after the last administration in claim 121; and the clinical response, as reflected by the reduction in the CGI-S score, is observed on day 7 after the last administration.
Terwey teaches that “clinical response” includes improvement on the CGI-S scale (clinical response definition). Terwey further teaches that “The clinical response occurs rapidly within 2 hours after 5-MeO-DMT administration”, and evaluates symptom scales at baseline, 2 hours, 1day, and 7 days after administration (example 2 section)
The combination of Terwey and Nakonezny fails to teach measuring that response specifically as a reduction in CGI-S score at each of the recited 2 hours/day 1/day 7 time points.
Jiang teaches that 1) the CGI-S is a widely used outcome scale in MDD clinical trials; 2) analyses changes from baseline in CGI-S together with MADRS and HAM-D; 3) correlations among CGI-S, MADRS, HAM-D and CGI-I are significant at all evaluating time points; and 4) HAM-D, MADRS, CGI-S and CGI-I scores present a consistent picture of response to venlafaxine treatment (abstract, results and conclusion).
It would have been obvious to a PHOSITA at the time of the invention to use the change from baseline CGI-S methodology taught by Jiang to assess the rapid and sustained antidepressant response taught by Terwey because Terwey identifies CGI-S improvement as a measure of clinical response, and Jiang teaches that changes in CGI-S provide a recognized measure of treatment response in MDD that correlates with MADRS and HAM-D. A PHOSITA would have been motivated to use the combination of Terwey, Nakonezny, and Jiang because the combination would advantageously provide a clinician-rated global measure for quantifying the same antidepressant response that Terwey evaluates using other established depression scales. A PHOSITA would have had a reasonable expectation of successfully making the combination because Terwey teaches clinical response at approximately two hours and evaluates clinical improvement through day 7, while Jiang teaches that changes from baseline in CGI-S track antidepressant response consistently with MADRS and HAM-D.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
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.
Claims 79-124 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7-10, 53-56, and 66-68 of copending Application No. 18/851,311 in view of Terwey (WO 2020/169851 A1, pub'd 08/27/2020, made of record in the IDS), Nakonezny et al. (J. Psychiatr. Res., 65, 124-30, pub'd 03/21/2015), and Jiang et al. (Ann. Gen. Psychiatry, 8, 4, pub'd 01/23/2009).
This is a provisional nonstatutory double patenting rejection.
The claims 1, 3, 4, 7-10, 53-56, and 66-68 of the ‘311 application are directed to administer 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient suffering from psychomotor retardation, wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or sub-cutaneous route. The claims further recite patients suffering from a mental or nervous system disorder, MDD or a treatment resistant form thereof, and improvement of the associated disorder, CGI-S clinical response, repeated administration and does escalation, peak psychedelic experience criteria, and intravenous administration.
The instant claims are directed to the same 5-MeO-DMT treatment, including the same intravenous, intramuscular, or subcutaneous administration, MDD/TRD patient populations, clinical response, repeated administration and dose escalation regimens, peak psychedelic experience criteria, and intravenous administration, with additional limitations relating to selection and treatment of patients experiencing social/emotional withdrawal or detachment, including anhedonia, emotional withdrawal, affective flattening, and/or reduced social engagement, SHAPS assessment, and specified treatment response outcomes.
The teachings of Terwey, Nakonezny, and Jiang are as discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The social/emotional withdrawal or detachment related patient selection criteria, anhedonia, and related symptom limitations, clinical rating scale limitations, and treatment response limitations recited in the instant claims 97-124 would have been prima facie obvious to one of ordinary skill in the art to variations of the 5-MeO-DMT treatment of ‘311 application in view of the combined teachings of Terwey, Nakonezny , and Jiang for the same reasons discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 79-124 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 114-120, and 124-137 of copending Application No. 18/851,294 in view of Terwey (WO 2020/169851 A1, pub'd 08/27/2020, made of record in the IDS), Nakonezny et al. (J. Psychiatr. Res., 65, 124-30, pub'd 03/21/2015), and Jiang et al. (Ann. Gen. Psychiatry, 8, 4, pub'd 01/23/2009).
This is a provisional nonstatutory double patenting rejection.
The claims 114-120, and 124-137 of the ‘294 application are directed to a method for treating anxiety in a patient comprising administering an effective amount of 5-methoxy-N,N dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. The claims further recite the treated patients including patients suffering from a mental or nervous system disorder, MDD or a treatment resistant form thereof, and improvement of the associated disorder, clinical response, repeated administration and does escalation, peak psychedelic experience criteria, and parenteral administration.
The instant claims are directed to the same 5-MeO-DMT treatment, including the same intravenous, intramuscular, or subcutaneous administration, MDD/TRD patient populations, clinical response, repeated administration and dose escalation regimens, peak psychedelic experience criteria, and intravenous administration, with additional limitations relating to selection and treatment of patients experiencing social/emotional withdrawal or detachment, including anhedonia, emotional withdrawal, affective flattening, and/or reduced social engagement, SHAPS assessment, and specified treatment response outcomes.
The teachings of Terwey, Nakonezny, and Jiang are as discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The social/emotional withdrawal or detachment related patient selection criteria, anhedonia, and related symptom limitations, clinical rating scale limitations, and treatment response limitations recited in the instant claims 97-124 would have been prima facie obvious to one of ordinary skill in the art to variations of the 5-MeO-DMT treatment of ‘294 application in view of the combined teachings of Terwey, Nakonezny , and Jiang for the same reasons discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 79-124 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-13, 92-100, and 109-111 of copending Application No. 18/851,349 in view of Terwey (WO 2020/169851 A1, pub'd 08/27/2020, made of record in the IDS), Nakonezny et al. (J. Psychiatr. Res., 65, 124-30, pub'd 03/21/2015), and Jiang et al. (Ann. Gen. Psychiatry, 8, 4, pub'd 01/23/2009).
This is a provisional nonstatutory double patenting rejection.
The claims 1, 10-13, 92-100, and 109-111 of the ‘349 application are directed to administer 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient suffering from sleep disturbance, wherein the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route. The claims further recite the treated patients including patients suffering from a mental or nervous system disorder, MDD or a treatment resistant form thereof, and improvement of the associated disorder, clinical response, repeated administration and does escalation, administration intervals, peak psychedelic experience criteria including MEQ30 and PES/PPEQ, and intravenous administration.
The instant claims are directed to the same 5-MeO-DMT treatment, including the same patient populations, route of administration, clinical response, repeated administration and dose escalation regimens, peak psychedelic experience criteria, and intravenous administration, with additional limitations relating to selection and treatment of patients experiencing social/emotional withdrawal or detachment, including anhedonia, emotional withdrawal, affective flattening, and/or reduced social engagement, SHAPS assessment, and specified treatment response outcomes.
The teachings of Terwey, Nakonezny, and Jiang are as discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The social/emotional withdrawal or detachment related patient selection criteria, anhedonia, and related symptom limitations, clinical rating scale limitations, and treatment response limitations recited in the instant claims 97-124 would have been prima facie obvious to one of ordinary skill in the art to variations of the 5-MeO-DMT treatment of ‘349 application in view of the combined teachings of Terwey, Nakonezny , and Jiang for the same reasons discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Claims 79-124 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 119, 121-126, 128-141, and 143 of copending Application No. 18/851,362 in view of Terwey (WO 2020/169851 A1, pub'd 08/27/2020, made of record in the IDS), Nakonezny et al. (J. Psychiatr. Res., 65, 124-30, pub'd 03/21/2015), and Jiang et al. (Ann. Gen. Psychiatry, 8, 4, pub'd 01/23/2009).
This is a provisional nonstatutory double patenting rejection.
The claims 119, 121-126, 128-141, and 143 of the ‘362 application are directed to a method for treating cognitive disfunction in a patient comprising administering an effective amount of 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein the 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered via an intravenous, intramuscular or subcutaneous route. The claims further recite the treated patients including patients suffering from a mental or nervous system disorder, MDD or a treatment resistant form thereof, and improvement of the associated disorder, CGI-S clinical response, repeated administration and does escalation, peak psychedelic experience criteria, and parenteral administration.
The instant claims are directed to the same 5-MeO-DMT treatment, including the same MDD/TRD patient populations, route of administration, clinical response, repeated administration and dose escalation regimens, peak psychedelic experience criteria, and intravenous administration, with additional limitations relating to selection and treatment of patients experiencing social/emotional withdrawal or detachment, including anhedonia, emotional withdrawal, affective flattening, and/or reduced social engagement, SHAPS assessment, and specified treatment response outcomes.
The teachings of Terwey, Nakonezny, and Jiang are as discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection and are herein incorporated by reference in their entirety.
The social/emotional withdrawal or detachment related patient selection criteria, anhedonia, and related symptom limitations, clinical rating scale limitations, and treatment response limitations recited in the instant claims 97-124 would have been prima facie obvious to one of ordinary skill in the art to variations of the 5-MeO-DMT treatment of ‘362 application in view of the combined teachings of Terwey, Nakonezny , and Jiang for the same reasons discussed supra in the 35 U.S.C. 102 and 35 U.S.C. 103 rejection, which reasons are herein incorporated by reference in their entirety.
Conclusion
Claims 97-124 are rejected.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
