DETAILED ACTION
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 .
Priority
Examiner acknowledges that, according to the Filing receipt received 01/22/2025, that the instant application 18/679,917 filed 05/31/2024 is a Continuation of U.S. application 17/431,634 (now abandoned) filed 08/17/2021 which is a 371 of PCT/EP2020/054804 filed 02/24/2020 which claims foreign priority of EPO application 19158806.0 filed 02/22/2019. A copy of the foreign priority document was provided with the 17/431,634 application.
However, the limitations of the instant claims are not adequately supported or enabled in the manner provided by 35 U.S.C. 112(a) or pre-AIA U.S.C. 112, first paragraph by EPO application 19158806.0. More specifically, the limitations of “a patient who is diagnosed with major depressive disorder by a licensed professional in accordance with accepted medical practice” are not taught or suggested in their entirety. More specifically, the limitations “by a licensed professional in accordance with accepted medical practice” are substantially broader in scope than the disclosure of a “physician or a psychologist” in accordance with the “DSM-5” (see page 12) in EPO application 19158806.0. Other deficiencies may also be present. As such, all the instant claims have been awarded the effective filing date of PCT/EP2020/054804 filed 02/24/2020.
Information Disclosure Statement
The Information Disclosure Statements filed on 08/26/2024, 08/29/2024, 09/27/2024, 10/28/2024, 11/26/2024, 12/27/2024, 01/31/2025, 02/27/2025, 03/28/2025, 04/30/2025, 05/30/2025, 06/30/2025, 07/31/2025, 08/29/2025, 09/26/2025, 10/31/2025, 12/15/2025, 01/21/2026, and 02/23/2026 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full, except where lined-through and annotated where relevant. A signed copy of list of references cited from the IDS is included with this Office Action.
Examiner notes that all references referred to as “N/A” or “n/a” have been lined-through as they do not correspond to any discernible reference provided in the file wrapper of the instant application.
Examiner notes that non-patent citation numbers 188, 231, 234 of the 90-page IDS filed 08/29/2024 appear to be incomplete as they do not specify the publisher of the article and/or an author.
Examiner notes that the non-patent citation numbers 498 (p. 80) and 6 (p. 83) of the 90-page IDS filed 08/29/2024 appear to be incomplete as they do not cite the full title, publisher, date, or pertinent pages of the reference.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see p. 7, 119, and 120). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the term "Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition" and "DSM-5", which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 34-51 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 34 recites the limitation "the intravenous, intramuscular, or subcutaneous route". There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites the limitation "the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5)" and "the American Psychiatric Association". There is insufficient antecedent basis for this limitation in the claim.
Claim 35 contains the trademark/trade name "the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5)" (trademark) and “American Psychiatric Association” (trade name). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe diagnostic criteria and, accordingly, the identification/description is indefinite.
Claim 42 recites the limitation "the interval between two administrations". There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 42, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 44 recites the limitation "the respective score". There is insufficient antecedent basis for this limitation in the claim.
Claim 46 recites the limitation "the clinical response" and "the respective score". There is insufficient antecedent basis for this limitation in the claim.
Claim 48 recites the limitation "the clinical response" and "the respective score". There is insufficient antecedent basis for this limitation in the claim.
Claim 50 recites the limitation "the clinical response" and "the respective score". There is insufficient antecedent basis for this limitation in the claim.
All dependent claims 35-51 are rejected for depending upon a rejected base claim and not clarifying the limitations at issue.
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 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) 34-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Journal of Psychopharmacology; 2018) in view of Russ et al. (WO 2018/195455 A1; 2018) and Carhart-Harris et al. (Lancet Psychiatry; 2016).
Davis et al. teaches an epidemiological survey wherein of individuals diagnosed with depression who have used 5-MeO-DMT (61% of respondents), 77% of those individuals reported an improvement in depression symptoms (Table 6). Davis et al. additionally teaches that the majority of respondents (i.e., greater than 50%), reported experiencing a complete mystical experience (“characterized by the endorsement of ≥ 60% of the total possible score across all four subscales of the MEQ30” p. 784, col. 1; Table 4).
Davis et al. does not teach a patient diagnosed with major depressive disorder or administration via an intravenous, intramuscular, or subcutaneous route. Davis et al. does not disclose diagnosing the disorder in accordance with the DSM-5. Davis et al. does not disclose that the major depressive disorder is indicated by a MADRS score or HAM-D score. Davis et al. does not teach that the major depressive disorder is treatment-resistant or that the 5-MeO-DMT is administered at a particular dose. These limitations are obvious over Russ et al. and Carhart-Harris et al.
Russ et al. teaches methods of treatment for subjects who are responsive to psychedelics (Abstract). Russ et al. teaches that the psychedelic agent may be a 5-HT2A agonist such as 5-MeO-DMT (p. 4, line 9). Russ et al. teaches a method of improving mental or physical well-being of a subject comprising providing the psychedelic agent to the subject, such as for treating depression in the subject (p. 6-7 bridging paragraph). Russ et al. teaches that the depressive disorder may be major depression (p. 8, lines 35-36). Russ et al. teaches that diagnostic guidance for psychological disorder can be found in the DSM-5 (p. 13, lines 30-34). Russ et al. teaches that the subject’s mystical experience may be measured according to the MEQ-30, ocean boundlessness, etc. (p. 15, lines 3-16). Russ et al. additionally suggests that the psychedelic compositions may be administered parenterally, such as by injection or infusion (e.g., intravenous, intramuscular, subcutaneous) (p. 28, lines 21-26). Russ et al. also discloses that a positive therapeutic response includes remission (p. 4, lines 21-22).
Carhart-Harris et al. teaches a method of treating treatment-resistant depression by administering psilocybin (Abstract). Carhart-Harris et al. teaches that psilocybin is a 5-HT2A agonist. Carhart-Harris et al. additionally discloses assessment of depression severity using the HAM-D and MADRS scales (p. 621, col. 1) wherein all patients had a HAM-D score of 17 or more (Table 1).
It would be prima facie obvious for one of ordinary skill in the art to administer 5-Meo-DMT for the treatment of major depressive disorder in a subject. One would have been motivated to do so, with reasonable expectation of success, as 5-MeO-DMT has been shown to improve symptoms of depression. In view of the guidance disclosed in Davis et al. and Russ et al., one of ordinary skill in the art would be apprised that administration of 5-MeO-DMT to an individual with major depressive disorder would provide beneficial mood-improving effects.
It would be prima facie obvious for one of ordinary skill in the art to administer the 5-Meo-DMT via an intravenous, intramuscular, or subcutaneous route, and to optimize the dose and schedule of administration according to the patient’s response (MADRS score, psychedelic experience, etc.). One would have been motivated to do so, with reasonable expectation of success, as Russ et al. sets forth that parenteral (intravenous, intramuscular, etc.) formulations may be administered and prepared via methods well known to one skilled in the art. Moreover, absent unexpected effects, optimization of doses, schedules, and ranges would be routine for one of ordinary skill in the art to arrive at, with the motivation of utilizing a dose that would afford therapeutic effects to the subject. MPEP 2144.05.
Finally, it would be prima facie obvious for one of ordinary skill in the art to further administer the 5-MeO-DMT to a treatment-resistant subject. One would be motivated to do so, with reasonable expectation of success, as 5-HT2A agonists have been demonstrated in the art to have beneficial therapeutic effects when administered to individuals with treatment-resistant depression as in Carhart-Harris et al. One would expect 5-MeO-DMT and psilocybin to have similar effects as they are both 5-HT2A agonists with evidence of having anti-depressant properties.
Claim(s) 34-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anonymous (EU Clinical Trials Register; 2019) in view of Russ et al. (WO 2018/195455 A1; 2018).
Anonymous discloses a method of treating treatment-resistant major depressive disorder in patients diagnosed with major depressive disorder according to DSM-5 criteria (p. 3) comprising administering 5-MeO-DMT via inhalation (p. 2). Anonymous discloses that the dose is 2 to 18 mg (p. 2). Anonymous discloses that the effect of the 5-MeO-DMT will be evaluated by mean change in the MADRS total score (p. 3).
Anonymous does not disclose administration via an intravenous, intramuscular, or subcutaneous route. Anonymous does not disclose the claimed dosing schedule. These limitations are obvious in view of Russ et al.
Russ et al. discloses as above.
It would be prima facie obvious for one of ordinary skill in the art to administer the 5-Meo-DMT via an intravenous, intramuscular, or subcutaneous route, and to optimize the dose and schedule of administration according to the patient’s response (MADRS score, psychedelic experience, etc.). One would have been motivated to do so, with reasonable expectation of success, as Russ et al. sets forth that parenteral (intravenous, intramuscular, etc.) formulations may be administered and prepared via methods well known to one skilled in the art. Moreover, absent unexpected effects, optimization of doses, schedules, and ranges would be routine for one of ordinary skill in the art to arrive at, with the motivation of utilizing a dose that would afford therapeutic effects to the subject. MPEP 2144.05.
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 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/373,904 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '904 application are directed to a method of treating moderate to severe postpartum depression. In view of the specification of the reference application, "PPD is diagnosed when major depressive disorder... symptoms begin during pregnancy or within four weeks of delivery" (p. 7). As such it would be clear to one of ordinary skill in the art that the claims of the reference application are drawn to a narrower invention, and therefore anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-85 of copending Application No. 18/373,906 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '906 application are drawn to a method of treating a mental or nervous system disorder in a breastfeeding mother by administering a dose of about 4 mg to about 20 mg 5-MeO-DMT. In looking to the specification to construe the scope of the claims, the disorder is disclosed on page 3 of the '906 specification to include major depressive disorder. Therefore, it would be clear to one of ordinary skill in the art that the instant invention and that of the '906 application substantially overlap such that one could arrive at the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-7, 15, 22, and 24 of copending Application No. 18/675,614 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '614 application substantially overlap with and/or are narrower than that of the instant invention, such that it would be obvious for one of ordinary skill in the art to arrive at the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of copending Application No. 18/373,903 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘903 claims are directed to a method of treating moderate to severe postpartum depression. In view of the specification of the reference application, "PPD is diagnosed when major depressive disorder... symptoms begin during pregnancy or within four weeks of delivery" (p. 8). Moreover, one of ordinary skill in the art would be apprised that the route of administration may be adjusted for optimal treatment results. It would therefore be obvious for one of ordinary skill in the art to arrive at the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-87 of copending Application No. 18/373,914 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '914 application are drawn to a method of treating a mental or nervous system disorder in a breastfeeding mother by administering a dose of about 1 mg to about 10 mg 5-MeO-DMT. In looking to the specification to construe the scope of the claims, the disorder is disclosed on page 3 of the '914 specification to include major depressive disorder. Therefore, it would be clear to one of ordinary skill in the art that the instant invention and that of the '906 application substantially overlap such that one could arrive at the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-82 of copending Application No. 18/851,322 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘322 claims are directed to a method of postpartum depression comprising administering 5-MeO-DMT. In view of the specification of the reference application, "PPD is diagnosed when major depressive disorder... symptoms begin during pregnancy or within four weeks of delivery" (p. 7). Moreover, one of ordinary skill in the art would be apprised that the route of administration may be adjusted for optimal treatment results. It would therefore be obvious for one of ordinary skill in the art to arrive at the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 78-112 of copending Application No. 18/851,356 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘356 claims are directed to a method of treating postpartum depression comprising administering 5-MeO-DMT. In view of the specification of the reference application, "PPD is diagnosed when major depressive disorder... symptoms begin during pregnancy or within four weeks of delivery" (p. 7). Moreover, one of ordinary skill in the art would be apprised that the route of administration may be adjusted for optimal treatment results. It would therefore be obvious for one of ordinary skill in the art to arrive at the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 34-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-68 of copending Application No. 18/850,394 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '394 application are drawn to a method of treating a mental or nervous system disorder in a breastfeeding mother by administering 5-MeO-DMT. In looking to the specification to construe the scope of the claims, the disorder is disclosed on page 3 of the '394 specification to include major depressive disorder. Therefore, it would be clear to one of ordinary skill in the art that the instant invention and that of the '906 application substantially overlap such that one could arrive at the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.E.B./Examiner, Art Unit 1624 06/11/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
Prosecution Insights