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 .
Status of the Claims
Claims 1-38 are pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Instant application is a continuation-in-part of PCT/EP2023/057874, filed 03/27/2023. PCT/EP2023/057874 claims priority of foreign applications PCT/EP2023/057885, filed 03/27/2023, EP23153996.6, filed 01/30/2023, EP23154014.7, filed 01/30/2023, EP22000084.8, filed 03/27/2022, and EP22000085.5, filed 03/27/2022. Therefore, the effective filing date is 03/27/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/22/2024, 07/23/2024, 08/26/2024, 09/27/2024, 10/01/2024, 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, 12/15/2025, and 01/21/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 reads “A method of treating a patient suffering from postpartum depression (PPD), wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning, comprising administering to the patient suffering from postpartum depression (PPD), wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning, …” (emphasis added), and to remove repetition, should instead read “A method of treating a patient suffering from postpartum depression (PPD), wherein the patient suffers from moderate or severe depression and from compromised or severely compromised maternal functioning, comprising administering…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-8, 20-35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Layzell et al. (US 20220062238 A1, published 3 March 2022).
Layzell et al. teaches, in claim 1, a pharmaceutical composition suitable for injection comprising a dimethyltryptamine compound that is substituted with methoxy at the 5 position (5-MeO-DMT). Paragraph [0093] teaches an embodiment where the DMT compound of the invention is 5-methoxy-N,N-dimethyltryptamine. A method of treating a psychiatric condition comprising administering the composition of claim 1 is taught in claim 17. Reference claim 19 teaches that the neurological condition is major depressive disorder or treatment resistant depression. Specifically, paragraph [0167] teaches “In some embodiments, a method of treating a psychiatric or neurological disorder in a patient with the above formulations is provided. … The disorder may be post-partum depression”, as in instant claims 1 and 38.
Layzell et al. fails to teach that the patient suffers from compromised maternal functioning or has the specific MADRS score or BIMF score required by instant claims 1-8.
However, it would be routine procedure for a physician to determine the MADRS and BIMF scores of a patient who is in need of treatment for postpartum depression, and it would be prima facie obvious to treat a patient with severe compromised maternal functioning and a high MADRS score or BIMF score with a known method of treating postpartum depression, such as that taught by Layzell et al.
One of ordinary skill in the art would have a reasonable expectation of success using a known method of treatment for postpartum depression on a patient any level of compromised maternal functioning or any specific MADRS or BIMF score, since the method is not limited to treating only patients with specific levels of compromised maternal functioning or MADRS or BIMFs scores.
Layzell et al. teaches, in claim 11, that the dimethyltryptamine compound is administered in a concentration of 2.5 mg/mL, as in instant claims 20-23 and 32-33.
Regarding instant claims 24-31, 34, and 35, which references specific dosage information, MPEP 2144.05 II A states: “‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (‘The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.’); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)”. Therefore, it would be considered routine optimization to determine the optimum dosages of a prior art reference and considered prima facie obvious, unless there is evidence of unexpected results.
Claims 1-8, 20-35, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Kruegel (WO 2023028086 A1), with a priority date of 23 August 2021.
Kruegel teaches, in claims 1, 33, and 70, a method of treating a psychiatric disorder in a patient comprising administering, by injection, 5-25 mg of 5-MeO-DMT. It is taught in claims 71 and 75 that the psychiatric disorder being treated is postpartum depression, as in instant claims 1 and 38.
Kruegel fails to teach that the patient suffers from compromised maternal functioning or has the specific MADRS score or BIMF score required by instant claims 1-8.
However, it would be routine procedure for a physician to determine the MADRS and BIMF scores of a patient who is in need of treatment for postpartum depression, and it would be prima facie obvious to treat a patient with severe compromised maternal functioning and a high MADRS score or BIMF score with a known method of treating postpartum depression, such as that taught by Kruegel.
One of ordinary skill in the art would have a reasonable expectation of success using a known method of treatment for postpartum depression on a patient any level of compromised maternal functioning or any specific MADRS or BIMF score, since the method is not limited to treating only patients with specific levels of compromised maternal functioning or MADRS or BIMFs scores.
Kruegel teaches, in claim 11, that the 5-MeO-DMT is administered in an amount of 5-25 mg, as in instant claims 20, 21, 23, 32, and 33.
Regarding instant claims 22, 24-31, 34, and 35, which references specific dosage information, MPEP 2144.05 II A states: “‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (‘The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.’); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)”. Therefore, it would be considered routine optimization to determine the optimum dosages of a prior art reference and considered prima facie obvious, unless there is evidence of unexpected results.
Claims 1-38 are rejected under 35 U.S.C. 103 as being unpatentable over Terwey (WO 2020169851 A1), published 27 August 2020, cited by Applicant in the IDS, hereinafter referred to as reference ‘851, further in view of Layzell et al. (US 20220062238 A1).
Reference ‘851 teaches, in claim 1, a method of treating major depressive disorder comprising administering 5-MeO-DMT intravenously, intramuscularly, or subcutaneously.
Reference ‘851 fails to teach that the depressive disorder is postpartum depression.
However, Layzell et al. teaches a method of treating postpartum depression comprising administering 5-MeO-DMT with an injection. See above rejection.
Therefore, it would be prima facie obvious to extend the method of treating depressive disorders taught by reference ‘851 to postpartum depression, since the same active ingredient was taught by Layzell et al. to treat postpartum depression.
Additionally, regarding instant claims 1-3 and 6-8, it would be routine procedure for a physician to determine the BIMF score of a patient who is in need of treatment for postpartum depression, and it would be prima facie obvious to treat a patient with severe compromised maternal functioning and a high BIMF score with a known method of treating postpartum depression.
One of ordinary skill in the art would have a reasonable expectation of success using a known method of treatment for postpartum depression on a patient any level of compromised maternal functioning or any specific BIMF score, since the method is not limited to treating only patients with specific levels of compromised maternal functioning or BIMF score.
Reference ‘851 teaches, in claim 4, that the patient has a MADRS score of 35 or more as in instant claims 4 and 5. It is taught in claim 9 that the dosage causes the patient to experience a peak psychedelic experience, as in instant claim 19. The dosage amounts of reference claims 10-15 and 18 read directly on instant claims 20-35 and 38. Reference claims 16 and 17 read directly on instant claims 36 and 37.
Regarding instant claims 9-18, administering the same composition to the same patient population would inherently result in the same effects. Therefore, the results recited in instant claims 9-18 would be inherent properties of the method taught in reference ‘851.
Nonstatutory 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 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 11, 13-18, and 56-68 of copending Application No. 18/851,311 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘311 teaches, in claims 1, 11, and 13 a method of treating postpartum depression comprising administering 5-MeO-DMT, wherein the patient suffers from compromised maternal functioning and the 5-MeO-DMT is administered intravenously, intramuscularly, or subcutaneously, as in instant claims 1-3, 7, and 38.
Reference claims 3, 4, 14-18, and 56-68 read directly on instant claims 6 and 8-37.
Regarding instant claims 4 and 5 it would be prima facie obvious to one of ordinary skill in the art to use the method of Application ‘311 in a patient with a MADRS score of 35 or more, since it is common practice to assess the MADRS score in patients and treat patients who have a more severe depression, represented by a higher MADRS score. One would have an expectation of success in using the same method to treat the same patient population.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-56, 57-69, 77, 79, 80, and 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.
Application ‘322 teaches, in claims 48 and 56, a method of treating postpartum depression comprising administering 5-MeO-DMT to a patient who suffers from severely compromised maternal functioning, as in instant claims 1-3 and 7.
Reference claims 49-55, 57-69, 77, 79, 80, and 82 read on instant claims 4-6, 8, 11-37.
Regarding instant claims 9 and 10, administering the same composition to the same patient population would inherently result in the same effects. Therefore, the remission of depressive symptoms on day 7 and day 28 recited in instant claims 9 and 10 would be an inherent property of the method taught in Application ‘322.
Regarding instant claim 38, it would be prima facie obvious to administer 5-MeO-DMT intravenously, since it is common procedure to determine the best administration route for a drug. One would have a reasonable expectation of success in taking the composition and methods taught in Application ‘322 and only changing the administration technique, since the same composition is being administered to the same patient population for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 15-22, and 96-112 of copending Application No. 18/851,349 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘349 teaches, in claims 1 and 15-17, a method of treating postpartum depression, wherein the patient has compromised maternal functioning, comprising administering 5-MeO-DMT intravenously, intramuscularly, or subcutaneously, as in instant claims 1-3, 7, and 38.
Reference claims 18-22 and 96-112 read on instant claims 6, 8, and 11-38.
Regarding instant claims 9 and 10, administering the same composition to the same patient population would inherently result in the same effects. Therefore, the remission of depressive symptoms on day 7 and day 28 recited in instant claims 9 and 10 would be an inherent property of the method taught in Application ‘349.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33, 39-54, and 62 of copending Application No. 18/851,329 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Application ‘329 teaches, in claims 33, 39, and 54, a method of treating depressive episodes in a breastfeeding mother who has severely compromised maternal functioning comprising administering 5-MeO-DMT intravenously, intramuscularly, or subcutaneously, as in instant claims 1-3, 7, and 38.
Reference claims 39-53 and 62 read on instant claims 6, 8, 11-19, 31, and 34-37.
Regarding instant claims 4 and 5 it would be prima facie obvious to one of ordinary skill in the art to use the method of Application ‘311 in a patient with a MADRS score of 35 or more, since it is common practice to assess the MADRS score in patients and treat patients who have a more severe depression, represented by a higher MADRS score. One would have an expectation of success in using the same method to treat the same patient population.
Regarding instant claims 9 and 10, administering the same composition to the same patient population would inherently result in the same effects. Therefore, the remission of depressive symptoms on day 7 and day 28 recited in instant claims 9 and 10 would be an inherent property of the method taught in Application ‘329.
Regarding the specific doses recited in instant claims 20-30, 32, and 33, MPEP 2144.05 II. A. states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Therefore, it would be routine optimization and prima facie obvious to determine the optimum working conditions of the method taught in Application ‘329.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, 55, and 69-87 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.
Application ‘914 teaches, in claims 1, 49, and 55, a method of treating postpartum depression in a patient, wherein the patient has compromised maternal functioning, comprising administering 5-MeO-DMT in a dosage of 1-10 mg intravenously, intramuscularly, or subcutaneously, with intervals of at least 1 hour between doses, as in instant claims 1-3, 7, 20-23, 31-33, 35, and 38.
Reference claims 69-87 read on instant claims 11, 12, and 19-38.
Regarding instant claims 4-6 and 8, it would be prima facie obvious to one of ordinary skill in the art to use the method of Application ‘311 in a patient with a specific MADRS score or BIMF score, since it is common practice to assess the MADRS score in patients and treat patients who have a more severe depression, represented by a higher MADRS score, and to evaluate the BIMF score in a patient. One would have an expectation of success in using the same method to treat the same patient population.
Regarding instant claims 9, 10, and 13-18, administering the same composition to the same patient population would inherently result in the same effects. Therefore, the results recited in instant claims 9, 10, and 13-18 would be inherent properties of the method taught in Application ‘914.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7-17, 46, and 48 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.
Application ‘356 teaches, in claims 1 and 7, a method of treating postpartum depression in a patient with severely compromised maternal functioning comprising administering 5-MeO-DMT, as in instant claims 1-3 and 7.
Reference claims 2, 4, 8-17, 46, and 48 read on instant claims 4-6 and 11-37.
Regarding instant claims 8-10, administering the same composition to the same patient population would inherently result in the same effects. Therefore, the results recited in instant claims 8-10 would be inherent properties of the method taught in Application ‘356.
Regarding instant claim 38, it would be prima facie obvious to administer 5-MeO-DMT intravenously, since it is common procedure to determine the best administration route for a drug. One would have a reasonable expectation of success in taking the composition and methods taught in Application ‘356 and only changing the administration technique, since the same composition is being administered to the same patient population for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 49, 50, 53, 55, and 69-80 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.
Application ‘906 teaches, in claims 1, 49, and 55, a method of treating postpartum depression in a patient with compromised maternal functioning comprising administering 5-MeO-DMT, as in instant claims 1-3 and 7.
Reference claims 50, 53, and 69-80 read on instant claims 11, 12, and 19-37.
Regarding instant claims 4-6 and 8, it would be prima facie obvious to one of ordinary skill in the art to use the method of Application ‘906 in a patient with a specific MADRS score or BIMF score, since it is common practice to assess the MADRS score in patients and treat patients who have a more severe depression, represented by a higher MADRS score, and to evaluate the BIMF score in a patient. One would have an expectation of success in using the same method to treat the same patient population.
Regarding instant claims 9, 10, and 13-18, administering the same composition to the same patient population would inherently result in the same effects. Therefore, the results recited in instant claims 8-10 would be inherent properties of the method taught in Application ‘906.
Regarding instant claim 38, it would be prima facie obvious to administer 5-MeO-DMT intravenously, since it is common procedure to determine the best administration route for a drug. One would have a reasonable expectation of success in taking the composition and methods taught in Application ‘906 and only changing the administration technique, since the same composition is being administered to the same patient population for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-38 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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.
/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624