DETAILED ACTION
Election Acknowledged
Applicants’ election without traverse the species of a,a-dideutero-N,N-dimethyltryptamine encompassing claims 1, 2, 8 is acknowledged. The restriction is made final without traverse.
It is noted that in the response filed 8/25/2026, claims 1, 2, 8, 9, 11, 12, 16, 18, 22, 25-27, 29, 33, 36, 37, 39, 48, 49 and 55 are listed as readable on the elected species. However, it appears this is incorrect with respect to claim 11. Claim 11 defines a compound where R2b and R3b are both CD3 which would result in N,N-di(trideuteromethyl)tryptamine, not a,a-dideutero-N,N-dimethyltryptamine as elected. For this reason, claim 11 11 is withdrawn as being directed to nonelected species.
Claims 1, 2, 8, 9, 11, 12, 16, 18, 22, 25-27, 29, 33, 36, 37, 39, 48, 49 and 55 are pending, claim 11 is withdrawn as being directed to nonelected species and claims 1, 2, 8, 9, 12, 16, 18, 22, 25-27, 29, 33, 36, 37, 39, 48, 49 and 55 are presented for examination.
The following rejections are made.
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/15/2024, 6/26/2024, 5/17/2024 and 5/17/2024 have been considered by the examiner.
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.
Claims 1, 2, 8, 9, 12, 16, 18, 22, 25-27, 29, 36, 37, 39, 48, 49 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (WO 2019/081764) in view of Becker et al. (US 2020/0360308).
Perez describes an injection formulation for delivering a compound which promotes neurogenesis and has hallucinogenic and/or psychedelic side effects having the structure:
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(see page 18; circle and square added by Examiner) wherein R3 and R4 are H, R5 can be protium (H) or deuterium (D), R1 is methyl and R2 is methyl (see pages 18-19). In the circumstance where, the R5 attached to the squared carbon are -H and the R5 attached to the circled carbon are -D, this result would result in applications elected species: a,a-dideutreo-N,N-dimethyltryptamine (see instant claims 1, 8, 9, 12 and 16).
Injectable solutions, e.g. intramuscular, are contemplated for delivery wherein the tryptamine is present as a free base and/or a salt (see page 19) and is administered in an amount of between 0.5-1000 mg (see page 29; see instant claim 55). See MPEP 2144.05(I) regarding the obviousness of overlapping ranges.
Regarding the concentration of the tryptamine as presented in present claims 1 and 22, one of ordinary skill in the art would be capable of titrating and identifying a concentration suitable for administration to a subject in need and if it were found that a concentration of about 10 mg/ml or greater (or between 15-70 mg/mL) yielded therapeutic benefit, e.g. nerve regeneration, then this would have been the product of ordinary skill and common sense.
Methods of administering the composition for the treatment of psychiatric and/or neurological disorders, e.g. obsessive compulsive disorders, depression, anxiety, etc., are contemplated (see abstract and pages 12 and 13; see instant claim 48).
Perez fails to teach the composition as being an aqueous composition comprising a base agent and a buffer wherein the composition has a pH of between about 5-6.5 and an osmolality of 250-350 mOsm/kg.
Becker teaches injectable ketamine compositions that are to be safe, reduce injection site irritation and pain thereby providing a tolerable dosage option for patients (see [0003]). The injectable composition of Becker is to be a low volume dosage meaning that the dosage is administered as a small volume. Table 14 teaches that injectable compositions are to provide a desired dosage of therapeutic in a volume of between 0.214-0.429 mL. Such low volume injections are useful for reducing injection site irritation and providing a better treatment experience for patients (see [0396]). It would be obvious to modify Perez’s injection composition to similarly use such a low volume so as to achieve the same desirable outcomes.
Becker’s composition is to be an aqueous formulation comprising a base, e.g. sodium hydroxide (see [0307]; see instant claims 1, 27, 36, 37 and 39), and a buffering system comprising an acid and its salt, e.g. citric acid/citrate (see [0012, 0256]; see instant claims 1, 18, 25, 26, 29, 36 and 39), the composition having a pH of between 4.5-6.5 (see [0039]; see instant claims 1 and 2) and an osmolality of about 300 mOsm/kg (see [0040]; see instant claim 1). Modifying the injectable deuterated DMT composition of Perez such that is comprised a base and an acid/buffer and an osmolality of 300 mOsm/kg and a pH of between 4.5-6.5 would have been obvious as such additives and properties are important to the stability, safety and comfortability of the injectable formulation. See MPEP 2143(I)(A).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Perez et al. (WO 2019/081764) in view of Becker et al. (US 2020/0360308) as applied to claims 1, 2, 8, 9, 12, 16, 18, 22, 25-27, 29, 36, 37, 39, 48, 49 and 55 above, and further in view of Maloney et al. (US 10653719).
Perez and Becker fail to teach their injectable compositions as having an oxygen content of less than 5 ppm.
Maloney is directed to injection compositions having from less than about 5 ppm dissolved oxygen (see claim 22). Such oxygen concentrations ensure that the composition remains safe, pure and stable during storage (see column 4, lines 50-55). Thus, modifying Perez and Becker’s composition such that oxygen was present in an amount of less than about 5 ppm would have been obvious as doing so would ensure that composition remains safe, pure and stable during storage.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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.
Claim 33 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 33, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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, 2, 8, 9, 11, 12, 16, 18, 22, 25-27, 29, 33, 36, 37, 39, 48, 49 and 55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12318477.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the patent document and the pending claims are to pharmaceutical formulations comprising a tryptamine compound:
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, an acid component, a base agent, a pH of between 5-6.5, an osmolality of between 250-350 mg/kg, a concentration of 10 mg/ml or greater of the freebase equivalent, wherein the dosage of the compound is within a volume of 5 ml or less. The only difference between the patent document and the instant claims is that a kit is contemplated by the patent claims. However, such is considered derivative and obvious and is contemplated by the specification of the present application. All other limitations are considered overlapping.
Claims 1, 2, 8, 9, 11, 12, 16, 18, 22, 25-27, 29, 33, 36, 37, 39, 48, 49 and 55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-76 of copending Application No. 19/192691 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims are directed methods of treating psychiatric or neurological conditions by administering a pharmaceutical formulation comprising a tryptamine compound:
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, an acid component, a base agent, a pH of between 5-6.5, an osmolality of between 250-350 mg/kg, a concentration of 10 mg/ml or greater of the freebase equivalent, wherein the dosage of the compound is within a volume of 5 l or less.. The present claims similarly claim a method of treating a psychiatric or neurological conditions with a composition of overlapping scope.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KYLE A PURDY/Primary Examiner, Art Unit 1611
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