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 .
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 21, 22, 25-27, 31-34 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 2, 13-21 of prior U.S. Patent No. 12,042,564. This is a statutory double patenting rejection.
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 21, 22, 24-27 and 31-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,042,564. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a solid dosage form comprising two or more compounds deuterated analogues of N,N-dimethyltryptamine. The dosage form comprising at least compound I, which is the compound 1 of claims 7 of 564. The solid dosage form is present in a fumerate salt, or free base form. The dosage forms can be used in a method for treating psychiatric disorders including depression and anxiety. The claims differ in that the 564 claims recite a specific concentration of the at least two compounds present in the dosage form. The instant claims are of a broader scope regarding the concentration of the DMT analogues. However, the instant claimed Compound is a species of claim 7 of the 564 claims. The scopes overlap and would render each other obvious if applied over one another. The instant claims cannot be allowed together.
Claims 21, 22, and 24-27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,471,417. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a dosage comprising deuterated N,N-dimethyltryptamine comprising the same compound. The claims overlap in scope but differ in that the instant claims are drawn to a combination of at least two deuterated compounds, while the 417 claims do not foreclose the inclusion of other compounds. The scope overlap and would be obvious variants of each other and as such cannot be allowed together.
Claims 21, 22 and 24-27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,771,681. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a dosage form comprising deuterated N,N-dimethyltryptamine mixture inclusion at least a deuterium at an α location. The claims are both drawn to a dosage form comprising a combination of deuterated DMT, with overlapping scopes. The instant claims do not disclose the specific combination of the two compounds, however the optimization of this combination would have been within the level of skill in the art through routine experimentation and as such would be an obvious variant of each other. The claims cannot be allowed together.
Claims 21, 22, 24-28 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 7, 12, 13, 18 and 19 of U.S. Patent No. 12,076,311. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compositions comprising deuterated DMT compositions comprising a combination of analogues of the deuterated DMT compounds. The claims also recite the compounds present in fumarate salt form and further comprise pharmaceutically acceptable excipients. The scopes of the claims overlap in the both sets of claims recite combinations of at least two DMT analogues. These claims would act as obviating art over one another and as such cannot be allowed together.
Claims 21, 22 and 24-28 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 21-23 of U.S. Patent No. 12,521,370. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to an inhalable formulation comprising a combination of at least two deuterate N,N-dimethyltryptamine analogues and pharmaceutical excipients. The claims overlap scopes in that the structure of the 370 claims is broader that the specific structure of the instant claims. However, the claims act as obviating art over one another as the structure reads on the compound of the instant claims. The scopes of the claims overlap in the both sets of claims recite combinations of at least two DMT analogues. These claims would act as obviating art over one another and as such cannot be allowed together.
Claims 21, 22 and 24-37 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 5-7 and 10-15 of U.S. Patent No. 11,660,289. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to compound having a N,N-dimethyltryptamine in free base and fumarate sall.t the compound comprises a combination of at least two of these analogues The compounds are useful in a method for treating psychiatric conditions including depression. The claims differ in that the structure is of broader scope than that of the instant claims, however claims would act as obviating art over each other. The scopes of the claims overlap in the both sets of claims recite combinations of at least two DMT analogues. These claims would act as obviating art over one another and as such cannot be allowed together.
Claim 21, 22 and 24-37 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8, 9, 11, 12, 16, 48 and 49 of copending Application No. 18/711,130 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to an injectable formulation comprising a N,N-dimethyltryptamine analogue where one of the modification can be the addition of deuterium. The injectable formulation further comprises excipients and can be used in a method to treat psychiatric conditions inclusion depression. The claims overlap in scope in that the instant claims are a species of the 130 claims recited a specific structure while the 13 claims receipt a broader structure. The instant claims would act as obviating art over the copending 130 claims and as such cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 21, 22 and 24-38 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 12, 13, 16-25 of copending Application No. 18/619,547 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to methods of treating psychiatric disorders including depression by the application of a composition comprising a combination of deuterated N,N-dimethyltryptamine analogues. The instant claims recite a specific analogue structure while the 547 claims recite various deuterated options. The instant claims would act as a species over the genus of the copending claims. The claims overlap in scope in that the instant claims are a species of the 547 claims recited a specific structure while the 547 claims receipt a broader structure. The instant claims would act as obviating art over the copending 547 claims and as such cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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, Michael Hartley can be reached at 5712720616. 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.
/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
Prosecution Insights