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 Claims
The amendments to the claims filed December 18, 2024 are acknowledged and entered. Claims 1-9 are pending.
Priority
This application is a CON of 17/245,388, filed April 30, 2021, now ABN, which is a CON of 16/935,557, filed July 22, 2020, now U.S. Patent No. 11,083,699, which is a CIP of PCT/US2020/014784, filed January 23, 2020, which claims benefit of 63/949,060, filed December 17, 2019, and benefit of 62/797,513, filed January 28, 2019.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
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 1-5 and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,083,699. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the patent claims.
Patent claim 1 recites a method comprising administering a therapeutically effective amount of a composition comprising one or more of a mitofusin activator or a pharmaceutically acceptable salt thereof to a subject having or suspected of having a mitochondria-associated disease, disorder or condition, the mitofusin activator having a structure represented by the following formula
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Patent claim 7 depends from patent claim 1 and recites wherein the mitofusin activator has a structure represented by one or more of the following formula
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The compound of patent claim 7 corresponds to the same compound recited in instant claims 1, 4 and 8-9.
Compound of the instant claims
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Patent claims 8 recites wherein the mitochondria-associated disease, disorder or condition is a peripheral nervous system (PNS) or central nervous system (CNS) genetic or non-genetic disorder, physical damage, and/or chemical injury.
Patent claim 9 recites the conditions (e.g. diabetes mellitus and deafness (DAD)…myoclonic epilepsy with ragged red fibers (MERRF)) recited in instant claim 3.
Patent claim 10 recited a composition comprising a mitofusin activator or a pharmaceutically acceptable salt thereof. Patent claim 15 depends from patent claim 10 and recites wherein the mitofusin activator has a structure represented by one or more of the following formula
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Patent claim 16 depends from patent claim 10 and recites further comprising a pharmaceutically acceptable excipient.
The patent claims recite the limitations of the instant claims and therefore anticipate the invention.
Claims 4 and 6-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,083,699 B2 in view of Drugs for the doctor’s bag (Drug Ther Bull 2005, 65-68)(hereinafter “Drugs”).
The patent claims are drawn to a method of administering a therapeutically effective amount of a composition comprising a compound of the claims to a subject having conditions such as DAD and/or MERRF, as well as a composition comprising the claimed compound, the limitations of which were discussed above and are incorporated herein by reference. The patent claims do not recite a kit; however, Drugs teaches there is a need for doctors to carry a range of medicines for use in acute situations when making home visits (Abstract). Drugs teaches that medicines should include those to treat diabetic emergencies and seizures (page 66-67).
The difference between the patent claims and the instant claims is that the instant claims are drawn to a kit comprising the patented composition. However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application to combine the composition of the patent claims into a kit because at the time it was suggested that doctors carry medicines to treat seizures and diabetic emergencies and both DAD and MERRF are conditions which could involve diabetic emergencies and seizures.
One would have been motivated as a matter of carrying pharmaceutical compositions that they may need to use when making home visits.
One would have had a reasonable expectation of success because at the time it was suggested that doctors carry medications to treat seizures and diabetic emergencies and the patented composition was useful for administration to a subject who may have a seizure or diabetic emergency.
Claims 1-5 and 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,026,904 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patent claims.
Patent claim 1 recites a method comprising administering a therapeutically effective amount of a composition comprising one or more of a mitofusin activator or a pharmaceutically acceptable salt thereof to a subject having or suspected of having a mitochondria-associated disease, disorder or condition.
Patent claims 10 recites wherein the mitochondria-associated disease, disorder or condition is a peripheral nervous system (PNS) or central nervous system (CNS) genetic or non-genetic disorder, physical damage, and/or chemical injury.
Patent claim 11 recites the conditions recited in instant claim 3.
Patent claim 9 recites wherein the mitofusin activator is selected from the structures set forth below which correspond to racemic forms of the compounds of the instant claims.
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Patent claim 12 is drawn to a composition comprising one or more mitofusin activators. Patent claim 20 depends indirectly from patent claim 12 and recites the same compounds as set forth in patent claim 9. Patent claim 21 recites further comprising a pharmaceutically acceptable excipient.
The difference between the patent claims and the instant claims is that the instant claims are drawn to the trans stereoisomers of the compounds recited in the patent claims. However, the trans stereoisomer of the instant claims would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention because one would have recognized that the compounds of the patent were racemic and that the trans stereoisomers could be separated using conventional methods in the art (e.g. chiral resolution).
One would have been motivated as a matter of assessing the activity of the compounds.
One would have had a reasonable expectation of success because the patented compounds were racemic and it would have been routine to isolate stereoisomers to assess their activity.
Claims 1-5 and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 18-21, 25 and 27-29 of copending Application No. 18/294,389 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the claims of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 1 recites a compound having Formula (I).
Reference claim 19 recites wherein the compound has the structure
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Reference claim 20 recites a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.
Reference claim 21 recites a method of treating a disease in a subject comprising administering the composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.
Reference claim 27 recites wherein the disease is peripheral nervous system (PNS) or central nervous system (CNS) genetic or non- genetic disorder, physical damage, or chemical injury.
Reference claim 28 recites wherein the disease is selected from those recited in instant claim 3.
The difference between the patent claims and the instant claims is that the instant claims require a C3 or C4 cycloalkyl. The patent claims and instant claims are thus related as homologs, differing only in the number of repeating -CH2- groups. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. See MPEP 2144.09.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify the reference claims into the instant claims because the claims are homologs of the compounds of the reference application.
One would have been motivated as a matter of preparing additional compounds that may be useful for treating conditions such as DAD.
One would have had a reasonable expectation of success in preparing the instantly claimed compounds because the compounds only differ from the reference application by repeating -CH2- groups.
Claims 1-5 and 8-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8, 10-14, 16-20 and 23-27 of copending Application No. 18/282,158 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 1 recites a compound having Formula (I).
Reference claim 18 recites wherein the compound has the structure
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The compound of reference claim 18 corresponds to the compound of the instant claims having structure
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Reference claim 19 recites a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.
Reference claim 20 recites a method of treating a disease in a subject comprising administering the composition comprising the compound of claim 1 and a pharmaceutically acceptable excipient.
Reference claim 25 recites wherein the disease is peripheral nervous system (PNS)[[,]] or central nervous system (CNS) genetic or non- genetic disorder, physical damage, or chemical injury.
Reference claim 26 recites wherein the disease is selected from those recited in instant claim 3.
The reference claims recite the limitations of the instant claims and therefore anticipate the invention.
Claims 4 and 6-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 8, 10-14, 16-20 and 23-27 of copending Application No. 18/282,158 (reference application) in view Drugs for the doctor’s bag (Drug Ther Bull 2005, 65-68)(hereinafter “Drugs”).
This is a provisional nonstatutory double patenting rejection.
The reference claims are drawn to a method of treating a disease in a subject comprising administering the composition comprising the compound of claim 1, wherein the disease is DAD and/or MERRF, as well as a composition comprising the claimed compound, the limitations of which were discussed above are incorporated herein by reference. The reference claims do not recite a kit; however, Drugs teaches there is a need for doctors to carry a range of medicines for use in acute situations when making home visits (Abstract). Drugs teaches that medicines should include those to treat diabetic emergencies and seizures (page 66-67).
The difference between the patent claims and the instant claims is that the instant claims are drawn to a kit comprising the patented composition. However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the instant application to combine the composition of the reference claims into a kit for the reasons provided above with regard to the double patenting rejection of claims 4 and 6-7 over US Patent No. 11,083,699 B2 in view of Drugs, the reasons of which are incorporated herein by reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached on (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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July 20, 2026
/KEVIN S MARTIN/Examiner, Art Unit 1624
Prosecution Insights