DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of the species
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in the reply filed on 11/24/2025 is acknowledged. A search of the prior art did not identify the elected species. The examiner has extended the search to encompass various species identified in the prior art below.
Claims 1-15, 17, 19, 23-24, 26, 29, 31 and 35 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 7/07/2023 is acknowledged and has been considered except where lined through.
Specification
The use of the term EUDRAGIT ®, 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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-12 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nagato et al. (US6949571B2, 2005-09-27).
Nagato et al. teach compounds represented by the following formula, a salt thereof, or hydrates thereof
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which have excellent AMPA receptor inhibitory action (Abstract). In particular, Nagato et al. teach specific compounds including, but not limited to, the following:
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all of which read on the claimed genus (see table beginning at column 141). Moreover, , Nagato et al. teach pharmaceutical composition comprising said compounds which are useful for treating a variety of diseases associated with AMPA receptor or kainite receptor including, but not limited to, epilepsy, vomiting, multiple sclerosis and HIV-myelopathy (Column 48, lines 27-67). Nagato et al. further teach numerous in vitro and in vivo tests for anticonvulsant action induced by AMPA, antimethamphetamine effect and the suppressing action to calcium influx into nerve cells induced by AMPA (see Test Examples beginning at column 215).
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.
Claim(s) 17, 19, 23-24, 26, 29, 31 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagato et al. (US6949571B2, 2005-09-27), as applied above to claims 1-12 and 14, in view of Altable, Marcos (Open Peer Review by Qeios, 2020-05-11: p.1-6, referred to herein as Altable) as evidenced by Ghahremanpour et al. (ACS Med. Chem. Lett. 2020, 11, 2526-2533).
Nagato et al. teach compounds represented by the following formula, a salt thereof, or hydrates thereof
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which have excellent AMPA receptor inhibitory action (Abstract). In particular, Nagato et al. teach specific compounds including, but not limited to, the following:
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all of which read on the claimed genus (see table beginning at column 141). Moreover, , Nagato et al. teach pharmaceutical composition comprising said compounds which are useful for treating a variety of diseases associated with AMPA receptor or kainite receptor including, but not limited to, epilepsy, vomiting, multiple sclerosis and HIV-myelopathy (Column 48, lines 27-67). With regards to the pharmaceutical composition, Nagato et al. teach that the pharmaceutical composition comprises the compound in combination with a pharmaceutically acceptable excipient and can be in the form for oral administration (column 47, lines 37-45). Nagato et al. further teach numerous in vitro and in vivo tests for anticonvulsant action induced by AMPA, antimethamphetamine effect and the suppressing action to calcium influx into nerve cells induced by AMPA (see Test Examples beginning at column 215).
Nagato et al. does not specifically teach that the AMPA related disease is COVID-19.
Altable discusses whether Perampanel, a drug currently used in epilepsy which acts through AMPA receptors thereby modulating the flow of glutamate, would have therapeutic and neuroprotective effects in COVID-19 infections (Abstract). Altable bases the discussion on some of the following:
Memantine, an N-methyl-D-aspartate receptor (NMDA) antagonist that regulates glutamate flux, decreases mortality and replication rates of SARS-CoV-1 in the central nervous system in a dose dependent manner (page 2, paragraph starting with Brison E)
A variant of SARS-CoV-1 that hosts a point mutation in it superficial spike protein (S) (Y241H) produces glutamate excitotoxicity and has been associated with dysregulation at the level of AMPA receptors (Page 3, paragraph bridging page 2).
Glutamate excitotoxicity may be involved in CNS infections with West Nile Virus, HIV, human herpes virus 6, human T-lymphotropic virus type 1 (HTLV-1), bornavirus and sindbis virus, wherein dysregulation of glutamate homeostatis leads to neuronal loss (neurodegeneration) as shown in other virus infections (page 3, 1st full paragraph).
4) Glutamatergic transmission modulators have shown antiviral properties against a human neurotropic and neuroinvasive virus (page 3, 2nd full paragraph).
In view of this, Altable suggests that it would be interesting to carry out new studies on the role of perampanel in models of SARS-CoV-1 and SARS-CoV-2 (Covid-19) incetion (page 3, last paragraph). While the prior art does not specifically teach the structure of perampanel, as evidenced by Figure 2 of Ghahremanpour et al., Perampanel has the following structure:
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which is identical to compound 7 above.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Nagato et al. to include patients with COVID-19 in view of the teachings of Altable. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Altable provides strong reasoning for the use of perampanel in patients with COVID-19 infection.
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 1-15, 17, 19, 23-24, 26, 29, 31 and 35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-9, 11, 13-17, 19 and 21-22 of copending Application No. 18/881,672 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds claimed and encompassed by formula I or formula (I-A) of the reference application substantially overlap in scope with the compounds claimed and encompassed by formula I or formula (I-A) of the instant application .
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Therefore, No claim is allowed. NOTE: When Rc is
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, the compounds of formula I are free of the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US7759367B1 to Smith, Terence (2010-07-02)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626