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 invention group I, claims 18-27 and 29, in the reply filed on 08/25/2025 is acknowledged.
Claims 33-34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/25/2025.
Applicants further elect N-[5-(1H-1,3-benzodiazol-2-yl)-2-methylpheny]]-4- [(4-chlorophenyl)methoxy]-3-methoxybenzamide a specific compound of formula (I). The elected species is free of art, and the examination moves to other species of formula (I).
Claims 18-27, 29 and 33-34 are pending, claims 18-27 and 29 are under examination.
Priority
Acknowledge is made that this application is national stage of international patent application PCT/EP2021/063205, filed on 05/18/2021; which claims priority from French Patent application FR2005250, filed on 05/20/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/16/2022 is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-27 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention.
While all of the factors have been considered, only those required for a prima facie case are set forth below.
The specification discloses 45 compounds in Table 1 with only compounds 2 (N-[5-(1H-1,3-benzodiazol-2-yl)-2-methylpheny]]-4- [(4-chlorophenyl)methoxy]-3-methoxybenzamide) and 3 being tested for anti-HIV activity (reactivating HIV in latent HIV-infected cells).
The claims are drawn to a method of treating HIV by reactivating HIV in latent HIV-infected cells by administering a compound of formula (I) with a widely different structure of heteroaryl as substituent A and ring structure as substituent Z.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claim indicates that these claims are drawn to a genus, i.e., any compound of formula (I) reactivating HIV in latent HIV-infected cells. There is only a single species (compounds 2 and 3 with both having benzodiazol as substituent A and phenyl as substituent Z) explicitly disclosed with reactivating HIV in latent HIV-infected cells activity.
The disclosure of a single disclosed species may provide an adequate written description of a genus when the species disclosed is representative of the genus. The present claim encompasses any and all compound of formula (I) reactivating HIV in latent HIV-infected cells. There is substantial variability among the species of compounds encompassed within the scope of the claims because compounds 2 and 3 are only two compounds (with the same substituents A and Z) amongst an entire class of compounds that can have widely differing structures and corresponding biological activities.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). Consequently, the Examiner notes that the claimed invention which is drawn to a genus of compounds may be adequately described if there is a (1) sufficient description of a representative number of species, or (2) by disclosure of relevant, identifying characteristics sufficient to describe the claimed invention in such full, clear, concise and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. Here, the specification discloses that compounds 2 and 3 are only two compounds (with the same substituents A and Z) showing reactivating HIV in latent HIV-infected cells activities. Since the claimed genus encompasses compounds yet to be discovered, the disclosed structural feature does not constitute a substantial portion of the claimed genus. Therefore, the disclosure of compounds 2 and 3 (with the same substituents A and Z) showing reactivating HIV in latent HIV-infected cells activities does not provide an adequate description of the claimed genus.
Weighing all the factors, the breadth of the claims reading on compound of formula (I) yet to be discovered, the lack of correlation between structure and function of the drugs, level of knowledge and skill in the art, one of ordinary skill in the art would not recognize from the disclosure that the applicant was in possession of the genus of compound of formula (I) with reactivating HIV in latent HIV-infected cells activities. At best, it simply indicates that one should run tests on a wide spectrum of compounds in the hope that at least one of them will work. Neither the exemplary embodiments nor the specification’s general method appears to describe structural features, in structural terms, that are common to the genus. That is, the specification provides neither a representative number of compounds to describe the claimed genus, nor does it provide a description of structural features that are common to the compounds. In essence, the specification simply directs those skilled in the art to go figure out for themselves the structure of the claimed compound.
The written description requirement is not satisfied.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nunes et al. (US20090099170) teaches a compound 525 (page 269, table 4) for treating HIV but there is no teaching of motivation to introduce Z ring substituent to prepare a compound of formula (I).
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No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613