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 .
According to a preliminary amendment filed on Jan. 10, 2025, the applicants have canceled claims 2-9 and 11-18 and furthermore, have amended claims 28 and 29.
Claims 1, 10 and 19-29 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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.
5.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.
6. Claims 1, 10 and 19 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no written description for preparing and using mixture of every known form I, form II and anhydrate form of R-fasoracetam in the art. The only written description is for using mixture of R-fasoracetam monohydrate form I, R-fasoracetam monohydrate form II and anhydrate R-fasoracetam having specific peaks using X-ray powder diffraction as shown in figures 1, 4 and 7.
Claim Rejections - 35 USC § 102
7. 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.
8. Claims 10, 19 and 28 are rejected under 35 U.S.C. 102(a) (1) as being clearly anticipated by Harmsen (J. Pharm. Sci.).
Harmsen teaches solid state forms of R-fasoracetam. The R-fasoracetam monohydrate form II and anhydrate R-fasoracetam disclosed in tables 2 and 3 (see pages 1319 and 1320) as well as onset melting temperature of anhydrate R-fasoracetam disclosed in figure 6 (see page 1320) clearly anticipates the instant claims.
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Harmsen (J. Pharm. Sci.).
Harmsen teaches R-fasoracetam monohydrate form I, R-fasoracetam monohydrate form II and anhydrate R-fasoracetam. Harmsen meets all the limitations of instant claim 1 except that it does not teach preparing mixture of R-fasoracetam monohydrate form I and anhydrate R-fasoracetam. However, Harmsen does mention that initial results seem to indicate the possibility to formulate both hydrate forms and anhydrate form in future pharmacologic applications (see conclusion). Therefore, it would have been obvious to one skilled in the art to prepare mixture of R-fasoracetam monohydrate forms and anhydrate R-fasoracetam with reasonable expectation of success.
Double Patenting
12. 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.
13. Claims 1, 10, 19-22 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 4-7 of U.S. Patent No. 12,110,284. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one skilled in the art to prepare R-fasoracetam form II, anhydrate R-fasoracetam as well as mixture of R-fasoracetam form I, R-fasoracetam form II and anhydrate R-fasoracetam with reasonable expectation of success.
14. Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,535,604. Although the claims at issue are not identical, they are not patentably distinct from each other because it would have been obvious to one skilled in the art to prepare instant R-fasoracetam form II with reasonable expectation of success.
Allowable Subject Matter
15. Claims 23-27 and 29 are objected to as being dependent upon a rejected base claim but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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