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 Oct. 6, 2023, the applicants have amended claims 3-9 and furthermore, have added new claims 10-18.
Claims 1-18 are pending in the application.
Claim Rejections - 35 USC § 102
(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.
Claims 1-16 and 18 are rejected under 35 U.S.C. 102(a) (1) as being clearly anticipated by Chang (MedRxiv).
Chang discloses treating corona virus and its symptoms by administration of Favipiravir. The method of treating corona virus and its symptoms (see discussion on page 15 as well as tables 2 and 3 on pages 23-24) by administration of Favipiravir (1600 mg twice a day on day 1 and 600 mg twice a day for 10 days disclosed by Chang clearly anticipate the instant claims.
Claims 1-8 and 10-15 are rejected under 35 U.S.C. 102(a) (1) as being clearly anticipated by Scavone (Br. J. Pharmacol.).
Scavone discloses treating corona virus and its symptoms by administration of Favipiravir. The method of treating corona virus and its symptoms (see 1st col., last paragraph to 2nd col., 1st paragraph on page 4816) by administration of Favipiravir disclosed by Scavone clearly anticipate the instant claims.
Claim Rejections - 35 USC § 103
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.
7. 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.
8. Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (MedRxiv).
Chang discloses treating corona virus and its symptoms by administration of Favipiravir. The method of treating corona virus and its symptoms (see discussion on page 15 as well as tables 2 and 3 on pages 23-24) by administration of Favipiravir (1600 mg twice a day on day 1 and 600 mg twice a day for 10 days disclosed by Chang meet all the limitations of anticipate the instant claims except that the dose of Favipiravir is 1800 mg twice a day on day 1 and 800 mg twice a day on day 2 onwards. However, Chang does teach treating corona virus and its symptoms by administration of Favipiravir (1600 mg twice a day on day 1 and 600 mg twice a day for 10 days. Therefore, it would have been obvious to one skilled in the art to select specific doses of Favipiravir to treat corona virus and its symptoms with reasonable expectation of success unless applicants provide unexpected results of superior activity of using 1800 mg twice a day on day 1 and 800 mg twice a day on day 2 onwards of Favipiravir.
Double Patenting
9. 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.
10. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-7 of copending Application No. 17/907,722 (reference application). 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 treat corona virus and its symptoms by Favipiravir with reasonable expectation of success. The selection of specific doses of Favipiravir will be within routine skill of an artesian.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. Claims 1-18 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/292,972 (reference application). 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 treat corona virus and its symptoms by Favipiravir with reasonable expectation of success. The selection of specific doses of Favipiravir will be within routine skill of an artesian.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
12. Claims 1-18 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1 and 9-13 of copending Application No. 18/559,873 (reference application). 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 treat corona virus and its symptoms by Favipiravir with reasonable expectation of success. The selection of specific doses of Favipiravir will be within routine skill of an artesian.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
13. 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