CTNF 18/573,785 CTNF 74143 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Dec. 22, 2023, the applicants have canceled claims 1-4 and furthermore, have added new claims 5-10. Claims 5-10 are pending in the application. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 5. 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. 07-21-aia AIA 6. Claim s 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hurst (Mol. Nutr. Food Res.) . Hurst teaches that Malvidin glycosides were beneficial in alleviating muscle damage in vitro as shown in figure 6 (see page 360 and last paragraph on page 361). Therefore, it would have been obvious to one skilled in the art to treat or inhibit muscle damage with glycosides with reasonable expectation of success. It is of note that an increase in blood myoglobin will be inherently suppressed following administration of glycosides for treating muscle damage. 7. Claims 5-10 are rejected under 35 U.S.C. 103 as being obvious over Ikeda (CA 3073804 A1) in view of Funes (Eur. J. Appl. Physiol.). Ikeda discloses composition comprising Kaempferol for improvement in physical activity efficiency and reducing fatigue (see claims 1-4, 6-14 and 16-17). Ikeda meets all the limitations of instant claims except that Ikeda does not teach treating or inhibiting muscle damage and suppression of myoglobin. However, Funes teaches that intense exercise is directly related to muscular damage and oxidative stress due to excessive reactive oxygen species (ROS) in plasma and white blood cells. Therefore, it would have been obvious to one skilled in the art to reduce muscle damage by administration of Kaempferol to improve physical activity efficiency with reasonable expectation of success. It is of note that an increase in blood myoglobin will be inherently suppressed following administration of Kaempferol for treating muscle damage . Double Patenting 08-33 AIA 8. 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. 08-36 AIA 9. Claim s 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-11 and 13-15 of U.S. Patent No. 12,048,683, cited on applicant’s form 1449) in view of Funes (Eur. J. Appl. Physiol.) . The PAT 12,048,683 discloses composition comprising Kaempferol for improvement in physical activity efficiency and reducing fatigue (see claims 1-11 and 13-15). The Patent 12,048,683 meets all the limitations of instant claims except that the patent does not teach treating or inhibiting muscle damage and suppression of myoglobin. However, Funes teaches that intense exercise is directly related to muscular damage and oxidative stress due to excessive reactive oxygen species (ROS) in plasma and white blood cells. Therefore, it would have been obvious to one skilled in the art to reduce muscle damage by administration of Kaempferol to improve physical activity efficiency and reducing fatigue with reasonable expectation of success. It is of note that an increase in blood myoglobin will be inherently suppressed following administration of Kaempferol for treating muscle damage. 10. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621 Application/Control Number: 18/573,785 Page 2 Art Unit: 1621 Application/Control Number: 18/573,785 Page 3 Art Unit: 1621 Application/Control Number: 18/573,785 Page 4 Art Unit: 1621 Application/Control Number: 18/573,785 Page 5 Art Unit: 1621 Application/Control Number: 18/573,785 Page 6 Art Unit: 1621