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 .
Notice of Pre-AIA or AIA Status
Claims 1-2 are rejected
Information Disclosure Statement
All references from IDS(s) received 10/27/2025 and 01/29/2026 have been considered unless marked with a strikethrough.
Claim Interpretation
Claims 1 and 2 recite the phrase “A method for immunomodulation in inflammatory processes…” and further contain “…to act on the subject’s inflammatory condition.” The phrases are interpreted in the manner that claims 1 and 2 are focused on reducing inflammation thus being an anti-inflammatory composition.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over DEMCHENKO (RU2569742C1; published 2014), in view of Chen (CN107205441A published 2017). Citations refer to translated copies provided by Espacenet, which have been attached to this action.
Demchenko discloses a pharmaceutical “capsule… fat-soluble vitamins are included in the capsule core, such as vitamins A… and/or carotenoids (provitamin A or lycopene or astaxanthin or lutein or zeaxanthin or mixtures thereof)… and/or non-steroidal anti-inflammatory drugs (ibuprofen or ketoprofen or others)…” (Claim 11). Varga discloses β-caryophyllene as a plant-derived FDA approved food additive with anti-inflammatory properties towards chronic and binge alcohol-induced liver injury and inflammation (Background and Aims).
Ben-Shabat discloses the immunomodulation and anti-inflammatory properties of cannabidiol (Introduction lines 14-18).
Leonel discloses the anti-inflammatory nature of tributyrin on ulcerative colitis (Abstract).
Chen discloses “a composition… compris(ing): … and one or more carotenoids selected from the group consisting of: lycopene, astaxanthin, beta-carotene, lutein, zeaxanthin, and canthaxanthin” (Claim 1). The use of the carotenoids in this invention is to reduce inflammation symptoms in bovine models.
The references above fail to teach the combination of the anti-inflammatory compounds listed above into one composition.
Demchenko, Varga, Ben-Shabbat, Leonel, and Chen are all considered to be analogous to the claimed invention as they are focused on anti-inflammatory treatments to different patient groups. Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to have modified Demchenko to incorporate the teachings of Varga, Ben-Shabbat, Leonel, and Chen to provide “a method for immunomodulation in inflammatory processes” (Claims 1 and 2). Doing so would aid in the anti-inflammatory effect, thereby improving the available anti-inflammatory therapeutics.
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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 and 9 of copending Application No. 18763849 (filed 2024 July 17, priority claimed 2022 January 05). Although the claims at issue are not identical, they are not patentably distinct from each other because in the copending application, the compositions listed in Claims 1 and 8 are comprised of identical compounds with synergistic effects to reduce effects of inflammation as claimed in Claim 1 of examined application. Differences in compositions between the two mentioned claims are deemed obvious as the inclusion of vitamin A and cannabidiol together as stated in the examined claims would be expected to have synergistic effect on reducing inflammation to one of ordinary skill in the art given Varga, Ben-Shabat, Leonel, and Reifen.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1 and 8 of copending Application No. 18763849 in view of Demchenko (RU2569742C1; published 2014) and in view of Chen (CN107205441A published 2017). Although the claims at issue are not identical, they are not patentably distinct from each other because in the copending application, the compositions listed in Claims 1 and 8 are comprised of identical compounds with synergistic effects to reduce effects of inflammation as claimed in Claim 1 of examined application. Demchenko discloses a pharmaceutical “capsule… fat-soluble vitamins are included in the capsule core, such as vitamins A… and/or carotenoids (provitamin A or lycopene or astaxanthin or lutein or zeaxanthin or mixtures thereof)… and/or non-steroidal anti-inflammatory drugs (ibuprofen or ketoprofen or others)…” (Claim 11). Varga discloses β-caryophyllene as a plant-derived FDA approved food additive with anti-inflammatory properties towards chronic and binge alcohol-induced liver injury and inflammation (Background and Aims). Chen discloses “a composition… compris(ing): … and one or more carotenoids selected from the group consisting of: lycopene, astaxanthin, beta-carotene, lutein, zeaxanthin, and canthaxanthin” (Claim 1). The use of the carotenoids in this invention is to reduce inflammation symptoms in bovine models. To a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to have modified Demchenko to incorporate the teachings of Varga, Ben-Shabbat, Leonel, and Chen to provide “a method for immunomodulation in inflammatory processes” (Claims 1 and 2). Applying at least KSR prong A, combining would aid in the anti-inflammatory effect, thereby improving the available anti-inflammatory therapeutics.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/E.G.T./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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