DETAILED ACTION
Requirement for Restriction/Election was mailed 19 February 2026.
Applicant’s Response to Requirement for Restriction/Election was received 20 April 2026.
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 .
Status of the Claims
The listing of claims filed 20 April 2026 has been examined.
Claims 1-18 are pending.
Claims 19-20 are cancelled.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 11 June 2024 and 22 December 2023 are acknowledged and have been considered. Any lined-through references have not been considered and must be submitted or resubmitted in proper format for consideration. For example, in the IDS filed on 22 December 2023, a copy of NPL documents entitled “Brown MS, Goldstein JL. LIPOPROTEIN METABOLISM IN THE MACROPHAGE: Implication for Cholesterol Deposition in Atherosclerosis. Annu Rev Biochem. 1983;52(1):223-261.” and “Stringham NT, Holmes PV, Stringham JM. Effects of macular xanthophyll supplementation on brain-derived neurotrophic factor, pro-inflammatory cytokines, and cognitive performance. Physiol Behav. 2019;211.” are missing.
Benefit of Earlier Filing Date
The instant application, filed 22 December 2023, claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 63/435,423, filed 27 December 2022. Acknowledgment is made of Applicant’s claim.
Restriction/Election
Applicant’s election of Group I (Claims 1-18) and cancellation of the claims in Group II (19-20) in the Response filed 20 April 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Applicant’s election with traverse of meso zeaxanthin as the macular xanthophyll, docosahexaenoic acid (DHA) as the omega-3 fatty acid, and magnesium as the single additional material in the election of species requirement in the Response filed 20 April 2026 is acknowledged. However, Applicant’s arguments in opposition to the election of species requirement have been fully considered and are persuasive.
The election of species requirement of 19 February 2026 is withdrawn.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites, “…the macular xanthophyll include lutein, zeaxanthin, and meso zeaxanthin.” This appears to be a typo. Examiner recommends amending to, “…the macular xanthophylls include lutein, zeaxanthin, and meso zeaxanthin.” [Emphasis added.]
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Howard (US 2020/0197349 A1; IDS dated 11 June 2024, Cite No. 1) in view of Zafer (WO 2021/162659 A1; IDS dated 11 June 2024, Cite No. 2).
Regarding claims 1-18, Howard teaches a method for improving human cognitive function (p. 1, ¶ [0002]) by administering a unit dose containing 10 mg meso-zeaxanthin, 10 mg lutein, 2 mg zeaxanthin, and fish oil (p. 25, Claims 1 and 10-11). The dosing regimen could be at least 1-3 doses per week or daily doses, and Howard suggests a skilled artisan would recognize the administration schedule could be adjusted according to the amount of each active ingredient (i.e., macular carotenoids and omega-3 fatty acids) in the composition (p. 5, ¶ [0053]). Additionally, Howard presents a study wherein subjects received a supplement containing 10 mg lutein, 10 mg, meso-zeaxanthin, 2 mg zeaxanthin, 15 mg vitamin E, and 1 g fish oil (p. 6, ¶ [0081]). The fish oil contained 430 g docosahexaenoic acid (DHA) and 90 mg eicosapentaenoic acid (EPA). Doses were provided as two capsules, and study participants were instructed to consume two capsules per day (p. 6, ¶ [0081]).
Howard does not explicitly teach a method for improving cardiovascular health.
Zafer teaches compositions for promoting and/or maintaining geriatric health, including muscle tissue building and cardiovascular health (p.1, Lines7-8), said compositions comprising, “…at least one source of beta-hydroxy-beta-methylbutyrate in combination with lutein and zeaxanthin.” (p. 15, Claim 1). Furthermore, Zafer discusses the various therapeutic benefits conferred by lutein and zeaxanthin, stating lutein may improve measures of cardiovascular health and zeaxanthin may positively impact arterial health (p. 6, Lines 11-27). Additionally, Zafer discloses an exemplary composition containing DHA, EPA, lutein, zeaxanthin, choline, vitamin D3, vitamin E, vitamin C, folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B12, calcium, magnesium, iron, zinc, manganese, copper, iodine, and selenium (p. 13-14, Example 2). The composition may also include medium chain triglycerides (p. 9, Lines 4-12).
Zafer does not explicitly teach meso zeaxanthin.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Howard would have found it prima facie obvious to apply the method for improving cognitive function disclosed by Howard to instead improve cardiovascular health based on the teachings of Zafer because Zafer discloses similar compositions for supporting cardiovascular health, specifically noting the roles lutein and zeaxanthin may play in improving cardiovascular health and/or arterial health. Thus, a skilled artisan would have had a reasonable expectation of success in using the compositions disclosed by Howard to improve cardiovascular health since Zafer suggests lutein and zeaxanthin may be useful in improving cardiovascular health. Furthermore, a skilled artisan would have recognized lutein and zeaxanthin are macular xanthophylls and been motivated to include an additional macular xanthophyll in the composition, such as meso zeaxanthin as disclosed by Howard. Additionally, because the method claimed by Howard includes using at least one omega-3 fatty acid (Claim 1), a PHOSITA would have found it obvious to try using fatty acids in various forms, like free fatty acids and/or triglycerides, as well as omega-3 fatty acid salts.
Non-Statutory 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.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,623,428 B2, claim 1 of U.S. Patent No. 8,962,043 B2, claim 1 of U.S. Patent No. 9,463,167 B2, claim 1 of US 9,603,813 B2 in view of Zafer (WO 2021/162659 A1; IDS dated 11 June 2024, Cite No. 2).
Patent ‘428 claims a method of treating macular degeneration in a human consisting essentially of administering lutein, zeaxanthin, and meso-zeaxanthin alongside an oil.
Patent ‘428 does not claim a method for improving cardiovascular health.
Patent ‘043 claims a capsule consisting essentially of mesozeaxanthin, lutein, zeaxanthin, and a fish oil containing an omega-3 fatty acid.
Patent ‘043 does not claim a method for improving cardiovascular health.
Patent ‘167 claims a capsule consisting essentially of mesozeaxanthin, lutein, zeaxanthin, and krill oil.
Patent ‘167 does not claim a method for improving cardiovascular health.
Patent ‘813 claims a capsule consisting essentially of mesozeaxanthin, lutein, zeaxanthin, fish oil containing an omega-3 fatty acid and Vitamin E.
Patent ‘813 does not claim a method for improving cardiovascular health.
Zafer teaches compositions for promoting and/or maintaining geriatric health, including muscle tissue building and cardiovascular health (p.1, Lines7-8), said compositions comprising, “…at least one source of beta-hydroxy-beta-methylbutyrate in combination with lutein and zeaxanthin.” (p. 15, Claim 1). Furthermore, Zafer discusses the various therapeutic benefits conferred by lutein and zeaxanthin, stating lutein may improve measures of cardiovascular health and zeaxanthin may positively impact arterial health (p. 6, Lines 11-27). Additionally, Zafer discloses an exemplary composition containing DHA, EPA, lutein, zeaxanthin, choline, vitamin D3, vitamin E, vitamin C, folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B12, calcium, magnesium, iron, zinc, manganese, copper, iodine, and selenium (p. 13-14, Example 2). The composition may also include medium chain triglycerides (p. 9, Lines 4-12).
Zafer does not explicitly teach meso zeaxanthin.
A PHOSITA would have been motivated to use the composition disclosed by Patents ‘428, ‘043, ‘167, and ‘813 to improve cardiovascular health because Zafer discloses similar compositions for supporting cardiovascular health, specifically noting the roles lutein and zeaxanthin may play in improving cardiovascular health and/or arterial health. Thus, a skilled artisan would have had a reasonable expectation of success in using the compositions disclosed by Patents ‘428, ‘043, ‘167, and ‘813 to improve cardiovascular health since Zafer suggests lutein and zeaxanthin may be useful in improving cardiovascular health.
Because claims 1-18 in the instant application would have been obvious over claim 1 of U.S. Patent No. 8,623,428 B2, claim 1 of U.S. Patent No. 8,962,043 B2, claim 1 of U.S. Patent No. 9,463,167 B2, and claim 1 of US 9,603,813 B2 in view of Zafer, claims 1-18 in the instant application are not patentably distinct from claim 1 of U.S. Patent No. 8,623,428 B2, claim 1 of U.S. Patent No. 8,962,043 B2, claim 1 of U.S. Patent No. 9,463,167 B2, and claim 1 of US 9,603,813 B2.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/388,554 in view of Zafer (WO 2021/162659 A1; IDS dated 11 June 2024, Cite No. 2).
Application ‘554 claims a dietary supplement for human consumption comprising lutein, zeaxanthin, and meso-zeaxanthin (Claim 1).
Application ‘554 does not claim a method for improving cardiovascular health.
Zafer teaches compositions for promoting and/or maintaining geriatric health, including muscle tissue building and cardiovascular health (p.1, Lines7-8), said compositions comprising, “…at least one source of beta-hydroxy-beta-methylbutyrate in combination with lutein and zeaxanthin.” (p. 15, Claim 1). Furthermore, Zafer discusses the various therapeutic benefits conferred by lutein and zeaxanthin, stating lutein may improve measures of cardiovascular health and zeaxanthin may positively impact arterial health (p. 6, Lines 11-27). Additionally, Zafer discloses an exemplary composition containing DHA, EPA, lutein, zeaxanthin, choline, vitamin D3, vitamin E, vitamin C, folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B12, calcium, magnesium, iron, zinc, manganese, copper, iodine, and selenium (p. 13-14, Example 2). The composition may also include medium chain triglycerides (p. 9, Lines 4-12).
Zafer does not explicitly teach meso zeaxanthin.
A PHOSITA would have been motivated to use the composition disclosed by Application ‘554 to improve cardiovascular health because Zafer discloses similar compositions for supporting cardiovascular health, specifically noting the roles lutein and zeaxanthin may play in improving cardiovascular health and/or arterial health. Thus, a skilled artisan would have had a reasonable expectation of success in using the compositions disclosed by Application ‘554 to improve cardiovascular health since Zafer suggests lutein and zeaxanthin may be useful in improving cardiovascular health.
Because claims 1-18 in the instant application would have been obvious over claims 1-7 of Application No. 18/388,554 in view of Zafer, claims 1-18 in the instant application are not patentably distinct from claims 1-7 of Application No. 18/388,554.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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