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 .
Status of the Claims
Acknowledgement is made of the response filed on April 30, 2026. In that response, claim 12 was amended; claims 1-11 and 13-20 were cancelled; and claims 21-27 were added. Claims 12 and 21-27 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 12 is objected to because of the following informalities: “VDT” should be written out in the first instance in the claims; “toa” is a typo; and in the phrase “component (B) is vitamin E, VE is tocotrienol” has a grammatical error which could be fixed by inserting a “wherein” after the comma.
Claim 21 is objected to because of the following informalities: “a content” implies there is more than one kind of content; “wherein content…” could be used. “[T]he composition” lacks antecedent basis.
Claim 22 is objected to because of the following informalities: “wherein” is missing after the comma; “a mass ratio” implies there is more than one mass ratio; “the content” lacks antecedent basis; and “a” is missing before the monoester and the diester. It appears the intended phrase would be “wherein the ester of astaxanthin comprises a monoester and a diester, and the mass ratio of the monoester to the diester is…”.
Claim 23 is objected to because of the following informalities: “prepared in a manner” seems like a reference to preparing component (A) or components (A) and (B), or a composition comprising either of them. “Taken in” however probably refers to the administering in claim 12. The phrase is interpreted as “wherein component (A) is administered at a dose of…”.
Claim 24 is objected to because of the following informalities: see objection to claim 23 above.
Claim 25 is objected to because of the following informalities: “an intake” is inconsistent with “administering”. The phrase is interpreted as “wherein the administering is oral administering”.
Claims 26 and 27 are objected to because of the following informalities: “[T]he composition” lacks antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 12 and 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Haines (US 2004/0076691) in view of Jensen (US 2018/0055788) and Hachiya (Hachiya, Y., et al., Fatigue Evaluation for Work Load of Visual Display Terminals (VDT) Operation, International Conference on Control, Automation and Systems 2007 Seoul, Korea).
Haines teaches treating ocular inflammation by administering an oral anti-inflammatory composition comprising a tocotrienol complex and astaxanthin (paras. 0002, 0063-64 Tables A &B; see title; abstract; paras.0024-25, 0051, 0079). Symptoms of inflammation in the eye include dry eye, blurred and/or impaired vision (paras.0008, 0072, 0074-77; claims 15, 17, 21), and therefore Haines’s anti-inflammatory compositions would improve vision in a subject. In peripheral blood mononuclear cells (PBMCs) of healthy donors, astaxanthin was found to suppress expression of T-cell surface antigens after treatment with phorbol 12 myristate 13-acetate and ionomycin (paras.0090-92). Haines states astaxanthin “dosages range from 0.1-4.0 g/kg body weight per day” (para.0053); however the “g/kg” appears to be a typo because Table A shows daily dosage of 1.00 MG for “Astaxanthin” (p.6). The daily dosage for tocotrienol complex is 50.00 MG (Table A, p.6).
Haines does not specifically teach administering its composition for “improving corrected vision or practical vision of a healthy subject following VDT workload” in claim 12, the concentration of astaxanthin in a composition, the ratio of a monoester to a diester of astaxanthin, or the dose of astaxanthin in claims 21-23.
Hachiya teaches that VDT causes disorders, specifically the “subjective symptoms of eyes; dry eyes, blurred vision, and eye-ache” in normal, i.e., healthy, subjects (p.1887 left col.; p. 1888 3.1 Subjects, 3.4 Questionnaire for fatigue evaluation). These symptoms constitute the “practical vision” following a VDT workload, and are identical to those that Haines teaches as manifestations of eye inflammation (see bolded text above).
Jensen is drawn to eye health compositions comprising astaxanthin and astaxanthin monoester with a C18-1 fatty acid (title; abstract; see paras.0015, 0017, 0029, 0032, 0051, 0061, 0094, 120-26; claims 18, 22, 28). Jensen teaches “astaxanthin compositions according to the invention comprise predominantly, i.e. to at least 50% by weight, … or at least 90% by weight, the monoester of a C18-1 fatty acid,” and “the total amount of unesterified astaxanthin, diesters and monoesters of an acid other than C18-1 fatty acids, does not exceed, in accordance with the invention, 50% by weight, … or 10% by weight, based on the total weight of astaxanthin and astaxanthin derivatives in the composition” (para.0051 (emphasis added)). Thus Jensen teaches a ratio of the monoester to diester of astaxanthin including 50-100 : 50-0, e.g., 50:10. Jensen further teaches astaxanthin may comprise 0.1 to 30% by weight of the composition, depending on the form of the composition (para.0094). The compositions may include tocopherol, and used as food of food supplement (abstract; paras.0084, 0094). Recommended dose is 0.1 to 50 mg/kg body weight (para.0112), or about 7 mg for a typical 70kg adult.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Haines and Hachiya and use Haines’s method of administering its composition to treat practical vision in a healthy subject after VDT workload. The skilled person would have been suggested to do so because both are drawn to identical conditions of the eye, i.e., dry eye, blurred vision, and therefore impaired vision, which Haines treats by administering astaxanthin to suppress inflammation.
Furthermore it would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Haines, Hachiya, and Jensen and use Haines’s method of administering Haines’s composition prepared as in claims 21-27. The skilled person would have been motivated to do so because all are drawn to conditions of eye health, Haines teaches compositions for eye care comprising astaxanthin and vitamin E, and Jensen teaches that monoesters of astaxanthin offer better oral bioavailability than nonesterified astaxanthin or corresponding diesters (para.0029) and suitable concentrations of astaxanthin.
Response to Arguments
Although new rejections are made above Applicant’s arguments are addressed now to the extent they have not been rendered moot and are relevant to the above rejections.
Applicant's arguments filed April 30, 2026 have been fully considered but they are not persuasive. Applicant argues that both Haines and Jensen are drawn to patients suffering from diseases, and Jensen’s bioavailability test was done on minipigs. (Remarks, 7-10, April 30, 2026.).
In response it is noted that a “reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments”. MPEP §2123 (citations omitted). Here both Haines and Jensen are drawn to compositions for human use, and Haines used human PBMC cells to assess anti-inflammatory effects of astaxanthin (see Example 1, paras.0090-92).
Applicant next argues that “the present application achieves unexpected technical effects” as shown in Figures 1-12, namely statistically significant improvements in both corrected and practical vision in healthy people following a VDT workload. (Remarks, 13-14.)
The study and the results in the Figures have been reviewed; however it cannot be agreed that the results are unexpected. Rather they appear to confirm the teaching in the cited art that astaxanthin and tocotrienols suppress inflammation in the eye, which the person of ordinary skill would understand would improve vision after a VDT workload, even for healthy people because they experience the same symptoms caused by eye inflammation as Hachiya teaches. Therefore the data do not aid in overcoming prima facie obviousness.
Furthermore any evidence of non-obviousness must be reasonably commensurate in scope with the claimed invention. MPEP § 2145 (citations omitted). Here the study was conducted using specific daily doses of astaxanthin and a mixture of rice tocotrienols, for a specific duration.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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H. SARAH PARK
Primary Examiner
Art Unit 1614
/H. SARAH PARK/Primary Examiner, Art Unit 1614
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