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 .
Specification
The disclosure is objected to because of the following informalities: foreign language characters throughout the substitute specification filed April 5, 2024 (e.g., paras.0007, 0102). See MPEP §608.01(V); 37 CFR 1.52(d).
Appropriate correction is required.
Claim Objections
Claims 1, 6, 12, 13, and 17-20 are objected to because of the following informalities: astaxanthin is not a proper noun and therefore should not be capitalized.
Claims 1, 6, 12, 13, and 17-20 are objected to because of the following informalities: astaxanthin does not need a “the” preceding it in these claims. In all claims, the following claim terms do not require a “the” preceding it: “VE”, “component (A)”, “component (B)”
Claims 1, 12, and 13 are objected to because of the following informalities: the “wherein” at the end of the preamble line should be followed by a colon.
Claims 3-6, 9-11 and 14-20 are objected to because of the following informalities: the hanging “wherein” at the end of the preamble line, followed by a phrase that could follow the “wherein” without a line break.
Claim 6 is objected to because of the following informalities: “, i.e. monoester/diester,” needs a comma after the second dot, and appears unnecessary; a “between” or a similar term should precede the “2”.
Claims 7 and 8 are objected to because of the following informalities: “prepared…” should be appended to the prior line without a line break.
Claim 9 is objected to because of the following informalities: “the intake” lacks antecedent basis.
Claim 12 is objected to because of the following informalities: “improve” should be “improving”; “to” in line 2 is grammatically unnecessary; and “making a subject to take in” could be “administering”. “A therapeutically effective amount” or similar phrase should follow the “administering” to avoid issues under 35 U.S.C. 112(a),(b).
Claims 17-20 are objected to because of the following informalities: “, i.e., monoester/diester,” appears unnecessary; and a “between” or a similar term should precede the “2”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim does not fall within at least one of the four categories of patent eligible subject matter because it recites a process without setting forth any steps involved in the process. Therefore claim 13 is not a proper process claim under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 14-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 1 recites “a group of esters of the Astaxanthin…”. “A group” renders the claims indefinite because the claims do not define this group. The specification does not help understand whether some specific esters, but not others, are encompassed by the subject matter of the claims. Claim 1 could simply recite “one or more esters of astaxanthin” to denote all esters of astaxanthin. None of the dependent claims resolves this issue and therefore are also rejected on this ground.
Claim 2 recites “wherein the VE is tocotrienols”. “Tocotrienols” is plural, and therefore claim 2 plainly requires more than one kind of tocotrienol. However
Claims 7 and 8 recite “prepared in a manner that the component …is taken in at a dose of …mg per day”. “Prepared in a manner” here renders the claims vague. It could be a reference to a single dose of the composition in a form such as a pill, injection, etc., which comprises the recited milligrams of either component (A) or (B). The claims and the specification does not make this or any other interpretation clear. Furthermore “[a] single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph”. MPEP § 2173.05(p)(II) (citations omitted). Claims 7-9 depend from claim 1 which is a composition claim; however claims 7-9 recite a method of taking a dose of the composition. Therefore the claims raise the question whether the claims encompass the composition or the method of using the composition.
Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 13 recites “application of a component (A)… in preparation of a composition for improving vision,…”. This is indefinite because it merely recites a use without any active, positive steps delimiting how this use, i.e., “application” is actually practiced.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14 and 15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 depends from claim 2, which depends from claim 1. Claim 2 recites wherein the VE is tocotrienols, i.e., claim 2 requires component (B). Claim 1 requires component (A) in all instances. Therefore “the composition contains the component (A)” in claim 14 does not recite an additional limitation not in claims 2 and 1. This analysis also applies to claim 15.
The remainder of claim 14 is “and vision is corrected vision and/or uncorrected vision”, and in claim 15 the phrase is “and vision is corrected vision, uncorrected vision, and/or practical vision”. The claim 14 phrase covers all types of vision, i.e., there is no other alternative type of vision different from corrected (e.g., with eye glasses) and uncorrected (naked eye). While claim 15 and the disclosure refers to “practical vision”, this is a measurement made using specific instrument such as the KOWA AS-28 (Specification para.[0082]). Even then the measurement must be made on an eye, whether with or without some means of correction. Thus these phrases do not require any limitation additional to those in claims 2 and 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 7- 9, and 12-15 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Haines (US 2004/0076691).
Haines teaches oral anti-inflammatory compositions for treating ocular inflammation, comprising a tocotrienol complex and astaxanthin (paras. 0002, 0063-64 Tables A &B; see title; abstract; paras.0051, 0079). Symptoms of inflammation in the eye include blurred and/or impaired vision (paras.0008, 0072, 0074-77), and therefore Haines’s compositions would improve vision in a subject.
Claim(s) 1, 3-5, 7, and 9-13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Barker (WO 03063848 A1).
Barker teaches improvement of visual performance by administering a composition comprising a colorant, specifically including astaxanthin and its esters, and tocopherol (p.3 lines 16-25, p.2 lines 6-9; see title; abstract; p.1 lines 15-16, 24-25, p.2 lines 16-31 , p.3 lines 16-). The composition may be a food or an additive (p.2 lines 30-31, p.3 lines 5-8). Astaxanthin may comprise about 0.1 to about 5 percent by weight (p.3 lines 20-21).
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Haines (US 2004/0076691) in view of Jensen (US 2018/0055788).
Haines does not specifically teach the ratio of a monoester to a diester for astaxanthin as recited in claims 6 and 17-20.
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).
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 Jensen as recited in the instant claim(s). The skilled person would have been motivated to do so because both are drawn to 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).
Conclusion
No claim is allowed.
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