DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The amendment filed July 13, 2026 has been received and entered.
3. Claims 1-12 are currently pending.
Election/Restrictions
4. Applicant's election with traverse of DHA for species A, Schizophytrium sp. for species B, sunflower oil for species C, and astaxanthin for species D in the reply filed on July 13, 2026 is acknowledged. The traversal is on the ground(s) that a search and examination of all of the species would not be burdensome because the species are sufficiently related. This is not found persuasive because each species has a separate status in the art.
The requirement is still deemed proper and is therefore made FINAL.
5. Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
6. Claims 1-5 and 7-12 are examined on the merits in regards to the elected species.
Specification
7. The disclosure is objected to because of the following informalities: the full word for the abbreviation “DPAn-6” is not listed in the specification. The full word represented by the abbreviation needs to be listed at least at the abbreviation’s first recitation. In addition, “Thraustochytrid” is misspelled as “Traustochytride” throughout the specification. Appropriate correction is required.
Claim Objections
8. Claim 2 is objected to because of the following informalities: “Thraustochytrid” is misspelled as “Traustochytride”. Appropriate correction is required.
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 1-5 and 7-12 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.
9. Regarding claim 1, the phrase "such as", at lines 2, 4, and 7 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
10. Regarding claim 2, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
11. Regarding claim 5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
12. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “selected from the following list: carotenoids, astaxanthin and lutein”, and the claim also recites “preferentially astaxanthin” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
13. Claim 8 is indefinite due to the phrase “short-chain fatty acids MCTs.” The specification at page 11 states that this phrase means “triglyceride with short-chain fatty acids (MCTs), i.e. C1-C10…”. However, “MCT” is typically used in the art as the abbreviation for “medium” chain triglycerides rather than “short”. Thus, it is confusing to refer to the triglycerides as both short and medium. Clarification of this claimed term is needed.
In addition, claim 8 is also indefinite because the use of “preferentially” and "such as" renders the claim indefinite because it is unclear whether the limitations following the terms are required limitations.
14. Claim 7 recites the broad recitation “food composition”, and the claim also recites “preferentially vegan” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
15. Claim 10 recites the broad recitation “medication”, and the claim also recites “preferentially as a food supplement” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
16. Claim 11 is indefinite because the metes and bounds of what pathologies are considered to be involved with the DHA or EPA deficiency are unclear.
In addition, claim 11 is also indefinite because the use of "such as" and “in particular” renders the claim indefinite because it is unclear whether the limitations following the terms are required limitations.
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.
17. Claim(s) 1-5, 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 11227365 A (English translation provided by applicant in IDS of August 28, 2024) with Hadley (WO 2011/047095) providing evidence of inherent characteristics of CN ‘365.
This reference teaches a pharmaceutical composition comprising DHA and DPA as an oil from Schizochytrium in combination with soy lecithin (a phospholipid) and sunflower oil. The reference teaches a composition with 22.32% DHA, 8.04% DPA, 12% lecithin, and 10% sunflower oil (see page 4 of the translation). DHA in Schizochytrium is inherently in the form of triglycerides and DPA is the n-6 fatty acid form (see Hadley – Table 4).
The reference does not teach that the composition is used for the same purposes as claimed by applicant. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
18. Claim(s) 1, 7, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 11227365 A in view of Zhu (CN 108041184 A – English translation).
The teachings of CN ‘365 are discussed above. The reference teaches including an antioxidant in the composition at a concentration between 2 to 4% to stabilize the composition (see page 3 of the translation). The reference does not specifically teach including astaxanthin as the antioxidant.
However, Zhu teaches the use of astaxanthin as antioxidant to stabilize oil composition which contain DHA. The reference also teaches using the stabilized oil compositions as food compositions (see pages 2 and 4 of the translation). Thus, the artisan of ordinary skill would reasonably expect that astaxanthin could be used successfully as an antioxidant in the composition taught by CN ‘365. This reasonable expectation of success would have motivated the artisan to modify CN ‘365 to include the use of astaxanthin in the composition.
19. Claim(s) 1 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 11227365 A in view of Pimentel (US 2004/0076719).
The teachings of CN ‘365 are discussed above. The reference does not teach including a triglyceride with short-chain fatty acids MCTs (defined by applicant’s specification at page 11 as “triglyceride with short-chain fatty acids (MCTs), i.e. C1-C10”). However, the reference does teach that the composition is useful for reducing blood lipid levels and reducing the risk of cardiovascular disease (see page 1 of the translation).
Pimentel teaches that medium chain triglycerides are useful for reducing blood lipid levels and reducing the risk of cardiovascular disease. The reference teaches that the triglycerides contains C8, C6, and C10 triglycerides. In addition, the reference teaches using the medium chain triglycerides in a concentration of 5 to 25% (see paragraphs 5, 17 and claim 6).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that reduce blood lipid levels and reduce the risk of cardiovascular disease. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to reduce blood lipid levels and reduce the risk of cardiovascular disease, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to reduce blood lipid levels and reduce the risk of cardiovascular disease. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
20. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
