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 .
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.
Claims 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because process, machine, manufacture or composition of matter is claimed. Specifically, while the claims recite a use, the claim fails to recite steps (MPEP §2173.05(q)).
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 11-14 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.
Regarding claims 11 and 12, the recitation “Use of at least one formulation according to claim 1” renders the claims indefinite because there are no active steps recited in the claim.
Regarding claims 13 and 14, the recitation “products comprising at least one formulation according to claim 1” renders the claims indefinite. Claim 1 from which claims 13 and 14 depend is directed to a formulation. It is not clear how a product could comprise more than one of the formulation.
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 1-10, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Goury et al. (WO 2019/206708)
Regarding claims 1-3, 7 and 8, Goury et al. disclose a coloring composition comprising a water, carotenoid, a phospholipid emulsifier and a polysorbate (p. 2/L36- p. 3/L3, p. 7/L12-13). Goury et al. disclose the coloring composition may include other ingredients including hydrocolloids, sugar and organic acids (i.e., auxiliary agents -p. 6/L31).
Goury et al. disclose the carotenoids are α-carontein, β-carontene, gamma-carotene, apocarotenals, 8’-apo-beta-carotenoic acid esters such as ethyl ester, canthanxanthin, astaxantin, saffron, lycopene, lutein, zeaxanthin, crocin, bixin, capsanthin, capsorubin, rubixanthin, violaxanthin, rhodoxanthin, cis/trans isomers thereof and combinations thereof (p. 4/C10-19).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have selected the combination of lutein and zeaxanthin because they are both disclosed as carotenoids to use in the coloring composition.
Goury et al. disclose the total amount of the combination of lutein and zeaxanthin is between 1 to 25% (w/w)(p. 4/L26-29).
Goury et al. disclose the amount of polysorbate in the coloring composition is between 0.5 and 20% (w/w) (p. 6/L9-11).
Goury et al. disclose the amount of water in the coloring composition is between 30 to 80% (w/w)(p. 7/L12-13).
While Goury et al. does not disclose the precisely claimed amount of carotenoid, polysorbate and water, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists (MPEP 2144.05).
While Goury et al. disclose a coloring composition comprising a combination of lutein and zeaxanthin in an amount between 1 to 25% (w/w), the reference is silent with respect to the ratio of lutein to zeaxanthin.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have combined lutein and zeaxanthin in any ratio with a reasonable expectation of success. Moreover, when faced with a mixture, one of ordinary skill in the art would be motivated by common sense to select a 1:1 ratio, a ratio that falls within the presently claimed amount, absent evidence of unexpected or surprising results. Case law holds that "[h]aving established that this knowledge was in the art, the examiner could then properly rely... on a conclusion of obviousness, 'from common knowledge and common sense of the person of ordinary skill in the art within any specific hint or suggestion in a particular reference.'" In re Bozek, 416 F.2d 1385, 1390, 163 USPQ 545, 549 (CCPA 1969).
Regarding claim 4, Goury et al. disclose all of the claim limitations as set forth above. Goury et al. disclose the average particles size (Dv(90)) of the solid carotenoid particles (i.e., lutein and zeaxanthin) is at most 1000 nm (i.e., 0.001 mm or less than 5 mm- p. 4/L34-37).
Regarding claims 5 and 6, Goury et al. discloses all of the claim limitations as set forth above. Goury et al. disclose the polysorbate may be polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 65 or polysorbate 80 (i.e., compound of formula (I) -p. 5/L29-32).
Regarding claim 9, Goury et al. disclose all of the claim limitations as set forth above. While Goury et al. disclose the coloring composition may comprise antioxidant (p. 6/L37-38), the reference disclose “preservative free” coloring compositions (see p.21-23- Examples 5 and 6)
Regarding claim 10, Goury et al. disclose all of the claim limitations as set forth above. Goury et al. disclose a coloring composition comprising glycerol (p. 21-23-Examples 5 and 6).
Regarding claims 13 and 14, Goury et al. disclose all of the claim limitations as set forth above. Goury et al. disclose a food product (i.e., edible products), an animal feed, a cosmetic or a pharmaceutical product comprising the coloring composition of claim 1 (p. 3/L18-20).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
-Behnam (US 2007/0148193 – IDS filed August 21, 2024) teaches a lutein concentrate comprising lutein, zeaxanthin, polysorbate and water. The composition of Behman comprises polysorbate in an amount of at least 10 times that of the lutein and zeaxanthin content.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/ Primary Examiner, Art Unit 1759
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