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 .
Election/Restrictions
Applicant’s election of group II, claims 9 – 14 in the reply filed on July 29, 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 § 818.01(a)).
Claims 1 – 14 are pending; claims 1 – 8 are withdrawn; claims 9 – 14 have been considered on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 31, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 9 – 10 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.
Claims 9, 10 and dependents are drawn to a method of producing carotenoids however are rendered indefinite because the claims fail to recite a modified host cell that must be used in the methods. For purposes of examination, the claims are interpreted to mean a method for producing carotenoids from a modified host cell.
Claim 9 is further indefinite because the claim fails to set forth positive steps that must be carried out (MPEP 2173.05(q)).
Claim 9 is indefinite for reciting “increased by at least 2 – 10%” because it is unclear to what the increase is compared.
In claims 12 and 14, the recitation of “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In claim 12, the recitation of “preferably a non-dichloromethane comprising composition” after the recitation of “dichloromethane” renders the claim indefinite because it appears to conflict with what is required by the claim. In this regard, the language muddles the scope of the claim.
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.
Claims 9 – 13 are rejected under 35 U.S.C. 102a1 as being anticipated by Bailey et al. (US 8288149) as evidenced by Finkelstein et al. (US 5422247).
Regarding claim 9, Bailey teaches a method for producing carotenoids with a modified oleaginous yeast, Yarrowia lipolytica (modified host cell), wherein the amount of carotenoids produced is 20 – 80% of the cell by dry weight (col. 19 line 4 – 11). Bailey teaches the carotenoid production is interpreted as increased (examples).
Regarding claim 10, Bailey teaches the method wherein the modified host cell is provided, cultured, and extracting carotenoids therefrom (example 3).
Regarding claim 11, carotenoids include astaxanthin, zeaxanthin, canthaxanthin, β-cryptoxanthin, lutein, lycopene and β-carotene (col.20 line 36 – 45, claims 5 – 9).
Regarding claim 12, the carotenoids are extracted with hexane, ethyl acetate (col.20 line 55 – col. 21 line 7, example 3).
Regarding claim 13, Bailey teaches method wherein the cells are subjected to lysis (col.22 line 25 – 37) and methods known in the art to include the teachings of US 5422247, which is incorporated by reference (col.20 line 59 – 65). US 5422247 teaches obtaining carotenoids from cells by enzymatic lysis (col.13 line 20 – 30).
Therefore, the reference anticipates the claimed subject matter.
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.
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 9 – 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bailey et al. (US 8288149) as evidenced by Finkelstein et al. (US 5422247); in view of Lemes et al. (2022).
Regarding claim 9, Bailey teaches a method for producing carotenoids with a modified oleaginous yeast, Yarrowia lipolytica (modified host cell), wherein the amount of carotenoids produced is 20 – 80% of the cell by dry weight (col. 19 line 4 – 11). Bailey teaches the carotenoid production is interpreted as increased (examples).
Regarding claim 10, Bailey teaches the method wherein the modified host cell is provided, cultured, and extracting carotenoids therefrom (example 3).
Regarding claim 11, carotenoids include astaxanthin, zeaxanthin, canthaxanthin, β-cryptoxanthin, lutein, lycopene and β-carotene (col.20 line 36 – 45, claims 5 – 9).
Regarding claim 12, the carotenoids are extracted with hexane, ethyl acetate (col.20 line 55 – col. 21 line 7, example 3).
Regarding claim 13, Bailey teaches method wherein the cells are subjected to lysis (col.22 line 25 – 37) and methods known in the art to include the teachings of US 5422247, which is incorporated by reference (col.20 line 59 – 65). US 5422247 teaches obtaining carotenoids from cells by enzymatic lysis (col.13 line 20 – 30).
Regarding claim 14, Bailey does not teach the method wherein the enzymes used include those claimed. However, at the time the claims were filed, the instant enzymes were commonly used in the art when extracting bioactive compounds from biological sources. In support, Lemes teaches cellulase, protease, xylanase, and beta-glucanase alone and in various combinations were used to extract bioactive compounds (Table 1). As such, at the time the claims were filed, one of ordinary skill in the art would have been motivated by routine practice to use the claimed enzymes when lysing Yarrowia since they were routinely used for the claimed purpose, and with a reasonable expectation for successfully extracting carotenoids therefrom by the methods of Bailey.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUTH A DAVIS whose telephone number is (571)272-0915. The examiner can normally be reached Monday - Friday (8am - 4pm).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUTH A DAVIS/ Primary Examiner, Art Unit 1699
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