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
Claims 1-16, 18-36, and 38-44 are pending (claim set as filed on 5/25/2026). Claims 1-16, 18-36, and 38-43 were withdrawn after restriction/election requirement. Claims 17, 37, and 45-48 are cancelled. Claim 44 is under examination.
Election/Restrictions
Claims 1-16, 18-36, and 38-43 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected products, method, and composition, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/25/2026.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. GB2116694.7, filed on 11/19/2021, and thus this application has priority benefit to the earliest effective filing date of 11/19/2021.
Claim Objections
Claim 44 is objected to because of the following informalities: “incapable production of ergosterol”. This is grammatically incorrect and appropriate correction is required to change to “incapable of the production of ergosterol”.
Claim Rejections - 35 USC § 112
Claim 44 is 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 claim 44, the term “squalene-hopene cyclopase” renders the claim indefinite as “cyclopase” does not refer to a known enzyme and thus one could not ascertain the meaning of the limitation. The examiner has interpreted the claim language to mean “squalene-hopene cyclase”, which is a known enzyme.
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.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Pronk (Publication No. WO/2021/133171 – date of publication 7/1/2021), in view of Loto (Loto et al., “Enhancement of carotenoid production by disrupting the C22-sterol desaturase gene (CYP61) in Xanthophyllomyces dendrorhous”, 2012 Oct 18, BMC Microbiology, 235, pgs. 1-16), and in further view of Wang (Publication No. CN107083338 – date of publication 8/22/2017).
Pronk’s general disclosure relates to a recombinant fungal cell with squalene-tetrahymanol cyclase and squalene-hopene cyclase activity (see abstract).
Regarding claim 44, Pronk teaches the culturing of genetically engineered recombinant fungal cells (see pg. 15, ¶ 1). Pronk suggests the use of the yeast species Yarrowia lipolytica as a particular embodiment of the fungal cell (see pg. 7, ¶ 2). Pronk teaches a squalene-tetrahymanol cyclase gene (see pg. 13, ¶ 14) and a squalene-hopene cyclase gene (see pg. 14, ¶ 15). As noted in the 112b rejection above, the term “cyclopase” does not refer to a known enzyme as thus the meaning is indefinite. For examination purposes, the term squalene-hopene cyclase has been interpreted to read on the claim limitation. As the squalene-tetrahymanol cyclase and squalene-hopene cyclase genes encode for proteins to synthesize a tetrahymanol and a hopanoid respectively, they are capable of providing such sterol surrogates. As the method of culturing the Yarrowia lipolytica subsequently produces 24-methylenecholesterol and/or isofucosterol, this reads on the claim limitation. Furthermore, the 24-methylenecholesterol and/or isofucosterol being used as insect feed is merely the intended use and if the structure of the sterols are present then they are also capable of the insect feed function. See MPEP 2111.02.
Pronk does not teach the attenuation or deletion of either an endogenous delta-24 sterol reductase enzyme, an endogenous sterol C-22 desaturase enzyme, or an endogenous sterol C-24 methyltransferase enzyme. Pronk also does not teach the presence of a heterologous nucleic acid sequence encoding a delta-7 sterol reductase enzyme.
Loto’s general disclosure relates to mutating fungal strains by deleting a C-22 sterol desaturase enzyme so that the mutant is incapable of producing ergosterol (see abstract).
Regarding claim 44, Loto teaches the disruption of the gene for the C-22 sterol desaturase enzyme, CYP61, in fungi (see abstract).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the deletion of the C-22 sterol desaturase gene as taught in Loto to the culturing method as taught in Pronk. One would be motivated to do so because Loto teaches that the deletion of this gene results in the inability of the fungus to produce ergosterol and instead accumulates alternative lipid compounds (see Loto pg. 9, ¶ 1). By doing so the fungus becomes resistant to certain fungicides that bind to ergosterol in their cell membranes (see pg. 12, ¶ 2), and thus the ordinary artisan would have been able to improve upon the disclosure of Pronk by adding the deletion of this gene to the method.
Wang’s general disclosure relates to a recombinant Yarrowia lipolytica strain that expresses the delta-7 sterol reductase enzyme, DHCR7 (see abstract and claim 1).
Regarding claim 44, Wang teaches a recombinant yeast strain has the nucleotide sequence for the delta-7 sterol reductase enzyme, or DHCR7, as it is capable of expressing it (see pg. 2, ¶ 5-6).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to add the gene for the delta-7 sterol reductase enzyme as taught in Wang to the culturing method as taught in Pronk and Loto. One would be motivated to do so because Wang teaches that introducing the gene for DHCR7 can shift the metabolic flow of the yeast cell from producing ergosterol to an alternative sterol such as campesterol (see Wang pg. 4, ¶ 5). This addition would be an advantage to Pronk and Loto which discloses a need to explore alternative sterol biosynthesis pathways outside of ergosterol (see Loto pg. 12, ¶ 2).
Conclusion
The claim is not allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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