Prosecution Insights
Last updated: May 29, 2026
Application No. 18/676,643

METHODS OF PRODUCING POLYOL LIPIDS

Non-Final OA §112§DOUBLEPATENT
Filed
May 29, 2024
Priority
Apr 21, 2016 — provisional 62/325,859 +3 more
Examiner
ARIANI, KADE
Art Unit
1651
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Regents of the University of California
OA Round
3 (Non-Final)
74%
Grant Probability
Favorable
3-4
OA Rounds
9m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allowance Rate
614 granted / 824 resolved
+14.5% vs TC avg
Strong +33% interview lift
Without
With
+33.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
21 currently pending
Career history
845
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
65.9%
+25.9% vs TC avg
§102
3.1%
-36.9% vs TC avg
§112
9.8%
-30.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 824 resolved cases

Office Action

§112 §DOUBLEPATENT
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 . Request for Continued Examination: A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/17/2026 has been entered. The claim amendment and response filed on February 17, 2026 is received. Claims 16 and 17 are canceled. New claims 21-22 are added. Claims 12-15, 18, 19 and 21-22 are pending in this application and are being examined. Answer to Arguments: Withdrawn Rejection(s): The rejection of claims 12, 14, 18 and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Tulloch et al. (Canadian Journal of Chemistry, 1964, Vol. 42, p. 830-835, which is cited in IDS filed on 08/07/2024), as evidenced by Wikipedia (Rhodotorula glutinis according to Wikipedia, downloaded on 05/17/2021, 4 pages of PDF, which is cited in IDS filed on 08/07/2024), is withdrawn due to the amendment to claims filed on 02/17/2026. The rejection of claims 12-19 under 35 U.S.C. 103 as being unpatentable over Tulloch et al. and Wikipedia, as applied to claims 12, 14, 18 and 19, and further in view of previously cited Sitepu et al. (which is cited in IDS filed on 08/07/2024), is withdrawn due to the amendment to claims filed on 02/27/2026. With respect to the nonstatutory double patenting rejections (See below for details) no Terminal Disclaimer is filed, and Applicant requested that the double patenting rejection be held in abeyance until the indication of allowable subject matter. Therefore the double patenting rejections are maintained and is extended to the newly added claims 21-22. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 21 i.e., “the one or more polyol lipid is a lipid selected from the group consisting of a 3-hydroxy fatty acid moiety from 10 to 24 carbon atoms in length, a sugar alcohol moiety esterified to the carboxyl end of a 3-hydroxy fatty acyl moiety, an acetylated 3-hydroxy fatty acyl moiety; acetylated, non-esterified hydroxy groups of a polyol lipid sugar alcohol moiety, a polyol lipid sugar alcohol moiety comprising a mannitol or arabitol backbone, and one or more polyol esters of fatty acid (PEFAs)”. Applicant should specifically point out the support for any amendments made to the disclosure. See MPEP § 2163.06. Double Patenting Rejection: The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. A) Claims 12-16 and 18-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-13, 16-19, 22 and 30-38 of U.S. Patent No. 10,196,663. Although the claims at issue are not identical, they are not patentably distinct from each other because: It should be noted that claimed polyol lipids (PL) are glycolipids secreted by yeast (See applicant’s specification paragraph [0004]). Claims 1, 7-13, 16-19, 22 and 30-38 of U.S. Patent No. 10,196,663 disclose/teach producing method of producing one or more glycolipids, comprising: a) culturing a population of yeast cells in a yeast cell culture comprising one or more hydrophilic carbon sources, and a carbon to nitrogen ratio of about 10:1 to about 200:1, wherein the yeast cells are from the group consisting of Rhodotorula and Rhodosporidiobolus, wherein the culture does not comprise one or more hydrophobic carbon sources, and b) harvesting the one or more glycolipids secreted into the medium, the population of yeast cells comprises one or more species selected from the group consisting of Rhodotorula babjevae, … , wherein the population of yeast cells comprises one or more strains selected from the group consisting of: a) Rhodotorula babjevae strain NRRL Y-67018 (UCDFST 04-877), … , wherein at least about 1 g/L glycolipid is produced, wherein the yeast cells secrete the one or more glycolipids into the medium in a form that can be harvested without solvent extraction. Therefore, the method taught by claims 1, 7-13, 16-19, 22 and 30-38 of U.S. Patent No. 10,196,663 anticipate the claimed method of producing one or more polyol lipids of claims 12-16 and 18-19 of instant application. B) Claims 12-19 and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-13, 16-19, 22 and 30-38 of U.S. Patent No. 10,196,663 in view of Sitepu et al. Regarding the limitations of claims 17 and 22, as indicated above, Sitepu et al. teach oleaginous basidiomycetous yeast cells strain, genera Rhodotorula (Rhodotorula babjevae UCDFST 05-775), and adding an iron salt of a concentration in the range of about 0.001 mg/L to about 10 g/L to the culture medium of a basidiomycetous yeast cells, and culture comprises a carbon to nitrogen ratio of about 5:1 to about 400:1. Regarding claim 21, because the basidiomycetous yeast cells strain is the same as the claimed yeast strain of genera Rhodotorula, as such the claimed one or more polyol lipid as recited in claim 21 is/are inherent to the method of the U.S. Patent No. 10,196,663. Therefore, a person of ordinary skill in the art would have been motivated to apply the teachings of Sitepu et al. and add an iron salt of a concentration in the range of about 0.001 mg/L to about 10 g/L taught by the prior art to be added in the culture medium of Basidiomycetous yeast cells, Rhodotorula, in the method taught by claims of U.S. Patent No. 10,196,663 to provide the claimed yeast culture as recited in claim 17 of instant application. Conclusion(s): No claim(s) is allowed at this time. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KADE ARIANI whose telephone number is (571)272-6083. The examiner can normally be reached IFP, Monday - Friday, 8:00 AM -4:00 PM EST. 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, Melenie L. Gordon can be reached at (571)272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KADE ARIANI/Primary Examiner, Art Unit 1651
Read full office action

Prosecution Timeline

May 29, 2024
Application Filed
Aug 26, 2024
Response after Non-Final Action
Jun 11, 2025
Non-Final Rejection mailed — §112, §DOUBLEPATENT
Sep 10, 2025
Response Filed
Oct 14, 2025
Final Rejection mailed — §112, §DOUBLEPATENT
Feb 17, 2026
Request for Continued Examination
Feb 24, 2026
Response after Non-Final Action
Mar 09, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT (current)

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Prosecution Projections

3-4
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+33.1%)
2y 9m (~9m remaining)
Median Time to Grant
High
PTA Risk
Based on 824 resolved cases by this examiner. Grant probability derived from career allowance rate.

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