DETAILED ACTION
Status of the Application
Claims 1, 4-6, 8-13 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendment of claim 1 as submitted in a communication filed on 2/2/2026 is acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/2/2026 has been entered.
Claims 8-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/19/2025.
Claims 1, 4-6 are at issue and are being examined herein.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Rejections - 35 USC § 112(b) or Second Paragraph (pre-AIA )
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, 4-6 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 pre-AIA the applicant regards as the invention.
Claim 1 (claims 4-6 dependent thereon) is indefinite in the recitation of “wherein the genetically engineered Pichia ciferrii mutant strain is cultured in a medium supplemented with fatty acid methyl ester (FAME) to enhance TAPS production” for the following reasons. It is unclear as to how the composition of a medium that can be used to culture the genetically engineered Pichia ciferrii mutant strain further limits the Pichia ciferrii mutant strain. Please note that indicating that the Pichia ciferrii mutant strain is cultured in a medium that comprises FAME does not further provide any additional structural or functional limitations to the Pichia ciferrii mutant strain, which is the product being claimed. In addition, the term “enhance” is a relative term and it is unclear in the absence of a reference to determine if enhancement is present (i.e., enhanced compared to what?). For examination purposes, no patentable weight will be given to the term. Correction is required.
When amending the claims, applicant is advised to carefully review all examined claims and make the necessary changes to ensure proper antecedent basis and dependency.
Claim Rejections - 35 USC § 103 (AIA )
Claims 1, 4-6 remain rejected under 35 U.S.C. 103 as being unpatentable over Schorsch et al. in view of Lee et al. (Biotechnology for Biofuels 11:310, pages 1-14, 2018; cited in the IDS), Pfleger et al. (Metabolic Engineering 29:1-11, 2015), Dulermo et al. (Metabolic Engineering 13:482-491, 2011; cited in the IDS), Schneider et al. (GenBank accession No. CCH40726, 9/13/2012; hereinafter Schneider 1), and Schneider et al. (GenBank accession No. CCH41258, 9/13/2012; hereinafter Schneider 2).
This rejection has been discussed at length in the prior Office action. It is maintained for the reasons of record and those set forth below.
Applicant argues that claim 1 has been amended to require the mutant strain to be cultured in a medium that comprises FAM to enhance TAPS production. Applicant states that this limitation is not taught or suggested by the cited prior art. Applicant states that culturing the strain in a medium containing FAM is not a mere modification of the cited references and that Applicant discovered that adding FAMEs to the culture medium of the mutant strain significantly increases TAPS production. Applicant cites Example 5 as evidence to show the effect of adding FAMs to the culture medium of the P. ciferrii mutant strain. Applicant states that the claimed strain’s ability to produce TAPS is not solely due to the culturing conditions but is a direct consequence of its genetic engineering.
Applicant’s arguments have been fully considered but not deemed persuasive to overcome the instant rejection. The Examiner acknowledges the amendments made to claim 1. However, the Examiner disagrees that the claimed strain is not obvious over the cited prior art. As explained above, indicating that the Pichia ciferrii mutant strain is cultured in a medium that comprises FAME does not further provide any additional structural or functional limitations to the Pichia ciferrii mutant strain, which is the product being claimed. Therefore, since the new limitation recited is not a limitation of the claimed product, namely the P. ciferrii mutant strain, it does not have to be taught or suggested by the cited prior art. This is also implied by Applicant in the response of 2/2/2026 (page 6) where it is stated that “Importantly, the claimed strain’s ability to produce higher TAPS level is not solely due to the culturing conditions but is a direct consequence of its genetic engineering. While the addition of FAME merely amplifies this property, the product of the claim (i.e., the mutant strain) possesses a distinctive technical advantage that sets it apart from the strains of the cited art and from strains lacking the specific genetic modifications, regardless of the culturing conditions”.
With regard to the genetic engineering of a P. ciferrii to produce TAPS by disrupting a PcPOX3 that comprises SEQ ID NO: 28, it is reiterated herein that it would have been obvious to one of ordinary skill in the art to (i) further modify the P. ciferrii cell of Schorsch et al. by disrupting the endogenous gene encoding the acyl-CoA oxidases 3 and 4, or in the alternative (ii) increase the availability of palmitoyl-CoA instead of L-serine in the P. ciferrii cell of Schorsch et al. As previously indicated, a person of ordinary skill in the art is motivated to disrupt the endogenous genes encoding the acyl-CoA oxidases 3 and 4 for the benefit of blocking the degradation of palmitoyl-CoA, which is the other precursor of TAPS, such that the availability of a precursor of TAPS increases. As previously indicated, the teachings of Lee et al., Dulermo et al. and Pfleger et al. show that (a) acyl-CoA oxidases such as the acyl-CoA oxidases of Schneider 1 and 2, catalyze the initial step in β-oxidation and that by deleting genes encoding these acyl-CoA oxidases (pox genes), the degradation of fatty acids is prevented because the conversion of fatty acyl-CoA to acetyl-CoA is avoided, (b) the simplest strategy for directing flux through metabolism is to block entrance into undesirable pathway, which in the case of oleochemicals (e.g., TAPS), is β-oxidation, and (c) inactivation of pox genes in another yeast has been shown to successfully increase free fatty acids content and accumulate lipids (oleochemical). It is reiterated herein that there is a reasonable expectation of success at disrupting the genes encoding acyl-CoA 3 and 4 because the molecular biology techniques required to disrupt a gene are well known in the art as evidenced by Lee et al, and Dulermo et al. Also, while there is no absolute certainty that the production of TAPS would be increased by disrupting the pox genes encoding the proteins of Schneider 1 and Schneider 2 in the P. ciferrii cell of Schorsch et al., there is a reasonable expectation of success at observing some increase in the production of TAPS compared to the P. ciferrii cell of Schorsch et al. because (i) the additional palmitoyl-CoA being produced due to the disruption of the pox genes could be replenishing the intracellular palmitoyl-CoA pool being depleted as a result of the conversion of the additional L-serine produced by the P. ciferrii cell of Schorsch et al. into 3-keto-sphinganine, thus avoiding palmitoyl-CoA becoming a limiting reagent and a decline in the production of the TAPS precursor 3-sphinganine, (ii) Schorsch et al. teach that blocking the degradation of another precursor of TAPS resulted in an increase in TAPS, and (iii) Lee et al., Dulermo et al. and Pfleger et al. teach that deletion of acyl-CoA oxidases (POX), which are enzymes of the β-oxidation pathway result in the accumulation of oleochemicals in other yeast. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is in condition for allowance.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to DELIA M RAMIREZ, Ph.D., whose telephone number is (571) 272-0938. The examiner can normally be reached on Monday-Friday from 8:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert B. Mondesi, can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/DELIA M RAMIREZ/Primary Examiner, Art Unit 1652
DR
February 20, 2026