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 Status
The amended claim set filed on 10 March 2026 is acknowledged. Claims 1-2, 4, 6, 9-14, 16, 19-20, and 22 are currently pending. Of those, claims 1, 4, 14, 19, and 22 are amended. There are no new claims, and claims 14, 16, 19-20, and 22 are withdrawn. Claims 3, 5, 7-8, 15, 17-18, and 21 are cancelled. Claims 1-2, 4, 6, and 9-13 will be examined on the merits herein.
Response to Amendment
Applicants’ arguments filed 10 March 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Final Office Action mailed 9 January 2026 will be referred to as “FOA”.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 April 2026 was filed after the mailing date of the Request for Continued Examination on 7 April 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objection(s) and Rejection(s) Withdrawn
The objections to claims 1 and 4 are withdrawn in view of the amendments to the claims.
The rejection of claims 1-2, 4, 6, and 9-13 under 35 U.S.C. 102 is withdrawn in view of the amendments to the claims.
New Rejection(s)
Claim Rejections - 35 USC § 112(b)
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.
Claim 9 is newly 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.
Claim 9 recites, “The variant of the genus Yarrowia of claim 8….” However, claim 8 is cancelled, so one of ordinary skill in the art cannot determine the scope of claim 9 as written. In the interest of compact prosecution, claim 9 has been interpreted as being dependent upon claim 1. Clarification is requested.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-2, 4, 6, and 9-13 are newly rejected under 35 U.S.C. 103 as being unpatentable over Malanovic et al. (2008, J. Biol. Chem.; herein “Malanovic”) as evidenced by Boumann et al. (2006, Mol. Biol. Cell; cited in IDS; herein “Boumann”) in view of Brevnova et al. (WO 2015/184277 A1; herein “Brevnova”) as evidenced by NCBI Reference Sequence XM_503613.1 (2017; cited in IDS; herein “XM_503613.1”) and NCBI Reference Sequence XM_503863.2 (2017; cited in IDS; herein “XM_503863.2”).
Regarding claim 1, Malanovic teaches Saccharomyces cerevisiae strains YNM3 and YNM4 which comprise a deletion of the cho2 gene and opi3 gene, respectively (Table 1). Malanovic teaches that the strain is cultured in a medium containing choline (pg. 23991, left col. and Figure 4 caption) and produces more fat than the parental strain that does not contain the cho2 or opi3 deletions, i.e., “wild type” (Figure 4C and pg. 23995, right col., para. 3).
Regarding the limitation “the variant strain of the genus Yarrowia is a choline auxotrophic strain,” Malanovic teaches that the genetic modification(s) to the cell may include deletion of either PEMT and phospholipid methyltransferase genes (i.e., cho2 and opi3, respectively) (para. 237-239). PEMT and phospholipid methyltransferase are two of the enzymes in the pathway that converts phosphatidylethanolamine (PE) into phosphatidylcholine (PC); the inability to utilize PE in such cells is remedied by utilizing choline to produce PC through a different pathway (as evidenced by Boumann, Figure 1 and pg. 1008, right col., para. 1). PC is a major structural component of organelle membranes in eukaryotes (as evidenced by Boumann, pg. 1006, left col., para. 1); thus, eukaryotes lacking one or both of PEMT and phospholipid methyltransferase are inherently choline auxotrophs. See MPEP 2112 for a discussion on inherency.
Regarding claim 9, Malanovic teaches that the increased production of fat is of triacylglycerol (TAG) (Figure 4C).
Regarding claims 10-13, Malanovic teaches a method comprising culturing the genetically modified S. cerevisiae YNM3 and YNM4 strains (Table 1); thus, Malanovic teaches a composition comprising a culture of the variant strain of S. cerevisiae. Malanovic also teaches extracting the lipids produced by the cells (i.e., an extract of the strain; pg. 23995, right col., para. 2); thus, Malanovic teaches a composition comprising a fat recovered from the genetically modified cells and/or culture.
With respect to the limitation in the preambles of claims 10-13, “cosmetic composition”, “food composition”, “feed composition”, and “medical composition”, respectively, please note that MPEP 2111.02(II) states "a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." In the instant case, the claims are drawn to compositions comprising “one or more of the variant strain of the genus Yarrowia of claim 1, a culture of the strain, an extract of the strain, a dry product of the strain, a lysate of the strain, and a fat…”, and the preamble does not affect the structure of the composition, as is evidenced by each of the claims reciting identical limitations. Therefore, the preambles in this case recite a statement of purpose or use, and therefore does not further limit the claims.
However, Malanovic does not teach that the variant strain is of the genus Yarrowia, as in claim 1, wherein the cho2 gene consists of a polynucleotide sequence of SEQ ID NO: 1, as in claim 2, wherein the opi3 gene consists of a polynucleotide sequence of SEQ ID NO: 11, as in claim 4, or wherein the strain is Yarrowia lipolytica, as in claim 6.
Regarding claim 1, Brevnova teaches a variant strain, which may be a Yarrowia strain (pg. 13, lines 3-8), comprising a knockout of the genes CHO2 and/or OPI3 (pg. 36, line 28 – pg. 37, line 10).
Regarding claim 2, the phosphatidylethanolamine methyltransferase gene in Y. lipolytica is the gene cho2, which has a nucleotide sequence identical to that of instant SEQ ID NO: 1 (as evidenced by XM_503613.1; see alignment in Figure 1 below).
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Figure 1: Alignment of instant SEQ ID NO: 1 (Qy) and XM_503613.1 (Db).
Regarding claim 4, the phospholipid methyltransferase gene in Y. lipolytica is the gene opi3, which has a nucleotide sequence identical to that of instant SEQ ID NO: 11 (as evidenced by XM_503863.2, see alignment in Figure 2 below).
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Figure 2: Alignment of instant SEQ ID NO: 11 (Qy) and XM_503863.2 (Db).
Regarding claims 6 and 9, Brevnova teaches that Yarrowia lipolytica is well-suited for use as the host microorganism because they can accumulate a large percentage of their weight as triacylglycerols (pg. 13, lines 11-13).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the teachings of Malanovic by using the Yarrowia lipolytica taught by Brevnova in the place of the S. cerevisiae taught by Malanovic, thereby arriving at the invention of claims 1-2, 4, 6, and 9-13. The person of ordinary skill in the art would have been motivated to make the modification because Brevnova teaches that Yarrowia lipolytica is able to accumulate a large percentage of their weight as triacylglycerols. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because Brevnova teaches that Yarrowia lipolytica may have deletions of the cho2 or opi3 genes. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (Malanovic) teaches a product that only differs from the claimed invention by the substitution of a single component (i.e., substitution of the variant strain used); the substituted element (i.e., the Yarrowia lipolytica) was already known and already shown to function as a host variant strain, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one host strain for another with a reasonable expectation of success (i.e., the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
