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 Invention I (claims 1-3) in the reply filed on 09/24/2025 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Claims 4-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2023.
Specification
The disclosure is objected to because of the following informalities:
As set forth in MPEP 1.821(d) states: “in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier (§ 1.823(a)(5) ), preceded by "SEQ ID NO:" or the like, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.”
Table 4 of the specification has several sequences without providing a Sequence Identifier as required above.
Appropriate correction is required.
Drawings
The drawings are objected to because several the drawing have small, blurry or illegible or nonreproducible text including Figs. 2A, 2B, 2C, 2D, 3B, 3C, 3D, 3E, 5A, 5B, 6A, 6B, 6C, 7A, and 7C. “All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.” 37 CFR 1.84(l).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-3 (all non-withdrawn claims) 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 1 and 3 recite “greater than 70% sequence identity to the nucleotide sequence of PP_0262 from P. putida KT 2440.” PP_0262 from P. putida (a gene nomenclature) is understood to provide an antecedent basis for “the nucleotide sequence.” However, the specification does not provide for what the nucleotide sequence of PP_0262 from P. putida KT 2440 is such that an ordinarily skilled artisan cannot determine how to avoid infringement. The specification provides for no suggestion for where “the nucleotide sequence of PP_0262 from P. putida KT 2440” is provided in the art nor any definition of a “the nucleotide sequence of PP_0262 from P. putida KT 2440” that would resolve a conflict between different a “nucleotide sequence of PP_0262 from P. putida KT 2440” that may be possibly reported in the art (although no such report is of record) nor any indication if an associated promoter or other control sequence is part of a “nucleotide sequence of PP_0262 from P. putida KT 2440” required for identity.
Further, the evidence of record does not indicate that any genomic data for P. putida KT2440 is publicly known as of the filing date of the current application. The specification, para. [0085], references Protein Data Bank 8AYV having a public release date of 03/01/2023. While an amino acid sequence is associated with Protein Data Bank 8AYV, no particular nucleotide sequence is associated with the same. As of the date of this Office Action, the nucleotide sequence of PP_0262 from P. putida KT 2440 does not appear to be available from any source. Without a definitive understanding of what “the nucleotide sequence of PP_0262 from P. putida KT 2440” is in the form of a specific sequence, an ordinarily skilled artisan at the time of filing cannot understand how to avoid infringement.
Comment regarding prior art
McNaught et al. (Initiation of fatty acid biosynthesis in Pseudomonas putida KT2440, Metabolic Eng. 76 2023, 193-203) sets forth the following:
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That is, prior to the filing date a homologous malonyl-ACP decarboxylase has been identified and characterized in E. coli. While PP_0262 was identified by a forward screen, McNaught is not prior art and PP_0262 does not appear to have a characterized function in P. putida as of the filing date of the current application. Whaley et al. (Malonyl-acyl carrier protein decarboxylase activity promotes fatty acid and cell envelope biosynthesis in Proteobacteria, JBC 297, 2021, 101434) provides additional information about the E. coli homolog enzyme.
Further, the existence of a malonyl-ACP decarboxylase that can function in initiation of fatty acid synthesis does not presuppose the existence of a homologous function in P. putida or other organisms. Zhang et al. (Will the Initiator of Fatty Acid Synthesis in Pseudomonas aeruginosa
Please Stand Up?, J. Bacteriol. 194, 2012, 5159-61), page 5159 sets forth:
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As such, it cannot be presupposed that the well-characterized fatty acid synthesis system in E. coli has fully parallel functional counterparts in Pseudomonas species. As such, there is no particular reason for a skilled artisan at the time of filing to look for or overexpress the PP_0262 gene in P. putida. While claim 1 does not require a particular effect on fatty acid initiation for overexpression of a malonyl-ACP decarboxylase, some motivation is needed to overexpress the same wherein no such motivation is fairly suggested in the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p.
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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