Prosecution Insights
Last updated: April 19, 2026
Application No. 18/554,448

PHOSPHOKETOLASE VARIANTS AND METHODS OF USE

Non-Final OA §103§112
Filed
Oct 06, 2023
Examiner
BERKE-SCHLESSEL, DAVID W
Art Unit
1651
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Genomatica Inc.
OA Round
1 (Non-Final)
66%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
484 granted / 731 resolved
+6.2% vs TC avg
Strong +32% interview lift
Without
With
+32.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
40 currently pending
Career history
771
Total Applications
across all art units

Statute-Specific Performance

§101
8.1%
-31.9% vs TC avg
§103
34.4%
-5.6% vs TC avg
§102
19.5%
-20.5% vs TC avg
§112
24.2%
-15.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 731 resolved cases

Office Action

§103 §112
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 without traverse of SEQ ID No 1 in the reply filed on 2/9/2026 is acknowledged. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Specification The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g). Claim Objections Claim 1 is objected to because of the following informalities: the claim provides a limitation towards Tables 1-4; since this limitation is plainly written in claim 20, without a reference to a table, it seems clear that there is no need for the claim to include a reference to the tables. See MPEP 2173.05(s). In fact, since it is clear that the Applicant was in possession of these embodiments at the time of filing, it would be more appropriate to claim these as distinct SEQ ID numbers. Appropriate correction is required. 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 appl icant regards as his invention. Claims 1-5, 17-18, 20, 33-38, 41-42 and 49-52 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. Claim 1 provides for a mutant of SEQ ID No 1, wherein the mutant is defined by the alterations provided in Table 1. All of these alterations are clear, unambiguous, and fully supported by specification, as outlined by the Written Description requirement of 35 USC 112(a). However, it is unclear what the metes and bounds of the claimed “functional fragment” are. It is unclear what amount of SEQ ID No 1 can be fragmented, and which parts can be mutated, in a manner to provide for a fragment that is “functional.” For example, if one amino acid residue is removed from the N-terminus, this would be a “fragment,” that is likely “functional.” It is unclear if this “fragment,” though, would be consistent with the claimed “functional fragment.” Since neither the claims nor the specification provides reasonable guidance as to what constitutes a fragment, and what degree of functionality must be maintained, it is unclear how to fully interpret the claimed “functional fragment.” Furthermore, since the amino acid numbering of the functional fragment would not be consistent with the numbering of the whole length claimed SEQ ID No 1, it is unclear how to perform the claimed mutations. The term “ substantially ” in claim 49 is a relative term which renders the claim indefinite. The term “ substantially ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Anaerobic culture is defined as no oxygen, if oxygen is present in small quantities the culture is defined as hypoxic, and atmospheric quantities as normoxic . If the Applicant is trying to claim an anaerobic culture, it cannot be substantially anaerobic, otherwise it would be defined as hypoxic. Claims 2 -5, 17-18, 20, 33-38, 41-42 and 49-52 are rejected insofar as these claims ultimately claim dependence on claim 1, but do not provide for any clarity with respect to a “functional fragment.” 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 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. Claim s 1-5, 17-18, 20, 33-38, 41-42 and 49-52 are rejected under 35 U.S.C. 103 as being unpatentable over Shaw, et al (US Pat. 10,760,105), Dischert, et al (US Pat. 10,774,320) Beck, et al (US Pat. 10,246,694) Dauner, et al (US Pat. 8,871,488) or Muramatsu, et al (US Pat. 9,340, 793 ), . Following a sequence search for SEQ ID No 1, the five above-mentioned patents all provide for a functional engineered phosphoketolase that provides for between 99.9% to 96.6% sequence homology. See Shaw, SEQ ID No 31; Dischert, SEQ ID No 24; Beck, SEQ ID No 50; Dauner, SEQ ID No 383 ; Muramatsu, SEQ ID No 3 . While it is noted that none of the patents provides for the claimed mutations, and as such, do not anticipate the claimed sequence alterations, the fact that 5 independent patents all provide for functional variants of the same enzyme, would suggest that the claimed enzymes must be obvious variants of those disclosed in the cited patents. The fact that the prior art provides for so many variants with the same functionality would suggest that point mutations would lead to obvious and predictable outcomes. That is to say, all of the claimed point mutations would lead to sequences with the same functionality as those described in the prior art, wherein the claimed alterations lead to obvious and predictable outcomes. This is highlighted by the fact that all of the cited prior art describes these variants as possessing some for m of increased activity , relative to the natural sequence . See Shaw, column 1 , lines 59-64 ; Dischert, column 1, lines 7-17; Beck, column 1, lines 29-37; Dauner, column 4, lines 61-67 ; Muramatsu, column 6, lines 44-55 . With respect to claims 1, 5, 20, and 33, as discussed above, it is clear from Tables 1 and 3, and the mutations provided in claim 20, that the cited prior art does not explicitly teach the claimed mutations. However, all of the claimed mutations would provide for a phosphoketolase enzyme that is functionally identical to those of the cited prior art, wherein the sequence difference is as little as 1 amino acid. As such, unless there is evidence that particular sequences provide for unexpectedly better activities, or unexpected properties , the claimed alterations are considered to be obvious to the ordinary artisan. With respect to claims 3 and 4, Shaw teaches that the claimed activity is an inherent function of the phosphoketolase enzyme. See column 22, lines 20-45. Dischert confirms this assessment. See column 3, lines 1-16. With respect to claims 17 and 18, the mutations provided in the 5 cited patents all show conservative and non-conservative mutations. These mutations would be obvious to the ordinary artisan, because the ordinary artisan possesses a PhD or Masters in proteomics, or a related field, and further possesses ample applied knowledge. See MPEP 2141.03. With respect to claim 34, although knowledge of a polypeptide sequence would inform the ordinary artisan of its nucleic acid sequence, the prior art also describes the nucleic acid sequence. See Shaw, column 23, lines 9-13 ; Beck, column 2, lines 64-67; Dauner, column 8, lines 61-67. With respect to claims 35 and 36, the prior art teaches vectors and promoters. See Shaw, column 9, lines 51-60 and column 10, lines 42-60; Dischert, column 5, lines 39-51; Dauner, column 10, lines 30-35 and 63-67. With respect to claims 37 , 38 , and 42 , the prior art describes this enzymatic pathway, and suggests its inclusion in a recombinant microbial cell. See Shaw, column 1, lines 23-47; Dischert, columns 7 and 8; Beck, column 16, lines 49-61 and column 20, lines 44-62; Dauner, column 111, lines 6-43; Muramatsu, column 3, lines 57-65. With respect to claim 41, Shaw describes homologous genes. See column 12, lines 38-41, and 51-67. With respect to claim 49, Dauner describes anaerobic cultures. See column 119, lines 1-3. With respect to claim 50, Shaw describes bacteria, yeast, and fungi as all possible organisms that can be transformed. See column 3, lines 19-24. With respect to claim 51, although the prior art does not appear to describe percent changes in production of biomolecules, the cited prior art makes the claimed microbial organisms obvious . As such, the prior art can be expected to provide for an increase that is consistent with that claimed. With respect to claim 52, all of the cited prior art is concerned with the production of a bioderived compound that is consistent with that claimed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DAVID W BERKE-SCHLESSEL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3643 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8AM-5:30PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Melenie Gordon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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. /DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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Prosecution Timeline

Oct 06, 2023
Application Filed
Mar 23, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+32.5%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 731 resolved cases by this examiner. Grant probability derived from career allow rate.

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