Prosecution Insights
Last updated: April 19, 2026
Application No. 18/030,700

BACILLUS CELL WITH REDUCED LIPASE AND/OR ESTERASE SIDE ACTIVITIES

Non-Final OA §112
Filed
Apr 06, 2023
Examiner
HOLLAND, PAUL J
Art Unit
1656
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BASF Corporation
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
3y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allow Rate
439 granted / 764 resolved
-2.5% vs TC avg
Strong +65% interview lift
Without
With
+65.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
55 currently pending
Career history
819
Total Applications
across all art units

Statute-Specific Performance

§101
8.0%
-32.0% vs TC avg
§103
31.6%
-8.4% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 764 resolved cases

Office Action

§112
DETAILED CORRESPONDENCE Application Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 2. Claims 1-14 are pending. Election/Restrictions 3. Applicant's election with traverse of Group I, claims 1-7 and 14 in the reply filed on 12/08/2025 is acknowledged. The traversal is on the ground(s) that applicants disagree that the technical feature linking the claims is reduced lipase. Applicants contend that the technical feature is inactivation of yitV and ypmR gene. This is not found persuasive in view of the rejections set forth below. Furthermore, not all of the claims share the feature of the yitV and ypmR gene because claim 9, which is grouped in Group III, recites a composition comprising a compound of interest with reduced contamination with lipase and/or esterase activity obtained by the method of claim 8. This claim is a product by process claim, wherein MPEP states “ [E] ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) ”. In the instant case, claim 9 need only to have reduced contamination with lipase and/or esterase activity and as such, the teachings of Herbots et al. meet that technical feature. The technical effect of inactivation of yitV and ypmR is also reduced lipase and/or esterase activity. As such, this technical feature is shared amongst all groups as set forth in the Restriction Requirement mailed on 10/06/2025. The requirement is still deemed proper and is therefore made FINAL. 4. 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 12/08/2025. Claims 1-7 and 14 are pending and examined on the merits. Priority 5. Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) to Europe Patent Application No s . EP20200558.3 and EP21184275.2 , filing date 10/07/2021 and 07/07/2021, respectively . The certified cop ies ha ve been filed in the present application, filed on 04/06/2023 . Information Disclosure Statement 6. The IDSs filed on 04/06/2023 and 06/07/2023 have been considered by the examiner and copies of the Form PTO/SB/08 are attached to the office action. Claim Objections 7. Claims 1-7 and 14 are objected to for the following informalities: The recitation of the genus Bacillus and gene names, yitV and ypmR , should be italicized. Appropriate correction is suggested. Claim Rejections - 35 USC § 112(b) 8 . 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. 9 . Claims 1-7 and 14 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. Regarding claims 1-7 and 14, there is insufficient antecedent basis for the limitation “the yitV and ypmR gene”. Further regarding claims 5 and 6, t he term "high stringency" is a relative term which renders the claim indefinite. The term "high stringency" is a term of degree and the examiner has reviewed the specification and can find no examples or teachings that can be used for ascertaining the variance intended by the recited term of degree. Moreover, there is nothing in the specification or prior art of record to indicate that one of ordinary skill in the art could have ascertain the scope of the recited degree. It is suggested that applicant clarify the meaning of the claims. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7165. Claim Rejections - 35 USC § 112 10. 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. 11. Claims 1-7 and 14 are 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. MPEP 2163.II.A.2.(a). i ) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention”. For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly , 119 F.3d at 1568, 43 USPQ2d at 1406. MPEP § 2163 further states that “[s] atisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’" The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. Claims 1-7 and 14 are drawn to a recombinant Bacillus cell comprising an inactivation of the yitV and ypmR gene. In the instant case, the specification discloses the actual reduction to practice of the following representative species of the inactivation of the yitV and ypmR gene in a Bacillus cell (i.e. deletion of the yitV and ypmR gene in a Bacillus cell). Other than the discloses species, the specifications fails to provide any other structures of the infinite methods of inactivation of yitV and ypmR genes in a Bacillus cell as encompassed by claims. To this end, there is no prior-art or disclosed teaching regarding the structure of the infinite number of mutations, deletions, insertions, modifications by either small molecule, RNAi, genetic modification that results in inactivation of yitV and ypmR genes, and there is no disclosed or art-recognized correlation between any structure other than the deletion of the genes in a Bacillus cell to have the desired inactivation. The breadth of the claims encompass any modification to a Bacillus cell including modification of any transcription or translation factor that controls the expression of said genes. Given what is known in the art about the likely outcome of substitutions on structure, conservation of structure is not necessarily a surrogate for conservation of function. In this case, there is no disclosed correlation between structure and function. Accordingly, one of skill in the art would not accept the disclosure of deletion of the yitV and ypmR gene in a Bacillus cell as being representative of all methods of inactivation of the yitV and ypmR genes as encompassed the claims. As such, the specification, taken with the pre-existing knowledge in the art of amino acid substitution, fails to satisfy the written description requirement of 35 U.S.C. 112 (a). Citation of Relevant Prior Art 12. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baunsgaard et al. ( WO 2016/184944 A1; examiner cited) teach the reduction of odor generated by the activity of a lipase by adding an inhibitor to a composition comprising said lipase; however, Baunsgaard et al. does not teach the inactivation of a yitV and ypmR gene. Conclusion 13. Status of the claims: Claims 1-14 are pending. Claims 8-13 stand withdrawn pursuant to 37 CFR 1.142(b). Claims 1-7 and 14 are rejected. No claims are in condition for an allowance. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PAUL J HOLLAND whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3537 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday to Friday from 8AM to 5PM . 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 Manjunath Rao can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0939 . 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. /PAUL J HOLLAND/ Primary Examiner, Art Unit 1656
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Prosecution Timeline

Apr 06, 2023
Application Filed
Dec 17, 2025
Non-Final Rejection — §112
Feb 26, 2026
Interview Requested
Mar 09, 2026
Applicant Interview (Telephonic)
Mar 10, 2026
Examiner Interview Summary

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
99%
With Interview (+65.3%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 764 resolved cases by this examiner. Grant probability derived from career allow rate.

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