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. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/06/2025 has been entered.
3. Claims 13 and 15-17 are cancelled.
4. Claims 1, 11-12, and 31 are pending.
5. Applicant’s remarks filed on 11/06/2025 in response to the Final Rejection mailed on 08/18/2025 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Claim Rejections - 35 USC § 102
6. The rejection of claims 13-17 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kolkman et al. (WO 2018/156705 A1, priority to 02/24/2017, published 08/30/2018; cited on IDS filed on 06/01/2022) is withdrawn in view of applicants’ amendment to the claims to cancel claims 13-17.
The rejection of claims 1, 11-12, and 31 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kolkman et al. (WO 2018/156705 A1, priority to 02/24/2017, published 08/30/2018; cited on IDS filed on 06/01/2022) is maintained for the reasons of record and the reasons set forth below. The rejection has been modified in order to address applicants’ amendment to the claims.
7. As amended claims 1, 11-12, and 31 are drawn to a modified Bacillus licheniformis cell derived from a parental B. licheniformis cell comprising a native rghR chromosomal locus, wherein the modified cell comprises at least one genetic modification of the rghR chromosomal locus selected from the group consisting of (a) a disruption or deletion of rghR1 gene, (b) a disruption or deletion of the native rghR2 gene, (c) a disruption or deletion of native rghR1 and native rghR2 gene, and (d) a disruption or deletion of native rghR1 gene, a native rghR2 gene, a native yvzC gene and a native Bli3644 gene, wherein wherein the native rghR2 gene does not comprise an 18-bp duplication encoding a six amino acid repeat of AAASIR, and wherein the modified cell produces an increased amount of a protein of interest relative to the parental cell when cultivated under the same conditions.
8. With respect to claim 1, Kolkman et al. teach a modified Bacillus licheniformis cell wherein the modified cell comprises at least one genetic modification of the rghR chromosomal locus selected from the group consisting of (a) a mutation, disruption, partial deletion, or complete deletion of rghR1 gene, (b) a mutation, disruption, partial deletion, or complete deletion of rghR2 gene, (c) a mutation, disruption, partial deletion, or complete deletion of rghR1 and rghR2 gene, and (d) a mutation, disruption, partial deletion, or complete deletion of rghR1 gene, a rghR2 gene, a yvzC gene and a Bli3644 gene, wherein the modified cell produces an increased amount of a protein of interest relative to the parental cell when cultivated under the same conditions [see Abstract; paragraph 0006, 0015-0016]. It is noted that “wherein the native rghR2 gene does not comprise an 18-bp duplication…” merely recites the structure of the native B. licheniformis prior to modification; however, a modified B. licheniformis wherein the rghR2 gene has been deleted such as in Kolkman et al., would result in the same structure no matter what the parental strain was since both strains would have rghR2 absent. Nevertheless, Kolkman et al. teach wherein the B. licheniformis is a native B. licheniformis which does not comprise an 18-bp duplication encoding a six amino acid repeat of AAASIR [see paragraphs 0199, 0209].
With respect to claim 11, Kolkman et al. teach the modified cell comprising one or more expression cassettes encoding a protein of interest [see paragraphs 0006 and 0257].
With respect to claim 12, Kolkman et al. teach the modified cell wherein the one or more expression cassettes encode an amylase protein [see paragraph 0006].
With respect to claim 31, Kolkman et al. teach the modified cell wherein the protein of interest is an amylase protein [see paragraph 0006].
RESPONSE TO REMARKS: Beginning on p. 3 of applicants’ remarks, applicants in summary contend that the claimed strains are structurally and functionally distinct. Applicants contend that the Kolkman reference targets a specific 18-bp duplication in the rghR2 that impairs transcriptional regulation, wherein the invention restores native function by deleting this 18-bp duplication. As such, applicants contend that Kolkman does not disclose the specific combinations of gene deletions/disruptions recited in the amended claims.
This argument is found to be not persuasive in view of the modified rejection set forth above.
Conclusion
9. Status of the claims:
Claims 1, 11-12, and 31 are pending.
Claims 1, 11-12, and 31 are rejected.
No claims are in condition for an allowance.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL J HOLLAND whose telephone number is (571)270-3537. The examiner can normally be reached Monday to Friday from 8AM to 5PM.
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/PAUL J HOLLAND/Primary Examiner, Art Unit 1656