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 .
Applicants’ Response Dated July 7, 2026
In the Response dated July 7, 2026, claims 1 and 3 were amended, and claims 4-7 were canceled. Claims 1-3 are pending. An action on the merits of claims 1-3 is contained herein.
The rejection of claims 1-3 is maintained for the reasons of record as set forth in the Office Action dated April 7, 2026.
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Schilling, Christoph, et al. "Engineering of the 2, 3-butanediol pathway of Paenibacillus polymyxa DSM 365." Metabolic engineering 61 (2020): 381-388 (Schilling) has been rendered moot in view of applicants’ amendment dated July 7, 2026. The claim has been amended to delete the term “a CRISPR”. Thus, the rejection has been withdrawn.
The rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Schilling, Christoph, et al. "Engineering of the 2, 3-butanediol pathway of Paenibacillus polymyxa DSM 365." Metabolic engineering 61 (2020): 381-388 (Schilling) and Hughes, Elizabeth Rose. Changes in the Gut Metabolic Landscape Drive Inflammation-Associated Dysbiosis and Host Responses. Diss. 2020 (Hughes) in combination has been rendered moot in view of applicants’ amendment dated July 7, 2026.
The rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Schilling, Christoph, et al. "Engineering of the 2, 3-butanediol pathway of Paenibacillus polymyxa DSM 365." Metabolic engineering 61 (2020): 381-388 (Schilling) and Hughes, Elizabeth Rose. Changes in the Gut Metabolic Landscape Drive Inflammation-Associated Dysbiosis and Host Responses. Diss. 2020 (Hughes) in combination has been rendered moot in view of applicants’ amendment dated July 7, 2026.
Rejections Set Forth in the Office Action Dated April 7, 2026
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 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.
Applicants’ arguments filed July 7, 2026, have been fully considered but they are not persuasive. Applicants submit that amended claim 1 provides structure for the target (e.g., “the DNA or RNA sequence…or Salmonella species”). Applicants argue that the recited inhibitor classes are established structures/technologies with known mechanisms for suppressing gene expression.
Applicants’ argument has been fully considered; however, the examiner respectfully disagrees that the recited inhibitor classes are established structures. Functional descriptions of chemical compounds/compositions must be coupled with a known or disclosed correlation between function and structure. “An antisense oligonucleotide, a gapmer, a sHRNA, or siRNA” embraces a nearly infinite number of compounds, embracing a nearly infinite number of nucleic acid sequences. The examiner finds no evidence in the record or prior art that supports applicants’ argument that the recited inhibitor classes are established structures. Thus, the rejection is maintained.
Conclusion
Claims 1-3 are pending. Claims 1-3 are rejected. No claims are allowed.
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.
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/