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 .
Applicant’s amendment and remarks filed on 6/2/2026 are acknowledged. Claim 79 is amended.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 6/2/2026 is acknowledged. Claims 60-87 are pending. Claims 85-87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 60-84 are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 10/17/2024 and 6/2/2026 have been considered. Signed copies are enclosed.
Drawings
The description of the drawings is objected to. According to 37 CFR 1.74, When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures, and to the different parts by use of reference letters or numerals (preferably the latter). The examiner should see to it that the figures are correctly described in the brief description of the drawing, that all section lines used are referred to, and that all needed section lines are used. If the drawings show Figures 1A, 1B, and 1C and the brief description of the drawings refers only to Figure 1, the examiner should object to the brief description, and require applicant to provide a brief description of Figures 1A, 1B, and 1C. In the instant case, there is no description of Figures 8A-8B and 9A-9B.
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 63, 65-67, and 71-82 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 pre-AIA the applicant regards as the invention. Claims not specifically mentioned below are included because they contain the issue of the parent claim.
Claim 63 is indefinite because it requires NS1 and NS2 to be on different nucleic acids. However, the parent claim requires them to be on the same nucleic acid.
Claim 65 is rendered indefinite by the phrase “(b) an RNA that is operable for guiding an RNA-guided nuclease or a precursor of the RNA”. The parent claim requires that P2 be a nuclease or operable with a nuclease to regulate production of P1. A precursor of an RNA that is operable for guiding an RNA-guided nuclease is not operable with a nuclease.
Claim 71 is rendered indefinite by the phrase “wherein the nucleic acid is comprised by a vector”. A vector could comprise the nucleic acid, but it is not clear how a nucleic acid can be “comprised by” a vector.
Claim 73 is rendered indefinite by the phrase “wherein the nucleic acid is comprised by a carrier cell”. A carrier cell could comprise the nucleic acid, but it is not clear how a nucleic acid can be “comprised by” a carrier cell.
Claim 74 is indefinite because it is not clear how a nucleic acid can be a phage since phages contain more than just nucleic acid.
Claim 76 is indefinite because it is not clear how the limitations of the claim fit into the parent claim. It is not clear if the nuclease and RNA (or precursor) are supposed to be the components cited in the parent claim or are in addition to the components required by the parent claim. Further, if part (b) is supposed to refer to P2 of the parent claim, The parent claim requires that P2 be a nuclease or operable with a nuclease to regulate production of P1. A precursor of an RNA that is operable for guiding an RNA-guided nuclease is not operable with a nuclease.
Claim 80 is rendered indefinite by the phrase “(b) P2 comprises a crRNA, or a precursor of the crRNA, that is operable in the host cell for guiding a Cas nuclease to cut the nucleic acid”. The parent claim requires that P2 be a nuclease or operable with a nuclease to regulate production of P1. A precursor of a crRNA that is operable for guiding an RNA-guided nuclease is not operable with a nuclease.
Claim 81 is rendered indefinite by the phrase “allowing transfer of the nucleic acid into the host cell comprised by the microbiota”. Microbiota could comprise the host cell, but it is not clear how a host cell can be “comprised by” the microbiota.
Claim 82 is indefinite because it is not clear how the limitations fit into the parent claim. The parent claim requires that R upregulate production of P2, which causes cutting of the nucleic acid which encodes P1, thus downregulating the production of P1. It is not clear how R would directly regulate Px is R is supposed to be upregulating production of P2.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 62 is rejected under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 62 requires that NS1 and NS2 are on the same nucleic acid. However, the parent claim already requires “a nucleic acid” that has both NS1 and NS2. Therefore, claim 62 does not further limit the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 60-61, 64, 68-70, and 83-84 are allowed. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO2019/002207 and WO2016/177682 (IDS filed 10/17/2024) are considered the closest prior art. Both references disclose nucleic acids that are similar to what is claimed. However, they do not disclose the specific method steps, particularly administration to a host cell in a subject, that are required by the instant claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN GANGLE/Primary Examiner, Art Unit 1645
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