DETAILED ACTION
Examiner prosecuting this application has changed.
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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/30/2025 has been entered.
Election/Restrictions
Newly submitted claims 58-59 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
A restriction and species election requirement was mailed on 01/03/2024, delineating ten inventive groups, including Group I (drawn to a fusion protein), Group II (drawn to a polynucleotide), and Group III (drawn to a viral particle). Newly submitted claim 58 is drawn to a polynucleotide (Group II), and claim 59 is drawn to a viral particle (Group III). In the Applicant’s response filed 03/04/2024, Applicant elected without traverse Group I, drawn to a fusion protein. Claims 58 and 59 are thus considered to be drawn to the inventions of unelected inventive Groups II and III.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 58-59 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims Status
Claims 2-5, 8, 10-16, 18-20, 23-26, 29-52 is/are cancelled and claims 53-59 is/are newly added. Claims 1, 6-7, 9, 17, 21-22, 27-28, 53-59 is/are currently pending with claims 21-22, 27-28, 58-59 withdrawn. Claims 1, 6-7, 9, 17, 53-57 is/are under examination.
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 1, 6-7, 9, 17, 53-57 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 53 recite the broad recitation “Cas13d”, and the claims also recite “CasRX” which is the narrower statement of the range/limitation (line 3 of each claim: “the…protein is CasRX/Cas13d”). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. As taught by Gearing (2018), “CasRX” is a specific Cas13d species derived from the species Ruminococcus favefaciens, while “Cas13d” is a genus of proteins, including but not limited to “CasRX”. As such, “CasRX” and “Cas13d” are not interchangeable terms. Claims 6, 9, and 17 depend on claim 1 and claims 54-57 depend on claim 53 but do not clarify this indefiniteness of claims 1 and 53; as such, claims 6, 9, 17, and 54-57 are also rejected for this indefiniteness.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 17, 53, 57 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hsu (WO2019040664A1, effective filing date 08/22/2017; provided by Applicant with IDS filed 03/10/2021).
Regarding claim 1, Hsu teaches a fusion protein comprising a CasRX protein (claims 20-21: “CasRX” is a Cas13d ortholog from R. flavefaciens) and METTL14 (page 43 lines 13-28).
Regarding claim 17, Hsu teaches that the fusion protein is bound to a guide RNA (claims 24, 26).
Regarding claim 53, Hsu teaches a fusion protein comprising a CasRX protein (claims 20-21: “CasRX” is a Cas13d ortholog from R. flavefaciens) and AlkB homolog 5, RNA demethylase (ALKBH5) (page 43 lines 13-28).
Regarding claim 57, Hsu teaches that the fusion protein is bound to a guide RNA (claims 24, 26).
Response to Arguments – 35 USC § 102
Applicant’s arguments with respect to claim(s) 1 and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 6-7, 9, 53-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hsu (WO2019040664A1, effective filing date 08/22/2017; provided by Applicant with IDS filed 03/10/2021), in view of Zhang (US20200248169A1, effective filing date 06/26/2017; previously cited in the action mailed 06/20/2024).
Regarding claim 1, Hsu teaches a fusion protein comprising a CasRX protein (claims 20-21: “CasRX” is a Cas13d ortholog from R. flavefaciens) and METTL14 (page 43 lines 13-28).
Regarding claim 17, Hsu teaches that the fusion protein is bound to a guide RNA (claims 24, 26).
Regarding claim 53, Hsu teaches a fusion protein comprising a CasRX protein (claims 20-21: “CasRX” is a Cas13d ortholog from R. flavefaciens) and AlkB homolog 5, RNA demethylase (ALKBH5) (page 43 lines 13-28).
Regarding claim 57, Hsu teaches that the fusion protein is bound to a guide RNA (claims 24, 26).
However, Hsu does not teach that the fusion protein comprises a linker.
Zhang teaches that proteins can be joined via linker to form a fusion protein.
Regarding claims 6 and 54, Zhang teaches that Cas13d-effector domain fusion proteins can comprise linkers joining the Cas13d and effector domains (paragraphs [0095], [0009], [0587]; claims 1-3).
Regarding claims 7, 9, 55, and 56, Zhang teaches that the linker can be a peptide linker or a non-peptide linker (paragraph [0096], “suitable linkers…include, but are not limited to, straight or branched-chain carbon linkers, heterocyclic carbon linkers, or peptide linkers”).
Zhang teaches that linkers in fusion proteins provide the benefit of preserving “some minimum distance or other spatial relationship between” the proteins which comprise the fusion protein, and such a distance can be “sufficient to ensure that each protein retains its required functional property” (paragraph [0096]). Hsu teaches that the fusion Cas13d-METTL14 and Cas13d-ALKBH5 proteins preserve the RNA-guided RNA-binding function of Cas13d and the RNA methylation (METTL14) or RNA demethylation (ALKBH5) functions of the effector domains (page 43 lines 13-28; claims 1-2). While Hsu does not teach that the Cas13d domain and the effector domain of a fusion protein are linked by a linker (peptide or non-peptide), the teachings of Zhang regarding the benefits provided by linkers would render obvious to a person of ordinary skill in the art at the time of filing that the fusion protein of Hsu should be modified by the addition of a peptide or non-peptide linker between the Cas13d domain and the effector domain, in order to preserve the functional properties of both domains.
Response to Arguments – 35 USC § 103
Applicant’s arguments with respect to claim(s) 1, 6-7, 9, and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; Applicant’s arguments specifically challenged the references Noack (2018) and Zhang (above) for not teaching a Cas13d-METTL14 or Cas13d-ALKBH5 fusion protein. As Hsu teaches these elements, Applicant’s prior arguments are moot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AFRICA M MCLEOD whose telephone number is (703)756-1907. The examiner can normally be reached Mon-Fri 9:00AM-6:00PM EST.
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/AFRICA M MCLEOD/ Examiner, Art Unit 1635
/RAM R SHUKLA/ Supervisory Patent Examiner, Art Unit 1635