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 .
Claim Status
Applicant’s amendments and remarks, filed 05/15/2026, are acknowledged.
Claims 2-4, 7, 12, 14-15, 17, 19-23, 26, 28-29, 31-43, and 45 are canceled.
Claims 1, 5-6, 10-11, 13, 16, 24-25, 27, 30, 44, 46, and 48 are amended.
Claims 1, 5-6, 8-11, 13, 16, 18, 24-25, 27, 30, 44, and 46-48 are pending.
Claims 24-25, 27, and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b),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 03/25/2024.
It is noted that Applicant did not properly amend claims 6, 44, and 46 to reflect previous changes. Specifically, claim 6 was amended “CRISPER” to “CRISPR” without striking through “CRISPER”; claim 44 was amended to add a semi-colon (;) after “type VI” but said semi-colon was not underlined; and, claim 46 has underlined a comma (,) between “SEQ ID NO: 35” and “SEQ ID NO: 42” which was previously presented in the amendments filed 09/03/2025.
37 CFR 1.121(c) states that: “Amendments to a claim must be made by rewriting the entire claim with all changes (e.g., additions and deletions) as indicated in this subsection, except when the claim is being canceled. Each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented, including the text of all pending and withdrawn claims, in the application. The claim listing, including the text of the claims, in the amendment document will serve to replace all prior versions of the claims, in the application. In the claim listing, the status of every claim must be indicated after its claim number by using one of the following identifiers in a parenthetical expression: (Original), (Currently amended), (Canceled), (Withdrawn), (Previously presented), (New), and (Not entered).” For the interest of compact prosecution and customer service, Examiner has considered Applicant’s remarks and amendments filed 05/15/2026. Applicant is advised that failure to ensure claims are compliant in any future reply will be considered non-compliant and will result in a Notice of Non-Compliant Amendment.
As such, claims 1, 5-6, 8-11, 13, 16, 18, 44, and 46-48 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/15/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Terminal Disclaimer
The terminal disclaimer filed on 05/14/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application No. 17/142,072 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 05/15/2026.
Withdrawn Rejections
Applicant’s arguments, see pages 16-18, filed 05/15/2026, with respect to claims 1, 5-6, 8-11, 13, 16, 18, 44, and 46-48 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s arguments, see pages 18-23, filed 05/15/2026, with respect to claims 1, 6, 8-11, 13, 18, 44, and 47-48 rejected under 35 USC 112(a) as allegedly lacking written description have been fully considered and are persuasive. The issue regarding the specification failing to disclose Applicant’s possession of CRISPR/Cas systems comprising any gRNA that targets a protospacer within any mammalian species of MPO gene have been sufficiently addressed through amendments to the claims. As such, the rejection under 35 USC 112(a) is withdrawn.
Applicant’s remarks, see pages 23-34, filed 05/15/2026, with respect to claims 1, 6, 8-11, 13, 18, 44, and 47-48 rejected under 35 USC 103 as allegedly being unpatentable over Shelley (WO 2017/048872 A1) in view of Van der Veen et al (2009) have been fully considered and are persuasive. While Examiner acknowledges that Shelley recites MPO as a target in a hematopoietic cell, the art is drawn to identifying several novel therapeutic targets and/or diagnostic and/or prognostic markers by correcting abnormal RhoH expression in a hematopoietic cell (see Abstract; see the table on pages 12-32); thus, it is not obvious that one would select MPO over the several other targets disclosed by Shelley. As such, the rejection of claims 1, 6, 8-11, 13, 18, 44, and 47-48 under 35 USC 103 is withdrawn.
Applicant’s remarks, see page 34, filed 05/15/2026, with respect to claims 1, 5-6, 8-11, 13, 16, 18, 44, and 46-48 provisionally rejected on the ground of non-statutory double patenting
as allegedly being unpatentable over claims 1, 3-6, 8-9, 11-13, 20, and 22-27 of copending Application No. 17/142,072 has been fully considered and are persuasive. Specifically, Examiner acknowledges the terminal disclaimer filed on 05/14/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application No. 17/142,072 has been reviewed and is accepted. As such, the provisional double patenting rejection is withdrawn.
New Objections and Rejections Necessitated by Amendment
Claim Objections
Claims 1, 5, 10, 16, 44, 46, and 48 are objected to because of the following informalities:
Claims 1, 5, 10, 16, 44, 46, and 48: “SEQ ID NO.” should read “SEQ ID NO:”.
Claims 1, 10, 44, and 48: “…wherein the Cas protein is a member of a CRISPR-associated system selected from the group consisting of type II, type I, type III, type IV, type V and type VI” should read ““…wherein the Cas protein is a member of a CRISPR-associated system selected from the group consisting of type I, type II, type III, type IV, type V and type VI”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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, 5-6, 8-11, 13, 16, 18, 44, and 46-48 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.
Claims 1, 44, and 48 recite the limitation "within the human MPO gene". There is insufficient antecedent basis for this limitation in the claims. As such, claims 1, 44, 48, and their dependent claims are rejected.
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 5, 16, and 46 recite the broad recitation “encoding a domain that includes… within amino acid residues”, and the claim also recites “encoding a domain that…is within amino acid residues” which is the narrower statement of the range/limitation. 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.
Further, the phrase “a domain that includes or is within amino acid residues 120-190, 150-260, 320-380, 250-270, 390- 510, 480-580 and/or 300-360 of human MPO as set forth in SEQ ID NO: 2” in claims 5, 16, and 46 renders the claims indefinite because the terms “includes” and “is within” followed by the recited residue ranges (i.e., 120-190 and 150-260; 150-260 and 2570-270; 390-510 and 480-580; and, 300-360 and 320-380) that overlap in scope.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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