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 .
Election/Restrictions
Applicant’s election without traverse of Group 4, claims 44 and 74 and species election of the polymorphic site rs1683564 and SEQ ID NO: 3779 in the reply filed on 15 August 2025 were previously acknowledged.
Claims 1-2, 6-7, 13, 17-18, 23-24, 26, 31, 36, 38, 40, 54-55, 64, 68 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 15 August 2025. Currently, only claim 54 remains withdrawn, as the other claims directed to the nonelected invention have since been canceled.
Applicant requested examination of other species, SEQ ID NOs: 2464, 2476, 2512, 2517, 2526, 3778, and 3780-3782, as being associated with editing the elected polymorphic site and further explaining SEQ ID NOs: 2464, 2476, 2512, 2517, and 2526 include the sequence of SEQ ID NO: 3779. Therefore, SEQ ID NOs: 2464, 2476, 2512, 2517, 2526, and 3778-3782 were included in the species election and have been examined on their merits.
Claim Status
Claims 1-2, 6-7, 13, 17-18, 23-24, 26, 31, 36, 38, 40, 55, 64, 68 were previously directed to a nonelected invention and now have been canceled, claims 3-5, 8-12, 14-16, 19-22, 25, 27-30, 32-35, 37, 39, 41-43, 45-53, 56-63, 65-67, 69-73 were previously cancelled, claims 77-80, and 85-95 have been newly canceled.
In total claims 1-43, 45-53, 55-73, 77-80, and 85-95 have been canceled, claim 54 has been withdrawn as being directed to a nonelected invention, claims 44, 54, 74-76, and 81-84 have been amended, and claims 44 and 74-76, and 81-84 have been considered on their merits.
Withdrawn Objections/Rejections
The claim objection of claim 44 has been withdrawn due to Applicant’s amendment to the claim.
The claim rejections under 35 USC 112(a) have been withdrawn due to Applicant’s amendment to the claims.
The claim rejections under 35 USC 112(b) have been withdrawn due to Applicant’s amendment to the claims.
The claim rejections under 35 USC 102(a)(1) have been withdrawn due to Applicant’s amendment to the claims.
The double patenting rejections have been withdrawn due to Applicant’s amendment to the claims. However, a new double patenting rejection has been set forth below.
Claim Objections
This is a new objection necessitated by Applicant’s amendment to the claims.
Claim 81 is objected to because of the following informalities: in the first line of the claim, the word “comprises” should be replaced with “comprising”, for grammatical correctness.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 44 and 74-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,480,140, issue date 25 November 2025.
The patented claims have not yet been published, therefore, the reference claims used will be the latest claims from 17/053,629 dated 15 April 2025.
This is a new rejection necessitated by Applicant’s amendment to the claims and the change in status of the previously utilized reference application 17/053,629. A response to Applicant’s traversal follows the rejection below.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Regarding claims 44 and 74-76, ‘629 claim 1 discloses an isolated gRNA (reads as an RNA molecule) that targets a mutant ELANE allele, wherein the gRNA comprises a CRISPR RNA comprising a nucleic acid sequence of 17-20 contiguous nucleotides set forth in SEQ ID NO: 888 or 889. Reference SEQ ID NO: 889 is 100% identical to instant SEQ ID NO: 3779. The 17-20 contiguous nucleotides of the reference application overlap with the limitations of the instant claims, 20-30 contiguous nucleotides. While the reference claims are silent to the length of the RNA molecule, the reference specification states at paragraph [0100] “In embodiments of the present invention, the first RNA molecule is up to 300 nucleotides in length.” Which read on the limitations of instant claim 44.
The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
Response to Traversal
Applicant's arguments filed 19 March 2026 have been fully considered but they are not persuasive. Regarding the arguments directed to the ‘629 patent not teaching an RNA molecule, while the reference claims may teach a method for inactivating cells, the claim still comprises the RNA molecule. Thus, read on the instant claims.
Regarding the arguments directed to the reference claims not teaching the spacer sequence of 20-30 nucleotides, the reference claims teach the gRNA sequence is 17-20 nucleotides, which overlaps with the claimed 20-30 nucleotides. The instant claim states the spacer sequence contains the nucleotide sequences of the sequences listed, therefore, the guide RNA reads as the spacer sequence.
Regarding the arguments directed to the provisional non-statutory double patenting rejection of co-pending application 17/090,804. This reference application has since been patented and the claims utilized for the rejection have been canceled.
Claims 44 and 74-76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/398,868 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Regarding claims 44 and 74-76, ‘868 claim 1 teaches an isolated guide RNA (gRNA) molecule that targets the mutant ELANE allele, wherein the gRNA comprises a nucleic acid sequence of 17-20 nucleotides set forth in SEQ ID NO: 913, 1046, 1122, or 1190. Reference SEQ ID NO: 913 corresponds to instant SEQ ID NO: 3780, reference SEQ ID NO: 1046 corresponds to instant SEQ ID NO: 3781, reference SEQ ID NO: 1122 corresponds to instant SEQ ID NO: 3778, Reference SEQ ID NO: 1190 corresponds to instant SEQ ID NO: 3782. The 17-20 contiguous nucleotides of the reference application overlap with the limitations of the instant claims, 20-30 contiguous nucleotides. While the reference claims are silent to the length of the RNA molecule, the reference specification states at paragraph [0100] “In embodiments of the present invention, the first RNA molecule is up to 300 nucleotides in length.” Which read on the limitations of instant claim 44.
The Court of Appeals for the Federal Circuit in Pfizer Inc, v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001 at page 1008 (March 2008), indicated that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 81-84 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The sequences in independent claim 81, specifically the amino acid sequence as set forth in SEQ ID NO: 3789 nor the nucleic acid sequences SEQ ID NO: 3790 or SEQ ID NO: 3791 were found in the prior art.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Claims 44 and 74-76 stand rejected.
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.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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