DETAILED ACTION
Applicants’ arguments, filed 15 January 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Specification – Amendment Entered
The amendment to the specification set forth on 15 January 2026 has been entered as it is a correction of an obvious error.
Reopening of Prosecution
This office action has been made NON-FINAL because it includes a rejection that was not necessitated by amendment of the instant claims or by the submission of an information disclosure statement. Further details regarding this issue are set forth below after the relevant rejection.
Non-Statutory 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 167 and 179 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 180-183, 186, and 189-190 of copending Application No. 18/660,467 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a composition comprising a water-based solution comprising a transfection competent vesicle as well as cargo encapsulated therein. The vesicle comprises DODMA, DOPE, DSPC, and cholesterol in specific amounts. The cargo is a Cas protein and guide RNA. Instant claim 179 recites Cas9, Cas10, Cas11, Cas12, or Cpf1.
The copending claims are drawn to a method of transfection comprising administering water-based solution comprising a transfection competent vesicle as well as cargo encapsulated therein. The vesicle comprises DODMA, DOPE, DSPC, and cholesterol in specific amounts. The cargo is a Cas protein and guide RNA. Copending claim 183 recites Cas9, Cas10, Cas11, Cas12, or Cpf1.
The instant and copending claims differ because the copending claims are drawn to a method of transfection, whereas the instant claims are drawn to a composition for transfection. Nevertheless, the composition used in the method of the copending claims appears to be within the scope of the composition recited by the instant claims. As such, the subject matter of the copending claims appears to effectively anticipate that of the instant claims. This results in a prima facie case of anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The examiner notes the following additional issues related to this rejection.
Rejection Permitted Based Upon Third Sentence of 35 U.S.C. 121: The examiner notes that MPEP 804.01, first paragraph, states the following:
The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. The 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction.
In this case, the copending ‘467 application is not actually a divisional of the instant application. As such, the prohibition against double patenting rejections set forth in 35 U.S.C. 121 is not applicable here.
Rejection is Applicable Because Instant and Copending Applications have the Same Patent Term Filing Date: MPEP 804(I)(B)(1)(b)(ii) states the following:
(ii) Application under examination has the same patent term filing date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted.
In this case, both the instant and copending applications are understood to have a patent term filing date of 9 October 2019. (This patent term filing date is determined based upon priority based upon continuation applications, divisional applications (i.e. 35 U.S.C. 120) and national phase entry but not foreign priority or priority to provisional applications.) As such, the applied provisional non-statutory double patenting rejection has not been withdrawn because it is the only remaining rejection.
Office Action is Non-Final: It is the examiner’s position that the applied provisional non-statutory double patenting is necessitated in view of amendments to the claims of the copending application rather than amendments to the instant claims. This is because, in the amendment on 15 January 2026 in the application file of application 18/660,467, the copending claims were further amendment to include particular features related to the required lipid nanoparticle formulation that are also recited by the instant claims.
It is the examiner’s understanding that a newly applied rejection that is necessitated by amendment to the instant claims may be made final in accordance with MPEP 706.07(a). However, in this case, the newly applied rejection is necessitated by amendment to the copending claims rather than by amendment to the instant claims. This fact pattern does not permit the examiner to make this office action final. As such, this office action has been made NON-FINAL.
Claims 171 and 178 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 180-183, 186, and 189-190 of copending Application No. 18/660,467 in view of Davidson et al. (US 2016/0355796 A1).
The instant claims are drawn to a composition comprising a water-based solution comprising a transfection competent vesicle as well as cargo encapsulated therein. The vesicle comprises DODMA, DOPE, DSPC, and cholesterol in specific amounts. The cargo is a Cas protein and guide RNA. The instant claims recite an acetate buffer and a pH of 4.
The copending claims are drawn to a method of transfection comprising administering water-based solution comprising a transfection competent vesicle as well as cargo encapsulated therein. The vesicle comprises DODMA, DOPE, DSPC, and cholesterol in specific amounts. The cargo is a Cas protein and guide RNA.
The copending claims do not teach the required acetate buffer and are silent regarding the pH.
Davidson et al. (hereafter referred to as Davidson) is drawn to compositions for CRISPR-Cas gene editing, as of Davidson, title and abstract. Davidson teaches the use of lipid nanoparticles, abbreviated as “LNPs”, as of paragraphs 0319-0320. Davidson teaches the use of a sodium acetate buffer in paragraph 0322. Davidson teaches a pH of 4 in paragraph 0368.
Davidson differs from the claimed invention at least because Davidson does not teach DODMA.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the composition used by the copending claims to have been in an acetate buffer and to have had a pH of 4. The composition used in the method of the copending claims is drawn to providing a CRISPR gene editing therapeutic agent for transfection by administration of a lipid nanoparticle comprising said therapeutic agent. The copending claims are silent as to the buffer or the pH of the administered composition. However, Davidson indicates that an acetate buffer and a pH of 4 can be used for administration of a CRISPR therapeutic agent in a lipid nanoparticle. As such, the skilled artisan would have been motivated to have modified the method of the copending claims to have administered the lipid nanoparticle in an acetate buffer with a pH of 4 in order to have predictably achieved transfection with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant has presented arguments in applicant’s response on 15 January 2026. These arguments appear to relate to rejections and objections that have been withdrawn. As such, applicant’s arguments are understood to be moot and will not be addressed substantively.
Terminal Disclaimer
The terminal disclaimer filed on 15 January 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent 11,865,190 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The terminal disclaimer filed on 15 January 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US patent 11,980,673 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Relevant Prior Art – No Rejection
As relevant prior art, the examiner cites Zhang et al. (WO 2018/213726 A1), which was previously cited in the file record. Zhang et al. (hereafter referred to as Zhang) is drawn to compositions and methods for nucleic acid editing, as of Zhang, title and abstract. Zhang teaches nucleic acid editing via CRISPR on page 7, top paragraph. Zhang teaches delivery via lipid nanoparticles on pages 10-11, paragraph 0051, which also indicates that particles used for delivering RNA can also be used for CRISPR materials delivery. Zhang provides teachings regarding the makeup of the lipid nanoparticles as of at least page 130, in which Zhang teaches a nanoparticle comprising cationic lipid, DSPC (distearoyl phosphatidylcholine), cholesterol, and a PEGylated lipid; relevant text has been reproduced below.
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Zhang differs from the claimed invention for at least the following reasons.
First, the above-indicated example of Zhang includes a PEGylated lipid; namely, PEG-C-DOMG. This renders Zhang different from the claimed invention because the instant claims are understood to exclude a PEGylated lipid. See the section entitled “Claim Interpretation” on pages 3-4 of the office action mailed on 15 October 2025. There would have been no motivation for the skilled artisan to have modified Zhang to have removed the indicated PEGylated lipid.
Secondly, the instant claims require that the cationic lipid is DODMA. Zhang does not teach DODMA as the cationic lipid; in contrast, Zhang teaches different cationic lipids.
Third, the instant claims require DOPE. This is not taught by the above example from Zhang (though is taught elsewhere in the broad disclosure of Zhang; namely, as of Zhang, page 137, paragraph 00424).
Fourth, the above-indicated example of Zhang teaches 40 mol% cationic lipid. This exceeds the 20-30 mol% range of cationic lipid DODMA required by the instant claims.
As such, there would have been no motivation for the skilled artisan to have modified the above-indicated example of Zhang (a) to have excluded a PEGylated lipid, (b) to have included both DOPE and DSPC together as helper lipids, let alone in their recited amounts, (c) to have used DODMA instead of the cationic lipids taught by Zhang, and (d) to have reduced the amount of cationic lipid taught by Zhang.
Additionally, the instant application appears to have presented results showing that the use of DODMA results in superior activity of nucleic acid as compared with the different cationic lipid DLinDAP, which was the cationic lipid actually used in the example of Zhang. See the instant specification on page 21, relevant text reproduced below.
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Also see the instant specification on page 22, paragraph 00079.
As such, for at least these reasons, no rejection has been written over Zhang.
The examiner also notes the rationale presented in the notice of allowance mailed on 23 August 2023 in parent application 17/941,669; the reasons presented there are also relevant in regard to the examiner’s decision not to reject the instant claims over prior art.
Conclusion
No claim is allowed.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612