DETAILED ACTION
This office action is in response to the Applicant’s filing dated May 4th, 2026.
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 .
Priority
This application is a 371 of PCT/US22/25074 filed on April 15th, 2022; and has a PRO of 63/316,575 filed on March 4th, 2022, 63/274,171 filed on November 1st, 2021 and 63/176,228 filed on April 17th, 2021.
Status of Claims
Claims 1, 3-6, 8, 10-12, 15-17, 19, 22, 24, 27, 29, 32, 34, 38, 51, 53, 62, 65, 67, 69, 74, 76-77 and 118 are pending in the instant application.
Election/Restrictions
Applicant’s election of Group I in the reply filed on May 4th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 77 and 118 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 4th, 2026.
Applicant’s election of CAS RN: 2415092-81-6 shown below as the ionizable lipid of the pharmaceutical composition in the reply filed on May 4th, 2026 is acknowledged:
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which is a compound of Formula (I) wherein Z1 is C2 alkylene; wherein Z2 is OH; wherein R1 is an unbranched C9 alkyl; wherein X1 is C6 alkylene; wherein X2 is absent; and wherein each R2 is C8 alkoxy. Applicant further elected DSPC as the neutral lipid, cholesterol as the helper lipid and PEG-2K-DMG as the PEG lipid. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
A prior art search was conducted for the elected species.
This search retrieved prior art.
Therefore, the Examiner’s search will not be extended unnecessarily to additional species of Formula (I) in/for/during this Office action.
Claims 1, 3-6, 8, 10-12, 15-17, 19, 22, 24, 27, 29, 32, 34, 38, 51, 53, 62, 65, 67, 69, 74 and 76 read on the elected species and will be examined herein.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-6, 8, 10-12, 15-16, 22, 24, 27, 32, 51, 53, 62, 65, 67, 69, 74 and 76 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parmar et al (WO 2020/072605 A1).
Regarding claims 1, 3-6, 8, 10-12, 15-16, 22, 24, 27, 32, 62, 65, 67, 69, 74 and 76, Parmar teaches Compound 10 shown below (pages 76-77, Example 10; page 135, claim 54, 5th compound):
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Compound 10 is the instantly elected ionizable lipid compound.
Parmer further teaches a lipid nanoparticle (LNP) composition comprising 50% Compound 10 as the ionizable (amine) lipid (pages 113-114, Example 55, Table 10); further comprising 10% DSPC; 38.5% cholesterol and 1.5% PEG-2K-DMG; wherein the concentrations are expressed as mol % (page 103, Example 2, first paragraph; page 107, Example 2, first paragraph). Parmer further discloses the LNP compositions are formulated at a 1:1 w/w ratio of single guide RNA and Cas9 mRNA.
It is noted that the formulation taught by Parmer teaches cholesterol making up 38.5% of the formulation and does not explicitly state the instantly claimed 39%. However, due to the “about” language present in the instant claims being defined in the specification (page 65, lines 16-21) as encompassing up to 25% of a stated reference value in either direction, the 38.5% falls well within the stated reference value of 39% ± 25% and thus anticipates this claim limitation.
Regarding claims 51 and 53, Parmer anticipates claims 1, 3-6, 8, 10-12, 15-16, 22, 24, 27, 32, 62, 65, 67, 69, 74 and 76 as discussed in the above rejection.
Parmer further discloses the LNP composition exhibited a polydispersity (PDI) of 0.049 (page 114, Example 55, Table 10, 6th column) and has a N:P ratio of 6.0 (page 113, Example 55, first paragraph).
Thus, the teachings of Parmer anticipate the composition of instant claims 1, 3-6, 8, 10-12, 15-16, 22, 24, 27, 32, 51, 53, 62, 65, 67, 69, 74 and 76.
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.
Claims 17, 19, 29, 34 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Parmar et al (WO 2020/072605 A1).
Regarding claims 17, 19, 29, 34 and 38, Parmer anticipates claims 1, 3-6, 8, 10-12, 15-16, 22, 24, 27, 32, 51, 53, 62, 65, 67, 69, 74 and 76 as discussed in the above rejection.
Parmer does not teach a composition with the recited concentrations of instant claims 17, 19, 29, 34 and 38.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of each component in the composition comprising Compound 10 taught by Parmer as a starting point for optimizing the composition utilized for genome editing since Parmer teaches the composition comprising Compound 10 is useful for genome editing (page 1, lines 25-28; page 113-114, Example 55; page 144, claim 88) and because dosage and treatment regimen are result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable dosages would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed dosage range, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all of this would result in the composition of instant claims 17, 19, 29, 34 and 38 with a reasonable expectation of success.
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 1, 3-6, 8, 10-12, 15-17, 19, 22, 24, 27, 29, 32, 34, 38, 51, 53, 62, 65, 67, 69, 74 and 76 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61, 65, 68, 71, 74-75, 79 and 87 of copending Application No. 17/282,157 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a Lipid NanoParticle (LNP) composition comprising a lipid component that comprises a compound represented by Formula I of which has significant overlap with the instant claims, specifically see claim 105 of the reference application where the compound claimed is the instantly elected compound CAS RN: 2415092-81-6. The LNP composition of the reference application further comprises a neutral lipid, a helper lipid and a PEG lipid in the lipid component; as well as a nucleic acid component, comprising a Cas nuclease mRNA and gRNA; all of which are present in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 3-6, 8, 10-12, 15-17, 19, 22, 24, 27, 29, 32, 34, 38, 51, 53, 62, 65, 67, 69, 74 and 76 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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