DETAILED ACTION
Claims 1-19 are currently pending in the instant application. Claims 1-7 and 9-13 are rejected. Claims 8 and 13 are objected. Claims 14-19 are withdrawn from consideration as being for non-elected subject matter.
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 I and the species:
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in the reply filed on 13 February 2026 is acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been extended to the entirety of Group I.
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.
Claim 1-7 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-12 of copending Application No. 19/011,725 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claims 7-12 are process claims for preparing formula 3, such as the compound 3-6 in conflicting claim 12:
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which is identical to and anticipates applicant’s instant elected species:
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-7 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19/181,743 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are drawn to lipid compositions and methods of use wherein the lipid compositions comprise an ionizable lipid which is a compound, such as in conflicting claim 7:
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. The compound in conflicting claim 7 is identical to and anticipates applicant’s instant elected species:
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 13 is objected to because of the following informalities: For the sake of clarity, claim 13 should be written as “A compound selected from the group consisting of:
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,……, and
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, or a salt thereof. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, the possible substituents on the possible aryl group substitution on the hydrocarbon groups represented by R63, R64, R65, and R66, which are found in the definition of R57 is amended in the claims filed 1/6/2025 to be:
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wherein “(hydrocarbon group having 1 to 12 carbon atoms)-R67” is amended to “a hydrocarbon group having 1 to 12 carbon atoms.” There is no written description found in the originally filed application for what -R67 is, nor is there any written description for the aryl group in the above definition to be substituted with “a hydrocarbon group having 1 to 12 carbon atoms” without a -R67 substituent. Amending the above paragraph to delete the -R67 from the hydrocarbon substituent is considered new matter. It is suggested that “a hydrocarbon group having 1 to 12 carbon atoms” be deleted from this definition.
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.
Claim 2-4 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. Specifically, claims 2-4 define certain variables with the phrase “as described above”. This renders the claims indefinite as “above” could reference in the claim or a claim before the claim at issue. Instant claim 1 defines R58 as:
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. Instant claim 2 defines R58 as:
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while also defining R58 “as described above”. It is therefore unclear if R58 in:
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of claim 2 is a hydrocarbon group of 1 to 12 carbon atoms or of 1 to 8 carbon atoms. Claim 3 defines R58 as:
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multiple times in the claim and also states:
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which renders claim 3 indefinite as it is unclear what the definitions of R53, R54, R55 and R58 are as these variables are defined differently in multiple instances “above”
Claim 4 has:
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which renders the claim indefinite as R58 is defined multiple ways “above” so it is unclear what R58 is.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 6, 7, and 9-12 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, claims 1 and claim 8 from which claims 4, 6, 7, and 9-12 ultimately depend are drawn to “A compound or a salt thereof”. Instant claims 4, 6, 7 and 9-12 are drawn to “The compound and a salt thereof” which is a mixture of a compound and a salt, whereas the ultimate parent claims are drawn to a compound or a salt. Therefore, claims 4, 6, 7, and 9-12 fail to limit the subject matter of the claim upon which they depend. It is suggested to amend claims 4, 6, 7, and 9-12 to read on “A compound or a salt thereof.” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 16 April 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
Prosecution Insights