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 .
Filing Receipt and Priority
The filing receipt filed 11/21/2023 states that the instant application is a 371 of PCT/US20/56252, filed 10/19/2020, which claims benefit of 62/923,258, filed 10/18/2019.
The provisional application supports the instant claims. Therefore the instant effective filing date is 10/18/2019.
Response to Amendments
The amendments made to the claims 01/29/2026 have been entered.
Withdrawn Rejections
The 112(d) and 102 rejection made in the office action of 10/01/2025 has been withdrawn.
The nonstatutory double patenting rejection made over co-pending application 18/293,419 has been withdrawn.
New Rejections
Claim Rejections - 35 USC § 112
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 2-3 and 28 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.
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, claim 2 recites the broad recitation “alkoxycarbonyl”, and the claim also recites the limitations “linear alkoxycarbonyl” and “branched alkoxycarbonyl” 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.
As claims 3 and 28 depend on claim 2, they are also rejected.
New Double Patenting Rejections
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.
Copending application 18/695,471
Claims 2-3, 28, and 50 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12, 19, 26, 28, 30, 33, and 37 of copending Application No. 18/695,471 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The references claims are drawn to lipid nanoparticles comprising the following specific compounds of Formula III, shown below.
Formula III
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420
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Reference claim 5 also claims compound C14-4.
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208
560
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Identical compounds are claimed or included in claimed methods in the following copending applications. The above analysis applies to these double patenting rejections.
Copending application 19/119,028
Claims 2-3, 28, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9-10 of copending Application No. 19/199,028 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference application claims lipid nanoparticles comprising an ionizable lipid, a neutral lipid, cholesterol, a polymer, and a cell targeting domain. Reference claim 10 claims compound C14-4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending application 19/288,484
Claim 2-3, 28, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-12 of copending Application No. 19/288,484 (reference application).
Reference application 19/288,484 claims methods comprising administering a lipid nanoparticle comprising an ionizable lipid, a neutral lipid, cholesterol, a polymer, and a cell targeting domain. Reference claim 11 specifies compounds that embrace the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending application 18/695,487
Claim 2-3, 28, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-4 of copending Application No. 18/695,487 (reference application).
The reference application claims a lipid nanoparticle comprising a ionizable lipid compound. Reference claim 4 species compound C14-4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Copending application 18/293,419
Claim 2-3, 28, and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 4 of copending Application No. 18/293,419 (reference application).
The reference application claims a lipid nanoparticle. Reference claim 4 specifies compound C14-4.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Maintained Rejections
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.
Co-pending application 17/769,893
Claims 2-3, 28, and 50 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-4, 8-9, 12, 18-19, 22, 26, 28-30, 33-34, 37, 39, and 46-48 of copending Application No. 17/769,893 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The reference claims are drawn to lipid nanoparticles comprising compounds of Formula III and methods comprising administering the lipid nanoparticles and/or compositions thereof, shown below, which embrace the instant claims.
Formula III
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Specific Compounds
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460
594
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152
602
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538
604
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These compounds embrace the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
Prosecution Insights