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 compound 30 of Formula (I) as recited in claim 41 in the reply filed on 5/26/26 is acknowledged.
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Claims 1-4, 81-9, 11, 19-20, 26, 30-31, 41 and 44-49 read on the elected species.
Claim 42 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/26.
Claims 5-7, 10, 12-18, 21-25, 27-29, 32-40 and 43 are cancelled.
Priority
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Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/17/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Applicant sequence listing filed 7/19/24 appears to be in accordance with the requirements of 37 CFR 1.821 - 1.825.
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 1-4, 8-9, 11, 19-20, 26, 30-31, 41 and 44-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18730688 in view of Hou et al. (Nature Reviews 2021, volume 6, pages 1078-1094). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending, which shares a common inventor and assignee, is also directed to compounds of the formula:
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And claims the elected compound in claim 29:
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The copending also teaches pharmaceutical compositions with at least pharmaceutically acceptable excipients or diluents (Claim 31), a lipoplex nanoparticle with nucleic acid (Claim 32) and method for delivering a nucleic acid to a cell, tissue, organ, animal or subject (Claim 33). While the copending does not expressly teach that the nucleic acid molecule comprising at least one of RNA and/or at least one DNA molecule in the weight ratios claimed, the scope of the claims includes lipoplexes comprising RNA or DNA [0180]. Regarding the amounts of components, the copending does not expressly teach a composition with about 10% to about 70% or about 20% to about 60% of the compound of Formula (I) by moles or the weight ratio of lipid to nucleic acid in the nanoparticle as claimed. However, it is merely routine optimization to arrive at a composition with about 10% to about 70% or about 20% to about 60% of the compound of Formula (I) by moles or the weight ratio of lipid to nucleic acid in the nanoparticle as claimed. See MPEP 2144.05 (II) (A): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
The copending does not expressly teach that the nanoparticle comprises at least one structural lipid, at least one phospholipid, at least one PEGylated lipid, or any combination thereof; wherein the at least one structural lipid is cholesterol, wherein the at least one phospholipid is dioleoylphosphatidylethanolamine (DOPE) or 1,2-Dioleoyl-sn-glycero-3-phosphocholine (DOPC), and/or wherein the PEGylated lipid is DMG-PEG2000 in the amount found in Table A. However, Hou et al. teach lipid nanoparticle–mRNA formulations typically contain other lipid components, such as phospholipids (for example, phosphatidylcholine and phosphatidylethanolamine), cholesterol or polyethylene glycol (PEG)- functionalized lipids (PEG- lipids) including DOPE (Page 1082, right column, other types of lipid) and DMG-PEG2000 (page 1083, bottom left). Accordingly, the ordinary artisan would add these typical components to make the formulation and optimize the amounts of each to arrive at the claimed molar percentages of the invention with a reasonable expectation of success.
The copending does not expressly teach genetically modifying a liver cell, T-cell or hematopoietic stem cell. However, performing the method of the copending application implicitly modifies a cell. The selection of which cell to genetically modify is at the discretion of the ordinary artisan. The ordinary artisan would do so in order to treat at least one disease or disorder such as, for example, liver disease by genetically modifying a liver cell with a reasonable expectation of success. The ordinary artisan so doing will have the genetically modified liver cell in hand. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 Claim 8 references “Table A”. Table A is found [0250] of the specification and contains 200 examples. MPEP 2173.05(s) applies here because it is more concise to incorporate by reference than duplicate the table into the claim.
Prosecution Insights