DETAILED ACTION
Claims 1, 3-8, 20, 25, 27, 31-35, 39, 40, 47 and 48 are currently pending in the instant application. Claims 1, 3, 5, 20, 25, 27, 31-34, 39, 40, and 47 are rejected. Claims 4, 6-8, 35 and 48 are objected.
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 8 December 2025 has been previously acknowledged.
The entirety of the pending claims has been searched and examined.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 8 May 2026 have been fully considered and entered into the instant application.
Applicant’s amendment has overcome the 35 USC 112 rejections of claims 32, 33-35, 39 and 40.
As US Patent Application NO. 19/923,839 has been amended to remove all references to HEP-E4-E10 and HEP-E3-E10, the provisional double patenting rejection is withdrawn.
In regards to the provisional double patenting rejection over US Patent Application N. 17/522,754, as the application has now issued as US Patent No. 12,576,030, the rejection is now no longer provisional. Applicant argues that the instant application is “first filed” subject matter based on patent term filing date and that the instant claims cannot be construed as a “second” patentably indistinct invention that would effectively extend the life of the subject matter of the ‘030 patent citing Acadia Pharms Inc. v. Aurobindo Pharma Ltd., 706F. Supp. 2d 477, 487 (D.Del. 2023) and also citing Ex parte Baurin et al., Appeal 2024-002920 (PTAB No. 6, 2024).
This argument is not persuasive as patent term is only one aspect of terminal disclaimers where the other major aspect is to avoid the potential for harassment of an accused infringer by multiple parties with patents covering the same patentable invention. Terminal disclaimers are filed for the purpose of preventing the prolongation of monopoly for patentably indistinct inventions and to enforce the covenant against dual ownership. See 37 CFR 1.321(c)(3). The doctrine of nonstatutory double patenting also seeks to prevent the possibility of multiple suits against an accused infringer by different assignees of patents claiming patentably indistinct variations of the same invention. In re Van Ornum, 686 F.2d 937, 944-48, 214 USPQ 761, 767-70 (CCPA 1982). The submission of a terminal disclaimer in compliance with 37 CFR 1.321(c) or (d) to overcome a double patenting rejection ensures that a patent owner with multiple patents claiming obvious variations of one invention retains all those patents or sells them as a group. Van Ornum, 686 F.2d at 944-45, 214 USPQ at 767. See MPEP 804.
In regards to the arguments citing Ex Parte Baurin, the fact pattern of the cited Ex Parte Baurin differs from that of the instant claims because the application under examination in Baurin has a known expiration date due to Terminal Disclaimers filed which render the application’s expiration date necessarily earlier than any possible expiration date of the reference patent(s) for which the NSDP rejections were successfully appealed. Furthermore, there are considerations beyond unjust-extension concern:
“There are at least two reasons for insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection in an application subject to a 20-year term under 35 U.S.C. 154(a)(2). First, 35 U.S.C. 154(b) includes provisions for patent term adjustment based upon prosecution delays during the application process. […] Second, 37 CFR 1.321(c)(3) requires that a terminal disclaimer filed to obviate a nonstatutory double patenting rejection based on commonly owned conflicting claims include a provision that any patent granted on that application be enforceable only for and during the period that the patent is commonly owned with the application or patent which formed the basis for the rejection.”(MPEP 804.02(VI)).
Additionally, the examiner is unaware of any official guidance regarding the cited decision in Ex Parte Baurin. Accordingly, while said decision is carefully considered and compared to the fact pattern of the instant case, it is not considered as binding precedent.
In regards to the provisional double patenting rejections over US Patent Application No. 18/552,165, US Patent Application 18/575,019, US Patent Application 18/661,393, and US Patent Application 18/847,135, applicant sites MPEP 804:
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.As the provisional nonstatutory double patenting rejections are not the only rejections remaining, the rejections are maintained.
As there are pending rejections, claims 4, 608, 35 and 48 are objected.
Claim Objections
Claims 4, 6-8, 35 and 48 are 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.
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, 5, 20, 25, 27, 31-34, 39, 40, and 47 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-23 of U.S. Patent No. 12,576,030. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are claiming a composition comprising an nRNA encapsulated in a lipid nanoparticle wherein the lipid nanoparticle comprises HEP-E3-E10 or HEP-E4-E10 (conflicting claims 1-2) wherein the lipid nanoparticle further comprises a non-cationic lipid and a PEG-modified lipid (conflicting claim 3) and a cholesterol-based lipid (conflicting claim 4). Conflicting claims 19 and 20 are methods utilizing the composition of conflicting claim 1. In regards to instant claims 20 and 25, R1 which is further defined, is not required to be present on the formula (I’), therefore, claims 20 and 25 are included in the rejection as R can be (ii). HEP-E4-E10 is:
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HEP-E3-E10 is
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. HEP-E4-E10 and HEP-E3-E10 corresponds to the instant claims, for example; in formula
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each R is (ii)
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; R2 is alkyl, specifically,
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; a is 3 for compound HEP-E3-E10 and a is 4 for compound HEP-E4-E10; A1 is
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; and Z1 is
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. HEP-E3-E10 corresponds to compound A9 in Table A (instant claim 32):
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and corresponds to the first compound in claim 47. HEP-E4-E10 corresponds to compound A17 in Table A (instant claim 32):
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Methods of use conflicting claims anticipate the products utilized, which in this case is HEP-E4-D10 and HEP-E3-E10 and the compositions comprising HEP-E4-D10 and HEP-E3-E10.
Claims 1, 3, 5, 20, 25, 27, 31-34, 39, 40, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 54, 56, 77, 84, 85, 124, and 135 of copending Application No. 18/552,165 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because conflicting claim 54 claims a lipid nanoparticle comprising a cationic lipid, a non-cationic lipid, a PEG-modified lipid and a cholesterol-based lipid wherein the cationic lipid is HEP-E3-E10 or HEP-E4-E10 (conflicting claim 56). The additional conflicting claims claim compositions and formulations of the lipid nanoparticle, kits comprising the lipid nanoparticle, and methods of utilizing the lipid nanoparticle. Methods of use conflicting claims anticipate the products utilized, which in this case is HEP-E4-D10 and HEP-E3-E10 and the compositions comprising HEP-E4-D10 and HEP-E3-E10. In regards to instant claims 20 and 25, R1 which is further defined, is not required to be present on the formula (I’), therefore, claims 20 and 25 are included in the provisional rejection as R can be (ii). Please see the above nonstatutory double patenting rejection as being unpatentable over Patent No. 12,576,030 for the discussion relevant to HEP-E3-E10 and HEP-E4-E10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 3, 5, 20, 25, 27, 31-34, 39, 40, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-12, 17-18, 20-24, 26-27, 29, 34-38, 47, 58-61, 67-70, and 72-75 of copending Application No. 18/575,019 (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 compositions comprising a lipid nanoparticle (conflicting claim 1) wherein the lipid nanoparticle comprises one or more cationic lipids, one or more non-cationic lipids, and one or more PEG-modified lipids (conflicting claim 34) wherein the cationic lipid can be HEP-E3-E10 or HEP-E4-E10 (conflicting claim 35) wherein the lipid nanoparticle further comprises one or more cholesterol-based lipids (conflicting claim 38). Conflicting claims 58-61, 67-71 and 72-75 are methods which utilize the lipid nanoparticle. Methods of use conflicting claims anticipate the products utilized, which in this case is HEP-E4-D10 and HEP-E3-E10 and the compositions comprising HEP-E4-D10 and HEP-E3-E10. In regards to instant claims 20 and 25, R1 which is further defined, is not required to be present on the formula (I’), therefore, claims 20 and 25 are included in the provisional rejection as R can be (ii). Please see the above nonstatutory double patenting rejection as being unpatentable over Patent No. 12,576,030 for the discussion relevant to HEP-E3-E10 and HEP-E4-E10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 5, 20, 25, 27, 31, 32, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 9-10, 13-14, 18, 20, 22, 38-39, 46, 49-51 and 64 of copending Application No. 18/661,393 (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 methods of treating primary ciliary dyskinesia (PCD) by administering an mRNA wherein the mRNA is encapsulated in a liposome (conflicting claim 20) which comprises one or more cationic lipids, one or more non-cationic lipids, and one or more PEG-modified lipids (conflicting claim 20), wherein the cationic lipid can be HEP-E4-E10 or HEP-E3-E10 (conflicting claim 22). Methods of use conflicting claims anticipate the products utilized, which in this case is HEP-E4-D10 and HEP-E3-E10 and the compositions comprising HEP-E4-D10 and HEP-E3-E10. In regards to instant claims 20 and 25, R1 which is further defined, is not required to be present on the formula (I’), therefore, claims 20 and 25 are included in the provisional rejection as R can be (ii). Please see the above nonstatutory double patenting rejection as being unpatentable over Patent No. 12,576,030 for the discussion relevant to HEP-E3-E10 and HEP-E4-E10.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 20, 25, 27, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, and 9 of copending Application No. 18/847,135(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 compounds of the formula (I’z):
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wherein A1 and Z1 are different (conflicting claim 1), compounds of the formula (III’z)
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wherein RA, RB, RC, and RD are not all identical (conflicting claim 3), compounds of the formula (Iaz)
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wherein A1 and Z1 are different, compounds of the formula (IIIaz):
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wherein RA, RB, RC and RD are not all identical, with specific compounds found in claims 9 and 20 such as:
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, A3-A6, and A8 which correspond to the instant formula
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wherein A1 is
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, Z1 is -S-S-; a is 3 or 4; and each R is (ii)
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wherein R2 is optionally substituted alkyl or optionally substituted alkenyl. In regards to instant claims 20 and 25, R1 which is further defined, is not required to be present on the formula (I’), therefore, claims 20 and 25 are included in the provisional rejection as R can be (ii).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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 ____________________ 3 August 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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