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, filed 04/18/2022 is a National Stage entry of PCT/US20/56255, International Filing Date: 10/19/2020. PCT/US20/56255 Claims Priority from Provisional Application 62916942, filed 10/18/2019.
Status of Claims
Claims 1-4, 8-9, 12, 18-19, 22, 26, 28-30, 33-34, 37, 39, and 45-46 are pending as of the response filed on 10/20/25. Claims 5-7, 10-11, 13-17, 20-21, 23-25, 27, 31-32, 35-36, 38, and 40-44 have been canceled.
Applicant’s election without traverse of invention I, claims 1-4, 8-9, 12, 18-19, 22, and 26; and the species C14-4, shown below, in the reply filed on 10/20/25 is acknowledged:
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.
Claims 28-30, 33-34, 37, 39, and 45-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/20/25.
The elected species C14-4 has been found to be free of the prior art. Therefore, in accordance with MPEP 803.02, search and examination have been extended to another species of formula (I), the compound C12-200:
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. This compound is included within formula (I), having A1 and A2=N; L1, L6=N; R8a, R8b, R9a, R9b, R10a, R10b, R11a, and R11b=hydrogen; x, w=0; o, p, q, r, s, t=0; L3, L4=CH2; n, u=1; R4a, R4b, R15a, R15b=hydrogen; R1=C12 alkyl substituted with hydroxyl; R2=ethyl substituted with N(2-hydroxyldodecane)2; R17=2-hydroxyldodecane; R18=2-hydroxydodecane. This compound is also included within formula (IV) of claim 2, having r, s, and t =2; R1, R2, R3, R4, R5=hydrogen; m, n, o, p, and q=9. This species is included within claims 1-2, 4, 8-9, 12, 18-19, 22, and 26.
Claims 1-4, 8-9, 12, 18-19, 22, and 26 were examined and are rejected.
Claim Rejections-35 USC § 103
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.
Claim(s) 1-2, 4, 8-9, 12, 18-19, 22, and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frederick, WO 2017120612 A1, publ. 7/13/2017, international filing date 1/10/2017, as evidenced by PubChem, CID 49785165, Nat. Lib. Med., publ. 12/6/2010.
Frederick teaches compositions comprising one or more therapeutic polynucleotides, in particular mRNAs that encode a binding molecule, e.g., an antibody or antigen binding portion thereof, which specifically binds to cytotoxic T-lymphocyte associated protein-4 (CTLA-4) (title & abstract; para [0007], [0017], [0114]). CTLA-4 is an inhibitory checkpoint receptor, and blockade of this receptor is a therapeutic approach in a broad range of malignancies by promoting T-cell activation (para [0002-0004]). Frederick further teaches an embodiment wherein the mRNAs encoding the antibody or antigen binding portion are chimeric (para [0024], [0032], [0166], [0235], [0282]); Frederick additionally teaches the mRNAs formulated with a delivery agent, with a lipid nanoparticle exemplified (para [0024], [0033], [0167], [0238], [0468]). The mRNAs are taught to be enclosed, surrounded, or encased within the delivery agent (para [0569]). The nanoparticles are taught to comprise at least one lipid, with C12-200 exemplified within a small, defined list as a lipid (para [0033], [0167], [0238], [0474], [0476]). C12-200 has the following chemical structure, as evidenced by PubChem:
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. This compound is included within formula (I), having A1 and A2=N; L1, L6=N; R8a, R8b, R9a, R9b, R10a, R10b, R11a, and R11b=hydrogen; x, w=0; o, p, q, r, s, t=0; L3, L4=CH2; n, u=1; R4a, R4b, R15a, R15b=hydrogen; R1=C12 alkyl substituted with hydroxyl; R2=ethyl substituted with N(2-hydroxyldodecane)2; R17=2-hydroxyldodecane; R18=2-hydroxydodecane. This compound is also included within formula (IV) of claim 2, having r, s, and t =2; R1, R2, R3, R4, R5=hydrogen; m, n, o, p, and q=9. Frederick further teaches an example wherein the lipoparticles also comprise cholesterol (para [0483-0484]), thereby meeting the limitation of a helper lipid as recited by claims 8-9. Frederick teaches an embodiment wherein the mRNAs encode a tumor antigen (para [0136]). The inclusion of one or more additional therapeutic agents, including therapeutic nucleic acids, is taught (para [0533], [0660]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at an LNP comprising at least one mRNA molecule and at least one compound of formula (I), C12-200, wherein the mRNA encodes a CAR, in view of Frederick. As discussed above, Frederick teaches compositions comprising mRNAs that encode an antibody or antigen which specifically binds to the CTLA-4 receptor, wherein LNPs are exemplified as delivery vehicles for the mRNAs, and wherein the mRNAs are enclosed within the LNPs. Frederick further exemplifies the lipid C12-200 for the LNPs, and that the mRNAs encoding the antibody or antigen binding portion are chimeric. Additionally, an embodiment wherein the mRNAs encode a tumor specific antigen is taught. As such, one of ordinary skill in the art would have arrived at the LNP composition of the claims by routine experimentation, in consideration of the guidance provided by Frederick, and have had a reasonable expectation of success. Regarding instant claim 26, it is noted the recitation of the composition being a vaccine is optional, therefore the teachings of Frederick meet this limitation.
Claim Rejections-Nonstatutory 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, 12, 18-19, 22, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12, 19, 26, 28, 30, and 37 of copending Application No. 18695471 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a lipid nanoparticle (LNP) comprising a lipid selected from formula (I), (II), (III), (IV), (V), (VI), and (VII) and at least one mRNA molecule, wherein the mRNA molecule encodes a CAR. Formulas (I), (II), (III), (IV), (V), (VI), and (VII) are substantially similar between the copending and instant claims. See copending claims 1-3, 26, and 30; and instant claims 1-2.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 8-9, 12, 18-19, 22, and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-6, 8-9, 11-13, 18-19, 20-21, 24-26, and 28 of copending Application No. 17769858 (reference application) in view of Frederick, WO 2017120612 A1, publ. 7/13/2017, international filing date 1/10/2017. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a lipid nanoparticle (LNP) comprising a lipid selected from formula (I), (II), (III), (IV), (V), (VI), and (VII) and at least one mRNA molecule. Formulas (I), (II), (III), (IV), (V), (VI), and (VII) are substantially similar between the copending and instant claims. See copending claims 1-3, 5, and 21-22; and instant claims 1-2. Although the copending claims don’t explicitly recite wherein the mRNA encodes a CAR as required by the instant claims, such a modification would have been prima facie obvious in consideration of Frederick. Frederick teaches compositions comprising one or more therapeutic polynucleotides, in particular mRNAs that encode a binding molecule, e.g., an antibody or antigen binding portion thereof, which specifically binds to cytotoxic T-lymphocyte associated protein-4 (CTLA-4) (title & abstract; para [0007], [0017], [0114]). CTLA-4 is an inhibitory checkpoint receptor, and blockade of this receptor is a therapeutic approach in a broad range of malignancies by promoting T-cell activation (para [0002-0004]). Frederick further teaches an embodiment wherein the mRNAs encoding the antibody or antigen binding portion are chimeric (para [0024], [0032], [0166], [0235], [0282]); Frederick additionally teaches the mRNAs formulated with a delivery agent, with a lipid nanoparticle exemplified (para [0024], [0033], [0167], [0238], [0468]). The mRNAs are taught to be enclosed, surrounded, or encased within the delivery agent (para [0569]). One of ordinary skill in the art would have been motivated to have modified the LNP of the copending claims by having the mRNA encode a CAR, CTLA-4 as Frederick teaches LNPs comprising a mRNA that encode a chimeric antigen receptor to be known in the art as therapeutic agents, and have had a reasonable expectation of success. As such, the instant and copending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Information Disclosure Statements
The IDS filed on 11/16/22, 1/17/24, 1/30/25, and 9/25/25 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627