DETAILED ACTION
Claims 1-5, 8, 11-12, 17, 20-21, 23-26, 28, 30, 32-34 and 44-45 are currently pending. Claims 6-7, 9-10, 13-16, 18-169, 22, 27, 29, 31, and 35-43 are cancelled.
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 invention Group 1 (claims 1-5, 8, 11-12, 17, 20-21, 23-26, 28, 30, 32-34 and 44-45) in the reply filed on 5/26/2026 is acknowledged.
Election was made without traverse in the reply filed on 5/26/2026.
Priority
Acknowledgement is made of the instant application which claims the benefit of provisional application No. 63/276,233, filed November 5, 2021. Acknowledgment is further made of applicants' claim for foreign priority to EP application 22315065.7, filed March 16, 2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/19/2022, 4/21/2023, 7/25/2024, 6/9/2025 and 5/26/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 30 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.
Claim 30 recites the following:
30. The RSV vaccine of claim 1, wherein the mRNA comprises a nucleic acid sequence with at least 80% identity to a nucleic acid sequence set forth in SEQ ID NO: 6 or SEQ ID NO: 14.
SEQ ID NO:6 is directed to a nucleotide sequence encoding RSV F protein antigen and comprises 1605 nucleotides. It is noted that 80% identity to SEQ ID NO:6 would permit up to 321 nucleotide substitutions, deletions or additions at any location in the nucleotide sequence.
SEQ ID NO: 14 is directed to a nucleotide sequence encoding RSV F protein antigen and comprises 1845 nucleotides. It is noted that 80% identity to SEQ ID NO:14 would permit up to 369 nucleotide substitutions, deletions or additions at any location in the nucleotide sequence.
Thus, claim 30 encompasses a broad range of diverse nucleotide sequences.
Upon review of the specification, the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of the broad range of diverse nucleotide sequences.
In the instant case the only references in the specification to nucleotide sequences encoding RSV F protein antigen are SEQ ID NO: 4, SEQ ID NO:5, SEQ ID NO:6, SEQ ID NO: 12, SEQ ID NO:13 and SEQ ID NO:14 (Specification at paragraphs [0030], [0031], [0172], [0173], [0063] and [0064]). A review of the specification shows that Applicants have not provided sufficient description of the invention to support they were in possession of the broad range of diverse nucleotide sequences encompassed by claim 30 as currently drafted.
Accordingly, the claims are considered to lack sufficient written description and are properly rejected under 35 USC 112, first paragraph.
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 1-5, 8, 11-12, 17, 20-21, 23-26, 28, 30, 32-34 and 44-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-39 of U.S. Patent No. 11,771,653 (“U.S. ‘771”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4, 10 and 28 of US ‘771 claim the following:
A pharmaceutical composition comprising a nucleic acid molecule encapsulated in a lipid nanoparticle (LNP), wherein the LNP comprises: a cationic lipid GL-HEPES-E3-E12-DS-4-E10 at a molar ratio between 35% and 45%, a polyethylene glycol (PEG) conjugated (PEGylated) lipid at a molar ratio between 0.25% and 2.75% wherein the PEGylated lipid is DMG-PEG2000, a cholesterol-based lipid at a molar ratio between 20% and 35% wherein the cholesterol-based lipid is cholesterol, and a helper lipid at a molar ratio of between 25% and 35% wherein the helper lipid is 1,2-dioleoyl-SN-glycero-3-phosphoethanolamine (DOPE), wherein all the molar ratios are relative to the total lipid content of the LNP.
4. The composition of claim 1, wherein the nucleic acid molecule(s) is an mRNA molecule comprising an open reading frame (ORF).
10. The composition of claim 4, wherein the mRNA molecule comprises an open reading frame (ORF) encoding a respiratory syncytial virus (RSV) F protein antigen.
28. The composition of claim 10, wherein the RSV F protein antigen comprises an amino acid sequence with at least 98% identity to SEQ ID NO: 16 or consists of an amino acid sequence of SEQ ID NO: 16.
The following sequence alignment shows that SEQ ID NO:16 of US 11,771,653 (US Application No. 17/810,064) is 100% identical to instant SEQ ID NO:3:
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840
670
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Thus, claim 28 of US ‘771 anticipates instant claims 1, 11-12, 17, 20-21, 23-26 and 44-45.
Claim 29 of US ‘771 reads on instant claim 2
Claim 3 of US ‘771 reads on instant claim 28.
Claims 35-36 of US ‘771 reads on instant claim 5.
Claim 37 of US ‘771 reads on instant claim 8.
Claim 32 of US ‘771 reads on instant claims 30 and 33-34 as SEQ ID NO:19, SEQ ID NO:17, and SEQ ID NO:20 of US ‘771 read on instant SEQ ID NO:10, SEQ ID NO:6 and SEQ ID NO:11, respectively.
Claim 33 of US ‘771 reads on instant claim 4.
Claims 1-5, 8, 11-12, 17, 20-21, 23-26, 28, 30, 32-34 and 44-45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-3, 7, 12, 16, 18-19, 21-22, 28 and 42 of copending Application No. 19/330,237 (reference application, benefit of earlier filing date to provisional Application No. 63/110965, filed 11/6/2020) (“copending ‘237”). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 16 and 28 claim the following:
A pharmaceutical composition comprising a nucleic acid molecule encapsulated in a lipid nanoparticle (LNP), wherein the LNP comprises:
a cationic lipid at a molar ratio between 35% and 45%, a polyethylene glycol (PEG) conjugated (PEGylated) lipid at a molar ratio between 0.25% and 2.75%, a cholesterol-based lipid at a molar ratio between 20% and 35%, and a helper lipid at a molar ratio of between 25% and 35%, wherein all the molar ratios are relative to the total lipid content of the LNP.
16. The composition of claim 1, wherein the nucleic acid molecule(s) is an mRNA molecule comprising an open reading frame (ORF), optionally wherein the mRNA molecule encodes an antigen, optionally a viral antigen or a bacterial antigen.
28. The composition of claim 16, wherein the mRNA molecule comprises an open reading frame (ORF) encoding a respiratory syncytial virus (RSV) F protein antigen, optionally wherein:
the RSV F protein antigen comprises an amino acid sequence with at least 98% identity to SEQ ID NO: 16 or consists of an amino acid sequence of SEQ ID NO: 16;
the RSV F protein antigen is a pre-fusion protein; the mRNA comprises a nucleic acid sequence with at least 80% identity to a nucleic acid sequence set forth in SEQ ID NO: 17;
the mRNA comprises a nucleic acid sequence with at least 80% identity to a nucleic acid sequence set forth in SEQ ID NO: 21; and/or the mRNA comprises of the following structural elements:(i) a 5' cap with the following structure:
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134
382
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(ii) a 5' untranslated region (5' UTR) having the nucleic acid sequence of SEQ ID NO: 19;
(iii) a protein coding region having the nucleic acid sequence of SEQ ID NO: 17;
(iv) a 3' untranslated region (3' UTR) having the nucleic acid sequence of SEQ ID NO: 20;
and(v) a poly(A) tail.
The following sequence alignment shows that SEQ ID NO:16 of copending ‘237 is 100% identical to instant SEQ ID NO:3:
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832
698
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Thus, claim 28 of copending ‘237 anticipates instant claims 1-4, 11-12, 30, and 32.
Claim 28 of copending ‘237 reads on instant claims 30 and 33-34 as SEQ ID NO:19, SEQ ID NO:17, and SEQ ID NO:20 of copending ‘237 read on instant SEQ ID NO:10, SEQ ID NO:6 and SEQ ID NO:11, respectively.
Claim 31 of copending ‘237 reads on instant claims 5 and 8.
Claims 3 and 7 of copending ‘237 read on instant claims 17, 20-21, 23-26, and 33-34.
Claim 12 of copending ‘237 reads on instant claim 28.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
However, it is noted that upon conducting a thorough prior art search, and sequence search for an amino acid sequence with at least 98% identity to SEQ ID NO: 3, none of the references reviewed by the Examiner taught a respiratory syncytial virus (RSV) comprising mRNA having an open reading frame encoding an RSV F antigen protein wherein the RSV F antigen comprises an amino acid sequence with at least 98% identity to SEQ ID NO:3 or consists of an amino acid sequence of SEQ ID NO:3.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to E. YVONNE PYLA whose telephone number is (571)270-7366. The examiner can normally be reached M-F 9am - 6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHRISTOPHER BABIC can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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E. YVONNE PYLA
Primary Examiner
Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633
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