DETAILED ACTION
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 in the reply filed on 07/1/2026 is acknowledged.
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 21, 23, 36-37 and 55 are 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.
Claim 21 is drawn to a protein that "consists" of an amino acid sequence having "at least 95% identity with the amino acid sequence as shown in SEQ ID NOs: 11". However, from the use of the close-ended transitional phrase "consists" and the use of the open-ended percent identity to the sequence ("at least 95%"), it is unclear if the sequence that can have the percent identity must be of the same length of the sequence of SEQ ID NOs: 11, or if the percent identity can allow for deletions and/or insertions. It is suggested that the transitional phrase "comprises" be employed instead of "consists" or that the language be clarified such that the percent identity must be tied to a sequence that is the same length of the listed sequence.
Claim 23 is drawn to a protein that "consists" of an amino acid sequence having "at least 95% identity with the amino acid sequence as shown in SEQ ID NOs: 10". However, from the use of the close-ended transitional phrase "consists" and the use of the open-ended percent identity to the sequence ("at least 95%"), it is unclear if the sequence that can have the percent identity must be of the same length of the sequence of SEQ ID NOs: 10, or if the percent identity can allow for deletions and/or insertions. It is suggested that the transitional phrase "comprises" be employed instead of "consists" or that the language be clarified such that the percent identity must be tied to a sequence that is the same length of the listed sequence.
Claim 36 is drawn to a nucleic acid that "consists" of a nucleotide sequence having "at least 95% identity with the sequence as shown in any one of SEQ ID NOs: 9,19, etc….". However, from the use of the close-ended transitional phrase "consists" and the use of the open-ended percent identity to the sequence ("at least 95%"), it is unclear if the sequence that can have the percent identity must be of the same length of the sequence of SEQ ID NOs: 9,19, etc..., or if the percent identity can allow for deletions and/or insertions. It is suggested that the transitional phrase "comprises" be employed instead of "consists" or that the language be clarified such that the percent identity must be tied to a sequence that is the same length of the listed sequences.
Claims 37 and 55 are also rejected because of their dependency to claim 36.
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.
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) 1-19, 28, 38-41, 43, and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koizumi US 20160257951 in view of BIONTECH, "BNT162 COVID-19 Vaccine," Program Update, April 2020, 15 pages and McKAY et al., "Self-amplifying RNA SARS-CoV-2 lipid nanoparticle vaccine induces equivalent preclinical antibody titers and viral neutralization to recovered COVID-19 patients," bioRxiv, doi:https//doi.org/10.1101/2020.04.22.055608, 14 pages; WANG et al., "An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development," Med Sci Monit, May 2020, 26(e924700):1-8.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Koizumi et al. provides a novel cationic lipid that forms a lipid particle in combination with an amphipathic lipid, a sterol, and a lipid reducing aggregation during lipid particle formation [0005].
Koizumi et al. discloses nucleic acid lipid particles containing a nucleic acid that is encapsulated into lipid particles containing a cationic lipid represented by general formula (Ia) (identical to the instant cationic lip of formula (Ia)), and also indicates that: a substance that targets a causative gene of an infectious disease or the like is adopted as said nucleic acid, or an mRNA of a virus or the like corresponds to said nucleic acid; said lipid particles further contain sterols such as cholesterol, an amphiphilic lipid such as a distearoylphosphatidylcholine (DSPC), and a PEG lipid that reduces aggregation when forming lipid particles; and from the viewpoint of translation efficiency, stability, immunogenicity, etc., an mRNA is configured to contain a Cap structure, 5'-UTR, 3'-UTR, Poly A, modified uridine, etc. (claims, paragraphs, [310]-[312], [0320]-[0322], [0338]-[0346], [0362]-[377], examples).
Koizumi et al. discloses wherein the lipid composition of the amphipathic lipid, the sterol, the cationic lipid, and the lipid reducing aggregation during lipid particle formation is 15% or less of the amphipathic lipid, 32% or more of the sterol, 45% to 65% of the cationic lipid, and 1.5% to 3% of the lipid reducing aggregation during lipid particle formation, in terms of molar quantity [0072].
Koizumi et al., discloses the “target gene” is not particularly limited as long as it is RNA in cells, tissues, or individuals to which or to whom this gene is introduced (hereinafter, they may be referred to as “recipients”). The target gene may be mRNA that is translated into a protein or may be non-coding RNA that is not translated into a protein. Examples of the non-coding RNA include functional RNA, for example, an untranslated region of mRNA, tRNA, rRNA, mRNA-like non-coding RNA (mRNA-like ncRNA), long non-coding RNA (long ncRNA), small nuclear RNA (snRNA), small nucleolar RNA (snoRNA), and microRNA (miRNA). Specifically, the target gene may be endogenous to the recipients for introduction or may be exogenous and introduced thereto by an approach such as gene transfer. It may also be a gene present on a chromosome or on an extrachromosomal gene. Examples of the exogenous gene include, but are not limited to, those derived from viruses, bacteria, fungi, and protozoans, which can infect the recipients. The function of the gene may be known or unknown [0362]-[377].
Koizumi et al., discloses wherein the average particle size is approximately 30 nm to approximately 300 nm [0079].
Koizumi et al. does not indicate that a nucleic acid capable of expressing the S protein, and/or a fragment thereof, of the novel corona virus SARS-Co V-2, is the nucleic acid encapsulated into lipid particles.
However, BIONTECH, (pp. 8-13), WANG, F. et al., (abstract, p. 3, fig. 1), and MCKAY, P. F. et al. (abstract, Main, Discussion, page 10 last paragraph), teach a SARS-CoV-2 vaccination in which an RNA, such as an mRNA, for coding the S protein of the SARS-Co V-2 receptor binding region (RBD), is encapsulated into lipid nanoparticles containing lipids such as a cationic lipid.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have conceived of using the a cationic lipid represented by general formula (Ia) of Koizumi et al., and encapsulating a nucleic acid such as mRNA that respectively codes a S protein fragment such as RBD and/or an S protein derived from SARS-CoV-2 or a variant thereof. The motivation is that Koizumi et al. discloses: “The present inventors have conducted diligent studies to obtain a lipid particle consisting of a cationic lipid that can encapsulate therein a nucleic acid such as a double-stranded polynucleotide (e.g., siRNA), DNA, or an antisense oligonucleotide and can be used at a low concentration. As a result, the present inventors have completed the present invention by finding a novel cationic lipid and further finding a nucleic acid lipid particle comprising the novel cationic lipid that can encapsulate therein a nucleic acid molecule, can be used at a low concentration, and permits a high level of delivery into cells” [0005]. Koizumi et al. discloses that the novel lipids useful for preparing nucleic acid lipid particles exhibit strong activity (see for example [0607], [0615], [0640], [0797]). Therefore, one of ordinary skill in the art would have been motivated to modify the primary references in the manner of the claims to achieve the expected benefits, optimizations and/or expanded applications as this is well known practice in the art.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
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 1-19, 28, 38-41, 43, and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36, 38, 40-44, 46-47, and 52-58 of copending Application No. 18/561868 in view of over Koizumi US 20160257951 in view of BIONTECH, "BNT162 COVID-19 Vaccine," Program Update, April 2020, 15 pages and McKAY et al., "Self-amplifying RNA SARS-CoV-2 lipid nanoparticle vaccine induces equivalent preclinical antibody titers and viral neutralization to recovered COVID-19 patients," bioRxiv, doi:https//doi.org/10.1101/2020.04.22.055608, 14 pages; WANG et al., "An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development," Med Sci Monit, May 2020, 26(e924700):1-8.
Both sets of claims are drawn to lipids comprising the formula of la, and particles comprising said lipid. Both sets of claims are drawn to lipid particles which further comprise PEG-lipids, such as PEG-C-DMA, sterols such as cholesterol, amphipathic lipids such as DSPC, and are in the same molar % or ratios to one another. Both claim lipid particles which comprise nucleic acids, such as RNA. Both claim N/P or weight/weight ratios of the overall nucleic acid to overall lipid amount. Both claim the same average particle sizes. Both claim that the lipid particle+nucleic acid are in compositions further comprising pharmaceutically acceptable carriers. The main difference is that the instant claims provide for the nucleic acid to encode an S protein of the SARS-Co V-2 receptor binding region. However, such optimization of the instant claims would be obvious, given the related teachings of over Koizumi US 20160257951 in view of BIONTECH, McKAY et al., and WANG et al. (See 103 rejection above).
This is a provisional nonstatutory double patenting rejection.
Claims 1-19, 28, 38-41, 43, and 45 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 26-29 of U.S. Patent No. 9,803,199 in view of in view of over Koizumi US 20160257951 in view of BIONTECH, "BNT162 COVID-19 Vaccine," Program Update, April 2020, 15 pages and McKAY et al., "Self-amplifying RNA SARS-CoV-2 lipid nanoparticle vaccine induces equivalent preclinical antibody titers and viral neutralization to recovered COVID-19 patients," bioRxiv, doi:https//doi.org/10.1101/2020.04.22.055608, 14 pages; WANG et al., "An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development," Med Sci Monit, May 2020, 26(e924700):1-8.
Both sets of claims are drawn to lipids comprising the formula of la, and particles comprising said lipid. Both sets of claims are drawn to lipid particles which further comprise PEG-lipids, such as PEG-C-DMA, sterols such as cholesterol, amphipathic lipids such as DSPC, and are in the same molar % or ratios to one another. Both claim lipid particles which comprise nucleic acids, such as RNA. Both claim N/P or weight/weight ratios of the overall nucleic acid to overall lipid amount. Both claim the same average particle sizes. Both claim that the lipid particle+nucleic acid are in compositions further comprising pharmaceutically acceptable carriers. The main difference is that the instant claims provide for the nucleic acid to encode an S protein of the SARS-Co V-2 receptor binding region. However, such optimization of the instant claims would be obvious, given the related teachings of over Koizumi US 20160257951 in view of BIONTECH, McKAY et al., and WANG et al. (See 103 rejection above).
Claims 1-19, 28, 38-41, 43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21, 26-29 of U.S. Patent No. 10,533,176 in view of in view of over Koizumi US 20160257951 in view of BIONTECH, "BNT162 COVID-19 Vaccine," Program Update, April 2020, 15 pages and McKAY et al., "Self-amplifying RNA SARS-CoV-2 lipid nanoparticle vaccine induces equivalent preclinical antibody titers and viral neutralization to recovered COVID-19 patients," bioRxiv, doi:https//doi.org/10.1101/2020.04.22.055608, 14 pages; WANG et al., "An Evidence Based Perspective on mRNA-SARS-CoV-2 Vaccine Development," Med Sci Monit, May 2020, 26(e924700):1-8.
Both sets of claims are drawn to lipids comprising the formula of la, and particles comprising said lipid. Both sets of claims are drawn to lipid particles which further comprise PEG-lipids, such as PEG-C-DMA, sterols such as cholesterol, amphipathic lipids such as DSPC, and are in the same molar % or ratios to one another. Both claim lipid particles which comprise nucleic acids, such as RNA. Both claim N/P or weight/weight ratios of the overall nucleic acid to overall lipid amount. Both claim the same average particle sizes. Both claim that the lipid particle+nucleic acid are in compositions further comprising pharmaceutically acceptable carriers. The main difference is that the instant claims provide for the nucleic acid to encode an S protein of the SARS-Co V-2 receptor binding region. However, such optimization of the instant claims would be obvious, given the related teachings of over Koizumi US 20160257951 in view of BIONTECH, McKAY et al., and WANG et al. (See 103 rejection above).
Claims 22 and 24 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEZIA RILEY whose telephone number is (571)272-0786. The examiner can normally be reached 7:30-6:00pm.
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/JEZIA RILEY/Primary Examiner, Art Unit 1681 12 September 2026
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