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 with traverse of Group I, claims 1-17 and 19 drawn to an immunogenic composition and a kit comprising the composition, and further election of 2’-deoxy-7-deazaguanosine as a species of a modified nucleoside, in the reply filed on 09/11/2025 is acknowledged.
The traversal is on the grounds that: the Examiner has erroneously assessed whether the claims share a general inventive concept as required by PCT Rules 13.1 and 13.2.
This is not found persuasive because: as indicated in the Restriction Action more completely, the invention of Group 2 (claims 21 and 22) recites a method for stimulating an immune response against SARS-CoV-2 in a mammalian subject, wherein the first step of the claimed method requires administration of a composition to a mammalian subject. Such element, of a mammalian subject, is not present in the invention of Group 1. Accordingly, the requirement is still deemed proper and is therefore made FINAL.
Claims 21 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 1-17 and 19 are under examination on the merits.
Priority
Applicant’s claim for domestic benefit of prior-filed provisional application No. 62/983,737 filed on 03/01/2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 04/04/2023, and 09/11/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
It is noted that no Drawings were filed with instant application.
Specification
The use of the term “MF59” on page 12, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that “MF59” is merely an example and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed. Other examples of improper uses include “AS03” and “AS04”, however, others will be identified by Applicant.
Claim Objections
Claim 12 is objected to because of the following informalities:
The recitation on claim 12 of “wherein the SARS-CoV-2 antigen comprises a truncated, recombinant S protein devoid of signal peptide, transmembrane, and cytoplasmic domains of a full length S protein” should read “wherein the SARS-CoV-2 antigen comprises a truncated, recombinant S protein devoid of a signal peptide, transmembrane, and cytoplasmic domains of a full length S protein.” Appropriate correction is required.
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 8-12, 17 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 8, as amended and submitted on 04/06/2023 recites “wherein the immunogenic composition comprises from about 750 µg to about 3000 µg of the oligonucleotide”. This recitation is unclear because the amounts of oligonucleotide in a composition, such as an immunogenic composition, are expressed as concentrations, for example micrograms per milliliter (µg/mL). The above recitation seemingly indicates absolute amounts of oligonucleotide, and therefore it is not clear if these amounts refer to levels of oligonucleotide in an immunogenic composition or not. It is noted that prior to the amendment claim 8 recited “a 0.5 ml dose”. Therefore, the claim is indefinite. The dependent claims 9-12 do not add clarity and therefore they are also indefinite. For purposes of compact prosecution and applying prior art, claim 8 was interpreted herein as referring to concentrations of micrograms per milliliter of an immunogenic composition (µg/mL).
Claim 17, as amended and submitted on 04/06/2023 recites “wherein the immunogenic composition comprises from about 0.05 mg to about 0.50 mg of Al+3”. This recitation is unclear because the amounts of a compound comprising an aluminum salt (as recited in claim 15) in a composition, such as an immunogenic composition, are expressed as concentrations, for example milligrams per milliliter (mg/mL). The above recitation seemingly indicates absolute amounts of a compound comprising an aluminum salt and therefore it is not clear if these amounts refer to levels of a compound comprising an aluminum salt in an immunogenic composition or not. It is noted that prior to the amendment claim 17 recited “a 0.5 ml dose”. Therefore, the claim is indefinite. For purposes of compact prosecution and applying prior art, claim 17 was interpreted herein as referring to concentrations of milligrams per milliliter of a compound comprising an aluminum salt in an immunogenic composition (mg/mL).
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this Office Action. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office Action.
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.
Claims 1-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over PG Pub US 2006/0257852 A1 to Rappuoli et al. published on 11/16/2006 (cited in Applicant’s IDS submitted on 01/14/2023), in view of Wu F, et al. “A new coronavirus associated with human respiratory disease in China” (Nature. 2020;579(7798):265-269) published 02/03/2020 (cited in Applicant’s IDS submitted on 01/14/2023) and US patent No. 7,745,606 B2 to Dina et al. from 06/29/2010 (See PTO-892: Notice of References Cited).
See claims 1-17 and 19 as submitted on 04/06/2023.
Regarding claim 1, Rappuoli et al. teach immunogenic compositions comprising SARS virus antigens (¶¶ [0008], [0122], [0560]-[0561]) and immunostimulatory oligonucleotides such as a TLR9 agonist comprising a single stranded, unmethylated CpG motif (¶¶ [0879]-[0881]).
Rappuoli et al. do not explicitly teach an immunogenic compositions comprising specifically a SARS-CoV-2 antigen. Further, Rappuoli et al. do not explicitly teach a TRL9 agonist wherein the is an oligonucleotide of from 10 to 35 nucleotides in length.
However, Wu et al. teach the full genomic sequence of SAR-CoV-2 comprising antigenic sequences including the RBD region of SARS-CoV-2 S protein (Abstract, pages 265-267).
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Dina et al. teach compositions comprising a viral antigen, and immunomodulatory polynucleotides, such as SEQ ID NO: 102, which is 13 nucleotides in length and shares 100% identity with instant SEQ ID NO: 3 (10 nucleotides in length) (column 14, lines 17-31, and column 10, line 16, column 20) for the benefit of an enhanced immune response (column 6). See alignment below (Qy is instant SEQ ID NO: 3; Db is Dina et al.’s SEQ ID NO: 102).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have incorporated the SARS-CoV-2 sequences of Wu et al. and the immunomodulatory polynucleotides as taught by Dino et al. into the immunogenic compositions taught by Rappuoli et al. for the benefit of formulating a vaccine composition against SARS-CoV-2 for an enhanced immune response. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in incorporating he SARS-CoV-2 sequences of Wu et al. and the immunomodulatory polynucleotides as taught by Dino et al. into the immunogenic compositions taught by Rappuoli et al. given that the methods of formulating vaccine compositions comprising viral sequences and known immunomodulatory polynucleotides such as TLR9 agonists are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 2, as indicated above the immunogenic composition of claim 1, wherein the oligonucleotide comprises instant SEQ ID No: 3 was rendered obvious by the teachings of Rappuoli et al., Wu et al. and Dina et al. (see alignment above).
Regarding claim 3, Dina et al. further teach a polynucleotide, SEQ ID NO: 1, which is 22 nucleotides in length and shares 100% identity with instant SEQ ID NO: 1 (22 nucleotides in length) (column 64, page 81). See alignment below (Qy is instant SEQ ID NO: 1; Db is Dina et al.’s SEQ ID NO: 1).
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Regarding claims 4-6, Rappuoli et al. further teach the immunostimulatory oligonucleotides such as a TLR9 agonist comprising a single stranded, unmethylated CpG motif bear modifications such as phosphorothioate modifications (linkages, as recited in claim 6) or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (relevant to claim 4) (¶¶ [0879]-[0881]).
Regarding claims 7 and 8, Rappuoli et al. further teach the immunostimulatory oligonucleotides are single-stranded oligodeoxynucleotides or CpG ODNs (¶ [0881) wherein the dose can be adjusted to reach a suitable concentration, as determined by techniques accepted and routine in the art (¶ [1124]). Rappuoli et al. further teach concentrations on the order of 5 to 20 µg of recombinant Spike antigen, alone or mixed with an equal volume of adjuvant, in 100 µl of the composition (¶ [1532]). These amounts are equivalent to 50 µg/mL to 200 µg/mL. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See MPEP 2144.05.01. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Further, the range recited in claim 8 is considered to be one determined by routine optimization according to one of skill in the art in view of the teachings of Rappuoli et al. (¶ [1532]).
Regarding claims 9 and 10, Rappuoli et al. further teach inactivated whole SARS-CoV virus, wherein the SARS-CoV virus is inactivated by treatment with formalin or ultraviolet light (¶ [0559]-[0561]). As indicated above, Wu et al. specifically teach a SARS-CoV-2 virus (Abstract, pages 265-267).
Regarding claim 11, as indicated above, Wu et al. specifically teach a SARS-CoV-2 virus, comprising antigenic sequences including the RBD region of SARS-CoV-2 S protein (Abstract, pages 265-267).
Regarding claim 12, as indicated above, Wu et al. further teach a recombinant truncated SARS-CoV-2 S fragment comprising the RBD domain of the spike protein only (page 270), wherein the RBD domain lacks other regions of a spike protein such as a signal peptide and/or a transmembrane domain, and/or a cytoplasmic domain (page 270, Fig. 7).
Regarding claim 13, Rappuoli et al. further teach compositions comprising one or more SARS-CoV antigens, including a membrane (M) protein, a nucleocapsid (N) protein, and an envelope (E) protein (¶ [0657]). As indicated above, Wu et al. specifically teach the full genomic sequences of SARS-CoV-2 virus, including a membrane (M) protein, a nucleocapsid (N) protein, and an envelope (E) protein. (Abstract, pages 265-267).
Regarding claims 14-17, Rappuoli et al. further teach compositions further comprise an aluminum salt adjuvant, such as aluminum hydroxide (¶¶ [0011], [0914]). Rappuoli et al. do not explicitly teach the concentration of the aluminum salt present in the composition. However, the use of such compounds in compositions is well known and routine in the art, see Rappuoli et al. (¶ [0914]). Accordingly, the range recited in claim 17 is considered to be one determined by routine optimization according to one of skill in the art in view of the teachings of Rappuoli et al. (¶ [0914]).
Regarding claim 19, the immunogenic composition of claim 1 was rendered obvious by the teachings of Rappuoli et al., Wu et al. and Dina et al. Rappuoli et al. further teach kits comprising the SARS composition and instructions for administration to humans to induce an immune response, including intramuscular administration (¶¶ [0181], [0028] and [0862]).
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 1-17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,684,669 B2 to Meinke et al. in view of Rappuoli et al. (US 2006/0257852 A1, “Rappuoli et al.”). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a immunogenic composition comprising a SARS-CoV-2 antigen and an oligonucleotide.
See claims 1-17 and 19 as submitted on 04/06/2023.
Regarding the instant claims, the patented claims are directed to a SARS-CoV-2 immunogenic composition comprising an inactivated SARS-CoV-2 whole virus particle comprising a particular sequence, a CpG-containing oligodeoxynucleotide consisting of SEQ ID NO: 4 (which is identical to instant SEQ ID NO: 1 and contains instant SEQ ID NO: 3), and an adjuvant comprising an aluminum salt. The instant claims differ from the patented claims in that instant claim 1 does not recite a whole virus nor a particular sequence for the SARS virus. In that respect, the patented claims are a species that anticipates the instantly claimed genus. Other limitations shared between the two sets of claims are CpG-ODN (relevant to instant claim 7), amounts of oligonucleotide in a composition (relevant to instant claims 8), virus inactivation (relevant to instant claims 9 and 10) aluminum hydroxide adjuvant and amounts thereof (relevant to instant claims 14-17) and a kit comprising the immunogenic composition(relevant to instant claim 19).
The patented claims do not specify unmethylated, single stranded, CpG with phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (relevant to instant claims 1, 4, 5, 6, 7). However, as explained above Rappuoli et al. teach immunogenic compositions of inactivated, whole SARS virus vaccines (¶¶ [0008], [0122], 0560]-[0561]) and immunostimulatory oligonucleotides such as single stranded, unmethylated CpG directed to TLR9, wherein the CpG has phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (¶¶ [0879]-[0881]).
It would have been prima facie obvious to one of ordinary skill in the art to have claimed these embodiments in the patent in view of the teachings of Rappuoli et al. One of ordinary skill in the art would have had been motivated to do so and would have had reasonable expectation of success in including the teachings of Rappuoli et al. to the immunogenic composition of the patent since Rappuoli et al. already teach that the compositions for SARS may be adapted for emerging strains of coronavirus and emerging strains of SARS (¶ [0961]).
Claims 1-17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6 of U.S. Patent No. 12,296,002 B2 to Kuo et al. in view of Rappuoli et al. (US 2006/0257852 A1, “Rappuoli et al.”). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a immunogenic composition comprising a SARS-CoV-2 antigen and an oligonucleotide.
See claims 1-17 and 19 as submitted on 04/06/2023.
Regarding the instant claims, the patented claims are directed to a SARS-CoV-2 immunogenic composition comprising an antigenic recombinant SARS-CoV-2 protein comprising a particular sequence, a CpG-containing oligodeoxynucleotide consisting of SEQ ID NO: 8 (which is identical to instant SEQ ID NO: 1 and contains instant SEQ ID NO: 3), and an adjuvant comprising an aluminum hydroxide. The instant claims differ from the patented claims in that instant claim 1 does not recite a particular sequence for the SARS-CoV-2 virus. In that respect, the patented claims are a species that anticipates the instantly claimed genus. Other limitations shared between the two sets of claims are CpG-ODN (relevant to instant claim 7), amounts of oligonucleotide in a composition (relevant to instant claims 8), virus inactivation (relevant to instant claims 9 and 10) and aluminum hydroxide adjuvant and amounts thereof (relevant to instant claims 14-17).
The patented claims do not specify unmethylated, single stranded, CpG with phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (relevant to instant claims 1, 4, 5, 6, 7), nor a kit comprising the immunogenic composition (relevant to instant claim 19). However, as explained above Rappuoli et al. teach immunogenic compositions of inactivated, whole SARS virus vaccines (¶¶ [0008], [0122], 0560]-[0561]) and immunostimulatory oligonucleotides such as single stranded, unmethylated CpG directed to TLR9, wherein the CpG has phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (¶¶ [0879]-[0881]). Rappuoli et al. further teach kits comprising the immunogenic composition for administration to humans to induce an immune response, including intramuscular administration (¶¶ [0181], [0028] and [0862]).
It would have been prima facie obvious to one of ordinary skill in the art to have claimed these embodiments in the patent in view of the teachings of Rappuoli et al. One of ordinary skill in the art would have had been motivated to do so and would have had reasonable expectation of success in including the teachings of Rappuoli et al. to the immunogenic composition of the patent since Rappuoli et al. already teach that the compositions for SARS may be adapted for emerging strains of coronavirus and emerging strains of SARS (¶ [0961]).
Claims 1-17 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, 14-17, 19 of copending Application No. 17802361 in view of Rappuoli et al. (US 2006/0257852 A1, “Rappuoli et al.”). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a immunogenic composition comprising a SARS-CoV-2 antigen and an oligonucleotide.
See claims 1-17 and 19 as submitted on 04/06/2023.
Regarding the instant claims, the copending claims are directed to a SARS-CoV-2 immunogenic composition comprising an inactivated SARS-CoV-2 whole virus particle, a CpG-containing oligodeoxynucleotide consisting of SEQ ID NO: 1, which is identical to instant SEQ ID NO: 1, and SEQ ID NO: 3 which is identical to instant SEQ ID NO: 3, and an adjuvant comprising an aluminum salt. The instant claims differ from the copending claims in that instant claim 1 does not recite a whole virus. In that respect, the copending claims are a species that anticipates the instantly claimed genus. Other limitations shared between the two sets of claims are: unmethylated, single stranded, CpG with phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (relevant to instant claims 1, 4, 5, 6, 7), single-stranded CpG-ODN (relevant to instant claim 7), amounts of oligonucleotide in a composition (relevant to instant claims 8), virus inactivation (relevant to instant claims 9 and 10) aluminum hydroxide adjuvant and amounts thereof (relevant to instant claims 14-17) and a kit comprising the immunogenic composition(relevant to instant claim 19).
The copending claims do not specify a method of virus inactivation with formalin and/or ultraviolet light (relevant to instant claim 10). However, as explained above, Rappuoli et al. teach immunogenic compositions of inactivated, whole SARS virus vaccines (¶¶ [0008], [0122], 0560]-[0561]), wherein the SARS-CoV virus is inactivated by treatment with formalin or ultraviolet light (¶ [0559]-[0561]).
It would have been prima facie obvious to one of ordinary skill in the art to have claimed these embodiments in the patent in view of the teachings of Rappuoli et al. One of ordinary skill in the art would have had been motivated to do so and would have had reasonable expectation of success in including the teachings of Rappuoli et al. to the immunogenic composition of the patent since Rappuoli et al. already teach that the compositions for SARS may be adapted for emerging strains of coronavirus and emerging strains of SARS (¶ [0961]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6 of copending Application No. 18592811 in view of Rappuoli et al. (US 2006/0257852 A1, “Rappuoli et al.”). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a immunogenic composition comprising a SARS-CoV-2 antigen and an oligonucleotide.
See claims 1-17 and 19 as submitted on 04/06/2023.
Regarding the instant claims, the copending claims are directed to a SARS-CoV-2 immunogenic composition comprising an antigenic recombinant SARS-CoV-2 protein comprising particular sequences, a CpG-containing oligodeoxynucleotide consisting of SEQ ID NO: 7, which is identical to instant SEQ ID NO: 1, and contains instant SEQ ID NO: 3, and an adjuvant comprising an aluminum salt. The instant claims differ from the copending claims in that instant claim 1 does not recite an antigenic recombinant SARS-CoV-2 protein consisting of residues 14-1205 of spike protein of SARS-CoV-2 Beta variant with proline substitutions at residues 983 and 984 and a “GSAS” substitution at residues 679 - 682 and a C-terminal T4 fibritin trimerization domain. In that respect, the copending claims are a species that anticipates the instantly claimed genus. Other limitations shared between the two sets of claims are: unmethylated, CpG (relevant to instant claim 1), amounts of oligonucleotide in a composition (relevant to instant claims 8), aluminum hydroxide adjuvant and amounts thereof (relevant to instant claims 14-17).
The copending claims do not specify a single stranded, CpG with phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (relevant to instant claims 1, 4, 5, 6, 7); a single-stranded CpG-ODN (relevant to instant claim 7); virus inactivation with formalin and/or ultraviolet light (relevant to instant claims 9 and 10); and a kit comprising the immunogenic composition (relevant to instant claim 19). However, as explained above Rappuoli et al. teach these limitations. Specifically Rappuoli et al. teach immunogenic compositions of inactivated, whole SARS virus vaccines (¶¶ [0008], [0122], 0560]-[0561]) and immunostimulatory oligonucleotides such as single stranded, unmethylated CpG directed to TLR9, wherein the CpG has phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (¶¶ [0879]-[0881]). Rappuoli et al. further teach wherein the oligonucleotides are single-stranded oligodeoxynucleotides or CpG ODNs (¶ [0881). Rappuoli et al. further teach the SARS-CoV virus is inactivated by treatment with formalin or ultraviolet light (¶ [0559]-[0561]). Rappuoli et al. further teach kits comprising the immunogenic composition for administration to humans to induce an immune response, including intramuscular administration (¶¶ [0181], [0028] and [0862]).
It would have been prima facie obvious to one of ordinary skill in the art to have claimed these embodiments in the patent in view of the teachings of Rappuoli et al. One of ordinary skill in the art would have had been motivated to do so and would have had reasonable expectation of success in including the teachings of Rappuoli et al. to the immunogenic composition of the patent since Rappuoli et al. already teach that the compositions for SARS may be adapted for emerging strains of coronavirus and emerging strains of SARS (¶ [0961]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-17 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 and 19 of copending Application No. 17908221 in view of Rappuoli et al. (US 2006/0257852 A1, “Rappuoli et al.”). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a immunogenic composition comprising a SARS-CoV-2 antigen and an oligonucleotide.
See claims 1-17 and 19 as submitted on 04/06/2023.
Regarding the instant claims, the copending claims are directed to a SARS-CoV-2 immunogenic composition comprising a SARS-CoV-2 antigen and a TLR9 agonist comprising a CpG-containing oligodeoxynucleotide consisting of SEQ ID NO: 1, which is identical to instant SEQ ID NO: 1, and SEQ ID NO: 3 which is identical to instant SEQ ID NO: 3, and an adjuvant comprising an aluminum salt. The instant claims differ from the copending claims in that instant claim 1 does not recite a truncated, recombinant S protein devoid of signal peptide, transmembrane, and cytoplasmic domains of a full length S protein. In that respect, the copending claims are a species that is encompassed by the instantly claimed genus. However, this limitation is also recited by instant claim 12. Other limitations shared between the two sets of claims are: unmethylated, single stranded, CpG with phosphorothioate modifications or other modifications, such as guanine replaced by 2’-deoxy-7-deazaguanosine (relevant to instant claims 1, 4, 5, 6, 7), single-stranded CpG-ODN (relevant to instant claim 7), amounts of oligonucleotide in a composition (relevant to instant claims 8), virus inactivation (relevant to instant claims 9 and 10) aluminum hydroxide adjuvant and amounts thereof (relevant to instant claims 14-17) and a kit comprising the immunogenic composition(relevant to instant claim 19).
The copending claims do not specify a method of virus inactivation with formalin and/or ultraviolet light (relevant to instant claim 10). However, as explained above, Rappuoli et al. teach immunogenic compositions of inactivated, whole SARS virus vaccines (¶¶ [0008], [0122], 0560]-[0561]), wherein the SARS-CoV virus is inactivated by treatment with formalin or ultraviolet light (¶ [0559]-[0561]).
It would have been prima facie obvious to one of ordinary skill in the art to have claimed these embodiments in the patent in view of the teachings of Rappuoli et al. One of ordinary skill in the art would have had been motivated to do so and would have had reasonable expectation of success in including the teachings of Rappuoli et al. to the immunogenic composition of the patent since Rappuoli et al. already teach that the compositions for SARS may be adapted for emerging strains of coronavirus and emerging strains of SARS (¶ [0961]).
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 MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672