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 .
Response to Amendment/Disposition of Claims
Applicant’s Amendment filed on 30 April 2026 has been received and entered. Claims 1-36 were pending. Claims 1, 4-5, 7, 10-13, 16-17, 20, 22-23, 27-30, 32, and 34 have been amended. Claims 2-3, 8-9, 18-19, 24-26, 31, and 33 have been cancelled. No new claims have been added.
Accordingly, Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are currently pending and will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2023/0210981 A1, Published 06 July 2023. Applicant’s amended Specifications as presented on 30 April 2026 and 08 December 2022 is acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Of note, there is still not an attorney of record on file due to a lack of an official power of attorney of record. While a customer number has been provided on the ADS submitted 12/08/2022, this is not the equivalent of a power of attorney or an authorization to act in a representative capacity. In order to expedite prosecution in the instant application, it is suggested that a power of attorney be filed as per MPEP §402 or MPEP §1807, or an Authorization to Act in a Representative Capacity be filed as per MPEP §403 in order for the Office to freely and openly discuss the merits of the case with the applicant's representative(s). Please refer to the MPEP or http://www.uspto.gov/patents/law/poafaqs.jsp#a if you have questions regarding the proper filing of a power of attorney.
Drawings
(Objection Withdrawn) – The objection to the Drawings for referring to colors is withdrawn in light of the amendments to the figure legends within the Specification.
Specification
Withdrawn Objections
(Objection Withdrawn) – The objection to the Abstract of the disclosure for containing implied language is withdrawn in light of the amendments to the Abstract.
New Objections
(New Objection) – The Abstract of the disclosure is objected to because of the following informalities: The first and last sentences of the amended Abstract are now incomplete sentences or sentence fragments. It is suggested that the first sentence be amended to recite “A vaccine comprising a Coronavirus disease 2019 (COVID-19) antigen in a combination with an immunoglobulin from post-exposure treatment is provided”. It is suggested that the last sentence be amended to recite “Also, a method of treating a subject in need thereof, by administering the vaccine to the subject, is provided”. Applicant is free to amend the Abstract as they deem necessary, however.
Appropriate correction is required.
Claim Objections
Withdrawn Objections
(Objection Withdrawn) – The objection to Claims 1-2, 7-8, 10, 16-18, 20, 22, 25, 27, 32, and 34 is withdrawn in light of the cancellation of some of the claims and the amendments to the remainder of the claims.
New Objections
(New Objection) – Claim 1 is objected to because of the following informalities: it is suggested that it say “…wherein the host subject was vaccinated with a nucleic acid molecule
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
(Rejection Withdrawn) – The rejection of Claims 5 and 12-13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection Withdrawn) – The rejection of Claims 23 and 30, and dependent claims 24-29 and 31-36 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection Withdrawn) – The rejection of Claim 23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection Withdrawn) – The rejection of Claims 30, and dependent claims 31-36 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 112(a); First Paragraph
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.
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 2, 4, 8-13, 18, 20, 25, 27, 32, and 34 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 is withdrawn in light of the cancellation of some of the claims and the amendments to the remainder of the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are 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. This is a new matter rejection.
The amendments to independent Claims 1 and 16 introduce new matter which is not supported by the original disclosure filed on 08 December 2022. Specifically, the recitation of the Claim 1 limitation “…wherein the host subject was vaccinated with a nucleic acid molecule comprising a nucleotide sequence encoding the amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6 and SEQ ID NO:8, and b) a nucleic acid molecule comprising a nucleotide sequence encoding a SARS-CoV-2 antigen comprising the amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6 and SEQ ID NO:8” and the recitation of the Claim 16 limitation “…wherein the nucleic acid molecule comprises a nucleotide sequence encoding the amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6 and SEQ ID NO:8” are not supported by the originally-filed disclosure. In the case of amended Claim 1, the instant Specification teaches one composition with the IVIG and nucleic acids, but does not provide a specific teaching of the species of IVIG now recited in the claim in one composition with the specific nucleic acids, and the amino acids they each encode, recited (see Paragraph 00171 of the original Specification, Paragraph 0179 of the PGPub of the instant application). Similarly for amended Claim 16, the instant Specification teaches one method for generating an immunogenic composition comprising IVIG from a host subject wherein the method comprises administering a nucleic acid molecule encoding a SARS-CoV-2 antigen to said host subject and isolating a biological sample comprising one or more immunoglobulin molecules from said host subject, but it does not provide a specific teaching of the species of SARS-CoV-2 antigens now recited in the claim in one method (see Paragraphs 0020, 00120, 00123-00124, 00164; 0021, 0123, 0126-0127, 0172, respectively, of the PGPub). These independent claims recite new, more specific embodiments of the claimed invention which is not explicitly disclosed in the original Specification. The original disclosure should teach, contemplate, and thus anticipate the instant claims. It is not sufficient that the instant Specification merely render the instant claims obvious. The original disclosure only provides a genus in each case, which does not equate to any species encompassed by said genus, and so there is no teaching or original contemplation of the claimed subject matter. Therefore, Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 do not meet the written description requirement as they contain new matter.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New Rejection – necessitated by amendment) – Claims 4-5, 20-21, 32, and 34-35 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 4, it recites the limitation “The immunogenic composition of claim 1, wherein the host subject was vaccinated with a nucleic acid molecule comprising a nucleotide sequence selected from the group consisting of: (a) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO: 1; (b) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO:3; (c) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO:5; and (d) the nucleotide sequence having at least about 90% identity over the entire length of the nucleic acid sequence set forth in SEQ ID NO:7”. Specifically, it refers to the nucleic acid introduced part a) of independent Claim 1. The antigen being claimed that corresponds to instant SEQ ID NOs: 2, 4, 6, or 8 in that limitation of Claim 1 is a product-by-process. The limitation recited in Claim 4 does not change the structure of the composition. Therefore, it does not further limit Claim 1. The same applies to dependent Claim 5, which depends on but does not further limit Claim 1. The fact pattern is the same for dependent Claims 20-21, which depend on but do not further limit independent Claim 16, and dependent Claims 32 and 34-35, which also depend on but do not further limit independent Claim 1.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims comply with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(Rejection Withdrawn) – The rejection of Claims 1, 6-7, 14-17, 22-24, 29-31, and 36 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) is withdrawn in light of the cancellation of some of the claims and the amendments to the remainder of the claims.
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.
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 2-5, 8-13, 18-21, 25-28, and 32-35 under 35 U.S.C. 103 as being unpatentable over Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) as applied to claims 1, 6-7, 14-17, 22-24, 29-31, and 36 above, and further in view of Yan et al. (US 2023/0338515 A1, earliest Priority Date 25 February 2020) is withdrawn in light of the cancellation of some of the claims and the amendments to the remainder of the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) (cited in the previous Office Action) and Rauch et al. (US 2021/0379181 A1, earliest Priority Date 04 February 2020).
Mond and Grossman teach human plasma compositions and immunoglobulin prepared therefrom containing antibodies specific for SARS-CoV-2 and methods for generating said compositions (see Abstract), wherein the plasma is obtained from plasma donors, wherein said donors are either COVID-19 convalescent plasma donors or COVID-19 vaccinated donors (see Paragraphs 0011, 0123), which reads on instant Claims 1, 6-7, and 22. Mond and Grossman also teach compositions further comprising excipients and/or adjuvants (see Paragraphs 0073, 0077, 0140, 0147), which reads on instant Claims 14-15. Furthermore, Mond and Grossman teach a method of inducing an immune response by administering an immunogenic or therapeutic composition as well as an immunotherapeutic agent to a subject, wherein said administration is via injection (see Paragraphs 0036, 0067, 0098, 0109-0110, 0141-0145), which reads on instant Claims 23 and 29. Additionally, Mond and Grossman teach administering a composition comprising pooled plasma and/or immunoglobulin which provide protective levels of anti-SARS-CoV-2 antibodies to a subject as well as a SARS-CoV-2 antigen or a nucleic acid encoding said antigen to said subject, wherein said administration is via injection (see Paragraphs 0013, 0036, 0067, 0098, 0109-0110, 0141-0145), which reads on instant Claims 30 and 36. Finally, Mond and Grossman teach a method of producing an immunoglobulin comprising obtaining a plurality of plasma samples from human plasma donors vaccinated with one or more coronavirus vaccines, such as a SARS-CoV-2 vaccine, or human plasma donors from donors who have recovered from COVID-19 (see Paragraphs 0012, 0026, 0144-0145), which reads on instant Claims 16-17.
While Mond and Grossman teach many of the limitations of the instant claims, they do not teach sequences which read on instant SEQ ID NOs: 1-8 or a nucleic acid wherein said nucleic acid comprises an expression vector or is incorporated into a viral particle.
Rauch et al. teach compositions comprising a nucleic acid suitable for use in treatment of an infection with a coronavirus, such as SARS-Cov-2 (see Abstract), wherein said nucleic acid encodes an amino acid sequence corresponding to a spike protein antigen that consists of prior art SEQ ID NO: 291, which comprises a sequence that is 100% identical to instant SEQ ID NO: 2 (see Sequence Listing; Paragraphs 0102-0104), which reads on instant Claims 1, 16, and 32. Since Rauch et al. teach a nucleic acid encoding the same spike protein antigen as the instant claims, the prior art nucleic acid sequence also renders instant SEQ ID NO: 1, which encodes instant SEQ ID NO: 2, obvious as it would be obvious for a skilled artisan to generate this nucleic acid sequence from the given amino acid sequence as all amino acid codons were known prior to filing and such a technique is well-known in the art. Thus, Rauch et al. also render obvious the limitations of instant Claims 4-5, 10-11, 20-21, 27-28, and 34-35. Additionally, Rauch et al. teach compositions wherein said nucleic acid is a DNA expression vector, wherein said DNA expression vector is an adenovirus, a poxvirus, a parapoxvirus (orf virus), a vaccinia virus, a fowlpox virus, a herpes virus, an adeno-associated virus (AAV), an alphavirus, a lentivirus, a lambda phage, or a lymphocytic choriomeningitis virus (see Paragraphs 0544-0546), which reads on the limitations of instant Claims 12-13.
A person having ordinary skill in the art would have been motivated to modify the teachings of Mond and Grossman with those of Rauch et al. in order to develop an immunogenic composition comprising immunoglobulin. It would have been obvious to use specific antigenic proteins or nucleic acids encoding said proteins, as disclosed by Rauch et al., to immunize a subject in order to generate an immune response against said specific antigenic proteins. This would be an efficient way to tailor an immune response against a desired protein or proteins, such as spike proteins corresponding to new or emerging SARS-CoV-2 variants, for example, and to generate and then extract neutralizing antibodies specific for said variants for use in the compositions disclosed by Mond and Grossman. The expression vectors of Rauch et al. would improve the overall yield of the antigenic protein or proteins and would thus elicit a more robust immune response and it would have been obvious to use an appropriate expression vector in the compositions of Mond and Grossman depending on the subject being immunized, for example. The nucleic acid delivered as part of the combination immunotherapy of Mond and Grossman can encode an immunotherapeutic protein or agent, such as the SARS-CoV-2 spike protein taught by Rauch et al., and Rauch et al. teach that the nucleic acid encoding SARS-CoV-2 proteins can be administered for therapeutic uses, just like the composition of Mond and Grossman. It would have been predictable that the nucleic acid sequence encoding instant SEQ ID NO: 2, which corresponds to the Spike protein, as taught by Rauch et al. would cure COVID-19 because it is well-known in the art that the body generates neutralizing antibodies against this specific SARS-CoV-2 protein. This would make the immunogenic or therapeutic composition disclosed by Mond and Grossman more effective at treating or protecting against new or emerging SARS-CoV-2 variants, for example, making the composition more cost-effective and therapeutically effective. The combination of these teachings thus renders obvious the invention encompassed by the instant claims.
Such modifications, combining prior art elements according to known methods in order to yield predictable results, would have had a reasonable expectation of success and arrived at the claimed invention prior to the effective filing date of the instant application. For at least these reasons, instant Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over the prior art.
Response to Arguments
Applicant's arguments filed with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered. While the original rejection has been withdrawn in light of the amendments to the claims, a new rejection was warranted which utilizes the teachings of Mond and Grossman and the arguments presented regarding these teachings will be addressed as applicable herein in the interest of compact prosecution.
In their Response, Applicant argues that “Mond does not teach or suggest a combination immunotherapy comprising a) an immunoglobulin isolated from a subject vaccinated with a nucleic acid molecule encoding a SARS-CoV-2 antigen, as recited in claim 1” and that “Yan does not cure the deficiencies of Mond as Yan does not teach or suggest a combination immunotherapy” (see Page 8 of Remarks, First Paragraph).
Examiner does not find these arguments persuasive. Mond and Grossman does indeed teach a combination immunotherapy comprising an immunoglobulin isolated from a subject vaccinated with a nucleic acid molecule encoding a SARS-CoV-2 antigen, as noted above in the obviousness rejection. The nucleic acid delivered as part of the combination immunotherapy can encode an immunotherapeutic protein or agent, such as the SARS-CoV-2 spike protein taught by Rauch et al., and Rauch et al. teach that the nucleic acid encoding SARS-CoV-2 proteins can be administered for therapeutic uses, as noted above again in the obviousness rejection. Yan et al. has not been utilized in this new obviousness rejection and thus any arguments presented regarding the teachings of Yan et al. are rendered moot.
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.
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36, formerly Claims 1-36, on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, and 21 of U.S. Patent No. 11,660,335 in view of Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) and Yan et al. (US 2023/0338515 A1, earliest Priority Date 25 February 2020) is withdrawn in light of the amendments to the claims and the cancellation of some of the claims.
(Rejection Withdrawn) – The provisional rejection of Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36, formerly Claims 1-36, on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10-11, 14, 17, and 23-24 of copending Application No. 17/662,141 (US PGPub 2022/0370598 A1) in view of Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) and Yan et al. (US 2023/0338515 A1, earliest Priority Date 25 February 2020) is withdrawn in light of the amendments to the claims and the cancellation of some of the claims.
(Rejection Withdrawn) – The provisional rejection of Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36, formerly Claims 1-36, on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, and 12-19 of copending Application No. 18/990,242 (US PGPub 2025/0121054 A1) in view of Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) and Yan et al. (US 2023/0338515 A1, earliest Priority Date 25 February 2020) is withdrawn in light of the amendments to the claims and the cancellation of some of the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, and 21 of U.S. Patent No. 11,660,335 in view of Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) and Rauch et al. (US 2021/0379181 A1, earliest Priority Date 04 February 2020).
Both claim sets are drawn to a nucleic acid molecule encoding a SARS-CoV-2 antigen, an expression vector encoding said antigen, and an immunogenic composition comprising said expression vector. Both claim sets are also drawn to a method of inducing an immune response against SARS-CoV-2 by administering said immunogenic composition. Patented sequence SEQ ID NO: 3 is 100% identical to instant SEQ ID NO: 1, 99.9% identical to instant SEQ ID NO: 3, 95.1% identical to instant SEQ ID NO: 5, and 94.9% identical to instant SEQ ID NO: 7. The main different between the instant claims and the patented claims is that the instant claims are drawn to a composition comprising intravenous immunoglobulin (IVIG) and a method of generating said composition.
The previous teachings of Mond and Grossman and Rauch et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the patented claims with those of Mond and Grossman and Rauch et al. in order to generate IVIG against specific antigenic proteins encoded by nucleic acids, as disclosed by the patented claims and Rauch et al., to immunize a subject in order to generate an immune response against said specific antigenic protein. This would be an efficient way to tailor an immune response against a desired protein or proteins, such as spike proteins corresponding to new or emerging SARS-CoV-2 variants, for example, and to generate and then extract neutralizing antibodies specific for said variants. This would make the composition disclosed by Mond and Grossman more effective at treating or protecting against new or emerging variants, for example, making the composition more cost-effective and therapeutically effective.
For at least these reasons, instant Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-8, and 21 of U.S. Patent No. 11,660,335 in view of Mond and Grossman and Rauch et al.
(New Rejection – necessitated by amendment) – Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10-11, 14, 17, and 23-24 of copending Application No. 17/662,141 in view of Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) and Rauch et al. (US 2021/0379181 A1, earliest Priority Date 04 February 2020).
Both claim sets are drawn to a method of inducing an immune response against SARS-CoV-2 or a method of protecting a subject from infection with SARS-CoV-2 by administering a composition comprising a nucleic acid via electroporation and/or injection, wherein an additional reagent is also administered to said subject for treating or preventing infection with the virus. Additionally, reference SEQ ID NO: 3 is 100% identical to instant SEQ ID NO: 1, 99.9% identical to instant SEQ ID NO: 3, 95.1% identical to instant SEQ ID NO: 5, and 94.9% identical to instant SEQ ID NO: 7. The main differences between the claim sets are that the instant claims are drawn to a composition additionally comprising an intravenous immunoglobulin (IVIG), while the reference claims are drawn to administering specific amounts of said nucleic acid and yielding specific results as far as measuring the immune response to said nucleic acid. The reference claims also do not specify the type of additional agent which can be administered with the nucleic acid molecule.
The previous teachings of Mond and Grossman and Rauch et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the reference claims with those of Mond and Grossman and Rauch et al. in order to generate IVIG against specific antigenic proteins encoded by nucleic acids, as disclosed by the reference claims and Rauch et al., to immunize a subject in order to generate an immune response against said specific antigenic protein. This would be an efficient way to tailor an immune response against a desired protein or proteins, such as spike proteins corresponding to new or emerging SARS-CoV-2 variants, for example, and to generate and then extract neutralizing antibodies specific for said variants. This would make the composition disclosed by Mond and Grossman more effective at treating or protecting against new or emerging variants, for example, making the composition more cost-effective and therapeutically effective.
For at least these reasons, instant Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 10-11, 14, 17, and 23-24 of the reference application view of Mond and Grossman and Rauch et al.
This is a provisional nonstatutory double patenting rejection.
(New Rejection – necessitated by amendment) – Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, and 12-20 of copending Application No. 18/990,242 in view of Mond and Grossman (US 2021/0277093 A1, earliest Priority Date 25 March 2020) and Rauch et al. (US 2021/0379181 A1, earliest Priority Date 04 February 2020).
Both claim sets are drawn to a nucleic acid encoding a SARS-CoV-2 antigen, an expression vector comprising said nucleic acid, and an immunogenic composition comprising said expression vector and an excipient. Both claim set are also drawn to a method of inducing an immune response against SARS-CoV-2 and a method of protecting a subject from infection with SARS-CoV-2 by administering said immunogenic composition comprising said expression vector and/or nucleic acid, wherein said composition is administered via electroporation. Additionally, reference SEQ ID NO: 5 is 94.8% identical to instant SEQ ID NO: 3, 100% identical to instant SEQ ID NO: 5, and 99.9% identical to instant SEQ ID NO: 7, while reference SEQ ID NO: 6 is 94.9% identical to instant SEQ ID NO: 3, 100% identical to instant SEQ ID NO: 5, and 99.8% identical to instant SEQ ID NO: 7. The main differences between the claim sets are that the instant claims are drawn to a composition additionally comprising intravenous immunoglobulin (IVIG), while the reference claims are also drawn to a method of treating a subject in need thereof against SARS-CoV-2 by administering an effective amount of the reference nucleic acid molecule and do not specify the type of additional agent which can be administered with said nucleic acid molecule.
The previous teachings of Mond and Grossman and Rauch et al. have been summarized above.
A person having ordinary skill in the art would have been motivated to modify the teachings of the reference claims with those of Mond and Grossman and Rauch et al. in order to generate IVIG against specific antigenic proteins encoded by nucleic acids, as disclosed by the reference claims and Rauch et al., to immunize a subject in order to generate an immune response against said specific antigenic protein. This would be an efficient way to tailor an immune response against a desired protein or proteins, such as spike proteins corresponding to new or emerging SARS-CoV-2 variants, for example, and to generate and then extract neutralizing antibodies specific for said variants. This would make the composition disclosed by Mond and Grossman more effective at treating or protecting against new or emerging variants, for example, making the composition more cost-effective and therapeutically effective.
For at least these reasons, instant Claims 1, 4-7, 10-17, 20-23, 27-30, 32, and 34-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, and 12-20 of the reference application view of Mond and Grossman and Rauch et al.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered. While the original rejections have been withdrawn in light of the amendments to the claims, new rejections were warranted which utilize the teachings of Mond and Grossman and the arguments presented regarding these teachings will be addressed as applicable herein in the interest of compact prosecution.
In their Response, Applicant requested that all nonstatutory double patenting rejections “be held in abeyance until claims are deemed allowable in the present application” (see Page 8 of Remarks, Paragraphs 4-6). Applicant’s amendments to the claims necessitated that the previous rejections be withdrawn and that new rejections be raised, however. The arguments presented regarding Mond and Grossman have already been rebutted above (see obviousness rejection) and so will not be reiterated here. The teachings of Rauch et al. have also been summarized previously and will also not be reiterated here. Yan et al. has not been utilized in these new nonstatutory double patenting rejections and thus any arguments presented regarding the teachings of Yan et al. are rendered moot.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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