DETAILED ACTION
Non-Final Rejection
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Group I, claims 1, 3-4, 6-8, 17-24 and 26-27 in the reply filed on 06/05/2026 is acknowledged.
Status of Claims
3. Claims 1, 3-4, 6-8, 17-24 and 26-31 as per claim listing filed on 06/05/2026 are pending.
4. Claims 28-31 are withdrawn from examination due to Election/Restriction as non-elected Groups II-III of invention.
5. Claims 1, 3-4, 6-8, 17-24 and 26-27 are under examination.
Information Disclosure Statement
6. The information disclosure statements (IDSs) submitted on 04/02/2024 and 05/03/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
7. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The instant specification pages 38-42 recited 49 references.
Priority
8. This patent application is 371 of PCT/US2022/026574 and claims the benefit of priority of US Provisional Patent Application No.63/180,472, filed April 27, 2021.
Claim Interpretation
9. 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 1: The instant claim 1 is directed to an engineered polynucleotide comprising:
a) a first polynucleotide encoding an influenza neuraminidase (NA) protein comprising a cytoplasmic tail and a transmembrane domain fused to a receptor binding domain (RBD) of a SARS-CoV-2 spike protein; and
b) a second polynucleotide encoding an influenza hemagglutinin (HA) protein; wherein the first polynucleotide is linked to the second polynucleotide by a third polynucleotide encoding a linker peptide.
Claim 1 comprises a polynucleotide construct comprising SARS-CoV-2 spike protein called the receptor binding domain (RBD) fused to an influenza neuraminidase gene segment derived membrane anchor so the RBD and influenza hemagglutinin (HA) in the same engineered segment that separated by a linker/2A element so both HA and RBD proteins can be expressed from one construct.
Claims 19-24 and 26-27: The instant claims 19-24 and 26-27 are directed to produce a recombinant influenza virus, using plasmid based reverse genetics, expressing SARS-CoV-2 RBD polypeptide using the NA gene segment and native or engineered HA gene for attenuation on the surface of the virus and the virus is produced in embryonated chicken eggs or cell culture. The produced recombinant virus is inactivated or used as an attenuated virus to produce pharmaceutical composition intended for vaccination to human or animals.
Claim 20: The instant claim 20 is directed to “a cell” that is present in a human, thus reading on a human being or human subject (instant specification pages 20, 32).
Claim Rejections - 35 USC § 103
10. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
11. Claims 1, 3-4, 17-24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Heaton et al 2019 (US20190224305A1, 07/25/2019) and further in view of Ma et al 2020 (Immunity, 53, 1315–1330, December 15, 2020), Loes et al 2020 (Viruses, 2020, Sep 5;12(9):987), Fazio et al 2022 (WO2022009121A1 published 01/13/2022 with an earlier priority to US2020425.3 published 07 July 2020).
Claim 1: Heaton et al 2019 (US20190224305A1, 07/25/2019) is in the art and teaches instant claim 1 limitations, an engineered polynucleotide comprising:
a) a first polynucleotide encoding an influenza neuraminidase (NA) protein comprising a cytoplasmic tail and a transmembrane domain fused to polynucleotide encoding a heterologous polypeptide. and
b) a second polynucleotide encoding an influenza hemagglutinin (HA) protein;
wherein the first polynucleotide is linked to the second polynucleotide by a third polynucleotide encoding a linker peptide by disclosing a detachable linker, (See, Heaton et al 2019, abstract and claims 2-3, Fig. 6 A with legends and Fig 6 F with legends, para [0009]-[0010], entire prior art).
Heaton et al 2019 teaches polynucleotide encoding a heterologous polypeptide a ZsGreen fluorescent polypeptide.
However, Heaton et al 2019 do not teach polynucleotide sequence encoding a receptor binding domain (RBD) of a SARS-CoV-2 spike protein required for (a) limitation above.
Ma et al 2020 is in the art and teaches SARS-CoV-2 Spike protein receptor binding domain (RBD) encoding polynucleotide sequence expressed as a RBD protein to develop a nanoparticle vaccine (See, abstract, page e5 for methods, Fig 1, entire article).
Loes et al 2020 is in the art and teaches a polynucleotide construct incorporation of a membrane-anchored form of the SARS-CoV-2 spike receptor binding domain (RBD) in place of the neuraminidase (NA) coding sequence in an influenza virus also possessing a mutation that reduces the affinity of hemagglutinin for its sialic acid receptor (See, abstract, methods pages 2-6, Fig 1 and legends, entire article).
Fazio et al 2022 is in the art and teaches combination vaccines comprising one or more influenza virus antigen and one or more SARS-CoV-2(Coronavirus SARS-CoV-2) antigen, particularly one or more SARS-CoV-2 spike protein antigen, as well as vaccines comprising polynucleotides encoding said antigens, and such vaccines for the treatment or prevention of COVID-19 (SARS-CoV-2 infection) and influenza infection (See, WO2022009121A1, abstract, claims 1-9).
It would have been obvious to one of ordinary skill in the art to modify the prior art teachings of Heaton et al 2019, with additional teachings of Ma et al 2010 on SARS-CoV-2 RBD polynucleotide sequence and Loes et al 2020 on SARS-CoV-2 RBD sequence and replace the heterologous sequence ZeGreen fluorescent protein from the polynucleotide sequence construct of Heaton et al 2019 with a polynucleotide encoding RBD of SARS-CoV-2 spike to arrive at the invention of claim 1 with an express motivation by the prior art Fazio et al 2022 on combined influenza and SARS-CoV-2 immunogenic composition based vaccine that would protect a subject from both influenza and SARS-CoV-2 virus with a reasonable expectation of success.
Claims 3-4: The combined prior art teachings of Heaton et al 2019, Ma et al 2020, Loes et al 2020 and, Fazio et al 2022 rendered obvious claim 1 as recited supra. The instant claims 3-4 depends on claim 1.
Heaton et al 2019 further teaches (partially) the added limitation of instant claims 3-4. Heaton et al 2019 teaches wherein the engineered polynucleotide is a polynucleotide encoding a heterologous polypeptide and it is a part of segment 4 (HA) from an influenza virus (See, claim 1). Heaton et al 2019 teaches polynucleotide encoding an influenza virus packaging signal (See, claim 11). The prior art teachings of Ma et al 2020 and Loes et al 2020 as recited supra for claim 1 disclosed SARS-CoV-2 RBD encoding polynucleotide sequence, and an influenza virus packaging signal (See, Heaton et al 2019 Fig 6A and 6F and legends for packaging signal, claims 1 and 11), Loes et al 2020 is directed to rescue of attenuated influenza virus using plasmids that comprise segment 4 (HA) and thus, absent evidence to the contrary, inherently teaches packaging signals for segment 4 (HA) and therefore it would have been obvious to one of the ordinary skills to replace a polynucleotide encoding a heterologous polypeptide with SARS-CoV-2 RBD encoding polynucleotide sequence to arrive at invention of claims 3-4 with an express motivation by the prior art Fazio et al 2022 on combined influenza and SARS-CoV-2 immunogenic composition based vaccine that would protect a subject from both influenza and SARS-CoV-2 virus with a reasonable expectation of success. One of the ordinary skills in the art would have a reasonable expectation of success given the applied combined prior art teachings to develop the claimed polynucleotide that express influenza HA and SARS-CoV-2 spike RBD sequence to further develop a chimeric influenza virus expressing both influenza HA and RBD of SARS-CoV-2 virus for safety, efficacy, production efficiency of a combined vaccine for commercial success. This is analogous to some teaching, suggestions, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention as claimed in claims 3-4. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
Claim 17: Heaton et al 2019 teaches added limitation of instant claim 17 wherein the engineered polynucleotide comprises a sequence having at least 60% sequence identity to instant SEQ ID NO: 1 by disclosing SEQ ID NO: 54 that has 81% identity match with instant full length 1-2736 nucleotide sequence as claimed in instant SEQ ID NO: 1 (See, US20190224305A1, para [0045]). The partial SEQ ID NO: 54 (Db- the prior art US20190224305A1) is shown below:
Length 2760; Matches 2257; Conservative 0; Mismatches 478; Indels 26; Gaps 4;
Qy 1 AGCAAAAGCAGGGGAAAATAAAAACAACCAAATTGAAGGCAAACCTACTGGTCCTGTTAA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 AGCAAAAGCAGGGGAAAATAAAAACAACCAAATTGAAGGCAAACCTACTGGTCCTGTTAA 60
Qy 61 GTGCACTTGCAGCTGCAGTTGCAGACACAATTTGTATAGGCCACCATGAACCCCAATCAA 120
|||||||||||||||||||||||||||||||||||||||||||||||||| || |||||
Db 61 GTGCACTTGCAGCTGCAGTTGCAGACACAATTTGTATAGGCCACCATGAATCCAAATCAG 120
Qy 121 AAAATTACAACCATCGGGTCTATCTGCCTCGTAGTCGGACTGATATCCCTAATTCTTCAG 180
||||| || || || || || || || || || ||||| || || || ||||||||
Db 121 AAAATCACCACAATTGGATCCATTTGTCTGGTGGTCGGTCTCATCAGTCTCATTCTTCAA 180
Qy 181 ATAGGTAATATCATATCTATCTGGATCAGTCATAGTATACAGACTAGAGTGCAGCCAACA 240
|| || || ||||| || || |||||||| ||| |||||| || | | || |
Db 181 ATTGGGAACATCATTTCAATTTGGATCAGCCATTCTATACAAACGATGGCTCAAAGCAAG 240
//
Qy 2676 CAGAATATGCATCTGAGATTAGAATTTCAGAAATATGAGGAAAAACACCCTTGTTTCTAC 2735
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 2700 CAGAATATGCATCTGAGATTAGAATTTCAGAAATATGAGGAAAAACACCCTTGTTTCTAC 2759
Qy 2736 T 2736
|
Db 2760 T 2760
Claim 18: Heaton et al 2019 is directed to rescue of chimeric influenza virus using plasmid based reverse genetics and thus teaches the added limitation of instant claim 18 a plasmid that can be modified to comprise the engineered polynucleotide of claims 1 with a reasonable expectation of success (See, para [0067]-[0076], claim 35).
Claim 19: Heaton et al 2019 teaches added limitation of instant claim 19, a plasmid composition comprising plasmids encoding influenza virus segments 1, 2, 3, 5, 6, 7, and 8. The plasmid of claim 18 is taught by the combined prior art teachings as applied to claim 18 recited supra (See, claim 42, para [0070], [0073], [0080], [0082]).
Claim 20: Heaton et al 2019 teaches added limitation of instant claim 20, a cell comprising the composition of claim 19 (See, para [0115]-[0116], [0158], claim 73, 80).
Claim 21: Heaton et al 2019 teaches added limitation of instant claim 21, an influenza virus produced by the cell of claim 20 (See, claim 49).
Claim 22: Heaton et al 2019 in combination with prior arts teachings applied to claim 1 teaches added limitation of instant claim 22, an influenza virus comprising the engineered polynucleotide of claim 1 (See, claim 49).
Claim 24. Heaton et al 2019 in combination with prior arts teachings applied to claim 22 teaches added limitation of instant claim 23, wherein the influenza virus can propagate itself (the limitation is interpreted that influenza virus can be propagated or influenza virus produced) in embryonated chicken eggs or in cell culture (See, para [0006], [0024], [0031], [0048], Example 1 [0126], [0134]).
Claim 26. Heaton et al 2019 in combination with prior arts teachings applied to claim 22 teaches added limitation of instant claim 26, wherein the influenza virus is inactivated or attenuated (See, para [0028], [0078], [0136], [0005]).
Claim 27. Heaton et al 2019 in combination with prior arts teachings applied to claim 22 teaches added limitation of instant claim 27, a pharmaceutical composition comprising the influenza virus of claim 22 and a pharmaceutically acceptable carrier (See, para [0015], [0090]- [0091], [0097]).
Claim 23: Loes et al 2020 in combination with prior arts teachings applied to claim 22 teaches instant claim 23 added limitation, wherein the influenza virus expresses both the RBD of the SARS-CoV-2 spike protein and the influenza HA protein on its surface by disclosing production of attenuated influenza virions expressing the SARS-CoV-2 RBD that also expresses HA protein on viral surface (See, Loes et al 2020, abstract, entire article).
It would have been obvious to one of ordinary skill in the art to modify the combined prior art teachings as applied to claim 1 with additional prior art teachings of Heaton et al 2019, and Loes et al 2020 as recited supra to arrive at the invention of claims 18-24, and 26-27
with a motivation to produce a chimeric influenza virus expressing RBD polypeptide of SARS-CoV-2 Spike in the coding region of NA and expressing influenza HA (a bivalent influenza virus vaccine) to develop an attenuated or inactivated immunogen or vaccine with an express motivation by the prior art Fazio et al 2022 on combined influenza and SARS-CoV-2 immunogenic composition based vaccine that would protect a subject from both influenza and SARS-CoV-2 virus with a reasonable expectation of success. One of the ordinary skills in the art would have a reasonable expectation of success given the applied combined prior art teachings to develop a recombinant influenza virus that express influenza HA and SARS-CoV-2 spike RBD polypeptide on the viral surface for safer attenuated or inactivated virus composition, to produce efficacious bivalent vaccine, vaccine production efficiency of a combined vaccine for commercial success. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. This is analogous to some teaching, suggestions, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention as claimed in claims 18-24, and 26-27. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
12. Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over combined teachings of Heaton et al 2019 (US20190224305A1, 07/25/2019), Ma et al 2020 (Immunity, 53, 1315–1330, December 15, 2020), Loes et al 2020 (Viruses, 2020, Sep 5;12(9):987), Fazio et al 2022 (WO2022009121A1 published 01/13/2022 with an earlier priority to US2020425.3 published 07 July 2020) as applied to claim 4 above and further in view of Watanabe et al 2003 (Journal of virology, 77(19), 10575-10583), and Fujii et al 2003 (PNAS, 100(4), 2002-2007).
Claim 6: The combined prior art teachings as recited supra taught claim 4. Heaton et al 2019 depicts but is not expressive about a viral 5' untranslated region (UTR) and a viral 3' UTR as shown in Fig 6 A and F.
Watanabe et al 2003 is in the art and teaches rescue of chimeric influenza virus expressing GFP fluorescent protein incorporated in HA segment (influenza genome segment 4) and thus teaches influenza virus segment 4 (HA) viral 5' untranslated region (UTR) and a viral 3' UTR and influenza virus packaging signal (See, Figs. 1-2 and legends, entire article).
Fujii et al 2003 is in the art and teaches rescue of chimeric influenza virus expressing GFP fluorescent protein incorporated in NA segment (influenza genome segment 6) and thus teaches influenza virus segment 6 (NA) viral 5' untranslated region (UTR) and a viral 3' UTR and influenza virus packaging signal (See, Figs. 6, 2 and 5 and legends, entire article). Watanabe et al 2003 and Fujii et al 2003 are directed to rescue of chimeric influenza A virus using RNA polymerase I and II promoter directed DNA plasmids based reverse genetics. The DNA plasmid has both sense strand (mRNA sense) and anti-sense strand (See, Watanabe et al 2003page 10576 for methods and Fujii et al 2003 for methods).
It would have been obvious to one of ordinary skill in the art to modify the combined prior art teachings, as applied to claim 4, of Heaton et al 2019, Ma et al 2010 on SARS-CoV-2 RBD polynucleotide sequence and Loes et al 2020 on SARS-CoV-2 RBD sequence and replace the heterologous sequence ZeGreen fluorescent protein from the polynucleotide sequence construct of Heaton et al 2019 with a polynucleotide encoding RBD of SARS-CoV-2 spike and teachings of Watanabe et al 2003 and Fujii et al 2003 on influenza viral 5’ and 3’ UTR to arrive at the invention of claim 6 with an express motivation by the prior art Fazio et al 2022 on combined influenza and SARS-CoV-2 immunogenic composition based vaccine that would protect a subject from both influenza and SARS-CoV-2 virus with a reasonable expectation of success. One of the ordinary skills in the art would have a reasonable expectation of success given the applied combined prior art teachings to develop the claimed polynucleotide that express influenza HA and SARS-CoV-2 spike RBD sequence to further develop a chimeric influenza virus expressing both influenza HA and RBD of SARS-CoV-2 virus for safety, efficacy, production efficiency of a combined vaccine for commercial success. This is analogous to some teaching, suggestions, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention as claimed in claims 6. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
13. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over combined prior art teachings of Heaton et al 2019 (US20190224305A1, 07/25/2019), Ma et al 2020 (Immunity, 53, 1315–1330, December 15, 2020), Loes et al 2020 (Viruses, 2020, Sep 5;12(9):987), Fazio et al 2022 (WO2022009121A1 published 01/13/2022 with an earlier priority to US2020425.3 published 07 July 2020) as applied to claim 1 and further in view of Ernst et al 2013 (FEBS Letters 587 (2013) 1411–141), Yang et al 2020 (Nature, 586(7830), 572-577), and Tai et al 2020 (Cell Research (2020) 30:932–935).
Claim 7. The combined prior art teachings of Heaton et al 2019, Ma et al 2020, Loes et al 2020, Fazio et al 202 rendered obvious claim 1 as recited supra. However, did not expressively disclose added some of the limitations of instant claim 7 regarding amino acids 1-40 of an influenza NA protein.
Ernst et al 2013 is in the art and directed to differential transport of Influenza A neuraminidase signal anchor peptides to the plasma membrane and disclosed amino acids 1–40 of influenza neuraminidase are sufficient for plasma membrane targeting as a signal peptide and thus can be used to develop the instant claimed polynucleotide (See, abstract, Figs 1-2 and legends entire article).
Loes et al 2020 teaches attenuated influenza virions expressing the
SARS-CoV-2 receptor-binding domain induce neutralizing antibodies in mice and disclosed SARS-CoV-2 spike RBD amino acid residues 331-531 (RBD subunit protein) is immunogenic to induce neutralizing antibodies against SARS-CoV-2 virus. Thus, the claimed 150- 250 amino acid residues of RBD are comprised in the disclosure of Loes et al 2020 (See, page 2 method, and abstract, entire article).
Yang et al 2020 is in the art and teaches a vaccine targeting the RBD of the S protein
of SARS-CoV-2 induces protective immunity (See, abstract, Fig 1, entire article).
Tai et al 2020 is in the art and teaches a novel receptor-binding domain (RBD)-based mRNA vaccine against SARS-CoV-2 virus (See, Fig 1 with legends, entire article).
Heaton et al 2019 is in the art and teaches the linker peptide comprises a protein tag or a self-cleaving polypeptide (See, claim 13, para [0065]-[0066]). Further, Heaton et al 2019 teaches the influenza HA protein is an HA subtype 1 (HA1) protein or an HA subtype 3 (HA3) protein (See, claims 57-59, para [0024])
It would have been obvious to one of ordinary skill in the art to modify the combined prior art teachings of Heaton et al 2019, Ma et al 2020, Loes et al 2020, Fazio et al 2022 with additional teachings of Ernst et al 2013, Yang et al 2020, and Tai et al 2020 as recited supra to arrive at the invention of claims 7 with an express motivation by the prior art Fazio et al 2022 on combined influenza and SARS-CoV-2 immunogenic composition based vaccine that would protect a subject from both influenza and SARS-CoV-2 virus with a reasonable expectation of success. One of the ordinary skills in the art would have a reasonable expectation of success given the applied combined prior art teachings to develop the claimed polynucleotide that express influenza HA and SARS-CoV-2 spike RBD sequence to further develop a chimeric influenza virus expressing both influenza HA and RBD of SARS-CoV-2 virus for safety, efficacy, production efficiency of a combined vaccine for commercial success. This is analogous to some teaching, suggestions, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention as claimed in claim 7. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
14. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over combined prior art teachings of Heaton et al 2019 (US20190224305A1, 07/25/2019), Ma et al 2020 (Immunity, 53, 1315–1330, December 15, 2020), Loes et al 2020 (Viruses, 2020, Sep 5;12(9):987), Fazio et al 2022 (WO2022009121A1 published 01/13/2022 with an earlier priority to US2020425.3 published 07 July 2020), Ernst et al 2013 (FEBS Letters 587 (2013) 1411–141), Yang et al 2020 (Nature, 586(7830), 572-577), and Tai et al 2020 (Cell Research (2020) 30:932–935) as applied to claim 7 above and further in view of Copik et al 2020 (US20200237822A1, 07/30/2020), Wang 2021 (WO2021194423A1, 09/30/2021 with earlier priority of 05/14/2020 to 10202004468Q), Yam et al 2018 (US20180142022A1, 05/24/2018), and Moss et al 2017 (US20170298387A1, 10/19/2017).
Claim 8. The combined prior art teachings as applied and as recited supra rendered obvious claim 7, however do not teach added limitations of instant claim 8.
Copik et al 2020 (US20200237822A) teaches the added limitation (a) the portion of the influenza NA protein comprises SEQ ID NO: 10 by disclosing SEQ ID NO: 1 (Db) as recited below:
Query Match 100.0%; Score 199; Length 50;
Best Local Similarity 100.0%;
Matches 40; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MNPNQKITTIGSICLVVGLISLILQIGNIISIWISHSIQT 40
||||||||||||||||||||||||||||||||||||||||
Db 1 MNPNQKITTIGSICLVVGLISLILQIGNIISIWISHSIQT 40
Copik et al 2020 do not teach limitations (b), (c), (d) and (e).
Wang 2021 is directed to detecting neutralizing antibodies in a patient's serum that interfere with the interaction between the spike protein of severe acute respiratory syndrome related coronoviruses (SARS-CoV) and teaches the added limitation (b) the RBD comprises SEQ ID NO: 11 by disclosing SEQ ID NO: 13 (See, para [0017], claim 25).
Query Match 100.0%; Score 1211; Length 223;
Best Local Similarity 100.0%;
Matches 223; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Query Match 100.0%; Score 1211; Length 223;
Best Local Similarity 100.0%;
Matches 223; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 RVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSASFSTFK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 RVQPTESIVRFPNITNLCPFGEVFNATRFASVYAWNRKRISNCVADYSVLYNSASFSTFK 60
Qy 61 CYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCVIAWNS 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 CYGVSPTKLNDLCFTNVYADSFVIRGDEVRQIAPGQTGKIADYNYKLPDDFTGCVIAWNS 120
Qy 121 NNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQSYGFQ 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 NNLDSKVGGNYNYLYRLFRKSNLKPFERDISTEIYQAGSTPCNGVEGFNCYFPLQSYGFQ 180
Qy 181 PTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVNF 223
|||||||||||||||||||||||||||||||||||||||||||
Db 181 PTNGVGYQPYRVVVLSFELLHAPATVCGPKKSTNLVKNKCVNF 223
Yam et al 2018 (US20180142022A1) teaches the added limitation (c) the linker peptide comprises SEQ ID NO: 12 by disclosing SEQ ID NO: 294 as recited below:
Query Match 100.0%; Score 63; Length 20;
Best Local Similarity 100.0%;
Matches 11; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 GSGDYKDDDDK 11
|||||||||||
Db 1 GSGDYKDDDDK 11
Moss et al 2017 (US20170298387A1, 10/19/2017) is directed to a recombinant vaccine comprising influenza HA teaches the added limitation (d) the influenza HA protein comprises SEQ ID NO: 14 by disclosing SEQ ID NO: 199 as recited below:
Query Match 100.0%; Score 3012; Length 565;
Best Local Similarity 100.0%;
Matches 565; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKANLLVLLSALAAADADTICIGYHANNSTDTVDTVLEKNVTVTHSVNLLEDSHNGKLCR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKANLLVLLSALAAADADTICIGYHANNSTDTVDTVLEKNVTVTHSVNLLEDSHNGKLCR 60
Qy 61 LKGIAPLQLGKCNIAGWLLGNPECDPLLPVRSWSYIVETPNSENGICYPGDFIDYEELRE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LKGIAPLQLGKCNIAGWLLGNPECDPLLPVRSWSYIVETPNSENGICYPGDFIDYEELRE 120
Qy 121 QLSSVSSFERFEIFPKESSWPNHNTNGVTAACSHEGKSSFYRNLLWLTEKEGSYPKLKNS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 QLSSVSSFERFEIFPKESSWPNHNTNGVTAACSHEGKSSFYRNLLWLTEKEGSYPKLKNS 180
Qy 181 YVNKKGKEVLVLWGIHHPPNSKEQQNLYQNENAYVSVVTSNYNRRFTPEIAERPKVRDQA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 YVNKKGKEVLVLWGIHHPPNSKEQQNLYQNENAYVSVVTSNYNRRFTPEIAERPKVRDQA 240
Qy 241 GRMNYYWTLLKPGDTIIFEANGNLIAPMYAFALSRGFGSGIITSNASMHECNTKCQTPLG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GRMNYYWTLLKPGDTIIFEANGNLIAPMYAFALSRGFGSGIITSNASMHECNTKCQTPLG 300
Qy 301 AINSSLPYQNIHPVTIGECPKYVRSAKLRMVTGLRNTPSIQSRGLFGAIA GFIEGGWTGM 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 AINSSLPYQNIHPVTIGECPKYVRSAKLRMVTGLRNTPSIQSRGLFGAIA GFIEGGWTGM 360
Qy 361 IDGWYGYHHQNEQGSGYAADQKSTQNAINGITNKVNTVIEKMNIQFTAVGKEFNKLEKRM 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 IDGWYGYHHQNEQGSGYAADQKSTQNAINGITNKVNTVIEKMNIQFTAVGKEFNKLEKRM 420
Qy 421 ENLNKKVDDGFLDIWTYNAELLVLLENERTLDFHDSNVKNLYEKVKSQLKNNAKEIGNGC 480
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Db 421 ENLNKKVDDGFLDIWTYNAELLVLLENERTLDFHDSNVKNLYEKVKSQLKNNAKEIGNGC 480
Qy 481 FEFYHKCDNECMESVRNGTYDYPKYSEESKLNREKVDGVKLESMGIYQILAIYSTVASSL 540
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Db 481 FEFYHKCDNECMESVRNGTYDYPKYSEESKLNREKVDGVKLESMGIYQILAIYSTVASSL 540
Qy 541 VLLVSLGAISFWMCSNGSLQCRICI 565
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Db 541 VLLVSLGAISFWMCSNGSLQCRICI 565
It would have been obvious to one of ordinary skill in the art to modify the combined prior art teachings of Heaton et al 2019, Ma et al 2020, Loes et al 2020, Fazio et al 2022, Watanabe et al 2003 and Fujii et al 2003, Ernst et al 2013, Yang et al 2020, and Tai et al 2020 as applied to claim 7 with additional teachings of Copik et al 2020, Wang 2021, Yam et al 2018, and Moss et al 2017 as recited supra to arrive at the invention of claim 8 with a motivation to use the previously known working sequences to develop a polynucleotide construct and an express motivation by the prior art Fazio et al 2022 on combined influenza and SARS-CoV-2 immunogenic composition based vaccine that would protect a subject from both influenza and SARS-CoV-2 virus with a reasonable expectation of success. One of the ordinary skills in the art would have a reasonable expectation of success given the applied combined prior art teachings to develop the claimed polynucleotide that express influenza HA and SARS-CoV-2 spike RBD sequence to further develop a chimeric influenza virus expressing both influenza HA and RBD of SARS-CoV-2 virus for safety, efficacy, production efficiency of a combined vaccine for commercial success. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. This is analogous to some teaching, suggestions, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the invention as claimed in claim 8. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) (see MPEP § 2143, example of rationales, A-G).
Claim Rejections - 35 USC § 101
15. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 20 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The instant claim 20 is directed to “a cell” that is present in a human, thus reading on a human being. The instant specification recites “In a preferred embodiment, the subject is a human” (See, page 20). The claimed composition is intended for use in humans as influenza and SARS-CoV-2 viruses cause infections in human population (See, page 32).
See, MPEP 2105, III. HUMAN ORGANISMS ARE NONSTATUTORY SUBJECT MATTER.
This rejection may be overcome by amending the claim to recite “isolated host cell” or equivalent language that recite a specific in vitro cell line or in vitro cell culture.
16. Relevant Prior Arts:
Chen et al 2019. US20190125858A1. Cold adapted and virulence factor deleted live attenuated vaccine suitable for mucosal delivery. Disclosed the mutated influenza virus produced by reverse genetics that express antigen from a SARS coronavirus or MERS coronavirus spike RBD.
Garcia-Sastre et al 2014. US8828406B2. Disclosed chimeric influenza virus gene segments and nucleic acid sequences encoding such chimeric influenza virus gene segments.
Fazio et al 2022. WO2022009121A1. SARS-CoV-2 and influenza combination vaccine.
Baden et al 2020 (New England journal of medicine, 384(5), 403-416) and Baden et al 2020 is in the art and teaches mRNA-1273 vaccine (a lipid nanoparticle–encapsulated mRNA-based vaccine) that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19 (See, abstract, entire article).
Conclusion
17. No claim allowed.
18. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMADHAN J JADHAO whose telephone number is (703)756-1223. The examiner can normally be reached M-F 8:00-5:00.
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/SAMADHAN JAISING JADHAO/Examiner, Art Unit 1672
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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