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 .
The preliminary amendment to the claims of 1/15/25 is entered. Claims 1-3, 5, 8, 10, 12, 14, 20, 22, 25-27, 32-34, 36-38, 40, 42, 48, 50-51, 56, 58, 60, 67-68, 71-72, 77, 79, 83, 85, 90 and 94 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/15/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Objections
Specification
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below. The specification is objected to because the description for figure 1 contains several amino acid sequences, but does not contain specific SEQ ID NO:s. The figure 1 description does mention SEQ ID NO:s, but these are for the full-length sequences of each protein, but figure 1 does not recite this sequence.
Applicants must comply with sequence rules in order to be considered a complete response to this 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.
Claim(s) 1-3, 5, 8, 10, 12, 14, 20, 22, 25-27, 32-34, 36-38, 40, 42, 48, 50-51, 56, 58, 60, 67-68, 71-72, 77, 79, 83, 85, 90 and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Palese et al. (WO/21/081120) in view of Kemter et al. (US PGPub 2019/0269618).
The claimed invention is drawn to an immunogenic composition comprising a recombinant neuraminidase (NA), wherein the recombinant NA comprises an influenza NA globular head domain and a paramyxovirus phosphoprotein tetramerization domain. In addition, the recombinant NA lacks an influenza virus NA stalk domain, transmembrane domain and cytoplasmic domain, and the composition comprises an adjuvant that comprises oligonucleotide of from 10 to 35 nucleotides in length comprising the sequence of 5’-GAACGTTCG-3’ in an admixture with a pharmaceutically acceptable carrier.
The claimed invention also requires a method of immunizing against influenza virus, inducing an immune response in a subject against influenza or preventing an influenza disease in a subject by administering the immunogenic composition of claim 1.
The oligonucleotide comprises SEQ ID NO: 4 and the adjuvant further comprises an aluminum salt.
The paramyxovirus phosphoprotein is from a measles virus, such as SEQ ID NO: 8 or an amino acid sequence having at least 80% identity to the amino acid sequence of SEQ ID NO: 8.
The influenza NA head domain is from an influenza A or B NA, wherein the influena A virus is A/Michigan/45/2015 or A/Kansas/14/2017 or the influenza B is B/Colorado/6/2017.
The globular head sequences can be at least 80% identical to SEQ ID NO:s 31, 32 or 33.
The recombinant NA further comprises a cleavage site, such as a thrombin cleavage site, SEQ ID NO: 36 or SEQ ID NO: 37.
The recombinant NA is enzymatically active.
-or-
an immunogenic composition comprising:
a) recombinant neuraminidase comprising an amino acid sequence having at least 80% identity to SEQ ID NO:50, 52, 54, 56 or 58, or SEQ ID NO:50, 52, 54, 56 or 58 without the signal sequence; and
b) an adjuvant, wherein the adjuvant comprises an oligonucleotide of from 10 to 35 nucleotides in length comprising the nucleotide sequence of 5'- GAACGTTCG-3', in an admixture with a pharmaceutically acceptable carrier.
The immunogenic composition comprises an influenza vaccine.
-or-
an immunogenic composition comprising a two or three recombinant neuraminidase (NA) proteins, wherein the recombinant NA proteins comprises an influenza NA globular head domain and a paramyxovirus phosphoprotein tetramerization domain. In addition, the recombinant NA lacks an influenza virus NA stalk domain, transmembrane domain and cytoplasmic domain, and the composition comprises an adjuvant that comprises oligonucleotide of from 10 to 35 nucleotides in length comprising the sequence of 5’-GAACGTTCG-3’ in an admixture with a pharmaceutically acceptable carrier.
The phosphoprotein tetramerization is of a measles virus.
-or-
an immunogenic composition, comprising
a) three recombinant neuraminidases, wherein:
i) the first recombinant neuraminidase comprises the amino acid sequence of SEQ ID NO:40, 42, 44, 46, or 48, or SEQ ID NO:40, 42, 44, 46, or 48 without the signal sequence;
ii) the second recombinant neuraminidase comprises the amino acid sequence of SEQ ID NO:50, 52, 54, 56, or 58, or SEQ ID NO:50, 52, 54, 56, or 58 without the signal sequence; and
iii) the third recombinant neuraminidase comprises the amino acid sequence of SEQ ID NO:60, 62, 64, 66, or 68, or SEQ ID NO:60, 62, 64, 66, or 68 without the signal sequence, and
b) an adjuvant, wherein the adjuvant comprises an oligonucleotide comprising the nucleotide sequence of 5'-GAACGTTCG-3', in an admixture with a pharmaceutically acceptable carrier.
Palese et al. teach the generation of a recombinant influenza NA protein that comprises a globular head and a tetramerization domain from a measles virus phosphoprotein. [see paragraph 12] Palese et al. also teach that addition of adjuvants with their immunogenic compositions, such as CpG adjuvants and aluminum salts. [see paragraph 174] The phosphoprotein employed by Palese et al. is SEID NO: 4, which is identical to the phosphoprotein of the instant invention. Palese et al. also teach the addition of a cleavage site (SEQ ID NO:s 51 and 52), which are identical to SEQ ID NO:s 36 and 38 of the instance invention, respectively and they teach the globular head (SEQ ID NO: 66) of the NA of A/Michigan/45/15, which is identical to SEQ ID NO: 31 of the instant invention and SEQ ID NO: 58 being identical to SEQ ID NO: 42 of the instant invention. Palese et al. also teach the globular head sequences from influenza A/Kansas/14/2017 (SEQ ID NO: 64) and influenza B/Colorado/06/2017 (SEQ ID NO: 65), which are identical to SEQ ID NO:s 32 and 33 of the instant invention. SEQ ID NO: 60 of Palese et al. is identical to SEQ ID NO: 60 of the instant invention and SEQ ID NO: 62 is identical to SEQ ID NO: 68 of the instant invention. Palese et al. also teach that the immunogenic composition can further comprise a trivalent influenza vaccine. [see paragraph 26] Palese et al. also teach that influenza virus infections can be treated by administering the immunogenic composition. [see paragraph 147]
However, Palese et al. do not teach the inclusion of an oligonucleotide comprising 5’-GAACGTTCG-3’, more specifically SEQ ID NO: 14.
Kemter et al. teach immunogenic compositions that comprise viral proteins and the inclusion of adjuvants with these immunogenic compositions. Examples of the viral proteins are influenza proteins and examples of the adjuvants are CpG1018, which comprises SEQ ID NO: 14, and MF59. [see paragraphs 105, 106, 108 and 110 and Table 2]
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Palese et al. in order to include an oligonucleotide adjuvant that comprises the sequence 5’-GAACGTTCG-3’, which is in SEQ ID NO: 14. One would have been motivated to do so, given the suggestion by Palese et al. that the oligonucleotides, such as CpGs can be included as adjuvants with their immunogenic compositions. There would have been a reasonable expectation of success, given the knowledge that using CpG 1018 as an adjuvant with immunogenic compounds, including viral immunogenic compounds was previously known, as taught by Kemter et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 1, 5, 10, 20, 25, 32, 36, 48, 51, 56, 58, 60, 67, 68, 74, 79, 83, 85, 90 and 94 are rejected under 35 U.S.C. 103 as being unpatentable over Rottier et al. (US PGPub 2013/0034578) Leenhouts et al. (US PGPub 2014/0093532) and in view of Kemter et al. (supra).
The claimed invention is drawn to an immunogenic composition comprising one or two recombinant neuraminidases (NA), wherein the recombinant NA comprises an influenza NA globular head domain and a paramyxovirus phosphoprotein tetramerization domain. In addition, the recombinant NA lacks an influenza virus NA stalk domain, transmembrane domain and cytoplasmic domain, and the composition comprises an adjuvant that comprises oligonucleotide of from 10 to 35 nucleotides in length comprising the sequence of 5’-GAACGTTCG-3’ in an admixture with a pharmaceutically acceptable carrier.
The oligonucleotide comprises SEQ ID NO: 4 and the adjuvant further comprises an aluminum salt. The specification at paragraph 72 states that CpG 1018 comprises SEQ ID NO: 4, which also comprises 5’-GAACGTTCG-3’
The recombinant NA is enzymatically active.
The globular head sequences can be at least 80% identical to SEQ ID NO:s 31.
The immunogenic composition also comprises an influenza vaccine.
The neuraminidase proteins may be from an influenza A N1, influenza A N2 or influenza B viruses.
Rottier et al. teach a recombinant influenza NA protein ectodomain comprising a tetramerization domain. The term "tetramerization domain" as used herein is defined as a domain that mediates the formation of a tetramer out of four monomeric proteins or parts thereof. Suitable tetramerization domains include, but are not limited to, the Sendai virus phosphoprotein tetramerization domain and a tetramerization domain (GCN4-pLI) derived by mutation from the yeast GCN4 dimerization domain. In a preferred embodiment, tetramerization of a recombinant influenza neuraminidase ectodomain or part thereof is provided by a GCN4-based tetramerization domain. [see paragraph 29] One example of the NA protein is a head domain from amino acids 75-469 of influenza A/California/04/2009 [see paragraph 58], which is attached to a GCN4 tetramerization domain. [see paragraph 83] In addition, SEQ ID NO: 19 of Rottier et al. is the NA protein from A/California/04/2009, which is 97% identical to SEQ ID NO: 31 of the instant invention. Rottier et al. further teach the addition of an adjuvant with the immunogenic composition, such as CpG oligonucleotides, alum, aluminium hydroxide or ISCOMs or carriers [see paragraph 30] and a pharmaceutically acceptable diluent. [see paragraph 12] Sendai virus is a paramyxovirus. Rottier et al. teach that the neuraminidase protein of any influenza A, B or C virus and any serotype from N1-N9 [see paragraph 14] and Rottier et al. further teach at paragraph 23: “Thus for example, 2, 3, 4, 5, 6, 7, 8, 9 or 10 trimeric hemagglutinin ectodomains or parts thereof can be combined, such as H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15 and/or H16, or 2, 3, 4, 5, 6, 7, 8 or 9 tetrameric neuraminidase ectodomains or parts thereof can be combined, such as N1, N2, N3, N4, N5, N6, N7, N8 and/or N9. Additionally, an immunogenic composition according to the invention may comprise a combination of one or more trimeric hemagglutinin ectodomains or parts thereof and one or more tetrameric neuraminidase ectodomains or parts thereof of different influenza subtypes. For example, 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 trimeric hemagglutinin ectodomains or parts thereof and 1, 2, 3, 4, 5, 6, 7, 8 or 9 tetrameric neuraminidase ectodomains or parts thereof can be combined, such as H1, H2, H3, H4, H5, H6, H7, H8, H9, H10, H11, H12, H13, H14, H15, H16, N1, N2, N3, N4, N5, N6, N7, N8 and/or N9. It will be clear to a skilled person that the term "one or more ectodomains" encompasses one or more ectodomains from one or more influenza virus subtypes, such as for example Influenza A virus and Influenza B virus. Thus, an immunogenic composition according to the invention can be a multivalent composition with which an improved protection against an influenza virus infection can be achieved as compared to an immunogenic composition comprising one recombinant trimeric influenza hemagglutinin ectodomain or part thereof or one recombinant tetrameric influenza neuraminidase ectodomain or part thereof. Additionally, or alternatively, with a multivalent composition a wider protection against more than one influenza virus type, or influenza virus subtypes or strains can be achieved. Furthermore, an immunogenic composition according to the invention may be less sensitive to antigenic alterations than traditional inactivated or live attenuated influenza virus vaccines.” Therefore, Rottier et al. teach generating a combination of multiple recombinant NA proteins and the inclusion of an influenza vaccine.
Leenhouts et al. teach the generation of recombinant influenza NA proteins comprising the head domain (amino acids 75-469 of the NA from A/Mallard/Netherlands/2/2005) and a GCN4 tetramerization domain. [see paragraph 91] Leenhouts et al. also teach that tetramerization domains from Sendai virus phosphoprotein can be used. [see paragraph 46] Leenhouts et al. further teach methods of eliciting an immune response by administering a recombinant protein. [see paragraph 57] Sendai virus is a paramyxovirus.
Kemter et al. teach immunogenic compositions that comprise viral proteins and the inclusion of adjuvants with these immunogenic compositions. Examples of the viral proteins are influenza proteins and examples of the adjuvants are CpG1018, which comprises SEQ ID NO: 14, and MF59. [see paragraphs 105, 106, 108 and 110 and Table 2]
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Rottier et al. and Leenhouts et al. in order to include an oligonucleotide adjuvant that comprises the sequence 5’-GAACGTTCG-3’, which is comprised by SEQ ID NO: 14. One would have been motivated to do so, given the suggestion by Rottier et al. that the oligonucleotides, such as CpGs, can be included as adjuvants with their immunogenic compositions and Rottier et al. and Leenhouts et al. both teach formulation of a recombinant influenza A NA head domain linked with a tetramerization domain, such as that of a Sendai phosphoprotein. There would have been a reasonable expectation of success, given the knowledge that using CpG 1018 as an adjuvant with immunogenic compounds, including viral immunogenic compounds was previously known, as taught by Kemter et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 2, 3, 26, 27, 71 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Rottier et al., Leenhouts et al. and in view of Kemter et al. as applied to claims 1, 5, 10, 20, 25, 32, 36, 48, 51, 56, 58, 60, 67, 68, 74, 79, 83, 85, 90 and 94 above, and further in view of GenBank Accession 4C5Q_A (12/1/2020).
The paramyxovirus phosphoprotein is from a measles virus, such as an amino acid sequence having at least 80% identity to the amino acid sequence of SEQ ID NO: 8, and the
The teachings of Rottier et al., Leenhouts et al. and Kemter et al. are summarized above. While Rottier et al. and Leenhouts et al. do teach the use of a tetramerization domain from a phosphoprotein of a Sendai virus, they do not teach the sequence of the phosphoprotein being at least 80% identical to SEQ ID NO: 8.
GenBank 4C5Q_A teach a phosphoprotein tetramerization domain of a measles virus that is 97% identical to SEQ ID NO: 8.
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Rottier et al. and Leenhouts et al. in order to include an oligonucleotide adjuvant that comprises the sequence 5’-GAACGTTCG-3’, which is comprised by SEQ ID NO: 14 and to use the phosphoprotein tetramerization domain of a measles virus, which is at least 80% identical to SEQ ID NO: 8. One would have been motivated to do so, given the suggestion by Rottier et al. that the oligonucleotides, such as CpGs, can be included as adjuvants with their immunogenic compositions and Rottier et al. and Leenhouts et al. both teach formulation of a recombinant influenza A NA head domain linked with a tetramerization domain, such as that of a Sendai phosphoprotein. There would have been a reasonable expectation of success, given the knowledge that using CpG 1018 as an adjuvant with immunogenic compounds, including viral immunogenic compounds was previously known, as taught by Kemter et al., and also given the knowledge that a measles virus phosphoprotein tetramerization domain with at least 80% identity to SEQ ID NO: 8 was previously known, as taught by GenBank Accession 4C5Q_A. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 8, 10, 33, 34, 37, 38, 77 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Rottier et al., Leenhouts et al. and in view of Kemter et al. as applied to claims 1, 5, 10, 20, 25, 32, 36, 48, 51, 56, 58, 60, 67, 68, 74, 79, 83, 85, 90 and 94 above, and further in view of Henderson et al. (US PGPub 20230000974), GenBank Accessions QBL89780 (3/18/2019) and QIA50738 (2/18/2020).
The claimed invention also requires:
The influenza NA head domain is from an influenza A or B NA, wherein the influenza A virus is A/Michigan/45/2015 or A/Kansas/14/2017 or the influenza B is B/Colorado/6/2017.
The globular head sequences can also be at least 80% identical to SEQ ID NO:s 32 or 33.
The teachings of Rottier et al., Leenhouts et al. and Kemter et al. are summarized above. While Rottier et al. and Leenhouts et al. do teach the neuraminidase head of specific influenza A viruses, and Rottier et al. teach that the neuraminidase protein of any influenza A, B or C virus and any serotype from N1-N9 [see paragraph 14], they do not teach the domains being that of influenza A virus is A/Michigan/45/2015 or A/Kansas/14/2017 or the influenza B is B/Colorado/6/2017 or at least 80% identical to SEQ ID NO:s 32 or 33.
Henderson et al. teach influenza neuraminidase protein of influenza B/Colorado/6/2017, which is SEQ ID NO: 3 and it is identical to SEQ ID NO: 33 of the instant invention.
GenBank Accessions QBL89780 and QIA50738 teach the neuraminidase proteins of A/Michigan/45/2015 and A/Kansas/14/2017, respectively, which comprise SEQ ID NO:s 31 and 32, respectively.
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Rottier et al. and Leenhouts et al. in order to include an oligonucleotide adjuvant that comprises the sequence 5’-GAACGTTCG-3’, which is comprised by SEQ ID NO: 14 and to use the phosphoprotein tetramerization domain of a measles virus, which is at least 80% identical to SEQ ID NO: 8 and to employ the head domains from influenza A/Michigan/45/2015 or A/Kansas/14/2017 or the influenza B is B/Colorado/6/2017. One would have been motivated to do so, given the suggestion by Rottier et al. that the oligonucleotides, such as CpGs, can be included as adjuvants with their immunogenic compositions and Rottier et al. and Leenhouts et al. both teach formulation of a recombinant influenza A NA head domain linked with a tetramerization domain, such as that of a Sendai phosphoprotein, and Rottier et al. teach that the neuraminidase protein of any influenza A, B or C virus and any serotype from N1-N9. There would have been a reasonable expectation of success, given the knowledge that using CpG 1018 as an adjuvant with immunogenic compounds, including viral immunogenic compounds was previously known, as taught by Kemter et al., also given the knowledge that a measles virus phosphoprotein tetramerization domain with at least 80% identity to SEQ ID NO: 8 was previously known, as taught by GenBank Accession 4C5Q_A, and also given the knowledge that the influenza virus neuraminidase proteins of A/Michigan/45/2015 or A/Kansas/14/2017 or the influenza B is B/Colorado/6/2017 are previously known. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim(s) 12, 14, 40 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Rottier et al., Leenhouts et al. and Kemter et al. as applied to claims 1, 5, 10, 20, 25, 32, 36, 48, 51, 56, 58, 60, 67, 68, 74, 79, 83, 85, 90 and 94 above, and further in view Garcia-Sastre et al, (US PGPub 2019/0099484).
The recombinant neuraminidase(s) further comprise a cleavage site, such as a thrombin cleavage site having the amino acid sequence of SEQ ID NO: 36.
The teachings of Rottier et al., Leenhouts et al. and Kemter et al. are summarized above. While Rottier et al. and Leenhouts et al. do teach the use of a thrombin cleavage site of SEQ ID NO: 36.
Garcia-Sastre et al. teach the generation of recombinant influenza HA proteins that possess a thrombin cleavage site and a heterologous trimerization domain. The cleavage site (SEQ ID NO: 19) is the same as SEQ ID NO: 36 of the instant invention. [see paragraph 163]
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Rottier et al. and Leenhouts et al. in order to include an oligonucleotide adjuvant that comprises the sequence 5’-GAACGTTCG-3’, which is comprised by SEQ ID NO: 14 and the use of a cleavage site comprising SEQ ID NO: 36. One would have been motivated to do so, given the suggestion by Rottier et al. that the oligonucleotides, such as CpGs, can be included as adjuvants with their immunogenic compositions and Rottier et al. and Leenhouts et al. both teach formulation of a recombinant influenza A NA head domain linked with a tetramerization domain, such as that of a Sendai phosphoprotein. There would have been a reasonable expectation of success, given the knowledge that using CpG 1018 as an adjuvant with immunogenic compounds, including viral immunogenic compounds was previously known, as taught by Kemter et al., and also given the knowledge that a measles virus phosphoprotein tetramerization domain with at least 80% identity to SEQ ID NO: 8 was previously known, as taught by GenBank Accession 4C5Q_A. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Rottier et al. (supra), Leenhouts et al. (supra) and in view of Kemter et al. (supra), GenBank Accessions QIA50738 (2/18/2020) and 4C5Q_A (12/1/2020).
The claimed invention is drawn to an immunogenic composition comprising:
a) recombinant neuraminidase comprising an amino acid sequence having at least 80% identity to SEQ ID NO:50, 52, 54, 56 or 58, or SEQ ID NO:50, 52, 54, 56 or 58 without the signal sequence; and
b) an adjuvant, wherein the adjuvant comprises an oligonucleotide of from 10 to 35 nucleotides in length comprising the nucleotide sequence of 5'- GAACGTTCG-3', in an admixture with a pharmaceutically acceptable carrier.
The teachings of Rottier et al., Leenhouts et al. and in view of Kemter et al., GenBank Accessions QIA50738 and 4C5Q_A are summarized above, however, they do not individually teach a recombinant neuraminidase with at least 80% identity with SEQ ID NO: 50.
It would have been obvious to one of ordinary skill in the art to modify the compositions and methods taught by Rottier et al. and Leenhouts et al. in order to include an oligonucleotide adjuvant that comprises the sequence 5’-GAACGTTCG-3’, which is comprised by SEQ ID NO: 14 and to use the phosphoprotein tetramerization domain of a measles virus, which is at least 80% identical to SEQ ID NO: 8 and to employ the head domains from influenza A/Kansas/14/2017. One would have been motivated to do so, given the suggestion by Rottier et al. that the oligonucleotides, such as CpGs, can be included as adjuvants with their immunogenic compositions and Rottier et al. and Leenhouts et al. both teach formulation of a recombinant influenza A NA head domain linked with a tetramerization domain, such as that of a Sendai phosphoprotein, and Rottier et al. teach that the neuraminidase protein of any influenza A, B or C virus and any serotype from N1-N9. There would have been a reasonable expectation of success, given the knowledge that using CpG 1018 as an adjuvant with immunogenic compounds, including viral immunogenic compounds was previously known, as taught by Kemter et al., also given the knowledge that a measles virus phosphoprotein tetramerization domain with at least 80% identity to SEQ ID NO: 8 was previously known, as taught by GenBank Accession 4C5Q_A, and also given the knowledge that the influenza virus neuraminidase proteins of A/Kansas/14/2017 is previously known, as taught by GenBank QIA50738.
Therefore, in view of the combined teachings of Rottier et al., Leenhouts et al., and in view of Kemter et al., GenBank Accessions QIA50738 (2/18/2020) and 4C5Q_A (12/1/2020), on of ordinary skill in the art would have a reasonable expectation of generating a protein sequence with at least 80% identity to SEQ ID NO: 50.
Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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, 2, 3, 4, 8, 10, 12, 14, 20, 22, 51, 56, 58, 60, 67, 68, 71, 72, 74, 77, 79, 83, 85, 90 and 94 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-18 of U.S. Patent No. 12655408 in view of Rottier et al. (supra) and Kemter et al. (supra). The patented invention is drawn to a recombinant neuraminidase proteins that comprises SEQ ID NO:s 31, 32 or 33, SEQ ID NO: 8 and the cleavage site of SEQ ID NO: 37, however, the patented invention do not recite the inclusion of an adjuvant comprising alum and an oligonucleotide, such as SEQ ID NO: 14. As discussed above, Rottier et al. teach the use of adjuvants comprising alum or CpG oligonucleotides with their immunogenic compositions and Kemter et al. teach the use of the CpG 1018 (which comprises SEQ ID NO: 14) as an adjuvant. Therefore, the instant invention is rendered obvious.
Claims 1, 2, 3, 4, 8, 10, 12, 14, 20, 22, 51, 56, 58, 60, 67, 68, 71, 72, 74, 77, 79, 83, 85, 90 and 94 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 50, 51 and 53-70 of copending Application No. 19679512 in view of Rottier et al. (supra) and Kemter et al. (supra). The invention of the copending application is drawn to method of administering a recombinant neuraminidase proteins that comprises SEQ ID NO:s 31, 32 or 33, SEQ ID NO: 8 and the cleavage site of SEQ ID NO: 37, however, the patented invention do not recite the inclusion of an adjuvant comprising alum and an oligonucleotide, such as SEQ ID NO: 14. As discussed above, Rottier et al. teach the use of adjuvants comprising alum or CpG oligonucleotides with their immunogenic compositions and Kemter et al. teach the use of the CpG 1018 (which comprises SEQ ID NO: 14) as an adjuvant. Therefore, the instant invention is rendered obvious.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
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