DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS’s) submitted on 6/27/2024 have been considered by the examiner.
Specification
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Paragraph [0001] of the instant published application, USPgPub 2024/0417699, incorporates PCT/US2014/015274, 61/794,155, and 61/762,768. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The use of the term “GenBank”, which is a trade name or a mark used in commerce, has been noted in this application, see paragraph [0017] of the instant published disclosure. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Applicant is required to properly annotate all trade names and/or marks present in the instant specification, if any additional trade names and/or marks are discovered.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 is drawn to a recombinant polynucleotide comprising a nucleotide sequence that possesses about 77% to 93% identity with the nucleotide sequence of the parent RSV genome, wherein the recombinant polynucleotide encodes the same amino acid sequence as the parent RSV. It is unclear how sequence comparison percentages can be determined without any structural consensus provided for comparison. The percent identity differences are indeterminate. There are no structural features required, only a broad range (77% - 93%) of percentage of sequence identity. There is no disclosure of structure, sequence, or physical properties of either the starting material (parent virus sequence) or the finished material. This rejection affects all dependent claims.
Claim 39 requires that the nucleotide sequence encoding each RSV protein, selected from any nine. However, since only nine proteins are listed, it is unclear what other proteins are intended to be encompassed.
Claims 42 and 43 are indefinite and incomplete for depending on non-existent claims 52 and 53. Since the limitations recited are indeterminable, these claims have not been further treated.
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.
Claims 1-41 and 44-51 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The instant claims are drawn to a polynucleotide sequence that possesses about 77% to 93% identity with the nucleotide sequence of the parent RSV genome, wherein the recombinant polynucleotide encodes the same amino acid sequence as the parent RSV. It is unclear how corresponding sequences between the instant codon-pair deoptimized RSV and a parent virus can be determined without any structural consensus provided for comparison. The percent identity differences are indeterminate. There are no structural features required, only a broad range (77% - 93%) of percentage of sequence identity. There is no disclosure of structure, sequence, or physical properties of either the starting material (parent virus sequence) or the finished material (codon-pair deoptimized virus sequence). The claims also encompass a vaccine comprising the recombinant RSV vaccine.
The instant disclosure does not adequately describe the genus of attenuated RSV claimed. Given the extensive sequence variation that exists between RSV A and B groups (see the abstract and discussion sections of Johnson et al. (PNAS. 1987; 84: 5625-5629, cited in the IDS). In addition, there is a lack of predictability for whether the specific site mutations selected from amino acid residues recited in instant claim 41 within the N, P, or, M2-1 would be sufficiently attenuating. Lee et al. (Journal of Virology. Dec. 2012; 86 (24): 13810-13811, cited in the IDS) show that even a single strain, HRSV-A/GN435/11, possesses 0.46% to 6.03% nucleic acid variability, see the first and third paragraphs.
The working examples indicate that the recombinant codon-deoptimized RSV were constructed based on strain A2, see paragraph [0061] of the instant disclosure, based on the synthetic attenuated virus engineering (SAVE) technique described by Coleman et al., see paragraph [0006] of the instant published disclosure, USPgPub 2024/0417699. In working examples 2, 4, 5, and 8, codon-pair-deoptimized (CPD) viruses demonstrate a lower replication rate, temperature-sensitive growth restriction, reduced synthesis of genomic RNA, virus particle production, and small plaque sizes in vitro compared with non-codon-deoptimized rRSV. The CPD viruses also exhibit the same abundance of genomic RNA copies per plaque forming units as rRSV and replication is shown to be only slightly reduced compared with rRSV. These results are depicted in instant Figures 1-3. When African Green Monkeys are inoculated with CPD viruses, a robust antibody response is induced despite reduced replication, see Figure 4 and Example 7. In addition, virus shedding is slightly delayed and of shorter duration when Min L is compared with rRSV-inoculated monkeys. It is also noted that the inventors, published as Nouen et al. (PNAS. Sept. 2014; 111 (36): 13169-13174, cited in the IDS), observe that the level of restriction of Min L in African Green Monkeys is comparable to two, live-attenuated RSV pediatric vaccine candidates currently in clinical trials, see the first full paragraph on page 13174.
However, the instant CPD RSV constructs are not limited to those only achieved by the SAVE method, but any codon-deoptimized method. Given the extensive sequence variation that exists between RSV A and B groups (see the abstract and discussion sections of Johnson et al. (PNAS. 1987; 84: 5625-5629, supra), there remains a lack of predictability for whether the specific site mutations within the NS1, NS2, N, P, M, SH, G, F, or M2-1, would be sufficiently attenuating, discussed at least sixty-six times in the instant disclosure. This is especially evident from the teachings of Nouen et al. (PNAS. Jan. 2017; 114 (3): E386-E395, cited in the IDS). Nouen et al. clearly indicate genetic instability of the RSV L codon-pair deoptimized constructs, see Table 1 for example, unless additional substitutions are present in Figures 3 and 5:
N protein [K136R]; P protein [El14V]; and M2-1 protein [N88K], identified as genetically stable isolate: NPM2-1[N88K]L, see “Genetic stability of the NPM2-1[N88K]L Virus” on page E393. Nouen et al. (all of substantial and expert skill in the art) conclude on page E395:
Therefore, deoptimization involving large numbers of nucleotide changes does not necessarily provide a stable attenuation phenotype.
Nonetheless, logarithmic quantities of codon pair nucleic acid sequences, deoptimized from any parent RSV encompasses variations from 77-93%, as instantly claimed. An artisan of the most ordinary skill would be unable to envision such sequences. Lee et al. (Journal of Virology. Dec. 2012; 86 (24): 13810-13811, cited in the IDS) show that even a single strain, HRSV-A/GN435/11, possesses 0.46% to 6.03% nucleic acid variability, see the first and third paragraphs. Due to the broad genetic variation of RSV, the functional success cannot be predicted with the broad genus of RSV parent viruses and the almost infinite quantity of mutations claimed, as evidenced by Nouen et al. (2017). Due to the significant genetic diversity of RSV (discussed by Johnson et at. and Lee et al.), one skilled in the art would not be able to predict the structural changes to any RSV within the broad scope claimed or predicting whether the altered genome would be sufficiently attenuating and/or immunogenic, as well as stable (discussed by Nouen et al. (2017). The species of codon-pair deoptimized RSV of the instant disclosure, rRSV Min A (Min A), rRSV Min B (Min B), rRSV Min L (Min L) and rRSV Min FLC (Min FLC), do not represent the entire genus of CPD RSV viruses claimed. CPD RSV species pRSV Min L_N, pRSV Min L_P, pRSV Min L_M21, pRSV Min L_NP, pRSV Min L_NM21, pRSV Min_LPM21, or pRSV_Min LNPM21 are recited in instant claim 51, but no structures are provided. The skilled artisan would be unable to predict the structures encompassed by these species without adequate description.
When a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed. However, the presence of multiple species with in a claimed genus does not necessarily demonstrate possession of the genus. See, In re Smyth, 178 U.S.P.Q. 279 at 284-85 (CCPA 1973) (stating “where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus or combination claimed at a later date in the prosecution of a patent application.”); and University of California v. Eli Lilly and Co., 43 USPQ2d 1398, at 1405 (Fed Cir 1997)(citing Smyth for support).
The instant CPD RSV genomes discussed in the instant working examples do not clearly provide structure or physical properties such as a minimum number of codon rearrangements, a minimum number of codon pairs to be modified in order to reach the required reduction in codon-pair bias, or a minimum percentage of sequence identity to correlate with the result of attenuated pathogenicity of viruses. Given that there is no known correlation between any structural component and the ability to attenuate viral pathogenicity, the specification's description of structurally different viral sequences does not correlate to a structural description of the claimed products possessing the necessary attributes of genetic stability, increased replication, sufficient attenuation and immunogenicity, as claimed. For these reasons, it is determined that the instant claims lack written description for the broad genus of CPD RSV claimed.
Claims 1-41 and 44-51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for rRSV Min A (Min A), rRSV Min B (Min B), rRSV Min L (Min L) and rRSV Min FLC (Min FLC) discussed in the instant working examples, does not reasonably provide enablement for pRSV Min L_N, pRSV Min L_P, pRSV Min L_M21, pRSV Min L_NP, pRSV Min L_NM21, pRSV Min_LPM21, or pRSV_Min LNPM21 or any codon pair deoptimized (CPD) RSV that possesses about 77% to 93% identity with the nucleotide sequence of the parent RSV genome, wherein the recombinant polynucleotide encodes the same amino acid sequence as the parent RSV. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
The instant claims are drawn to a codon-pair deoptimized recombinant polynucleotide and vaccine comprising a nucleotide sequence that possesses about 77% to 93% identity with the nucleotide sequence of the parent RSV genome, wherein the recombinant polynucleotide encodes the same amino acid sequence as the parent RSV or encodes an RSV amino acid sequence with up to three amino acid substitutions, additions, or deletions compared with the parent RSV amino acid sequence. It is unclear how corresponding sequences between the instant codon-pair deoptimized RSV and a parent virus can be determined without any structural consensus provided for comparison. The percent identity differences are indeterminate. There are no structural features required, only a broad range (77% - 93%) of percentage of sequence identity. There is no disclosure of structure, sequence, or physical properties of either the starting material (parent virus sequence) or the finished material (codon-pair deoptimized virus sequence). The claims also encompass an RSV vaccine.
The instant disclosure does not adequately describe the genus of attenuated RSV claimed. Given the extensive sequence variation that exists between RSV A and B groups (see the abstract and discussion sections of Johnson et al. (PNAS. 1987; 84: 5625-5629, cited previously), there is a lack of predictability for whether the specific site mutations selected from amino acid residues recited in instant claim 41 within the N, P, or M2-1, would be sufficiently attenuating. Lee et al. (Journal of Virology. Dec. 2012; 86 (24): 13810-13811, cited previously) show that even a single strain, HRSV-A/GN435/11, possesses 0.46% to 6.03% nucleic acid variability, see the first and third paragraphs.
The working examples indicate that the recombinant codon-deoptimized RSV were constructed based on strain A2, see paragraph [0061] of the instant disclosure, based on the synthetic attenuated virus engineering (SAVE) technique described by Coleman et al., see paragraph [0006] of the instant disclosure. In working examples 2, 4, 5, and 8, codon-pair-deoptimized (CPD) viruses demonstrate a lower replication rate, temperature-sensitive growth restriction, reduced synthesis of genomic RNA, virus particle production, and small plaque sizes in vitro compared with non-codon-deoptimized rRSV. The CPD viruses also exhibit the same abundance of genomic RNA copies per plaque forming units as rRSV and replication is shown to be only slightly reduced compared with rRSV. These results are depicted in instant Figures 1-3. When African Green Monkeys are inoculated with CPD viruses, a robust antibody response is induced despite reduced replication, see Figure 4 and Example 7. In addition, virus shedding is slightly delayed and of shorter duration when Min L is compared with rRSV-inoculated monkeys. It is also noted that the inventors, published as Nouen et al. (PNAS. Sept. 2014; 111 (36): 13169-13174, cited previously), observe that the level of restriction of Min L in African Green Monkeys is comparable to two, live-attenuated RSV pediatric vaccine candidates currently in clinical trials, see the first full paragraph on page 13174.
However, the instant CPD RSV constructs are not limited to those only achieved by the SAVE method, but any codon-deoptimized method. Given the extensive sequence variation that exists between RSV A and B groups (see the abstract and discussion sections of Johnson et al. (PNAS. 1987; 84: 5625-5629, supra), there remains a lack of predictability for whether the specific site mutations within the NS1, NS2, N, P, M, SH, G, F, or M2-1, would be sufficiently attenuating, discussed at least sixty-six times in the instant disclosure. This is especially evident
from the teachings of Nouen et al. (PNAS. Jan. 2017; 114 (3): E386-E395, cited previously). Nouen et al. clearly indicate genetic instability of the RSV L codon-pair deoptimized constructs, see Table 1 for example, unless additional substitutions are present in Figures 3 and 5:
N protein [K136R]; P protein [El 14V]; and M2-1 protein [N88K], identified as genetically stable isolate: NPM2-1[N88K]L, see “Genetic stability of the NPM2-1[N88K]L Virus” on page E393. Nouen et al. (all of substantial and expert skill in the art) conclude on page E395:
Therefore, deoptimization involving large numbers of nucleotide changes does not necessarily provide a stable attenuation phenotype.
Nonetheless, logarithmic quantities of codon pair nucleic acid sequences, deoptimized from any parent RSV encompasses variations from 77-93%, as instantly claimed. An artisan of the most ordinary skill would be unable to envision such sequences. Lee et al. (Journal of Virology. Dec. 2012; 86 (24): 13810-13811, cited previously) show that even a single strain, HRSV-A/GN435/11, possesses 0.46% to 6.03% nucleic acid variability, see the first and third paragraphs. Due to the broad genetic variation of RSV, the functional success cannot be predicted with the broad genus of RSV parent viruses and the almost infinite quantity of mutations claimed, as evidenced by Nouen et al. (2017). Due to the significant genetic diversity of RSV (discussed by Johnson et at. and Lee et al.), one skilled in the art would not be able to predict the structural changes to any RSV within the broad scope claimed or predicting whether the altered genome would be sufficiently attenuating and/or immunogenic, as well as stable (discussed by Nouen et al. (2017).
In the paragraph pages 435-436 of Ruckwardt et al. (Immunity. September 2019; 51: 429-442, cited in the IDS), state:
The expression of NS1 and NS2 virulence genes can also be diminished by codon deoptimization (Meng et al., 2014). Each set of mutations must be empirically tested, and the in vivo response can be complicated by age- and host-dependent susceptibility factors. It is unknown if these strategies can alter the context of vaccine antigen presentation enough to shift the paradigm of natural infection toward the generation of more durable adaptive responses, as these vaccines still possess some of the immunomodulatory features of wildtype RSV. Ultimately, immune responses superior to natural infection will be needed to confer protective and durable immunity.
Therefore, there are unexpected differences in RSV structure and predicted function according to the conclusions in the current state of the art. In the instant case, the claims encompass RSV recombinants with indefinite structure ranging between 77% to 93% at the nucleic acid level compared to any parent RSV and no correlated function, such as replication efficiency and/or immunogenicity and/or attenuated and/or stability, ect.
The species of codon-pair deoptimized RSV of the instant disclosure, rRSV Min A (Min A), rRSV Min B (Min B), rRSV Min L (Min L) and rRSV Min FLC (Min FLC), do not represent the entire genus of CPD RSV viruses claimed. CPD RSV species pRSV Min L_N, pRSV Min L_P, pRSV Min L_M21, pRSV Min L_NP, pRSV Min L_NM21, pRSV Min_LPM21, or pRSV_Min LNPM21 are recited in instant claim 51, but no structures are provided. The skilled artisan would be unable to predict the level of attenuation and/or stability of the viruses encompassed by within the broad genus claimed without sufficient guidance.
The instant CPD RSV genomes discussed in the instant working examples do not clearly provide structure or physical properties such as a minimum number of codon rearrangements, a minimum number of codon pairs to be modified in order to reach the required reduction in codon-pair bias, or a minimum percentage of sequence identity to correlate with the result of attenuated pathogenicity of viruses, mentioned at least sixty-six times throughout the instant disclosure. Given that there is no known correlation between any structural component and the ability to attenuate viral pathogenicity, the specification's description of structurally different viral sequences does not correlate to a structural description of the claimed products possessing the necessary attributes of genetic stability, increased replication, sufficient attenuation and immunogenicity, as claimed. For these reasons, it is determined that an undue quantity of experimentation would be required of the skilled artisan to make and use the broad genus of CPD RSV claimed.
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 1-3, 28-34, 41, 44, 45, 47, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 7-10 of U.S. Patent No. 9,957,486. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 2 of ‘486, drawn to a recombinant polynucleotide encoding RSV with an L protein that has been codon-deoptimized resulting in a nucleotide sequence sharing between 70%-90%, or 79% identity to the corresponding parent virus, anticipating instant claims 1-3, 28, and 29. Claim 3 of ‘486 requires that the nucleic acid sequence encoding the RSV L protein has the sequence corresponding to nucleotides 8387-14884 of SEQ ID NO: 5, anticipating instant claim 30. Claim 4 of ‘486 requires that the recombinant polynucleotide further comprises a nucleotide change in one or more of the following: the codon encoding amino acid 136 of the N protein; the codon encoding amino acid 114 of the P protein; the codon encoding amino acid 88 and/or 73 of the M2-1 protein, anticipating instant claim 41, as well as the nucleotide sequences encoding each parent RSV protein, comprising any two to four recombinant polynucleotides encoding different RSV proteins selected from: N, P, M2-1, and L proteins, encompassed by instant claims 31-34. Claims 7-10 of ‘486 anticipate instant claims 44, 45, 47, and 48, respectively.
Claims 1-4, 7, 22, 25, 28, 32-35, 40, 41, and 44-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 6-13 of U.S. Patent No. 11,371,024. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘486, drawn to a recombinant polynucleotide encoding RSV proteins that have been codon-deoptimized resulting in a nucleotide sequence sharing between 75%-95% for NS1, recited in instant claim 4; 75%-95% for NS2, recited in instant claim 7; 65%-85% for G, recited in instant claim 22; 65%-85% for F, recited in instant claim 25; and 70%-90% for L, recited in instant claim 28, identity to the corresponding parent virus, anticipating instant claims 1-3. Claim 2 of ‘024 anticipates the recombinant RSV genomes recited in instant claim 40. Claim 3 of ‘024 requires that the recombinant polynucleotide further comprises a nucleotide change in one or more of the following: the codon encoding amino acid 136 of the N protein; the codon encoding amino acid 114 of the P protein; the codon encoding amino acid 88 and/or 73 of the M2-1 protein, anticipating instant claim 41, as well as the nucleotide sequences encoding each parent RSV protein, comprising any two to five recombinant polynucleotides encoding different RSV proteins selected from: NS1, NS2, G, F, and L proteins, encompassed by instant claims 31-35. Claims 6-13 of ‘024 anticipate instant claims 44-51, respectively.
Claims 1-9 and 44-48 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-11, 13, and 17-20 of U.S. Patent No. 12,054,749. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 3-5 of ‘749, drawn to a recombinant polynucleotide encoding RSV proteins that have been codon-deoptimized resulting in a nucleotide sequence sharing between 75%-95% or 87% for NS1, recited in instant claims 4 and 5, or has nucleotides 99-518 of SEQ ID NO: 5, recited in instant claims 6 and 7. Claims 3, 8, and 9 of ‘749 recites the polynucleotide is about 75%-95%, or 88% identical for NS2 of SEQ ID NO: 5, recited in instant claims 7 and 8. Claims 10 and 11 of ‘749 anticipate the NS2 protein having nucleotides 628-1002 of SEQ ID NO: 5, anticipating instant claim 9. The identities correspond to the corresponding parent virus, anticipating instant claims 1-3. Claims 13 and 17-20 of ‘749 anticipate and correspond to instant claims 44-48, respectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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