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 .
Specification
The disclosure is objected to because of the:
At page 7 and elsewhere in the specification, sequences are described by reference to Genbank Accession Nos., which are subject to change, rather than to sequences set forth in the specification. This is an improper incorporation by reference, since the information required to describe and enable the required sequences is found in the NCBI database, extraneous to the application. Furthermore, since the NCBI sequences are not irrevocably fixed but are corrected and updated as additional sequence information becomes available, the NCBI accession numbers may refer to sequences which change after the application filing date. Thus, the disclosure is objected to for this improper incorporation by reference.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-5 and 7 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 4 and 7 are unclear because they refer to a Genbank accession number rather than to sequences set forth in the specification. This is seen as an improper incorporation by reference, since the information required to describe and enable the required sequences is found in the Genbank database, extraneous to the application. Furthermore, since Genbank sequences are not irrevocably fixed but are corrected and updated as additional sequence information becomes available, the Genbank accession number may refer to sequences which change before or after the application filing date. The incorporation of essential material in the specification by reference to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference. The amendment must be accompanied by an affidavit or declaration executed by the applicant, or a practitioner representing the applicant, stating that the amendatory material consists of the same material incorporated by reference in the referencing application. See In re Hawkins, 486 F.2d 569, 179 USPQ 157 (CCPA 1973); In re Hawkins, 486 F.2d 579, 179 USPQ 163 (CCPA 1973); and In re Hawkins, 486 F.2d 577, 179 USPQ 167 (CCPA 1973). Furthermore, if a required sequence was not set forth in the specification as filed, and was not publicly available from Genbank at the time the application was filed, the amendment will be treated as an attempt to introduce new matter (similar to attempts to incorporate essential material by reference to unpublished material).
In claims 5 and 7, it is not clear what the metes and bounds of “derived” are. Is the sequence changed or is it just the RBD portion comes from the sequence? It is treated as a portion of the whole that contains the RBD.
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, 3-4, 7-8, and 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US10953089) as evidenced by Broeker (20090208523).
For claims 1 and 16, Smith et al. teach protein subunit vaccine comprising two SARS-CoV-2 RBD (column 14, lines 58-62) and that can be mixed with the adjuvant MF59 (col 27, line 32). For claim 3, chemical bonds can be peptide (amino acid) bonds and . For claims 4 and 7, the strain can be WuHan (col 1, line 44). For claim 7, one of ordinary skill in the art would know that subunits can be joined and not just expressed as a fusion. For claims 5, 13, and 15, the vaccine can contain more than one strain of the same virus and be packed as a kit with multiple containers (col 22, lines 60-65). For claim 8, one of ordinary skill in the art would know that when chemically conjugating proteins to make dimers, not all would form dimers and some would remain as monomers even though the goal is to make dimers. For claim 10, a method of generating an immune response is taught (col 1, line 29) For claims 11-15, the use of two doses or a prime and boost are taught (example 2).
Smith et al. suggest MF59 as an adjuvant but does not teach the components of MF59.
Broeker teach MF59:
1. squalene (2, 6, 10, 15, 23-hexamethyl-2, 6, 10, 14, 18, 22-tetracosahexane), about 5% (39 mg/ml)
2. polysorbate 80 (Tween® 80), approx. 0.5% (4.7 mg/ml)
3. sorbitan trioleate 85 (Span® 85), approx. 0.5% (4.7 mg/ml)
4. citrate buffer pH 6.5 (trisodium citrate dihydrate, citric acid monohydrate, water for injection). (para 14-18)
While Broeker does not teach the specific citrate buffer amount, one of ordinary skill in the art would be able to determine the amount that is suitable for injection.
One of ordinary skill in the art at the effective time of filing would have the expectation of success knowing the combination was taught to be used together.
Thus, it would have been prima facie obvious before the effective date of filing to choose MF59 as a adjuvant in a RBS SARS-CoV-2 subunit vaccine.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US10953089) as applied to claims 1, 3-4, 7-8, and 10-16 above, and further in view of Wang (US11112412B1).
Smith et al. do not teach SEQ ID# 1.
Wang teach SEQ ID# 13 that is 100 % identical to SEQ ID# 1.
One or ordinary skill in the art before the effective filing date would have been able to choose among known sequences of RBS and have the expectation of success knowing the the RBS have similar function.
Thus, it would have been prima facie obvious before the effective date of filing to the RBS SARS-CoV-2 subunit vaccine of Smith et al. with the RBS of of Wang and have the expectation that the RBS with function similarly.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US10953089) as applied to claims 1, 3-4, 7-8, and 10-16 above, and further in view of Diamond et al. (Research Square, 2021, DOI: doi.org/10.21203/rs.3.rs-228079/v1).
Smith et al. do not teach the specific strains.
Diamond et al. teach that the UK variant and the South African variant possible strains of concern.
One of ordinary skill in the art before the effective time of filing would have been motivated to make constructs with strains that that are notable and been able to choose from known strains. One of ordinary skill in the art before the effective time of filing would have the expectation of success knowing the RBS are functionally similar.
Thus, it would have been prima facie obvious before the effective date of filing to the RBS SARS-CoV-2 subunit vaccine of Smith et al. with the RBS of of Diamond et al. and have the expectation that the RBS with function similarly.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US10953089) as applied to claims 1, 3-4, 7-8, and 10-16 above, and further in view of VUJADINOVIC et al. (20190240312).
Smith et al. do not teach combination of MF59 and MLP.
VUJADINOVIC et al. teach that one or more adjuvants can be used including MF59 and MPL (para 74).
One of ordinary skill in the art before the effective time of filing would have been motivated to make constructs with strains that that are notable and been able to choose from known strains. One of ordinary skill in the art before the effective time of filing would have the expectation of success knowing the RBS are functionally similar.
Thus, it would have been prima facie obvious before the effective date of filing to the RBS SARS-CoV-2 subunit vaccine of Smith et al. with the RBS of of Diamond et al. and have the expectation that the RBS with function similarly.
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 1-16 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18558680 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to obvious variants.
Claims 1, 3, 5, and 16 have the same RBD and adjuvant as reference claims 1, 3, and 7. The species of claim 5 make obvious the genus of refernce (ref) claim 1.
For claims 2 (SEQ ID# 1 is WuHan) and 4 and 7, the strain can be WuHan as in ref claim 2. For claim 6, the same SEQ ID# 5 is in ref claim 4. For claim 8, one of ordinary skill in the art would know that when chemically conjugating proteins to make dimers, not all would form dimers and some would remain as monomers even though the goal is to make dimers.
For claim 9, the limitation is met by ref claims 7-8. For claim 10, the method is taught in ref claim 9. For claims 11, 12, and 14, the method can have one or more doses, or two doses or booster, see ref claims 10, 11, and 16. For claims 13 and 15, the kit is taught at ref claims 12 and 17.
Thus, the application claims are obvious over the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671