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 .
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. 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 evidenced by Broeker (20090208523) 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 evidenced by Broeker (20090208523) 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 evidenced by Broeker (20090208523) 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.
Applicant argues all the art rejections together.
Applicant argues that immunogen, adjuvant and interaction of the two cannot be predicted.
Applicant agues the choice of antigen is critical and points to Figure 1 and explains it.
Then, Applicant agues the choice of adjuvant is critical and points to Figure 2 and explains it.
Then, Applicant agues the immune response for spike and MF-59 teaches away citing Chappel et al.
Then, Applicant agues that the additional references do not cure the deficiency of the primary rejection.
Applicant’s arguments have been fully considered and not found persuasive.
First, the broadest claims are not limited to consisting of RBD.
The Smith reference gives both antigens, and points out a RBD dimer as cited in the rejection and well as suggest the use of MF-59. They are both in the same reference and there are limited choices to choose from and thus within the skill of one in the art to choose the immunogen and adjuvant pair with the expectation of success.
Figure 1 is not commensurate with the claimed invention and thus not particularly relevant. While it compares antigens and adjuvants, it does not use MF-59.
For Figure 2, it is not commensurate with the claimed invention and thus not particularly relevant. While it compares antigens and adjuvants, it does not use MF-59.
For the Chappel et al. reference, it does not teach away because it does not say the combination will fail or cause immediate harm. To the contrary, it teaches that the MF59-adjuvanted, molecular clamp-stabilised recombinant spike protein elicits strong immune responses with a promising safety profile. (Interpretation). It did not there was a cross reactivity with their clamp antigen and not that they were abandoning all vaccine formulations, but were going to test others.
The deficiencies in the primary reference have been addresses and the additional references provide for the added limitations as noted by applicant.
The rejections are maintained.
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 reference (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.
In reply to the rejections, applicant requests that the double patenting rejection be held in abeyance and will be addressed in the reference application.
Applicant’s request has been considered, but is denied. According to 37 CFR 1.111, applicant is required to respond to every ground of rejection. Only objections or requirements as to form not necessary to further consideration may be held in abeyance, not rejections. With regard to overcoming all types of non-statutory double patenting, MPEP § 804.02 states that these rejections can be overcome by 1) amending the claims so that the rejection is no longer applicable, or 2) filing a terminal disclaimer.
Applicant has done neither of these two remedies in the instant case. Subsequent lack of attention to this matter may be treated as non-responsive.
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.
Applicant acknowledges this and leaves the claim as is arguing the other claims are allowable as well.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon, Tues, Thurs, Fri..
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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
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