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 .
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, 6-8, 11-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chackerian et al. (US20190201540A1) as applied to claims 1, 6-8, 11-13, and 15 above, and further in view of Carrillo Molina et al. (20190315807).
For claims 1, 6-7, and 15, Chackerian et al. teach …VLPs displaying full-length mature ApoC3 (SEQ ID NO:3) were constructed by genetically inserting the ApoC3 gene at the C-terminal of a single-chain dimer version of the AP205 coat protein. In this conformation, each recombinant VLP displays 90 copies of the ApoC3 protein.” (para 16) as well as in the same paragraph “Displaying a target antigen on the surface of a virus-like particle (VLP) can increase the immunogenicity of the antigen. VLP display can elicit strong antibody responses against self-antigens, which are normally poorly immunogenic. For claim 7, the “consisting” is interpreted as limiting in that the fusion to the elements recited in claim 1 and no extra elements in the fusion.
For claim 8 ApoC3 is a self molecule.
For claim 11, the AP205 construct can be a pharmaceutical composition (para 25).
For claim 12-13, the AP205 construct can be administered to immunize or treat (abstract).
Chackerian et al. is silent on linkers.
Linkers are well known in the art and routinely used in fusion proteins and include GGGS (Example 7, SEQ ID# 12) as used in a fusion protein in a VLP, see Carrillo Molina et al. paragraph 228.
One of ordinary skill in the art before the effective date of filing would be motivated to use linkers to improve flexibility for protein folding and movement so VLPs can form and art before the effective date of filing would have the expectation of success as linkers are routinely used in fusion proteins.
Thus, it would have been prima facie obvious before the effective time of filing to modify the AP205 to use GGS linkers as taught by Carrillo Molina et al.
Applicant argues that the reference does not teach the specific linkers in the claims.
Applicant’s argument has been fully considered and not found persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
The reference is used to show that linkers are used including as claimed. The GGGS linker of Applicant’s claims meets the limitation of the recited linker sequence of claim 1 part a and b.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chackerian et al. (US20190201540A1) and Carrillo Molina et al. (20190315807) as applied to claims 1, 3, 6-8, 11-13, and 15 above, and further in view of Steyaert et al. (20210206880).
Chackerian et al. and Carrillo Molina et al. is discussed above.
Chackerian et al. and Carrillo Molina et al. is silent on the sequence of the single chain AP205 dimer.
Steyaert et al. teach a AP205 dimer that has a sequence at least 90% identical to instant SEQ ID# 7 (the individual AP205 in the prior art are at least 90% to SEQ ID# 26 in the dimer), see comparison sheet.
One of ordinary skill in the art before the effective date of filing would be able to choose any AP205 dimer sequence taught that can be used to display antigens. One of ordinary skill in the art before the effective date of filing would have the expectation of success as the sequence is used to display peptides on the surface.
Thus, it would have been prima facie obvious before the effective time of filing to modify the AP205 of Chackerian et al. and Carrillo Molina et al. to use the sequence taught by Steyaert et al.
Applicant argues that the Steyaert et al. reference does not cure the deficiency in the base rejection.
Applicant’s argument has been fully considered and not found persuasive.
The deficiencies in the base rejection are addressed above.
Claim(s) 9, 14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over over Chackerian et al. (US20190201540A1) and Carrillo Molina et al. (20190315807) as applied to claims 1, 3, 6-8, 11-13, and 15 above, and further in view of Wang (11112412).
Chackerian et al. and Carrillo Molina et al. is discussed above.
Chackerian et al. and Carrillo Molina et al. does not teach SSARS-CoV-2 RBM SEQ ID# 95.
For claims 9, 14, and 16-7, Wang teaches SEQ 14 as the RBM (col 4, line 41) and this is identical to instant SEQ ID# 95 and this can detect neutralizing antibodies (patent claim 1).
For claims 18-20, one of ordinary skill in the art before the effective date of filing would have been motivated to use the modified AP205 VLP displaying SEQ ID# 95 to treat or immunize against SARS-CoV-2 as the VLPs are taught to be immunogenic by Chackerian et al.
One of ordinary skill in the art before the effective date of filing would know the RBM would be useful to make neutralizing antibodies that can be used to treat or prevent a SARS-CoV-1 infection and be motivated to use it as a vaccine antigen. One of ordinary skill in the art before the effective date of filing would have the expectation of success knowing it binds neutralizing antibodies.
Thus, it would have been prima facie obvious before the effective time of filing to modify the AP205 of Chackerian et al. and Carrillo Molina et al.to display the SARS-CoV-2 RBM of Wang and use to treat or immunize.
Applicant argues that the Wang et al. reference does not cure the deficiency in the base rejection.
Applicant’s argument has been fully considered and not found persuasive.
The deficiencies in the base rejection are addressed above.
Allowable Subject Matter
Claim 10 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
