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 .
DETAILED ACTION
Election/Restriction
After search and consideration the restriction/election requirement mailed 9/4/25 is withdrawn.
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, 4, 6-8, 19-21, 23, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Kanekiyo et al. (US20160303224A1) and Hu et al. (Chem Soc Rev. 2016 Mar 21;45(6):1691-719).
For claims 1 and 4, Kanekiyo et al. teach a ferritin EBV fusion (claims 13-14) and for claim 27, nucleic acid (claim 27-28, the reference expresses the protein from clones (DNA and mRNA is translated to make the proteins). For claims 6-7, there is a linker on the amino terminus of ferritin (Figure 2 and description of Figure 2). For claim 7, the surface exposed asparagine to non-asparagine is shown (N19Q in para 158). For claim 8, one of ordinary skill in the art before the effective time of filing would be motivated to remove an internal cysteine to avoid competition with the introduced cysteine. For claim 19 the reference teaches seq ID 11 that is 98% identical to SEQ ID# 206. For claim 20, it is a nanoparticle with ferritin and EBV (claims 13-14). For claims 21 and 23, compositions can be formulated for administration (pharmaceutically) and with adjuvant (para 149 and 139). For claims 25 and 26, the composition can be used to vaccinate a human (claim 20 and para 80).
Kanekiyo et al. do not teach cysteine mutations or cysteine containing linkers.
For claims 5- 7, Hu et al. that cysteines are rare on surface exposed protein portion and can be added to add functionality of bioconjugates in a highly specific manner (sec 2.2.1) and that linkers can use cysteine to increase functionality to specifically add a payload and small molecules (immunopotentiators) targeting specific receptors have also been conjugated to modulate the immune activity of antibodies or protein antigens. (sec 2).
One of ordinary skill in the art at the effective time of filing would have been motivated to increase the immunogenicity of peptide antigens. One of ordinary skill in the art at the effective time of filing would had the expectation of success knowing that immune stimulating moieties have been attached to proteins by way of exposed cysteine residues.
Thus, it would have been prima facie obvious before the effective time of filing to modify the EBV-Ferritin polypeptide of Kanekiyo et al. with the immune stimulating moiety of Hu et al. with the expectation of success that it would increase the immunogenicity of the EBV-Ferritin polypeptide.
Claim(s) 5 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanekiyo et al. (US20160303224A1) and Hu et al. (Chem Soc Rev. 2016 Mar 21;45(6):1691-719) as applied to claims 1, 4-8, 19-21, 23, and 25-27 above, and further in view of Moyle et al. Bioconjugate Chem. 2014, 25, 5, 965–978 (Year: 2014)).
Kanekiyo et al. and Hu et al. are discussed above.
Kanekiyo et al. and Hu et al. do not teach TLR2 agonist as an immune stimulating moiety.
Moyle et al. teach that subunit vaccines are often weakly immunogenic and are often administered with adjuvant and they demonstrate the use of TLR2 agonist as an immune stimulator that works with polypeptides (abstract).
One of ordinary skill in the art at the effective time of filing would have been motivated to increase the immunogenicity of polypeptide antigens. One of ordinary skill in the art at the effective time of filing would had the expectation of success knowing that TLR2 agonist as immune stimulating moieties have been attached to proteins as an adjuvant.
Thus, it would have been prima facie obvious before the effective time of filing to modify the EBV-Ferritin polypeptide of Kanekiyo et al. and Hu et al. with the immune stimulating moiety of Moyle et al. with the expectation of success that it would increase the immunogenicity of the EBV-Ferritin polypeptide.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 4, 6-8, 19-21, and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 10-16 of U.S. Patent No. 11617780. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are both drawn to ferritin antigen peptide fusion.
For claims 1, 4, 6,13, and 20, the patent teaches ferritin antigen peptide fusion that comprises a mutation replacing a surface-exposed amino acid with a cysteine, comprising one or more of E12C, S26C, S72C, A75C, K79C, S100C, and S111C mutations of H. pylori ferritin (pat claim 1, 10, and 14).
For claim 7, the ferritin protein of claim 1, further comprising a mutation replacing a surface-exposed asparagine with a non-asparagine amino acid, this is met by patent claim 15.
For claims 8-9, the patent teaches the same mutation in claim 16.
For claim 10, the patent teaches the combination (claims 1, 14, 16).
For claim 11, the patent teaches the change can be to serine (column 23 part 3).
For claim 12, the patent teaches the corresponding position 18 (claims 15).
For claim 13, the patent teaches the same mutations (claims 14).
For claim 19, the patent teaches related sequence (claim 1, SEQ ID NOs: 226-231 or 241-242 are related to the ferritin but contain fusion sequence).
For claim 21, the patent teaches the pharmaceutical carrier (claims 10).
For claims 25-26, the patent teaches immunizing a human (claims 11).
For claim 27, the patent teaches the nucleic acid (claims 12).
Thus, the patent anticipates the claims.
Claims 5, 18, and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 14 of U.S. Patent No. 11617780 in view of Hu et al. (Chem Soc Rev. 2016 Mar 21;45(6):1691-719).
The patent ‘7780 is discussed above.
The patent does not teach linked immune stimulators or adjuvant.
For claims 5 and 18, Hu et al. that cysteines are rare on surface exposed protein portion and can be added to add functionality of bioconjugates in a highly specific manner (sec 2.2.1) and that linkers can use cysteine to increase functionality to specifically add a payload and small molecules (immunopotentiators) targeting specific receptors have also been conjugated to modulate the immune activity of antibodies or protein antigens. (sec 2).
For claim 23 it is obvious to use adjuvants in subunit vaccines as adjuvants are routinely used..
It would be obvious to one of ordinary skill in the art to modify the ferritin compositions of the patent to make them more immune stimulating as taught by Hu et al. and have the expectation of success knowing the modifications have been made.
Thus, the patent obvious the claims the claims.
Claims 1, 4, 6-8, 19-21, and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11904009. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are both drawn to ferritin antigen peptide fusion.
For claims 1, 4, 6, 13, and 20, the patent teaches ferritin antigen peptide fusion that comprises a mutation replacing a surface-exposed amino acid with a cysteine, comprising one or more of E12C, S26C, S72C, A75C, K79C, S100C, and S111C mutations of H. pylori ferritin (pat claim 1, 2, 4, 6, 10, and 14).
For claims 5 and 18, the patent teaches linking immunostimulatory moiety (claim 3 and 10).
For claim 7, the ferritin protein of claim 1, further comprising a mutation replacing a surface-exposed asparagine with a non-asparagine amino acid, this is met by patent claim 5.
For claims 8-9, the patent teaches the corresponding mutation in claims 1 and 6.
For claim 10, the patent teaches the combination (claim 6).
For claim 11, the patent teaches the change can be to serine (claim 7).
For claim 12, the patent teaches the corresponding position 18 (claims 8).
For claim 13, the patent teaches the same mutations (claims 9).
For claim 19, the patent teaches the same sequences (claim 11).
For claims 25-26, the patent teaches immunizing a human (claims 11).
For claim 27, the patent teaches the nucleic acid (claims 14).
Thus, the patent anticipates the claims.
Claims 21, 23, 25 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 14 of U.S. Patent No. 11904009 in view of Kanekiyo et al. (US20160303224A1).
The patent ‘009 is discussed above.
The patent does not teach adjuvant.
Kanekiyo et al. teach for claims 21 and 23, compositions can be formulated for administration (pharmaceutically) and with adjuvant (para 149 and 139). For claims 25 and 26, the composition can be used to vaccinate a human (claim 20 and para 80).
It would be obvious to one of ordinary skill in the art to use ferritin compositions of the patent to make and use as to administer to humans as taught by Kanekiyo et al. and have the expectation of success knowing the compositions have been made and used.
Thus, the patent makes obvious the claims.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/ Examiner, Art Unit 1648
/Shanon A. Foley/ Primary Examiner, Art Unit 1671