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After search and consideration, the restriction/election requirement mailed 9/4/25 is withdrawn.
Rejection 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 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, 6-13, 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.
Response to Rejections
In reply to the rejections, applicant requests that the double patenting rejection be held in abeyance until allowable subject matter is indicated.
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.
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-Fri.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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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
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