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 .
Applicant’s reply and amendments have cured the objections to the claims and rejections under 35 USC § 112(b).
It is noted that support for “XBB.1.5”, “XBB.1.6”, and “EG.5”, is found in paragraph [0228] of the instant published disclosure, USPgPub 20240226276, of record.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63,384,740, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Support for “XBB.1.5”, “XBB.1.6”, and “EG.5”, recited as newly presented limitations in claims 1, 27, 28, 35, and 36, is found in paragraph [0228] of the instant published disclosure, USPgPub 20240226276. However, no support for “XBB.1.5”, “XBB.1.6”, and “EG.5” is found in provisional Application No. 63,384,740. Accordingly, claims 1, 27, 28, 35, and 36 are not entitled to the benefit of the prior application filed November 22, 2022.
Specification
The amendment filed 8/13/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: SEQ ID NOs: 33-55. The proposed amendment received 8/13/2026 affixes SEQ ID NOs: 56 and 57 to the short amino acid sequences originally presented in paragraph [0128] of the instant published disclosure, USPgPub 20240226276 (not paragraph [0127] as stated in the amendment). However, there is no support in the original disclosure for added sequences corresponding to SEQ ID NO: 33-55 because the original sequence submission only contains SEQ ID NOs: 1-32.
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
Claims 1-3, 7-12, 14-18, 21, 23, 27, 28, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (WO 2021/174128, published Sept 2, 2021, of record, which is more than a year prior to the instant effective filing date) and Parums (Medical Science Monitor: International Medical Journal of Experimental and Clinical Research. 2023 Sep 1;29:e942244-1).
Note: no support for “XBB.1.5”, “XBB.1.6”, and “EG.5” is found in provisional Application No. 63,384,740. Accordingly, claims 1, 27, 28, 35, and 36 are entitled to the benefit of the filing date of the instant application, November 22, 2023.
In reply to the rejection of record, applicant points out that Zhu et al. do not teach the Omicron variants instantly recited. However, the teachings of Parums satisfy these newly presented limitations.
Claim 1 of Zhu et al. is drawn to a peptide comprising a monomeric Fc immunoglobulin fragment recognized by a neonatal receptor (FcRn); a SARS-CoV-2 antigen; and a trimerization domain, as required by instant claim 1. Claims 2-6 of Zhu et al. require that the SARS-CoV-2 antigen is a full-length soluble spike protein, an S1, S2, or receptor binding domain (RBD) of S1, recited in instant claims 2 and 3. Claims 7-9 of Zhu et al. state that the FcRn comprises cysteine substitutions to serine residues at positions 226 and 229 of human IgG1 required for dimer formation, corresponding to instant claims 7-9. Claim 10 of Zhu et al. recites the C1q motif (in the Fc monomeric fragment) is mutated such that the fragment is non-lytic, required in instant claim 10. Claims 11 and 13 of Zhu et al. state that the monomeric Fc fragment of an
immunoglobulin recognized by a FcRn comprises a CH2 domain and a CH3 domain or is an IgG Fc fragment, corresponding to instant claim 11. Claim 12 of Zhu et al. recite the one or more mutations in the CH2 domain ablate Clq binding to the monomeric Fc fragment, corresponding to instant claim 12. Claims 14 and 15 of Zhu et al. require the trimerization domain is a T4 fibritin trimerization domain and is a foldon, corresponding to instant claims 14 and 15. Claims 16-19 of Zhu et al. require the monomeric Fe fragment conjugated to the carboxy terminal end of the SARS-Co V-2 spike protein and further comprises one or more linkers between the
trimerization domain and the SARS-Co V-2 antigen or between the monomeric Fc fragment and the trimerization domain, as required by instant claims 16-18. Claims 21 and 23 of Zhu et al. are drawn to a peptide complex comprising three claimed peptides and a composition comprising at least one claimed peptide, corresponding to instant claims 21 and 23. Claims 27 of Zhu et al. is drawn to a method for eliciting a protective immune response against SARS-CoV-2
comprising administering to a subject an effective amount of a composition comprising one or more claimed peptides, as required by instant claim 27. Claim 28 of Zhu et al. is drawn to a method for eliciting a protective immune response against SARS-Co V-2 comprising administering to a subject an effective amount of a peptide complex, wherein the peptide complex comprises three peptides forming a trimer, wherein each of the three peptides comprises a monomeric Fc fragment of an immunoglobulin recognized by a FcRn; a SARS-CoV-2 antigen; and a trimerization domain, wherein the administering is to a mucosal epithelium, required in instant claim 28. Claim 35 of Zhu et al. is drawn to a method of treating a subject exposed to SARS-CoV-2 or at risk of being exposed to SARS-CoV-2 comprising administering to the subject an effective amount of a composition comprising one or more claimed peptides, as required by instant claim 35. Claim 36 of Zhu et al. is drawn to a method of treating a subject exposed to SARS-CoV-2 or at risk of being exposed to SARS-CoV-2 comprising administering to the subject an effective amount of a composition comprising a peptide complex, wherein the peptide complex comprises three peptides forming a trimer, wherein each of the three peptides comprises a monomeric Fc fragment of an immunoglobulin recognized by a FcRn; a SARS-CoV-2 antigen; and a trimerization domain, wherein the administering is to a mucosal
epithelium, as required by instant claim 36.
Zhu et al. do not mention that the SARS-CoV-2 recited as the antigen and the pathogen is from the Omicron XBB.1.5., as recited in instant claims 1, 27, 28, 35, and 36.
Parums discusses Omicron variants: EG.5 (Eris), XBB.1.5 (Kraken), and XBB.1.16 (Arcturus) in the abstract.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have used a full-length soluble spike protein, an S1, S2, or receptor binding domain (RBD) of S1 of Zhu et al. derived from Omicron variants: EG.5, XBB.1.5, and XBB.1.16, taught by Parums because these subtypes identified as large percentages of infection in the US population, see the abstract, the last paragraph of the second column on page 1, and Table 1. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used a full-length soluble spike protein, an S1, S2, or receptor binding domain (RBD) of S1 of Zhu et al. derived from SARS-CoV-2 Omicron variants: EG.5, XBB.1.5, and XBB.1.16, taught by Parums because Parums teach EG.5, XBB.1.5, and XBB.1.16 sequence data is known on pages 2-3 and Zhu et al. teach the SARS-CoV-2 spike protein antigen is a variant with a sequence only 50% identical to the ones disclosed, see paragraphs [0077-0083 and 0122-0128].
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 1-3, 7, 9-12, 14, 16, 21, 23, 27, 28, 35, and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-10, and 12-16 of U.S. Patent No. 12,297,232 in view of Parums (Medical Science Monitor: International Medical Journal of Experimental and Clinical Research. 2023 Sep 1;29:e942244-1).
Note: no support for “XBB.1.5”, “XBB.1.6”, and “EG.5” is found in provisional Application No. 63,384,740. Accordingly, claims 1, 27, 28, 35, and 36 are entitled to the benefit of the filing date of the instant application, November 22, 2023.
In reply to the rejection of record, applicant In reply to the rejection, 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 unsupported as a proper request. 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(I)(B)(1) 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.
Claim 1 of ‘232 is drawn to a peptide comprising a monomeric Fc immunoglobulin fragment recognized by a neonatal receptor (FcRn); a full-length soluble SARS-CoV-2 antigen; and a trimerization domain, as required by instant claim 1. Claims 2, 4, and 5 of ‘232 state that the FcRn comprises cysteine to serine substitutions required for dimer formation and that the C1q motif (in the Fc monomeric fragment) is mutated such that the fragment is non-lytic, required in instant claims 7, 9, and 10. Claims 6 and 7 of ‘232 state that the monomeric Fc fragment of an immunoglobulin recognized by a FcRn comprises a CH2 domain and a CH3 domain and one or more mutations in the CH2 domain ablate Clq binding to the monomeric Fc fragment, corresponding to instant claims 11 and 12. Claim 8 of ‘232 requires the trimerization domain is a T4 fibritin trimerization domain, corresponding to instant claim 14. Claim 9 of ‘232 recites the monomeric Fe fragment conjugated to the carboxy terminal end of the SARS-Co V-2 spike protein, as required by instant claim 16. Claims 10 and 12 of ‘232 are drawn to a peptide complex comprising three claimed peptides and a composition comprising at least one claimed peptide, corresponding to instant claims 21 and 23. Claim 13 of ‘232 is drawn to a method for eliciting a protective immune response against SARS-CoV-2 comprising administering to a subject an effective amount of a composition comprising one or more claimed peptides, as required by instant claim 27. Claim 14 of ‘232 is drawn to a method for eliciting a protective immune response against SARS-Co V-2 comprising administering to a subject an effective amount of a peptide complex, wherein the peptide complex comprises three peptides forming a trimer, wherein each of the three peptides comprises a monomeric Fc fragment of an immunoglobulin recognized by a FcRn; a SARS-CoV-2 antigen; and a trimerization domain, wherein the administering is to a mucosal epithelium, required in instant claim 28. Claim 15 of ‘232 is drawn to a method of treating a subject exposed to SARS-CoV-2 or at risk of being exposed to SARS-CoV-2 comprising administering to the subject an effective amount of a composition comprising one or more claimed peptides, as required by instant claim 35. Claim 16 of ‘232 is drawn to a method of treating a subject exposed to SARS-CoV-2 or at risk of being exposed to SARS-CoV-2 comprising administering to the subject an effective amount of a composition comprising a peptide complex, wherein the peptide complex comprises three peptides forming a trimer, wherein each of the three peptides comprises a monomeric F c fragment of an immunoglobulin recognized by a FcRn; a SARS-CoV-2 antigen; and a trimerization domain, wherein the administering is to a mucosal epithelium, as required by instant claim 36.
The claims of ‘232 do not recite the SARS-CoV-2 recited as the antigen and the pathogen is from the Omicron XBB.1.5., XBB.1.16., or EG.5, as recited in instant claims 1, 27, 28, 35, and 36.
Parums discusses Omicron variants: EG.5 (Eris), XBB.1.5 (Kraken), and XBB.1.16 (Arcturus) in the abstract.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have used a full-length soluble spike protein, an S1, S2, or receptor binding domain (RBD) of S1 of ‘232 derived from Omicron variants: EG.5, XBB.1.5, and XBB.1.16, taught by Parums because these subtypes identified as large percentages of infection in the US population, see the abstract, the last paragraph of the second column on page 1, and Table 1. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used a full-length soluble spike protein, an S1, S2, or receptor binding domain (RBD) of S1 of ‘232 derived from SARS-CoV-2 Omicron variants: EG.5, XBB.1.5, and XBB.1.16, taught by Parums because Parums teach EG.5, XBB.1.5, and XBB.1.16 sequence data is known on pages 2-3 and Zhu et al. teach the SARS-CoV-2 spike protein antigen is a variant with a sequence only 50% identical to the ones disclosed, see paragraphs [0077-0083 and 0122-0128].
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 SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at 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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/Shanon A. Foley/ Primary Examiner, Art Unit 1671
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