DETAILED ACTION
Election/Restrictions
Applicant’s election of Group I, claims 65-77, and selected species in the reply filed on May 4, 2026 is acknowledged. Because Applicant did not distinctly and specifically point out any supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 78-91 are withdrawn from consideration being directed to non-elected subject matter.
Drawings
The drawings are objected to because Figure 11 recites an amino acid sequence that requires a sequence identifier “QTQTNSPRRAR”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In lieu of filing a corrected drawing sheet, the brief description of Fig. 11 may be amended to include a sequence identifier.
Claims Summary
Claim 65 is directed to a method of inducing and/or activating a protective immune response against SARS-CoV-2 in a subject, comprising administering to the upper respiratory tract an effective amount of a pseudotyped lentiviral vector particle encoding a SARS-CoV-2 spike (S) protein or a derivative thereof (elected species). The specification does not appear to provide a definition for “derivative”. The SARS-CoV-2 S protein has an amino acid sequence identical to SEQ ID NO: 1 (claim 70). SEQ ID NO: 1 is 1273-aa and represents a SARS-CoV-2 S protein. The derivative has an amino acid sequence at least 95% identical to SEQ ID NO: 1 (claim 70). The SARS-CoV-2 S is expressed from a coding sequence comprising SEQ ID NO: 2 (claim 72). SEQ ID NO: 2 is 3822-nt and represents a coding sequence for a SARS-CoV-2 S protein. The derivative is expressed from a coding sequence comprising a nucleotide sequence at least 80% identical to SEQ ID NO: 2 (claim 71). The SARS-CoV-2 S protein or derivative comprises a peptide selected from SEQ ID NO: 15, 16 and 17 (claim 72). The SARS-CoV-2 derivative comprises an amino acid modified relative to SEQ ID NO: 1, K986P and V987P (claim 73). The derivative comprises or consists of SEQ ID NO: 1 (claim 74).
The vector particle is integrative or nonintegrative (claim 75). The nonintegrative particle comprises a D64V mutation in an integrase coding sequence (claim 76). The vector particle is pseudotyped with VSV-G (claim 77). The vector particle is administered by aerosol inhalation, nasal instillation, or nasal insufflation (claim 66). The treatment course consists of a single administration, or comprises more than one administrations to the upper respiratory tract (claim 67). In another embodiment, the treatment course comprises at least one priming administration outside of the respiratory tract followed by one boosting administration to the upper respiratory tract (claim 68). The protective immune response comprises production of SARS-CoV-2 S-specific T cells (claim 69).
Claim Objections
Claims 67, 68, 74 and 77 are objected to because of the following informalities:
Claims 67 and 68 refer to “the treatment course”, which is referring to the administration step in claim 65. However, consistent terminology should be used. Suggested language is, “wherein administering comprises a treatment course”.
In claim 74, the first word of the sentence is missing.
In claim 77, “envelop” should be “envelope”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 65-69, 72, 73 and 75-77 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 65 is directed to a method employing a SARS-CoV-2 S protein derivative. It is not clear from the specification what portion of the original S protein is retained in the derivative, thus the metes and bounds of the claim cannot be determined. The same applies to claims 72 and 73, where, although the presence of a peptide and two mutations is specified, it is not clear what remains of the original S protein from which the derivative is derived. Claims 66-69 and 75-77 are included as they depend either directly or indirectly from claim 65.
The mutation, D64V, in claim 76 needs to be referenced by a sequence identifier, otherwise the location of the mutation in an integrase coding sequence cannot be determined with any certainty.
Regarding claims 67 and 68, the phrases “in particular” and “such as” render the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further, claim 76 recites “the administering nonintegrative lentiviral particle”, which lacks antecedent basis in claims 69 and 65. Correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 65-67, 69, 70, 72, 74 and 77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qin et al. (CN111088283A, published May 1, 2020, filed March 20, 2020, “Qin”, English translation provided and referenced herein, 27 pages, 2026). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Qin discloses VSV-G (lentiviral) vectors expressing SARS-CoV-2 RBD in a pseudotyped construct for inducing protective immunity via S-specific T cells, for example (see abstract, pages 2, 3, 5, and Example 6 on page 12) (claims 65, 69 and 77). Administration is via a variety of routes including nasal drip, which goes to the upper respiratory tract, and may be administered once (see page 4) (claims 65-67). Qin’s SEQ ID NO: 2, which is 1273-aa and 100% identical in content and length to Applicant’s SEQ ID NO: 1 (claims 70 and 74). Qin’s SEQ ID NO: 2 comprises the peptide represented by Applicant’s SEQ ID NO: 15-17 (claim 72). Therefore, the claimed embodiments are anticipated by the prior art.
Claims 65-67, 69 and 75 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yahalom-Ronen et al. (bioRxiv, posted online June 19, 2020, 2020.06.18.160655, cited in the IDS filed 1/11/2023, “Yahalom-Ronen”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Yahalom-Ronen discloses a single dose recombinant VSVΔG SARS-CoV-2 S protein construct administered by intranasal instillation that induces neutralizing antibodies in animal models and protected them from SARS-CoV-2 challenge (see abstract and pages 4-5) (claims 65-67). Although S-specific T cells are not mentioned, such are expected to be a natural outcome of doing what the prior art teaches (claim 69). Yahalom-Ronen does not indicate that the VSV vector is rendered nonintegrative, thus it is reasonably considered integrative (claim 75). Therefore, the claimed embodiments are anticipated by the prior art.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 65-67, 69 and 75-77 are rejected under 35 U.S.C. 103 as being unpatentable over Charneau et al. (US 2010/0297168 A1, “Charneau”) in view of Walls et al. (Cell, April 16, 2020, 180:281-292, of record in the IDS filed 1/11/2023, “Walls”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Charneau discloses integrative and non-integrative VSV-G pseudotyped lentiviral vectors that express viral surface proteins, such as those from coronavirus (see abstract, and paragraphs [0070], [0071] and [0078]) (claims 65, 75 and 77). Nonintegrative vectors have a D64V mutation in an integrase coding sequence (see paragraph [0148]) (claim 76). Intranasal administration or inhalation (which goes to the upper respiratory tract) is disclosed, as well as a single administration or a prime-boost administration in order to elicit protective immunity (see abstract, paragraphs [0173] and [0278]) (claim 66 and 67).
Charneau discloses vectors expressing any pathogen of interest, including coronavirus surface antigen, but does not disclose a SARS-CoV-2 S protein. However, it would have been obvious to have used Walls’ SARS-CoV-2 S protein in Charneau’s construct with a reasonable expectation of success. One would have been motivated to use the S protein because of its antigenic significance and the global impact of SARS-CoV-2 (see Walls’ abstract, and page 281) (claim 65). As for the induction of a protective immune response, this would have been a natural outcome of doing what the prior art suggests, including the induction of SARS-CoV-2 S-specific T cells by administering the pseudotyped lentiviral vector (claims 65 and 69). Therefore, the claimed embodiments would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Charneau et al. (US 2010/0297168 A1, “Charneau”) in view of Walls et al. (Cell, April 16, 2020, 180:281-292, of record in the IDS filed 1/11/2023, “Walls”), as applied to claim 65 above, and further in view of Thakur et al. (Front. Immunol., 2018, Vol. 9, Article 2825, 21 pages, “Thakur”). Claim 68 is directed to an embodiment wherein the prime dose is administered outside the respiratory tract, and the boost is administered to the upper respiratory tract.
The teachings of Charneau and Walls are outlined and do not include an express teaching to administer a priming dose outside the respiratory tract, and a boosting dose administered to the upper respiratory tract. However, Charneau teaches that the choice of administration regimen is a function of the immune response generated upon dosing/boosting (see paragraph [0250]).
Thakur’s teachings are directed to a TB subunit vaccine that is administered as a priming dose outside the respiratory tract, and intrapulmonary as the boosting dose, showing mucosal and systemic immunogenicity (see Thakur, abstract). Thakur also provides a review of other vaccines administering in a parenteral prime and intranasal boost strategy, all in an effort to improve immunogenicity (see Thakur, page 16, right col., top paragraph). It would have been obvious to have administered Charneau’s vector expressing the S protein as a priming dose outside the respiratory tract, and intrapulmonary as the boosting dose, with a reasonable expectation of success of achieving a mucosal and systemic immune response. Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Charneau et al. (US 2010/0297168 A1, “Charneau”) in view of Walls et al. (Cell, April 16, 2020, 180:281-292, of record in the IDS filed 1/11/2023, “Walls”), as applied to claim 65 above, and further in view of Zhang et al. (CN111363858A, published July 3, 2020, filed May 26, 2020, “Zhang”, English translation provided and referenced herein, 15 pages). Claim 71 is directed to an embodiment wherein the S protein is expressed from a coding sequence identical to SEQ ID NO: 2, or at least 80% identical to SEQ ID NO: 2.
The teachings of Charneau and Walls are outlined above and do not include a disclosure of SEQ ID NO: 1. Charneau’s teachings are general with regard to antigens used in the lentiviral vectors. Thus, it would have been obvious to have used any known sequence of SARS-CoV-2 S protein with a reasonable expectation of success, such as Zhang’s SEQ ID NO: 4, which is 3822-nt and identical in content and length to Applicant’s SEQ ID NO: 2. Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Charneau et al. (US 2010/0297168 A1, “Charneau”) in view of Walls et al. (Cell, April 16, 2020, 180:281-292, of record in the IDS filed 1/11/2023, “Walls”), as applied to claim 65 above, evidenced by Kirchdoerfer et al. (Sci Rep., 2018, 8:15701, 11 pages, “Kirchdoerfer”). Claim 73 is directed to an embodiment wherein the S derivative comprises an amino acid modification relative to SEQ ID NO: 1, specifically K986P and V987P.
The teachings of Charneau and Walls are outlined above. Walls discloses two consecutive proline substitutions to stabilize the ectodomain trimer (see page 285, left column). Walls does not identify the location of the proline substitutions, but references Kirchdoerfer et al. (Sci Rep., 2018, 8:15701, 11 pages, “Kirchdoerfer”) as disclosing the proline substitutions. Kirchdoerfer identifies the substitutions in SARS-CoV as K968P and V969P (see page 8, third full paragraph). Given the teachings of Kirchdoerfer, one would have identified Walls’ substitutions in SARS-CoV-2 S protein as correlating to K986P and K987P.
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 65, 66, 69 and 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-38 of copending Application No. 18/726,286 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Copending claim 36 is directed to an immunogenic composition comprising a pseudotyped lentiviral vector particle encoding an S protein of a SARS-CoV-2. Copending claim 38 is directed to an embodiment wherein the composition is formulated for intranasal administration. The copending composition claims renders obvious a method of inducing and/or activating a protective immune response to SARS-CoV-2 by administering to the upper respiratory tract a pseudotyped lentiviral vector particle encoding a SARS-CoV-2 S protein (instant claim 65), administered by nasal instillation or nasal insufflation (instant claim 66). The S protein of the copending claim comprises K986P and V987P, which reads on instant claim 73. The immunogenic effects of instant claim 69 are expected outcomes of administering the copending claims’ composition. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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