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 .
Election/Restrictions
Applicant's election with traverse of the new claims in the reply filed on 3/31/26 is acknowledged. The traversal is on the ground(s) that the sequences are related. This is not found persuasive because each sequence requires a different search. However, because the claims were limited to one sequence and included a second related sequence in the dependent claim, the new set will be examined.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 24-26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims exclude the SH gene. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 20-34 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.
The V/P lacks a reference sequence to determine the positions of the 157 and 308 mutations and thus the metes and bounds of the position of the mutants cannot be determined.
Claims 22, 24, and those that depend on them are unclear as to the coding sequence. The viral genome is made of several individual coding segments (encoding the different proteins) in the length of the genome that includes non-coding regions (5’, 3’, and intergenic sequences. The coding regions can have multiple or alternative start codons as well as in the V/P with pseudotemplated insertion of two G residues at a specific site during transcription. Thus, the specific amount of coding sequence that can be changed and still be at least 98% is not clear.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for inducing an immune response to a heterologous vaccine antigen in a susceptible host, does not reasonably provide enablement for the vector being highly immunogenic in all hosts. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The specification does not teach how to make the vector itself highly immunogenic but teaches that expressed heterologous vaccine antigens can induce an immune response (See experiments and Figures 2-4 for immune response against SARS CoV-2).
Wang, Ting et al., (Journal of Medical Virology Vol 95, No 3, doi.org/10.1002/jmv.28622, 2023) teach that PIV5 is known used as a vaccine vector and infection in these reservoir hosts (humans and some animals) is generally asymptomatic and has few safety concerns (abstract).
Chen et al. (Rev Med Virol. 2018; 28:e1965) teach that “Interestingly, prior exposure of PIV5 does not prevent a PIV5-vectored vaccine from generating robust immunity, indicating that the vector can be used more than once.” (abstract).
Thus, the art teaches that PIV5 vectors are not themselves are not highly immunogenic.
Thus, it would take undue experimentation to make and use the invention as claimed.
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.
Claim(s) 20 and 27 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Timani et al. (JOURNAL OF VIROLOGY, Sept. 2008, p Vol. 82, No. 18, 9123–9133).
Timani et al. teach a viral vector and viral particle of a PIV5 with a mutation of A, D, and F at position 157 that increase protein production (Table 1 and first paragraph of Materials and Methods).
Thus, Timani et al. anticipate the claimed invention.
Claim(s) 20 is rejected under 35 U.S.C. 102a1 as being anticipated by He (US10329585).
He teaches PIV5 vectors that contain the positions 157 or 308 of the V/P mutated to A (alanine) (column 31 line 20).
Thus, He anticipates the claimed invention.
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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over He (US10329585).
He teaches PIV5 vectors that contain the positions 157 or 308 of the V/P mutated to A (alanine) (column 31 line 20) and these lead to cell death.
It would have been obvious to combine mutations that have the same function and have the expectation of success knowing that they both have the same function.
Thus, it would have been prima facie obvious before the effective time of filing to combine the two mutants of He in one PIV5 vector.
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 20 and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 18501667 in view of Timani et al. (JOURNAL OF VIROLOGY, Sept. 2008, p Vol. 82, No. 18, 9123–9133).
The reference application teaches a PIV5 vector with SEQ ID# 1 that expresses a heterologous sequence. Said SEQ ID# 1 is the same as application SEQ ID# 61.
The reference does not teach mutation of V/P 157.
Timani et al. teach a viral vector and viral particle of a PIV5 with a mutation of A, D, and F at position 157 that increase protein production (Table 1 and first paragraph of Materials and Methods).
It would have been prima facie obvious to modify the vector to express more and obvious to make viral particles from the viral vector.
This is a provisional nonstatutory double patenting rejection.
Conclusion
US-19-125-921 is undergoing pre-exam and not yet assigned a filing date and thus cannot be considered a completed application. It appears that at least claim 1 and shares a sequence identical to SEQ ID# 61 would be rejected for NSDP (OTDP) it shares the same vector sequence and expresses a heterologous antigen.
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 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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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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