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
1. Applicant’s election without traverse of Group I and species (SEQ ID NO: 7 in combination with SEQ ID NO: 8; same virus (BVDV-2; BVDV-2 E2 and BVDV-2/Erns; GM-CSF; HCMV promoter; BoHV-1 as virus causing the infection; SEQ ID NO: 7 in combination with SEQ ID NO: 8) in the reply filed on 8/24/2026 is acknowledged.
Claims 22, 24, 33, 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/24/2026.
Claims 1, 3, 5-9, 13, 16, 17, 19, 20, 30-32, 34 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 6/20/2023; 2/27/2024; 4/4/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
3. The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on p. 33. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Nucleotide and/or Amino Acid Sequence Disclosures
4. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (Fig. 1) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
5. Claim 19 is objected to because of the following informalities: Claim 19 recites “promotor”. For improved spelling, the claim should recite “promoter”.
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.
6. Claims 1, 3, 5-9, 13, 16, 17, 19, 20, 30-32, 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.
See claims 1, 3, 5-9, 13, 16, 17, 19, 20, 30-32, 34 as submitted 6/20/2023.
As to claim 1, the claim recites amino acid positions 30-32, 80-96, as well as 1 to 67 (claim 3). It is not clear what the position numbers are relative to, or what constitutes position number one. Claims 3, 5-9, 13, 16, 17, 19, 20, 30-32, 34 depend on this claim.
Further as to claim 5, the claim depends on canceled claim 2. It is not clear which claim the claim depends on.
Further as to claim 6, the claim recites SEQ ID NO: 7 in combination with SEQ ID NO: 8. It is not clear what the relationship is between SEQ ID NO: 7 and SEQ ID NO: 8, or how they are combined. It is not clear if they are intended to read on a fusion protein or not.
Further as to claims 22, 30, the claims recite “in particular”. It is not clear if the subsequence language is a limitation or not.
Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
7. Claims 1, 7, 8, 9, 13, 16, 17, 19, 20, 30, 31, 34 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Chowdhury et al. (US20180353596)(cited in applicant’s IDS submitted 6/20/2023).
See claims 1, 7, 8, 9, 13, 16, 17, 19, 20, 30, 31, 34 as submitted 6/20/2023.
Chowdhury et al. teaches: BoHV-1 vector [0006]; comprising: deletion of a cytoplasmic tail of envelope glycoprotein gE (gE-CT); deletion of envelope protein ULA49.5 residues 30-32; deletion of UL49.5 cytoplasmic tail residues 80-96, or a combination thereof [0007](as recited in claim 1); gG gene deletion [0030](as recited in claim 1); that can express one or more heterologous antigens, on or more glycoproteins of one or more isolated viruses [0144](as recited in claim 7); linked to heterologous promoter [0199](as recited in claim 17); compositions with carrier [0162](as recited in claim 20); live attenuated vaccine [0006](as recited in claim 30); vaccine [0006]; adjuvant [0152](as recited in claim 34); BVDV E2 and BVDV Erns antigens [0118, 0082, 0235](as recited in claims 8, 9); fusion proteins [0070](as recited in claim 13); GM-CSF [0086](as recited in claim 16); CMV promoter [0200](as recited in claim 19); use of BOHV-1 protein antigens [0128](as recited in claim 31).
In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a “base” product they exemplify. As such, the claimed vector is within the scope of Chowdhury et al., and thus Chowdhury et al. renders the vector prima facie obvious. The rationale to support this conclusion of obviousness is that Chowdhury et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Thus, Chowdhury et al. anticipates or renders obvious the instant claims.
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.
8. Claims 1, 7, 13, 16, 17, 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11083787.
See claims 1, 7, 13, 16, 17, 20 as submitted as submitted 6/20/2023.
Claims 1-21 of U.S. Patent No. 11083787 recite a BoHV-1 recombinant vector comprising at least one heterologous antigen inserted therein, where the BoHV-1 vector has a deletion of a cytoplasmic tail of envelope glycoprotein gE (gE-CT), a deletion of an entire envelope protein, a deletion of envelope protein UL49.5 residues 30-32, a deletion of UL49.5 cytoplasmic tail residues 80-96, or a combination thereof, wherein at least one heterologous antigen is selected from the group consisting of a BVDV Erns antigen having at least 95% amino acid sequence identity to SEQ ID NO: 42, a BVDV E2 antigen having at least 95% amino acid sequence identity to SEQ ID NO:2, 3, 4, 5, 7, 10, 12, 55, or 57, BVDV E2 antigen encoded by a nucleic acid segment with at least 95% nucleotide sequence identity to SEQ ID NO:6, 8, 9, 11, 13, 14, 56, or 58, and a BVDV Erns antigen encoded by a nucleic acid segment with at least 95% nucleotide sequence identity to SEQ ID NO:40 or 59, and wherein the at least one heterologous antigen is inserted in the recombinant vector at least at a site of the deletion of the cytoplasmic tail of envelope glycoprotein gE (gE-CT) or at a site of a deletion of glycoprotein G (gG); wherein at least one heterologous antigen is expressed from a heterologous promoter; wherein at least one heterologous antigen is expressed from an elongation factor 1a promoter; wherein at least one heterologous antigen is expressed as a fusion protein; wherein at least one heterologous antigen is expressed as a fusion protein with a fusion partner selected from a gD signal sequence, a V5 epitope, a histidine tail comprising 2-10 histidine residues, GM-CSF, or any combination thereof; composition comprising a carrier and at least one BoHV-1 recombinant vector of claim 1; further comprising a GM-CSF polypeptide.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 7, 13, 16, 17, 20 and claims 1-21 of U.S. Patent No. 11083787 recite a bovine herpesvirus-1 (BoHV-1) recombinant vector comprising a deletion of a cytoplasmic tail of envelope glycoprotein gE (gE-CT), a truncation of glycoprotein gG, a deletion of envelope protein UL49.5 amino acid residues 30-32, and a deletion of UL49.5 cytoplasmic tail amino acid residues 80-96.
Conclusion
9. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet Andres can be reached at 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
