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 .
Claims Summary
Claim 1 is directed to a genetically engineered Pichinde virus comprising:
A first genomic segment comprising a coding region encoding a Z protein and a coding region encoding an L RDRP protein;
A second genomic segment comprising a coding region encoding a glycoprotein (GPC); the segment also comprises a multiple cloning site (MCS) that comprises a first enzyme restriction site (claim 2);
A third genomic segment comprising a coding region encoding a nucleoprotein (NP); the segment also comprises a multiple cloning site (MCS) that comprises a second enzyme restriction site (claim 2);
(Claim 8) A fourth genomic segment encoding a T7 RNA polymerase;
wherein at least one of the second and third genomic segment further comprises a donor gene sequence that encodes an adenovirus capsid protein or a fragment thereof. Although the claims do not explicitly state that the Z, L, GPC and NP proteins are those of Pichinde virus, it is presumed so. The donor gene sequence is located at the first enzyme restriction site (claim 2), or the second enzyme restriction site (claim 3). The adenovirus capsid protein is a full-length hemorrhagic enteritis virus (HEV) capsid protein (claim 4). The donor gene sequence comprises a nucleic acid sequence having at least 80% identity to HEV Fiber Protein (claim 5). Each of the genomic segments further comprises a regulatory sequence, such as a promoter, among others (claim 6). At least one of the genomic segments further comprises a reporter gene sequence encoding a detectable marker (claim 7). Also claimed is an infectious virus particle comprising the genomic segment of claim 1 (claim 9), and a composition comprising the infectious virus particle (claim 10).
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 5, as amended in the preliminary amendment filed December 20, 2023, is directed to an embodiment wherein the donor gene sequence comprises a nucleic acid sequence having at least 80% identity to HEV Fiber Protein. The specification does not appear to provide support for this embodiment, rather, it provides support for “at least 80% identity to SEQ ID NO: 15 and 20”, for example. The specification must be amended to include the subject matter of claim 5.
Claim Objections
Claims 1-10 are objected to because of the following informalities:
Claim 1 is directed to a virus comprising three genomic segments. There should be an “and” at the end of line 4 to clearly indicate that all three segments are present in the virus. Claims 2-10 are included in this objection because they are dependent on claim 1.
Claim 3 recites “a second enzyme restriction site”. Claim 3 is dependent on claim 1. Claim 1 does not have a “first” enzyme restriction site, thus the reference to a “second” site where there is no “first” site must be corrected.
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.
Claim 5 is 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 5, as amended in the preliminary amendment filed December 20, 2023, is directed to an embodiment wherein the donor gene sequence comprises a nucleic acid sequence having at least 80% identity to HEV Fiber Protein. The metes and bounds of a nucleic acid sequence that is at least 80% identical to a protein without any reference sequence cannot be determined. In order to calculate 80% identity, there must be a reference sequence with which to make a comparison and determine whether the sequence falls within the scope of the claim. Correction is required.
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 1-4, 6, 7, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (US 2020/0165578 A1, cited in the IDS filed 12/20/2023, “Ly”) in view of Michael et al. (WO 99/31249 A1, cited in the IDS filed 12/20/2023, “Michael”). The claims are summarized above and correlated with the teachings of the prior art below.
Ly discloses a genetically engineered Pichinde virus comprising:
A first genomic segment comprising a coding region encoding a Z protein and a coding region encoding an L RDRP protein;
A second genomic segment comprising a coding region encoding a nucleoprotein (NP); and
A third genomic segment comprising a coding region encoding a glycoprotein (GPC)
The second or third genomic segment further comprises a coding region encoding a first protein and/or second protein, respectively (see Ly, claims 53-54) (instant claim 1). The second and/or third genomic segments include a MCS with one or more restriction sites where the additional coding region is inserted (see paragraphs [0066]-[0067]) (instant claims 2 and 3). The genomic segments further comprise a promoter, such as the T7 promoter (see paragraph [0083]), as well as a marker (see Ly’s claim 55) (instant claims 6 and 7). Ly also discloses infectious virus particles and compositions comprising the particles (see Ly’s claims 76-77) (instant claims 9 and 10).
Ly discloses viral antigens as the encoded proteins of the Pichinde construct, as well as the vaccination of turkeys, but does not specifically name HEV, nor any of the capsid proteins. In view of Ly’s suggestion to use any viral antigen and the suggestion to vaccinate turkeys, one would have been motivated to select a capsid protein of HEV with a reasonable expectation of success, since it is a viral pathogen of turkeys that has significant economic impact (see Michael, abstract, and page 1) (instant claim 1). Michael teaches vectors comprising coding sequences for capsid proteins such as hexon, penton and fiber, or fragments thereof (see Michael, page 8, lines 3-13) (instant claims 1 and 4). 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 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ly et al. (US 2020/0165578 A1, cited in the IDS filed 12/20/2023, “Ly”) in view of Michael et al. (WO 99/31249 A1, cited in the IDS filed 12/20/2023, “Michael”) as applied to claim 1 above, and further in view of Orlinger et al. (WO 2015/082570 A1, “Orlinger”). Claim 8 is directed to an embodiment wherein the construct further comprises a fourth genomic segment encoding a T7 RNA polymerase.
The teachings of Ly and Michael are outlined above. While Ly discloses the use of T7 promoters and cell that express T7 polymerase (see Ly’s claims 67 and 75), Ly does not suggest a fourth genomic segment coding for T7 polymerase. However, as an alternative to Ly’s cell line that expresses T7 polymerase, it would have been obvious to have introduced into the vector a genomic segment encoding a T7 polymerase, with a reasonable expectation of success, since both approaches accomplish transcription by providing the T7 polymerase to work with the T7 promoter in the genomic segments. Orlinger discloses the two approaches as alternatives in paragraphs [00226] and [00393]. 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.
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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