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
Claims 1-15 are considered.
Priority
From provisional, App# 63/380,631, 10/24/2022 was used as the effective filing date for examination.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicant’s duty to disclose all information known to be material to patentability.
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
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.
Specification
The disclosure is objected to because of the following informalities:
The drawings are indicated by “Figure” rather than “FIG.” See objection to the drawings, above.
Change “non-Hodgkin’s lymphoma” to “non-Hodgkin lymphoma”.
Appropriate correction is required.
Claim Objections
Claims 6, 12 and 15 objected to because of the following informalities:
Claim 6: Add comma after H54Y.
Claim 12: Add a period after “intramuscularly”.
Claim 15: Change “non-Hodgkin’s lymphoma” to “non-Hodgkin lymphoma”.
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 8, 9 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 8: Both the oncolytic virus and a comparative sequence for the G protein, to use for investigating the one or more amino acid mutations, are not identified. As a result, it is not clear what the position numbers are relative to or what/where position 1, for example, is located.
Claim 9 is rejected on the basis of being dependent on rejected claim 8.
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.
(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.
Claim 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (Park)(2020)(See PTO-892 Notice of References Cited).
Park teaches a method of treatment of an individual having cancer(in this ref, demonstrated with mouse tumor models), comprising the steps of administering to the individual an oncolytic virus (in this ref, an oncolytic virus (OV) is the chimeric poxvirus-based OV)(p. 2, Introduction) comprising nucleotide sequences encoding an antigen (in this ref, a truncated non-signaling variant of CD19 (CD19t)(as recited in claim 2) or OV10t; and administering to the individual genetically engineered T cells expressing a chimeric antigen receptor (CAR) that recognizes the antigen (in this ref, CD19-CAR T cells). Park showed effective anti-tumor responses by combined treatment with OV19t and CD19-CAR T cells (p.2. Introduction).
Accordingly, Park teaches each and every aspect of claims 1 and 2.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claims 1 and 2 above (see § 102), and further in view of Zhang et al. (Zhang)(WO2022046788-A2)(See PTO-892 Notice of References Cited).
Claim 3 as submitted 10/24/2023.
Park teaches claims 1 and 2 but does not teach a specific sequence for the antigen CD19.
Zhang, however, teaches a polypeptide or a polynucleotide encoding the polypeptide, wherein the polypeptide comprises, or consists essentially of, or yet further consists of (i) an amino acid sequence (also referred to herein as a peptide) of a Chimeric Antigen Receptor (CAR) and (ii) an amino acid sequence of a bispecific antibody. Further, the CAR peptide comprises, or consists essentially of, or yet further consists of (1) an antigen binding amino acid sequence (such as a single-chain variable fragment, i.e., an scFv) that recognizes and binds a tumor associated antigen (TAA) (anti-TAA antigen binding sequence)(p. 1, Abstract). One example of the tumor associated antigen provided by Zhang is a truncated CD19 amino acid sequence, SEQ ID 170 with 100% match to instant application SEQ ID NO: 7 (See Result 1, BKT35669, 4/21/22; us-18-493-787-7.align150.rag, 2/17/2026, in supplemental content tab).
One of ordinary skill in the art would have been motivated to substitute SEQ ID 170 as taught by Zhang for SEQ ID NO: 7 since they are 100% identical (See MPEP 2143 Rationale B. Simple substitution of one known element for another to obtain predictable results) and to achieve the same effect.
One of ordinary skill in the art would have had a reasonable expectation of success for using an identical sequence such as SEQ ID 170 as taught by Zhang. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claim 1 above (see § 102), and further in view of June et al. (June)(WO2012079000-A1)(See PTO-892 Notice of References Cited).
Claim 4 as submitted 10/24/2023.
Park teaches claim 1 but does not teach the specific amino acid sequence of the chimeric antigen receptor (CAR).
June, however, teaches compositions and methods for treating cancer in a human and more specifically, administering a genetically modified T cell to express a CAR wherein the CAR comprises an antigen binding domain, a transmembrane domain, a costimulatory signaling region, and a CD3 zeta signaling domain (p. 1, Abstract). For the CAR, June teaches CD19-BB zeta chimeric antigen receptor (CAR) protein SEQ ID NO: 12 with 100% match to instant application SEQ ID NO: 10 (See Result 1, AZX24799, 8/02/12; us-18-493-787-10.align150.rag, 2/17/2026, in supplemental content tab).
One of ordinary skill in the art would have been motivated to substitute SEQ ID NO: 12 as taught by June for SEQ ID NO: 10 since they are 100% identical (See MPEP 2143 Rationale B. Simple substitution of one known element for another to obtain predictable results) and to achieve the same effect.
One of ordinary skill in the art would have had a reasonable expectation of success for using an identical sequence such as SEQ ID NO:12 as taught by June. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 5, 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claim 1 above (see § 102), and further in view of Suzuki et al. (WO2021091560A1)(See PTO-892 Notice of References Cited).
Claims 5, 10-15 as submitted 10/24/2023.
Park teaches claim 1. Park does not teach specifics like T cell derivation, the vesicular stomatitis virus (VSV), methods of administration, co-therapies or surgeries, or the breadth of cancers treatable.
Like Park, Suzuki, teaches a method of treating cancer (see reference application claim 1). Suzuki’s invention utilizes (i) an oncolytic virus; (ii) a virus comprising nucleic acid encoding an immunomodulatory factor; and (iii) at least one cell comprising a chimeric antigen receptor (CAR) specific for a cancer cell antigen (p. 1, Abstract). In some embodiments, Suzuki limits the components to the oncolytic virus and at least one cell comprising a chimeric antigen receptor (CAR) specific for a cancer cell antigen (p. 4).
Regarding claim 5: “In some embodiments, the cell [T cells] may be from, or may have been obtained from, a human subject. Where the CAR-expressing cell is to be used in the treatment of a subject, the cell may be from the subject to be treated with the CAR-expressing cell (i.e. the cell may be autologous), or the cell may be from a different subject (i.e. the cell may be allogeneic)(p. 26)”.
Regarding claim 10: In some embodiments, the oncolytic virus of the present disclosure is, or is derived from, an adenovirus (Ad), herpes simplex virus (HSV), vaccinia virus (VV), vesicular stomatitis virus (VSV)(p. 13).
Regarding claims 11, 12, 13: Viruses, CARs, nucleic acids, and cells according to the present disclosure may be formulated as pharmaceutical compositions or medicaments for clinical use and may comprise a pharmaceutically acceptable carrier, diluent, excipient or adjuvant. The composition may be formulated for topical, parenteral, systemic, intracavitary, intravenous, intra-arterial, intramuscular, intrathecal, intraocular, intraconjunctival, intratumoral, subcutaneous, intradermal, intrathecal, oral or transdermal routes of administration which may include injection or infusion (p. 50-51).
Regarding claim 14: In some embodiments, the treatment may further comprise other therapeutic or prophylactic intervention, e.g. chemotherapy, immunotherapy, radiotherapy, surgery, vaccination and/or hormone therapy. Such other therapeutic or prophylactic intervention may occur before, during and/or after the therapies encompassed by the disclosure (p. 54).
Regarding claim 15: The cancer to be treated/prevented may be any kind of cancer, including any one of an acute lymphoblastic leukemia…non-Hodgkin lymphoma (p. 43).
One of ordinary skill in the art would have been motivated to substitute vesicular stomatitis virus for the OV vaccinia, broaden the administration options as taught by Suzuki because Suzuki teaches a similar invention that also includes a method a method of treating a cancer, comprising administering to a subject (i) an oncolytic virus; and (ii) at least one cell comprising a chimeric antigen receptor (CAR) specific for a cancer cell antigen where the cell is a T cell (See MPEP 2143, Rationale B. Simple Substitution of one known element for another to obtain predictable results).
One of ordinary skill in the art would have had a reasonable expectation of success for substituting vesicular stomatitis virus and broadening the administration options as taught by Suzuki. There would have been a reasonable expectation of success given the underlying materials and methods are known in the context of oncolytic virotherapy and CAR T cell therapy, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claim 1 above (see § 102), and further in view of Qin et al. (Qin)(WO2019184459-A1 & Description Translation)(See PTO-892 Notice of References Cited).
Claim 6 as submitted 10/24/2023.
Park teaches claim 1. Park does not teach wherein the oncolytic virus comprises M protein comprising one or more amino acid mutations.
Qin, however teaches immunotherapeutic methods for treating cancer, including oncolytic virus therapy, oncolytic virus vaccines, and oncolytic virus vaccines in combination with T cells (p. 1). For instance, Qin teaches administration of a recombinant oncolytic baculovirus, e.g., vesicular stomatitis virus (VSV), having a nucleic acid fragment encoding a modified matrix protein (M) and identified as vesicular stomatitis virus matrix protein (M) mutant (RV-3Mut) SEQ ID 5 which has a 100% match to instant application claim 6 SEQ ID NO: 1 with all amino acid mutations N32S, N49D, M51R, H54Y, V221F, V225I and S226R (See Result 1, BGUI5577, 18493787_1_all_subs.align150.rag, 2/19 /2026, in supplemental content tab) with the intent of treating a variety of different cancers.
One of ordinary skill in the art would have been motivated to substitute the M protein sequence with all of the amino acid mutations as taught by Qin because it meets the specification of an oncolytic virus comprises M protein comprising one or more amino acid mutations (See MPEP 2143, Rationale B. Simple Substitution of one known element for another to obtain predictable results) and to ultimately treat the particular cancer(s) of interest.
One of ordinary skill in the art would have had a reasonable expectation of success for substituting the M protein as taught by Qin. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claim 1 above (see § 102), and further in view of Ilkow et al. (Ilkow)(WO2021102585-A1)(See PTO-892 Notice of References Cited).
Park teaches claim 1 but does not teach the G protein amino acid sequence.
Ilkow teaches a recombinant tumor-selective viral particle comprising a nucleic acid encoding a recombinant polypeptide for directing an extracellular vesicle (EV) to at least one target cell, said recombinant polypeptide comprising: at least one targeting moiety for directing said EV to said at least one target molecule expressed by said at least one target cell; at least one EV-anchoring polypeptide; and at least one intravesicular polypeptide. The viral particle may be from an oncolytic viruses (p.1, Abstract) such as a vesicular stomatitis virus [00237].
Ilkow more specifically teaches a recombinant VSVG-VEEV capsid protein fusion construct which has a V53I mutation (as recited in claim 8) and also is 100% identical to the instant application claim 9, SEQ ID NO: 4 (See Result 14, BJK56154, us-18-493-797-4.align150.rag, 2/17/2026, in supplemental content tab). Ilkow further teaches administering a recombinant tumor-selective viral particle comprising a nucleic acid encoding a recombinant polypeptide for targeted therapy [0021].
One of ordinary skill in the art would have been motivated to substitute the G protein as taught by Ilkow because it is identical to SEQ ID NO: 4 of instant application claim 9 (See MPEP 2143, Rationale B. Simple Substitution of one known element for another to obtain predictable results) and consequently would achieve the same effect.
One of ordinary skill in the art would have had a reasonable expectation of success for substituting the G protein as taught by Ilkow. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Cornelius whose telephone number is (571) 272-0860. The examiner can normally be reached M-F, 0930-1700.
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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672