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 .
Claim Status
Claim 12 are cancelled. Claims 1-11 and 13-21 as filed on 26 December 2026 are pending and under examination.
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.
Claims 1-5, 7-8, 10-11, and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (WO 2017143026 A1) (IDS).
Claim 1 is to a fusion protein comprising at least a portion of CSF1 and a portion of granzyme B. There is no limiting definition of a portion of granzyme B or CSF1 so the claim includes a single amino acid of granzyme B and CSF1. Instant SEQ ID NO: 2-4 is taught by applicant as portions of CSF1 protein, but are not required by claims 1-5, 7-8, 10-11, and 13-19.
Regarding claim 1, Lin teaches a cell-targeted cytotoxic agents comprising a construct of granzyme B, a linker, and a cell targeting moiety (Figure 1). Lin teaches cell targeting moieties include cytokines for cancer ([0098]). Lin teaches cytokines including macrophage stimulating factors which is CSF1 ([00104]).
Regarding claim 2, Lin teaches a granzyme B of SEQ ID NO: 3 which matches instant SEQ ID NO: 7 (Figure 6 and [0063]).
Regarding claims 3-4, Lin teaches a linker sequence of GGGS (figure 1 and [0030]).
Regarding claim 5, Lin teaches the linkers are flexible linkers ([0030]).
Regarding claims 7-8, Lin teaches a polynucleotide encoding the peptides ([0013]). Lin teaches viral vectors expressing the polynucleotide ([00166]).
Regarding claims 11 and 13, Lin teaches the treatment of cancer by administering the fusion protein of Lin (abstract and claims 70-75).
Regarding claim 14, Lin teaches the treatment of glioma ([00132]).
Regarding claim 15, Lin teaches the treatment of inflammatory bowel disease ([0026]).
Regarding claim 16, Lin teaches SEQ ID NO: 32 which comprises instant SEQ ID NO: 11 ([00129]).
Regarding claim 17, Lin teaches the linker sequence links the CSF1 portion ot the granzyme Z portion (Figure 1).
Regarding claim 18, Lin teaches a linker of GGGS (figure 1 and [0030]) which matches instant SEQ ID NO: 13.
Regarding claim 19, Lin teaches an adenovirus ([00166]).
Claims 1, 7, 9-10, and 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hou et. al. Nat Rev Drug Discov. 20:531-550 (2021) (PTO-892), as evidenced by Ho et. al. ACS Synth Biol. 6(8):1484-1495. (2018) (PTO-892) and Johnson. Annu. Rev. Biochem. 73:355-382. (2004) (PTO-892).
Claim 1 is to a fusion protein comprising at least a portion of CSF1 and a portion of granzyme B. B. There is no limiting definition of a portion of granzyme B or CSF1 so the claim includes a single amino acid of granzyme B and CSF1. Instant SEQ ID NO: 2-4 is taught by applicant as portions of CSF1 protein, but are not required by claims 1, 7, 9-10, and 20-21.
Regarding claims 1, 7, and 9-10, Hou teaches COVERT proteins that comprise granzyme B fused to an N-terminal inhibitory peptide in a CAR T cell where the binding of the CAR to its antigen initiates the delivery of COVERT (page 537 in col 1 in par 1). A COVERT comprises granzyme B and a SUMO protein, as evidenced by Ho (abstract). SUMO comprises a sequence that would be a portion of CSF1 by comprising amino acids present in instant SEQ ID NO: 2 including glycine and leucine, as evidenced by Johnson (Figure 2). Hou teaches oncolytic viruses engineered to express the CAR (page 538 in col 1 in lines 3-5 and lines 18-24).
Regarding claims 20-21, Hou teaches the CAR binds tumor specific antigens (page 631 in col 1 in par 1 and 538 in col 1 in lines 3-5 and lines 18-24). Hou further teaches the CAR are SynNothc (Figure 1).
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.
Claims 1-8, 10-11, and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (WO 2017143026 A1) (IDS) and Graddis (US 6291661 B1) (PTO-892).
Regarding claim 1, Lin teaches a cell-targeted cytotoxic agents comprising a construct of granzyme B, a linker, and a cell targeting moiety (Figure 1). Lin teaches cell targeting moieties include cytokines for cancer ([0098]). Lin teaches cytokines including macrophage stimulating factors which is CSF1 ([00104]).
Regarding claim 2, Lin teaches a granzyme B of SEQ ID NO: 3 which matches instant SEQ ID NO: 7 (Figure 6 and [0063]).
Regarding claims 3-5, Lin teaches a linker sequence of GGGS (figure 1 and [0030]). Lin further teaches the linkers are flexible linkers ([0030]).
Regarding claims 6, Lin teaches SEQ ID NO: 3 which matches amino acids 1 to 227 of instant SEQ ID NO: 28 (Figure 6 and [0063]), and linker sequence GGGS repeated 1-6 or more times ([0032]), this teaches amino acids 1 to 248 of instant SEQ ID NO: 28. Lin teaches the fusion proteins comprises a linkage of cytotoxic agents of granzyme B to a cell targeting moiety ([0002]). Lin teaches cell targeting moieties include cytokines for cancer ([0098]). Lin teaches cytokines including macrophage stimulating factors which is CSF1 ([00104]).
Regarding claim 6, Lin teaches SEQ ID NO: 3 which matches amino acids 1 to 227 of instant SEQ ID NO: 28 (Figure 6 and [0063]), and linker sequence GGGS repeated 1-6 or more times ([0032]), this teaches amino acids 1 to 248 of instant SEQ ID NO: 28. Lin teaches the fusion proteins comprises a linkage of cytotoxic agents of granzyme B to a cell targeting moiety ([0002]). Lin teaches cell targeting moieties include cytokines for cancer ([0098]). Lin teaches cytokines including macrophage colony-stimulating factors ([00104] and [0039]) which is CSF1.
Regarding claims 7-8, Lin teaches a polynucleotide encoding the peptides ([0013]). Lin teaches viral vectors expressing the polynucleotide ([00166]).
Regarding claims 11 and 13, Lin teaches the treatment of cancer by administering the fusion protein of Lin (abstract and claims 70-75).
Regarding claim 14, Lin teaches the treatment of glioma ([00132]).
Regarding claim 15, Lin teaches the treatment of inflammatory bowel disease ([0026]).
Regarding claim 16, Lin teaches SEQ ID NO: 32 which comprises instant SEQ ID NO: 11 ([00129]).
Regarding claim 17, Lin teaches the linker sequence links the CSF1 portion ot the granzyme Z portion (Figure 1).
Regarding claim 18, Lin teaches a linker of GGGS (figure 1 and [0030]) which matches instant SEQ ID NO: 13.
Regarding claim 19, Lin teaches an adenovirus ([00166]).
Lin then teaches a fusion protein that comprise amino acids 1 to 248 of instant SEQ ID NO: 28. Instant SEQ ID NO: 28 is 396 amino acids in length, the remainder of instant SEQ ID NO: 28 not taught by Lin is instant SEQ ID NO: 2, 149 amino acids in length, which is a subpart of human CSF1 and is shown in instant SEQ ID NO: 1 which is 554 amino acids in length.
Lin does not teach the amino acid sequence of instant SEQ ID NO: 2 which is a subset of CSF1 and is amino acids 248 to 396 of instant SEQ ID NO: 28.
This deficiency is filled by Graddis.
Regarding claims 2 and 6, Graddis teaches SEQ ID NO: 20 which is a human M-CSF or CSF1 polypeptide that binds its receptor and matches instant SEQ ID NO: 2 and amino acids 248 to 396 of instant SEQ ID NO: 28 (Figure 1, col 2 in lines 9-21, col 9 in lines 53-58, and col 57-58). Graddis further teaches the polypeptide of CSF1 used in a fusion protein (claim 7).
It would have been obvious at the time the application was filed to substitute the generic receptor binding cytokine of CSF1 in the fusion of Lin with the amino acid sequence of SEQ ID NO: 20 of Graddis that is taught as a CSF1 that effectively binds its receptor for use in fusion proteins which would produce a fusion protein of instant SEQ ID NO: 28. First, it would be prima facie obvious to substitute the generic CSF1 cytokine that binds its receptor of Lin with the species of SEQ ID NO: 20 of Graddis that is taught to have the required activity of binding its receptor and functions in a fusion protein. Second, one of skill in the art would have been motivated to find a specific sequence known to bind its receptor and can be used in a fusion protein. There would have been a reasonable expectation of success as Lin teaches its fusions can comprise a variety of binding domains as part of its fusion protein including the cytokine CSF1.
Conclusion
No claims allowable.
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/F.E./Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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