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
Claims 1 – 21 are pending.
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 – 21 are rejected under 35 U.S.C. 103 as being unpatentable over Coffin (U.S. Patent Application No. US 2020/0199542 A1, cited on IDS), in view of Caballero et al. (Chimeric Infectious Bursal Disease Virus-Like Particles as Potent Vaccines for Eradication of Established HPV-16 E7–Dependent Tumors. PLoS ONE 7(12): e52976.; hereinafter Caballero) and Brown (U.S. Patent Application No. 2005/0214316 A1, cited on IDS).
Regarding claims 1 and 14, Coffin teaches a method for treatment or prophylaxis of cancer in an individual in need thereof (claim 37). Claim 37 further discloses administering a therapeutically effective amount of the virus of any one of claims 1 to 24. Coffin discloses (paras. [0014] and [0016]) that the invention provides oncolytic viruses expressing genetic modifications: a fusogenic protein and at least one immune stimulatory molecule. Also, paragraph [0014] discloses that the oncolytic viruses of the invention provide improved treatment of cancer through improved direct oncolytic effects. Coffin does not teach an oncolytic double stranded RNA (dsRNA) virus, wherein the dsRNA virus is selected from Infectious Pancreatic Necrosis virus ("OV1") and Infectious Bursal disease Virus (IBDV) ("OV2").
Caballero teaches that the IBDV (Abstract/Introduction) can be used as a vaccine in the treatment of cancer.
Brown teaches an oncolytic double stranded RNA (dsRNA) virus, wherein the dsRNA virus is selected from infectious Pancreatic Necrosis virus ("OV1") and Infectious Bursal disease Virus ("OV2") (Abstract; claim 40). Brown discloses (para. [0164]) how IBDVs belong to the Birnaviridae family and the Virnavirus genus. IBDV is an RNA, double stranded bi-segmented virus. Brown also teaches (para. [0162]) that the first effect of Infectious bursal disease (IBD) was lymphocyte lysis in bursa of Fabricus (BF) with no significant lesions in other organs. The results suggested IBDV induced systemic lymphocyte apoptotic lysis in addition to that in primary lymphoid organs (para [0191]). Also, paragraph [0165] discloses that Birnaviral infections include infectious pancreatic necrosis virus (“OV1”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the motivation of Caballero’s study and combine the IBDV of Brown with the invention/method of Coffin, to provide novel oncolytic virus treatment options for treatment or prophylaxis of cancer in an individual in need thereof.
Regarding claims 2, 3 and 15, Coffin further teaches the OV1 or the OV2 comprises a genetic modification of its genome that enhances its oncolytic function. As stated in paragraph [0014], Coffin discloses that the invention provides oncolytic viruses expressing a fusogenic protein and at least one immune stimulatory molecule. Oncolytic viruses of the invention provide improved treatment of cancer through improved direct oncolytic effects, viral replication and spread through tumors, mediated by the fusogenic protein, which (i) increases the amount of tumor antigens, including neoantigens, which are released for the induction of an anti-tumor immune response; and (ii) enhances the expression of the virus-encoded immune stimulatory molecule(s). Expression of the immune stimulatory molecule(s) further enhances and potentiates the anti-tumor immune effect.
Regarding claims 4, 5, 17 and 18, Coffin further teaches the genetic modification comprises a sequence encoding a therapeutic payload in claim 3 (Granulocyte-macrophage colony-stimulating factor (GM-CSF) included; claim 3 of Coffin).
Regarding claims 6 and 16, Coffin in view of Caballero and Brown makes obvious the method of claims 2 and 15, yet does not expressly teach wherein the genetic modification comprises a disruption or mutation of a segment of the viral genome that encodes the viral VP5 protein such that the viral VP5 protein is not produced within cells infected with the OV1 or the OV2. Coffin does teach a genetic modification comprising a disruption or mutation of a segment of the viral genome with altered tropism. Coffin discloses (para. [0008]) that in herpes simplex virus (HSV) when only the ICP34.5 genes have been disrupted can replicate in many tumor cell types in vitro, and replicate selectively in tumor tissue, but not in surrounding tissue, in mouse tumor models. Clinical trials of ICP34.5 deleted, or ICP34.5 and ICP6 deleted, HSV have also shown safety and selective replication in tumor tissue in humans.
Also, Brown teaches IBDV VP5 is a non-essential structural protein and that VP5 was the last IBDV protein identified (para. [0325]). This protein is not essential for IBDV replication in vitro or in vivo, however, it plays an important role in viral pathogenesis. It has cytotoxic properties and it may play a role in the release of the IBDV progeny.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the genetic modification could comprise a disruption or mutation of a segment of the viral genome that encodes the viral VP5 protein according to Coffin, to potentially modulate its pathogenicity, and any altered host tropism according to Coffin.
Regarding claim 7, Coffin teaches the individual in need thereof is a mammal that is optionally a human or a canine. Coffin teaches specifically in paragraph [0008] as stated above, clinical trials involving human tumor tissue.
Regarding claims 8, 9 and 19, Caballero teaches administering the OV1 or the OV2 inhibits growth of cancer cells in the individual and the cancer cells are present in a tumor thereby causes the cancer cells to comprise an isolated or recombinantly produced OV (Abstract; FIG. 3).
Regarding claims 10 and 11, Caballero teaches administering an effective amount of a OV2 vaccine (FIG. 3) and not OV1. However, the disclosed amount can serve as starting point for OV1 and be further optimized.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that an effective amount of OV1 or OV2 could be administered according to Caballero.
Regarding claim 12, Brown teaches cDNA amplified from a segment of a genomic RNA of an OV. Brown discloses (para. [0054]) that in one embodiment, the sample is a paraffin embedded tissue sample. In an advantageous embodiment, IBDV cDNAs are generated by extracting RNA from the paraffin-embedded tissue sample and reverse transcriptase-polymerase chain reaction amplification of the IBDV cDNA with IBDV-specific primers. Brown further discloses (para. [0055]) that advantageously, the IBDV-specific primers amplify a hypervariable portion of IBDV, such as VP1, VP2, VP3, VP4 or VP5.
Regarding claim 13, Coffin in view of Caballero and Brown makes obvious the cDNA of claim 12, yet does not expressly teach cRNA transcribed from a cDNA. However, Brown teaches generating riboprobes from cDNA. Brown states in an advantageous embodiment (para. [0075]), the IBDV cDNA generated from the sample suspected of having IBDV is used as a probe to screen cDNA or genomic libraries specific to the sample to isolate a full length clone corresponding to the novel strain of IBDV. Brown further (para. [0235]) discloses that using in situ hybridization staining with riboprobes specific for the VP2 gene of IBDV, no virus was detected in the proventriculi of 3 week-old chickens experimentally exposed to IBDV strain Delaware A and no histologically evident proventricular lesions were present.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the riboprobes comprise cRNA.
Regarding claim 20, Coffin teaches a pharmaceutical composition comprising an OV in paragraph [0020].
Regarding claim 21, Brown teaches one or more expression vectors encoding one or two segments of an OV in paragraphs [0099] and [0100].
Conclusion
The invention as claimed is prima facie obvious over Coffin, in view of Caballero and Brown. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached Monday - Friday 9:00A - 5:00P.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638