REMARKS
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`Claims l—18, 27, and 38—46 were pending. Claim 1 is amended herein without prejudice
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`and without acquiescence. Support for amendment to claim 1 comes from the originally filed
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`application at least at page 19, lines 18 to 22. No new matter is added herein.
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`The amendments are made to expedite the prosecution of this application. The Applicant
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`is not conceding that the claims prior to amendment are not patentable. No inference should be
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`made the Applicant is disclaiming any subject matter of the present application, and Applicant
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`reserves the right to pursue the non—amended claims or any other broader or narrower claim
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`supported by the disclosure at a later date, including any one or more continuing applications.
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`Cancellation of any claim herein is without prejudice to reinstatement in this or continuing
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`application.
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`1.
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`Issues Under 35 USC § 102 (a)(1)
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`Claims 1, 4, 5, 13—18, 27, and 39—46 were rejected under 35 USC § lO2(a)(l) as being
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`anticipated by WO 2014/036412 (“Vanderwalde”).
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`Presently submitted claim 1 is directed to an oncolytic Virus comprising: (i) a
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`heterologous GM—CSF—encoding gene; and (ii) a heterologous immune co—stimulatory pathway
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`activating molecule—encoding gene, wherein both heterologous genes are inserted into the
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`genome of the Virus. Vanderwalde fails to anticipate the presently submitted claims because the
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`reference lacks teaching of at least one element of the claims.
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`Vanderwalde refers to treating melanoma using a herpes simplex Virus (HSV) and an
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`immune checkpoint inhibitor (see title and abstract of Vanderwalde). Vanderwalde discloses a
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`HSV that contains a single heterologous gene only, which is a GM—CSF—encoding gene. It does
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`not disclose a HSV that contains other heterologous genes in its genome in addition to GM—CSF.
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`In contrast, present claim 1 of the instant application requires that the oncolytic virus contains at
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`least two heterologous genes in its genome: a GM—CSF—encoding gene and an immune co—
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`stimulatory pathway activating molecule—encoding gene.
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`Furthermore, Vanderwalde does not disclose an immune checkpoint inhibitor that is
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`encoded by a HSV nor does Vanderwalde disclose that the genome of the oncolytic virus contain
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`a gene encoding a heterologous immune co—stimulatory pathway activating molecule, such as a
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`CTLA—4 inhibitor. In Vanderwalde, the immune checkpoint inhibitor is to be administered to a
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`patient as a separate, independent agent, in addition to a HSV that contains a heterologous GM—
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`CSF—encoding gene. For example, the Example of Vanderwalde explains that the HSV that
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`contains GM—CSF (Talimogene Laherparepvec) was administered to the patients by intratumoral
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`injection, whereas the anti—CLTA—4 antibody (Ipilimumab) was administered to the patient
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`intravenously (see page 22, lines 23 to 29 of Vanderwalde). Thus, the two agents: (1) a HSV
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`that contains GM—CSF and (2) an anti—CLTA—4 antibody were administered separately to the
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`patients via different administration routes.
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`Hence, Vanderwalde does not disclose an oncolytic virus that contains in its genome both
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`a heterologous GM—CSF—encoding gene and an immune checkpoint inhibitor—encoding gene, as
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`required by claim 1.
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`Claim 1 is therefore novel, and all of claims 2—5, 13 to 18, 27, 39— 46 depend from, or
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`otherwise incorporate the features of claim 1, and so these claims are also novel.
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`Applicants respectfully request withdrawal of the rejection.
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`11.
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`Conclusion
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`Applicant respectfully asserts that the presently claimed invention is allowable.
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`The Examiner is invited to contact the undersigned agent with any questions, comments
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`or suggestions relating to the referenced patent application. The Director is hereby authorized to
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`charge any deficiency in the fees filed, asserted to be filed or which should have been filed
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`herewith to our Deposit Account No. 06—2375, under Order No. KEMP.P0086US from which the
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`undersigned is authorized to draw.
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`Respectfully submitted,
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`/Melissa L. Sistrunk/
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`Melissa L. Sistrunk
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`Reg. No. 45,579
`Agent for Applicants
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`NORTON ROSE FULBRIGHT US LLP
`1301 McKinney, Suite 5100
`Houston Texas 77010
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`(713) 651—3735
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`Date:
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`February 26, 2020
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