REMARKS
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`Claims 1—18, 27, and 38—46 were pending. Claims 1, 3, and 7 are amended herein
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`without prejudice and without acquiescence. Support for amendment to claim 1 comes from the
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`originally filed 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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`Issue Under 35 USC § 112, first paragraph
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`Claim 12 was rejected under 35 USC § 112, first paragraph, for allegedly failing to
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`provide an adequate written description and for allegedly failing to provide an enabling
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`disclosure. The claims concern particular biological deposits of viral strains.
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`The undersigned is an attorney of record for the Applicant. Applicant deposited the
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`noted HSVl strains at the ECACC, Culture Collections, Public Health England, on December
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`19, 2016, under the Budapest Treaty on the International Recognition of the Deposit of
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`Microorganisms for the Purposes of Patent Protection. The corresponding Certificates are
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`attached herewith in Appendix 1.
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`Applicant asserts the following:
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`(a) that access to the deposit will be available during pendency of the patent application
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`making reference to the deposit to one determined by the Commissioner to be entitled thereto
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`under § 1.14 and 35 U.S.C. 122;
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`(b) all restrictions imposed by the depositor on the availability to the public of the
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`deposited material will be irrevocably removed upon the granting of the patent;
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`(c) the deposits will be replaced if they should become nonviable or non—replicable.
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`(d) the deposit is made for a term of at least thirty (30) years and at least five (5) years
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`after the most recent request for the furnishing of a sample of the deposit was received by the
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`depository. In any case, samples are stored under agreements that make the deposited material
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`available beyond the enforceable life of the patent for which the deposit was made.
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`Applicants respectfully request withdrawal of the rejection.
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`11.
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`Issues Under 35 USC § 102 (a)(1)
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`A. WO 2014/036412
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`Claims 1—4, 13—18, 27, and 39—46 were rejected under 35 USC § 102(a)(1) 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 both (i) a GM—
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`CSF encoding gene and (ii) a heterologous immune co—stimulatory pathway activating molecule—
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`encoding gene.
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`In contrast, Vanderwalde discloses a combination treatment for melanoma involving two
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`separate agents: (i) a HSV lacking ICP34.5 and ICP47 gene and comprising a gene encoding
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`human GM—CSF, and (ii) an immune checkpoint inhibitor, 6. g. anti—CTLA—4 antibody (see
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`claims 2 and 7 of Vanderwalde). Vanderwalde does not disclose an oncolytic virus comprising
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`both a GM—CSF encoding gene and a heterologous immune co—stimulatory pathway activating
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`molecule—encoding gene, as required by current claim 1.
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`Claim 1 is therefore novel, and all of claims 2 to 4, 13 to 18, 27, 39 to 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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`B. Senzer et al. (2009)
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`Claims 1, 10, 13—15, and 17—18 were rejected under 35 USC § 102(a)(1) as being
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`anticipated by Senzer er al. (2009; J. Clinical Oncology, Vol. 27, No. 34, pp. 5763-5771;
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`“Senzer”).
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`Senzer discloses an oncolytic HSVl, OncoVEXGM'CSF, which comprises a GM—CSF—
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`encoding gene. However, the virus described in Senzer does not comprise a heterologous
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`immune co—stimulatory pathway activating molecule—encoding gene, as specified in present
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`claim 1.
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`Indeed, the virus described in Senzer does not contain any immune co—stimulatory
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`pathway activating molecule—encoding genes. No naturally occurring viruses would express
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`immune co—stimulatory pathway activating molecules naturally or would contain immune co—
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`stimulatory pathway activating molecule—encoding genes naturally. This is because these
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`molecules are well known in the art at the filing date to activate T—cells via co—stimulatory
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`receptors. Examples of co—stimulatory pathway activating molecules include CD40 ligand,
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`ICOS ligand, GITR ligand, 4—1—BB ligand, 0X40 ligand, TLlA, CD30 ligand, CD27 or flt3
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`ligand, as provided in claim 2 and page 20, second and third paragraph of the present application.
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`Hence, a person of ordinary skill would recognize that these molecules are n_ot naturally present
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`in viruses. Furthermore, it has been made clear in claim 1 that the immune co—stimulatory
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`pathway activating molecule—encoding gene is a “heterologous” gene, and hence this gene is not
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`naturally present in the virus.
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`Therefore, the virus disclosed in Senzer does not contain genes that encode both GM—
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`CSF and an immune stimulatory pathway activating molecule, which genes are not naturally
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`present in this virus. Accordingly, claim 1 is not anticipated by Senzer. All of claims 10, 13 to
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`15 and 17 to 18 depend from, or otherwise incorporate the features of claim 1, and so these
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`claims are also novel in view of Senzer.
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`Applicants respectfully request withdrawal of the rejection.
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`C. Coffin et al. (2003)
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`Claims l, 10, 13—15, and 17—18 were rejected under 35 USC § 102(a)(1) as being
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`anticipated by Coffin et al. (2003, Gene Therapy, Vol. 10, pp. 292—303).
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`Coffin describes the same oncolytic HSVl that is described in Senzer. As explained
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`above, present claim 1 requires an oncolytic virus comprising a heterologous immune co—
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`stimulatory pathway activating molecule encoding gene and no viruses expressed such molecules
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`naturally. The virus disclosed in Coffin does not contain genes that encode both GM—CSF and a
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`heterologous immune co—stimulatory pathway activating molecule, which genes are not naturally
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`present in this virus.
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`Accordingly, claim 1 is not anticipated by Coffin. All of claims 10, 13 to 15 and 17 to 18
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`depend from, or otherwise incorporate the features of claim 1, and so these claims are also novel
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`in view of Coffin.
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`Applicants respectfully request withdrawal of the rejection.
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`111.
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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: November 15, 2019
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