REMARKS
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`Claims 1—18, 27, and 38—46 were pending. Applicant notes that the Advisory Action
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`states that the previous claim amendments were not entered.
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`Claim 1 is amended herein without prejudice and without acquiescence. Support for
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`amendment to claim 1 comes from the originally filed application at least at page 12, last
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`paragraph, and page 19, lines 18 to 22. No new matter is added herein.
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`The Terminal Disclaimer filed March 12, 2020, was disapproved. Applicant submits the
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`AIA/25 form herewith.
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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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`In the Advisory Action, the Examiner considers the prior art documents U.S. Patent No.
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`9,492,482 (Beechl) and WO 2010/042189 (Beech2) to be of concern with respect to the pending
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`claims. The content of the two documents is the same, because Beechl is a U.S. patent derived
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`from the International application Beech2. The following arguments refer to these documents
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`collectively as Beech and make reference to the text in Beech2.
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`Presently pending claim 1 is as follows:
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`“An oncolytic virus comprising: (i) a heterologous GM-CSF-encoding gene; and (ii) a
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`heterologous immune co-stimulatory pathway activating molecule-encoding gene, wherein both
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`heterologous genes are inserted into the genome of the virusz and the virus is selectively
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`replication competent in tumor tissue.” (emphasis added)
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`Beech is concerned with using vectors to express immunomodulators in immune cells or
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`therapy support cells for the purpose of gene therapy (see paragraph [0008] of Beech2). The
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`immunuomodulators are described in paragraph [0009] of Beech2, which includes a long list of
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`immunomodulators which includes inter alia GM—CSF and immune co—stimulatory pathway
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`activators, such as OX40L and 4—l—BBL. The vectors include viral vectors (see paragraph
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`[0184] of Beech2).
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`The Examiner has made the assumption that “all viral vectors are oncolytic inherently”
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`(see second last sentence of the Advisory Action). However, viral vectors are n_ot inherently
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`oncolytic. Oncolytic viruses such as the viruses of claim 1 selectively infect and replicate in
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`tumor tissues such that the tumor tissues are killed (see page 12 last paragraph of the
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`specification).
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`By contrast, Beech does not disclose or teach tumor tissues as host cells, but instead
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`teaches immune cells or therapy support cells as host cells (see paragraph [0008] of Beech2).
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`Immune cells are defined in Beech as:
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`. .“immune cells” include dendritic cells, macrophages, neurophils,
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`mast cells, eosinophils, basophils, natural killer cells and lymphocytes (e.g., B
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`and T cells).” (see paragraph [0353] of Beech2)
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`Therapy support cells are defined in Beech as:
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`“... ”therapy support cells ” (TSC) are cells that can be modified (e.g.,
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`transfected, electroporated, etc.) with the vector of the invention to deliver the
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`one or more proteins having the function of an immunomodulator and,
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`optionally, a protein having the function of IL- 12, to tumor
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`microenvironments. Such TSC include, but are not limited to, stem cells,
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`fibroblasts, endothelial cells and keratinocytes.” (see paragraph [0356] of
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`Beech2).
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`In such gene therapy, it is not desirable that the viral vectors kill the host cells in which
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`expression of the encoded therapeutic gene is desired, especially when the host cells, such as
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`those described in Beech, have important physiological functions.
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`Indeed, the adenoviral vector described in the Examples of Beech is replication—deficient
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`in normal mammalian cells, because it is deficient in the El and E3 regions, and can replicate
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`only in cells engineered to harbor the adenovirus—S El region, which engineered cells provide the
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`El function in trans (see paragraph [0434] of Beech2).
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`Thus, it is not an inherent property of viral vectors that they can selectively infect and
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`replicate in tumor tissues. Therefore, the claimed viruses are distinct from the viral vectors
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`described in Beech because the viral vectors described in Beech are not “oncolytic viruses” that
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`are “selectively replication competent in tumour tissues”, as required by claim 1.
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`Claim 1 is therefore novel and non—obvious in view of Beech. All of claims 2 to 4, 13 to
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`18, 27, 39 to 46 depend from, or otherwise incorporate, the features of claim 1, and so these
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`claims are also novel and non—obvious.
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`Applicants respectfully request withdrawal of the rejection.
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`1.
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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: March 31, 2020
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