UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`16/068, 830
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`07/09/2018
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`Robert COFFIN
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`KEMP.P0086US
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`4383
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`NORTON ROSE FULBRIGHT US LLP
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`98 SAN JACINTO BOULEVARD
`SUITE 1100
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`AUSTIN, TX 78701-4255
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`LL 3A0 Q
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`1648
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`01/02/2020
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`ELECTRONIC
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
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`aoipdocket @ nortonrosefulbright.com
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`PTOL-90A (Rev. 04/07)
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`

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`0/7709 A0170” Summary
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`Application No.
`16/068,830
`Examiner
`BAO Q Li
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`Applicant(s)
`COFFIN, Robert
`Art Unit
`AIA (FITF) Status
`1648
`Yes
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`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
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`Status
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`1)C] Responsive to communication(s) filed on 15 November 2019.
`El A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) D This action is non-final.
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`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
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`4):] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Expade Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
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`5)
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`Claim(s)
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`1—18,27 and 38—46 is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`
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`[:1 Claim(ss)
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`is/are allowed.
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`8)
`Claim(s 1— 18 ,27 and 38—46 is/are rejected.
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`D Claim(ss_) is/are objected to.
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`) ) ) )
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`S)
`are subject to restriction and/or election requirement
`[:1 Claim(s
`* If any claims have been determined aflowable. you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
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`10)|:l The specification is objected to by the Examiner.
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`is/are: a)[] accepted or b)l:] objected to by the Examiner.
`11)[:] The drawing(s) filed on
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
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`Priority under 35 U.S.C. § 119
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`12)D Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)I:l All
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`b)|:] Some**
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`c)l:i None of the:
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`1C] Certified copies of the priority documents have been received.
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`2C] Certified copies of the priority documents have been received in Application No.
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`3D Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
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`** See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`1) [3 Notice of References Cited (PTO-892)
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`2) C] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
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`3) E] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20191119
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`

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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 2
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`DETAILED ACTION
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`Notice of Pre-AIA or AIA Status
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`1.
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`The present application, filed on or after March 16, 2013, is being examined
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`under the first inventor to file provisions of the AIA.
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`Summary
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`2.
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`The response and amendment filed on 11/15, 2019 have been acknowledged.
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`Claims 1, 3 and 7 have been amended. Claims 19-26, 28-37, 47-48 have been
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`canceled.
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`3.
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`4.
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`Claims 1-18, 27, 38-46 are pending and considered.
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`Claims interpretation: Some of the following rejection are based on a broadest
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`reasonable interpretation of claim 1 as a composition comprising an oncolytic virus with
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`an inhibitor of ODO, an antagonist of an immune co-stimulatory pathway or an agonist
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`of an immune stimulator pathway.
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`Claim Rejections - 35 USC § 1 12
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`5.
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`The rejection of Claim 12 under 35 U.S.C. 112, first paragraph, as containing
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`subject matter which was not described in the specification in such a way as to enable
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`one skilled in the art to which it pertains, or with which it is most nearly connected, to
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`make and/or use the invention has been removed in view of the persuasive argument
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`filed on 11/15/2019.
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`Claim Rejections - 35 USC § 102
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`6.
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`In the event the determination of the status of the application as subject to AIA 35
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`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
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`correction of the statutory basis for the rejection will not be considered a new ground of
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`rejection if the prior art relied upon, and the rationale supporting the rejection, would be
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`the same under either status.
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`7.
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
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`form the basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`

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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 3
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`(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
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`on sale or othenNise available to the public before the effective filing date of the claimed
`invention.
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`8.
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`Claims 1, 4, 5, 13-18, 27, 39-46 are still rejected under 35 U.S.C. 102 (a) (1) as
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`being anticipated by WO 2014/036412A2 by Vanderwalde Ari et al.
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`9.
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`In t eresponse, Applicants argue the cited reference by Vanderwalde Ari et al.
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`does not teach the oncolytic HSV encoding both GM-CSF and a heterologous immune
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`co-stimulatory pathway activating molecule —encoding genome
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`10.
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`Applicants’ argument has been respectfully considered; however it is not found
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`persuasive. Because Vanderwalde Ari et al. describe a method for the treatment of
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`melanoma comprising administering to a patient with stages lllb to IV melanoma an
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`effective amount of an immune checkpoint inhibitor and a herpes simplex virus, wherein
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`the herpes simplex virus lacks functional ICP34.5 genes, lacks a functional ICP47 gene
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`and comprises a gene encoding human GM-CSF (Claim 1), where the immune
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`checkpoint inhibitor is considered as an immune co-stimulatory pathway activating
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`molecule gene, which is CTLA-4 inhibitor, or more preferably is CTLLA-4 antibody or
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`fragment thereof. Therefore, the rejection is maintained.
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`11.
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`The rejection of Claims 1, 10, 13, 14, 15, 17, 18. under 35 U.S.C. 102 (a) (1) as
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`being anticipated by Journal of Clinical Oncology 2009, Vol. 27, No. 34, pp. 5763-5771.
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`To Senzer et al. has been removed as Applicants argue that Senzer does not teach any
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`immune-stimulatory pathway activating molecule encoding gene. The naturally
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`occurring viruses taught by the cited reference does not contain such molecule. This
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`argument is persuasive.
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`12.
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`The rejection of Claims 1, 10, 13, 14, 15, 17, 18 under 35 U.S.C. 102 (a) (1) as
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`being anticipated by Coffin R et al. (Gene Therepy 2003, Vol. 10, pp. 292-303) has
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`been removed as Applicants argue that the cited reference is Sender does not teach
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`any immune-stimulatory pathway activating molecule encoding gene. The naturally
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`occurring viruses taught by the cited reference does not contain such molecule. This
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`argument is persuasive.
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`

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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 4
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`Conclusion
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`1.
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action.
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`In the event a first reply is filed within
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`TWO MONTHS of the mailing date of this final action and the advisory action is not
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`mailed until after the end of the THREE-MONTH shortened statutory period, then the
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`shortened statutory period will expire on the date the advisory action is mailed, and any
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`extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action.
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`In no event, however, will the statutory period for reply expire later
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`than SIX MONTHS from the mailing date of this final action.
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`13.
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`/BAO Q Ll/
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`Primary Examiner, Art Unit 1648
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