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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`05/31/2019
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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 2 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). Responsive to communication(s) filed on 21 December 2018.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a)D This action is FINAL.
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`2b) C] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`5)
`Claim(s)
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`1—18,20—22,24—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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`E] Claim(s) _ is/are allowed.
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`C] Claim(s)
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`is/are rejected.
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`[j Claim(s) _
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`is/are objected to.
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`) ) ) )
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`6 7
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`8
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`Claim(s) 1—18,20—22,24—27 and 38—46 are subject to restriction and/or election requirement
`9
`* 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
`10)[:] The specification is objected to by the Examiner.
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`11)[:] The drawing(s) filed on
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`is/are: a)D accepted or b)l:] objected to by the Examiner.
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`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
`12):] 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)D All
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`b)I:J Some”
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`c)C] None of the:
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`1.[:] Certified copies of the priority documents have been received.
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`2.[:] Certified copies of the priority documents have been received in Application No.
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`3.[:] 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) C] Notice of References Cited (PTO-892)
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`2) E] 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) C] 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 20190528
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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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`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 under the
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`first inventor to file provisions of the AIA.
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`DETAILED ACTION
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`Election/Restriction
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`2.
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`REQUIREMENT FOR UNITY OF INVENTION
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`As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention
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`only or to a group of inventions so linked as to form a single general inventive concept
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`(”requirement of unity of invention"). Where a group of inventions is claimed in a national
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`stage application, the requirement of unity of invention shall be fulfilled only when there is a
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`technical relationship among those inventions involving one or more ofthe same or
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`corresponding special technical features. The expression ”special technical features" shall mean
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`those technical features that define a contribution which each ofthe claimed inventions,
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`considered as a whole, makes over the prior art.
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`The determination whether a group of inventions is so linked as to form a single general
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`inventive concept shall be made without regard to whether the inventions are claimed in
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`separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
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`When Claims Are Directed to Multiple Categories of Inventions:
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`As provided in 37 CFR 1.475 (b), a national stage application containing claims to
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`different categories of invention will be considered to have unity of invention ifthe claims are
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`drawn only to one of the following combinations of categories:
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`(1)A product and a process specially adapted for the manufacture of said product; or
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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 3
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`(2) A product and a process of use of said product; or
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`(3) A product, a process specially adapted for the manufacture ofthe said product, and
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`a use ofthe said product; or
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`(4) A process and an apparatus or means specifically designed for carrying out the said
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`process; or
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`(5) A product, a process specially adapted for the manufacture ofthe said product, and
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`an apparatus or means specifically designed for carrying out the said process.
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`Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
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`3.
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`Restriction is required under 35 U.S.C. 121 and 372.
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`This application contains the following inventions or groups of inventions which are not
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`so linked as to form a single general inventive concept under PCT Rule 13.1.
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`In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a
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`single invention to which the claims must be restricted.
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`Group |, claim(s) 1—18, 27, 38, 39, 40, 41, 442, 44, 45 and 46 drawn to an oncolytic virus
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`comprising: (i) a GM—CSF—encoding gene and (ii) an immune co—stimulatory pathway activating
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`molecule or an immune co—stimulatory pathway activating molecule—encoding gene and
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`subject—matter relating thereto.
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`Group II, claim(s) 20—22, 24, 25, 26 drawn to an oncolytic virus comprising: (i) a GM—CSF—
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`encoding gene and (ii) an immune co—stimulatory pathway activating molecule or an immune
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`co—stimulatory pathway activating molecule—encoding gene and (iii) at least three heterologous
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`genes as well as a subject—matter relating thereto.
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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 4
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`Group | and group II lack unity of invention because even though the inventions ofthese
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`groups require the technical feature of an oncolytic virus encoding i). GM—CSF and another
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`immune co—stimulatory activating molecule activating molecule encoding gene , this technical
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`feature is not a special technical feature as it does not make a contribution over the prior art in
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`view of Liu B et al. (GENE THERAPY, Vol. 10, No. 4, 2003, pages 292—303) and SENZER ET AL.
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`(JOURNAL OF CLININCAL ONCOLOGY, 2009, Vol. 27, No. 34, pp. 5763—5771).
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`4.
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`This application contains claims directed to more than one species of the generic
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`invention. These species are deemed to lack unity of invention because they are not so linked
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`as to form a single general inventive concept under PCT Rule 13.1.
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`The species are as follows:
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`A). costimulatory pathway activating molecule: 1). CD40 ligand; 2). |COS ligand; 3). GITR
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`ligand; 4). 4—1—BBB ligand; 5). OX40 ligand; 6). TL|A; 7). CD30 ligand; 8). CD27; 9). Flt3 ligand/
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`B). fusogenic protein encoding gene: i). VSV—G protein; ii). Synciti—1; iii). Syncitin—2; iv).
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`SV5—F protein; v). Measles virus (MV)—H protein; vi). MV—F protein; vii). RSV—F protein; viii). G
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`protein of GALV; ix). Murine leukemia virus (MLV); x). MPMV—G protein; xi). EIAV—G protein.
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`C). oncolytic virus species: a). herpes virus; b). poxvirus; c). adenovirus; d). retrovirus; e).
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`rhabdoviruses; f). paramyxovirus, g). reovirus and h). clinincal isolate virus.
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`D). promoters: aa). CMV promoter; bb). RSV promoter; cc). SV40 promoter; and dd).
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`Retrovirus LTR promoter.
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`Applicant is required, in reply to this action, to elect a single species to which the claims
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`shall be restricted if no generic claim is finally held to be allowable. The reply must also identify
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`the claims readable on the elected species, including any claims subsequently added. An
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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 5
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`argument that a claim is allowable or that all claims are generic is considered non—responsive
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`unless accompanied by an election.
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`Upon the allowance of a generic claim, applicant will be entitled to consideration of
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`claims to additional species which are written in dependent form or otherwise require all the
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`limitations of an allowed generic claim. Currently, the following claim(s) are generic: Claims 2,
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`7, 10, 13, 20 and 42.
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`5.
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`The groups of inventions listed above do not relate to a single general inventive concept
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`under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special
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`technical features for the following reasons:
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`Where a single claim defines alternatives of a Markush group, the requirement of a
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`technical interrelationship and the same or corresponding special technical features as defined
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`in Rule 13.2, is considered met when the alternatives are of a similar nature. When the
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`Markush grouping is for alternatives of chemical compounds, the alternatives are regarded as
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`being of a similar nature where the following criteria are fulfilled:
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`(A) all alternatives have a common property or activity; AND
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`(B)(1) a common structure is present, that is, a significant structural element is shared
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`by all of the alternatives; OR
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`(B)(2) in cases where the common structure cannot be the unifying criteria, all
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`alternatives belong to a recognized class of chemical compounds in the art to which the
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`invention pertains.
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`The phrase ”significant structural element is shared by all of the alternatives" refers to
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`cases where the compounds share a common chemical structure which occupies a large
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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 6
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`portion oftheir structures, or in case the compounds have in common only a small
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`portion oftheir structures, the commonly shared structure constitutes a structurally
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`distinctive portion in view of existing prior art, and the common structure is essential to
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`the common property or activity.
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`The phrase ”recognized class of chemical compounds" means that there is an
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`expectation from the knowledge in the art that members ofthe class will behave in the
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`same way in the context ofthe claimed invention, i.e. each member could be
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`substituted one for the other, with the expectation that the same intended result would
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`be achieved.
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`Each different species listed from different categories of (A) to (D) are not regarded as
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`being of similar nature or even functions because all ofthe alternatives do not share a common
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`property or activity. For example, reovirus is not herpes virus, CD40 ligand not 0X40 etc.
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`6.
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`Applicant is reminded that upon the cancellation of claims to a non—elected invention,
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`the inventorship must be corrected in compliance with 37 CFR l.48(a) if one or more of the
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`currently named inventors is no longer an inventor of at least one claim remaining in the
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`application. A request to correct inventorship under 37 CFR l.48(a) must be accompanied by an
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`application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her
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`legal name and by the processing fee required under 37 CFR l.l7(i).
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to BAO Q Li whose telephone number is (571)272—0904. The
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`examiner can normally be reached on M—F 8 am to 8 pm EST.
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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 7
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`Examiner interviews are available via telephone, in—person, and video conferencing
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`using a USPTO supplied web—based collaboration tool. To schedule an interview, applicant is
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`encouraged to use the USPTO Automated Interview Request (AIR) at
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`http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Janet Andres can be reached on 571—272—0867. The fax phone number for the
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`organization where this application or proceeding is assigned is 571—273—8300.
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`Information regarding the status of an application may be obtained from the Patent
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`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see http://pair—direct.uspto.gov. Should you have questions on access to the Private
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`PAIR system, contact the Electronic Business Center (EBC) at 866—217—9197(toll—free). If you
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`would like assistance from a USPTO Customer Service Representative or access to the
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`automated information system, call 800—786—9199 (IN USA OR CANADA) or 571—272—1000.
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`BAO Q. LI
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`Examiner
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`Art Unit 1648
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`7.
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`/BAO QLI/
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`Primary Examiner, Art Unit 1648
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`Application/Control Number: 16/068,830
`Art Unit: 1648
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`Page 8
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