UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`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
`
`15/310,132
`
`11/10/2016
`
`Austin L. GURNEY
`
`2293.1220001/PAC/E-H
`
`7085
`
`Sterne, Kessler, Goldstein & Fox P.L.L.C.
`1100 New York Avenue NW
`
`Washington, DISTRICT OF COLUMBIA 20005
`UNITED STATES OF AMERICA
`
`NATARAJAN‘ MEERA
`
`1 643
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/02/2018
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`
`following e—mail address(es):
`e-offiee @ Sternekessler. com
`
`pealvo @ Sternekesslereom
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Off/09 A0170” Summary
`
`Application No.
`15/310,132
`Examiner
`MEERA NATARAJAN
`
`Applicant(s)
`GURNEYetal.
`Art Unit
`AIA Status
`1643
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`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).
`
`Status
`
`1). Responsive to communication(s) filed on 12/13/2017.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a)D This action is FINAL.
`
`2b) C] This action is non-final.
`
`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.
`
`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.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`80—99 is/are pending in the application.
`
`5a) Of the above claim(s)
`
`is/are withdrawn from consideration.
`
`E] Claim(s) _ is/are allowed.
`
`C] Claim(s)
`
`is/are rejected.
`
`[j Claim(s) _
`
`is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
`
`Claim(s) 80-99 are subject to restriction and/or election requirement
`9
`* If any claims have been determined aflowabte. you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`http://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10)[:] The specification is objected to by the Examiner.
`
`11)[:] The drawing(s) filed on
`
`is/are: a)D accepted or b)l:] objected to by the Examiner.
`
`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).
`
`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:
`
`a)D All
`
`b)I:J Some”
`
`c)C] None of the:
`
`1.[:]
`
`Certified copies of the priority documents have been received.
`
`2.[:]
`
`Certified copies of the priority documents have been received in Application No.
`
`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)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`1) C] Notice of References Cited (PTO-892)
`
`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
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20180625
`
`

`

`Application/Control Number: 15/310,132
`Art Unit: 1643
`
`Page 2
`
`DETAILED ACTION
`
`Election/Restriction
`
`1.
`
`REQUIREMENTFORUNITYOFINVENTION
`
`As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or
`
`to a group of inventions so linked as to form a single general inventive concept (”requirement of unity of
`
`invention”). Where a group of inventions is claimed in a national stage application, the requirement of
`
`unity of invention shall be fulfilled only when there is a technical relationship among those inventions
`
`involving one or more of the same or corresponding special technical features. The expression ”special
`
`technical features” shall mean those technicalfeatures that define a contribution which each ofthe
`
`claimed inventions, considered as a whole, makes over the prior art.
`
`The determination whether a group of inventions is so linked as to form a single general
`
`inventive concept shall be made without regard to whetherthe inventions are claimed in separate
`
`claims or as alternatives within a single claim. See 37 CFR 1.475(e).
`
`When Claims Are Directed to Multiple Categories of Inventions:
`
`As provided in 37 CFR 1.475 (b), a national stage application containing claims to different
`
`categories of invention will be considered to have unity of invention ifthe claims are drawn only to one
`
`of the following combinations of categories:
`
`(1) A product and a process specially adapted for the manufacture of said product; or
`
`(2) A product and a process of use of said product; or
`
`(3) A product, a process specially adapted for the manufacture of the said product, and a use of
`
`the said product; or
`
`(4) A process and an apparatus or means specifically designed for carrying out the said process;
`
`or
`
`

`

`Application/Control Number: 15/310,132
`Art Unit: 1643
`
`Page 3
`
`(5) A product, a process specially adapted for the manufacture of the said product, and an
`
`apparatus or means specifically designed for carrying out the said process.
`
`Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
`
`2.
`
`Restriction is required under 35 U.S.C. 121 and 372.
`
`This application contains the following inventions or groups of inventions which are not so
`
`linked as to form a single general inventive concept under PCT Rule 13.1.
`
`In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single
`
`invention to which the claims must be restricted.
`
`0 Group |, claim(s) 80-81, 92, 94- drawn to an antibody or antigen binding fragment thereofthat
`
`specifically binds the extracellulardomain of V-set and transmembra ne domain-containing
`
`protein 4 (VSTM4)
`
`0 Group II, claim(s) 82-85, 93, 95 drawn to a soluble receptor comprising the extracellulardomain
`
`of VSTM4 or a fragment thereof.
`
`0 Group III, claim(s) 86, 88, and 90, drawn to an isolated polynucleotide encoding the antibody
`
`of Group |, a vector comprising said polynucleotide and a host cell comprising said
`
`polynucleotide.
`
`0 Group IV, claim(s) 87, 89 and 91, drawn toan isolated polynucleotide encoding the soluble
`
`receptor of Group II
`
`0 Group V, claim(s) 96, drawn to an agent that specifically binds the extracellulardomain of
`
`VSTM4 or B-H4.
`
`0 Group VI, claim(s) 97-99, drawn to a method comprising administering the antibody of Group |,
`
`the soluble receptor of Group II or the agent of Group VI.
`
`

`

`Application/Control Number: 15/310,132
`Art Unit: 1643
`
`Page4
`
`3.
`
`The groups of inventions listed above do not relate to a single general inventive concept under
`
`PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical
`
`features for the following reasons: Groups I-VI lack unity of invention because the groups do not share
`
`the same or corresponding technical feature. Groups II, IV-VI do not require an antibody that binds the
`
`extracellulardomain of VSTM4, Groups I, III, Vdo not require a soluble receptor comprising the
`
`extracellulardomain of VSTM4and Groups | and N do not require an agent that disrupts signaling from
`
`B7-H4/VSTM4 pathway.
`
`4.
`
`This application contains claims directed to more than one species of the generic invention.
`
`These species are deemed to lack unity of invention because they are not so linked as toform a single
`
`general inventive concept under PCT Rule 13.1.
`
`The species are as follows:
`
`> |fGroup| or III is elected applicant is required to elect one species from (i) — (v) listed in
`
`Claim 81
`
`> |fGroup II or IV is elected applicant is required to elect one species from (i) — (v) listed in
`
`Claim 83
`
`> If Group VI is elected applicant is required to elect either the antibody of Group |, the
`
`soluble receptor of Group II or the agent of Group V to be administered.
`
`Applicant is required, in reply to this action, to elect a single species to which the claims shall be
`
`restricted if no generic claim is finally held to be allowable. The reply must also identify the claims
`
`readable on the elected species, including any claims subsequently added. An argument that a claim is
`
`allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to
`
`additional species which are written in dependent form or otherwise require all the limitations of an
`
`allowed generic claim.
`
`

`

`Application/Control Number: 15/310,132
`Art Unit: 1643
`
`Page 5
`
`5.
`
`Applicant is reminded that upon the cancellation ofclaims to a non-elected invention, the
`
`inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently
`
`named inventors is no longer an inventor of at least one claim remaining in the application. A request to
`
`correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in
`
`accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing
`
`fee required under 37 CFR 1.17(i).
`
`6.
`
`The examiner has required restriction between product or apparatus claims and process claims.
`
`Where applicant elects claims directed to the product/appa ratus, and all product/appa ratus claims are
`
`subsequently found allowable, withdrawn process claims that include all the limitations ofthe allowable
`
`product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected
`
`process invention must include all the limitations of an allowable product/apparatus claim for that
`
`process invention to be rejoined.
`
`In the event of rejoinder, the requirement for restriction between the product/apparatus claims
`
`and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully
`
`examined for patenta bility in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims
`
`must meet all criteria for patentabilityincluding the requirements of 35 U.S.C. 101, 102, 103 and 112.
`
`Until all claims to the elected product/appa ratus are found allowable, an otherwise proper restriction
`
`requirement between product/a ppa ratus claims and process claims may be maintained. Withdrawn
`
`process claims that are not commensurate in scope with an allowable product/apparatus claim will not
`
`be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that
`
`the process claims should be amended during prosecution to require the limitations ofthe
`
`product/a ppa ratus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition
`
`against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is
`
`withdrawn by the examiner before the patent issues. See MPEP § 804.01.
`
`

`

`Application/Control Number: 15/310,132
`Art Unit: 1643
`
`Page 6
`
`7.
`
`Any inquiry concerning this communication or earlier communications from the examiner
`
`should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner
`
`can normally be reached on M-F 9AM - 5PM.
`
`Examiner interviews are available via telephone, in-person, and video conferencing using a
`
`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
`
`the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
`
`Ifattemptsto reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
`
`MISOOK YU can be reached on 571-272-0839. The fax phone number for the organization where this
`
`application or proceeding is assigned is 571-273-8300.
`
`Information rega rdingthe status of an application may be obtained from the Patent Application
`
`Information Retrieval (PAIR) system. Status information for published applications may be obtained
`
`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
`
`through Private PAIR only. For more information about the PAIR system, see http://pair-
`
`direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). Ifyou would like assistance from a USPTO Customer
`
`Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR
`
`CANADA) or 571-272-1000.
`
`/Meera Nataraja n/
`
`Examiner, Art Unit 1643
`
`

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