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
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`15/310,132
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`11/10/2016
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`Austin L. GURNEY
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`2293.1220001/PAC/E-H
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`7085
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`Sterne, Kessler, Goldsteln & Fox P.L.L.C.
`1100 New York Avenue NW
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`Washington, DC 20005
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`NATARAJAN‘ MEERA
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`ART UNIT
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`1 643
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`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`11/16/2018
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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):
`e-offiee @ sternekessler. com
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`pealvo @ sternekesslereom
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`PTOL-90A (Rev. 04/07)
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`

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`Off/09 A0170” Summary
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`Application No.
`15/310,132
`Examiner
`MEERA NATARAJAN
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`Applicant(s)
`GURNEYetal.
`Art Unit
`AIA Status
`1643
`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). Responsive to communication(s) filed on 9/14/2018.
`[: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)
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`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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`80—99 is/are pending in the application.
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`5a) Of the above claim(s) 80—81,86—92,94 and 96—99 is/are withdrawn from consideration.
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`E] Claim(s)
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`is/are allowed.
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`Claim(s) 82—85,93 and 95 is/are rejected.
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`C] 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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`
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`are subject to restriction and/or election requirement
`[:1 Claim(s)
`9
`* If any claims have been determined allowable, 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.'sp 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)C] accepted or b)E] 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)C] 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)C] All
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`b)C] Some”
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`c)C] None of the:
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`1C]
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`Certified copies of the priority documents have been received.
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`2C]
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`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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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`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 20181112
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`

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`Application/Control Number: 15/310,132
`Art Unit: 1643
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`Page 2
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`DETAILED ACTION
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`Election/Restrictions
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`1.
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`Applicant’s election without traverse of Group II and species IgV-type domain of VSTM4 in the
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`reply filed on 09/14/2018 is acknowledged.
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`2.
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`Claims 80-81, 86-92, 94, 96-99 are withdrawn from further consideration pursuant to 37 CFR
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`1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
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`Election was made without traverse in the reply filed on 09/14/2018.
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`3.
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`4.
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`Claims 82-85, 93 and 95 will be examined on the merits.
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`The present application, filed on or after March 16, 2013, is being examined under the first
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`inventor to file provisions of the AIA.
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`5.
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`The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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`Claim Rejections - 35 USC § 112
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`(a) IN GENERAL—The specification shall contain a written description of the invention, and
`of the manner and process of making and using it, in such full, clear, concise, and exact terms as to
`enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to
`make and use the same, and shall set forth the best mode contemplated by the inventor orjoint
`inventor of carrying out the invention.
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`The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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`The specification shall contain a written description of the invention, and of the manner and
`process of making and using it, in such full, clear, concise, and exact terms as to enable any person
`skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the
`same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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`6.
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`Claims 82-85, 93 and 95 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first
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`paragraph, as failing to comply with the written description requirement. The claim(s) contains subject
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`matter which was not described in the specification in such a way as to reasonably convey to one skilled
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`

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`Application/Control Number: 15/310,132
`Art Unit: 1643
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`Page 3
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`in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the
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`application was filed, had possession of the claimed invention.
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`7.
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`The claims are broadly drawn any soluble receptor comprising the IgV-type extracellular domain
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`of VSTM4 further comprising any non-VSTM4 polypeptide comprising an Fc region which disrupts
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`signaling, binding, or activation. To provide adequate written description and evidence of possession of
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`the claimed genus of VSTM4 soluble protein the instant specification can structurally describe
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`representative constructs or describe structural features common to the members of the genus, which
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`features constitute a substantial portion of the genus. Alternatively, the specification can show that the
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`claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics,
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`functional characteristics when coupled with a known or disclosed correlation between function and
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`structure, or some combination of such characteristics (see University of California v. Eli Lilly and Co.,
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`119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) and Enzo Biochem, Inc. V. Gen-Probe Inc.).
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`8.
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`Although Applicants may argue that it is possible to screen for VSTM4 extracellular domain
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`soluble receptors, the court found in (Rochester v. Sear/e, 358 F.3d 916, Fed Cir., 2004) that screening
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`assays are not sufficient to provide adequate written description for an invention because they are
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`merely a wish or plan for obtaining the claimed chemical invention. ”As we held in Lilly, ”[a]n adequate
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`written description of a DNA ’requires a precise definition, such as by structure, formula, chemical
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`name, or physical properties,’ not a mere wish or plan for obtaining the claimed chemical invention.”
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`119 F.3d at 1566 (quoting Fiers, 984 F.2d at 1171). For reasons stated above, that requirement applies
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`just as well to non-DNA (or RNA) chemical inventions.” The instant claims are drawn to a broad scope of
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`a genus of VSTM4 soluble receptors that would need to be tested in order to not only determine
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`disruption of B7-H4/VSTM4 signaling, activation or binding but treating cancer when administered as
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`instantly claimed.
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`

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`Application/Control Number: 15/310,132
`Art Unit: 1643
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`Page 4
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`9.
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`In this case, the only factor present in the claims is a recitation of broad components that make
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`up the soluble receptor without any guidance on what structure relates to the function of the receptor.
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`The instant specification fails to describe structural features common to the members of the genus,
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`which features constitute a substantial portion of the genus because the instant specification fails to
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`disclose a full exemplary sequence that functions as claimed. A definition by function does not suffice to
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`define the genus because it is only an indication of what the receptor does, rather than what it is. The
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`specification fails to provide any structural features coupled to the claimed functional characteristics
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`(VSTM4 soluble receptor that is capable of treating cancer). The instant specification fails to describe a
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`representative number of sequences for the genus of soluble receptors that function as claimed.
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`Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the
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`specification does not provide adequate written description of the claimed genus.
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`10.
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`Applicants are directed to the recent and relevant decision in Abeie Deutschland GmbH v.
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`Janssen Biotech, Inc. (Fed. Cir. 2014). The court found that if the disclosed species only abide in a corner
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`of the genus, one has not described the genus sufficiently to show that the inventor invented, or had
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`possession of, the genus.
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`11.
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`In the instant case, the instant specification fails to disclose any examples of soluble receptors
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`that successfully treat cancer. Applicants have not established any reasonable structure-function
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`correlation with regards to what structure achieves disruption of B7-H4/VSTM4 signaling, activation or
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`binding in order to treat cancer. The instant claims attempt to claim every possible soluble receptor
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`comprising the VSTM4 IgV-type extracellular domain, a non-VSTM4 polypeptide comprising an Fc region,
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`that would achieve a desired result, i.e., treat cancer, wherein the instant specification does not
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`describe representative examples to support the full scope of the claims because the instant
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`specification fails to disclose the full structure of soluble receptors. Therefore one could not readily
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`envision members of the broadly claimed genus.
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`

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`Application/Control Number: 15/310,132
`Art Unit: 1643
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`Page 5
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`12.
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`In the instant case, the specification fails to provide a description of structural features that are
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`common to the soluble receptors. Because the genus of constructs encompassed by the claims is
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`extensive and the artisan cannot envision the detailed structure of the encompassed receptors and
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`therefore conception is not achieved until reduction to practice has occurred, regardless of the
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`complexity or simplicity of the method of isolation. Thus one of skill in the art cannot "visualize or
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`recognize" most members of the genus of soluble VSTM4 receptors capable of treating to show
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`applicants were in possession of the invention at the time of filing.
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`Conclusion
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`13.
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`14.
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`Claims 82-85, 93 and 95 are rejected.
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`No Claim is allowed.
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`15.
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`Any inquiry concerning this communication or earlier communications from the examiner
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`should be directed to MEERA NATARAJAN whose telephone number is (571)270-3058. The examiner
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`can normally be reached on M-F 9AM - 5PM.
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`Examiner interviews are available via telephone, in-person, and video conferencing using a
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`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
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`the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`MISOOK YU can be reached on 571-272-0839. The fax phone number for the organization where this
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`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 Application
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`Information Retrieval (PAIR) system. Status information for published applications may be obtained
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`from either Private PAIR or Public PAIR. Status information for unpublished applications is available
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`through Private PAIR only. For more information about the PAIR system, see http://pair-
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`Application/Control Number: 15/310,132
`Art Unit: 1643
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`Page 6
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`direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic
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`
`/Meera Natarajan/
`Examiner, Art Unit 1643
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`