`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMlVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
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`
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`
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`15/121,623
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`08/25/2016
`
`Cecilia Anna Wilhelmina GEUIJEN
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`MRX5-017US
`
`5717
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`07/07/2017 —NELSON MULLINS RILEY & SCARBOROUGH LLP m
`7590
`959
`FLOOR 30, SUITE 3000
`RAWLINGS’ STEPHENL
`ONE POST OFFICE SQUARE
`BOSTON, MA 02109
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`PAPER NUMBER
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`1643
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`NOTIFICATION DATE
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`DELIVERY MODE
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`07/07/2017
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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.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`
`ipboston.d0cketing @ nelsonmullins.c0m
`Chris. schlauch @ nelsonmullins.c0m
`
`ipqualityassuranceboston @ nelsonmullins.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Application No.
`Applicant(s)
`15/121,623
`GEUIJEN ET AL.
`
`Office Action Summary
`Examiner
`Art Unit
`AIA (First Inventorto File)
`
`
`1643STEPHEN RAWLINGS $233
`-- The MAILING DA TE of this communication appears on the cover sheet with 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).
`after SIX (6) MONTHS from the mailing date of this communication.
`If 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).
`
`In no event, however, may a reply be timely filed
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`-
`-
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`Status
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`1)IXI Responsive to communication(s) filed on 03 January 2017.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2b)|:| This action is non-final.
`2a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
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`; the restriction requirement and election have been incorporated into this action.
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`4)|:I 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 EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`
`5)|XI Claim(s) 1-13 18-22 28-33 35 36 40 and 49 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`'
`is/are rejected.
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`is/are objected to.
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`1-13 18-22 28-33 35 36 40 and 49 are subject to restriction and/or election requirement.
`* 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
`htt
`:/,’\va.usoto. ov/ atents/init events"
`h/index.‘s
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`
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`or send an inquiry to PPI1feedback©usgto.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|:I The drawing(s) filed on _ is/are: a)I:I accepted or b)I:I 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).
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`Priority under 35 U.S.C. § 119
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)I:I All
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`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.
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`Attachment(s)
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`
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`3) D Interview Summary (PT0_413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) D Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`Paper No(s)/Mai| Date .
`US. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
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`Part of Paper No./Mai| Date 20170703
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`

`

`Application/Control Number: 15/121 ,623
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`Page 2
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`Art Unit: 1643
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`DETAILED ACTION
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`Note: The present application,
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`filed on or after March 16, 2013,
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`is being
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`examined under the first inventor to file provisions of the AIA.
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`1.
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`The preliminary amendment filed January 3, 2017 is acknowledged and has
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`been entered.
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`2.
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`Claims 1-13, 18-22, 28-33, 35, 36, 40, and 49 are pending in the application and
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`are currently subject to the following restriction and election requirement.
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`3.
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`Restriction is required under 35 U.S.C. 121 and 372.
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`Election/Restrictions
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`This application contains the following inventions or groups of inventions which
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`are not 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
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`elect a single invention to which the claims must be restricted.
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`Group |, claim(s) 1-13, 18-22, 28-33, and 35, drawn to a bispecific antibody.
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`Group II, claim(s) 36, 40, and 49, drawn to a method for the treatment of a
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`subject having a tumor or at risk of having a tumor or for counteracting the formation of
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`metastases in a subject.
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`4.
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`The groups of inventions listed above do not relate to a single general inventive
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`concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or
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`corresponding special technical features for the following reasons:
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`The inventions of Groups | and II appear to be linked by a common concept, or
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`special technical feature, namely the claimed fusion protein. However, Robinson et al.
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`

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`Application/Control Number: 15/121 ,623
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`Page 3
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`Art Unit: 1643
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`(Br. J. Cancer. 2008 Nov 4; 99 (9): 1415-25) teaches a bispecific antibody that binds to
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`ErbBZ and ErbB3, which is suitably and effectively used to treat cancer. As such, the
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`technical feature that appears to link the inventive concepts of Groups | and II does not
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`constitute a special technical feature as defined by PCT Rule 13.1, as it does not define
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`a contribution over the prior art.
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`Accordingly the special technical feature of the invention of Group I
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`is making a
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`bispecific antibody.
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`The special technical feature of the invention of Group II is treating or preventing
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`a tumor or the metastasis thereof.
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`Accordingly,
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`the inventions of Groups | and II do not share the same or
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`corresponding special technical feature so as to form a single general inventive concept
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`under PCT Rules 13.1 and 13.21.
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`5.
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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
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`linked as to form a single general inventive concept under PCT Rule 13.1.
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`A.
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`1.
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`The species of the inventions of Groups | and II are as follows:
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`The invention wherein said antibody is an antibody comprising at least the
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`CDR3 of the heavy chain variable region of an anti-ErbB2 antibody binding domain
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`selected from the group consisting of MF2926, MF2930, MF1849; MF2973, MF3004,
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`MF3958, MF2971, MF3025, MF2916, MF3991, MF3031, MF2889, MF2913, MF1847,
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`MF3001, MF3003 and MF1898 as depicted in Figure 16A or Figure 16E.
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`In addition, Applicant is reminded that PCT Rules 13.1 and 13.2 do not provide for a single general
`1
`inventive concept to comprise more than the first mentioned product, the first mentioned method for
`making said product, and the first mentioned method for using said product.
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`

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`Application/Control Number: 15/121 ,623
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`Page 4
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`Art Unit: 1643
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`2.
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`The invention wherein said antibody is an antibody comprising at least the
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`CDR3 of the heavy chain variable region of an anti-ErbBB antibody binding domain
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`selected from the group consisting of MF3178; MF3176; MF3163; MF3099; MF3307;
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`MF6055; MF6056; MF6057; MF6058; MF6059; MF6060; MF6061; MF6062; MF6063;
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`MF6064; MF6065; MF6066; MF6067; MF6068; MF6069; MF6070; MF6071; MF6072;
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`MF6073 and MF6074 as depicted in Figure 168 or Figure 16E or Figure 37.
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`Note: Applicant is required to elect a single species of the invention of Group | or
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`the invention of Group II by specifically identifying one of the heavy chain variable
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`regions of an anti-ErbB2 antibody binding domain fl one of the heavy chain variable
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`regions of an anti-ErbBB antibody binding domain, as identified above,
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`to which the
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`claims shall be restricted if no generic claim is finally held to be allowable.
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`B.
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`The species of the inventions of Group II are as follows:
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`The invention in which the method comprises administering one or more
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`compounds selected from the group consisting of an inhibitor of a component of the
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`PBKinase pathway, an inhibitor of a component of the MAPK pathway, a microtubuli
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`disrupting drug and an HD AC inhibitor, a tyrosine kinase inhibitor, a P|3Ka inhibitor, an
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`Akt inhibitor, an mTOR inhibitor, an Src inhibitor, vorinostat and paclitaxel.
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`Note:
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`If electing the invention of Group II, Applicant is required to elect a single
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`species of the invention by specifically identifying one or more of these compounds to
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`which the claims shall be restricted if no generic claim is finally held to be allowable.
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`6.
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`Applicant is required, in reply to this action, to elect a single species to which the
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`claims shall be restricted if no generic claim is finally held to be allowable. The reply
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`must also identify the claims readable on the elected species,
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`including any claims
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`subsequently added. An argument that a claim is allowable or that all claims are generic
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`is considered non-responsive unless accompanied by an election.
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`Application/Control Number: 15/121 ,623
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`Page 5
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`Art Unit: 1643
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`Upon the allowance of a generic claim, applicant will be entitled to consideration
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`of claims to additional species which are written in dependent form or otherwise require
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`all the limitations of an allowed generic claim.
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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
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`invention only or to a group of inventions so linked as to form a single general inventive
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`concept (“requirement of unity of invention”). Where a group of inventions is claimed in
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`a national stage application, the requirement of unity of invention shall be fulfilled only
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`when there is a technical relationship among those inventions involving one or more of
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`the same or corresponding special technical features. The expression “special technical
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`features” shall mean those technical features that define a contribution which each of
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`the claimed inventions, 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
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`general inventive concept shall be made without regard to whether the inventions are
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`claimed in separate claims or as alternatives within a single claim. See 37 CFR
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`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
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`invention if the
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`claims are 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
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`product; or
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`(2) A product and process of use of said product; or
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`(3) A product, a process specially adapted for the manufacture of the said
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`product, and a use of the said product; or
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`Application/Control Number: 15/121 ,623
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`Page 6
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`Art Unit: 1643
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`(4) A process and an apparatus or means specifically designed for carrying out
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`the said process; or
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`(5) A product, a process specially adapted for the manufacture of the said
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`product, and an apparatus or means specifically designed for carrying out the said
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`process.
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`Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
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`7.
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`Applicant
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`is advised that the reply to this requirement to be complete must
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`include (i) an election of a species or invention to be examined even though the
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`requirement may be traversed (37 CFR 1.143) and (ii)
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`identification of the claims
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`encompassing the elected invention.
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`The election of an invention or species may be made with or without traverse. To
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`preserve a right to petition, the election must be made with traverse.
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`If the reply does
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`not distinctly and specifically point out supposed errors in the restriction requirement,
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`the election shall be treated as an election without
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`traverse. Traversal must be
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`presented at the time of election in order to be considered timely. Failure to timely
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`traverse the requirement will result in the loss of right to petition under 37 CFR 1.144.
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`lf
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`claims are added after the election, applicant must indicate which of these claims are
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`readable on the elected invention or species.
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`Should applicant
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`traverse on the ground that
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`the inventions have unity of
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`invention (37 CFR 1.475(a)), applicant must provide reasons in support
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`thereof.
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`Applicant may submit evidence or identify such evidence now of record showing the
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`inventions to be obvious variants or clearly admit on the record that this is the case.
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`Where such evidence or admission is provided by applicant, if the examiner finds one of
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`the inventions unpatentable over the prior art, the evidence or admission may be used
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`in a rejection under 35 U.S.C. 103(a) of the other invention.
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`8.
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`Applicant
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`is reminded that upon the cancellation of claims to a non-elected
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`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
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`

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`Application/Control Number: 15/121 ,623
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`Page 7
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`Art Unit: 1643
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`or more of the currently named inventors is no longer an inventor of at least one claim
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`remaining in the application. Any amendment of inventorship must be accompanied by
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`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
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`9.
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`The examiner has required restriction between product and process claims.
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`Where applicant elects claims directed to the product, and the product claims are
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`subsequently found allowable, withdrawn process claims that depend from or otherwise
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`require all the limitations of the allowable product claim will be considered for rejoinder.
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`fl claims directed to a nonelected process invention must require all the limitations of
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`an allowable product claim for that process invention to be rejoined.
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`In the event of rejoinder,
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`the requirement for restriction between the product
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`claims and the rejoined process claims will be withdrawn, and the rejoined process
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`claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to
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`be allowable, the rejoined claims must meet all criteria for patentability including the
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`requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product
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`are found allowable, an otherwise proper restriction requirement between product
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`claims and process claims may be maintained. Withdrawn process claims that are not
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`commensurate in scope with an allowable product claim will not be rejoined. See MPEP
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`§ 821 .04(b). Additionally,
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`in order to retain the right to rejoinder in accordance with the
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`above policy, applicant is advised that the process claims should be amended during
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`prosecution to require the limitations of the product claims. Failure to do so may result
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`in a loss of the right to rejoinder. Further, note that the prohibition against double
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`patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement
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`is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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`Conclusion
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`10.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to STEPHEN RAWLINGS whose telephone number is
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`(571)272-0836. The examiner can normally be reached on Monday-Friday, 8:30AM-
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`5:00PM.
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`