8224029
`
`U'.'II'rED STATES OEPARTr\fENT OF COMMERCE
`
`United Stntcs f>nknt nnd Trndcmnrk Offic<'
`
`March 11, 2022
`
`THIS IS TO CERTIFY THAT ANNEXED IS A TRUE COPY FROM THE
`RECORDS OF THIS OFFICE OF THE FILE WRAPPER AND CONTENTS
`OF:
`
`APPLICATION NUMBER: 14/997,136
`FILING DATE: January 15, 2016
`PATENT NUMBER: 9540445
`ISSUE DATE: January 10, 2017
`
`Certified by
`
`Under Secretary of Commerce
`for lntelkctual Property
`aud Director of the United States
`Patent and Trademark Office
`
`Miltenyi Ex. 1021 Page 1
`
`

`

`U NIT.HD S TATES P ATENT AND TRADEMARK O FFICE
`
`UNITED STATES DEPARTMENT 01<' COMMERCE
`I 1nited States P atent and T rad emark Office
`A,klre.s:COMM lSSIONER FOK PATTTNTS
`ro, s.,. 1450
`A)~iUJdri.i., Virginia ll.-:\11- 145(\
`www.11spt,;,,gov
`
`APPLlCA11O!v '.'10,
`
`141997, 136
`
`f,l(.,lNCi DA 1'!::
`
`01/(5/20(6
`
`l'lR.~T NAM(;.}) INVENTOR
`
`A TrQRNIW DOCKl,'l' NO.
`
`CONFIRMAl'ION NO.
`
`C'-arl H. June
`
`O-t6483-600 I US 13(01088)
`
`-1 I 64
`
`04/, l 11111 h
`7590
`7$9<15
`Saul Ewing LLP (Philadelphia)
`Attn: Patent Docket Clerk
`Centre Square West
`1500 Market Street, 38th Floor
`Philadelphia, PA 19102-2186
`
`EXAMINER
`
`BllRKllART, MICITAEL D
`
`AR1'1.1Nl'f
`
`163.'I
`
`PAPER NUMB.ER
`
`NOm~(),\ TION DATii
`
`DEi.,l VnRY MODii
`
`fWll/2016
`
`.ELBC'.l'RONlC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for rep1y, 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):
`putl.\nls@saul.com
`
`IYJ'OL-90A(Rcv. 04/07)
`
`Miltenyi Ex. 1021 Page 2
`
`

`

`Application No.
`14/997,i36
`
`Applicant(s)
`JUNE ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`- The MAILING DATE of this communication appears on the cover sheet with the correspondence address -
`Period for Reply
`
`Examiner
`Michael Burkhart
`
`Art Unit
`1633
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE,z MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`- Extensions of lime may be available under 1he provisions of 37 CFR 1.136(a), In no event. however. may a reply be timely filed
`after SIX (6) MONTHS fromihe mailing da1e of this communication.
`If NO period for reply is specified above, the ma,(imum statutory period will apply and Will expire SIX (6) MO NTHS from 1he mailing dale of this communication.
`Failure to reply wijhfn the set or extended period for reply will, by statute. cause the application 10 become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after 1he maillng dale of this communtca1ion, even ii timely filed, may reduce any
`earned paten t 1erm adjustment. See 37 CFR 1.704(b).
`
`-
`
`Status
`1 )D Responsive to cornmunication(s) filed on __ .
`D A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)O This action is FINAL.
`2b)[8l This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the in1erview on
`_ _
`; the restriction requirement and electlon have been incorporated into this action.
`4)0 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 Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims"
`5)[8l Claim(s) 90-119 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8l Claim(s) 90-119 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`• )f any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`participating intellectual property office for the correspondihg application. For more informatioJl, please see
`hftpJ/www.uspto.goV/patents/lnit events/pph/index:.isp or send an inquiry to PPHfeedback@uspto.gov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner_
`11 )0 The drawing(s) filed on __ is/are: a)D accepted or b)D objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. Ses 37 CFR i .85(a).
`Replacement drawfng sheet(s) including the correction is required 1f the drawing(s) is obJected to. See 37 CFR 1,121 (d)
`
`Priority under 35 U.S.C. § 119
`12)0 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)D Some** c)D None of the:
`LO Certified copies of the priority documents have been received.
`2.0
`Certified copies of the priority documents have been received in AppOcat,on No. __ .
`3.0
`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) D Notice of References Ci1ed (PTO-892)
`2) [8] Information Disclosure S1atemen1(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Da1e 1/15/16:2/29/ 16.
`
`3) D lntervfew Summary (PTO-413)
`Paper No(s)/Mail Dale, __
`4) D Other: __ .
`
`U.S. Patent and Trademalk Ol/1ce
`PTOL-326 (Rev.11-13)
`
`Office Action Summary
`
`Part o f Paper No./Mall Dale 20160418
`
`Miltenyi Ex. 1021 Page 3
`
`

`

`Application/Control Number: 14/997,136
`Art Unit: 1633
`
`Page2
`
`DETAILED ACTION
`
`The present application is being examined under the pre-AIA first to invent provisions.
`
`Priority
`
`Applicant's claim for tbc benefit of a prior-filed application under 35 U .S.C. 1 l 9(e) or
`
`under 35 U .S.C. 120, 12 l, or 365(c) is acknowledged, Applicant has not complied with one or
`
`more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as
`
`follows:
`
`The later-filed application must be an application for a patent for an invention which is
`
`also disclosed in the prior application (the parent or original nonprovisional application or
`
`provisional application). The disclosure of the invention in the parent application and in the later(cid:173)
`
`f'iled application must be sufficient to comply with the requirements of 35 U.S.C. l 12(a) or the
`
`f1l'St paragraph of pre-AIA 35 U.S.C. 112, except fos the best mode requirement. See Transco
`
`Products, Inc. v. Pe,forma,zce Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
`
`The disclosure of the plior-filed application, Application Nos. 61/502,649 and
`
`61/421,470, fail to provide adequate support or enablement in the manner provided by 35 U.S.C.
`
`l 12(a) or pre-AJA 35 U.S.C. 112, first paragraph for one or more claims of this application. The
`
`'649 and '470 applications do not disclose any of the SEQ ID NOs recited in the claims. The first
`
`disclosure of such SEQ ID NOs was in PCT/USl 1/64191. thus, the benefit of pdority for the
`
`claims is given to the filing date of the application, 12/9/2011.
`
`Miltenyi Ex. 1021 Page 4
`
`

`

`Application/Control Number: 14/997,136
`Art Unit: 1633
`
`Page3
`
`Claim. Rejections - 35 USC§ 112
`
`The fo1lowing is a quotation of 35 U .S.C. 1 I 2(b ):
`(b) CONCLUSION.- The specification shall conclude with one or more claims particularly pointing,
`out arnl dislinclly clai:rnlng the subject mailer which Lhc inventor or a joint inventor regards as Lhc
`invention.
`
`The following is a quotation of 35 U .S.C. 112 (pre-AIA), second paragraph:
`The specification s.ball conclude wilb one or more claims particularly poh1Ling our and distinclly
`claiming lhe subject matter which the applicant regru·ds as his invention.
`
`Claim 94 is re:_jected uuder .35 U.S.C. 112(b) or 35 U .S.C. l 12 (pre-AIA), second
`
`paragraph, as being indefinite for failing to paiiicularly point out and distinctly claim the subject
`
`matter which the inventor or a joint inve11tor, or for pre-AJA the applicant regards as the
`
`invention.
`
`Claim 94 recites the limitation "the scFv" in line 1. TI1ere is insufficient antecedent basis
`
`for this limitation in the claim.
`
`Double Patetzti11g
`
`Claims 90, 93. 95-115 of this application are patentably indistinct from claims 90-92, 94-
`
`113 of Application No. 14/997,042. Pursuant to 37 CFR l.78(f) or pre-AJA 37 CFR l.78(b),
`
`when two or more applications filed by the same applicant contain patentably indistinct claims,
`
`elimination of such claims from all but one application may be required in the absence of good
`
`and sufficient reason for their retention dwi.ng pendency in more than one application. Applicant
`
`is required to either cancel the patentably indistinct claims from all but one application or
`
`maintain a clear line of demarcation between the applications. See MPEP § 822.
`
`A rejection based on double patenting of the "same invention" type finds its s upport in
`
`the language of 35 U.S.C. l O I which states that "whoever invents or discovers any new and
`
`Miltenyi Ex. 1021 Page 5
`
`

`

`Application/Control Number: 14/997, 136
`Art Unit: 1633
`
`Page4
`
`useful process ... may obtain a patent therefor ... " (Emphasis added). Thus, the term "same
`
`invention,n in this context, means an invention drawn to identical subject matter. Sec Miller,,.
`
`Eagle Mfg. Co., 151 U.S. 186 (1894); fore Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);
`
`and /11 re Ockeri, 245 F.2d 467, l 14 USPQ 330 (CCPA 1957).
`
`A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by
`
`canceling or amending the claims that are directed to the samejnventio11 so they are no longer
`
`coextensive in scope. The filing of a tenninal disclaimer cannot overcome a double patenting
`
`rejection based upon 35 U.S.C. 101.
`
`Claims 90, 93, 95-115 are provisionally rejected under 35 U.S.C. 101 as claiming the
`
`same invention as that of claims 90-92, 94-113 of copending Application No. 14/997 ,042
`
`(reference application). This is a provisional statutory double patenting rejection since the claims
`
`directed to the same invention have not in fact been patented. The cells claimed in bot},
`
`applications have the same ~-tructural limitations, and the cells, claimed in the ' 042 application are
`
`clearly directed to a "pharmaceutical composition." See, e.g. claims 114-116 of the '042
`
`application, and the specification.
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine
`
`grounded in public poli,cy (a policy reflected in the statute) so as to prevent the unjustified or
`
`improper timewise extension of the "right to exclude" granted by a patent and to prevent possible
`
`harassment by multiple assignees. A nonstatuto1y double patenting rejection is approp1iate where
`
`the claims at issue a.re not identical, but at least one examined application claim is not patentably
`
`Miltenyi Ex. 1021 Page 6
`
`

`

`Application/Control Number: 14/997, 136
`Art Unit: 1633
`
`Page5
`
`distinct from the reference claim(s) because the examined application claim is either anticipated
`
`by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d
`
`1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Coodma11. 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cfr. 1993); In re J,ongi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In ,-e Van Ornum, 686
`
`F.2d 937. 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA
`
`1970); and ln re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR l.32l(c) or 1.321(d) may
`
`be used to overcome an actual or provisional rejection based on a nonstatutory double patenting
`
`ground provided the reference application OT patent either is shown to be commonly owned with
`
`this application, or claims an invention made as a result of activities undertaken within the scope
`
`of a joint research agreement. See MPEP § 717.02 for apptications subject to examination w1der
`
`the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§
`
`706.02(1)(1) - 706.02(1)(3) for applications not subject to examination under the first inventor to
`
`file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR
`
`l.32 l (b).
`
`The USPTO Internet website contains tenuinal disclaimer forms which may be used.
`
`P1ease visit www.uspto.gov/forms/. The filing date of the application in which the form is filed
`
`determines what form (e.g .• PTO/SB/25, PTO/SB/26. PTO/AIA/25, or PTO/AlA/26) should be
`
`used. A web-based eTe1minal Disclaimer may be filled out completely on line using web-screens.
`
`An eTerminal Disclaimer that meets all requirements is auto-processed and approved
`
`immediately upon submission. For more infoimation about eTenni.naJ Disclaimers, refer to
`
`http://www. uspto .gov/patents/process/file/ef s/ guidance/e TD-info-[ .jsp.
`
`Miltenyi Ex. 1021 Page 7
`
`

`

`Application/Control Number: 14/997, 136
`Art Unit: 1633
`
`Page 6
`
`Claims 90-11 9 are rejected on the ground of nonstatu tory double patenting as being
`
`unpatentable over claims 1-2 1 of U.S. Patent No. 8,9 11,993. Although the claims at issue are not
`
`identical, they are not patentably distinct from each other because the in stant cells comprise the
`
`same elements (e.g. a CAR comprising a CD19 binding dom ain encoded by SEQ ID NO: 20,
`
`TM and hinge domains, 4 I BB costimulatory domain, a CD3 zeta signaling domam) as those
`
`claimed in the '933 patent, or are disclosed as preferred embodiments.
`
`Claims 90-119 are rejected on the ground of nonstatuto1y double patenting as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 8,906,682. Although the claims at issue are not
`
`identical. they are not patentably distinct from each other because the instant cells comprise the
`
`same ele ments (e.g. a CAR comprising a CD19 binding domaih e ncoded by SEQ ID NO: 20,
`
`TM and hinge domains, 41BB costimulatory domain, a CD3 zeta signaling domain) as those
`
`used in the methods claimed in the '682 patent, or are disclosed as preferred embodiments.
`
`Claim~ 90-11 9 are 1'ejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims l -30 of U.S. Patent No. 9,102,760. Although the claims at issue are not
`
`identical, they are not patentab1 y distinct from each other because the instant ce11s comprise the
`
`same elements (e.g. a CAR comprising a CD 19 binding domain encoded by SEQ ID NO: 20,
`
`TM and hinge domains1 4 1 BB costimulatory domain, a CD3 zeta signaling domain) as those
`
`claimed in the ' 760 patent, or are disclosed as prefen-ed embodiments.
`
`Miltenyi Ex. 1021 Page 8
`
`

`

`Application/Control Number: 14/997, 136
`Art Unit: 1633
`
`Page7
`
`Claims 90-119 are rejected on the ground of nonstarutory double patenting as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 9, 101,584. Although the claims at issue are not
`
`identical, they are not patentably distinct from each other because the instant cells comp1ise the
`
`same elements (e.g. a CAR comprising a CD19 binding domain encoded by SEQ ID NO: 20,
`
`TM and hiuge domains, 41BB costimulatory domain, a CD3 zeta signaling domain) as those
`
`used i 11 the methods claimed in the ' 584 patent, or are disclosed as preferred embodiments.
`
`Claims 90-119 are rejected on the ground of nonstatutory double patentiug as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 9,102,761. Although the claims at issue are not
`
`identical, they are not patentably distinct from each other because the instant cells comprise the
`
`same elements (e.g. a CAR comprising a CD 19 binding domain encoded by SEQ ID NO: 20,
`
`TM and hinge domains, 4 1BB costimulator y domain, a CD3 zeta signaling domain) as those
`
`claimed in the '76 1 patent, or are disclosed as prefen-ed embodiments.
`
`Claims 90-119 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1- 15 of U.S. Patent No. 9,328,156. Although the claims at issue are not
`
`identical, they are not pate ntabl y distinct from each other because the instant cells comprise the
`
`same elements (e.g. a CAR comp1ising a CD19 binding domaii, encoded by SEQ ID NO: 20,
`
`TM and hinge domains, 41 BB costimulatory domain, a CD3 zeta signaling domain) as those
`
`claimed in the' 156 patent. or are disclosed as preferred embodiments.
`
`Claims 90- 11 9 are provisionally rejected on the ground of nonstatutory double patenting
`
`as being unpatentable overclairns 2 1-25, 3 1-36, 44-48, 50-69, 93-103 ofcopending Application
`
`Miltenyi Ex. 1021 Page 9
`
`

`

`Application/Control Number: 14/997,136
`Art Unit: 1633
`
`Page 8
`
`No. 13/992,622. Althongh the claims at issue are not identical, they are not patent.ably distinct
`
`from each other because the instant cells comprise the same elements (e.g. a CAR comprising a
`
`CDI9 binding domain encoded by SEQ ID NO: 20, TM and hinge domains. 41BB costimulatory
`
`domain, a CD3 zeta signaling domain) as those claimed in the ' 622 application, or are disclosed
`
`as prefe1Ted embodiments.
`
`This is a provisional nonstatuto1y double patenting rejection because the patentably
`
`indistinct claims have not in fact been patented.
`
`Claims 90-119 are provisionally rejected on the ground of nonstatut01y double patenting
`
`as being unpatentable over claims 90~ 119 of copending Application No. 14/996.953. Although
`
`the claims at issue are not identical, they are not patentably distinct from each other because the
`
`instant cells comprise the same elements (e.g. a CAR comp1ising a CD] 9 binding domain
`
`encoded by SEQ ID NO: 20, TM and hinge domains, 41BB costimulatory domain, a CD3 zeta
`
`signaling domain) as those claimed in the '953 application, or are disclosed as preferred
`
`embodiments.
`
`This is a provisional nonstatutory double patenting rejection because the patentably
`
`indistillct claims have not in fact been patented.
`
`Claims 90-119 are provisionally rejected on the ground of nonstatutory double patenting
`
`as bein_g unpatentable over claims 90-119 of copending Application No. 14/984,371. Although
`
`the claims at issue are not identical, they are not patentably distinct from each other because the
`
`instant cells compiise the same elements (e.g. a CAR compiising a CD 19 binding domain
`
`encoded by SEQ ID NO: 20, TM and hinge domains, 41 BB costimulatory domain, a CD3 zeta
`
`Miltenyi Ex. 1021 Page 10
`
`

`

`Application/Control Number: 14/997,136
`Art Unit: 1633
`
`Page 9
`
`signaling domain) as those claimed in the ' 371 application, or are disclosed as preferred
`
`embodiments.
`
`This is a provisional nonstatutory double patenting rejection because the patentably
`
`indistinct claims have not in fact been patented.
`
`Co11clusio11
`
`No claim is allowed.
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915.
`The exami ner can nmmally be reached on M-F 8AM-5PM.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`supervisor, Cluistopher Babic can be reached on (571) 272-8507. The fax phone number for the
`organization where this application or proceeding is assigned is 571 -273-8300.
`Information regarding the status of an application may be obtained from the Patent
`Application Info1mation Retrieval (PAIR) system. Status info1mation for published applications
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`applications is available th.rough Private PAIR only. For more info1mation about the PATR
`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). If you would
`like assistance from a USPTO Customer Service Representative or access to the automated
`information system, call 800-786-9199 ON USA OR CANADA) or 571 -272-1000.
`
`/Michael Bw-lchait/
`Primary Examiner, Art Unit 1633
`
`Miltenyi Ex. 1021 Page 11
`
`