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: 14/996,953
`FILING DATE: January 15, 2016
`PATENT NUMBER: 9464140
`ISSUE DATE: October 11, 2016
`
`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 a nd T rad ema rk O ffice
`A,klre.s:COMM lSSIONER FOK PATTTNTS
`ro, s.,. 1450
`A)~iUJdri.i., Virginia ll.-:\11- 145(\
`www.11spt,;,,gov
`
`APPLlCAT'lOJ\l NO,
`
`f1IL,lNCi DAl'I::
`
`l'lR.~T NAM(;.}) INVENTOR
`
`ATfORN!lY DOCKl,'l' NO.
`
`CONFffiMAl'ION NO.
`
`01/15/20(6
`
`C'-arl H. June
`
`0-16483-600 I US 1 I (00853 J
`
`3710
`
`()2/2?/11)1 h
`7590
`78\)(IS
`Saul Ewing LLP (Phjladelphia)
`Attn: Patent Docket Clerk
`Centre Square West
`l 500 Market Street, 38th Floor
`Philadelphia, PA 19102-2 LR6
`
`EXAMINER
`
`BllRKllART, MTCITAEL D
`
`ARTl.'Nl'f
`
`PAPER NUMBER
`
`16'.B
`
`NOm~(:,\ TION Dt\ 'l'E
`
`DEi.,l VKRY MODii
`
`01/2Z/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.
`14/996.953
`
`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~ 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 from ihe mailing da1e of this communication.
`If NO period for reply is specified above, the ma,(imum statutory period will apply and Will e xpire 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 O ffice later than three months after 1he maillng dale of th is communtca1ion, even ii timely filed, may reduce any
`earned paten t 1erm adjustment. See 3 7 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 1115/2016.
`
`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./Mail Date 20160217
`
`Miltenyi Ex. 1021 Page 3
`
`

`

`Application/Control Number: 14/996,953
`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: 14/996,953
`Art Unit: 1633
`
`Page3
`
`Double Patenting
`
`Applicant is advised that hould claim 90 be found allowable. claims 95 and 96 w ill be
`
`objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an
`
`application are duplicates or else are so close in content that they both cover the same thing,
`
`despite a slight difference in wording. it is proper after allowing one claim to object to the other
`
`as being a substantial duplicate of the allowed claim. See lvfPEP § 706.03(k). The dependent
`
`claims mere ly recite a limitation (scFv, SEQ ID NO: 20) already found in claim 90.
`
`The nonstatutory double patentiug rejection is based on a judicially created doctrine
`
`grounded in public policy (a po licy 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 assig nees. A nonstatutory double patenting rejection is appropriate where
`
`the claims at issue are not identical, but at least one examined application claim is not patentably
`
`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 Goodman. 11 F.3d 1046, 29 USPQ2d 2010 (Fed.
`
`Cir. 1993); In re Umgi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re \fan Omum, 686
`
`F.2d 937,214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA
`
`1970 ); and In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed tenninal disclaimer in compliance with 37 CFR l.32 l (c) or l.32l(d) may
`
`be used to overcome an actual or provisional rejection based on a nonstatutoiy double patenting
`
`ground provided the reference application or patent either is shown to be commonly owned with
`
`Miltenyi Ex. 1021 Page 5
`
`

`

`Application/Control Number: 14/996,953
`Art Unit: 1633
`
`Page4
`
`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 app1ications subject to examination under
`
`the first inventor to file provisions of the AJA as explained in MPEP § 2159. See MPEP §~
`
`706.02(1)( I) - 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 CPR
`
`I .32 J(b).
`
`The USPTO Internet website contains terminal disclaimer fo1ms which may be used,
`
`Please visit www.uspto.gov/forms/. The filing date of the application in which the form is filed
`
`detennines what fonn (e.g., PTO/SB/25, PTO/SB/26, PTO/ AIA/25, or PTO/ AIA/26) should be
`
`used. A web-based eTerminal Disclaimer may be filled out completely on line using web-screens.
`
`Ao eTerminal Disclaimer that meets all requirements is auto-processed and approved
`
`immediately upon submission. For more info1mation about eTenn.inal Disclaimers, refer to
`
`http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
`
`Claims 90-119 are rejected on the growid of nonstatutory double patenting as being
`
`unpatentable over claim~ 1-2 1 of U.S. Patent No.8,911 ,993. 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 comprising a CD 19 binding domain encoded by SEQ ID NO: 20,
`
`CD8a TM and hinge domains, 41BB costimulatory domain, a CD3 zeta signaling domain) as
`
`those claimed in the '933 patent or arc disclosed as preferred embodiments.
`
`Claims 90-1 l9 are rejected on the grow1d of nonstatutory double patenting as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 8,906,682. Although the claims at issue are not
`
`Miltenyi Ex. 1021 Page 6
`
`

`

`Application/Control Number: 14/996,953
`Art Unit: 1633
`
`Page 5
`
`identical, they are not patentabl y distinct from each other because the instant methods use cells
`
`comprising the same elements (e.g. a CAR comprising a CD19 binding domain encoded by SEQ
`
`ID NO: 20, CD8a 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 prefened
`
`embodiments.
`
`Claims 90-119 are Tejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 9,102,760. Although the claims at jssue are not
`
`identical, they are not patentably distinct from each other because the instant methods use cells
`
`comp1ising the same elements (e.g. a CAR compiising a CD19 binding domain encoded by SEQ
`
`ID NO: 20, CD8a TM and hinge domains, 41BB costimulato1y domain, a CD3 zeta signaling
`
`domain) as those claimed in the '760 patent, or arc disclosed as preferred embodiments.
`
`Claims 90-119 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 9,10 1,584. Although the claims at issue are not
`
`identical, they axe not patentably distinct from each other because the instant methods use cells
`
`and method steps comp1ising the same elements (e.g. a CAR comprising a CD 19 binding domain
`
`encoded by SEQ ID NO: 20, CD8a. TM and hinge domains, 41 BB costimulatory domain, a CD3
`
`zeta signaling domai11) as those used in the methods claimed in the '584 patent, or a.re disclosed
`
`as prefeITed embodiments.
`
`Claims 90-1 l 9 are rejected on the ground of nonstatutory double patenting 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 methods use cells
`
`Miltenyi Ex. 1021 Page 7
`
`

`

`Application/Control Number: 14/996,953
`Art Unit: 1633
`
`Page 6
`
`compiising the same eleinents ( e.g. a CAR comprising a CD 19 binding domain encoded by SEQ
`
`ID NO: 20. CD8o. TM and binge domains. 41BB costimulatory domain, a CD3 zeta signaling
`
`doma-in) as those claimed in the '761 patent, or are disclosed as preferred embodiments.
`
`Claims 90-119 are provisionally rejected on the grow1d of nonstatutory double patenting
`
`as being unpatentable over claims 21-25, 31, 32 44-48, 50-69, 93-103 of copending Application
`
`No. 13/992,622. Although the claims at issue are not identical, they are not patentably distinct
`
`from each other because the instant methods use cells and method steps comp1ising the same
`
`elements (e.g. a CAR comp1ising a CD 19 binding domain encoded by SEQ ID NO: 20, CD8a
`
`TM and hinge domains, 41 BB costimulatory domain, a CD3 zeta signaling domain) as those
`
`claimed in the '622 application, or are disclosed as preferred embodiments.
`
`This is a provisional nonstatuto1y double patenting reject-ion because the patentably
`
`indistinct claims have not in fact been patented.
`
`Claims 90-119 are provisionally rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over claims 106-12 1 of copending Application No. 14/ 107,302. Although
`
`the claims at issue are not identical, they are not patentably distinct from each other because the
`
`in~tant methods use cells compiising the same elements (e.g. a CAR comp1i~ing a CD19 binding
`
`domain encoded by SEQ ID NO: 20, CD8a TM and hinge domains, 4 1BB costim.ulatory
`
`domaiu, a CD3 zeta signaLing domain) as those claimed in the ' 302 application. or are disclosed
`
`as preferred embodiments.
`
`Miltenyi Ex. 1021 Page 8
`
`

`

`Application/Control Number: 14/996,953
`Art Unit: 1633
`
`Page7
`
`This is a provisional nonstatutory double patenting rejection because the patentably
`
`indistinct claims have not in fact been patented.
`
`Claims 90-119 are provisionally rejected on the ground of nonstatutory double patenting
`
`as being 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 methods use cells and method steps comptising the same elements (e.g. a CAR
`
`comp1ising a CDJ 9 binding domain encoded by SEQ ID NO: 20, CD8u TM and hinge domains.
`
`4 lBB costirnulatory domain, a CD3 zeta 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.
`
`Claims 90- 119 are provisionally rejected on the ground of nonstatutory double patenting
`
`as being unpatentable over claims 90-116 of copending Application No. 14/9971042. Although
`
`the claims at issue are not identical, they are not patentably distinct from each other because the
`
`instant methods use cells comprising the same elements (e.g. a CAR comprising a CD19 binding
`
`domain encoded by SEQ ID NO: 20, CD8u TM and hinge domains. 41 BB costirnulatory
`
`domain, a CD3 zeta signaling domaln) as those claimed in the '042 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.
`
`Miltenyi Ex. 1021 Page 9
`
`

`

`Application/Control Number: 14/996,953
`Art Unit: 1633
`
`Page 8
`
`Claims 90-119 are provisionally rejected on the ground of nonstatuto1y double patenting
`
`as being unpatentable over claims 90-119 of copending Application No. 14/997.136. Although
`
`the claims at issue are not identical, they are not patentably distinct from each other because the
`
`instant methods use cells comprising the same elements (e.g. a CAR comprising a CD19 bindi ng
`
`domain encoded by SEQ ID NO: 20, CD8a TM and hinge domains, 41BB costimulatory
`
`domain, a CD3 zeta signaling domain) as those claimed in the ' 136 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.
`
`No claim is allowed.
`
`Conclusion
`
`Any inquiry concerning this communication or ear1ier communications from the
`examiner should be directed to Michael Bmkhart whose telephone number is (571 )272-2915.
`The examiner can normally be reached on M-F 8AM-5PM.
`If attempts to reach the examiner by telephone are uns uccessful, the examiner's
`supervisor, Christopher 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 regru·ding the status of an application may be obtained from the Patent
`Application Infonnation Retrieval (PAIR) system. Status information for published applications
`may be obtained from ejther Private PAIR or Public PA1R. 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). If you 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.
`
`/Michael Burkhart/
`Primaiy Examiner, Art Unit l 633
`
`Miltenyi Ex. 1021 Page 10
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`

`

`Application/Control Number: 14/996,953
`Art Unit: 1633
`
`Page 9
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`Miltenyi Ex. 1021 Page 11
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`