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: 15/353,899
`FILING DATE: November 17, 2016
`
`Certified by
`
`Under Secretary of Commerce
`for lntelkctual Property
`aud Director of the United States
`Patent and Trademark Office
`
`Miltenyi Ex. 1028 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
`
`(5/353,899
`
`f,l(.,lN(i 1)1\ 1'1::
`
`11!17/20(6
`
`FIRST NAME.l) INVl1N'J'OR
`
`ATrQRN!lY DOCK'c'l' NO.
`
`CONFffiMA1'10N NO.
`
`C-arl H. June
`
`0-16483-600 I US 14(01102J
`
`-1 LU
`
`7$905
`7590
`05/ J I 12018
`Saul Ewing Arnstein & Lehr LLP (Philade lphia)
`Attn: Patent Docket Clerk
`Centre Square West
`1500 Market Street, 38th Floor
`Philadelphia, PA 19102-2 LR6
`
`EXAMINER
`
`BURKIIART, MTCITAEL D
`
`AR1'1.'Nl'f
`
`163.'I
`
`PAPER NUMBER
`
`N01'fH(:A TION DATI.i
`
`Otii,l VfiRY MOD!i
`
`05/11/2018
`
`.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. 1028 Page 2
`
`

`

`Application No.
`15/353 ,899
`
`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
`
`Ari Unit
`1633
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EX PIRE~ MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`• Extensions of lime may be available under 1he provisions of 37 CFR 1.136(a), lo no e vent. 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 fit&!, may reduce any
`earned patent 1erm adjustment. See 37 CFR 1.704(b).
`
`•
`
`Status
`1 )D Responsive to cornmunication(s) filed on __ .
`0 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 restr'iction requ1rement 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) 1-28 is/are pending in the application.
`5a) Of the above claim(s) __ is/are wtthdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)[8l Claim(s) 1-28 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 corresponding application. For more infor matioJl, please see
`http Jtwww.uspto.goVlpatents/lnit events/pph/incteicisp or send an jnqulry 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)O accepted or b)O 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 drawfng sheet(s) including the correction is required 1f the drawfng(s) fs 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)O All
`b)O Some** c)O None of the:
`1.0
`Certified copies of the priority documents have been received.
`2.D Certified copies of the priority documents have been received in AppOcatlon No. __ .
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`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) [8l Notice of References Ci1ed (PTO-892)
`
`2) ~ Information Disclosure S1atemen1(s) (PTO/ SB/08a and/or PTO/ SB/08b)
`Paper No(s)/Mail Date 2/2:12/6/ 17:9/6/ 17:6/28/ 17: 11/17/16:11/ 17/16.
`
`3 ) D lntervfew Summary (PTO-41 3)
`Paper No(s)/Mail Date, __
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev.11 -13)
`
`Office Action Summary
`
`Part o f Paper No./Mal l Date 20180402
`
`Miltenyi Ex. 1028 Page 3
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page2
`
`DETAILED ACTION
`
`The present application is being examined under the pre-A.IA first to invent provisions.
`
`Priority
`
`Applicant' s claim for the benefit of a prior-filed application under 35 U .S.C. ll 9(e) or
`
`under 35 U.S.C. 120, 121, 365(c), or 386(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. l 19(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)
`
`filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the
`
`first paragraph of pre-AJA 35 U.S.C. 112, except f01' the best mode requirement. See Transco
`
`Protlurts, Inc. v. Performance Contratting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
`
`The disclosure of the prior-filed application, Application No. 61/421 ,470, fails to provide
`
`adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35
`
`U.S.C. I J 2, first paragraph for one or more claims of this application. The '470 application does
`
`not disclose memo1y T cells comprising the instant CAR or a nucleic acid encoding such.
`
`Therefore, claims 1-] 4 are granted a priority date of 6/29/201], the filing date of the 61 /502,649
`
`application which does disclose such memory cells.
`
`Miltenyi Ex. 1028 Page 4
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page3
`
`Claim. Rejections - 35 USC§ 102
`
`The following is a quotation of the appropriate paragraphs of pre-AJA 35 U.S.C. 102 that
`
`fonn the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless -
`
`(b) the invention was patented or tlescribcd in u printctl publicution in this or u foreign counu·y or in
`public use or on sale in lhis counLry, more thaa orn: year prior to I.be dale of applicalion for patcal in t.be
`Un.ited Stales.
`
`Claim(s) 15-28 is/are rejected under pre-AIA 35 U.S.C. J02(b) as being anticipated by
`
`Imai et al (2004, Leukemia, of record).
`
`Imai et al teach T cells from patients with leukemia modified to express a CAR
`
`comp1ising a CD 19-specific scFv, a CO8 t:ransmembrane and hinge domain, a 4 lBB co(cid:173)
`
`stimulatory region and a CD3zeta signaling domain. See Figure l and p. 677, first col., first 9[
`
`and CJ[ bridging first and second cols. The cells comprised a vector (nucleic acid) encoding the
`
`CAR (p. 677). The instant specification does not provide a limiting definition for the phrase
`
`"persisting population". The T cells. of Imai et al could persist and continue to expand for at
`
`least three weeks (p. 681, ii Linking first and second cols.) and are thus considered a "persisting
`
`population."
`
`Claim Rejectiom - 35 USC§ 103
`
`ln the event the determination of the status of the application as subject to AIA 35 U .S.C.
`
`102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incoffect, any correction of the
`
`statutory basis for the rejection will not be considered a new ground of rejection if the pLior rut
`
`relied upon, and the rationale supporting the rejection, would be the same under either status.
`
`Miltenyi Ex. 1028 Page 5
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page4
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A palcnl may nor be obtained tbougb lhe invention is not identically disclosed or desctibed as scl
`forth in seclion 102 of this title. if the differences between the subject muller sought to be patented and
`the prior art are such that the subject marter as a whole would have been obvfous at d~e lime the
`invention was made to a person having_ ordinary skill in the ai1 to which said subject matter pertains.
`Patcntability shall not be negatived by the manner in which the invention was maue.
`
`The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459
`
`( 1966). that are applied for establishing a background for determining obviousness under pre(cid:173)
`
`AIA 35 U.S.C. 103(a) are summruized as follows:
`
`I . Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating obviousness or
`
`nonobviousness.
`
`This application c utTently names joint inventors. In conside1ing patentability of the
`
`claims under pre-AI A 35 U.S.C. l03(a), the examiner presumes that the subject matter of the
`
`various claims was commonly owned at the time any inventions covered therein were made
`
`absent any evidence to the contrary. Applicant is advised of the obligation under 37 CPR 1.56 to
`
`point o ut the inventor and invention dates of each claim that was not commonly owned at the
`
`time a later invention was made in order for the examiner to consider the applicability of pre-
`
`A.IA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (t) or (g) prior a1t under pre-AIA
`
`35 U .S.C. 103(a).
`
`Miltenyi Ex. 1028 Page 6
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page5
`
`Claims 1-28 a.re rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
`
`Imai et a1 (2004, of record) in view of Berger et al (2008, J. Clin. Invest.) and Berger et al (2009,
`
`CuIT. Opin. ImmunoL).
`
`The teachings of Imai et al are as above and applied as before.
`
`Although intended for human treatment. Imai et al do not specifically teach m emory T
`
`cells from human cancer patients.
`
`Berger et al (2009) teach T-ceUs expressing tumor-specific CAR molecules wherein the T
`
`cells are Tern (or T central memory cells) and their superior properties for adoptive T cell therapy.
`
`The modified T cells are used in methods of treating cancer See in particular Fig. 3, the abstract
`
`and page 227, second column to page 229.
`
`Berger et al (2008) teach techniques of producing Tcru cells for adoptive transfer (e.g. Fig.
`
`I), and the supe1ior properties of such cells (such as persistence in vivo) for adoptive T cell
`
`transfer (e.g. abstract).
`
`The claimed cells are essentially disclosed by Imai et al with the exception of the
`
`memmy T cell limitation. The ordinary skilled a11isan, seeking to improve the efficacy of
`
`adoptive T cell therapy in human cancer patients, would have been motivated to use the
`
`teachings of the Berger references with those of Imai et al because both Berger references teach
`
`the desirability of using memory T cells for such purposes (e.g. the benefit of T cell persistence
`
`in vivo). It would have been obvious for the skilled artisan to do this because of the known
`
`benefit of using CAR-modified T cells fot cancer therapy as taught by both Imai and Berger et al
`
`(2009). Given the teachings of the cited references and the level of skill of the ordina1y skilled
`
`artisan at the time of applicants' invention, it must be considered, absent evidence to the
`
`Miltenyi Ex. 1028 Page 7
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page 6
`
`contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in
`
`practicing the claimed invention.
`
`Double Patenting
`
`A rejection based on double patenting of the "same invention" type finds its support in
`
`the language of35 U.S.C. 10 l which states that "whoever invents or discovers any new and
`
`useful process ... may obtain a patent therefor ... " (Emphasis added). Thus~ the term "same
`
`invention," in this context, means an invention drawn to identical subject matter. See Miller v.
`
`Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel. 422 F.2d 438, 164 USPQ 619 (CCPA 1970);
`
`In re Ockert. 245 F.2d467, 114 USPQ330 (CCPA 1957).
`
`A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by
`
`cahceling or amending the claims that are di1'ected to the same inventioh so they are .no longer
`
`coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting
`
`rejection based upon 35 U.S.C. 101.
`
`Claims 8-14 are objected to under 37 CPR 1.75 as being a substantial duplicate of claims
`
`1-7. When two claims in an application are duplicates or else are so close jn 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 MPEP
`
`§ 706.03(k). The claims only differ only in the recitation of a nucleic acid in claims 1-7. The
`
`specification and prior a1t do not teach any means other than a recombinant nucleic acid which
`
`provides the cells of claims 8-14, thus they necessaiily comprise the nucleic acids of claims 1-7.
`
`Miltenyi Ex. 1028 Page 8
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page 7
`
`Claims 22-28 are objected to under 37 CFR 1.75 as being a substantial duplicate of
`
`claims 15-21. 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 MPEP * 706.03(k). The claims only differ only in the recitation of a nucleic acid in claims
`
`15-2 J. The specification and prior art do not teach any means other than a recombinant nucleic
`
`acid which provides the cells of claims 22-28, thus they necessarily comp1ise the nucleic acids of
`
`claims 15-21.
`
`The nonstatut01y double patenting rejection is based on a judicially created doctrine
`
`grounded in public policy (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 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., Zn 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 Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); /11 re Va11
`
`Omum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); and Tn re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`Miltenyi Ex. 1028 Page 9
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page 8
`
`A timely filed terminal disclaimer in compliance with 37 CFR l.32l(c) or l.32l(d) may
`
`be used to overcome an actual or provisional 1·ejection based on a nonstatutoiy double patenting
`
`ground provided the reference application or 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. A terminal discla@eT rnuf)t be signed in compliance with 37 CFR
`
`1.321 (b ).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be used.
`
`Please visit http://www.uspto.gov/fo1ms/. The tiling date of the application will determine what
`
`form should be used. A web-based eTerminal Discla@er may be filled out completely online
`
`using web-screens. An eTenninal Disclaimer that meets all requirements is auto-processed and
`
`approved immediately upon submission. For more information about eTerminal Disclaimers,
`
`refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
`
`Claims 1-28 ru·e rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-53 of U.S. Patent No. 9,499,629. Although the claims at issue are not
`
`identical, they are not patentably distinct from each other because the methods and cells of the
`
`·629 patent comprise a CAR having a CD19-specifc domain (which may be a scFv), a 4-l BB
`
`costimulatory domain, and a CD3 zeta signaling domain. The CD8alpha hinge and TM domain
`
`are taught as a prefe1Ted embodiment (see Fig. l A) as are memo1y T cells (col. 3).
`
`Claims 1-28 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-21 of U.S. Patent No. 8,911,993. Although the claims at issue ru·e not
`
`identical, they ru·e not patentably distinct from each other because the instant cells comprise the
`
`Miltenyi Ex. 1028 Page 10
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page 9
`
`same elements (e.g. a CAR comprising a CD19 binding domain, TM and hinge domains, 41BB
`
`costimulatory domain, a CD3 zeta signaling domarn) as those claimed in the '933 patent, or are
`
`disclosed as preferred embodiments (see Fig. lA and col. 3).
`
`Claims 1-28 am rejected oh the ground of nonstatutory double patenting as being
`
`unpatentable over claims l-30 of U.S. Patent No. 8,906,682. Although the claims at issue are not
`
`identica1, they are not patentab1y distinct from each other because the instant cells comprise the
`
`same elements (e.g. a CAR comprising a CD 19 binding domain, TM and hinge domains, 41BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '682 patent, or arc
`
`disclosed as preferred embodiments (see Fig. lA and col. 3).
`
`Claims 1-28 are rejected 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 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 19 binding domain, TM and mnge domains, 41BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '760 patent, or are
`
`disclosed as preferred embodiments (see Fig. 1 A and col. 3).
`
`Claims 1-28 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 9, I 01,584. 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, TM and hinge domains, 41BB
`
`co.stimulatory domain, a CD3 zeta signaling domain) as those claimed in th.e ' 584 patent, or are
`
`disclosed as preferred embodiments (see Fig. l A and col. 3).
`
`Miltenyi Ex. 1028 Page 11
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page 10
`
`Claims 1-28 a.re 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 a.re not patentably distinct from each other because the instant cells comp1ise the
`
`same elements (e.g. a CAR comprising a CD l 9 binding domain, TM and hinge domains, 41 BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '761 patent, or are
`
`disc1osed as prefe1Ted embodiments (see Fig. l A and col. 3).
`
`Claims 1-28 a.re rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-1 S of U.S. Patent No. 9.328, 156. Although the claims at issue are not
`
`identical, they a.re not patentably distinct from each other because the instant cells comprise the
`
`same elements (e.g. a CAR comprising a CD 19 binding domain, 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 e mbodiments (see Fig. 1 A and col. 3).
`
`Claims 1-28 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-26 of U.S. Patent No. 9,5 L8,123. 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 CD19 binding domain, TM and hinge domaitl5, 41BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '123 patent. or are
`
`disclosed as preferred embodiments (see Fig. lA and col. 3).
`
`Claims 1-28 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-26 of U.S. Patent No. 9,518, 123. 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, TM and hinge domains, 41BB
`
`Miltenyi Ex. 1028 Page 12
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page 11
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in tl1e ' 156 patent, or are
`
`disclosed as preferred embodiments (see Fig. J A and col. 3).
`
`Claims 1-28 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-30 of U.S. Patent No. 9,481,728. 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, ™- and hinge domains. 4 I BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those daimed in the ' 728 pateut, or are
`
`disclosed as preferred e mbodime nts (see Fig. 1 A and col. 3).
`
`Claims 1-28 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-28 of U.S. Patent No. 9,464, 140. Although 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 CDl 9 binding domain, TM and hinge domains, 41 BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the ' 140 patent, or are
`
`disclosed as preferred embodiments (see Fig. I A and col. 3).
`
`Claims 1-28 am rejected oh the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-21 of U.S. Patent No. 8,911,993. Although 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 CD 19 binding domain, TM and hinge domains, 41BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '993 patent, or are
`
`disclosed as preferred embodiments (see Fig. lA and col. 3).
`
`Claims 1-28 a.re rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-28 of U.S. Patent No. 8,916,38 1. AJthough the claims at issue are not
`
`Miltenyi Ex. 1028 Page 13
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`Page 12
`
`identical, they are not patentably distinct from each other because the instant cells compdse the
`
`same elements (e.g. a CAR comprising a CD 19 binding domain, TM and hinge domains, 41 BB
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '38 1 patent, or are
`
`disclosed as preferred embodiments (see Fig. I A and col. 3).
`
`Claims 1-28 are rejected on the ground of nonstatutory double patenting as being
`
`unpatentable over claims 1-17 of U.S. Patent No. 8,975,071. 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 COl 9 binding domain, TM and hinge domains, 41B8
`
`costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '071 patent, or are
`
`disclosed as preferred embodiments (see Fig. 1 A and col. 3).
`
`Claims 1-28 are provisionally rejected on the ground of nonstatutory double patenting as
`
`being unpatentable over claim I of copending Application No. 15/696,584 (reference
`
`application). 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. an antigen binding domain,
`
`a costimulatory domain, a CD3 zeta signaling domain) as those claimed in the '584 patent, or arc
`
`disclosed as prefe1Ted embodiments (see Fig. lA and col. 3).
`
`This is a provisional nonstatuto1y double patenting rnjectfon because the patentably
`
`indistinct claims have not in fact been patented,
`
`Miltenyi Ex. 1028 Page 14
`
`

`

`Application/Control Number: 15/353,899
`Art Unit: 1633
`
`No claim is allowed.
`
`Co11clusion
`
`Page 13
`
`Any inquiry concerning this commun ication or ear.Lier communications from the
`examiner should be directed to Michael Burkhart whose telep·hone number is (571)272-2915.
`The examiner can n01m ally be reached on M-F 8AM-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.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`supervisor, Christopher Babic can be reached on (57 1) 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 Information Retrieval (PAIR) system. Status info1mation for publ.ished applications
`may be obtained from either P1ivate PAIR or Public PAIR. Status infonnation for unpublished
`applications is available through Private PAIR only. For more information about the PAIR
`syste m, 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 syste m, call 800~786-9199 (IN USA OR CAN ADA) or 571-272-1000.
`
`/Michael Burkhart/
`
`Primaiy Examiner. Art Unit 1633
`
`Miltenyi Ex. 1028 Page 15
`
`