8329857
`
`December 28, 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: 14/006,641
`FILING DATE: May 05, 2014
`PATENT NUMBER: 9987308
`ISSUE DATE: June 05, 2018
`
`Miltenyi Ex. 1008 Page 1
`
`

`

`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`
`ATTY. DOCKET NO.
`
`360056.420USPC
`
`APPLICATION NO.
`
`14/006,641
`
`Sheet _1 of 3.
`
`INFORMATION DISCLOSURE STATEMENT
`(Use several sheets ifnecessary)
`
`Stanley R. Riddell etal.
`INTERNATIONALFILING DATE
`
`March 23, 2012
`
`*EXAMINER
`
`DOCUMENT NUMBER
`
`U.S. PATENT DOCUMENTS
`KIND
`
`AM
`
`APPLICANTS
`
`
`
`
`
`
`FILING DATE
`STRAE™||pocemenrwexmer|CODE DATE IFAPPROPRIATE
`
`
`
`
`
`
`[fans|[owas[Rosas
`
`
`[a[eoman[a[oni[dieters
`
`
`[Pffamornssfa[onionsegat
`
`
`
` BUTCHERetal., “Lymphocyte homing and homeostasis,” Science 272(5258): 60, 1996, 13 pages
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`BASKARetal., “Unique Cell Surface Expression of Receptor Tyrosine Kinase ROR1 in Human
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`B-Cell Chronic Lymphocytic Leukemia,” Clin. Cancer Res. 14(2): 396-404, January 15, 2008
`BERGERetal., “Adoptive transfer of effector CD8+ T cells derived from central memory cells
`establishes persistent T cell memory in primates,” The Journal of Clinical Investigation 118(1):
`294-305, January
`2008
`BERGERetal., “Adoptive transfer of virus-specific and tumor-specific T cell immunity,” Current
`Opinion in Immunology 21: 224-232, 2009
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`
`
`
`
`
`
`BLEAKLEYetal., “Molecules and mechanismsofthe graft-versus-leukaemia effect,” Nature
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`BOLLARDet al., “Cytotoxic T Lymphocyte Therapy for Epstein-Barr Virus’ Hodgkin’s Disease,”
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`2003
`
`EXAMINER
`
`* EXAMINER:_
`
`30038721
`
`DATE CONSIDERED
`
`Initial if reference considered, whetheror not citation is in conformance with MPEP 609. Draw line throughcitation if not in
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`Dated: March 10, 2014
`Miltenyi Ex. 1008 Page 2
`
`Miltenyi Ex. 1008 Page 2
`
`

`

`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`
`INFORMATION DISCLOSURE STATEMENT
`(Useseveral sheets ifnecessary)
`
`
`
`
`
`ATTY. DOCKET NO.
`
`360056.420USPC
`APPLICANTS
`
`Stanley R. Riddell etal.
`INTERNATIONALFILING DATE
`
`Sheet 2 of 3.
`
`APPLICATION NO.
`
`14/006,641
`
`GROUP ART UNIT
`
`March 23, 2012
`
`NON-PATENT LITERATURE DOCUMENTS(Including Author, Title, Date, Pertinent Pages, Etc.)
`CHEADLEet al., “Natural Expression of the CD19 Antigen Impacts the Long-Term Engraftment
`but Not Antitumor Activity of CD19-Specific Engineered T Cells,” The Journal ofImmunology
`: 1885-1896, Janua
`CHEEVERet al., “Specificity of adoptive chemoimmunotherapy of established syngeneic tumors,”
`
`The Journal ofImmunology 125(2): 711-714, August 1980
`DUDLEYetal., “Adoptive Transfer of Cloned Melanoma-Reactive T Lymphocytes for the
`Treatment of Patients with Metastatic Melanoma,” Journal ofImmunotherapy 24(4): 363-373,
`2001
`
`DUDLEYetal., “A phase I Study of Nonmyeloablative Chemotherapy and Adoptive Transfer of
`Autologous Tumor Antigen-Specific T Lymphocytes in Patients With Metastatic Melanoma,” J.
`Immunother. 25(3): 243-251, 2002
`DUDLEYet al, “Cancer Regression and Autoimmunity in Patients After Clonal Repopulation
`with Antitumor Lymphocytes,” Science 298(5594): 850-854, October 25, 2002
`DUDLEYetal., “Adoptive Cell Transfer Therapy Following Non-Myeloablative but
`Lymphodepleting Chemotherapy for the Treatment of Patients With Refractory Metastatic
`
`Melanoma,” J. Clin. Oncol. 23(10): 2346-2357, April 1, 2005
`FUKUDAet al., “Antisera induced by infusions of autologous Ad-CD154-leukemia B cells
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`GATTINONTet al., “Acquisition of full effector function in vitro paradoxically impairs the in vivo
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`Investigation 115(6): 1616-1626, June 2005
`GATTINONTet al., “Adoptive immunotherapy for cancer: building on success,” Nat. Rev.
`Immunol. 6(5): 383-393, May 2006
`HUDECEKetal., “Naive CD4+ T Cells Modified to Express a ROR1-Specific CAR Mediate Anti-
`TumorActivity and Provide Superior Help to CD8+ RORI-CART Cells,” Blood (ASH Annual
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`KESSELSet al., “Immunotherapy through TCR genetransfer,” Nature Immunology 2(10): 957-
`961, October 2001
`KLEIN etal., “Gene Expression Profiling of B Cell Chronic Lymphocytic Leukemia Reveals a
`Homogeneous Phenotype Related to Memory B Cells,” J. Exp. Med. 194(11): 1625-1638,
`December3, 2001
`LAPALOMBELLAet al., “Lenalidomide treatment promotes CD154 expression on CLLcells and
`enhances production of antibodies by normalB cells through a PI3-kinase-dependent pathway,”
`Blood 115(13): 2619-2629, April 1, 2010
`MITSUYASUet al., “Prolonged survival andtissue trafficking following adoptive transfer of
`CD4¢ gene-modified autologous CD4+ and CD8+ T cells in human immunodeficiency virus-
`infected subjects,” Blood 96(3): 785-793, August 2000
`
`22
`
`EXAMINER
`
`DATE CONSIDERED
`
`
`
`* EXAMINER:_
`
`30038721
`
`Initial if reference considered, whetheror not citation is in conformance with MPEP 609. Draw line throughcitation if not in
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`Dated: March 10, 2014
`Miltenyi Ex. 1008 Page 3
`
`Miltenyi Ex. 1008 Page 3
`
`

`

`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
`
`INFORMATION DISCLOSURE STATEMENT
`(Useseveral sheets ifnecessary)
`
`ATTY. DOCKET NO.
`
`360056.420USPC
`APPLICANTS
`
`Stanley R. Riddell etal.
`INTERNATIONALFILING DATE
`
`March 23, 2012
`
`APPLICATION NO.
`
`14/006,641
`
`GROUP ART UNIT
`
`Sheet 3 of 3.
`
`NON-PATENT LITERATURE DOCUMENTS(Including Author, Title, Date, Pertinent Pages, Etc.)
`MORGANetal., “Cancer Regression in Patients After Transfer of Genetically Engineered
`Lymphocytes,” Science 314(5796): 126-129, October 6, 2006
`PAHL-SEIBERTet al., “Highly Protective In Vivo Function of Cytomegalovirus IE1 Epitope-
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`RIDDELLet al., “The use of anti-CD3 and anti-CD28 monoclonal antibodies to clone and expand
`human antigen-specific T cells,” Journal of Immunological Methods 128: 189-201, 1990
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`27
`
`
`
`
`
`10, 1992
`Transfer of T Cell Clones,” Science 257: 238-241, July
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`Virus-Induced Lymphomain Allogeneic Transplant Recipients,” Blood 92(5): 1549-1555,
`September 1, 1998
`ROSENWALDetal., “Relation of Gene Expression Phenotype to Immunoglobulin Mutation
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`28
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`SALLUSTOetal., “Central Memory and Effector Memory T Cell Subsets: Function, Generation,
`and Maintenance,” Annu. Rev. Immunol. 22: 7745-763, 2004
`SCHMITTet al., “Maintenance of T Cell Specification and Differentiation Requires Recurrent
`Notch Receptor-Ligand Interactions,” J. Exp. Med. 200(4): 469-479, August 16, 2004
`SINGHetal., “Selective Reprogramming of CD 19-Specific T Cells with IL-21 and CD28
`Signaling for Adoptive Immunotherapy of Acute Lymphoblastic Leukemia,” Biology ofBlood and
`1, 2009, Abstract No. 164, 2
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`TCRgenetransfer,” Nature Immunology 2(10): 962-970, October 2001
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`WANGetal., “Cellular Immunotherapy for Follicular Lymphoma Using Genetically Modified
`CD20-Specific CD8° Cytotoxic T Lymphocytes, Molecular Therapy
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`YEEet al., “Adoptive T cell therapy using antigen-specific CD8" T cell clones for the treatment of
`patients with metastatic melanoma: /n vivo persistence, migration, and antitumoreffect of
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`
`29
`
`31
`
`32
`
`33
`
`34
`
`35
`
`EXAMINER
`
`* EXAMINER:_
`
`30038721
`
`DATE CONSIDERED
`
`Initial if reference considered, whetheror not citation is in conformance with MPEP 609. Draw line throughcitation if not in
`conformance and not considered. Include copy of this form with next communication to applicant.
`
`Dated: March 10, 2014
`Miltenyi Ex. 1008 Page 4
`
`Miltenyi Ex. 1008 Page 4
`
`

`

`PATENT COOPERATION TREATY
`
`Applicants
`Int’! Application No.
`U.S. Application No.
`Int’! Filing Date
`Title
`
`: Stanley R. Riddell et al.
`: PCT/US2012/030388
`:
`14/006,641
`: March 23, 2012
`: METHOD AND COMPOSITIONS FOR CELLULAR
`
`IMMUNOTHERAPY
`
`Docket No.
`
`: 360056.420USPC
`
`Date
`
`: March 10, 2014
`
`Mail Stop PCT
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`applications are not required and accordingly have not been provided. Copies of any other cited
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`references are made knownto the Patent and Trademark Office in compliance with Applicants’
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`Miltenyi Ex. 1008 Page 5
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`Application No. 14/006,641
`Information Disclosure Statement Transmittal
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`Applicants believe this Information Disclosure Statement has been timely filed, however,
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`Sheet 1 of 1
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`pee]eeeTae
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`*EXAMINER
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`FILING DATE
`
`IF APPROPRIATE
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`
`gosios |wo
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`U.S. DEPARTMENT OF COMMERCE
`PATENT AND TRADEMARK OFFICE
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`ATTY. DOCKETNO.
`360056.420USPC
`APPLICANTS
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`APPLICATION NO.
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`INFORMATION DISCLOSURE STATEMENT
`(Use several sheets ifnecessary)
`
`Stanley R. Riddell et ai.
`INTERNATIONALFILING DATE
`
`GROUP ART UNIT
`
`March 23, 2012
`
`U.S. PATENT DOCUMENTS
`KIND
`
`oe
`
`
`
`
`ALTENSCHMIDTet al., “Cytolysis of Tumor Cells Expressing the Neu/erbB-2, erbB-3, and
`erbB-4 Receptors by Genetically Targeted Naive T Lymphocytes,” Clinical Cancer Research 2:
`
`1001-1008, June 1996
`ALTENSCHMIDTet al., “Adoptive Transfer of In Vitro-Targeted, Activated T Lymphocytes
`Results in Total Tumor Regression,” The Journal of Immunology 159: 5509-5515, 1997
`HINRICHSet al., “Adoptively transferred effector cells derived from naive rather than central
`memory CD8*"T cells mediate superior antitumor immunity,” PNAS 106(41): 17469-17474,
`October 13, 2009
`HINRICHSet al., “Human effector CD8+ T cells derived from naive rather than memory subsets
`possess superior traits for adoptive immunotherapy,” Blood 1/7(3): 808-814, 2011
`HUDECEKetal., “The B-cell tumor-associated antigen ROR1 can be targeted with T cells
`
`modified to express a ROR 1-specific chimeric antigen receptor,” Blood 116(22): 4532-4541, 2010
`KERSHAWetal., “Gene-Engineered T Cells as a Superior Adjuvant Therapy for Metastatic
`Cancer,” The Journal of Immunology 173: 2143-2150, 2004
`MOELLERetal., “Adoptive transfer of gene-engineered CD4" helper T cells induces potent
`i
`tumorrejection,” Blood 106: 2995-3003, 2005
`TENGetal.,“Immunotherapy of Cancer Using Systemically Delivered Gene-Modified Human T
`Lumphocytes, ” Human Gene Therapy 15: 699-708, July 2004
`WALKERet al., “Long-term in vivo survival of receptor-modified syngeneic T cells in patients
`with human immunodeficiency virus infection,” Blood 96: 467-474, 2000
`WANGet al., “Engraftment of human central memory-derived effector CD8" T cells in
`immunodeficient mice,” Blood 117(6): 1888-1898, 2011
`WESTWOODet al., “Genetic redirection of T cells for cancer therapy,” Journal ofLeukocyte
`Biology 87. 791-803, May 2010
`
`Sma[|pocuwmyrswowner|foe|pare[county
`|_| +|wo 20067060878
`
`EXAMINER
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`DATE CONSIDERED
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`* EXAMINER:_
`
`Initial if reference considered, whetheror not citation is in conformance with MPEP 609. Draw line throughcitation if not in
`conformance and not considered. Include copy of this form with next communication to applicant.
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`3167690_1
`
`Dated: 7 12, 2014
`Miltenyi Ex. 1008 Page 7
`
`Miltenyi Ex. 1008 Page 7
`
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`

`PATENT COOPERATION TREATY
`
`Applicants
`Int’! Application No.
`U.S. Application No.
`Int’! Filing Date
`Title
`
`: Stanley R. Riddell et al.
`: PCT/US2012/030388
`:
`14/006,641
`: March 23, 2012
`: METHOD AND COMPOSITIONS FOR CELLULAR
`
`IMMUNOTHERAPY
`
`Docket No.
`
`: 360056.420USPC
`
`Date
`
`: May 12, 2014
`
`Mail Stop PCT
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`P.O. Box 1450
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`applications are not required and accordingly have not been provided. Copies of any other cited
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`references are enclosed. As to any reference cited, Applicants do not admit that it is “prior art”
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`Application No. 14/006,641
`Information Disclosure Statement Transmittal
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`Applicants believe this Information Disclosure Statement has been timely filed, however,
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`the Director is authorized to charge any fee due by way ofthis Information Disclosure Statement
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`Jeffrey C. Pepe, Ph.D.
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`Miltenyi Ex. 1008 Page 10
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`
`
`Applicant(s)
`Application No.
` 14/006,641 RIDDELL ET AL.
`
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`Michael Burkhart Na 1633
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`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
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`earned patent term adjustment. See 37 CFR 1.704(b).
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`Status
`1)L] Responsive to communication(s) filed on
`LJ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon__
`a)L] This action is FINAL.
`2b)L] This action is non-final.
`3)X] An election was made bythe applicant in responsetoarestriction requirementset forth during the interview on
`21 April 2016; the restriction requirement and election have been incorporatedinto this action.
`4)[] Since this application is in condition for allowance exceptfor 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)KX] Claim(s) 39-70 is/are pending in the application.
`5a) Of the above claim(s) 43,48,57 and 68 is/are withdrawn from consideration.
`6)L] Claim(s)____is/are allowed.
`
`7) Claim(s) 39-42,44-47,49,51-56,58-61,63-67,69 and 70 is/are rejected.
`8)X] Claim(s) 50and62 is/are objected to.
`
`9)L] Claim(s)
`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
`participating intellectual property office for the corresponding application. For more information, please see
`or send an inquiry to PPHieedback@uspte. doy.
`isp
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`Application Papers
`10)L] The specification is objected to by the Examiner.
`
`11)L] The drawing(s)filed on
`is/are: a)L_] accepted or b)L_] 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)[] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)L] All
`b)[-] Some** c)L] None ofthe:
`1..] Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies of the certified copies of the priority documents have been receivedin 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.
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` Attachment(s)
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`1) CT] Notice of References Cited (PTO-892)
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`2) X Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
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`3) CT] Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
`4 Ol Other:
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`Paper No(s)/Mail Date 3/10/14 35/12/14 :2/8/16;3/11/16.
`
`U.S. Patent and Trademark Office
`.
`PTOL-326 (Rev. 11-13)
`Part of Paper No./Mail Date 20160421
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`Office Action Summary
`
`Miltenyi Ex. 1008 Page 11
`
`

`

`Application/Control Number: 14/006,641
`
`Art Unit: 1633
`
`Page 2
`
`The present application is being examined underthe pre-AIAfirst to invent provisions.
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`DETAILED ACTION
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`Election/Restrictions
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`REQUIREMENT FOR UNITY OF INVENTION
`
`Asprovided in 37 CFR 1.475(a), a national stage application shall relate to one invention
`
`only or to a group of inventionsso linked as to form a single general inventive concept
`
`(“requirement of unity of invention’’). Where a group of inventionsis claimedin a national stage
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`application, the requirement of unity of invention shall be fulfilled only when there is a technical
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`relationship among those inventions involving one or more of the same or corresponding special
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`technical features. The expression “special technical features” shall mean those technical features
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`that define a contribution which each of the claimed inventions, considered as a whole, makes
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`over the priorart.
`
`The determination whether a group of inventionsis so linked as to form a single general
`
`inventive concept shall be made without regard to whether the inventions are claimed in separate
`
`claimsor as alternatives within a single claim. See 37 CFR 1.475(e).
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`Miltenyi Ex. 1008 Page 12
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`Miltenyi Ex. 1008 Page 12
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`

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`Application/Control Number: 14/006,641
`
`Art Unit: 1633
`
`Page 3
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`WHEN CLAIMS ARE DIRECTED TO MULTIPLE CATEGORIES OF INVENTIONS
`
`Asprovided in 37 CFR 1.475(b), a national stage application containing claims to
`
`different categories of invention will be considered to have unity of invention if the claims are
`
`drawn only to one of the following combinations of categories:
`
`(1) A product and a process specially adapted for the manufacture of said product; or
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`(2) A product and processof use of said product; or
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`(3) A product, a process specially adapted for the manufacture of the said product, and a
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`use of the said product; or
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`(4) A process and an apparatus or meansspecifically designed for carrying out the said
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`process; or
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`(5) A product, a process specially adapted for the manufacture of the said product, and
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`an apparatus or means specifically designed for carrying out the said process.
`
`Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
`
`This application contains claims directed to more than one species of the generic
`
`invention. These species are deemedto lack unity of invention becausethey are not so linked as
`
`to form a single general inventive concept under PCT Rule 13.1.
`
`The species are as follows:
`
`Species I, elect one specific antigen, e.g. as recited in claims 40-43, 54-57, 66-68;
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`Species II, elect either “same” or “different” intracellular signaling domains, e.g. as
`
`recited in claims 47-48
`
`Applicant is required, in reply to this action, to elect a single species to which the claims
`
`shall be restricted if no generic claim is finally held to be allowable. The reply must also identify
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`Miltenyi Ex. 1008 Page 13
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`Miltenyi Ex. 1008 Page 13
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`

`

`Application/Control Number: 14/006,641
`
`Art Unit: 1633
`
`Page 4
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`the claims readable on the elected species, including any claims subsequently added. An
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`argumentthat a claim is allowable or that all claims are generic is considered non-responsive
`
`unless accompaniedby an election.
`
`Upon the allowance of a generic claim, applicant will be entitled to consideration of
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`claims to additional species which are written in dependent form or otherwise require all the
`
`limitations of an allowed generic claim. Currently, the following claim(s) are generic: claim 39
`
`The groups of inventions listed above do notrelate to a single general inventive concept
`
`under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or correspondingspecial
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`technical features for the following reasons: the species are mutually exclusive and thus cannot
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`share a special technical feature.
`
`During a telephone conversation with Jeff Pepe on 4/21/2016 a provisional election was
`
`made withouttraverse to prosecute the species of CD19 as antigen (claim 42) and the species of
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`the same signaling domain (claim 47). Affirmation of this election must be made by applicant in
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`replying to this Office action. Claims 43, 48, 57, 68 are withdrawn from further consideration by
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`the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
`
`Applicant is reminded that upon the cancellation of claims to a non-elected invention, the
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`inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the
`
`currently named inventors is no longer an inventorof at least one claim remaining in the
`
`application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an
`
`Miltenyi Ex. 1008 Page 14
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`Miltenyi Ex. 1008 Page 14
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`

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`Application/Control Number: 14/006,641
`
`Art Unit: 1633
`
`Page 5
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`application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her
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`legal nameand bythe processing fee required under 37 CFR 1.17(4).
`
`Claim Rejections - 35 USC § 102
`
`The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that
`
`form the basis for the rejections under this section madein this Office action:
`
`A personshall be entitled to a patent unless —
`
`(b) the invention was patented or described in a printed publication in this or a foreign country orin
`public use or on sale in this country, more than one yearprior to the date of application for patent in the
`United States.
`
`Claims 39-42, 44-47, 49, 51-56, 58-61, 63-67, 69 and 70 are rejected under pre-AIA 35
`
`U.S.C. 102(b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious
`
`over Huangetal (2008, cited by applicants) in view of Bergeret al (2009, cited by applicants)
`
`and Sallusto et al (cited by applicants).
`
`Huanget al teach a T cell composition comprising CD4+ and CD8+cells expressing a
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`CD19-specific chimeric antigen receptor (CAR)that in turn comprises a CD19 scFv, a
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`transmembrane domain, a 4-1BB signaling domain and a CD3intracellular domain. See, e.g. the
`
`abstract and Fig. la. Thus, both T cell subsets are considered to have the sameintracellular
`
`signaling domain. The T cells used are considered autologousrelative to the organism from
`
`which they were derived. The CAR T cells were used in methods of immunotherapy of CD19+
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`tumorcells (e.g., page 585). The CD4+cells expressed CD62L (page 585, second col.),
`
`considered to be CD62L-+4as recited in the claims absent a definitive definition, and were 95% of
`
`the population. Huangetal do not specifically teach that the CD8+ cells were CD62L+ and
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`CD45RO4,northat the CD4+ cells were CD45RA+, CD45RO- CD62L+ naive cells. However,
`
`Miltenyi Ex. 1008 Page 15
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`Miltenyi Ex. 1008 Page 15
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`

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`Application/Control Number: 14/006,641
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`Art Unit: 1633
`
`Page 6
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`Bergeret al teaches that the pool of T cells for immunotherapy inherently comprises naive
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`CD45RA+ CD62L+cells and CD45RO+ CD62L+ central memory cells (page 227, second col.,
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`first {). Likewise, Sallusto et al teach (e.g. Figure 1) that CD8+ memory cells are CD62L+
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`CD45RO+.
`
`Allowable Subject Matter
`
`Claims 50 and 62 are objected to as being dependent upon a rejected base claim, but
`
`would be allowable if rewritten in independent form includingall of the limitations of the base
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`claim and any intervening claims. There are no teachings in the prior art of compositions
`
`comprising both CD4+ naive and CD4+ central memory cells as recited in claims 50 and 62.
`
`Any inquiry concerning this communication or earlier communications from the
`examiner should be directed to Michael Burkhart whose telephone numberis (571)272-2915.
`The examiner can normally be reached on M-F 8AM-5PM.
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`supervisor, Christopher Babic can be reached on (571) 272-8507. The fax phone numberfor 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 information for published applications
`maybe obtained from either Private PAIR or Public PAIR. 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/
`Primary Examiner, Art Unit 1633
`
`Miltenyi Ex. 1008 Page 16
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`Miltenyi Ex. 1008 Page 16
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`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT
`
`Applicants
`Application No.
`Filed
`
`Stanley R. Riddell ef al.
`:
` 14/006,641
`:
`> May 5, 2014
`
`For
`
`: METHOD AND COMPOSITIONS FOR CELLULAR
`
`IMMUNOTHERAPY
`
`Examiner
`
`: Michael D. Burkhart
`
`Art Unit
`
`Docket No.
`
`Date
`
`:
`
`>
`
`:
`
`1633
`
`360056.420USPC
`
`October 4, 2016
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`REPLY AND AMENDMENT UNDER37 C.F.R. §§1.111 AND 1.121
`
`Commissionerfor Patents:
`
`Further to the Office Action dated May 4, 2016, please extend the time for response two
`
`(2) months, to expire on October 4, 2016. Enclosedis a Petition for an Extension of Time, along
`
`with the requisite fee. Please enter into the record of the above-identified application the
`
`following:
`
`Amendments to the Claims, which are reflected in the Listing of Claims and
`
`begin on page 2 of this paper; and
`
`Remarks, which begin on page 13 ofthis paper.
`
`The Director is authorized to charge any additional fees due by way of this Amendment,
`
`or credit any overpayment, to our Deposit Account No. 19-1090.
`
`Miltenyi Ex. 1008 Page 17
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`Miltenyi Ex. 1008 Page 17
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`

`

`Application No. 14/006,641
`Reply to Office Action dated May 4, 2016
`
`Amendments to the Claims
`
`Please cancel claims 41, 46, 51, 52, 55, 60, and 62-64 without prejudice; amend claims
`
`39, 40, 42-45, 47-50, 53, 54, 56-59, 61, and 65-70; and add new claims 71-85, as shown below.
`
`This listing of claims will replace all prior versions, andlistings, of claims in the application:
`
`Listing of Claims
`
`1. — 38.
`
`(Canceled)
`
`39.
`
`(Currently Amended) An adoptive cellular immunotherapy composition
`
`
`raphocytes
`I
`
`
`
`
`S comprising chimeric antioen receptor-modified CD44
`
`
`(a)
`the chimeric antigen receptor-madified CD4+ T ivmphocytes in the composition
`+
`
`
`
`consist ot e-helper T lymphocytes-s¢it-sreseratien-
`
`sf
`
`CDS:
`
`Do4+-celle-
`
`+ that contain a chimeric antigen receptor that specifically binds to
`
`
`an antigen, and
`
`(b)
`
`thechimencantigenreceptorsmodifiedCD3+Tlymphocytesinthecomposition
`
`consist of CD8+ a-cytotoxic T lymphocytes
`
`+ that
`
`are derived from a central memory-eniched CH8+cells
`
`antiges-reaetive population and contain a chimeric antigen receptor that specifically binds to the
`
`antigen-
`
`
`
`AO.
`
`(Currently Amended) The adoptive cellular immunotherapy composition
`
`according to claim 39, wherein the antigen is associated with a disease or disorder selected from
`
`a solid tumor, hematologic malignancy, melanoma,-errat and infection with a pathogen.
`
`41.
`
`(Canceled)
`
`2
`
`Miltenyi Ex. 1008 Page 18
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`Miltenyi Ex. 1008 Page 18
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`

`

`Application No. 14/006,641
`Reply to Office Action dated May 4, 2016
`
`42.
`
`(Currently Amended) The adoptive cellular immunotherapy composition
`
`according to claims 39, wherein the antigen is-as-erphas-bresine-anase-ceeepter
`
`selected from
`
`ROR1, tEGFR, Her2, L1-CAM, CD19, CD20, CD22, mesothelin, and CEA;-e:-repatitis-B
`
`43.
`
`(Withdrawn — Currently Amended) The adoptive cellular immunotherapy
`
`composition according to claim 39, wherein the antigen is a pathogen specific cell surface
`
`antigen selected from an HIV antigen, an HCV antigen, an HBV antigen, 4 hepatitis B surface
`
`antigen, a CMV antigen,-sr and a parasitic antigen.
`
`44.
`
`(Currently Amended) The adoptive cellular immunotherapy composition
`
`
`
`} and/or (b} comprises an according to claim 39, wherein the chimeric antigen receptor_of {4
`
`extracellular antibody variable damain or single-chain antibody fragment specific for an antigen
`associated with a disease or disorder, and an intracellular signaling module.
`
`45.
`
`(Currently Amended) The adoptive cellular immunotherapy composition
`
`according to claim 44, wherein_¢ach ofthe intracellular signaling