UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria., Virginia 22313-1450
`www .uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/523,650
`
`10/24/2014
`
`JohnC. BYRD
`
`PIR-88501
`
`1095
`
`11/03/2016
`7590
`136314
`FOLEY HOAG, LLP (W/PIR)
`PATENT GROUP, Seaport West
`155 SEAPORT BL VD
`BOSTON, MA 02210
`
`EXAMINER
`
`TRAN, MY CHAU T
`
`ART UNIT
`
`PAPER NUMBER
`
`1629
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`11/03/2016
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
`following e-mail address(es):
`Patent@foleyhoag.com
`pair_foleyhoag@firsttofile.com
`ABBVIE_PATENTS_ABT_PRK@abbvie.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Application No.
`14/523,650
`
`Applicant(s)
`BYRD ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`Yes
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`MY-CHAU T. TRAN
`
`Art Unit
`1629
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`1 )~ Responsive to communication(s) filed on 07/22/2016.
`DA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)~ This action is FINAL.
`2b)D This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election 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)~ Claim(s) 1.3-11.15.16 and 18-25 is/are pending in the application.
`5a) Of the above claim(s) 19 and 20 is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 1.3-6.15.16.18.21 and 25 is/are rejected.
`8)~ Claim(s) 7-11 and 22-24 is/are objected to.
`9)0 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
`http:ilwww.usoto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )~ The drawing(s) filed on 10/24/2014 is/are: a)~ accepted or b)D 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).
`
`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:
`Certified copies of the priority documents have been received.
`1. □
`Certified copies of the priority documents have been received in Application No. __ .
`2. □
`Copies of the certified copies of the priority documents have been received in this National Stage
`3. □
`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) ~ Notice of References Cited (PTO-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 07/06/2016.
`
`3) D Interview Summary (PTO-413)
`Paper No(s)/Mail Date. __ .
`4) D Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20161029
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 2
`
`DETAILED ACTION
`
`Application and Claims Status
`
`1.
`
`Applicant's amendment and response filed on 07/22/2016 are acknowledged and entered.
`
`2.
`
`Claims 1-20 were pending. Applicants have amended claims 1, 7-9, 11, and 16;
`
`cancelled claims 2, 12-14, and 17; and added claims 21-25. Therefore, claims 1, 3-11, 15, 16,
`
`and 18-25 are currently pending. Claims 19 and 20 are drawn to non-elected species and/or
`
`inventions, wherein the election was made without traverse in the reply filed on 02/02/2016, and
`
`thus these claims remain withdrawn from further consideration by the examiner, 37 CPR
`
`l.142(b), there being no allowable generic claim. Accordingly, claims 1, 3-11, 15, 16, and 18-25
`
`are under consideration in this Office Action.
`
`3.
`
`The present application, filed on or after March 16, 2013, is being examined under the
`
`first inventor to file provisions of the AIA.
`
`Information Disclosure Statement
`
`4.
`
`The information disclosure statement (IDS) that was filed on 07/06/2016 has been
`
`reviewed, and the references that have been considered are initialed as recorded in PTO-1449
`
`forms.
`
`Status of Claim(s) Objection(s) and for Rejection(s)
`
`5.
`
`The rejection of claims 1 and 3-18 under 35 U.S.C. 112(a) or 35 USC 112 (pre-AIA),
`
`first paragraph (scope of enablement) has been withdrawn in view of applicant's amendments of
`
`claims 1, 7-9, 11, and 16 and/or cancellation of claims 12-14, and 17 thereto.
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 3
`
`6.
`
`The rejection of claims 1, 3-6, 11, 12, and 18 under 35 U.S.C. 102(a)(l)/102(a)(2) as
`
`being anticipated by Izumi et al. (US Patent Application Publication US 2015/0086507 Al;
`
`Effective Filing Date of 04/11/2012) has been withdrawn in light of applicant's arguments (see
`
`pages 6-8, filed on 07/22/2016) and/or amendments of claims 1, 7-9, 11, and 16 thereto.
`
`7.
`
`The rejection of claims 1-18 under 35 U.S.C. 102(a)(l)/102(a)(2) as anticipated by or, in
`
`the alternative, under 35 U.S.C. 103 as obvious over Izumi et al. (US Patent Application
`
`Publication US 2015/0086507 Al; Effective Filing Date of 04/11/2012) has been withdrawn in
`
`view of applicant's arguments (see pages 6-8, filed on 07/22/2016) and/or amendments of claims
`
`1, 7-9, 11, and 16 and/or cancellation of claims 2, 12-14, and 17 thereto.
`
`8.
`
`The provisional rejection under the judicially created doctrine of obviousness-type double
`
`patenting of claim 2 over claim 1 of copending Application No. 14/558,297 (US Patent
`
`Application Publication US 2015/0157634 Al) has been withdrawn in light of the cancellation of
`
`claim 2 thereto.
`
`Maintained Rejection(s)
`
`Double Patenting
`
`9.
`
`The nonstatutory 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
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 4
`
`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 Langi, 759 F.2d 887,225 USPQ 645 (Fed. Cir. 1985); In re Van
`
`Ornum, 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 terminal disclaimer in compliance with 37 CPR l.32l(c) or l.32l(d) may
`
`be used to overcome an actual or provisional rejection based on a nonstatutory 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 disclaimer must be signed in compliance with 37 CPR
`
`l.32l(b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be used.
`
`Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what
`
`form should be used. A web-based eTerminal Disclaimer may be filled out completely online
`
`using web-screens. An eTerminal 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/patentsiprocess/fi1e/efs/guidance/eTD-1nfo-I.isp.
`
`10.
`
`Claims 1, 3-6, 15, 16, and 18 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1-5, 16, 17, and 19 of copending Application
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 5
`
`No. 14/558,297 (Based on the amendment filed on 08/22/2016; hereinafter refers to as Blazar et
`
`al.). Although the conflicting claims are not identical, they are not patentably distinct from each
`
`other because both the method of the instant claims 1, 3-6, 15, 16, and 18, and the method of
`
`claims 1-5, 16, 17, and 19 of Blazar et al. used a compound with similar structural features.
`
`14/523,650
`1. A method of treating graft versus host
`disease (GVHD) or reducing the severity of
`GVHD occurrence in a patient having
`chronic GVHD, comprising administering to
`the patient a therapeutically effective
`amount of a compound of Formula (A)
`R,1 •• ,_..R,i
`~-,:
`N ~1-··4. '
`A
`II
`'
`'\N,✓,:'.l..N
`'
`' R4
`
`-R,~
`
`having the structure: Fomn.ib v\i: wherein: A
`is N; R1 is phenyl-0-phenyl or phenyl-S(cid:173)
`phenyl; R2 and R3 are independently H; Ri is
`L3-X-L4-G, wherein, L3 is optional, and
`when present is a bond, optionally
`substituted or unsubstituted alkyl, optionally
`substituted or unsubstituted cycloalkyl,
`optionally substituted or unsubstituted
`alkenyl, optionally substituted or
`unsubstituted alkynyl; X is optional, and
`when present is a bond, -0-, -C(=0)-, -S-, -
`S(=0)-, -S(=0h-, -NH-, -NR9-, -NHC(0)-, -
`C(0)NH-, -NR9C(0)-, -C(0)NR9-, -
`S(=0hNH-, -NHS(=0h-, -S(=0hNR9-, -
`NR9S(=0h-, -0C(0)NH-, -NHC(0)0-, -
`0C(0)NR9-, -NR9C(0)0-, -CH=N0-, -
`0N=CH-, -NR10C(0)N R10-, heteroaryl-,
`aryl-, -N R10C(=NRll)N R10-, -N
`R10C(=NRll)-, -C(=NRll)NR10-, -
`0C(=NRll)-, or -C(=NRll)0-; L4 is
`optional, and when present is a bond,
`substituted or unsubstituted alkyl,
`
`14/558,297
`1. A method of treating alloantibody
`driven chronic graft versus host disease
`(cGVHD) in a patient in need thereof,
`comprising administering to the patient a
`therapeutically effective amount of a
`compound of Formula (A) having the
`Rh ,.R;:
`-· N
`R,
`N .... ¾_~--{ '·
`;;
`I ,A
`·:
`R4
`
`ri·
`
`' - • .::, , , . N. ,
`
`Fqrn1ula {i\}~
`
`wherein: A is N;
`structure:
`R1 is phenyl-0-phenyl or phenyl-S-phenyl;
`R2 and R3 are H; R4 is L3-X-L4-G, wherein,
`L3 is optional, and when present is a bond,
`optionally substituted or unsubstituted
`alkyl, optionally substituted or
`unsubstituted cycloalkyl, optionally
`substituted or unsubstituted
`alkenyl, optionally substituted or
`unsubstituted alkynyl; X is optional, and
`when present is a bond, -0-, -C(=0)-, -S-, -
`S(=0)-, -S(=0h-, -NH-, -NR9-, -NHC(0)-,
`-C(0)NH-, -NR9C(0)-, -C(0)NR9-, -
`S(=0hNH-, -NHS(=0h-, -S(=0hNR9-, -
`NR9S(=0h-, -0C(0)NH-, -NHC(0)0-, -
`0C(0)NR9-, -NR9C(0)0-, -CH=N0-, -
`0N=CH-, -NR10C(0)N R10-, heteroaryl-,
`aryl-, -N R10C(=NRll)N R10-, -N
`R10C(=NRll)-, -C(=NRll)NR10-, -
`0C(=NRll)-, or -C(=NRll)0-; L4 is
`optional, and when present is a bond,
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`substituted or unsubstituted cycloalkyl,
`substituted or unsubstituted alkenyl,
`substituted or unsubstituted
`alkynyl, substituted or unsubstituted aryl,
`substituted or unsubstituted heteroaryl,
`substituted or unsubstituted heterocycle; or
`L3, X and L4 taken together form a nitrogen
`containing heterocyclic ring; G is
`
`, wherein, R6, R7 and Rs are independently
`selected from among H, halogen, CN, OH,
`substituted or unsubstituted alkyl or
`substituted or unsubstituted heteroalkyl or
`substituted or unsubstituted cycloalkyl,
`substituted or unsubstituted
`heterocycloalkyl, substituted or
`unsubstituted aryl, substituted or
`unsubstituted heteroaryl; each R9 is
`independently selected from among H,
`substituted or unsubstituted lower alkyl, and
`substituted or unsubstituted lower
`cycloalkyl; each R 10 is independently H,
`substituted or unsubstituted lower alkyl, or
`substituted or unsubstituted lower
`cycloalkyl; or two R10 groups can together
`form a 5-, 6-, 7-, or 8-membered
`heterocyclic ring; or R10 and Rn can
`together form a 5-, 6-, 7-, or 8-membered
`heterocyclic ring; or each Rn is
`independently selected from H or substituted
`or unsubstituted alkyl; or a pharmaceutically
`acceptable salt thereof, thereby treating graft
`versus host disease (GVHD) or reducing the
`severit of GVHD occurrence in the atient.
`3. The method of claim 1, wherein L3, X and
`L4 taken together form a nitrogen containing
`heteroc die rin .
`4. The method of claim 2, wherein the
`nitrogen containing heterocyclic ring is a
`i eridine rou .
`5. The method of claim 1, wherein G is
`
`Page 6
`
`substituted or unsubstituted alkyl,
`substituted or unsubstituted cycloalkyl,
`substituted or unsubstituted alkenyl,
`substituted or unsubstituted
`alkynyl, substituted or unsubstituted aryl,
`substituted or unsubstituted heteroaryl,
`substituted or unsubstituted heterocycle; or
`L3, X and L4 taken together form a
`nitrogen containing heterocyclic ring; G is
`tY1.3'.,,,
`,,.l,,cc,,,, ,;)()\,. ·YI,,,)~,,.
`
`'
`
`,-.;_,
`
`f::~
`
`. '.;)-
`
`-',;
`
`wherein, R6 , R7 and Rs are independently
`selected from H, halogen, CN, OH,
`substituted or unsubstituted alkyl or
`substituted or unsubstituted heteroalkyl or
`substituted or unsubstituted cycloalkyl,
`substituted or unsubstituted
`heterocycloalkyl, substituted or
`unsubstituted aryl, and substituted or
`unsubstituted heteroaryl; each R9 is
`independently selected from H, substituted
`or unsubstituted lower alkyl, and
`substituted or unsubstituted lower
`cycloalkyl; each R10 is independently H,
`substituted or unsubstituted lower alkyl, or
`substituted or unsubstituted lower
`cycloalkyl; or two R10 groups can together
`form a 5-, 6-, 7-, or 8-membered
`heterocyclic ring; or R10 and Rn can
`together form a 5-, 6-, 7-, or 8-membered
`heterocyclic ring; or each Rn is
`independently selected from H and
`substituted or unsubstituted alkyl; or
`a pharmaceutically acceptable salt thereof,
`thereby treating the cGVHD in the patient.
`2. The method of claim 1, wherein L3, X
`and L4 taken together form a nitrogen
`containin heteroc die rin .
`3. The method of claim 2, wherein the
`nitrogen containing heterocyclic ring is a
`i eridine rou .
`4. The method of claim 1, wherein G is
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 7
`
`6. The method of claim 1, wherein the
`compound of Formula (A) is l-[(3R)-3-[ 4-
`amino-3-( 4-phenoxyphenyl)-pyrazolo[3,4-
`d]pyrimidin- l -yl)piperidin- l -yl)prop-2-en-
`1-one.
`
`5. The method of claim 1, wherein the
`compound of Formula (A) is (R)-1-(3-( 4-
`amino-3-( 4-phenoxyphenyl)-1H(cid:173)
`pyrazolo[3,4-d]pyrimidin-l-yl)piperidin-l(cid:173)
`yl)prop-2-en-l-one (ibrutinib)
`
`15. The method of claim 1, wherein the
`compound of Formula (A) is administered at
`a dosage of between about 0.1 mg/kg per
`day to about 100 mg/kg per day.
`16. The method of claim 1, wherein the
`amount of the compound of Formula (A)
`administered is about 40 mg/day, about 140
`mg/day, about 280 mg/day, about 420
`mg/day, about 560 mg/clay, or about 840
`mg/day.
`18. The method of claim 1, wherein the
`compound of Formula (A) is administered
`orally.
`
`16. The method of claim 1, wherein the
`compound of Formula (A) is administered
`at a dosage of between about 0.1 mg/kg
`per day to about 100 mg/kg per day.
`17. The method of claim 1, wherein the
`amount of the compound of Formula (A)
`administered is about 40 mg/day, about
`140 mg/day, about 280 mg/day, about 420
`mg/day, about 560 mg/clay, or about 840
`mg/day.
`19. The method of claim 1, wherein the
`compound of Formula (A) is administered
`orally.
`
`That is the method of the instant application is generic to the method of Blazar et al. or in
`
`other word claims 1, 3-6, 15, 16, and 18 are anticipated by claims 1-5, 16, 17, and 19 of
`
`copending Application No. 14/558,297 (US Patent Application Publication US 2015/0157634
`
`Al).
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 8
`
`Consequently, the examined claims would be obvious over the claims of copending
`
`Application No. 14/558,297 (US Patent Application Publication US 2015/0157634 Al).
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`Response to Arguments
`
`11.
`
`Applicant's arguments directed to the above nonstatutory obviousness-type double
`
`patenting rejection for claims 1, 3-6, 12, and 15-18 were considered but they are not persuasive
`
`for the following reasons. Please note that the above rejection has been modified from its
`
`original version to more clearly address applicant's newly amended and/or added claims and/or
`
`arguments.
`
`[l] Applicant contends that the nonstatutory obviousness-type double patenting rejection
`
`for claims 1, 3-6, 12, and 15-18 should be withdrawn. Because "Blazar was filed on December
`
`2, 2014. The instant application was filed on October 24, 2014. So, because the instant
`
`application has an earlier filing date, it is the "earlier-filed" application. Importantly:
`
`If a ''provisional" nonstatutory double patenting rejection is the only
`rejection remaining in an application having the earliest effective U.S.
`filing date (including any benefit claimed under 35 U.S.C. 120, 121, 365( c),
`or 386( c)) compared to the reference application( s), the examiner should
`withdraw the rejection in the application having the earliest effective U.S.
`filing date and permit that application to issue as a patent, thereby
`converting the ''provisional" nonstatutory double patenting rejection in the
`other application( s) into a nonstatutory double patenting rejection when the
`application with the earliest U.S. effective filing date issues as a patent.
`MPEP 804(I)(B)(l).
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 9
`
`Therefore, because Applicant believes that the other pending rejections are overcome by
`
`this Amendment, Applicant respectfully requests withdrawal of the rejections based on
`
`obviousness- type double patenting in view of Blazar".
`
`This is not found persuasive for the following reasons:
`
`[l] The examiner respectfully disagrees. It is the examiner's position that since this the
`
`nonstatutory obviousness-type double patenting rejection is not the only rejection remaining it
`
`would be maintained.
`
`Therefore, the examined claims would be obvious over the claims of copending Application
`
`No. 14/558,297 (US Patent Application Publication US 2015/0157634 Al), and the rejection is
`
`maintained.
`
`New Rejection(s) - Necessitated by Amendment
`
`Double Patenting
`
`12.
`
`The nonstatutory 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., 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 Langi, 759 F.2d 887,225 USPQ 645 (Fed. Cir. 1985); In re Van
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 10
`
`Ornum, 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 terminal disclaimer in compliance with 37 CPR l.32l(c) or l.32l(d) may
`
`be used to overcome an actual or provisional rejection based on a nonstatutory 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 disclaimer must be signed in compliance with 37 CPR
`
`l.32l(b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be used.
`
`Please visit http://www.uspto.gov/fom1s/. The filing date of the application will determine what
`
`form should be used. A web-based eTerminal Disclaimer may be filled out completely online
`
`using web-screens. An eTerminal 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.
`
`13.
`
`Claims 21 and 25 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 21 and 22 of 14/558,297 (Based on the amendment
`
`filed on 08/22/2016; hereinafter refers to as Blazar et al.). Although the conflicting claims are
`
`not identical, they are not patentably distinct from each other because both the method of the
`
`instant claims 21 and 25, and the method of claims 21 and 22 of Blazar et al. has similar method
`
`step and the compound used by these methods has similar structural features.
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 11
`
`14/523,650
`21. A rnethod of treating chronic graft
`versus host disease (GVHD; comprising
`adrn]njstering to a patient having
`chronic GVHD a therapeutically
`effeClive arnoum of a compound of lhe
`
`15/558,297
`21. A rnethod of treating al loanU body
`driven chronic graft versus host
`disease (ClVHD) in a patient in need
`thereof, comprising adrniniste1ing to
`the patiem a therapeutically effective
`amount of a compound of the
`
`structure:
`pharmaceutically acceplable salt
`thereof.
`
`25, The method of claim 21, wherein
`the therapeutically efieclive mnounl of
`the compound is about 40 mg/day,
`about 140 mg/day, about 280 mg/day,
`about 420 mg/day, about 560 rng/day,
`or about 840 mg/dav,
`
`;,
`
`, or a
`structure:
`phannaceulically acceptable sall
`thereof.
`22, The method of claim 21, wherein
`the therapeutically dfoclive mnounl of
`the compound is about 40 mg/day,
`about 140 mg/day, about 280 mg/day,
`about 420 mg/day, about 560 rng/day,
`or about 840 mg/dav,
`
`That is the method of the instant application is generic to the method of Blazar et al. or in
`
`other word claims 21 and 25 are anticipated by claims 21 and 22 of copending Application No.
`
`15/558,297.
`
`Consequently, the examined claims would be obvious over the claims of copending
`
`Application No. 15/558,297.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 12
`
`14.
`
`Claims 1, 3-6, 15, 16, and 18 are provisionally rejected on the ground of nonstatutory
`
`double patenting as being unpatentable over claims 1, 48, and 49 of copending Application No.
`
`15/060,010 (Based on the amendment filed on 05/18/2016; hereinafter refers to as Blazar et al.).
`
`Although the conflicting claims are not identical, they are not patentably distinct from each other
`
`because both the compound used by the method of the instant claims 1, 3-6, 15, 16, and 18, and
`
`the compound of claims 1, 48, and 49 of Blazar et al. has similar structural features.
`
`14/523,650
`1. A method of treating graft versus host
`disease (GVHD) or reducing the severity of
`GVHD occurrence in a patient having
`chronic GVHD, comprising administering to
`the patient a therapeutically effective
`amount of a compound of Formula (A)
`
`15/060,010
`1. A high-load solid tablet formulation
`
`comprising ibrutinib and one or more
`
`pharmaceutically acceptable excipients,
`
`wherein ibrutinib is a compound with the
`
`structure of Compound 1,
`
`i-,,m,,,,, ',\i; wherein: A is
`having the structure:
`N; R1 is phenyl-0-phenyl or phenyl-S(cid:173)
`phenyl; R2 and R3 are independently H; Ri is
`L3-X-L4-G, wherein, L3 is optional, and
`when present is a bond, optionally
`substituted or unsubstituted alkyl, optionally
`substituted or unsubstituted cycloalkyl,
`optionally substituted or unsubstituted
`alkenyl, optionally substituted or
`unsubstituted alkynyl; X is optional, and
`when present is a bond, -0-, -C(=O)-, -S-, -
`S(=O)-, -S(=Oh-, -NH-, -NR9-, -NHC(O)-, -
`C(O)NH-, -NR9C(O)-, -C(O)NR9-, -
`S(=OhNH-, -NHS(=Oh-, -S(=OhNR9-, -
`NR9S(=Oh-, -OC(O)NH-, -NHC(O)O-, -
`OC(O)NR9-, -NR9C(O)O-, -CH=NO-, -
`ON=CH-, -NR10C(O)N R10-, heteroaryl-,
`aryl-, -N R10C(=NRll)N R10-, -N
`R10C(=NRll)-, -C(=NRll)NR10-, -
`
`

`

`Page 13
`
`and wherein the
`
`high-load solid tablet formulation
`
`comprises at least 50% w/w of ibrutinib.
`
`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`OC(=NRn)-, or -C(=NRn)O-; L4 is
`optional, and when present is a bond,
`substituted or unsubstituted alkyl,
`substituted or unsubstituted cycloalkyl,
`substituted or unsubstituted alkenyl,
`substituted or unsubstituted
`alkynyl, substituted or unsubstituted aryl,
`substituted or unsubstituted heteroaryl,
`substituted or unsubstituted heterocycle; or
`L3, X and L4 taken together form a nitrogen
`containing heterocyclic ring; G is
`
`, wherein, R6, R7 and R8 are independently
`selected from among H, halogen, CN, OH,
`substituted or unsubstituted alkyl or
`substituted or unsubstituted heteroalkyl or
`substituted or unsubstituted cycloalkyl,
`substituted or unsubstituted
`heterocycloalkyl, substituted or
`unsubstituted aryl, substituted or
`unsubstituted heteroaryl; each R9 is
`independently selected from among H,
`substituted or unsubstituted lower alkyl, and
`substituted or unsubstituted lower
`cycloalkyl; each R 10 is independently H,
`substituted or unsubstituted lower alkyl, or
`substituted or unsubstituted lower
`cycloalkyl; or two R10 groups can together
`form a 5-, 6-, 7-, or 8-membered
`heterocyclic ring; or R10 and Rn can
`together form a 5-, 6-, 7-, or 8-membered
`heterocyclic ring; or each Rn is
`independently selected from H or substituted
`or unsubstituted alkyl; or a pharmaceutically
`acceptable salt thereof, thereby treating graft
`versus host disease (GVHD) or reducing the
`severit of GVHD occurrence in the atient.
`3. The method of claim 1, wherein L3, X and
`L4 taken together form a nitrogen containing
`heteroc die rin .
`4. The method of claim 2, wherein the
`nitrogen containing heterocyclic ring is a
`i eridine rou .
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`5. The method of claim 1, wherein G is
`
`Page 14
`
`6. The method of claim 1, wherein the
`compound of Formula (A) is l-[(3R)-3-[ 4-
`amino-3-( 4-phenoxyphenyl)-pyrazolo[3,4-
`d]pyrimidin- l -yl)piperidin- l -yl)prop-2-en-
`1-one.
`15. The method of claim 1, wherein the
`compound of Formula (A) is administered at
`a dosage of between about 0.1 mg/kg per
`of claim 1, wherein ibrutinib is in an
`day to about 100 mg/kg per day.
`1 - -~ - - - - -~~~ -~ - - - - - - - - - - i
`16. The method of claim 1, wherein the
`amount of the compound of Formula (A)
`administered is about 40 mg/day, about 140
`mg/day, about 280 mg/day, about 420
`mg/day, about 560 mg/clay, or about 840
`mg/day.
`18. The method of claim 1, wherein the
`
`48. The high-load solid tablet formulation
`
`amount of about 420 or about 560 mg.
`
`compound of Formula (A) is administered
`
`orally.
`
`49. The high-load solid tablet formulation
`of claim 1, wherein the high-load solid
`tablet formulation is used for one tablet
`once a day dosing.
`
`That is the compound used by method of the instant application is generic to the
`
`compound of Blazar et al. or in other word claims 1, 3-6, 15, 16, and 18 are anticipated by claims
`
`1, 48, and 49 of copending Application No. 15/060,010.
`
`Consequently, the examined claims would be obvious over the claims of copending
`
`Application No. 15/060,010.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 15
`
`13.
`
`Claims 21 and 25 are provisionally rejected on the ground of nonstatutory double
`
`patenting as being unpatentable over claims 1 and 48 of copending Application No. 15/060,010
`
`(Based on the amendment filed on 05/18/2016; hereinafter refers to as Blazar et al.). Although
`
`the conflicting claims are not identical, they are not patentably distinct from each other because
`
`both the compound used by the method of the instant claims 21 and 25, and the compound of
`
`claims 1 and 48 of Blazar et al. has similar structural features.
`
`14/523,650
`21. A rnethod of treating chronic graft
`
`versus host disease (GVHD) comprising
`
`adrninistering lO a pat1em having
`
`chronic GV HD a therapeutically
`
`effeClive arnoum of a compound of lhe
`
`structure:
`
`or a
`
`pharmaceutically acceplable salt
`
`thereof.
`
`25, The method of claim 21, 'Nhereln
`the therapeutically effective amount of
`the compound is about 40 mg/day,
`about 140 rngiday, about 280 mg/day,
`about 420 mg/day, about 560 mg/day,
`or about 840 mg/day.
`
`15/060,010
`1. A high-load solid tablet formulation
`comprising ibrutinib and one or more
`pharmaceutically acceptable
`excipients, wherein ibrutinib is a
`compound with the structure of
`r"'''""(cid:173)
`,y··\-. ii
`-..:.: .... -~ ....
`i "1
`1sH•, ',;:;;..I
`,t' !
`~.~·
`-·~'<'-··'"'\':,
`.J
`l:
`.N
`.,t.❖"''·\,
`/"""
`/" \
`\...,.,...N-{
`,G,
`
`~-
`.......... 1',
`
`Con,i)<xaid l:
`
`and
`Compound 1,
`wherein the high-load solid tablet
`formulation comprises at least 50%
`w/w of ibrutinib.
`
`48. The high-load solid tablet
`
`formulation of claim 1, wherein
`
`ibrutinib is in an amount of about 420
`
`or about 560 mg.
`
`

`

`Application/Control Number: 14/523,650
`Art Unit: 1629
`
`Page 16
`
`That is the compound used by method of the instant application is generic to the
`
`compound of Blazar et al. or in other word claims 21 and 25 are anticipated by claims 1 and 48
`
`of copending Application No. 15/060,010.
`
`Consequently, the examined claims would be obvious over the claims of copending
`
`Application No. 15/060,010.
`
`This is a provisional obviousness-type double patenting rejection because the conflicting
`
`claims have not in fact been patented.
`
`Allowable Subject Matter
`
`14.
`
`Claims 7-11 and 22-24 are objected to as being dependent upon a rejected base claim, but
`
`would be allowable if rewritten in independent form including all of the limitations of the base
`
`claim and any intervening claims.
`
`Conclusion
`
`15.
`
`Applicant's amendment necessitated the new ground(s) ofrejection presented in this
`
`Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
`
`Applicant is reminded of the extension of time policy as set forth in 37 CPR 1.136( a).
`
`A shortened statutory period for reply to this final action is set to expire THREE
`