`(PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Patent Application of:
`John C. Byrd, efal.
`
`Application No.: 14/523,650
`
`Confirmation No.: 1095
`
`Filed: October 24, 2014
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`Art Unit: 1629
`
`For: METHODS OF TREATING AND
`PREVENTING GRAFT VERSUS HOST
`DISEASE
`
`Examiner: TRAN, My Chau T.
`
`AMENDMENT AND RESPONSE TO FINAL OFFICE ACTION
`
`DearSir:
`
`In response to the pending Final Office Action, dated November3, 2016, in connection with
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`the above-referenced application, Applicant submits this Amendment and Response. Please amend
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`the application as follows.
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`Amendments to the Claims begin on page2.
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`Remarksbegin on page 8.
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`B4628250.5
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`SAN EX 1028, Page 01
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`SAN EX 1028, Page 01
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`Application No. 14/523,650
`Amendment and Response
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`IN THE CLAIMS:
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`1-20. (Canceled)
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`2
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`Docket No.: PIR-88501
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`21.
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`(Currently Amended) A methodoftreating chronic graft versus host disease
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`(GVHD)comprising administering to a patient having chronic GVHDatherapeutically effective
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`amount of a compoundofthe structure:
`
`NH.
`
`N7 S\
`LL Z
`NZ
`
`TN
`
`0
`
`2
`
`
`
`
`
`era-pharmaceuticallyacceptablesaltthereof
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`thereby treating the chronic GVHD in the patient.
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`22.
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`(Previously Presented) The method of claim 21, wherein the patient has classic
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`chronic GVHD.
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`23.
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`(Previously Presented) The method of claim 21, wherein the patient has overlap
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`chronic GVHD.
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`24.
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`(Previously Presented) The method of claim 21, wherein the patient has steroid-
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`dependent/refractory chronic GVHD.
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`25.
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`(Previously Presented) The methodof claim 21, wherein the therapeutically effective
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`amount of the compoundis about 40 mg/day, about 140 mg/day, about 280 mg/day, about
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`420 mg/day, about 560 mg/day, or about 840 mg/day.
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`B4628250.5
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`SAN EX 1028, Page 02
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`Application No. 14/523,650
`Amendment and Response
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`3
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`Docket No.: PIR-88501
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`26.
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`(New) The method of claim 21, wherein, following administration of the compound,
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`the patient achieves partial response (PR), wherein the PR is an objective response in one involved
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`organ in the patient with no evidence of progression elsewhere and no requirements for additional
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`systemic therapy.
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`27.
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`(New) The method of claim 21, wherein, following administration of the compound,
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`the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms
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`attributable to GVHD.
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`28.
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`(New) The method of claim 21, wherein, following administration of the compound,
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`the severity of the GVHD is reduced.
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`29.
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`(New) The method of claim 21, wherein the patient has chronic lymphocytic
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`leukemia (CLL).
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`30.|(New) The method of claim 21, wherein the patient had a hematopoietic cell
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`transplantation.
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`31.
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`(New) The method of claim 21, wherein the chronic GVHDis sclerodermatous
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`GVHD,steroid resistant GVHD,cyclosporin-resistant GVHD,refractory GVHD, oral GVHD,
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`reticular oral GVHD,erosive GVHD,or ulcerative oral GVHD.
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`32.|(New) The method of claim 21, wherein the chronic GVHDis sclerodermatous
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`GVHD.
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`33.|(New) The method of claim 21, wherein the chronic GVHDis steroid resistant
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`GVHD.
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`GVHD.
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`34.
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`(New) The method of claim 21, wherein the chronic GVHDis cyclosporin-resistant
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`(New) The method of claim 21, wherein the chronic GVHDis refractory GVHD.
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`(New) The method of claim 21, wherein the chronic GVHDis oral GVHD.
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`(New) The method of claim 21, wherein the chronic GVHDis reticular oral GVHD.
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`(New) The method of claim 21, wherein the chronic GVHDis erosive GVHD.
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`35.
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`36.
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`37.
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`38.
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`SAN EX 1028, Page 03
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`Application No. 14/523,650
`Amendment and Response
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`4
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`Docket No.: PIR-88501
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`39.
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`(New) The method of claim 21, wherein the chronic GVHDis ulcerative oral
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`GVHD.
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`AO.
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`(New) The method of claim 21, wherein about 420 mg/day of the compoundis
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`administered.
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`41.
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`(New) The method of claim 21, wherein about 420 mg of the compoundis
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`administered once per day.
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`42.
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`43.
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`(New) The method of claim 21, wherein the compoundis administered orally.
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`(New) The method of claim 21, wherein about 420 mg/day of the compoundis
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`administeredorally.
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`44.
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`(New) The method of claim 21, wherein about 420 mg of the compoundis
`
`administered orally once per day.
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`45.
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`(New) The method of claim 24, wherein about 420 mg/day of the compoundis
`
`administered.
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`46.
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`(New) The method of claim 24, wherein about 420 mg of the compoundis
`
`administered once per day.
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`47.
`
`(New) The method of claim 24, wherein about 420 mg/day of the compoundis
`
`administeredorally.
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`48.
`
`(New) The method of claim 24, wherein about 420 mg of the compoundis
`
`administered orally once per day.
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`49.
`
`(New) The method of claim 24, wherein, following administration of the compound,
`
`the patient achieves partial response (PR), wherein the PR is an objective response in one involved
`
`organ in the patient with no evidence of progression elsewhere and no requirements for additional
`
`systemic therapy.
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`50.
`
`(New) The methodof claim 24, wherein, following administration of the compound,
`
`the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms
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`attributable to GVHD.
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`SAN EX 1028, Page 04
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`Application No. 14/523,650
`Amendment and Response
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`5
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`Docket No.: PIR-88501
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`51.
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`(New) The method of claim 24, wherein, following administration of the compound,
`
`the severity of the GVHD 1s reduced.
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`52.
`
`(New) The method of claim 26, wherein about 420 mg/day of the compoundis
`
`administered.
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`53.
`
`(New) The method of claim 26, wherein about 420 mg of the compoundis
`
`administered once per day.
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`54.
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`(New) The method of claim 26, wherein about 420 mg/day of the compoundis
`
`administeredorally.
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`55.
`
`(New) The method of claim 26, wherein about 420 mg of the compoundis
`
`administered orally once per day.
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`56.
`
`(New) The method of claim 27, wherein about 420 mg/day of the compoundis
`
`administered.
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`57.
`
`(New) The method of claim 27, wherein about 420 mg of the compoundis
`
`administered once per day.
`
`58.
`
`(New) The method of claim 27, wherein about 420 mg/day of the compoundis
`
`administeredorally.
`
`59.
`
`(New) The method of claim 27, wherein about 420 mg of the compoundis
`
`administered orally once per day.
`
`60.
`
`(New) The method of claim 33, wherein about 420 mg/day of the compoundis
`
`administered.
`
`61.
`
`(New) The method of claim 33, wherein about 420 mg of the compoundis
`
`administered once per day.
`
`62.
`
`(New) The method of claim 33, wherein about 420 mg/day of the compoundis
`
`administeredorally.
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`63.
`
`(New) The method of claim 33, wherein about 420 mg of the compoundis
`
`administered orally once per day.
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`SAN EX 1028, Page 05
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`Application No. 14/523,650
`Amendment and Response
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`6
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`Docket No.: PIR-88501
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`64.
`
`(New) The methodof claim 33, wherein, following administration of the compound,
`
`the patient achieves partial response (PR), wherein the PR is an objective response in one involved
`
`organ in the patient with no evidence of progression elsewhere and no requirements for additional
`
`systemic therapy.
`
`65.
`
`(New) The method of claim 33, wherein, following administration of the compound,
`
`the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms
`
`attributable to GVHD.
`
`66.
`
`(New) The method of claim 33, wherein, following administration of the compound,
`
`the severity of the GVHD is reduced.
`
`67.
`
`(New) The method of claim 35, wherein about 420 mg/day of the compoundis
`
`administered.
`
`68.|(New) The method of claim 35, wherein about 420 mg of the compoundis
`
`administered once per day.
`
`69.
`
`(New) The method of claim 35, wherein about 420 mg/day of the compoundis
`
`administeredorally.
`
`70.
`
`(New) The method of claim 35, wherein about 420 mg of the compoundis
`
`administered orally once per day.
`
`71.
`
`(New) The method of claim 35, wherein, following administration of the compound,
`
`the patient achieves partial response (PR), wherein the PR is an objective response in one involved
`
`organ in the patient with no evidence of progression elsewhere and no requirements for additional
`
`systemic therapy.
`
`72.
`
`(New) The method of claim 35, wherein, following administration of the compound,
`
`the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms
`
`attributable to GVHD.
`
`73.
`
`(New) The method of claim 35, wherein, following administration of the compound,
`
`the severity of the GVHD is reduced.
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`B4628250.5
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`SAN EX 1028, Page 06
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`SAN EX 1028, Page 06
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`Application No. 14/523,650
`Amendment and Response
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`7
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`Docket No.: PIR-88501
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`74.
`
`(New) A method oftreating chronic graft versus host disease (GVHD) comprising
`
`administering to a patient having chronic GVHD from 140 mg/day to 840 mg/day of a compound of
`
`the structure:
`
`O
`
`NH,
`
`N7 Sw
`
`\
`
`(>
`
`One
`
`75.
`
`(New) A method oftreating chronic graft versus host disease (GVHD) comprising
`
`administering to a patient having chronic GVHD about 420 mg/day of a compoundofthe structure:
`
`B4628250.5
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`SAN EX 1028, Page 07
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`SAN EX 1028, Page 07
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`Application No. 14/523,650
`Amendment and Response
`
`8
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`Docket No.: PIR-88501
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`Remarks
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`Claims 1, 3-11, 15, 16, and 18-25 were pending, of which claims 19 and 20 were withdrawn.
`
`By this Amendment, claims 1, 3-11, 15, 16, and 18-20 have been canceled without prejudice, claim
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`21 has been amended, and new claims 26-75 have been added. Support for the claim amendments
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`and new claims may be found throughout the specification and claims as originally filed. No new
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`matter has been added.
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`For example, support for new claims 26, 27, 49, 50, 64, 65, 71, and 72 may be foundatleast
`
`in paragraphs [00247] and [00248] of the specification as originally filed.
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`Support for new claims 29 and 30 may be found in previous claims 10 and 11, which have
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`been canceled.
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`Claims 31-39 are based on previous claims 7-9, which have been canceled.
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`Amendmentor cancellation of claims should in no way be construed as an acquiescence to a
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`rejection, or surrender of any subject matter. Applicant reserves the option to prosecute the
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`originally filed claims, or similar ones, in the instant or subsequently filed patent applications.
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`Interview Summary
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`Applicant
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`thanks the Examiner for extending the courtesy of an Examiner Interview
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`conducted on December 8, 2016,
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`in order to discuss the outstanding rejections of record. As
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`discussed, the only remaining rejections in this case are provisional nonstatutory double patenting
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`rejections overlater-filed applications.
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`Response to Claim Objections
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`The Office objects to claims 7-11 and 22-24 because they depend from a rejected base
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`claim. Furthermore, Applicant thanks the Examiner for her indication that the subject matter of
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`claims 7-11 and 22-24 would be allowable if rewritten in independent form. In response, Applicant
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`requests that the Examiner consider the arguments submitted herewith as they are believed to
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`overcomeall of the pending rejections. Incidentally, while claims 7-11 have been canceled, new
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`claims 29-39 recite the features of previous claims 7-11.
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`Application No. 14/523,650
`Amendment and Response
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`9
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`Docket No.: PIR-88501
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`Response to Rejections based on the Judicially Created Doctrine of
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`Obviousness-Type Double Patenting
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`Claims 1, 3-6, 15, 16, 18, 21, and 25 stand rejected on the grounds of nonstatutory
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`obviousness-type double patenting as allegedly being unpatentable over claims 1-5, 16, 17, 19, 21,
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`and 22 of U.S. Patent Appl. No. 14/558,297 (Blazar) filed on December2, 2014.
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`Claims 1, 3-6, 15, 16, 18, 21, and 25 stand rejected on the grounds of nonstatutory
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`obviousness-type double patenting as allegedly being unpatentable over claims 1, 48, and 49 of US.
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`Patent Appl. No. 15/060,010 (Chong) filed on March 3, 2016.
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`MPEP § 804(1)(B)(1) states “If a ‘provisional’ nonstatutory obviousness-type double
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`patenting (ODP) rejection is the only rejection remaining in the earlier filed of the two pending
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`applications, while the later-filed application is rejectable on other grounds, the examiner should
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`withdraw that rejection and permit the earlier-filed application to issue as a patent without a
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`terminal disclaimer.” Importantly, the MPEP furtherclarifies the meaning of “earlier-filed”: “Where
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`at least one of the two applications is entitled to the benefit of a U.S. nonprovisional application
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`under 35 U.S.C. 120, 121, or 365(c), the "earlier-filed" application is the one having the earliest date
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`to which it is entitled benefit under 35 U.S.C. 120, 121, and/or 365(c).” (MPEP 1490(VI)(D)).
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`By these terms, the subject application is the earlier-filed application with respect to both
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`Blazar and Chong. Since this provisional obviousness-type double patenting (ODP) rejection is the
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`only remaining rejection in this application, Applicants request that the ODP rejection should be
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`withdrawn, and the subject application should be passed to allowance.
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`Application No. 14/523,650
`Amendment and Response
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`10
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`Docket No.: PIR-88501
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`Conclusion
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`The Applicant believes that the fees due in connection with thefiling of this paper have been
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`paid. Nevertheless, the Director is hereby authorized to charge any and all required fees to our
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`Deposit Account No. 06-1448, reference PIR-885.01. If a telephone conversation with Applicant’s
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`Attorney would expedite prosecution of the application,
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`the Examiner is urged to contact the
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`undersigned.
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`Dated: April 27, 2017
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`Respectfully submitted,
`
`By: /Hathaway P. Russell]
`Hathaway P. Russell
`Registration No.: 46,488
`FOLEY HOAG LLP
`155 Seaport Blvd
`Boston, Massachusetts 02210
`(617) 832-1000
`Attorney For Applicant
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`Electronic Patent Application Fee Transmittal
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`Title of Invention:
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`METHODSOF TREATING AND PREVENTING GRAFT VERSUS HOST DISEASE
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`First Named Inventor/Applicant Name:
`
`John C. BYRD
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`Attorney Docket Number:
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`PIR-88501
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`Filed as Large Entity
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`Filing Fees for Utility under 35 USC 111(a)
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`Description
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`Fee Code
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`Sub-Total in
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`USD(S)
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`Quantity
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`1202 pasfm 2800
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`Basic Filing:
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`CLAIMS IN EXCESS OF 20
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`Miscellaneous-Filing:
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`Patent-Appeals-and-Interference:
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`Post-Allowance-and-Post-Issuance:
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`SAN EX 1028, Page 011
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`SAN EX 1028, Page 011
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`Extension-of-Time:
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`1253
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`1400
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`1400
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`Total in USD ($)
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`Extension - 3 months with $0 paid
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`Miscellaneous:
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`SAN EX 1028, Page 012
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`SAN EX 1028, Page 012
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`Title of Invention:
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`METHODSOF TREATING AND PREVENTING GRAFT VERSUS HOST DISEASE
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`Electronic AcknowledgementReceipt
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`Application Number:
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`14523650
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`International Application Number:
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`Confirmation Number:
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`1095
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`en
`a
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`Paymentinformation:
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`SAN EX 1028. Page 013
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`061448
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`Hathaway Russell
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`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpaymentas follows:
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`37 CFR 1.16 (National application filing, search, and examination fees)
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`37 CFR 1.17 (Patent application and reexamination processing fees)
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`SAN EX 1028, Page 013
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`37 CFR 1.19 (Document supply fees)
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`37 CFR 1.20 (Post Issuance fees)
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`37 CFR 1.21 (Miscellaneous fees and charges)
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`134737
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`PIR_88501_Response_to_Final
`_OA_dated_03nov16_.pdf
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`7Sfoaefed82ff5b15 1aaSac34ead4a460273
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`fee-info.pdf
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