IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Docket No.: PIR-88501
`
`(PATENT)
`
`In re Patent Application of:
`John C. Byrd, er a].
`
`Application No.: 14/523,650
`
`Confirmation No.: 1095
`
`Filed: October 24, 2014
`
`Art Unit: 1629
`
`For: METHODS OF TREATING AND
`PREVENTING GRAF T VERSUS HOST
`
`Examiner: TRAN, My Chau T.
`
`DISEASE
`
`AMENDMENT AND RESPONSE TO FINAL OFFICE ACTION
`
`Dear Sir:
`
`In response to the pending Final Office Action, dated November 3, 2016, in connection with
`
`the above-referenced application, Applicant submits this Amendment and Response. Please amend
`
`the application as follows.
`
`Amendments to the Claims begin on page 2.
`
`Remarks begin on page 8.
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`B4628250.5
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`SAN EX 1028, Page 01
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`

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`Application No. 14/523,650
`Amendment and Response
`
`IN THE CLAIMS:
`
`1-20. (Canceled)
`
`2
`
`Docket No.: FIR-88501
`
`21.
`
`(Currently Amended) A method of treating chronic graft versus host disease
`
`(GVHD) comprising administering to a patient having chronic GVHD a therapeutically effective
`
`amount of a compound of the structure:
`
`NH2
`
`N \ \
`K /
`’N
`N
`
`N
`
`N?
`
`O
`
`7
`
`eFa—pharmaeeu-tiealliyLaeeepmble—sal-t—thereef
`
`thereb treatin the chronic GVHD in the atient.
`
`
`22.
`
`(Previously Presented) The method of claim 21, wherein the patient has classic
`
`chronic GVHD.
`
`23.
`
`(Previously Presented) The method of claim 21, wherein the patient has overlap
`
`chronic GVHD.
`
`24.
`
`(Previously Presented) The method of claim 21, wherein the patient has steroid-
`
`dependent/refractory chronic GVHD.
`
`25.
`
`(Previously Presented) The method of claim 21, wherein the therapeutically effective
`
`amount of the compound is about 40 mg/day, about 140 mg/day, about 280 mg/day, about
`
`420 mg/day, about 560 mg/day, or about 840 mg/day.
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`B4628250.5
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`Application No. 14/523,650
`Amendment and Response
`
`3
`
`Docket No.: FIR-88501
`
`26.
`
`(New) The method of claim 21, 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.
`
`27.
`
`(New) The method of claim 21, wherein, following administration of the compound,
`
`the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms
`
`attributable to GVHD.
`
`28.
`
`(New) The method of claim 21, wherein, following administration of the compound,
`
`the severity of the GVHD is reduced.
`
`29.
`
`(New) The method of claim 21, wherein the patient has chronic lymphocytic
`
`leukemia (CLL).
`
`30.
`
`(New) The method of claim 21, wherein the patient had a hematopoietic cell
`
`transplantation.
`
`31.
`
`(New) The method of claim 21, wherein the chronic GVHD is sclerodermatous
`
`GVHD, steroid resistant GVHD, cyclosporin-resistant GVHD, refractory GVHD, oral GVHD,
`
`reticular oral GVHD, erosive GVHD, or ulcerative oral GVHD.
`
`32.
`
`(New) The method of claim 21, wherein the chronic GVHD is sclerodermatous
`
`GVHD.
`
`GVHD.
`
`GVHD.
`
`33.
`
`(New) The method of claim 21, wherein the chronic GVHD is steroid resistant
`
`34.
`
`(New) The method of claim 21, wherein the chronic GVHD is cyclosporin-resistant
`
`35.
`
`(New) The method of claim 21, wherein the chronic GVHD is refractory GVHD.
`
`36.
`
`(New) The method of claim 21, wherein the chronic GVHD is oral GVHD.
`
`37.
`
`(New) The method of claim 21, wherein the chronic GVHD is reticular oral GVHD.
`
`38.
`
`(New) The method of claim 21, wherein the chronic GVHD is erosive GVHD.
`
`B4628250.5
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`Application No. 14/523,650
`Amendment and Response
`
`4
`
`Docket No.: FIR-88501
`
`39.
`
`(New) The method of claim 21, wherein the chronic GVHD is ulcerative oral
`
`GVHD.
`
`40.
`
`(New) The method of claim 21, wherein about 420 mg/day of the compound is
`
`administered.
`
`41.
`
`(New) The method of claim 21, wherein about 420 mg of the compound is
`
`administered once per day.
`
`42.
`
`(New) The method of claim 21, wherein the compound is administered orally.
`
`43.
`
`(New) The method of claim 21, wherein about 420 mg/day of the compound is
`
`administered orally.
`
`44.
`
`(New) The method of claim 21, wherein about 420 mg of the compound is
`
`administered orally once per day.
`
`45.
`
`(New) The method of claim 24, wherein about 420 mg/day of the compound is
`
`administered.
`
`46.
`
`(New) The method of claim 24, wherein about 420 mg of the compound is
`
`administered once per day.
`
`47.
`
`(New) The method of claim 24, wherein about 420 mg/day of the compound is
`
`administered orally.
`
`48.
`
`(New) The method of claim 24, wherein about 420 mg of the compound is
`
`administered orally once per day.
`
`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.
`
`50.
`
`(New) The method of claim 24, wherein, following administration of the compound,
`
`the patient achieves complete response (CR), wherein the CR is a complete restoration of symptoms
`
`attributable to GVHD.
`
`B4628250.5
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`Application No. 14/523,650
`Amendment and Response
`
`5
`
`Docket No.: FIR-88501
`
`51.
`
`(New) The method of claim 24, wherein, following administration of the compound,
`
`the severity of the GVHD is reduced.
`
`52.
`
`(New) The method of claim 26, wherein about 420 mg/day of the compound is
`
`administered.
`
`53.
`
`(New) The method of claim 26, wherein about 420 mg of the compound is
`
`administered once per day.
`
`54.
`
`(New) The method of claim 26, wherein about 420 mg/day of the compound is
`
`administered orally.
`
`55.
`
`(New) The method of claim 26, wherein about 420 mg of the compound is
`
`administered orally once per day.
`
`56.
`
`(New) The method of claim 27, wherein about 420 mg/day of the compound is
`
`administered.
`
`57.
`
`(New) The method of claim 27, wherein about 420 mg of the compound is
`
`administered once per day.
`
`58.
`
`(New) The method of claim 27, wherein about 420 mg/day of the compound is
`
`administered orally.
`
`59.
`
`(New) The method of claim 27, wherein about 420 mg of the compound is
`
`administered orally once per day.
`
`60.
`
`(New) The method of claim 33, wherein about 420 mg/day of the compound is
`
`administered.
`
`61.
`
`(New) The method of claim 33, wherein about 420 mg of the compound is
`
`administered once per day.
`
`62.
`
`(New) The method of claim 33, wherein about 420 mg/day of the compound is
`
`administered orally.
`
`63.
`
`(New) The method of claim 33, wherein about 420 mg of the compound is
`
`administered orally once per day.
`
`B4628250.5
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`SAN EX 1028, Page 05
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`Application No. 14/523,650
`Amendment and Response
`
`6
`
`Docket No.: FIR-88501
`
`64.
`
`(New) The method of 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 compound is
`
`administered.
`
`68.
`
`(New) The method of claim 35, wherein about 420 mg of the compound is
`
`administered once per day.
`
`69.
`
`(New) The method of claim 35, wherein about 420 mg/day of the compound is
`
`administered orally.
`
`70.
`
`(New) The method of claim 35, wherein about 420 mg of the compound is
`
`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.
`
`B4628250.5
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`Application No. 14/523,650
`Amendment and Response
`
`7
`
`Docket No.: FIR-88501
`
`74.
`
`(New) A method of treating 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:
`
`co
`
`NH2
`
`N
`
`N k
`
`\ \
`/
`/N
`
`Nb
`
`“?
`
`O
`
`.
`
`75.
`
`(New) A method of treating chronic graft versus host disease (GVHD) comprising
`
`administering to a patient having chronic GVHD about 420 mg/day of a compound of the structure:
`
`B4628250.5
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`Application No. 14/523,650
`Amendment and Response
`
`8
`
`Docket No.: FIR-88501
`
`Remarks
`
`Claims 1, 3-11, 15, 16, and 18-25 were pending, ofwhich claims 19 and 20 were withdrawn.
`
`By this Amendment, claims 1, 3-11, 15, 16, and 18-20 have been canceled without prejudice, claim
`
`21 has been amended, and new claims 26-75 have been added. Support for the claim amendments
`
`and new claims may be found throughout the specification and claims as originally filed. No new
`
`matter has been added.
`
`For example, support for new claims 26, 27, 49, 50, 64, 65, 71, and 72 may be found at least
`
`in paragraphs [00247] and [00248] of the specification as originally filed.
`
`Support for new claims 29 and 30 may be found in previous claims 10 and 11, which have
`
`been canceled.
`
`Claims 31-39 are based on previous claims 7-9, which have been canceled.
`
`Amendment or cancellation of claims should in no way be construed as an acquiescence to a
`
`rejection, or surrender of any subject matter. Applicant reserves the option to prosecute the
`
`originally filed claims, or similar ones, in the instant or subsequently filed patent applications.
`
`Interview Summary
`
`Applicant
`
`thanks the Examiner for extending the courtesy of an Examiner Interview
`
`conducted on December 8, 2016,
`
`in order to discuss the outstanding rejections of record. As
`
`discussed, the only remaining rejections in this case are provisional nonstatutory double patenting
`
`rejections over later-filed applications.
`
`Response to Claim Objections
`
`The Office objects to claims 7-11 and 22-24 because they depend from a rejected base
`
`claim. Furthermore, Applicant thanks the Examiner for her indication that the subject matter of
`
`claims 7-11 and 22-24 would be allowable if rewritten in independent form. In response, Applicant
`
`requests that the Examiner consider the arguments submitted herewith as they are believed to
`
`overcome all of the pending rejections. Incidentally, while claims 7-11 have been canceled, new
`
`claims 29-39 recite the features of previous claims 7-1 1.
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`Application No. 14/523,650
`Amendment and Response
`
`9
`
`Docket No.: FIR-88501
`
`Response to Rejections based on the Judicially Created Doctrine of
`
`Obviousness-Type Double Patenting
`
`Claims 1, 3-6, 15, 16, 18, 21, and 25 stand rejected on the grounds of nonstatutory
`
`obviousness-type double patenting as allegedly being unpatentable over claims 1-5, 16, 17, 19, 21,
`
`and 22 of US. Patent Appl. No. 14/558,297 (Blazar) filed on December 2, 2014.
`
`Claims 1, 3-6, 15, 16, 18, 21, and 25 stand rejected on the grounds of nonstatutory
`
`obviousness-type double patenting as allegedly being unpatentable over claims 1, 48, and 49 of US.
`
`Patent Appl. No. 15/060,010 (Chong) filed on March 3, 2016.
`
`MPEP § 804(I)(B)(1) states “If a ‘provisional’ nonstatutory obviousness-type double
`
`patenting (ODP) rejection is the only rejection remaining in the earlier filed of the two pending
`
`applications, while the later-filed application is rejectable on other grounds, the examiner should
`
`withdraw that rejection and permit the earlier-filed application to issue as a patent without a
`
`terminal disclaimer.” Importantly, the MPEP further clarifies the meaning of “earlier-filed”: “Where
`
`at least one of the two applications is entitled to the benefit of a US. nonprovisional application
`
`under 35 U.S.C. 120, 121, or 365(c), the "earlier-filed" application is the one having the earliest date
`
`to which it is entitled benefit under 35 U.S.C. 120, 121, and/or 365(c).” (MPEP 1490(VI)(D)).
`
`By these terms, the subject application is the earlier-filed application with respect to both
`
`Blazar and Chong. Since this provisional obviousness-type double patenting (ODP) rejection is the
`
`only remaining rejection in this application, Applicants request that the ODP rejection should be
`
`withdrawn, and the subject application should be passed to allowance.
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`Application No. 14/523,650
`Amendment and Response
`
`10
`
`Docket No.: FIR-88501
`
`m
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`The Applicant believes that the fees due in connection with the filing of this paper have been
`
`paid. Nevertheless, the Director is hereby authorized to charge any and all required fees to our
`
`Deposit Account No. 06-1448, reference FIR-885.01. If a telephone conversation with Applicant’s
`
`Attorney would expedite prosecution of the application,
`
`the Examiner is urged to contact the
`
`undersigned.
`
`Dated: April 27, 2017
`
`Respectfully submitted,
`
`By: /Halhaway P. Russell/
`Hathaway P. Russell
`Registration No: 46,488
`FOLEY HOAG LLP
`
`155 Seaport Blvd
`Boston, Massachusetts 02210
`(617) 832-1000
`Attorney For Applicant
`
`B4628250.5
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`Electronic Patent Application Fee Transmittal
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`Title of Invention:
`
`METHODS OF TREATING AND PREVENTING GRAFT VERSUS HOST DISEASE
`
`
`
`First Named Inventor/Applicant Name:
`
`John C. BYRD
`
`Attorney Docket Number:
`
`PIR—88501
`
`Filed as Large Entity
`
`Filing Fees for Utility under 35 USC111(a)
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`USD($)
`
`Basic Filing:
`
`Pages:
`
`CLAIMSIN EXCESSOon
`
`1202 -n 2800
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`Miscellaneous-Filing:
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`Patent-Appeals-and-lnterference:
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`Post-Allowance-and-Post-lssuance:
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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
`
`1400
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`Extension — 3 months with $0 paid
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`Total in USD (S)
`
`Miscellaneous:
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`SAN EX 1028, Page 012
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`Electronic Acknowledgement Receipt
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`“—
`
`——
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`
`
`——
`——
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`Title of Invention:
`
`METHODS OF TREATING AND PREVENTING GRAFT VERSUS HOST DISEASE
`
`Payment information:
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`SAN EX 1028 Pae 013
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`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`37 CFR 1.16 (National application filing, search, and examination fees)
`
`37 CFR 1.17 (Patent application and reexamination processing fees)
`
`Deposit Account
`
`Authorized User
`
`061448
`
`Hathaway Russell
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`37 CFR 1.1 9 (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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`File Listing:
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`Document
`Number
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`Document Descri
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`tion
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`p
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`File Size(Bytes)/
`Message Digest
`1 34737
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`Pages
`Multi
`Part /.zip (if appl.)
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`1
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`P|R_88501_Response_to_Final
`_OA_dated_O3nov16_.pdf
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`75fbaefed82ff5b151aaSac34ead4a460273
`4588
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`Multipart Description/PDF files in .zip description
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`Information:
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`Amendment Copy Claims/Response to Suggested Claims
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`ApplicantArguments/RemarksMadeinanAmendment _-
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`Information:
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`Fee Worksheet (SBO6)
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`fee—info.pdf
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`52cec27ca1be888399e17849e0bdd678b93
`5807b
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`the application.
`
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