`
`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.
`
`
`
`
`CONFIRMATIONNO.
`
`
`12/986,310
`
`01/07/2011
`
`Nicholas S. Bodor
`
`20009904-0067
`
`6100
`
`DED
`
`TL
`
`DENTONS USTIP a
`
`mesons
`
`P.O. BOX 061080
`Chicago, IL 60606-1080
`
`LAU, JONATHAN §
`
`ART UNIT
`
`1673
`
`PAPER NUMBER
`
`
`
`
`
` NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/25/2014
`
`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):
`martin.bruehs @dentons.com
`patents.us@dentons.com
`
`PTOL-90A (Rev. 04/07)
`
`Page 1 of 14
`Page 1 of 14
`
`Merck 2047
`TWi v Merck
`
`IPR2023-00049
`
`Merck 2047
`TWi v Merck
`IPR2023-00049
`
`

`

`
`Application No.
`Applicant(s)
`
`Responseto Rule 312 Communication
`
`12/986,310
`-
`Examiner
`
`Jonathan S. Lau
`
`1673
`
`BODOR ET AL.
`:
`Art Unit
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address —
`
`1. K] The amendmentfiled on 12 June 2014 under 37 CFR 1.312 has been considered, and has been:
`
`a) entered.
`
`b) K] entered as directed to matters of form not affecting the scope ofthe invention.
`
`c) 1 disapproved because the amendmentwasfiled after the paymentof the issue fee.
`
`Any amendment filed after the date the issue fee is paid must be accompaniedbya petition under 37 CFR 1.313(c)(1)
`
`and the required fee to withdraw the application from issue.
`
`d)( disapproved. See explanation below.
`
`e)( entered in part. See explanation below.
`
`The specification is amended to omit that which is well-known to those skilled in the art. Therefore this amendment is
`directed to matters of form not affecting the scope of the invention.
`
`
`
`
`
`/SHAOJIA ANNA JIANG/
`Supervisory Patent Examiner, Art Unit 1673
`
`U.S. Patent and Trademark Office
`
`/Jonathan S Lau/
`Examiner, Art Unit 1673
`
`
`
`PTOL-271 (Rev. 04-01)
`
`Reponseto Rule 312 Communication
`
`Part of Paper No. 20140617
`
`Page 2 of 14
`Page 2 of 14
`
`

`

`PART B - FEE(S) TRANSMITTAL
`
`Complete and send this form, together with applicable fee(s), to: Mail Mail Stop ISSUE FEE
`Commissionerfor Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`or Fax (571)-273-2885
`
`through 5 should be completed where
`INSTRUCTIONS: This form should be used for transmitting the ISSUE FEE and PUBLICATION FEE(if required). Blocks 1
`appropriate. All further correspondence including the Patent, advance orders and notification of maintenance fees will be mailed to the current correspondence address as
`inrened unless corrected below or directed otherwise in Block 1, by (a) specifying a new correspondence address; and/or (b) indicating a separate "FEE ADDRESS"for
`maintenance fee notifications.
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`CURRENT CORRESPONDENCE ADDRESS(Note: Use Block 1 for any change of address)
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`7920
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`;
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`DoTeONS
`
`can only be used for domestic mailings of the
`Note: A certificate of mailing
`Fee(s) Transmittal. This certificate cannot be used for any other accompanying
`apers. Each additional paper, such as an assignment or formal drawing, must
`have its own certificate of mailing or transmission.
`Certificate of Mailing or Transmission
`I hereby certify that this Fee(s) Transmittal is being deposited with the United
`States Postal Service with sufficient postage for first class mail in an envelope
`addressed to the Mail Stop ISSUE FEE address above, or being facsimile
`transmitted to the USPTO (571) 273-2885, on the date indicated below.
`(Depositor's name)
`(Signature)
`
`(Date)
`
`APPLICATION NO.
`
`FILING DATE
`
`
`
`
`
` FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATION NO.
`
`01/07/2011
`12/986,310
`TITLE OF INVENTION: ORAL FORMULATIONS OF CLADRIBINE
`
`Nicholas $. Bodor
`
`20009904-0067
`
`6100
`
`
`
`
`
`
`
`APPLN. TYPE PUBLICATION FEE DUE|PREV. PAID ISSUE FEEENTITY STATUS ISSUE FEE DUE TOTAL FEE(S) DUE DATE DUE
`
`
`
`
`
`nonprovisional
`
`UNDISCOUNTED
`
`LAU, JONATHAN S
`
`$960
`
`1673
`
`1. Change of correspondenceaddress or indication of "Fee Address" (37
`CFR 1.363).
`LI Change of correspondence address (or Change of Correspondence
`Address form PTO/SB/122) attached.
`L] "Fee Address" indication (or "Fee Address” Indication form
`PTO/SB/47; Rev 03-02 or more recent) attached. Use of a Customer
`Numberis required.
`
`
`
`
`
`$0
`
`$0
`
`$960
`
`06/13/2014
`
`514-046000
`
`DENTONS US LLP
`:
`2. For printing on the patent front page,list
`(1) The namesofup to 3 registered patent attorneys
`or agents OR,alternatively,
`(2) The nameofa single firm (having as a member a
`2
`registered attorney or agent) and the namesof up to
`2 registered patent attorneys or agents. If no nameis
`listed, no namewillbe printed.
`
`
`
`43
`
`oe) . ASSIGNEE NAME AND RESIDENCE DATATO BE PRINTED ON THE PATENT(printor type)
`If an assignee is identified below, the document has been filed for
`PLEASE NOTE: Unless an assignee is identified below, no assignee data will appear on the patent.
`recordation as set forth in 37 CFR 3.11. Completion of this form is NOT a substitute for filing an assignment.
`(A) NAME OF ASSIGNEE
`(B) RESIDENCE:(CITY and STATE OR COUNTRY)
`
`ARES TRADING S.A.
`
`AUBONNE, SWITZERLAND
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`Please check the appropriate assignee category or categories (will not be printed on the patent) :
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`(I) individual yy Corporation or other private group entity (] Government
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`4b. Paymentof Fee(s): (Please first reapply any previously paid issue fee shown above)
`4a. The following fee(s) are submitted:
`(J A check is enclosed.
`KI Issue Fee
`x) Paymentby credit card. Form PTO-2038 is attached.
`_] Publication Fee (No small entity discount permitted)
`The Director is hereby authorized to charge the required fee(s), any deficiency, or credits any
`XI Advance Order - # of Copies
`4
`overpayment, to Deposit Account Number_1 9-3 40__(enclose an extra copyofthis form).
`5. Change in Entity Status (from status indicated above)
`| Applicantcertifying micro entity status. See 37 CFR 1.29
`
` Lj Applicant changing to regular undiscounted fee status.
`
`Lj Applicant asserting small entity status. See 37 CFR 1.27
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`
`NOTE:Absenta valid certification of Micro Entity Status (see forms PTO/SB/15A and 15B), issue
`fee paymentin the micro entity amountwill not be accepted at the risk of application abandonment.
`
`NOTE:If the application was previously under micro entity status, checking this box will be taken
`to be a notification ofloss of entitlement to micro entity status.
`NOTE: Checking this box will be taken to be a notification ofloss of entitlement to small or micro
`entity status, as applicable.
`
`NOTE: This form mustbe signed in accordance with 37 CFR 1.31 and 1.33. See 37 CFR 14 for signature requirements andcertifications.
`
`Authorized Signature
`
`
`/MARTIN A. BRUEHS/
`Date
`JUNE 13, 2014
`
`Typed or printed name MARTIN A. BRUEHS
`Registration No.
`45635
`
`PTOL-85 Part B (10-13) Approved for use through 10/31/2013.
`
`Page 2 of 3
`Page 3 of 14
`Page 3 of 14
`OMB 0651-0033
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Title of Invention:
`
`ORAL FORMULATIONS OF CLADRIBINE
`
`Utility under 35 USC 111(a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Sub-Total in
`USD(S$)
`
`a
`
`Extension-of-Time:
`
`Basic Filing:
`
`Miscellaneous-Filing:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Page 4 of 14
`
`

`

`Miscellaneous:
`
`Total in USD ($)
`
`Page 5 of 14
`Page 5 of 14
`
`

`

`Application Number:
`
`International Application Number:
`
`19296893
`
`12986310
`
`Confirmation Number:
`
`6100
`
`Title of Invention:
`
`Electronic AcknowledgementReceipt
`
`ORAL FORMULATIONS OF CLADRIBINE
`
`First Named Inventor/Applicant Name:
`
`Customer Number:
`
`Filer Authorized By:
`
`Attorney Docket Number:
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`Application Type:
`
`Paymentinformation:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was successfully received in RAM
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
` File Listing:
`
`Document
`
`ms
`
`File Size(Bytes)/
`
`Multi
`
`Pages
`
`Page 6 of 14
`
`
`
`

`

`Issue Fee Payment (PTO-85B)
`
`0067|ssueFee.pdf
`
`138250
`
`2eb3403798e7695bcf1f5c91 bac8a384bf3F|
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`51ca62ba91<4490634ba5d750bfacfobat24]
`9of
`
`the application.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shownon this AcknowledgementReceiptwill establish the international filing date of
`
`This AcknowledgementReceipt evidences receipt on the noted date by the USPTOofthe 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.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary componentsfora filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shownonthis
`AcknowledgementReceiptwill establish thefiling date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903indicating acceptanceof the application as a
`national stage submission under35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`Page 7 of 14
`Page 7 of 14
`
`

`

`PATENT
`Attorney Docket No.: 20000904-0067
`
`iN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`MAIL STOP ISSUE FEE
`
`Examiner: Jonathan S. LAU
`
`Group Art Unifi 1623
`
`Confirmation No.: 67106
`
`} } } ) } ) }
`
`)
`
`Applicant: Nicholas 8. BODOR et al.
`
`Application No. 12/986,310
`
`Fed: January 7, 20147
`
`Tile: ORAL FORMULATIONS OF
`
`CLADRISINE
`
`REPLY AND AMENDMENT PURSUANT TO 37 C.F.R. § 1.372
`
`in response to the Notice to File Corrected Application Papers dated April 17,
`
`2014, Applicants hereby submit the following amendment and remarks pursuant io 37
`
`CER. §1.342.
`
`Page 8 of 14
`Page 8 of 14
`
`

`

`Attorney Docket No. 20009904-D067
`Application No. 12/986,310
`Pade 2
`
`AMENDMENTS TO THE SPECIFICATION:
`
`Please replace page 23 of the as-filed specification with the attached new page
`
`23, which deleted the final sentence in the paragraph af lines 7-29.
`
`Attached: Marked-Up and Clean Copies of Page 23
`
`Page 9 of 14
`Page 9 of 14
`
`

`

`Attorney Docket No. 20008¢04-0067
`Application No. 12/986,310
`Page 3
`
`REMARKS
`
`After allowance of this application, tt was noted that page 23 of the as-filed
`
`specification contained references to applications for which no application numbers
`
`were given. These were provisional applications which were abandoned without the
`
`filing of non-provisional applications based thereon. Further, they were not for
`
`inventions of the present inventors and belonged to a former assignee. They were not
`
`made available to the public.
`
`In the parent case, now patented (Application No.
`
`12/986, 310), the sentence in question was deleted during prosecution, by an
`
`amendment made October 3, 2008. Accordingly, page 23 of the specification has been
`
`amended fo delete the final sentence on page 23, consistent with the parent.
`
`This amendment was not proposed sooner because it was not realized that the
`
`error had not been corrected until after allowance. This amendment does not raise any
`
`new issues and thus is appropriate at this time. Entry is respectfully requested.
`
`Respectiully submitied,
`
`DENTONS US LLP
`
`
`Date: June Te, 2014
`
`Mary Katherine Baumeister!
`Mary Katherine Baumeister
`Registration No. 26254
`
`Customer No. 13974
`Dentons US LLP
`1301 K Street NV, Sulte 600, East Tower
`Washington, D.C. 20005
`Phone: 202-408-9186
`Fax: 202-408-6399
`
`Page 10 of 14
`Page 10 of 14
`
`

`

`MARRED-UP COPY
`
`-33..
`
`10
`
`15
`
`20
`
`Physicians, Vol. 111, No. 1, 35-44 (7989); Selby et al., The Canadian
`Joumal ofNeurological Sciences, 25, 298-299 (1988); Tortorelia etai.,
`Current Opinion in investigational Drugs, 2 (12), 1751-1756 (2001): Rice et
`al., Neurology, 54, 1145-1159 (2000); and Karlsson et al., British Journal of
`Haematology, 116, §38-548 (2002); all of which are incorporated by
`reference herein in thelr entireties and relied upon.
`Moreover, the route of administration for which the therapeutically
`effective dosages are taught in the Hlerature should be taken into
`consideration. While the instant compositions optimize the bioavailability of
`cladribine following oral administration, it will be appreciated that even
`optimal bioavailability from oral desage forms is not expected to approach
`bioavailability obtain after intravenous administration, particularly at early
`time points. Thus,it is offen appropriate to Increase a dosage suggested for
`intravenous administration to arrive at a suitable dosage for incorporation
`into a solid oral dosage form. At the present time, His envisioned that, for
`the freatrnent of multiple sclerosis, 10 mg of cladribine in the instant cornpiex
`cladribine-cyciodextrin camplex in the instant solid dosage form would be
`administered once per day for a period of five to seven Gays in the first
`month, repeated for another period of five to seven days in the second
`month, followed by ten months of no veatment. Alternatively the patient
`would be treated with 16 mg of cladribine in the instant complex cladribine-
`cyclodextrin complex in the instant dosage form once Ber cay for a period of
`five fo seven days per month for a total of she months, followed by sighteen
`
`
`3 Samosamonths of no treatment, Ferfurthere i
`‘
`a
`gy
`& 8.
`
`
`af
`Sh geesedg cea Ee
`on
`‘
`BeeketNe-asags
`LE IRS
`
`
`
`
`Siar HS
`
`Sand
`re
`
`5
`ee §
`SANT
`YS Wao SRS Re Re
`
`2S
`
`
`Page 11 of 14
`Page 11 of 14
`
`

`

`CLEAN COPY
`
`33a
`Physicians, Vol. 111, No. 1, 35-44 (1989); Selby ef al., The Canadian
`Joumal ofNeurological Sciences, 25, 295-299 (1998); Tortorella at al.,
`Current Opinion in investigational Drugs, 2 (12), 1751-1756 (2001); Rice et
`al., Neurology, 64, 1145-1155 (2000); and Karlsson et al., Brifish Journal of
`Haematology, 118, 538-548 (2002); all of which are incarporated by
`reference herein in thelr entireties and relied upon.
`Moreover, the route of administration for which the therapeutically
`effective dosages are taught in the literature should be taken into
`consideration. While the instant compositions optimize the bioavailability of
`cladribine following oral administration, it will be appreciated that even
`optimal bioavailability from oral dosage forms is not expected to approach
`bioavailability obtain after intravenous administration, particularly at early
`time points. Thus, it is often appropriate to Increase a dosage suggested for
`intravenous administration to arrive at a Suilabie dosage for incorporation
`info a solid oral dosage form. Af the present time, itis envisioned that, for
`the treatment of multiple sclerosis, 10 mg of cladribine in the instant complex
`cladribine-cyclodextrin complex in the instant solid desage form would be
`administered once per day for a period of five to seven days in the first
`month, repeated for another period of fve to seven days in the secand
`rmonth, followed by ten months of no treatment Alternatively the patient
`would be treated with 10 mg of cladribine in the instant complex cladribine-
`eyclodextrin complex in the Instant dosage form once per day for a period of
`five to seven days per month for a total of six months, followed by eighteen
`months of no treatment.
`
`1
`
`45
`
`2g
`
`Page 12 of 14
`Page 12 of 14
`
`

`

`Electronic AcknowledgementReceipt
`
`19292491
`
`12986310
`
`Application Number:
`
`International Application Number:
`
`Confirmation Number:
`
`Title of Invention:
`
`ORAL FORMULATIONS OF CLADRIBINE
`
`Utility under 35 USC 111)
`
`First Named Inventor/Applicant Name:
`
`Nicholas S. Bodor
`
`Customer Number:
`
`13974
`
`Mary Katherine Baumeister/Rebecca Brimmer
`
`Filer Authorized By:
`
`Mary Katherine Baumeister
`
`Attorney Docket Number:
`
`20009904-0067
`
`Receipt Date:
`
`Filing Date:
`
`12-JUN-2014
`
`07-JAN-2011
`
`Time Stamp:
`
`18:18:08
`
`Application Type:
`
`Paymentinformation:
`
`Submitted with Payment
`
`File Listing:
`
`Jaaf1c6d1026e3403772a0cb4aacbef87c09}
`
`Pages
`Multi
`File Size(Bytes)/
`DocumentDescription
`Document
`
`
`
`Number Message Digest|Part/.zip|P (if appl.)
`189700
`
`312-Amendment.pdf
`
`Page 13 of 14
`Page 13 of 14
`
`

`

`ee
`
`Multipart Description/PDF files in .zip description
`
`The page size in the PDF is too large. The pages should be 8.5 x 11 or A4.If this PDF is submitted, the pages will be resized upon entry into the
`Image File Wrapper and mayaffect subsequent processing
`
`Information:
`
`the application.
`
`New International Application Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary componentsfor
`an international filing date (see PCT Article 11 and MPEP 1810), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/105)will be issued in due course, subject to prescriptions concerning
`national security, and the date shownon this AcknowledgementReceiptwill establish the international filing date of
`
`This AcknowledgementReceipt evidences receipt on the noted date by the USPTOofthe 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.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary componentsfora filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shownonthis
`AcknowledgementReceiptwill establish thefiling date of the application.
`
`National Stage of an International Application under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/EO/903indicating acceptanceof the application as a
`national stage submission under35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`Page 14 of 14
`Page 14 of 14
`
`