UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`APPLICATION NO.
`DATED
`INVENTOR(S)
`
`: 8,598,149 B2
`: 12/199114
`: December 3, 2013
`: Be1anoff et al.
`
`Page 1 of 1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:
`
`On the Title Page:
`
`The first or sole Notice should read --
`
`Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b)
`by 990 days.
`
`Signed and Sealed this
`Thirtieth Day of December, 2014
`
`Michelle K. Lee
`Deputy Director of the United States Patent and Trademark Office
`
`NEPTUNE GENERICS – Ex. 1003
`Page 1
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`KILPATRICK TOWNSEND & STOCKTON
`LLP
`TWO EMBARCADERO CENTER
`EIGHTH FLOOR
`SAN FRANCISCO CA 94111-3834
`
`In re Patent No. 8,598,149
`Joseph K. Belanoff
`Issue Date: 12/03/2013
`Application No. 12/199114
`Filing or 371(c) Date: 08/27/2008
`Atty. Docket No::
`85178-756824(004110US)
`
`~~niLrew
`SEP 0 3 2014 .
`
`OFFICE OF PETITIONS
`
`: ON REDETERMINATION OF
`: PATENT TERM ADJUSTMENT
`
`This is a re~ponse·to applicants "REQUEST FOR RECONSIDERATION OF PATENT TERM
`ADJUSTMENT UNDER 37 CFR 1.705(d)", requesting that the Office adjust the PTA in view of
`Exelixis v .. Kappas. The Office has re-determined the PTA to be 990 days.
`
`This redetermination of patent term adjustment is not the Director's decision on the applicant's
`request for reconsideration within the meaning of 35 U.S.C. 154(b)(4) that triggers a 180-day period
`for applicant disagreeing with the Office redetermination to commence a civil action in the District
`Court for the Eastern District of Virginia.
`
`Relevant Procedural History
`
`On December 3~ 2013, the above-identified application matured into U.S. Patent No. 8,598,149. The
`patent issued with a PTA of 866 days. The present request for redetermination of the patent term
`adjustment was timely filed within two months of the issue date of the patent. Patentee requests
`recalculation of the Patent Term Adjustment in view of Exelixis v. Kappas.
`.
`
`:
`
`Decision
`
`Patents' arguments have been carefully considered. Upon review, the USPTO finds that patentee is
`entitled to 990 days of PTA. The Office has revisited the amount of"B" delay under 35 U.S.C. §
`154(b)(1)(B) and the amount of overlapping days under 35 U.S.C. § 154(b)(2)(A) pursuant to the
`Federal Circuit's decision in Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014). Patentee and the
`Office are in agreement as to the amount of"applicant delay" under 35 U.S.C. § 154(b)(2)(C) and
`1.704(b); however, patentee and the Office continue to disagree regarding the amount of"A" delay
`under 35 U.S.C. § 154(b)(1)(A) and 37 CFR 1.702(a).
`
`NEPTUNE GENERICS – Ex. 1003
`Page 2
`
`

`

`Patent No. 8,598,149
`
`Page 2
`
`As for the amount of"B" delay, the Federal Circuit reviewed the statutory interpretation of35 U.S.C.
`§ 154(b )(1)(B)(i) and issued a decision regarding the effects of a Request for Continued Examination
`("RCE") on "B" delay in Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014). In Novartis, the Federal
`Circuit agreed with the Office that ·"no ["B" delay] adjustment time is available for any time in
`continued examination, even if the continued examination was initiated more than three calendar
`years after the application's filing." Novartis, 740 F.3d at 601. However, the Novartis court found
`that if the Office issues a notic;e of allpwance after an RCE is filed, the period after the notice of
`allowance should not be excluded from the "B" delay period but should be counted as "B" delay. /d.
`at 602. The Federal Circuit issued its mandate in the Novartis appeal on March 10, 2014.
`
`Pursuant to the Novartis decision, the USPTO has determined that the patentee is entitled to 519 days
`of"B" delay. In this case, it was previously determined that the application filing date is August 27,
`2008, and the issue date of the patent is December 3, 2013. Accordingly, the total pendency of the
`application ~a$. ~925 days. Thus, the application was pending for 1925- 1096 = 829 days beyond
`the three-year 'aimiversary pfthe application's filing date. This three-year pendency period began on
`August 28, 2011, and ended on December 3, 2013. During this time, the ;:tpplicant filed one RCE on
`September 27, 2012, and the Office mailed a Notice of Allowance on August 2, 2013, for a total of
`310 days; which is excluded from the amount of"B" delay. Accordingly, in light of the RCE, the
`amount of"B" ~elay amounted to 519 days (1925 1096- 310 = 519).
`
`Regarding patentee delay, Office records confirm that the due date for the reply to the final
`Office action mailed April4, 2012, was July 4, 2012, a Federal Holiday, and the due date for the
`reply was therefore July 5, 2012. Applicant filed a reply to the Office action on September 27,
`2012. Accordingly, a period of reduction of 84 days, not 85 days, is properly entered for the
`reply. /d.
`
`The Office finds that there are no overlapping days. In Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir.
`2010), the United States Court of App~als for the Federal Circuit determined that overlap occurs
`when the calendar days overlap between the "A" and "B" delays. Under this interpretation, the
`Office finds t~at no days of"A" ddayovedap with the B periods iterated above.
`
`Overall PTA.Calc~Iation.
`
`Formula:
`
`"A" delay + "B" delay + "C" delay - Overlap - applicant delay = X
`
`USPTO's Calculation:
`
`637 + 519 + 0-0- 166 = 990
`
`Patentee's Calculation
`
`637 + 519 + 0--:.0 167 = 989
`
`J
`
`~.
`
`~ . .
`
`NEPTUNE GENERICS – Ex. 1003
`Page 3
`
`

`

`Patent No. 8,598,149
`
`Conclusion
`
`Page 3
`
`Patentee is entitled to a PTA of nine hundred ninety (990) days. Using the formula "A" delay+
`"B" delay + "C" delay·- overlap - applicant delay = X, the amount of PTA is calculated as
`following: 637 + 519 + 0-0 166 = 990 days.
`
`The Office acknowledges submission of the $200.00 fee set forth in 37 CFR 1.18(e). No
`additional fees are required.
`·
`
`Patentee is given TWO (2) MONTHS from the mail date of this decision to respond to this
`redetermination. Extensions of time under 37 CFR 1.136(a) are permitted. This is not final
`agency action within the meaning of 5 U.S.C. § 704.
`
`The application is being forwarded to the Certificate of Corrections Branch for issuance of a
`certificate of correction. The Office will issue a certificate of correction indicating that the term
`of the above-identified patent is extended or adjusted by nine hundred ninety (990) days.
`
`Telephone inquiries specific to this matter should be directed to the undersigned at (571) 272-
`3232.
`
`/DW/
`
`Derek Woods
`:.
`Attorney Advisor
`Office of Petitions
`
`Enclosure:· Adjusted PTA calculation
`Draft Certificate of Correction
`
`NEPTUNE GENERICS – Ex. 1003
`Page 4
`
`

`

`f!TA/PTE Information
`r-
`Application Number*: :·121991"i'4·····-······--···-.. -· ..... : [~earchj Explanation of PTA Calculation
`...................................................................................................................................................................................... .
`. PTA Calculations for Application: 12199114
`1
`I,······_· ----~~~~~~~~~---.------------~~~~~~~~~~~~~~---.·~
`.................... ~P!!.I.I.~Ca. .. ~!~.'-! .. !:.1.1!.~.~ .. !?.!!~! Q~l.~?l~9..Q~ ... -._· .
`.. .. _ -···--~ .......... -~o.!!.!!.~!!PP..i .. "..!! ... !>..IJ.V.'!!J ... !~'.a.!!' . .!~-1\'.'.!.l,l..!l.l .. ~! .. I~I!~~J::.>. 9. .................. .
`Issue Date of Patent 12/03/2013
`Non-Overlapping USPTO Delays: 1033
`. .... : .......... ~.!'?. ... ~.!!!'.!:!!!.I .. ~I,IJ':'.!!.!!'.!!.!!! ;~~ .... ·
`....... ·············-··---............................... ~ ... !?~.I!!:V.! ~}1 .. ----·--
`··--·~-·······-.... ····:r-;;t:&i'P'ii(days) 99o·-···
`.............. _.c .. oei&~ a ........ -.. _·-· ..........
`B Delays 396
`Applicant Delay (APPL) 167
`
`.... ............
`.. ...... ~- .......... -.................................
`·· ---·-- ..................... _.__
`
`Explanation of PTE Calculation
`
`* - Sorted Column
`
`Aml1!1
`Description
`
`Aslliul·.
`A!:tiiU!.
`A'tiQD ~YC A!:tiiU!.
`l1!!mll!u ~ Qi!m ~
`Qi!m
`83
`09/02/2014
`P028
`Adjustment of PTA Calculation by PTO
`83
`09/02/2014
`P028
`. ~djuotmefiJ of PTA Calci.olation by PTO
`77
`12/03/2013
`PTAC
`Patent looue Date Uoad in PTA calculation
`76
`11/01/2013
`EFDC
`Expot1 to Final Data Capture
`10/31/2013
`01935
`Dispatch to FDC
`75
`74
`10/31/2013
`PILS
`Application Is Considered Ready for Issue
`73
`10/28/2013
`N084
`looue Fee Payment Verified
`72
`10/2812013
`IFEE
`Issue Fee Pa'(ment Received
`08/31/2013
`FlOC
`Finished Initial Data Capture
`71
`08/02/2013
`MN/=.
`Mall Notice of Allowance
`67
`66
`07/29/2013
`OAR
`Office Action Review
`65
`OAR
`Office Action Review
`07/29/~013
`·ISsue Revision Completed
`61
`07/29/2013
`IREV
`60
`07/2912013
`OVER
`Oocument Verification
`59
`07/29/2013
`Notice of Allowance Data Verification Completed
`N/=.
`case Docketed to Examiner in GAU
`58
`07129/2013
`DOCK
`Allowed Case Returned to the Examiner for Clerical Processing
`07/29/2013
`ACRE
`57
`56
`07/2912013
`OAR
`Office Action Review
`Office Action Review
`55
`0712912013
`OAR
`Reasons for Allowance
`54
`07/23/2013
`EX.R
`53
`07/23/2013
`CNTA
`Allowability Notice
`Date Forwarded to Examiner
`52
`07/19/2013
`FWDX
`Response after Ex Parte Quayle Action
`51
`07/18/2013
`A.QU
`50
`05/24/2013
`ELC_RVW Electronic Review
`49
`EML_NTF Email Notification
`05/24/2013
`48
`05/24/2013
`Mall Ex Parte Quayle Action (PTOL- 326)
`01/27/2013 MCTE,Q
`Office Action Review
`47
`05/21/2013
`OAR
`46
`05/20/2013
`Quayle action
`cTEQ
`Date Forwarded to Examiner
`45
`10/01/2012
`FWDX
`Disposal for a RCE I CPA / Rl29
`42
`10/01/2012
`ABN9
`Amendment Submitted/Entered with Filing of CPA/RCE
`44
`09/27/2012
`AMSB
`Request for Continued Examination (RCE)
`09/27/2012
`07/04/2012 RCEX
`43
`Request for Extension of Time Granted
`41
`09/27/2012
`XT/G
`40
`09/27/2012
`BRCE
`Workflow - Request for RCE - Begin
`77.5
`09/26/2012
`08/27/2011 PTA36M
`PTA 36 Months
`ELC_RVW Electronic Review
`39
`04/04/2012
`EML_NTF Email Notification
`38
`04/04/2012
`Mall Final Rejection (PTOL - 326)
`37
`MCTFR
`04/04/2012
`Office Ac:tion Review
`36
`03/28/2012
`OAR
`Final Rejec:tlon
`35
`03/27/2012
`CTFR
`Date·Forwarded to Examiner
`33
`FWDX
`01/26/2012
`Response after Non-Final Action
`32
`0112412012
`11/03/2011 A.;,
`Request for Extension of Time - Granted
`31
`01/24/2012
`XTIG
`ELC_RVW Electronic Review
`30
`08/03/2011
`EML_NTF Email Notification
`29
`08/03/2011
`Mail Non-Final Rejection
`MCTNF
`28
`08/03/2011
`Office Action Review
`27
`07/2912011
`OAR
`Non-Final Rejec:tlon
`26
`07/28/2011
`CTNF
`Date Forwarded to Examiner
`24
`FWDX
`05/24/2011
`Response to Election I Restriction Filed
`23
`ELC.
`05/18/2011
`Request for Extension of nme - Granted
`22
`05/18/2011
`XT/G
`ELC_RVW Electronic Review
`21
`0313112011
`EML_NTF E mall Notification
`20
`03/31/2011
`Mail Restriction Requirement
`19
`03/31/2011
`10/27/2009 MCTRS
`Office Action Review
`18
`03/2812011
`OAR
`
`"'\
`
`l2l!m1i!m l2l!mt!lln Rru:!:nt
`A!:1i.!!n
`fiQ
`APPL
`Number
`ill
`ill
`
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`43
`0
`0
`0
`0
`0
`37
`0
`0
`0.5
`0
`0
`0
`0
`0
`0
`28
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0.5
`0
`
`u
`
`lLl:
`
`lli
`
`uq
`
`NEPTUNE GENERICS – Ex. 1003
`Page 5
`
`

`

`17
`16
`15
`14
`13
`12
`11
`10
`9
`
`03/28/2011
`12/05/2009
`1~to6t~oo9
`08/18/2009
`03/05/2009
`01/31/2009
`12/04/201!8
`11/17/2.001.!
`11/17/2008
`11/17/2008
`11/07/2008
`
`6
`
`11/07/2008
`
`4
`3
`2
`
`09/11/2008
`09/11/2008
`08/27/2008
`08/27/2008
`08/27/2008
`0.5
`08/27/2008
`Export to:
`\am
`
`~
`
`Restriction/Election Requirement
`CTRS
`DOCk
`Case Docketed to Examiner In GAU
`DOCK
`Case Docketed to Examiner In GAU
`DOCK
`Case Docketed to Examiner In GAU
`PG"ISSUE PG·Pub lssue Notification
`TSSCOMP IFw TSS Processing by Tech Center Complete
`OIPE
`Application Dispatched from OIPE
`Change In ~o.wer of Attorney (May Include Associate POA)
`PA ..
`PGPC
`Sent to Chss•Jflcatlon Contractor
`FLRCPT.U Rllng Receipt • Updated
`AOOFLFEE Additional Application Filing Fe""
`
`OATHDECL :n::;':~:~~;;,"oo:t:::~~~:v:;:~:-satisfying the requirement
`
`Notice Mailed--Application Incomplete-Filing Oete Assigned
`IN CD
`FLRCPT.O Filing Receipt
`Cleared by OIPE CSR
`Ll94
`SCAN
`IFW Scan Ill PACR Auto Security Review
`Initial Exam Team nn
`IEXX
`EFILE
`Filing date
`
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`0
`
`0
`
`0
`0
`0
`0
`0
`0
`
`~
`
`ril'
`
`NEPTUNE GENERICS – Ex. 1003
`Page 6
`
`

`

`Patent No. 8,598,149
`
`Page4
`
`DRAFT COPY
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`: 8,598, 149. 82
`
`PATENT
`
`DATED
`
`: December 3, 2013
`
`INVENTOR(S) : Belanoff et al.
`
`It is certified that error appears in ttie above-identified patent and that said Letters
`Patent is hereby corrected as shown below:
`
`On the cover page,
`
`Subject to any disclaimer, the term of this patent is extended or adjusted
`[*] Notice:
`under 35 USC 154(b) by- 866 days.
`
`Delete the phrase "by 866 days" and insert- by 990 days--
`
`·.,.
`
`NEPTUNE GENERICS – Ex. 1003
`Page 7
`
`

`

`I hereby certify that this correspondence is being filed via
`EFS-Web with the United States Patent and Trademark Office
`"'"1-- 3- ZOILf
`on
`
`KILPATRICK TOWNSEND & STOCKTON LLP
`
`By \Hh L
`
`PATENT
`Docket No.: 85178-756824 (004110US)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re application of: Belanoff
`
`Confirmation No.: 5376
`
`Examiner: Hui, San Ming R.
`
`Technology Center/Art Unit: 1629
`
`REQUEST FOR
`RECONSIDERATION OF PATENT
`TERM ADJUSTMENT UNDER 37
`CFR 1. 705(b)
`
`Patent No.: 8,598,149
`
`Issued: December 3, 2013
`
`Application No. 121199,114
`
`For: OPTIMIZING MIFEPRISTONE
`LEVELS IN PLASMA SERUM OF
`PATIENTS SUFFERING FROM
`MENTAL DISORDERS TREATABLE
`WITH GLUCOCORTICOID RECEPTOR
`ANTAGONISTS
`
`Customer No. 20350
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Commissioner:
`
`Pursuant to 3 7 C.F .R. § 1. 705(b ), Applicants respectfully request reconsideration
`
`of the patent term adjustment determination. This request is accompanied by the fee set forth in
`
`§ 1.18(e) and a statement of facts as required under 37 C.F.R. § 1.705(b)(2).
`
`In view of the following, it is respectfully requested that Applicants be granted a
`
`corrected patent term adjustment of 989 days.
`
`Statement of Facts as Required under 37 C.F.R. § 1.705(b)(2)
`
`The correct patent term adjustment is 989 days and not 866 days as stated on the
`
`face page of U.S. Patent No. 8,598,149 (see Exhibit A).
`
`NEPTUNE GENERICS – Ex. 1003
`Page 8
`
`

`

`Belanoff.
`Application No. 12/199,114
`Page2
`
`PATENT
`
`The period of adjustment under§ 1.702(a) is 637 days ("A delay").
`
`The period of adjustment under § 1. 702(b) is 519 days ("B delay").
`
`The overlap period under§ 1.703(a)-(e) is 0 days (overlap).
`
`The period of adjustment under§ 1.704(a) is 167 days ("applicant delay").
`
`The period of adjustment under§ 1.703(±) is 989 days.
`
`The Relevant Dates as Specified in 37 C.F.R. §§ 1.703(a)-(e), §§ 1.704 and the Adjustment
`
`Specified in 37 C.F.R. § 1.703(0)
`
`1.
`
`§ 1.703(a)
`
`Applicants are in agreement with the Patent Office's determination of a period of
`
`adjustment of 637 days under 37 C.F.R. § 1.703(a). This period of adjustment is comprised of
`
`two delay periods of 520 days under§ 1.703(a)(l) and 117 days under§ 1.703(a)(2).
`
`2.
`
`§§ 1. 703(b)
`
`The Office failed to issue the above-identified patent within three years from its
`
`filing date. The period of adjustment under 37 C.F.R. § 1.702(b) begins on the day after the date
`
`that is three years from the filing date ofthe instant application, August 27, 2011, and is paused
`
`with the filing of an RCE or Notice of Appeal. After the filing of an RCE, the period of
`
`adjustment under 37 C.F.R. § 1.702(b) resumes upon the mailing of a Notice of Allowance and
`
`ends on the day the patent is issued (see Novartis AG v. Lee, Nos. 2013-1160, -1179 (Jan. 15,
`
`2014) and Exelixis v. Lee, Nos. 2013-1175,-1198 (Jan. 15, 2014) (per curiam)).
`
`Applicants are not in agreement with the Patent Office's determination of
`
`adjustment under 37 C.F.R. § 1.703(b) as 396 days. Applicants submit that an RCE was filed on
`
`September 27, 2012, which is after the three-year pendency date of August 27, 2011. In
`
`accordance with Novartis AG v. Lee, Nos. 2013-1160, -1179 (Jan. 15, 2014) and Exelixis v. Lee,
`
`Nos. 2013-1175, -1198 (Jan. 15, 2014) (per curiam), Applicants have calculated two periods of
`
`delay under 37 C.F.R. § 1.703(b): 396 days as the period oftime between the date that is three
`
`years from the filing date (August 27, 2011) through the filing of an RCE on September 27,
`
`NEPTUNE GENERICS – Ex. 1003
`Page 9
`
`

`

`Belanoff.
`Application No. 12/199,114
`Page 3
`
`PATENT
`
`2012; and 123 days as the period oftime between the Notice of Allowance mailed on August 2,
`
`2013 through the December 3, 2013 issue date of the instant patent. Thus, the effective period of
`
`adjustment under 37 C.P.R. § 1.702(b) is 519 days.
`
`3.
`
`1.703(c)-(e)
`
`There are no relevant dates a specified under§§ 1.703(c)-(e)
`
`4.
`
`Overlapping periods under§ 1.703(a)-(e)
`
`Applicants have calculated the days of overlap under 35 U.S.C. § 154(b )(1 )(A)
`
`and 35 U.S.C. § 1.54(b)(1)(B) and submit that there are 0 days of overlap applicable to the
`
`subject patent.
`
`5.
`
`Adjustment of Patent Term Under 37 C.F.R. §1.704
`
`Applicants do not dispute the calculation by the Office of the period of adjustment
`
`under§ 1.704(a) as total of 167 days indicated by the attached Patent Term Adjustment History
`
`(see Exhibit B). This period of adjustment is the sum of two delay periods: 82 days and 85 days
`
`under§ 1.704(b) for a total of 167 days.
`
`6.
`
`§ 1.703(f)
`
`The period of adjustment under 37 C.P.R.§ 1.702(£) is as follows:
`
`Type "A" delay:
`
`Type "B" delay:
`
`"A" and "B" overlap:
`
`Applicant delay
`
`Adjusted
`
`637 days
`
`519 days
`
`0 days
`
`167 days
`
`989 days
`
`Terminal disclaimer
`
`The instant application is not subject to a terminal disclaimer.
`
`NEPTUNE GENERICS – Ex. 1003
`Page 10
`
`

`

`Belanoff.
`Application No. 12/199,114
`Page4
`
`Statement under 37 C.F.R. § 1.705(b)
`
`PATENT
`
`The instant patent issued on December 3, 2013 and Applicants submit that this
`
`request for reconsideration of patent term adjustment is being filed within the two-month time
`
`frame set forth under 37 CFR §1.705(b).
`
`PATENT TERM ADJUSTMENT DETERMINATION
`
`Pursuant to Novartis AG (Nos. 2013-1160, -1179 (Jan. 15, 2014), Applicants are
`
`entitled to 989 days of patent term adjustment, i.e.:
`
`[1156 days (A+ B delay) minus 0 overlap days] minus [167 days (applicant delay)].
`
`Based on the foregoing, Applicants respectfully request reconsideration of the
`
`patent term adjustment determination and issuance of a Certificate of Correction to adjust the
`
`patent term awarded to U.S. Patent No. 8,598,149.
`
`The $200.00 fee set forth in 37 C.F.R. § 1.18(e) is being charged concurrently
`
`herewith. Please deduct any additional fees from, or credit any overpayments to Deposit
`
`Account No. 20-1430, referencing Attorney Docket No. 85178-756824 (00411 OUS).
`
`Respectfully submitted,
`
`Alexander R. Trimble
`Reg. No. 52,301
`
`KILPATRICK TOWNSEND & STOCKTON LLP
`Two Embarcadero Center, Eighth Floor
`San Francisco, California 94111-3834
`Tel: (415) 576-0200
`Fax: (415) 576-0300
`ART: jtl
`65971883V.l
`
`NEPTUNE GENERICS – Ex. 1003
`Page 11
`
`

`

`EXHIBIT A
`
`111111
`
`1111111111111111111111111111111111111111111111111111111111111
`US008598149B2
`
`(12) United States Patent
`Belanoff
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 8,598,149 B2
`Dec. 3, 2013
`
`(54) OPTIMIZING MIFEPRISTONE LEVELS IN
`PLASMA SERUM OF PATIENTS SUFFERING
`FROM MENTAL DISORDERS TREATABLE
`WITH GLUCOCORTICOID RECEPTOR
`ANTAGONISTS
`
`(75)
`
`Inventor:
`
`Joseph K. Belanoff, Woodside, CA (US)
`
`(73) Assignee: Corcept Therapeutics, Inc., Menlo
`Park, CA (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 866 days.
`
`(21) Appl. No.: 12/199,114
`
`(22) Filed:
`
`Aug. 27,2008
`
`(65)
`
`US 2009/0062248 Al
`
`Prior Publication Data
`Mar. 5, 2009
`
`Related U.S. Application Data
`
`(60) Provisional application No. 60/969,027, filed on Aug.
`30,2007.
`
`(51)
`
`Int. Cl.
`A61K 31156
`(52) U.S. Cl.
`USPC ........................................... 514/178; 5141182
`
`(2006.01)
`
`(58) Field of Classification Search
`USPC .................................................. 514/182, 178
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`6,964,953 B2 * 11/2005 Belanoff ....................... 514/178
`OTHER PUBLICATIONS
`
`Sarkm·, European Journal of Obstetrics and Gynecology and Repro(cid:173)
`ductive Biology, 2002;101: 113-120*
`Medical Encyclopedia of Medline (http:// http://www.nlm.nih.gov/
`medlineplus/ency/mticle/003430.htm, Oct. 2005. •
`* cited by examiner
`Primary Examiner- San-Ming Hui
`(74) Attorney, Agent, or Firm- Kilpatrick Townsend &
`Stockton LLP.
`
`ABSTRACT
`(57)
`The present invention provides a method for optimizing lev(cid:173)
`els of mifepristone in a patient suflering fi"Oln a mental dis(cid:173)
`order amenable to treatment by mifcpristone. The method
`comprises the steps of treating the patient with seven or more
`daily doses of mifepristone over a period of seven or more
`days; testing the senun levels of the patient to determine
`whether the blood levels ofmifepristone arc grcaterthanl300
`ng/mL; and adjusting the daily dose of the patient to achieve
`mifepristone blood levels greater than 1300 ng/mL.
`
`7 Claims, 6 Drawing Sheets
`
`BPRS PSS -Days 7 and 56 Response
`
`40
`
`35
`
`35%
`
`30
`
`% of patients
`who have at 25
`least 50%
`reduction
`from baseline 20
`in BPRS PSS
`scores at
`days 7 and 56
`
`15
`
`10
`
`5
`
`0
`
`p < .01
`
`Corlux
`
`n=443
`
`Placebo
`n=281
`
`NEPTUNE GENERICS – Ex. 1003
`Page 12
`
`

`

`EXHIBIT B
`
`Page 1 of 4
`
`12/199,114
`
`OPTIMIZING MIFEPRISTONE LEVELS IN PLASMA SERUM
`OF PATIENTS SUFFERING FROM MENTAL DISORDERS 85178-756824 02-03-
`TREATABLE WITH GLUCOCORTICOID RECEPTOR
`(004110US)
`2014::18:42:29
`ANTAGONISTS
`Patent Term Adjustments
`Patent Term Adjustment (PTA) for Application Number: 12/199,114
`
`Filing or 371(c) Date:
`
`08-27-2008 Overlapping Days Between {A and B} or {A and C}:
`
`PTO
`(Days)
`
`APPL
`(Days)
`
`396
`
`Issue Date of Patent:
`A Delays:
`
`12-03-2013 Non-Overlapping USPTO Delays:
`637
`PTO Manual Adjustments:
`
`396
`B Delays:
`C Delays:
`0
`Patent Term Adjustment History
`
`Applicant Delays:
`Total PTA Adjustments:
`Explanation Of Calculations
`
`Number Date
`
`Contents Description
`
`77.5
`
`77
`
`76
`
`75
`
`74
`
`73
`
`72
`
`71
`
`67
`
`66
`
`65
`
`61
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`60
`
`59
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`58
`
`57
`
`56
`
`09-26-
`2012
`
`12-03-
`2013
`
`11-01-
`2013
`10-31-
`2013
`10-31-
`2013
`
`10-28-
`2013
`
`10-28-
`2013
`
`08-31-
`2013
`
`08-02-
`2013
`07-29-
`2013
`07-29-
`2013
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`07-29-
`2013
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`07-29-
`2013
`
`07-29-
`2013
`
`07-29-
`2013
`07-29-
`2013
`07-29-
`2013
`
`07-29-
`
`PTA 36 Months
`
`Patent Issue Date Used in PTA Calculation
`
`Export to Final Data Capture
`
`Dispatch to FDC
`
`Application Is Considered Ready for Issue
`
`Issue Fee Payment Verified
`
`Issue Fee Payment Received
`
`Finished Initial Data Capture
`
`Mail Notice of Allowance
`
`Office Action Review
`
`Office Action Review
`
`Issue Revision Completed
`
`Document Verification
`
`Notice of Allowance Data Verification Completed
`
`Case Docketed to Examiner in GAU
`
`Allowed Case Returned to the Examiner for Clerical
`Processing
`
`Office Action Review
`
`0
`
`1033
`0
`
`167
`866
`
`Start
`
`0.5
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`https://ppair.uspto.gov/pair/PAIRPrintServlet
`
`2/3/2014
`
`NEPTUNE GENERICS – Ex. 1003
`Page 13
`
`

`

`EXHIBIT B
`
`Page 2 of 4
`
`55
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`54
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`53
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`52
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`50
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`49
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`48
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`46
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`45
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`44
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`42
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`41
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`40
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`39
`
`38
`
`37
`
`36
`
`35
`
`33
`
`32
`
`31
`
`30
`
`2013
`07-23-
`2013
`07-23-
`2013
`07-19-
`2013
`
`07-18-
`2013
`
`05-24-
`2013
`
`05-24-
`2013
`05-24-
`2013
`05-21-
`2013
`05-20-
`2013
`
`10-01-
`2012
`
`09-27-
`2012
`
`09-27-
`2012
`10-01-
`2012
`09-27-
`2012
`09-27-
`2012
`
`04-04-
`2012
`
`04-04-
`2012
`
`04-04-
`2012
`03-28-
`2012
`03-27-
`2012
`01-26-
`2012
`01-24-
`2012
`
`01-24-
`2012
`
`08-03-
`2011
`
`Office Action Review
`
`Reasons for Allowance
`
`Allowability Notice
`
`Date Forwarded to Examiner
`
`Response after Ex Parte Quayle Action
`
`Electronic Review
`
`Email Notification
`
`Mail Ex Parte Quayle Action (PTOL - 326)
`
`117
`
`Office Action Review
`
`Quayle action
`
`Date Forwarded to Examiner
`
`Amendment Submitted/Entered with Filing of
`CPA/RCE
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`43
`
`0
`
`0
`
`0
`
`0
`
`Request for Continued Examination (RCE)
`
`85
`
`37
`
`Disposal for a RCE I CPA I R129
`
`Request for Extension of Time - Granted
`
`Workflow - Request for RCE - Begin
`
`Electronic Review
`
`Email Notification
`
`Mail Final Rejection (PTOL- 326)
`
`Office Action Review
`
`Final Rejection
`
`Date Forwarded to Examiner
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`Response after Non-Final Action
`
`82
`
`28
`
`Request for Extension of Time - Granted
`
`Electronic Review
`
`0
`
`0
`
`https :/ /ppair. uspto. gov /pair/P AIRPrintServlet
`
`2/3/2014
`
`NEPTUNE GENERICS – Ex. 1003
`Page 14
`
`

`

`EXHIBIT B
`
`Page 3 of 4
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`29
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`28
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`27
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`10
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`8
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`7
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`6
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`5
`
`4
`
`08-03-
`2011
`08-03-
`2011
`07-29-
`2011
`07-28-
`2011
`
`05-24-
`2011
`
`05-18-
`2011
`
`05-18-
`2011
`03-31-
`2011
`03-31-
`2011
`03-31-
`2011
`
`03-28-
`2011
`
`03-28-
`2011
`
`12-05-
`2009
`10-06-
`2009
`08-18-
`2009
`03-05-
`2009
`
`01-31-
`2009
`
`12-04-
`2008
`
`11-17-
`2008
`11-17-
`2008
`11-17-
`2008
`11-07-
`2008
`
`11-07-
`2008
`
`09-11-
`2008
`09-11-
`2008
`
`Email Notification
`
`Mail Non-Final Rejection
`
`Office Action Review
`
`Non-Final Rejection
`
`Date Forwarded to Examiner
`
`Response to Election 1 Restriction Filed
`
`Request for Extension of Time - Granted
`
`Electronic Review
`
`Email Notification
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`0
`
`Mail Restriction Requirement
`
`520
`
`0.5
`
`Office Action Review
`
`Restriction/Election Requirement
`
`Case Docketed to Examiner in GAU
`
`Case Docketed to Examiner in GAU
`
`Case Docketed to Examiner in GAU
`
`PG-Pub Issue Notification
`
`IFW TSS Processing by Tech Center Complete
`
`Application Dispatched from OIPE
`
`Change in Power of Attorney (May Include Associate
`POA)
`
`Sent to Classification Contractor
`
`Filing Receipt - Updated
`
`Additional Application Filing Fees
`
`A statement by one or more inventors satisfying the
`requirement under 35 USC 115, Oath of the Applic
`
`Notice Mailed--Application Incomplete--Filing Date
`Assigned
`
`Filing Receipt
`
`0
`
`0
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`0
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`0
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`0
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`https://ppair.uspto.gov/pair/PAIRPrintServlet
`
`2/3/2014
`
`NEPTUNE GENERICS – Ex. 1003
`Page 15
`
`

`

`EXHIBIT B
`
`3
`
`2
`
`1
`
`0.5
`
`08-27-
`2008
`08-27-
`2008
`08-27-
`2008
`
`08-27-
`2008
`
`Close Window
`
`Cleared by OIPE CSR
`
`IFW Scan & PACR Auto Security Review
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`Initial Exam Team nn
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`Filing date
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`2/3/2014
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`NEPTUNE GENERICS – Ex. 1003
`Page 16
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`12199114
`
`27-Aug-2008
`
`Title of Invention:
`
`OPTIMIZING MIFEPRISTONE LEVELS IN PLASMA SERUM OF PATIENTS
`SUFFERING FROM MENTAL DISORDERS TREATABLE WITH GLUCOCORTICOID
`RECEPTOR ANTAGONISTS
`
`First Named Inventor/Applicant Name:
`
`Joseph K. Belanoff
`
`Filer:
`
`Alexander Reed Trimble/Jeffrey Luo
`
`Attorney Docket Number:
`
`85178-756824(00411 OUS)
`
`Filed as Large Entity
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`Utility under 35 USC 111 (a) Filing Fees
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`Application for patent term adjustment
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`1455
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`200
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`200
`
`Patent-Appeals-and-Interference:
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`Post-Allowance-and-Post-Issuance:
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`Extension-of-Time:
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`NEPTUNE GENERICS – Ex. 1003
`Page 17
`
`

`

`Description
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`Fee Code
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`Quantity
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`Amount
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`Sub-Total in
`USD($)
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`Miscellaneous:
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`Total in USD ($)
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`200
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`NEPTUNE GENERICS – Ex. 1003
`Page 18
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`18101671
`
`12199114
`
`International Application Number:
`
`Confirmation Number:
`
`5376
`
`Title of Invention:
`
`OPTIMIZING MIFEPRISTONE LEVELS IN PLASMA SERUM OF PATIENTS
`SUFFERING FROM MENTAL DISORDERS TREATABLE WITH GLUCOCORTICOID
`RECEPTOR ANTAGONISTS
`
`First Named Inventor/Applicant Name:
`
`Joseph K. Belanoff
`
`Customer Number:
`
`20350
`
`Filer:
`
`Alexander Reed Trimble/Jeffrey Luo
`
`Filer Authorized By:
`
`Alexander Reed Trimble
`
`Attorney Docket Number:
`
`85178-756824(00411 OUS)
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`NEPTUNE GENERICS – Ex. 1003
`Page 19
`
`

`

`1
`
`Patent Term Adjustment Petition
`
`REQ_RECONSID.pdf
`
`no
`
`9
`
`348682
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`Warnings:
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`Information:
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`fadcaaf06d6eadc00db2c9c86bfbd35d24e6
`73e7
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`UNITED STATES pATENT AND TRADEMARK OFFICE
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
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`APPLICATION NO.
`
`12/199,114
`
`ISSUE DATE
`
`12/03/2013
`
`PATENT NO.
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`8598149
`
`85178-756824(004110US)
`
`5376
`
`11/13/2013
`7590
`20350
`KlloPATRICK TOWNSEND & STOCKTONLLP
`TWO EMBARCADERO CENTER
`EIGHTH FLOOR
`SAN FRANCISCO, CA 94111-3834
`
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