Doc Code: TRACK1.REQ
`Document Description: TrackOne Request
`
`PTO/SB/424 (12-11)
`
`CERTIFICATION AND REQUEST FOR PRIORITIZED EXAMINATION
`UNDER 37 CFR 1.102(e) (Page 1 of 1)
`
`Joseph K. Belanoff
`
`I Nonprovisional Application Number (if I
`
`known):
`
`CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A INHIBITORS
`
`First Named
`Inventor:
`Title of
`Invention:
`
`APPLICANT HEREBY CERTIFIES THE FOLLOWING AND REQUESTS PRIORITIZED EXAMINATION FOR
`THE ABOVE-IDENTIFIED APPLICATION.
`
`1. The processing fee set forth in 37 CFR 1.17(i), the prioritized examination fee set forth in 37
`CFR 1.17(c), and if not already paid, the publication fee set forth in 37 CFR 1.18(d) have been
`filed with the request. The basic filing fee, search fee, examination fee, and any required
`excess claims and application size fees are filed with the request or have been already been
`paid.
`
`2. The application contains or is amended to contain no more than four independent claims and
`no more than thirty total claims, and no multiple dependent claims.
`
`3. The applicable box is checked below:
`F1 Original Application (Track One) - Prioritized Examination under§ 1.1 02(e)(1)
`
`I.
`
`i.
`
`(a) The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a).
`This certification and request is being filed with the utility application via EFS-Web.
`---OR---
`(b) The application is an original nonprovisional plant application filed under 35 U.S.C. 111 (a).
`This certification and request is being filed with the plant application in paper.
`
`ii. An executed oath or declaration under 37 CFR 1.63 is filed with the application.
`
`II.
`
`[] Request for Continued Examination - Prioritized Examination under§ 1.1 02(e)(2)
`
`i. A request for continued examination has been filed with, or prior to, this form.
`ii.
`If the application is a utility application, this certification and request is being filed via EFS-Web.
`iii. The application is an original nonprovisional utility application filed under 35 U.S.C. 111 (a), or is
`a national stage entry under 35 U.S.C. 371.
`iv. This certification and request is being filed prior to the mailing of a first Office action responsive
`to the request for continued examination.
`v. No prior request for continued examination has been granted prioritized examination status
`under 37 CFR 1.102(e)(2).
`
`Signature /Yifan Mao/
`~p~~~Typed) Yifan Mao
`
`Date June 19, 2017
`60 804
`'
`
`Practitioner
`Registration Number
`
`Note: Signatures of all the inventors or assignees of record of the entire interest or their representative(s) are required in accordance with
`37 CFR 1.33 and 11. 18. Please see 37 CFR 1.4(d) for the form of the signature. If necessary, submit multiple forms for more than one
`signature, see below*.
`
`[] *Total of 1
`
`forms are submitted.
`
`1
`
`TEVA1035, pt. 1
`
`

`

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`Page 2
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`2
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`~--·:::;~---~~~·;;~~,:.:;~:;~;~~~---:
`! ~~ R.l~426:33-
`~
`
`~~
`
`14
`
`Study Day
`
`FIG.l
`
`28
`
`I
`l ···•···· D~~~ -~ 2 Ak>nB
`l .. ~~~~~~~---=~~~-~--~~-:~:~~-~~=~~~~~~~~~~:~:J
`
`Nomina! Elapsed Tkne {hours)
`
`FIG.2
`
`-97-
`
`KILPATRICK TOWNSEND 69468060 1
`
`3
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`

`

`ABSTRACT
`
`CONCOMITANT ADMINISTRATION of GLUCOCORTIFCOID RECEPTOR
`
`MODULATORS and CYP3A INHIBITORS
`
`Applicant provides methods of treating diseases including Cushing's syndrome and
`
`hormone-sensitive cancers by concomitant administration of a glucocorticoid receptor antagonist
`
`(GRA) and steroidogenesis inhibitors, and by concomitant administration of a GRA and CYP3A
`
`inhibitors. Applicant provides methods of treating diseases including Cushing's syndrome and
`
`hormone-sensitive cancers by concomitant administration of mifepristone and ketoconazole.
`
`Subjects treated with CYP3A inhibitors or steroidogenesis inhibitors may suffer from
`
`toxicity or other serious adverse reactions; concomitant administration of other drugs would be
`
`expected to increase the risk of such toxicity and adverse reactions. Applicant has surprisingly
`
`found that GRAs may be administered to subjects receiving CYP3A inhibitors or steroidogenesis
`
`inhibitors such as ketoconazole without increasing risk adverse reactions; for example, Applicant
`
`has found that mifepristone may be concomitantly administered with ketoconazole (a CYP3A
`
`inhibitor and a steroidogenesis inhibitor), providing safe concomitant administration of the GRA
`
`and ketoconazole. In embodiments, the GRA dose may be reduced.
`
`-92-
`
`4
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`

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`CLAIMS
`
`1.
`
`A method of treating Cushing's syndrome in a patient who is taking a glucocorticoid
`
`receptor antagonist (GRA) comprising reducing the daily dose of said GRA from an original
`
`dose to an adjusted dose that is at least 33% less than said original dose when the patient is
`
`receiving concomitant administration of a CYP3A inhibitor.
`
`2.
`
`The method of claim 1, wherein said original dose is selected from 900 milligrams (mg)
`
`per day and 1200 mg per day of said GRA, and said adjusted dose is 600 mg per day of said
`
`GRA.
`
`3.
`
`The method of claim 1, wherein said original dose is 600 milligrams (mg) per day of said
`
`GRA, and said adjusted dose is 300 mg per day of said GRA, further comprising titrating the
`
`adjusted dose to a maximum of 600 mg per day of said GRA.
`
`4.
`
`The method of claim 1, wherein said GRA is mifepristone and said CYP3A inhibitor is a
`
`strong CYP3A inhibitor.
`
`5.
`
`The method of claim 2, wherein said GRA is mifepristone and said CYP3A inhibitor is a
`
`strong CYP3A inhibitor.
`
`6.
`
`The method of claim 3, wherein said GRA is mifepristone and said CYP3A inhibitor is a
`
`strong CYP3A inhibitor.
`
`7.
`
`8.
`
`9.
`
`The method of claim 1, wherein said CYP3A inhibitor is ketoconazole.
`
`The method of claim 4, wherein said CYP3A inhibitor is ketoconazole.
`
`The method of claim 5, wherein said CYP3A inhibitor is ketoconazole.
`
`10.
`
`A method of treating symptoms associated with elevated cortisol levels in a patient who
`
`is taking a glucocorticoid receptor antagonist (GRA) comprising reducing the daily dose of said
`
`GRA from an original dose to an adjusted dose that is at least 33% less than said original dose
`
`when the patient is receiving concomitant administration of a CYP3A inhibitor.
`
`11.
`
`The method of claim 10, wherein said original dose is selected from 900 milligrams (mg)
`
`per day and 1200 mg per day of said GRA, and said adjusted dose of GRA is 600 mg per day of
`
`said GRA.
`
`12.
`
`The method of claim 10, wherein said original dose is 600 milligrams (mg) per day of
`
`said GRA, and said adjusted dose is 300 mg per day of said GRA, further comprising titrating
`
`the adjusted dose to a maximum of 600 mg per day of said GRA.
`
`-89-
`
`5
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`

`

`13.
`
`The method of claim 10, wherein said GRA is mifepristone and said CYP3A inhibitor is
`
`a strong CYP3A inhibitor.
`
`14.
`
`The method of claim 11, wherein said GRA is mifepristone and said CYP3A inhibitor is
`
`a strong CYP3A inhibitor.
`
`15.
`
`The method of claim 12, wherein said GRA is mifepristone and said CYP3A inhibitor is
`
`a strong CYP3A inhibitor.
`
`16.
`
`17.
`
`18.
`
`19.
`
`The method of claim 10, wherein said CYP3A inhibitor is ketoconazole.
`
`The method of claim 13, wherein said CYP3A inhibitor is ketoconazole.
`
`The method of claim 14, wherein said CYP3A inhibitor is ketoconazole.
`
`A method of controlling hyperglycemia secondary to hypercortisolism in a patient with
`
`endogenous Cushing's syndrome who is taking a glucocorticoid receptor antagonist (GRA)
`
`comprising reducing the daily dose of said GRA from an original dose to an adjusted dose that is
`
`at least 33% less than said original dose when the patient is receiving concomitant administration
`
`of a CYP3A inhibitor.
`
`20.
`
`The method of claim 19, wherein said original dose is selected from 900 milligrams (mg)
`
`per day and 1200 mg per day of said GRA, and said adjusted dose of GRA is 600 mg per day of
`
`said GRA.
`
`21.
`
`The method of claim 19, wherein said original dose is 600 milligrams (mg) per day of
`
`said GRA, and said adjusted dose is 300 mg per day of said GRA, further comprising titrating
`
`the adjusted dose to a maximum of 600 mg per day of said GRA.
`
`22.
`
`The method of claim 19, wherein said GRA is mifepristone and said CYP3A inhibitor is
`
`a strong CYP3A inhibitor.
`
`23.
`
`The method of claim 20, wherein said GRA is mifepristone and said CYP3A inhibitor is
`
`a strong CYP3A inhibitor.
`
`24.
`
`The method of claim 21, wherein said GRA is mifepristone and said CYP3A inhibitor is
`
`a strong CYP3A inhibitor.
`
`25.
`
`26.
`
`27.
`
`The method of claim 19, wherein said CYP3A inhibitor is ketoconazole.
`
`The method of claim 22, wherein said CYP3A inhibitor is ketoconazole.
`
`The method of claim 23, wherein said CYP3A inhibitor is ketoconazole.
`
`-90-
`
`6
`
`

`

`28.
`
`A method of controlling hyperglycemia secondary to hypercortisolism in a patient with
`
`endogenous Cushing's syndrome comprising administering a daily dose of 600 milligrams (mg)
`
`mifepristone when the patient is receiving concomitant administration of a CYP3A inhibitor.
`
`29.
`
`30.
`
`The method of clam 28, wherein the CYP3A inhibitor is ketoconazole.
`
`The method of claim 29, wherein said daily dose of mifepristone is titrated up to 600 mg
`
`per day from 300 mg per day.
`
`-91-
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`7
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`

`

`At!y. Do<:kctNo. 085178-1053027-0! l4lOUS
`
`PTOiAIAi01 (06·12)
`t\pproved for use through 01131/2014. OMB 0651-0032
`U.S. Patent and Trademark Office: U.S, DEPARTMENT OF COMMERCE
`Under t~1e P;aperwork Reduction Act of "1995, no persons ars required to respond to a collection of infurmauon unless i! displays a va!id OMS control number.
`
`DECLARATION (37 CFR 1.63) FOR UTILITY OR DESIGN APPLICATION USING AN
`
`APPLICATION DATA SHEET (37 CFR 1.76)
`CONCOM1TANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR
`Titie of
`Invention MODULATORS AND CYP3A INHIBITORS
`
`As the below named inventor, I hereby declare that:
`
`Ttlis declaration
`is directed to:
`
`!21 The attached application, or
`
`0 United Stales appHcation or PCT international appfication number
`
`filed on
`
`The above-identified application was made or authorized to be made by me.
`
`I believe that I am the original inventor or an original joint inventor of a claimed invention in the application.
`
`I hereby acknowledge that any willful false statement made in this. declaration is punishable under 18 U.S.C. 1001
`by fine or imprisonment of not more than five (5) y'ears, or both.
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`LEGAL NAME OF INVENTOR
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`Date (Optional): l /~'{ /1 ·f-/ __ .... _~'+',~-----·
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`Inventor: .Joseph K. Belanoft
`Signature: __ (i))\i,_'"'_"-_·.'-. ----------------------------------
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`PTO/AIN14 (11-15)
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`085178-1053027-01141 ous
`
`Application Number
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`Title of Invention
`
`CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A
`INHIBITORS
`
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`Legal Name
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`
`I B ~oseph
`
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`City
`j'Aenlo Park
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`~-
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`~elanoff
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`I:Jo Corcept Therapeutics, Inc.
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`I!'Aenlo Park
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`149 Commonwealth Drive
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`pefiling@kilpatricktownsend.com
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`Title of the Invention
`r.YP3A INHIBITORS
`Attorney Docket Number p85178-1 053027-01141 ous
`Non provisional
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`111\1~1
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`EFSWeb2.2.12
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`PTO/AIN14 (11-15)
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A
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`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`085178-1053027-01141 ous
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`Attorney Docket Number
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`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`
`CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A
`INHIBITORS
`
`Prior Application Status
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`j:>ending
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`Filing Date (YYYY-MM-DD)
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`Statement under 37 CFR 1.55 or 1.78 for AlA (First Inventor to File) Transition
`Applications
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`This application (1) claims priority to or the benefit of an application filed before March 16, 2013 and (2) also
`contains, or contained at any time, a claim to a claimed invention that has an effective filing date on or after March
`D 16,2013.
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, with a filing date on or after March
`16, 2013, will be examined under the first inventor to file provisions of the AlA.
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`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`085178-1053027-01141 ous
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`Attorney Docket Number
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`Application Data Sheet 37 CFR 1.76
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`Application Number
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`Title of Invention
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`CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A
`INHIBITORS
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`Authorization or Opt-Out of Authorization to Permit Access:
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`When this Application Data Sheet is properly signed and filed with the application, applicant has provided written
`authority to permit a participating foreign intellectual property (IP) office access to the instant application-as-filed (see
`paragraph A in subsection 1 below) and the European Patent Office (EPO) access to any search results from the instant
`application (see paragraph Bin subsection 1 below).
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`Should applicant choose not to provide an authorization identified in subsection 1 below, applicant must opt-out of the
`authorization by checking the corresponding box A orB or both in subsection 2 below.
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`NOTE: This section of the Application Data Sheet is ONLY reviewed and processed with the INITIAL filing of an
`application. After the initial filing of an application, an Application Data Sheet cannot be used to provide or rescind
`authorization for access by a foreign IP office(s). Instead, Form PTO/SB/39 or PTO/SB/69 must be used as appropriate.
`
`1. Authorization to Permit Access by a Foreign Intellectual Property Office(s)
`
`A. Prioritv Document Exchange IPDXl- Unless box A in subsection 2 (opt-out of authorization) is checked, the
`undersigned hereby grants the USPTO authoritv to provide the European Patent Office (EPO), the Japan Patent Office
`(JPO), the Korean Intellectual Property Office (KIPO), the State Intellectual Property Office of the People's Republic of
`China (SIPO), the World Intellectual Property Organization (WI PO), and any other foreign intellectual property office
`participating with the USPTO in a bilateral or multilateral priority document exchange agreement in which a foreign
`application claiming priority to the instant patent application is filed, access to: (1) the instant patent application-as-filed
`and its related bibliographic data, (2) any foreign or domestic application to which priority or benefit is claimed by the
`instant application and its related bibliographic data, and (3) the date of filing of this Authorization. See 37 CFR 1.14(h)
`(1 ).
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`B. Search Results from U.S. Application to EPO- Unless box Bin subsection 2 (opt-out of authorization) is checked,
`the undersigned hereby grants the USPTO authoritv to provide the EPO access to the bibliographic data and search
`results from the instant patent application when a European patent application claiming priority to the instant patent
`application is filed. See 37 CFR 1.14(h)(2).
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`The applicant is reminded that the EPO's Rule 141(1) EPC (European Patent Convention) requires applicants to submit a
`copy of search results from the instant application without delay in a European patent application that claims priority to
`the instant application.
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`2. Opt-Out of Authorizations to Permit Access by a Foreign Intellectual Property Office(s)
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`A. Applicant DOES NOT authorize the USPTO to permit a participating foreign IP office access to the instant
`D application-as-filed. If this box is checked, the USPTO will not be providing a participating foreign IP office with
`any documents and information identified in subsection 1A above.
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`B. Applicant DOES NOT authorize the USPTO to transmit to the EPO any search results from the instant patent
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`application.
`NOTE: Once the application has published or is otherwise publicly available, the USPTO may provide access to the
`application in accordance with 37 CFR 1.14.
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`EFS Web 2.2.12
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`12
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`

`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`085178-1053027-01141 ous
`
`Attorney Docket Number
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`
`CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A
`INHIBITORS
`
`Applicant Information:
`
`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title 37 of CFR
`to have an assignment recorded by the Office.
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`I Remove I
`Applicant
`11
`If the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and address of the legal representative who is the applicant under 37 CFR
`1.43; or the name and address of the assignee, person to whom the inventor is under an obligation to assign the invention, or person
`who otherwise shows sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an
`applicant under 37 CFR 1.46 (assignee, person to whom the inventor is obligated to assign, or person who otherwise shows sufficient
`proprietary interest) together with one or more joint inventors, then the joint inventor or inventors who are also the applicant should be
`identified in this section.
`
`I Clear
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`• Assignee
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`Person to whom the inventor is obligated to assign.
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`Legal Representative under 35 U.S.C. 117
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`Joint Inventor
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`Person who shows sufficient proprietary interest
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`I
`If applicant is the legal representative, indicate the authority to file the patent application, the inventor is:
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`l:l
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`Name of the Deceased or Legally Incapacitated Inventor: I
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`Organization Name
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`If the Applicant is an Organization check here.
`I ~orcept Therapeutics, Inc.
`Mailing Address Information For Applicant:
`
`~
`
`Address 1
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`Address 2
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`City
`CountrY I 1-Js
`Phone Number
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`Email Address
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`~49 Commonwealth Drive
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`jvlenlo Park
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`State/Province
`
`CA
`
`Postal Code
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`Fax Number
`
`94025
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`Additional Applicant Data may be generated within this form by selecting the Add button.
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`Assignee Information including Non-Applicant Assignee Information:
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`Providing assignment information in this section does not substitute for compliance with any requirement of part 3 of Title
`37 of CFR to have an assignment recorded by the Office.
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`13
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`

`

`PTO/AIN14 (11-15)
`Approved for use through 04/30/2017. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
`085178-1053027-01141 ous
`
`Attorney Docket Number
`
`Application Data Sheet 37 CFR 1.76
`
`Application Number
`
`Title of Invention
`
`CONCOMITANT ADMINISTRATION OF GLUCOCORTICOID RECEPTOR MODULATORS AND CYP3A
`INHIBITORS
`
`Assig