UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES 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.
`
`CONFIRMATION NO.
`
`13/256,396
`
`11/29/2011
`
`Lenny Dang
`
`C2081-7013US
`
`9930
`
`7 5 90
`3 7 46 2
`LANDO & ANASTASI, LLP
`ONE MAIN STREET, SUIIB 1100
`CAMBRIDGE, MA 02142
`
`10/28/2013
`
`EXAMINER
`
`POHNERT, STEVEN C
`
`ART UNIT
`
`PAPER NUMBER
`
`1634
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/28/2013
`
`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):
`docketing@LALaw.com
`gengelson@LALaw.com
`
`PTOL-90A (Rev. 04/07)
`
`Rigel Exhibit 1021
`Page 1 of 582
`
`

`

`Notice of Abandonment
`
`Application No.
`
`13/256,396
`Examiner
`
`Applicant(s)
`
`DANG ET AL.
`Art Unit
`
`1634
`STEVEN POHNERT
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`
`Th is application is abandoned in view of:
`
`1. 1:8] Applicant's failure to timely file a proper reply to the Office letter mailed on 11 January 2013.
`(a) D A reply was received on __ (with a Certificate of Mailing or Transmission dated __ ), which is after the expiration of the
`period for reply (including a total extension of time of __ month(s)) which expired on __ .
`(b) DA proposed reply was received on __ , but it does not constitute a proper reply under 37 CFR 1.113 (a) to the final rejection.
`(A proper reply under 37 CFR 1.113 to a final rejection consists only of: (1) a timely filed amendment which places the
`application in condition for allowance; (2) a timely filed Notice of Appeal (with appeal fee); or (3) a timely filed Request for
`Continued Examination (RCE) in compliance with 37 CFR 1.114).
`(c) 1:8] A reply was received on 10 Julv2013 but it does not constitute a proper reply, or a bona fide attempt at a proper reply, to the
`non-final rejection. See 37 CFR 1.85(a) and 1.111. (See explanation in box 7 below).
`(d) D No reply has been received.
`
`2. D Applicant's failure to timely pay the required issue fee and publication fee, if applicable, within the statutory period of three months
`from the mailing date of the Notice of Allowance (PTOL-85).
`(a) D The issue fee and publication fee, if applicable, was received on __ (with a Certificate of Mailing or Transmission dated
`__ ), which is after the expiration of the statutory period for payment of the issue fee (and publication fee) set in the Notice of
`Allowance (PTOL-85).
`(b) D The submitted fee of$ __ is insufficient. A balance of$ __ is due.
`The issue fee required by 37 CFR 1.18 is $ __ . The publication fee, if required by 37 CFR 1.18(d), is$ __ .
`(c) D The issue fee and publication fee, if applicable, has not been received.
`
`3.0 Applicant's failure to timely file corrected drawings as required by, and within the three-month period set in, the Notice of
`Allowability (PT0-37).
`(a) D Proposed corrected drawings were received on __ (with a Certificate of Mailing or Transmission dated __ ), which is
`after the expiration of the period for reply.
`(b) D No corrected drawings have been received.
`
`4. D The letter of express abandonment which is signed by the attorney or agent of record, the assignee of the entire interest, or all of
`the applicants.
`
`5. D The letter of express abandonment which is signed by an attorney or agent (acting in a representative capacity under 37 CFR
`1.34(a)) upon the filing of a continuing application.
`
`6. D The decision by the Board of Patent Appeals and Interference rendered on __ and because the period for seeking court review
`of the decision has expired and there are no allowed claims.
`
`7. 1:8] The reason(s) below:
`
`The response of 7/10/2013 did not amend the claims or provide arguments to overcome the issues of record.
`
`/Steven C Pohnert/
`Primary Examiner, Art Unit 1634
`
`Petitions to revive under 37 CFR 1.137(a) or (b), or requests to withdraw the holding of abandonment under 37 CFR 1.181, should be promptly filed to
`minimize any neqative effects on patent term.
`U.S. Patent and Trademark Office
`PTOL-1432 (Rev. 04-01)
`
`Notice of Abandonment
`
`Part of Paper No. 20131022
`
`Rigel Exhibit 1021
`Page 2 of 582
`
`

`

`PETITION FOR EXTENSION OF TIME UNDER 37 CFR 1.136(a)
`
`Application Number
`
`For
`
`13/256,396
`
`Docket Number (Optional)
`C2081-7013US
`
`Filed
`
`March 12, 201 O
`
`METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED DISORDERS
`
`Art Unit
`
`1634
`
`Examiner
`
`S. C. Pohnert
`
`This is a request under the provisions of 37 CFR 1.136(a) to extend the period for filing a reply in the above-identified application.
`
`The requested extension and fee are as follows (check time period desired and enter the appropriate fee below):
`
`Fee
`$200
`
`$600
`
`$1,400
`
`$2,200
`
`$3000
`
`Small Entitt Fee
`$100
`
`Micro Entitt Fee
`$50
`
`$300
`
`$700
`
`$1,100
`
`$1,500
`
`$150
`
`$350
`
`$550
`
`$750
`
`$
`
`$
`
`$
`
`$
`
`$
`
`1,400.00
`
`□ One month (37 CFR 1.17(a)(1))
`□ Two months (37 CFR 1.17(a)(2))
`G Three months (37 CFR 1.17(a)(3))
`□ Four months (37 CFR 1.17(a)(4))
`□ Five months (37 CFR 1.17(a)(5))
`□ Applicant asserts small entity status. See 37 CFR 1.27.
`□ Applicant certifies micro entity status. See 37 CFR 1.29.
`□ A check in the amount of the fee is enclosed.
`□ Payment by credit card. Form PTO-2038 is attached.
`G The Director has already been authorized to charge fees in this application to a Deposit Account.
`G The Director is hereby authorized to charge any fees which may be required, or credit any overpayment, to
`G Payment made via EFS-Web.
`
`Form PTO/SB/15A or B or equivalent must either be enclosed or have been submitted previously.
`
`Deposit Account Number
`
`50/2762
`
`WARNING: Information on this form may become public. Credit card information should not be included on this form. Provide
`credit card information and authorization on PTO-2038.
`I am the
`
`□ applicant.
`G attorney or agent of record. Registration Number
`□ attorney or agent acting under 37 CFR 1 .34. Registration number
`
`54,301
`
`/Catherine M. McCarty/
`Signature
`
`Catherine M.McCarty
`Typed or printed name
`
`July 10, 2013
`Date
`
`(617) 395-7015
`Telephone Number
`
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and certifications. Submit
`multiple forms if more than one signature is required, see below*.
`
`D *Total of
`
`forms are submitted.
`
`Rigel Exhibit 1021
`Page 3 of 582
`
`

`

`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`13256396
`
`29-Nov-2011
`
`Title of Invention:
`
`METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED
`DISORDERS
`
`First Named Inventor/Applicant Name:
`
`Lenny Dang
`
`Filer:
`
`Catherine M. McCarty/Kelly Burke
`
`Attorney Docket Number:
`
`C2081-7013US
`
`Filed as Large Entity
`
`U.S. National Stage under 35 USC 371 Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Basic Filing:
`
`Pages:
`
`Claims:
`
`Miscellaneous-Filing:
`
`Petition:
`
`Patent-Appeals-and-Interference:
`
`Post-Allowance-and-Post-Issuance:
`
`Extension-of-Time:
`
`Extension - 3 months with $0 paid
`
`1253
`
`1
`
`1400
`
`1400
`
`Rigel Exhibit 1021
`Page 4 of 582
`
`

`

`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Miscellaneous:
`
`Total in USD ($)
`
`1400
`
`Rigel Exhibit 1021
`Page 5 of 582
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`16278099
`
`13256396
`
`International Application Number:
`
`Confirmation Number:
`
`9930
`
`Title of Invention:
`
`METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED
`DISORDERS
`
`First Named Inventor/Applicant Name:
`
`Lenny Dang
`
`Customer Number:
`
`37462
`
`Filer:
`
`Catherine M. McCarty
`
`Filer Authorized By:
`
`Attorney Docket Number:
`
`C2081-7013US
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`10-JUL-2013
`
`29-NOV-2011
`
`19:41:22
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was successfully received in RAM
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
`yes
`
`Deposit Account
`
`$1400
`
`6633
`
`502762
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.R. 1.492 (National application filing, search, and examination fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
`
`Rigel Exhibit 1021
`Page 6 of 582
`
`

`

`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`File Size(Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`1
`
`Extension of Time
`
`Th ree_Mont h_Req u est_for _Ext
`ension_of_ Time_Under_37 _CF
`R_ 1136a_ 1.pdf
`
`20726
`
`no
`
`1
`
`07850f1cd9660255743d328c777d347b1 63
`83b6d
`
`Warnings:
`
`Information:
`
`2
`
`Fee Worksheet (SB06)
`
`fee-info.pdf
`
`no
`
`2
`
`30702
`
`aa 7 a098a059bc2 628bbf5b0ff2 78bbe2e 1 6
`3178
`
`Warnings:
`
`Information:
`
`Total Files Size (in bytes)
`
`51428
`
`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.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a 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 shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication 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/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication 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 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Rigel Exhibit 1021
`Page 7 of 582
`
`

`

`Docket No.: C2081-7013US (PATENT)
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicant
`Serial No.
`Filed
`Title
`
`1634
`Art Unit
`Dang et al.
`Examiner : Steven C. Pohnert
`13/256,396
`Conf. No. : 9930
`March 12, 2010
`METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED
`DISORDERS
`
`CERTIFICATE OF TRANSMISSION UNDER 37 C.F.R. §1.8(a)
`
`The undersigned hereby certifies that this document is being electronically filed in accordance with §1.6(a)(4), on
`the 27 th day of June 2013.
`
`/Asimina T. Georges Evangelinos/
`Asimina T. Georges Evangelinos (Reg. No. 66,888)
`
`Commissioner for Patents
`
`Madam:
`
`INTERVIEW SUMMARY
`
`Applicants thank the Examiner for the courtesy of the telephonic interview with
`
`Applicants' representative Catherine M. McCarty on May 21, 2013. Applicants agree with the
`
`Examiner's characterization of the interview as provided in the Interview Summary mailed on
`
`May 29, 2013.
`
`This Interview Summary is being timely filed within one month of the mailing date of the
`
`Examiner's Interview Summary form, which was May 29, 2013. No fees are believed to be due.
`
`However, any necessary charges, or any credits, should be applied to Deposit Account No. 50-
`
`2762, referencing Attorney Docket No. C2081-7013US.
`
`Respectfully submitted,
`Lenny Dang, et al.
`
`By: /Asimina T. Georges Evangelinos/
`Asimina T. Georges Evangelinos, Reg. No. 66,888
`LANDO & ANASTASI, LLP
`Riverfront Office Park
`One Main Street
`Cambridge, MA 02142
`Tel.: (617) 395-7067
`Fax: (617) 395-7070
`Attorney for Applicant
`
`Rigel Exhibit 1021
`Page 8 of 582
`
`

`

`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`16169691
`
`13256396
`
`International Application Number:
`
`Confirmation Number:
`
`9930
`
`Title of Invention:
`
`METHODS AND COMPOSITIONS FOR CELL-PROLIFERATION-RELATED
`DISORDERS
`
`First Named Inventor/Applicant Name:
`
`Lenny Dang
`
`Customer Number:
`
`37462
`
`Filer:
`
`Asimini T. Georges Evangelinos
`
`Filer Authorized By:
`
`Attorney Docket Number:
`
`C2081-7013US
`
`Receipt Date:
`
`Filing Date:
`
`Time Stamp:
`
`27-JUN-2013
`
`29-NOV-2011
`
`14:13:21
`
`Application Type:
`
`U.S. National Stage under 35 USC 371
`
`Payment information:
`
`Submitted with Payment
`
`I no
`
`File Listing:
`
`Document
`Number
`
`Document Description
`
`File Name
`
`1
`
`Applicant summary of interview with
`examiner
`
`T2021-7013US_Response_to_l
`nterview_Summary_ 1.pdf
`
`Warnings:
`
`Information:
`
`File Size(Bytes)/
`Message Digest
`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
`
`17795
`
`no
`
`1
`
`c7b66b88c595d2a 1 dff382b 121 e31 dcd39d
`775ab
`
`Rigel Exhibit 1021
`Page 9 of 582
`
`

`

`Total Files Size (in bytes)
`
`17795
`
`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.
`
`New Applications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a 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 shown on this
`Acknowledgement Receipt will establish the filing 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/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`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 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/RO/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Rigel Exhibit 1021
`Page 10 of 582
`
`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES 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.
`
`CONFIRMATION NO.
`
`13/256,396
`
`11/29/2011
`
`Lenny Dang
`
`C2081-7013US
`
`9930
`
`7590
`37462
`LANDO & ANASTASI, LLP
`ONE MAIN STREET, SUIIB 1100
`CAMBRIDGE, MA 02142
`
`05/29/2013
`
`EXAMINER
`
`POHNERT, STEVEN C
`
`ART UNIT
`
`PAPER NUMBER
`
`1634
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/29/2013
`
`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):
`docketing@LALaw.com
`gengelson@LALaw.com
`
`PTOL-90A (Rev. 04/07)
`
`Rigel Exhibit 1021
`Page 11 of 582
`
`

`

`Applicant-Initiated Interview Summary
`
`Application No.
`
`13/256,396
`
`Examiner
`
`STEVEN POHNERT
`
`Applicant(s)
`
`DANG ET AL.
`
`Art Unit
`
`1634
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) STEVEN POHNERT.
`
`(2) Catyh McCarty.
`
`Date of Interview: 21 May 2013.
`
`(3) __ .
`
`(4) __ .
`
`Type: ~ Telephonic □ Video Conference
`D Personal [copy given to: D applicant D applicant's representative]
`
`Exhibit shown or demonstration conducted: □ Yes
`If Yes, brief description: __ .
`
`~No.
`
`Issues Discussed ~101 0112 0102 □ 103 □ Others
`(For each of the checked box( es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: 93 and 97.
`
`Identification of prior art discussed: none.
`
`Substance of Interview
`(For each issue discussed, provide a detailed description and indicate if agreement was reached. Some topics may include: identification or clarification of a
`reference or a portion thereof, claim interpretation, proposed amendments, arguments of any applied references etc ... )
`
`AQQ_/icant's reg_resentative contacted the examiner about the 101 reiection of record. The examiner indicated that his
`current understanding_ of the 101 g_uidance in view of the Sug_reme Courts Prometheus decision is for a claim to
`overcome the reiection the claim would either have a novel or non-obvious reag_ent or treatment. The examiner further
`indicated that he had heard sug_g_estions that limiting_ claims to a sg_ecific g_og_ulation, may overcome the 101 issues, but
`most recent direction sug_g_ested that would not be sufficient. The examiner indicated if he were the reg_resentative he
`would look into arg_uments that imag_ing_ a whole human for 2HG for the detection of cancer is non-obvious. The
`examiner ag_olog_ized for his inability to g_ive a sg_ecific route to overcome the 101, but indicated he had not been g_iven
`any sg_ecific g_uidance other than novel or non-obvious reag_ents and treatments. There were no ag_reements on
`g_atentability. The examiner did indicate he would be og_en to further interviews of discussion ug_on reg_uest and
`scheduling_ availability . .
`
`Applicant recordation instructions: The formal written reply to the last Office action must include the substance of the interview. (See MPEP
`section 713.04). If a reply to the last Office action has already been filed, applicant is given a non-extendable period of the longer of one month or
`thirty days from this interview date, or the mailing date of this interview summary form, whichever is later, to file a statement of the substance of the
`interview
`
`Examiner recordation instructions: Examiners must summarize the substance of any interview of record. A complete and proper recordation of
`the substance of an interview should include the items listed in MPEP 713.04 for complete and proper recordation including the identification of the
`general thrust of each argument or issue discussed, a general indication of any other pertinent matters discussed regarding patentability and the
`general results or outcome of the interview, to include an indication as to whether or not agreement was reached on the issues raised.
`D Attachment
`/Steven C Pohnert/
`Primary Examiner, Art Unit 1634
`
`U.S. Patent and Trademark Office
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20130521
`
`Rigel Exhibit 1021
`Page 12 of 582
`
`

`

`Manual of Patent Examining Procedure (MPEP), Section 713.04, Substance of Interview Must be Made of Record
`A complete written statement as to the substance of any face-to-face, video conference, or telephone interview with regard to an application must be made of record in the
`application whether or not an agreement with the examiner was reached at the interview.
`
`Summary of Record of Interview Requirements
`
`Title 37 Code of Federal Regulations (CFR) § 1.133 Interviews
`Paragraph (b)
`
`In every instance where reconsideration is requested in view of an interview with an examiner, a complete written statement of the reasons presented at the interview as
`warranting favorable action must be filed by the applicant. An interview does not remove the necessity for reply to Office action as specified in§§ 1.111, 1.135. (35 U.S.C. 132)
`
`37 CFR §1.2 Business to be transacted in writing.
`All business with the Patent or Trademark Office should be transacted in writing. The personal attendance of applicants or their attorneys or agents at the Patent and
`Trademark Office is unnecessary. The action of the Patent and Trademark Office will be based exclusively on the written record in the Office. No attention will be paid to
`any alleged oral promise, stipulation, or understanding in relation to which there is disagreement or doubt.
`
`The action of the Patent and Trademark Office cannot be based exclusively on the written record in the Office if that record is itself
`incomplete through the failure to record the substance of interviews.
`It is the responsibility of the applicant or the attorney or agent to make the substance of an interview of record in the application file, unless
`the examiner indicates he or she will do so. It is the examiner's responsibility to see that such a record is made and to correct material inaccuracies
`which bear directly on the question of patentability.
`
`Examiners must complete an Interview Summary Form for each interview held where a matter of substance has been discussed during the
`interview by checking the appropriate boxes and filling in the blanks. Discussions regarding only procedural matters, directed solely to restriction
`requirements for which interview recordation is otherwise provided for in Section 812.01 of the Manual of Patent Examining Procedure, or pointing
`out typographical errors or unreadable script in Office actions or the like, are excluded from the interview recordation procedures below. Where the
`substance of an interview is completely recorded in an Examiners Amendment, no separate Interview Summary Record is required.
`
`The Interview Summary Form shall be given an appropriate Paper No., placed in the right hand portion of the file, and listed on the
`"Contents" section of the file wrapper. In a personal interview, a duplicate of the Form is given to the applicant (or attorney or agent) at the
`conclusion of the interview. In the case of a telephone or video-conference interview, the copy is mailed to the applicant's correspondence address
`either with or prior to the next official communication. If additional correspondence from the examiner is not likely before an allowance or if other
`circumstances dictate, the Form should be mailed promptly after the interview rather than with the next official communication.
`
`The Form provides for recordation of the following information:
`-Application Number (Series Code and Serial Number)
`- Name of applicant
`- Name of examiner
`- Date of interview
`- Type of interview (telephonic, video-conference, or personal)
`-Name of participant(s) (applicant, attorney or agent, examiner, other PTO personnel, etc.)
`-An indication whether or not an exhibit was shown or a demonstration conducted
`-An identification of the specific prior art discussed
`An indication whether an agreement was reached and if so, a description of the general nature of the agreement (may be by
`-
`attachment of a copy of amendments or claims agreed as being allowable). Note: Agreement as to allowability is tentative and does
`not restrict further action by the examiner to the contrary.
`- The signature of the examiner who conducted the interview (if Form is not an attachment to a signed Office action)
`
`It is desirable that the examiner orally remind the applicant of his or her obligation to record the substance of the interview of each case. It
`should be noted, however, that the Interview Summary Form will not normally be considered a complete and proper recordation of the interview
`unless it includes, or is supplemented by the applicant or the examiner to include, all of the applicable items required below concerning the
`substance of the interview.
`A complete and proper recordation of the substance of any interview should include at least the following applicable items:
`1) A brief description of the nature of any exhibit shown or any demonstration conducted,
`2) an identification of the claims discussed,
`3) an identification of the specific prior art discussed,
`4) an identification of the principal proposed amendments of a substantive nature discussed, unless these are already described on the
`Interview Summary Form completed by the Examiner,
`5) a brief identification of the general thrust of the principal arguments presented to the examiner,
`(The identification of arguments need not be lengthy or elaborate. A verbatim or highly detailed description of the arguments is not
`required. The identification of the arguments is sufficient if the general nature or thrust of the principal arguments made to the
`examiner can be understood in the context of the application file. Of course, the applicant may desire to emphasize and fully
`describe those arguments which he or she feels were or might be persuasive to the examiner.)
`6) a general indication of any other pertinent matters discussed, and
`7) if appropriate, the general results or outcome of the interview unless already described in the Interview Summary Form completed by
`the examiner.
`Examiners are expected to carefully review the applicant's record of the substance of an interview. If the record is not complete and
`accurate, the examiner will give the applicant an extendable one month time period to correct the record.
`
`Examiner to Check for Accuracy
`
`If the claims are allowable for other reasons of record, the examiner should send a letter setting forth the examiner's version of the
`statement attributed to him or her. If the record is complete and accurate, the examiner should place the indication, "Interview Record OK" on the
`paper recording the substance of the interview along with the date and the examiner's initials.
`
`Rigel Exhibit 1021
`Page 13 of 582
`
`

`

`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES 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.
`
`CONFIRMATION NO.
`
`13/256,396
`
`11/29/2011
`
`Lenny Dang
`
`C2081-7013US
`
`9930
`
`7590
`37462
`LANDO & ANASTASI, LLP
`ONE MAIN STREET, SUIIB 1100
`CAMBRIDGE, MA 02142
`
`01/11/2013
`
`EXAMINER
`
`POHNERT, STEVEN C
`
`ART UNIT
`
`PAPER NUMBER
`
`1634
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`01/11/2013
`
`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):
`docketing@LALaw.com
`gengelson@LALaw.com
`
`PTOL-90A (Rev. 04/07)
`
`Rigel Exhibit 1021
`Page 14 of 582
`
`

`

`Office Action Summary
`
`Application No.
`
`13/256,396
`
`Examiner
`
`Applicant(s)
`
`DANG ET AL.
`
`Art Unit
`
`1634
`STEVEN POHNERT
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1 )IZI Responsive to communication(s) filed on 20 December 2012.
`2a)D This action is FINAL.
`2b)IZI This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election have been incorporated into this action.
`4)0 Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Ex parte Quayle, 1935 G.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`5)1Zl Claim(s) 41-99 is/are pending in the application.
`5a) Of the above claim(s) 41-92 and 94-95
`is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)1Zl Claim(s) 93 and 96-99 is/are rejected.
`8)1Zl Claim(s) 93 and 96-99 is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway
`program at a participating intellectual property office for the corresponding application. For more information, please see
`htto:/iwww.uspto.aov/oatents/init events/pph/index.is_p or send an inquiry to PPHfeedback@uspto.qov.
`
`Application Papers
`
`1 0)D The specification is objected to by the Examiner.
`11 )IZI The drawing(s) filed on 30 September 2011 is/are: a)D accepted or b)IZI objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`
`12)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`a)D All b)D Some * c)D None of:
`1.0 Certified copies of the priority documents have been received.
`2.0 Certified copies of the priority documents have been received in Application No. __ .
`3.0 Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`*Seethe attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) [8J Notice of References Cited (PTO-892)
`
`2) [8J Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mail Date 12/20/2012.
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 09-12)
`
`3) D Interview Summary (PTO-413)
`Paper No(s)/Mail Date. __ .
`4) D Other: __ .
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20130108
`
`Rigel Exhibit 1021
`Page 15 of 582
`
`

`

`Application/Control Number: 13/256,396
`Art Unit: 1634
`
`Page 2
`
`DETAILED ACTION
`
`Election/Restrictions
`
`1.
`
`Applicant's election with traverse of group 17, claims 93 (in part) and 96-99 in the
`
`reply filed on 11/29/2012 is acknowledged. The traversal is on the ground(s) that the
`
`response asserts nothing in Balss teaches or suggests evaluating a subject or selecting
`
`a subject based on IDH1 or IDH2 allele with 2HG neoactivity. The response further
`
`asserts Balss is silent with regard to 2HG neoactivity. This is not found persuasive
`
`because the specification lacks a limiting definition of 2HG neoactivity. Thus the
`
`broadest reasonable interpretation of the claims appears to merely require the detection
`
`of mutant IDH1 or IDH2 or 2HG which is obvious or anticipated over the teachings of
`
`Balss and Struys (FEBS(2004) volume 557, pages 115-120) which teaches detection of
`
`2HG in subjects without2-hydroxyglutaric aciduria.
`
`Claims 41-92 and 94-95 are withdrawn from further consideration pursuant to 37
`
`CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable
`
`generic or linking claim. Applicant timely traversed th