`
`UNITED STATES DEPARTMENT OF COMMERCE
`United State-s Patent and Trademark Office-
`Address: COMMISSIONER FOR PA TENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`13/939,519
`
`07/11/2013
`
`Leonard Luan C. Dang
`
`C2081-701320
`
`2110
`
`09/07/2017
`
`7590
`94970
`LANDO & ANASTASI, LLP
`C2081
`ONE MAIN STREET, SUITE 1100
`CAMBRIDGE, MA 02142
`
`EXAMINER
`
`HIXSON, CHRISTOPHER
`
`ART UNIT
`
`PAPER NUMBER
`
`1797
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/07/2017
`
`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
`pair_ agios@firsttofile.com
`CKent@LALaw.com
`
`PTOL-90A (Rev. 04/07)
`
`Rigel Exhibit 1020
`Page 1 of 1266
`
`
`
`Notice of Abandonment
`
`Application No.
`
`13/939,519
`Examiner
`
`Applicant(s)
`
`Dani:i et al.
`Art Unit
`
`1797
`CHRISTOPHER A HIXSON
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address-(cid:173)
`
`This application is abandoned in view of:
`
`1. Ii'.) Applicant's failure to timely file a proper reply to the Office letter mailed on 09 February 2017.
`(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) D A proposed reply was received on __ , but it does not constitute a proper reply under 37 CFR 1.113 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) if this is utility or plant
`application, a timely filed Request for Continued Examination (RCE) in compliance with 37 CFR 1.114. Note that RCEs are not
`permitted in design applications.)
`(c) DA reply was received on __ 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) Ii'.) 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 1.1 B(d), is$ __ .
`(c) D The issue fee and publication fee, if applicable, has not been received.
`
`3. D Applicant's failure to timely file corrected drawings as required by, and within the three-month period set in, the Notice of
`Allowability (PTO-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 or other party authorized under 37 CFR 1.33
`(b). See 37 CFR 1.138(b).
`
`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) 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. D The reason(s) below:
`
`/Christopher Adam Hixson/
`Primary Examiner, Ari Unit 1797
`
`Petitions to revive under 37 CFR 1.137, or requests to withdraw the holding of abandonment under 37 CFR 1.181, should be promptly filed to minimize
`anv neaative effects on oatent term.
`U.S. Patent and Trademark Office
`PTOL-1432 (Rev. 07-14)
`
`Notice of Abandonment
`
`Part of Paper No. 20170905
`
`Rigel Exhibit 1020
`Page 2 of 1266
`
`
`
`UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`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.
`
`CONFIRMATION NO.
`
`13/939,519
`
`07/11/2013
`
`Leonard Luan C. Dang
`
`C2081-701320
`
`2110
`
`05/02/2017
`
`7590
`94970
`LANDO & ANASTASI, LLP
`C2081
`ONE MAIN STREET, SUITE 1100
`CAMBRIDGE, MA 02142
`
`EXAMINER
`
`HIXSON, CHRISTOPHER
`
`ART UNIT
`
`PAPER NUMBER
`
`1797
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`05/02/2017
`
`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
`pair_agios@firsttofile.com
`CKent@LALaw.com
`
`PTOL-90A (Rev. 04/07)
`
`Rigel Exhibit 1020
`Page 3 of 1266
`
`
`
`Applicant-Initiated Interview Summary
`
`Application No.
`
`13/939,519
`
`Examiner
`
`Christopher A. Hixson
`
`Applicant(s)
`
`DANG ET AL.
`
`Art Unit
`
`1797
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) Christopher A. Hixson.
`
`(2) Asimina T. Georges Evanqelinos.
`
`Date of Interview: 26Apri/2O17.
`
`(3) _ _ .
`
`(4) __ .
`
`Type: ~ Telephonic □ Video Conference
`D Personal [copy given to: D applicant D applicant's representative]
`
`Exhibit shown or demonstration conducted: □ Yes □ No.
`If Yes, brief description: __ .
`
`Issues Discussed ~101 D112 D102 0103 □ Others
`(For each of the checked box( es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: __ .
`
`Identification of prior art discussed: __ .
`
`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 ... )
`
`Previous/'{__, the examiner had offered certain subiect matter to the applicants as potential/'{__ allowable subiect matter. At
`the time, the declined the examiner's offer. However, at last RCE filing, the'{__ amended their claims to comport with the
`examiner's previous offer. The applicant phoned toda'i.. to inquire as to wh'i.. instead of a notice of allowance, the non-
`final reiection mailed 9 Feburar'i..2O17 was issued. The examiner explained that in the time since the original offer was
`made, he realized Cafter training and discussion with colleques/ that the subiect matter previous/'{__ identified as allowable
`was in fact not subiect matter eligible. The examiner indicated that subiect matter he had previous/'{__ considered non-
`conventional could in fact be demonstrated as being conventional, and in his reiection he cited evidence supporting this
`understanding. The applicant informed the examiner that though the evidence was received b'i.. them, it was illegible.
`The examiner agreed to provide the best COP'i.. he could obtain .
`
`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
`/Christopher A. Hixson/
`Primary Examiner, Art Unit 1797
`
`U.S. Patent and Trademark Office
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20170426
`
`Rigel Exhibit 1020
`Page 4 of 1266
`
`
`
`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 1020
`Page 5 of 1266
`
`
`
`UNITED STA TES p A TENT AND TRADEMARK OFFICE
`
`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.
`
`CONFIRMATION NO.
`
`13/939,519
`
`07/11/2013
`
`Leonard Luan C. Dang
`
`C2081-701320
`
`2110
`
`02/09/2017
`
`7590
`94970
`LANDO & ANASTASI, LLP
`C2081
`ONE MAIN STREET, SUITE 1100
`CAMBRIDGE, MA 02142
`
`EXAMINER
`
`HIXSON, CHRISTOPHER
`
`ART UNIT
`
`PAPER NUMBER
`
`1797
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`02/09/2017
`
`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
`pair_agios@firsttofile.com
`CKent@LALaw.com
`
`PTOL-90A (Rev. 04/07)
`
`Rigel Exhibit 1020
`Page 6 of 1266
`
`
`
`Application No.
`13/939,519
`
`Applicant(s)
`DANG ET AL.
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`Christopher A. Hixson
`
`Art Unit
`1797
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS 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 )~ Responsive to communication(s) filed on 13 January 2017.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)O This action is FINAL.
`2b)~ 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 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)~ Claim(s) 93-95.99.101-103 and 105-107is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 93-95.99.101-103 and 105-107is/are rejected.
`8)0 Claim(s) __ 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
`http:ilwww.usoto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )0 The drawing(s) filed on __ is/are: a)O accepted or b)O 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).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment{s)
`1) ~ Notice of References Cited (PTO-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date __ .
`
`3) 0 Interview Summary (PTO-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20170206
`
`Rigel Exhibit 1020
`Page 7 of 1266
`
`
`
`Application/Control Number: 13/939,519
`Art Unit: 1797
`
`Page 2
`
`1.
`
`The present application is being examined under the pre-AIA first to invent
`
`provisions.
`
`DETAILED ACTION
`
`2.
`
`The RCE dated 13 January 2017 is acknowledged. Claims 1-92, 96-98, 100,
`
`104,108 are cancelled. Therefore claims 93-95, 99, 101-103, 105-107 are pending and
`
`considered on the merits below.
`
`3.
`
`The rejection over enablement is withdrawn. Other rejections over 35 USC 101
`
`are maintained, as the amendment merely changes the precise grounds upon which the
`
`claims can be rejected. A new rejection over indefiniteness is presented.
`
`Continued Examination Under 37 CFR 1. 114
`
`4.
`
`A request for continued examination under 37 CFR 1 .114, including the fee set
`
`forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this
`
`application is eligible for continued examination under 37 CFR 1.114, and the fee set
`
`forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action
`
`has been withdrawn pursuant to 37 CFR 1 .114. Applicant's submission filed on 13
`
`January 2017 has been entered.
`
`Rigel Exhibit 1020
`Page 8 of 1266
`
`
`
`Application/Control Number: 13/939,519
`Art Unit: 1797
`
`Page 3
`
`Priority
`
`5.
`
`Because no support for the correlation between mutants of IDH1 and IDH2 and
`
`2HG neoactivity, required by all claims as filed, can be found in earlier priority
`
`documents, priority for claims including such a requirement are traced to US
`
`61 /173,518, filed 28 April 2009.
`
`Claim Interpretation
`
`6.
`
`The examiner notes that the word "neoactivity" is defined by the applicant's
`
`specification. Provisional application 61 /160,253 is incorporated by reference into the
`
`present disclosure in [0001 ]. On p.3 of the '253 application, neoactivity is said to mean
`
`an activity which arises as a result of a mutation of an enzyme. In [0018] of the present
`
`specification, 2HG neoactivity is defined to "refer[] to the ability to convert alpha
`
`ketoglutarate to 2-hydroxyglutarate (sometimes referred to herein as 2HG)" because of
`
`the mutation of an enzyme.
`
`Claim Rejections - 35 USC § 112
`
`7.
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.-The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`8.
`
`Claim(s) 93-95 and 99, 101-103, and 105-107 is/are rejected under 35 U.S.C.
`
`112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to
`
`Rigel Exhibit 1020
`Page 9 of 1266
`
`
`
`Application/Control Number: 13/939,519
`Art Unit: 1797
`
`Page 4
`
`particularly point out and distinctly claim the subject matter which the inventor or a joint
`
`inventor, or for pre-AIA the applicant regards as the invention.
`
`Regarding claim 93, the claim requires that the MR signal is to be at about
`
`2.5ppm. However, the chemical shift of a MR signal depends entirely on a variety of
`
`factors, including the specific nature of the nuclei being probed (proton, 13C, etc). In the
`
`claim, this is not specified. Because this is required to understand what is being
`
`claimed, and because the claim is silent as to this issue, the claim lacks the required
`
`clarity, and is therefore rejected.
`
`Dependent claims suffer from a similar defect, and are rejected on the same
`
`basis.
`
`Claim Rejections - 35 USC§ 101
`
`9.
`
`35 U.S.C. 101 reads as follows:
`
`Whoever invents or discovers any new and useful process, machine, manufacture, or
`composition of matter, or any new and useful improvement thereof, may obtain a patent
`therefor, subject to the conditions and requirements of this title.
`
`Claims 93-95 and 99, 101-103, and 105-107 are rejected under 35 U.S.C. 101
`
`because the claimed invention is directed to a judicial exception (i.e., a law of nature, a
`
`natural phenomenon, or an abstract idea) without significantly more.
`
`Claim(s) 93-95 and 99, 101-103, and 105-107 is/are directed to a method which
`
`recites both an abstract idea and a natural law. Claim 93 is directed to the correlation of
`
`2HG presence, distribution, or level in a particular type of subject and the "presence or
`
`Rigel Exhibit 1020
`Page 10 of 1266
`
`
`
`Application/Control Number: 13/939,519
`Art Unit: 1797
`
`Page 5
`
`susceptibility to cancer" in a step in which the patient is said be "evaluated" (the
`
`correlation is a natural law, the implied diagnosis is an abstract idea).
`
`The claim(s) does/do not include additional elements that are sufficient to amount
`
`to significantly more than the judicial exception.
`
`Regarding claim 93, the analysis step is recited features which are understood by
`
`the examiner to be conventional, and because it is a necessary step to gather
`
`information for the abstract idea and is otherwise necessary to make much use of the
`
`natural correlation, it cannot be said to add anything significantly more to the claim.
`
`Specifically, one is to measure the level "non-invasively by imaging or spectroscopic
`
`analysis with a signal at about 2.5 ppm." In a previous action, the examiner officially
`
`noted that MRI has been used to detect particular molecules in a subject (see the
`
`molecular MRI field), but this went unchallenged and so is taken as admitted.
`
`Additionally, the examiner cited to Sosnovik et al. (Curr Op Biotech 2007), pp.7-8, and
`
`this was further evidence that such is to be considered conventional by the examiner.
`
`Furthermore, as is described by McRobbie et al. (MRI from Picture to Proton
`
`2007) describes that glutamine and glutamate-type analytes are generally found by
`
`looking at chemical shifts at around 2.5 ppm (p.308, first column, first few lines).
`
`Even looking to the claim as a whole, the examiner sees nothing "significantly
`
`more" capable of conveying subject matter eligibility.
`
`Dependent claims fail to add anything significantly more, and many simply raise
`
`new issues of subject matter eligibility.
`
`Rigel Exhibit 1020
`Page 11 of 1266
`
`
`
`Application/Control Number: 13/939,519
`Art Unit: 1797
`
`Page 6
`
`Claims such as 94, 95, 101-103, and 105-107 simply appear to refine the natural
`
`law and/or the abstract idea claimed and therefore cannot be said to add something
`
`"significantly more."
`
`Claims such as claims 99 and 104 for example recite particulars of the analysis
`
`step, but do so in ways which remain entirely conventional. In a previous action, the
`
`examiner officially noted that MRI has been used to detect particular molecules in a
`
`subject (see the molecular MRI field), but this went unchallenged and so is taken as
`
`admitted. Additionally, the examiner cited to Sosnovik et al. (Curr Op Biotech 2007),
`
`pp.7-8, and this was further evidence that such is to be considered conventional by the
`
`examiner. That one must analyze "a tissue, product, or bodily fluid of the subject"
`
`scarcely limits the analysis step in any meaningful way. The examiner does not see
`
`that these limitations add something significantly more as is required when taken
`
`individually or when considering the claim as a whole.
`
`Response to Arguments
`
`10.
`
`Applicant's arguments filed 15 September 2016 have been fully considered but
`
`they are not persuasive.
`
`The applicants appear to argue on the basis of their amendment. However,
`
`evidence to reject the present claims is presented above.
`
`Rigel Exhibit 1020
`Page 12 of 1266
`
`
`
`Application/Control Number: 13/939,519
`Art Unit: 1797
`
`Page 7
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to Christopher A. Hixson whose telephone number is
`
`(571 )270-5027. The examiner can normally be reached on M-F 9 am - 6 pm.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
`
`supervisor, Lyle Alexander can be reached on (571 )272-1254. The fax phone number
`
`for the organization where this application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of an application may be obtained from the
`
`Patent Application Information Retrieval (PAIR) system. Status information for
`
`published applications may be obtained from either Private PAIR or Public PAIR.
`
`Status information for unpublished applications is available through Private PAIR only.
`
`For more information about the PAIR system, see http://pair-direct.uspto.gov. Should
`
`you have questions on access to the Private PAIR system, contact the Electronic
`
`Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a
`
`USPTO Customer Service Representative or access to the automated information
`
`system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
`
`/Christopher A. Hixson/
`Primary Examiner, Art Unit 1797
`
`Rigel Exhibit 1020
`Page 13 of 1266
`
`
`
`Notice of References Cited
`
`Application/Control No.
`
`13/939,519
`
`Examiner
`
`Christopher A. Hixson
`
`U.S. PATENT DOCUMENTS
`
`Applicant(s)/Patent Under
`Reexamination
`DANG ET AL.
`
`Art Unit
`
`1797
`
`Page 1 of 1
`
`*
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`Name
`
`CPC Classification
`
`US Classification
`
`A US-
`B US-
`C US-
`D US-
`E US-
`F US-
`US-
`
`G
`H US-
`US-
`
`I
`
`US-
`
`J
`K US-
`US-
`
`L
`M US-
`
`*
`
`Document Number
`Country Code-Number-Kind Code
`
`Date
`MM-YYYY
`
`Country
`
`Name
`
`CPC Classification
`
`FOREIGN PATENT DOCUMENTS
`
`N
`
`0
`
`p
`
`Q
`
`R
`s
`
`T
`
`*
`
`Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages)
`
`NON-PATENT DOCUMENTS
`
`u McRobbie, Donald W. et al. "MRI from Picture to Proton." Cambridge Univ. Press (2007).
`
`pp.307-308.
`
`V
`
`w
`
`X
`
`*A copy of this reference 1s not being furnished with this Office action. (See MPEP § 707.05(a).)
`Dates in MM-YYYY format are publication dates. Classifications may be US or foreign.
`
`U.S. Patent and Trademark Office
`PTO-892 (Rev. 01-2001)
`
`Notice of References Cited
`
`Part of Paper No. 20170206
`
`Rigel Exhibit 1020
`Page 14 of 1266
`
`
`
`Search Notes
`
`Application/Control No.
`
`Applicant(s)/Patent Under
`Reexamination
`
`13939519
`
`Examiner
`
`DANG ET AL.
`
`Art Unit
`
`CHRISTOPHER A HIXSON
`
`1797
`
`A61 B5/055
`A61 K31 /41,426
`A61 K45/06
`A61 K2300/00
`C12N15/1137
`C12N2310/14
`C12O1 /32,6886
`C12Y101/01042
`G01N33/574
`G06F19/328
`
`CPC-SEARCHED
`
`Symbol
`
`Date
`6 feb 2017
`6 feb 2017
`6 feb 2017
`6 feb 2017
`6 feb 2017
`6 feb 2017
`6 feb 2017
`6 feb 2017
`6 feb 2017
`6 feb 2017
`
`Examiner
`cah
`cah
`cah
`cah
`cah
`cah
`cah
`cah
`cah
`cah
`
`CPC COMBINATION SETS - SEARCHED
`
`Symbol
`
`Date
`
`I
`I
`
`I Examiner
`I
`
`US CLASSIFICATION SEARCHED
`
`Class
`
`I
`I
`
`Subclass
`
`Date
`
`I
`I
`
`I Examiner
`I
`
`SEARCH NOTES
`
`Search Notes
`searched in east as attached, inventor name search, google.com,
`scholar.google.com
`searched in east as attached, inventor name search, google.com,
`scholar.qooqle.com
`search in google as attached, inventor name search
`searched in east as attached, inventor name search
`
`Date
`4 sept 2015
`
`Examiner
`cah
`
`26 may 2016
`
`cah
`
`7 oct 2016
`6 feb 2017
`
`cah
`cah
`
`INTERFERENCE SEARCH
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. : 20170206
`
`Rigel Exhibit 1020
`Page 15 of 1266
`
`
`
`US Class/
`CPC Symbol
`
`US Subclass / CPC Group
`
`Date
`
`Examiner
`
`U.S. Patent and Trademark Office
`
`Part of Paper No. : 20170206
`
`Rigel Exhibit 1020
`Page 16 of 1266
`
`
`
`Index of Claims
`
`Application/Control No.
`
`Applicant(s)/Patent Under
`Reexamination
`
`13939519
`
`Examiner
`
`DANG ET AL.
`
`Art Unit
`
`CHRISTOPHER A HIXSON
`
`1797
`
`✓
`
`Rejected
`
`Cancelled
`
`N Non-Elected
`
`=
`
`Allowed
`
`Restricted
`
`Interference
`
`A
`
`0
`
`Appeal
`
`Objected
`
`□ CPA
`
`□ T.D.
`
`□ R.1.47
`
`DATE
`
`09/04/2015 06/02/2016 10/07/2016 02/0