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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`www.uspto.gov
`
`
`
`
`
`12/720,482
`
`03/09/2010
`
`Shigeki JOKO
`
`28951.5423 C1
`
`9159
`
`STEPTOE & JOHNSON LLP
`1330 CONNECTICUT AVE., NW
`WASHINGTON, DC 20036
`
`SISSON, BRADLEY L
`
`ART UNIT
`
`1634
`
`PAPER NUIVIBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`12/05/2014
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`
`ipdocketing @ steptoe.c0m
`hfox @ steptoe.c0m
`lfielding @ steptoe.c0m
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`
`Application No.
`
`Applicant(s)
`
`
` _ _ _ _ 12/720,482 JOKO, SHIGEKI
`
`
`Applicant-Initiated Interwew Summary
`Examiner
`Art Unit
`
`
`
`
`
`Bradley L. Sisson
`
`1634
`
`All participants (applicant, applicant’s representative, PTO personnel):
`
`(1) Bradley L. Sisson, Primary Examiner.
`
`(2) Roger Parkhurst, Reg.No. 25,177.
`
`Date of Interview: 02 December 2014.
`
`(3)Li Gou.
`
`(4)
`
`.
`
`Type:
`
`I:I Video Conference
`IZI Telephonic
`I:l Personal [copy given to: El applicant
`
`|:| applicant’s representative]
`
`IZI Yes
`Exhibit shown or demonstration conducted:
`If Yes, brief description: Draft claim 1; copy attached.
`
`E! No.
`
`IXI112 D102 D103 |:IOthers
`|X|101
`Issues Discussed
`(For each of the checked b0x(es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: _1.
`
`Identification of prior art discussed: US 6,074,818 (Caetano-Ano/les eta/.1.
`
`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...)
`
`See Continuation Sheet.
`
`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.
`
`IZI Attachment
`
`
`
`/Bradley L. Sisson/
`Primary Examiner, Art Unit 1634
`
`Attachment: Draft claim amendment
`
` US. Patent and Trademark Office
`
`PTOL-413 (Rev. 8/11/2010)
`
`Interview Summary
`
`Paper No. 20141202
`
`

`

`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 bythe 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.
`A“ 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.
`accurate, the examiner will give the applicant an extendable one month time period to correct the record.
`
`If the record is not complete and
`
`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.
`
`

`

`Continuation Sheet (PTOL-413)
`
`Application No. 12/720,482
`
`Continuation of Substance of Interview including description of the general nature of what was agreed to if an
`agreement was reached, or any other comments:
`
`Examiner Sisson acknowledged receipt of the proposed amendment to claim 1 (copy attached hereto).
`
`The aspect of changing the first step to read "adding an added nucleotide sequence" was discussed.
`
`The rejection of claims under 35 USC 101/112 for not having a specific, substantial, and credible utility (asserted or
`well known) was discussed. Attention was directed to MPEP 2107.01 B (D), which specifies that a method of making a
`material (here nucleic acids) that itself has no specific, substantial, and/or substantial utility, also does not have a
`substantial utility.
`
`Mr. Parkhurst noted that the prior Office action, at page 11, acknowledges that the specification, at page 18, second
`paragraph, asserts that the probes "can be used as a detection probe or target in gene analysis." Examiner Sisson
`noted that such narrowing limitations, as well as specific nucleic acid molecules which both were known at the time of
`filing and which have utility under 35 USC 101, have not and cannot be read into the claims, citing MPEP 2111.01 and
`the decision of Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir.
`2004)
`Examiner Sisson encouraged applicant to consider narrowing the claims such that the method results in the production
`of a product (nucleic acids) that do satisfy the utility requirements of 35 USC 101.
`Examiner Sisson noted that the subject application has an effective filing date of June 29, 2004, and that by
`comparison, the nucleotide sequence for the last human chromosome was not made public until May 2006.
`
`The rejection of claims under 35 USC 101 for not being direct to patent-eligible subject matter was discussed.
`Examiner Sisson indicated general agreement with Mr. Parkhurst that the claims recite elements/steps that do not
`occur in nature. Examiner Sisson noted that the presence or use of non-naturally occurring compounds in and of itself
`does not save the claimed method, noting that one had to first manufacture the thiopurine drugs that were administered
`and metabolized by patients in in Mayo Collaborative Services v. Prometheus Laboratories Inc. (US 2012) 101
`USPQ2d 1961, but that the aspect of the non-naturally occurring drugs being metabolized was a natural phenomenon.
`Examiner Sisson drew an analogy between the metabolism of the drugs in Mayo and the reaction between the 3-
`methyl DNA glycosylase and the hypoxanthine.
`Examiner Sisson noted that applicant teaches at page 36 that 3-methyladenine DNA glycosylase type II enzyme is
`commercially available and that the action of the enzyme upon the base is a natural phenomenon.
`Examiner Sisson encouraged applicant to consider amending the claims such that they recite additional
`elements/steps that help shift the balance in favor of patent eligibility, noting that which can satisfy Factors e) and f),
`for example, but not satisfy Factor j) would help shift the balance in favor of patent eligibility.
`
`