Interview Summary
`
`Application No.
`
`Applicant(s)
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`11/788,076
`
`Examiner
`
`DUNCAN ET AL.
`
`Art Unit
`
`LYNDSEY BECKHARDT
`
`1615
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) L YNDSEY BECKHARDT.
`
`(2) MICHAEL WOODWARD.
`
`Date of Interview: 09 June 2009.
`
`(3)DR. BRITTAIN.
`
`(4)MR. PARADISO.
`
`Type: a)O Telephonic b)O Video Conference
`c)[8J Personal [copy given to: 1)0 applicant 2)0 applicant's representative]
`
`Exhibit shown or demonstration conducted: d)[8J Yes
`e)O No.
`If Yes, brief description: 2.5 mg concentrate ampule of nicardipine hvdrochloride and premixed nicardipine in an
`I.V. bag.
`
`Claim(s) discussed: All pending claims discussed, 1-5, 7-11, 14-19,21-26,28-30,40-45.
`
`Identification of prior art discussed: all prior art.
`
`Agreement with respect to the claims f)0 was reached. g)O was not reached. h)[8J N/A.
`
`Substance of Interview including description of the general nature of what was agreed to if an agreement was
`reached, or any other comments: See Continuation Sheet.
`
`(A fuller description, if necessary, and a copy of the amendments which the examiner agreed would render the claims
`allowable, if available, must be attached. Also, where no copy of the amendments that would render the claims
`allowable is available, a summary thereof must be attached.)
`
`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 MAILINGDATEOFTHIS INTERVIEW SUMMARY FORM, WHICHEVER IS LATER, TO
`FILE A STATEMENT OF THE SUBSTANCE OF THE INTERVIEW. See Summary of Record of Interview
`requirements on reverse side or on attached sheet.
`
`LMB
`
`U.S. Patent and Trademark Office
`PTOL-413 (Rev. 04-03)
`
`Interview Summary
`
`Paper No. 20090609
`
`I
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`EKR Therapeutics, LLC Exhibit 2013 Page 1
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`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.
`
`EKR Therapeutics, LLC Exhibit 2013 Page 2
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`Continuation Sheet (PTOL-413)
`
`Application No. 11/788,076
`
`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: Applicant described the prior art
`teachings are directed toward the concentrated form of nicardipine, which is not the same as the
`premixed formulation presented in the claims. The stability of the premixed formulation was
`discussed as an improvement over previous diluted samples of the prior art concentrate. The
`stability of nicardipine hydrochloride to hydrolysis was discussed. The stability of the formulation
`with respect to the copolyester, polyethylene or polyolefin container was discussed. Applicant may
`file a declaration with regard to these issues.
`
`IMP WOODWARDI
`Supervisory Patent Examiner, Art Unit 1615
`
`EKR Therapeutics, LLC Exhibit 2013 Page 3
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