UNITED STATES PATENT 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.
`
`15/405,171
`
`01/12/2017
`
`Yoshiyuki Tatsumi
`
`12102.0003-00000
`
`1590
`
`09/05/2017
`7590
`22852
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
`LLP
`901 NEW YORK A VENUE, NW
`WASHINGTON, DC 20001-4413
`
`EXAMINER
`
`RAILEY, JOHNNY F
`
`ART UNIT
`
`PAPER NUMBER
`
`3991
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`09/05/2017
`
`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):
`regional-desk@finnegan.com
`
`PTOL-90A (Rev. 04/07)
`
`Page 1 of 161
`
`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1667
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
`
`

`

`UNITED STATES DEPARTMENT OF COMMERCE
`U.S. Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`APPLICATION NO./
`CONTROL NO.
`15/405,171
`
`FILING DATE
`
`12 January, 2017
`
`FIRST NAMED INVENTOR I
`PATENT IN REEXAMINATION
`TATSUMI ET AL.
`
`ATTORNEY DOCKET NO.
`
`12102.0003-00000
`
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
`LLP
`901 NEW YORK AVENUE, NW
`WASHINGTON, DC 20001-4413
`
`EXAMINER
`
`MICHAEL FUELLING
`
`ART UNIT
`
`PAPER
`
`3992
`
`20170831
`
`DATE MAILED:
`
`Please find below and/or attached an Office communication concerning this application or
`proceeding.
`
`Action by the Office in this application is suspended in view of the Patent Trial and Appeal Board's stay Order in IPR2017-00190.
`
`Commissioner for Patents
`
`/MICHAEL FUELLING/
`Supervisory Patent Examiner, Art Unit 3992
`
`PT0-90C {Rev.04-03)
`
`Page 2 of 161
`
`

`

`· Trials@uspto.gov
`571-272-7822
`
`Paper 31
`Entered: August 31, 20 17
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE 1BE PATENT TRIAL AND APPEAL BOARD
`
`A CRUX DDS PTY LTD. & A CRUX LIMITED,
`Petitioner,
`
`V.
`
`KAKEN PHARMACEUTICAL CO., LTD. and V ALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner and Licensee.
`
`Case IPR20 17-00190
`Patent 7,214,506 B2
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.
`
`ORDER
`Stay of Reissue Application No. 151405,171
`37 C.F.R. 42.3(a); 37 C.F.R. § 4.122(a)
`
`Page 3 of 161
`
`

`

`lPR20 17-00 190
`Patent 7,214,506 B2
`
`Before institution of the instant inter partes proceeding, Kaken
`
`Pharmaceutical Co., Ltd. and Valeant Pharmaceuticals International, Inc.
`
`(collectively, "Petitioner") requested authorization to file a motion to stay
`
`Reissue Application No. 15/405,171 (''the '171 Reissue Application"),
`
`which involves that patent at issue here, U.S. Patent No. 7,214,506 ("the
`
`'506 Patent"). Paper 11, 2. At that time, we agreed with Patent Owner that
`
`a motion for a stay of the reissue proceeding would be premature, but invited
`
`Petitioner to renew its request to file a motion to stay should an inter partes
`
`review be instituted. !d. at 3.
`
`On May 1, 2017, we instituted an inter partes review of claims 1 and
`
`2 of the '506 Patent based on six grounds. Paper 12, 24. Petitioner renewed
`
`its request for authorization to file a motion for a stay, and we granted such
`
`authorization. Paper 16, 2. Petitioner filed its Motion to Stay Related
`
`Reissue Proceeding, which Patent Owner opposed. Papers 19, 21, 22. For
`
`the reasons stated below, the Board exercises its discretion to stay
`
`examination of the ' 171 Reissue Application.
`
`DISCUSSION
`
`The Director has authority to stay a reissue proceeding pursuant to
`
`35 U.S.C. § 315(d), which provides:
`
`(d) MUL TlPLE PROCEEDINGS.- Notwithstanding sections
`135(a), 251, and 252, and chapter 30, during the pendency of an
`inter partes review, if another proceeding or matter involving
`the patent is before the Office, the Director may determine the
`manner in which the inter partes review or other proceeding or
`matter may proceed, including providing for stay, transfer,
`consolidation, or termination of any such matter or proceeding.
`37 C.F.R. § 42.122 permits the Board to enter an order to effect a stay as
`
`follows:
`
`2
`
`Page 4 of 161
`
`

`

`IPR2017-00190
`Patent 7,214,506 B2
`
`(a) Multiple Proceedings. Where another matter involving the
`patent is before the Office, the Board may during the pendency
`of the· inter partes review enter any appropriate order regarding
`the additional matter including providing for the stay, transfer,
`consolidation, or termination of any such matter.
`37 C.F.R. § 42.122(a); see also 37 C.F.R. § 42.3 (providing the Board
`
`authority to exercise exclusive jurisdiction within the Office over an
`
`involved application and patent during the proceeding).
`
`As Patent Owner correctly points out, ordinarily we will not stay a
`
`reissue application unless good cause is shown because reissue applications
`
`are accorded special status~ See Bio-Rad Labs., Inc. v. GE Healthcare Rio(cid:173)
`
`Sciences AB, Case IPR2015-01826, slip op. at 2-3 (PTAB April8, 2016)
`
`(paper 18) (citing MPEP § 1442). In this case, however, Petitioner has
`
`shown good cause to stay the reissue application.
`
`A stay may be warranted to avoid duplicating efforts in the Office, to
`
`avoid potentially inconsistent results, or to simplify the issues in a reissue
`
`application. See Hewlett-Packard Co. v. MCM Portfolio LLC, Case, Case
`
`IPR2013-00217, slip op. at 2-3 (PTAB May 10, 2013) (paper 8). Here all
`
`three reasons support staying prosecution of the reissue application.
`
`As Petitioner points out and Patent Owrter agrees, reissue claims 1 and
`
`2 are essentially identical to claims 1 and 2, respectively, of the '506 patent
`
`at issue in this proceeding. Paper 19, 2; Paper 21, 2 (stating "[o]nly claims 1
`
`and 2 are substantively identical to the two claims at issue in this IPR).
`
`Proceeding with concurrent examination of the '1 71 Reissue Application
`
`and this inter partes review would duplicate the efforts of the Office at least
`
`as to claims.1 and 2 involved in each proceeding and could potentially result
`
`in inconsistencies between the two proceedings. Also, any final written
`
`3
`
`Page 5 of 161
`
`

`

`IPR2017-00190
`Patent 7,214,506 B2
`
`decision in this inter partes review with respect to the patentability of the
`
`challenged claims may simplify the issues In the reissue application.l
`
`Based upon the facts presented in the instant proceeding and in the
`
`'171 Reissue Application, the Board exercises its discretion under 35 U.S.C.
`
`§ 315(d) and 37 C.F.R. § 42.122(a), and orders that examination of the' 171
`
`Reissue Application be stayed pending the termination or completion of the
`
`instant proceeding.
`
`It is
`
`ORDER
`
`ORDERED that examination ofReissue Application 15/405,171, filed
`
`on January 12, 2017, is stayed pursuant to 37 C.F.R. §§ 42.3 and 42.122
`
`pending the termination or completion ofiPR2017-00190; and
`
`FURTHER ORDERED that any due dates in Reissue Application
`
`15/405,171 are tolled.
`
`1 In opposition to Petitioner's good cause showing, Patent Owner focuses its
`argument on the 31 new claims of varying scope in the ' 171 Reissue
`Application "that are not at issue in this IPR and which raise new issues of
`patentability not raised here." Paper 21, 1. Because we find that the overlap
`between claims 1 and 2 of the '506 Patent and the '171 Reissue Application
`prompts us to exercise our discretion to stay examination of the '171 Reissue
`Application, we need not analyze further the issues raised concerning
`whether claims 3-33 are patentably distinct from claims 1 and 2 of the '506
`patent as resolution of these issues in favor of Patent Owner would not
`overcome the good cause shown for staying the '171 Reissue Application.
`See Paper 19, 2-33; Paper 21, 2-5; Paper 22, 1-3.
`4
`
`Page 6 of 161
`
`

`

`IPR2017-00190
`Patent 7,214,506 B2
`
`For PETITIONER:
`
`E. Anthony Figg
`Aydin H. Harston
`ROTHWELL FIGG, ERNST & MANBECK, P.C.
`effig@rothwellfigg.com
`aharston@rothwellfigg.com .
`
`For PATENT OWNER:
`
`John D. Livingstone
`N aoki Yoshida
`Anthony Hartmann
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`KakeniPR@finnegan.com
`naoki.yoshida@finnegan.com
`hartmana@finnegan.com
`
`ToanP. Vo
`V ALEANT PHARMACEUTICALS NORTH AMERICA LLC
`To an. vo@bausch.com
`
`5
`
`Page 7 of 161
`
`

`

`Trials@uspto.gov
`571-272-7822
`
`Paper 31
`Entered: August 31, 2017
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`ACRUX DDS PTY LTD. & ACRUX LIMITED,
`Petitioner,
`
`v.
`
`KAKEN PHARMACEUTICAL CO., LTD. and V ALEANT
`PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner and Licensee.
`
`Case IPR20 17-00 190
`Patent 7,214,506 B2
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`ROBERT A. POLLOCK Administrative Patent Judges.
`
`MITCHELL, Administrative Patent Judge.·
`
`ORDER
`Stay of Reissue Application No. 15/405,171
`37 C.F.R. 42.3(a); 37 C.FR. § 4.122(a)
`
`Page 8 of 161
`
`

`

`IPR20 17-00190
`Patent 7,214,506 B2
`
`Before institution of the instant inter partes proceeding, Kaken
`
`Pharmaceutical Co., Ltd. and Valeant Pharmaceuticals International, Inc.
`
`(collectively, "Petitioner") requested authorization to file a motion to stay
`
`Reissue Application No. 15/405,171 ("the '171 Reissue Application"),
`
`which involves that patent at issue here, U.S. Patent No. 7,214,506 ("the
`
`'506 Patent"). Paper 11, 2. At that time, we agreed with Patent Owner that
`
`a motion for a stay of the reissue proceeding would be premature, but invited
`
`Petitioner to renew its request to file a motion to stay should an inter partes
`
`review be instituted. !d. at 3.
`
`On May 1, 2017, we instituted an inter partes review of claims 1 and
`
`2 of the '506 Patent based on six grounds. Paper 12, 24. Petitioner renewed
`
`its request for authorization to file a motion for a stay, and we granted such
`
`authorization. Paper 16, 2. Petitioner filed its Motion to Stay Related
`
`Reissue Proceeding, which Patent Owner opposed. Papers 19, 21, 22. For
`
`the reasons stated below, the Board exercises its discretion to stay
`
`examination of the '171 Reissue Application.
`
`DISCUSSION
`
`The Director has authority to stay a reissue proceeding pursuant to
`
`35 U.S.C. § 315( d), which provides:
`
`(d) MULTIPLE PROCEEDINGS.- Notwithstanding sections
`135(a), 251, and 252, and chapter 30, during the pendency of an
`inter partes review, if another proceeding or matter involving
`the patent is before the Office, the Director may determine the
`manner in which the inter partes review or other proceeding or
`matter may proceed, including providing for stay, transfer,
`consolidation, or termination of any such matter or proceeding.
`37 C.P.R. § 42.122 permits the Board to enter an order to effect a stay as
`
`follows:
`
`2
`
`Page 9 of 161
`
`

`

`IPR20 17-00190
`Patent 7,214,506 B2
`
`(a) Multiple Proceedings. Where <mother matter involving the
`patent is before the Office, the Board may during the pendency
`of the inter partes review enter any appropriate order regarding
`the additional matter including providing for the stay, transfer,
`consolidation, or termination of any such matter.
`37 C.F.R. § 42.122(a); see also 37 C.F.R. § 42.3 (providing the Board
`
`authority to exercise exclusive jurisdiction within the Office over an
`
`involved application and patent during the proceeding).
`
`As Patent Owner correctly points out, ordinarily we will not stay a
`
`reissue application unless good cause is shown because reissue applications
`
`are accorded special status. See Bio-Rad Labs., Inc. v. GE Healthcare Rio(cid:173)
`
`Sciences AB, Case IPR2015-01826, slip op. at 2-3 {PTAB AprilS, 2016)
`
`(paper 18) (citing MPEP § 1442). In this case, however, Petitioner has
`
`shown good cause to stay the reissue application.
`
`A stay may be warranted to avoid duplicating efforts in the Office, to
`
`avoid potentially inconsistent results, or to simplify the issues in a reissue
`
`application. See Hewlett-Packard Co. v. MCM Portfolio LLC, Case, Case
`
`IPR2013-00217, slip op. at 2-3 (PTAB May 10, 2013) (paper 8). Here all
`
`three reasons support staying prosecution of the reissue application.
`
`As Petitioner points out and Patent Owner agrees, reissue claims 1 and
`
`2 are essentially identical to claims 1 and 2, respectively, of the '506 patent
`
`at issue in this proceeding. Paper 19, 2; Paper 21, 2 (stating "[o]nly claims 1
`
`and 2 are substantively identical to the two claims at issue in this IPR).
`
`Proceeding with concurrent examination of the '171 Reissue Application
`
`and this inter partes review would duplicate the efforts of the Office at least
`
`as to claims 1 and 2 involved in each proceeding and could potentially result
`
`in inconsistencies between the two proceedings. Also, any final written
`
`3
`
`Page 10 of 161
`
`

`

`IPR20 17-00190
`Patent 7,214,506 B2
`
`decision in this inter partes review with respect to the patentability of the
`
`challenged claims may simplify the issues in the reissue application. 1
`
`Based upon the facts presented in the instant proceeding and in the
`
`'171 Reissue Application, the Board exercises its discretion under 35 U.S.C.
`
`§ 315(d) and 37 C.P.R.§ 42.122(a), and orders that examination ofthe '171
`
`Reissue Application be stayed pending the termination or completion of the
`
`instant proceeding.
`
`It is
`
`ORDER
`
`ORDERED that examination ofReissue Application 15/405,171, filed
`
`on January 12, 2017, is stayed pursuant to 37 C.P.R. §§ 42.3 and 42.122
`
`pending the termination or completion ofiPR2017-00190; and
`
`FURTHER ORDERED that any due dates in Reissue Application
`
`15/405,171 are tolled.
`
`1 In opposition to Petitioner's good cause showing, Patent Owner focuses its
`argument on the 31 new claims of varying scope in the ' 171 Reissue
`Application "that are not at issue in this IPR and which raise new issues of
`patentability not raised here." Paper 21, 1. Because we find that the overlap
`between claims 1 and 2 of the '506 Patent and the '171 Reissue Application
`prompts us to exercise our discretion to stay examination of the '1 71 Reissue
`Application, we need not analyze further the issues raised concerning
`whether claims 3-33 are patentably distinct from claims 1 and 2 of the '506
`patent as resolution of these issues in favor of Patent Owner would not
`overcome the good cause shown for staying the '171 Reissue Application.
`See Paper 19, 2-33; Paper 21, 2-5; Paper 22, 1-3.
`4
`
`Page 11 of 161
`
`

`

`IPR20 1 7-00 190
`Patent 7,214,506 B2
`
`For PETITIONER:
`
`E. Anthony Figg
`Aydin H. Harston
`ROTHWELL FIGG, ERNST & MANBECK, P.C.
`effig@rothwellfigg.com
`aharston@rothwellfigg.com
`
`For PATENT OWNER:
`
`John D. Livingstone
`Naoki Yoshida
`Anthony Hartmann
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`KakeniPR@finnegan.com
`naoki.yoshida@finnegan.com
`hartmana@finnegan.com
`
`Toan P. Vo
`V ALEANT PHARMACEUTICALS NORTH AMERICA LLC
`To an. vo@bausch.com
`
`5
`
`Page 12 of 161
`
`

`

`UNITED STATES pATENT 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.
`
`15/405,171
`
`01112/2017
`
`Y oshiyuki Tatsumi
`
`12102.0003-00000
`
`1590
`
`22852
`7590
`07118/2017
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
`LLP
`901 NEW YORK A VENUE, NW
`WASHINGTON, DC 20001-4413
`
`EXAMINER
`
`RAILEY, JOHNNY F
`
`ART UNIT
`
`PAPER NUMBER
`
`3991
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`07/18/2017
`
`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):
`regional-desk@ finnegan. com
`
`PTOL-90A (Rev. 04/07)
`
`Page 13 of 161
`
`

`

`Applicant-Initiated Interview Summary
`
`Application No.
`
`Applicant(s)
`
`15/405,171
`
`Examiner
`
`TATSUMI ET AL.
`
`Art Unit
`
`JOHNNY F. RAILEY II
`
`3991
`
`All participants (applicant, applicant's representative, PTO personnel):
`
`(1) JOHNNY F. RAILEY II.
`
`(2) CHARLES E. VAN HORN.
`
`(3) __ .
`
`(4) __ .
`
`Date of Interview: 06 Julv 2017.
`Type: ~ Telephonic 0 Video Conference
`0 Personal [copy given to: 0 applicant
`Exhibit shown or demonstration conducted: 0 Yes
`If Yes, brief description: __ .
`
`0 applicant's representative]
`
`~No.
`
`Issues Discussed 01 01 0112 01 02 01 03 ~Others
`(For each of the checked box( es) above, please describe below the issue and detailed description of the discussion)
`
`Claim(s) discussed: None.
`
`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 ... )
`
`Mr. Van Horn called to note that this reissue application was filed on 12 Januarv 2017 and inquired as to when the first
`action on this reissue would occur. The examiner informed Mr. Van Horn that there is a copending inter partes review
`OPR2017-001901 that has a motion to suspend this reissue application pending the outcome of the IPR. As a result. the
`time to first action on the reissue is currentlv indeterminant while awaiting decision bv the PTAB on the motion to
`suspend
`
`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.
`
`0 Attachment
`/JOHNNY F. RAILEY II/
`Primary Examiner, Art Unit 3991
`
`U.S. Patent and Trademark Off1ce
`PTOL-413 (Rev. 8/11/2010)
`
`/Jean C. Witz/
`Supervisory Patent Re-Examination Specialist
`CRU 3991
`
`Interview Summary
`
`Paper No. 20170706
`
`Page 14 of 161
`
`

`

`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.
`
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`Litigation Search Report CRU 3999
`
`TO: Jean Witz
`Location: CRU
`Art Unit: 3991
`Date: 02/13/2017
`
`From: Patricia Volpe
`Location: MDE 4B21
`Phone: (571) 272-6825
`patricia.volpe@uspto.gov
`
`Litigation search for U.S. Patent Number: 7,214,506
`
`.......................................................................................................................................................................................................................•.......................................................
`
`l~:~: -~c'-"-~ ~~~ :~ Lt~ ~s ::::: :ar::::~l:cal~o , Ltd
`
`t::2~17:~ 01 ~0 j
`
`1) I performed a KeyCite Search in Westlaw, which retrieves all history on the patent including any litigation.
`
`2) I performed a search on the patent in Lexis CourtLink for any open dockets or closed cases.
`
`3) I performed a search in Lexis in the Federal Courts and Administrative Materials databases for any cases
`found.
`
`4) I performed a search in Lexis in the IP Journal and Periodicals database for any articles on the patent.
`
`5) I performed a search in Lexis in the news databases for any articles about the patent or any articles about
`litigation on this patent.
`
`Page 16 of 161
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`685266 (10) 7214506 May B, 2007
`
`UNITED STATES PATENT .Af\lD TRADEti!ARK OffiCE GRANTED PATENT
`
`7214506
`
`Get Drawin~1 Sheet 1 of I.J
`Access PDF of Official Patent *
`Order Patent File History I Wrapper from REEDf.AX®
`Link to Claims Section
`
`fvlay 8, 2007
`
`rvJethod for treating onychomycosis
`
`INVENTOR: Tatsumi, Yoshiyuki ~ Otsu, Japan (JP), Japan () ; Yokoo, f''lamoru ~ Otsu, Japan
`(JP), Japan () ; Nakamura, Kosho- r'1oriyama, Japan (JP), Japan () ; Arika, Tadashi - Suita,
`Japan (JP), Japan ()
`
`APf'l-NO: 685266 (10)
`
`FilED-DATE: October 14, 2.003
`
`GRANTED-DATE: l\1ay B, 2007
`
`ASSIGNEE-PRE-ISSUE:
`October 14, 2003 - ASSIGNfv1Ef'JT Of .ASSIGNORS IP~TEREST (SEE DOClJfv1ENT fOR DETAILS),,
`K/\KEN PHARI\'1/\CEUTICAL CO., LTD., 28~8, HINK0~1V\GOf•1E 2~CHm•1E BUNKYO+U, TOKYO,
`JAPAN ( ), 113-8650, Reel and frame Number: 014614/0495
`August 16, 2004 -CORRECTIVE .ASSIGf'Jfi!ENT TO CORRECT THE ASIGNEE'S ADDRESS
`PREVIOUSLY RECORDED ON REEL 014614 FRA~11E 0495. ASSIGNOR(S) HEREBY CONFIRf•1S THE
`.ASSIGNEE'S ADDRESS WAS iNCORRECTLY RECORDED AS 28-8, HlNKGri!AGOfvJt Af\lD SHOULD
`BE 28-8 HOP~KOI\1AGOfv1C, KAKEN PHARI\'1ACEUTICAL CO., LTD., BUNK'y'O-KU, 28-8,
`HONKOI\'1AGO!VJE 2~CHOf,'1f., TOKYO, JAPAN ( ), 113~8650, Reel and Frame Number:
`014991/041/
`
`ASSIGNEE-AT-ISSUE:
`Kaken Pharmaceutical Co., Ltd., Bunkyo-ku, Tokyo, Japan (JP), foreign company or corporation
`(03)
`
`lEGAl-STATUS:
`
`October 14, 2003 - ASSIGNfv1EI\lT
`.August 16, 2004- ASSlGNfvJENT
`October 20, 2010 ~ fEE P.An,1ENT
`October 20, 2010 ~ Payment of fv1aintenance Fee, 4th Year, Large Entity,
`October 8, 2014 - Payment of fv1aintenance Fee, 8th Year, Large Entity.
`
`PR.IM-EXMR: Weber, Jon
`
`ASST-EXMR: Srivastava, Kailash C.
`
`CORE TERMS: antimicrobial, skin, microorganism, nail, fungus, feet, medium, animal, infected,
`therapeutic, tinea, funqus-neqative, dialysis, above~mentioned, antitunqal, evaluated,
`onychomycosis, preparation, pathogenic, detecting, unguium, pig, removing, terbinafine,
`lanoconazole, biosample, compound, topical, agar, infection
`
`Page 17 of 161
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`ENGUSH-ABST:
`
`.A novel method for evaluating an effect of an antimicrobial agent which comprises removing the
`antimicrobial agent rernaining in a biological sample or the like to thereby accurately evaluate
`the effect of the antimicrobial agent without being affected by the remaining antimicrobial
`agent. A therapeutic agent for onychomycosis which can be obtained according to the
`evaluation method of the dru9 effect.
`
`NO-Of-ClAIMS: 2
`
`EXMPl-ClAIM: 1
`
`PARENT-PAT-INFO:
`
`[0001]This application is a divisional under 35 U.S,C. 120 of LLS, Non-Provisional application
`Ser. No. 10/031,929 filed 25 Jan. 2002, novv abandoned, which was a f\Jational Staqe filinq
`under 35 LLS.C. 371 of PCT/JP00/04617 filed 11 Jul. 2000, which claimed priority to Japanese
`patent application Ser. No, 11/214,369 filed 28 Jul. 1999.
`
`SUMMARY:
`
`TECHNICAL fiELD
`
`[0002]The present invention relates to a method for detecting pathogenic microorganism,
`method for evaluating an effect of an antimicrobial agent on patho9enic microorganism and a
`method tor detecting an antimicrobial aqent. The present invention also relates to an
`antimicrobial agent and a therapeutic agent for onychomycosis, which are obtained according to
`the above-mentioned method for evaluating the drug effect.
`
`BACKGROUND ART
`
`[0003]A method for evaluating a drug effect with an animal model is needed in order to explore
`a novel antimicrobial a9ent (also hereinafter referred to "drug"). Further, a method enabling a
`druq effect to be evaluated with accuracy is needed because of wate importance in view of
`predicting a clinical therapeutic efficiency thereof.
`
`[0004]Historically, an experimental dermatophytosis model that back, planta and interdiQital of
`a guniea pig have been infected with Trichophyton mentagrophytes has been used in order to
`evaluate an effect of an antifungal agent on dermatophytosis. Such anirnal models have been
`already emplo·y'ed to develop some antifungal aqent. The evaluation of the effect of such
`antifungal agent carried out by applying the antifungal agent to the infected animal, by excising
`the skin after the certain period of time to cut into plural srnall pieces, by cultivating the skin
`pieces on the medium, and by countinq the number of pieces wherein no wowth of funqus is
`seen or the number of animals or feet wherein no growth of fungus is seen in all skin pieces, as
`an indicator (Antimicrobial Agents and Chemotherapy, 36: 2523···2525, 1992, 39: 2353···2355,
`1995). Hereinafter, the conventional method for evaluating the drug effect is referred to as "the
`conventional method".
`
`[OOOS]Aithough the drug having a potent activity against Trichophyton in vitro such as
`lanoconazole or amorolfine has been marketed in these days, an improvement of cure rate in a
`
`Page 18 of 161
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`clinical use is hardly seen, As a main reason thereof, a relapse that since fungus in the skin is
`not completely killed after a treatrnent, the funr,ws grow again is pointed.
`
`[0006]In also animal experiments, when an effect of lanoconazole on guniea pig models of
`tinea pedis was evaluated using the conventional method, thou9h "fungus~negative" was
`observed in all feet out of 2.0 feet 2 days after the last treatment, a relapse was observed in 1.1
`out of 20 feet 30 clays after the last treatment, and no correlation was seen betvveen the effect
`2 days after the last treatrnent and the effect 30 days after the last treatment (36th
`Interscience Conference on Antimicrobial Agents and Chemotherapy, New Orleans, La., 1996,
`.AbstL F80).
`
`[0007]As a reason thereof, there were followings, Since lanoconazole have very po