`
`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.
`
`14/195,435
`
`
`
`
` FILING DATE
`
`
`03/03/2014
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKETNO.
`
`CONFIRMATIONNO.
`
`Howard C. Root
`
`2005.86USREI6
`
`9278
`
`PATTERSON THUENTE PEDERSEN,P.A. aee
`PAIR
`SERSED
`rT
`PAT
`4800 IDS CENTER
`WILLIAMS, CATHERINE SERKE
`80 SOUTH 8TH STREET
`MINNEAPOLIS, MN 55402-2100
`
`PAPER NUMBER
`
`3993
`
`MAIL DATE
`
`10/06/2015
`
`DELIVERY MODE
`
`PAPER
`
`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.
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Applicant(s)
`Application No.
` 14/195,435 ROOT ETAL.
`
`Examiner
`Art Unit
`AIA(First Inventorto File)
`Office Action Summary
`
`3993CATHERINE S. WILLIAMS Na
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available underthe provisions of 37 CFR 1.136(a).
`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).
`Anyreply received by the Office later than three months after the mailing date of this communication, evenif timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply betimely filed
`
`Status
`1)X] Responsive to communication(s)filed on 1/9/15.
`LJ A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiledon__
`2a)L] This action is FINAL.
`2b) This action is non-final.
`3)L] Anelection was made bythe applicant in responsetoarestriction requirementset forth during the interview on
`
`___} the restriction requirement and election have been incorporated into this action.
`4)[] Since this application is in condition for allowance exceptfor 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)KX] Claim(s) 25-50 is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6)L] Claim(s)____is/are allowed.
`7)X] Claim(s) 25-42 and 44-50 is/are rejected.
`8)X] Claim(s) 43 is/are objected to.
`
`9)L] 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
`
`
`
`nite://www.usoto.gov/patenis/init events/pph/index.isp or send an inquiry to PPHieedback@uspto.qov.
`
`Application Papers
`10)L] The specification is objected to by the Examiner.
`
`11)L] The drawing(s)filed on
`is/are: a)L_] accepted or b)L_] 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)L] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)L] All
`b)[-] Some** c)L] None ofthe:
`1..] Certified copies of the priority documents have been received.
`2.L] Certified copies of the priority documents have been received in Application No.
`3.L] Copies of the certified copies of the priority documents have been receivedin this National Stage
`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) X Notice of References Cited (PTO-892)
`:
`.
`2) X Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`
`3) CT] Interview Summary (PTO-413)
`Paper No(s)/Mail Date.
`4) Ol Other:
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20150916
`
`
`Paper No(s)/Mail Date 3/6/14, 6/12/14, 7/23/14, and 8/12/14.
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`

`

`Application/Control Number: 14/195,435
`
`Art Unit: 3993
`
`Page 2
`
`DETAILED ACTION
`
`Thepresent application is being examined underthe pre-AIAfirst to invent provisions.’
`
`For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251
`
`and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012.
`
`Where specifically designated, these are “pre-AIA” provisions.
`
`For reissue applicationsfiled on or after September 16, 2012, all references to 35 U.S.C.
`
`251 and 37 CFR 1,172, 1.175, and 3.73 are to the current provisions.
`
`This reissue application wasfiled after September 16, 2012; therefore, all references to
`
`35 U.S.C. 251 and 37 CFR 1.172, 1.75, and 3.73 are to the current provisions enacted under the
`
`Leahy-Smith American Invents Act (AIA), see Federal Register, Vol. 77, No. 157, pg. 48820,
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`August 16, 2012.
`
`Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely
`
`apprise the Office of any prior or concurrent proceeding in which Patent No. 8,292,850 (“the
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`*850 patent’’) is or was involved. These proceedings would includeinterferences, reissues,
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`reexaminations, andlitigation.
`
`Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely
`
`apprise the Office of any information which is material to patentability of the claims under
`
`consideration in this reissue application.
`
`' It is noted that while the examination ofthe currentreissue application falls under the pre-AIA
`first to invent provisions dueto the filing date of US Patent No. 8,292,850; the application for
`reissue filing date is after September 16, 2012 and therefore is subject to the reissue rule changes
`enacted under the Leahy-Smith American Invents Act (AIA), see Federal Register, Vol. 77, No.
`157, pg. 48820, August 16, 2012.
`
`

`

`Application/Control Number: 14/195,435
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`Art Unit: 3993
`
`Page 3
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`These obligations rest with each individual associated with the filing and prosecution of
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`this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
`
`Terminal Disclaimer
`
`The terminal disclaimerfiled on 12/19/14 disclaiming the terminal portion of any patent
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`granted on this application which would extend beyond the expiration date of US Pat. Nos.
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`8,048,032; 8,142,413 and 8,292,850 and Reissue Application Nos. 14/195,413; 14/195,385 and
`
`14/070,161 has been reviewed and is accepted. The terminal disclaimer has been recorded.
`
`Specification
`
`The amendmentto the specification filed 3/6/14 has been received and approved.
`
`Information Disclosure Statements
`
`The information disclosure statement (IDS) submitted on 3/6/14 is in compliance with the
`
`provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been
`
`considered by the examiner. It is noted that the court documents cited on pages 6-7 of the IDS
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`have been considered; however,their listing is struck through on the form since these documents
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`will not be printed on the face of a reissue patent.
`
`The information disclosure statement (IDS) submitted on 6/12/14 is in compliance with
`
`the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been
`
`considered by the examiner.
`
`

`

`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 4
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`The information disclosure statements (IDS) submitted on 7/23/14 and 8/12/14 have been
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`considered by the examiner. It is noted that the court documents cited have been considered;
`
`however,their listing is struck through on the form since these documents will not be printed on
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`the face of a reissue patent.
`
`Response to Arguments
`
`Applicant’s remarks filed 6/11/14 have been reviewed. Applicant’s request for a
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`telephonic interview has been noted; however, the amountof prior art applied below warrants
`
`this office action in order to enable a meaningful telephonic interview. Once reviewed, the
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`examiner will arrange a time for a telephonic interview at applicant's requested date and time.
`
`Claim Rejections - 35 USC § 103
`
`The following is a quotation of pre-AIA 35 U.S.C. 103(a) which formsthe basis forall
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`obviousnessrejections set forth in this Office action:
`
`(a) A patent may not be obtained thoughthe inventionis not identically disclosed or described as set
`forth in section 102 of thistitle, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obviousat the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`Claims 25, 27-28, 30-35, 37-38 and 47 are rejected under pre-AIA 35 U.S.C. 103(a) as
`
`being unpatentable over US 2004/0010280 to Adamsetal. (“Adams ‘280”) in view of US
`
`5,120,323 to Shockeyet al. (“Shockey’’).
`
`Regarding independent claim 25, Adams discloses a device to create proximalstasis that
`
`includes a method (see | GOS9) for advancing a distal end (12) of a guide catheter (10) having a
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`lumen through a main flood vessel to an ositum of a coronaryartery (“The distal end 12 of the
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`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 5
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`guide catheter ts shown inserted tn the ostiam O of a coronary veasel V which has a lesion L."
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`see fig. TB): advancing a distal end of a guide extension catheter through, and beyond the distal
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`ent of the guide catheter (sec “[gmide seal 20 shown with distal vessel sealing portion 13
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`deployed beyondthe distal end of the guide catheter expanded agaist the walls of the vessel...”
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`@ 0059 2°" column page 6) while a segment defining a side opening (io the right 11 1a) ofthe
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`guide extension catheter and a proximal end of a nibular structure (110) of the snide extension
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`catheter remain within the guide catheter (see embodiments ot figs, LA and 115 in conpunction
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`with fig. 1B), the side opening (to the right of Lila} extending for adistance along a longitudinal
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`axis of the guide extension catheter and accessible from a longitudinal side defined tranaverse ta
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`the longitudinal axis (see annctated fig. LIA below}, the tubular structure having a cross-
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`sectional inner diameter that is not more than one French size smaller than a cross-sectional inner
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`diameter of the humen of the guide catheter (see Y G032); and with the distal end of the guide
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`extension catheter positioned beyond the distal end of the guide catheter (see fig. 1B), advancing
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`a treatrnent catheter at least partially through the guide catheter and the guide extension catheter
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`and into the coronary artery (see 98 0011-0027), including advancing a distal portion ofthe
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`treatrnent catheter through a hemostatic valve associated with a proximal end ofthe guide
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`catheter (9 O0G60), along a substantially rigid segment (113) of the guide extension catheter,
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`through the side opening (fo the right of 1] 1a}, and through the tubular structure (111),
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`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 6
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`“longitudinal axis”
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`“tubular structure”
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`Regarding clairns 27-28 and 30-31, see (9 0060-0061 which discusses a hemostasis valve
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`O atthe end of ¥ connector 7... guide seal is then loaded inte the proatma!l end of the guide
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`catheter through the ¥ connector with the aid of an introducer and advanced distally. ..the
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`embolic protection device is now advanced through the guide seal and through the vessel across
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`the lesion...” ris noted that the advancement of the guide seal through the hemostasis valve at
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`the end of the Y connector inchide the tubular structure (110), the side opening (]ila} and the
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`substantiallyrigid segment (113).
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`Kegarding clairn 32, this coaxial alignment can be seen in fig. 1B of Adams.
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`Regarding claim 33, see fig. 1B clearly showing the proximal end of the tubular structure
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`20b/1 10 within the suide catheter 10, See also] OG61 which discusses the movement of the
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`treatment catheter inte the tubular structure within the guide catheter.
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`Regarding claim 34, Adams states “fdleployment of the distal sealing portion of the guide
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`seal results in a seal being formed between the guide catheter and the vessel..." See (0061.
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`

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`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 7
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`Regarding claim 35, “[wihen the guide seal is used in the osthum of a coronaryartery it
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`ray be provided with structural features which prevent the distal sealing portion from expanding
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`too rapidly which could result in the distal tip of the guide catheter being dislodged fromthe
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`osthum.” See FE OQ6E,
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`Regarding claims 37-38, see | 0064
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`Regarding clair 47, Adams teaches advancing the treatment catheter at least partially
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`through the tubular structure includes advancing the treatment catheter through a reinforcing
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`braid or coil having a length of 20 to 30 cm. see endof pp. OUS0.
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`Claims 25-42, 44-45 and 47 are rejected under pre-AIA 35 U.S.C. 103(a) as being
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`unpatentable over US 5,527,292 to Adamset al. (“Adams ‘292”) in view of US 2004/0010280
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`to Adams (“Adams ‘280”’) in further view of US 5,120,323 to Shockey et al (“Shockey’’).
`
`Regarding independent claim 25, Adamsdiscloses an intravascular device for coronary
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`heart treatmentthat includes a rnethod {see cols, 4-5, 1. 56-7 and col. $, UE. S5-67) for advancing
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`a distal end of a ginde catheter (12) having a himen (27) through a main blood vessel to an
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`ostium of a coronary artery (“the murde catheter is inserted at the femoral artery and advanced
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`through a pationt’s arterial systemto the coronary ostium of the artery requiring treatment’, see
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`eal 4, U. 36-38) advancing a distal end of a guide extension catheter through, and beyondthe
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`distal end of the guide catheter (the guide catheter (diameter and rigidity) does not permut the
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`guide catheter to advance beyond the osthiminto the artery requiring weatment. The distal
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`Art Unit: 3993
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`Page 8
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`extension however is designed for insertion through coronaryarteries requiring treatment, see
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`col 4, ll. 39-63) while a segment defining a side opening (38) of the guide extension catheter and
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`a proximal end ofa tubular structure (32) of the guide extension catheter remain within the gnide
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`catheter (see fig. 2), and with the distal end of the guide extension catheter posinoned beyond the
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`distal end of the guide catheter, advancing a treatment catheter at least partially through the guide
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`catheter and the guide extension catheter andinte the coronary artery (see fig.
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`ft, and cols. 4-5, 1.
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`63-3 and col. 9, IL 1-11), imchuding advancmng a distal portion of the treatment catheter through a
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`hemostatic valve associated with a proximal end of the guide catheter (col, 3, 1L 27-29), along a
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`substantially rigid segment (19/34) of the guide extension catheter, through the side opening
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`(38), and through the tubular structure (32).
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`Regarding clairn 26, see col. 5,1 17-24.
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`Regarding claims 27, 30, 38-39, a hernostatic valve on channel log 17 is disclosed, see
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`coL 3, i. 27-29,
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`Regarding clairn 28, see col. 4, H, 63-67.
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`Regarding claims 29, 32-33, 40, see fig. 2.
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`Regarding claim 31, the ngid segment (19/34) is advanced within the himen ofthe guide.
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`eatheter (12). See cal. 6 IL 4-8.
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`Regarding claim 34, the injection offluid andor drugs is disclosed, see cal. 5, H. 20-27
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`and col, 6, 1h 63-65.
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`Regarding claims 33-36, see col. 4, 1. 66 which discluses the anchor function ofthe distal
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`extension member. See alsa col. & WH. 2P2-17.
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`Regarding clairn 47, the tubular structure is 20-30cmin length, see col. 5, 1. 61-62.
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`

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`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 9
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`Regarding claim 25, Adarns °292 meets the claim limitations as described above bat docs
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`ncd teach the side opening extending for a distance along a longitudinal axis of the suide
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`extension catheter and accessible from a longitudinal side defined transverse to the longitudinal
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`axis.
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`However, Adams ‘280 discloses a connection (73a/1 lla} made between the tubular
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`structure (70/1103 and the rigid portion (73/113) that results in a sue opening extending for a
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`distance along a longitudinal axis of the guide exterision catheter. [tis the gathering of wires
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`(36a) ma connection with the crimp tube (34) that result in an angled openiig that extends for a
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`distance along a fongitudinal axis of the guide extension catheter. See Adams "280 4 0067,
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` Concavetrack
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`Regarding claims 41-42 and 44-45, Fig. 3A of Adams “280 above shows the angled
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`opening which has a portion (annotated as concave track above) which meets the limitations
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`regarding a concave, arcuate, hernicylindrical, and inclined sloped strecture.
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`Regarding clainis 46 and 46, Adams “280 disclases howthe wires 364 of braid 36 are
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`gathered at the proxirnal end and guide seal 30 is covered over at least a portion adjacent the
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`distal end 33 with a fluid impermeable membrane. See YY] 0066-0067.
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`At the time of the invention, it would have been obvious to incorporate the connection
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`resultiag in an angled opening as taught by Adams ‘280inte the invention of Adams “292,
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`

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`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 10
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`Adams °292 discloses that “the elongate flexible tube 32 is formed of a coil spring 40 made from
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`stainless steel or a platinun:...”; therefore, incorporating the crimping techniques resulting in the
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`angled opening as taught by Adams “280 would have been a reasonable alternative for attaching
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`the substantially rigid segrnent (19/34) of the guide extension catheter to the tubular stracture
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`(32), Further, the modification would have resulted in predictable results, 1.e, secure attachment
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`of the rigid segment to the tubular structure.
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`Additionally with respect to clair 25, Adarns “292 racets the claim lUmutations as
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`described above but does not teach the tubular structure having a cross-sectional miner diameter
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`that is not more than one French size smaller than a cross-sectional inner ciameter of the himen
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`of the guide catheter.
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`However, Shockey discloses a telescoping guide catheter systemthat inclades 4 teaching
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`of mserting a second guide catheter within the lamen ofa first guide catheter. "With the second
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`guide catheter advancedso that its distal end portion is contained within the coronaryartery to be
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`treated, it provides backup support for the blood vessel during the recanGahzation procedure and
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`allows repeated exchanges of working catheters with a minimumof damage to the intima.” See
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`cal 2,11 48-33. The second catheter is one French less than the first catheter. See cal. 3, HL. 52-
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`59. This is structured in order to provide clearance between the two catheters.
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`At the time of the invention, it would have been obvious to size the tabular structure (32
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`of Adams °292) not more than one French size smaller than the guide catheter (12). The
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`rnotivation for this incorporation would have been in order to prevent frictional resistance
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`between the two catheters during advancement of the tubular structure (32). The incorporation
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`

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`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 11
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`of these sizes would have yielded predictable results in enabling the fanctioning of the tebular
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`structure as taught by Adams “292.
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`Regarding claira 37, Adams *292 does not disclose advancing a stent. However, stent
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`deployment is offen 4 necessary treatment for stenotic coronaryarteries. Therefore, it would
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`have been obvious to incorporate a stent procedure in conjunction with the balloon catheter for
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`furthertreating the patient's coronary vessel. The rotivation would have been in orderto
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`provide the patient with the best standard ofcare.
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`Reparding claims 49-30. Adams "292 fails to teach advancing the treatment catheter
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`through a structure having one or more cuts. However, Adams ‘280 teaches openings Flow
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`windows 366) which are located in the tubular structure for use im patients that cannot tolerate
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`the stasis or retrograde flow situation which allows some flow. At the time of the invention, it
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`would have been obvious to incorporate these flow windows nto the combination in orderto
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`provide a treatment to the patient i necessary. The combination would have yielded predictable
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`results in providing an extension to a guide catheter for placement ofa treatment catheter,
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`Allowable Subject Matter
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`Claim 43 is objected to as being dependent upona rejected base claim, but would be
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`allowable if rewritten in independent form includingall of the limitations of the base claim and
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`any intervening claims.
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`The following is a statement of reasonsfor the indication of allowable subject matter:
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`regarding claim 43, the prior art fails to teach wherein the arcuate cross-sectional shape extends
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`for a length of 5 cm.
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`

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`Application/Control Number: 14/195,435
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`Art Unit: 3993
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`Page 12
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`Conclusion
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to CATHERINE S. WILLIAMSwhosetelephone numberis
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`(571)272-4970. The examiner can normally be reached on Monday- Friday.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Lillis Eileen can be reached on 571/272-6928. The fax phone numberfor the
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`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
`
`maybe 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
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800-786-9199 (IN USA OR CANADA)or 571-272-1000.
`
`/Catherine S. Williams/
`Primary Examiner
`Central Reexamination Unit 3993
`
`Conferees:
`
`/ple/ and /GAS/
`
`