UNITED STA (cid:9) [ES PA (cid:9) 1ENT 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. (cid:9)
`
`14/195,435
`
`FILING DATE
`
`03/03/2014
`
`FIRST NAMED INVENTOR (cid:9)
`
`I ATTORNEY DOCKET NO. I CONFIRMATION NO.
`
`Howard C. Root
`
`2005.86USREI6
`
`9278
`
`10/06/2015
`7590 (cid:9)
`24113 (cid:9)
`PATTERSON THUEN IL PEDERSEN, P.A.
`4800 IDS CENTER
`80 SOUTH 8TH STREET
`MINNEAPOLIS, MN 55402-2100
`
`EXAMINER
`
`WILLIAMS, CATHERINE SERKE
`
`ART UNIT
`
`PAPER NUMBER
`
`3993
`
`MAIL DATE
`
`DELIVERY MODE
`
`10/06/2015
`
`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)
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`Page 1
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`Medtronic Exhibit 1469
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`Application No.
`14/195,435
`
`Applicant(s)
`ROOT ET AL.
`
`Examiner
`CATHERINE S. WILLIAMS
`
`Art Unit
`3993
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`— The MAILING DATE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 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)Z Responsive to communication(s) filed on 1/9/15.
`A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on (cid:9)
`2a)0 This action is FINAL. (cid:9)
`2b)Z 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 0.G. 213.
`
`
`
`Disposition of Claims*
`5)E1 Claim(s) 25-50 is/are pending in the application.
`5a) Of the above claim(s) (cid:9)
`is/are withdrawn from consideration.
`6)0 Claim(s) (cid:9)
`is/are allowed.
`7)E1 Claim(s) 25-42 and 44 -50 is/are rejected.
`8)Z Claim(s) 43 is/are objected to.
`9)0 Claim(s) (cid:9)
`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
`httpliwwwusptagovipatents/init events/pphlindex.jsp or send an inquiry to PPI-lteedback@usptaaov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11)0 The drawing(s) filed on (cid:9)
`is/are: a)Eaccepted or bElobjected 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)E All b)0 Some** c)1=1 None of the:
`1.0 Certified copies of the priority documents have been received.
`.
`2.0 Certified copies of the priority documents have been received in Application No. (cid:9)
`3.0 Copies of the certified copies of the priority documents have been received in 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) Z Notice of References Cited (PTO-892)
`
`2) Z Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 3/6/14, 6/12/14, 7/23/14, and 8/12/14.
`
`3)
`
`4)
`
`Interview Summary (PTO-413)
`Paper No(s)/Mail Date. (cid:9)
`
`Other: (cid:9)
`
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20150916
`
`Page 2
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`Medtronic Exhibit 1469
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`(cid:9)
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
`
`Page 2
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`DETAILED ACTION
`
`The present application is being examined under the pre-AIA first 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 applications filed 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 was filed after September 16, 2012; therefore, all references to
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`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,
`
`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
`
`'850 patent") is or was involved. These proceedings would include interferences, reissues,
`
`reexaminations, and litigation.
`
`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 It s noted that while the examination of the current reissue application falls under the pre-AIA
`first to invent provisions due to 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.
`
`Page 3
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`Medtronic Exhibit 1469
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
`
`Page 3
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`These obligations rest with each individual associated with the filing and prosecution of
`
`this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
`
`Terminal Disclaimer
`
`The terminal disclaimer filed on 12/19/14 disclaiming the terminal portion of any patent
`
`granted on this application which would extend beyond the expiration date of US Pat. Nos.
`
`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.
`
`The amendment to the specification filed 3/6/14 has been received and approved.
`
`Specification
`
`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
`
`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
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`considered by the examiner.
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`Page 4
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`Medtronic Exhibit 1469
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
`
`Page 4
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`The information disclosure statements (IDS) submitted on 7/23/14 and 8/12/14 have been
`
`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 amount of 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 forms the basis for all
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`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, 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 obvious at 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 Adams et al. ("Adams '280") in view of US
`
`5,120,323 to Shockey et al. ("Shockey").
`
`Regarding independent claim 25, Adams discloses a device to create proximal stasis that
`
`includes a method see 0059) for advancing a distal end (12) of a guide catheter (10) having a
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`lumen through a main blood vessel to an ostram of a coronary artery ("The distal end 12 of the
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`Page 5
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`Medtronic Exhibit 1469
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
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`Page 5
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`guide catheter is shown inserted in the ostium 0 of a coronary vessel V which has a lesion L.
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`see fig, I B); advancing a distal end of a guide extension catheter through, and beyond the distal
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`end of the guide catheter (see "rgluide seal 20 shown with distal vessel sealing portion 13
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`deployed beyond. the distal end of the guide catheter expanded against the walls of the vessel.,."
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`0059 2n" column page 6) while a segment defining a side opening (to the right 111a) of the
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`guide extension catheter and a proximal end of a tubular structure (110) of the guide extension
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`catheter remain within the guide catheter (see embodiments of figs, 11A and 11B in conjunction
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`with fig. 1.B), the side opening (to the right of 111a) extending for a distance along a longitudinal
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`axis of the guide extension catheter and accessible from a longitudinal side defined transverse to
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`the longitudinal axis (see annotated fig. 11A 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 lumen of the guide catheter (see ¶11 0052); 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. 1.B), advancing
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`a treatment catheter at least partially through the guide catheter and the guide extension catheter
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`and into the coronary artery (see (cid:9)
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`0011.-0027), including advancing a distal portion of the
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`treatment catheter through a hemostatic valve associated with a proximal end of the guide
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`catheter (1[ 0060), along a substantially rigid segment (113) of the guide extension catheter,
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`through the side opening (to the right of 111a), and through the tubular structure (111),
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`Page 6
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`Medtronic Exhibit 1469
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
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`Page 6
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`F16
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`1/9 "side opening"
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`"tubular structure"
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`"longitudinal axis"
`.1.11
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`Ma,
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`115
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`1 16
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`• (cid:9)
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`!RR.,
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`Regarding claims 27-28 and 30-31, see ¶jI 0060-0061 which discusses a hemostasis valve
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`9 at the end of Y connector 7... 'guide seal is then loaded into the proximal end of the guide
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`catheter through the Y 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..." It is noted that the advancement of the guide seal through the hemostasis valve at
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`the end of the Y connector include the tubular structure, (110), the side opening (11 la) and the
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`substantiality rigid segment (113).
`
`Regarding claim 32, this coaxial alignment can be seen in fig. 1B of Adams,
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`Regarding claim 33, see fig. 1.B dearly showing the proximal end of the tubular structure
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`20b/110 within the guide catheter 10. See also 9 0061 which discusses the movement of the
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`treatment catheter into the tubular structure within the guide catheter.
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`Regarding claim 34, Adams states "[d]eployment 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 I 0061,
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`Page 7
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`Medtronic Exhibit 1469
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
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`Page 7
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`Regarding claim 35, "[w]hen the guide seal is used in the ostium of a coronary artery it
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`may 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 from the
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`ostium." Seel 0061.
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`Regarding claims 37•38, see ¶ 0064
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`Regarding claim 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 end of pp, 0050.
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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 Adams et 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, Adams discloses an intravascular device for coronary
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`heart treatment that includes a method (see cols. 4-5,11. 56-7 and col, 8,11. 55-67) for advancing
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`a distal end of a guide catheter (12) having a lumen (27) through a main blood vessel to an
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`ostium of a coronary artery ("the guide catheter is inserted at the femoral artery and advanced
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`through a patient's arterial system to the coronary ostium of the artery requiring treatment", see
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`col. 4, 11. 56-58); advancing a distal end of a guide extension catheter through, and beyond the
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`distal end of the guide catheter (the guide catheter (diameter and rigidity) does not permit the
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`guide cathete,r to advance beyond the °sawn into the artery requiring treatment. The distal
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
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`Page 8
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`extension however is designed for insertion through coronary arteries requiring treatment, see
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`col, 4,11. 59-63) While a segment defining a side opening (38) of the guide extension catheter and
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`a proximal end of a tubular structure (32) of the guide extension catheter remain within the guide
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`catheter (see fig. 2, and with the distal end of the guide extension catheter positioned 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 and into the coronary artery (see fig. 1, and cols. 4.-5,11,
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`63-3 and col. 9,11. 1-11), including advancing 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, 5, 11, 27-29), along a
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`substantiality 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 claim 26, see col. 5, H. 17-24.
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`Regarding claims 27, 30, 38-39, a hemostatic valve on channel log 17 is disclosed, see
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`col. 5,11. 27-29.
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`Regarding claim 28, see col. 4,11 63-67.
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`Regarding claims 29, 32-33, 40, see fig.
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`Regarding claim 31, the rigid segment (19/34) is advanced within the lumen of the guide
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`catheter (12). See col. 6, U. 4-8.
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`Regarding claim 34, the injection of fluid and. or drugs is disclosed, see col. 5,11. 20-27
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`and col. 6,11, 61-65.
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`Regarding claims 35-36, see col. 4, L 66 which discloses the anchor function of the distal
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`extension member. See also col. 9, IL P..-17.
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`Regarding claim 47, the tubular structure is 20-30cm in length, see col. 5, IL 61-62.
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`Page 9
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`Medtronic Exhibit 1469
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`Application/Control Number: 14/195,435 (cid:9)
`Art Unit: 3993
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`Page 9
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`Regarding claim 25, Adams '292 meets the claim limitations as described above but does
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`not teach the side opening extending for a distance along a longitudinal axis of the guide
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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/111a) made between the tubular
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`structure (70/110) and the rigid portion (73/113) that results in a side opening extending for a
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`distance along a longitudinal axis of the guide extension catheter. It is the gathering of wires
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`(36a) in connection with the crimp tube (34) that result in an angled opening that extends for a
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`distance along a longitudinal axis of the guide extension catheter. See Adams '280 1 0067.
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`Concave track
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`F76' 3A
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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, bernicylindrical, and inclined sloped structure.
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`Regarding claims 46 and 48, Adams '280 discloses how the wires 36a of braid 36 are
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`gathered at the proximal 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
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`NA 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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`resulting in an angled opening as taught by Adams '280 into the invention of Adams '292.
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`Application/Control Number: 14/195,435 (cid:9)
`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 stc.sei or a platinum..."; 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 segment (19/34) of the guide extension cathete,r to the tubular structure
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`(32). :Further, the modification would have resulted in predictable results, i.e. secure attachment
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`of the rigid segment to the tubular structure.
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`Additionally with respect to claim 25, Adams '292 meets the claim limitations as
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`described above but does not teach the tubular structure having a cross-sectional inner diameter
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`that is not more than one French size smaller than a cross-sectional inner diameter of the lumen
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`of the guide catheter,
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`However, Shockey discloses a telescoping guide catheter system that includes a teaching
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`of inserting a second guide catheter within the lumen of a first guide catheter. With the second
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`guide catheter advanced, so that its distal end portion is contained within the coronary artery to be
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`treated, it provides backup support for the blood vessel during the re,can3alization procedure and
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`allows repeated exchanges of working catheters with a minimum of damage to the intima." See
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`col. 2, U. 48-51 The second catheter is one French less than the first catheter. See col. 3, IL 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 tubular 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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`motivation 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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`Application/Control Number: 14/195,435 (cid:9)
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`Page 11
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`of these sizes would have yielded predictable results in enabling the functioning of the tubular
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`structure as taught by Adams '292.
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`Regarding claim 37, Adams '292 does not disclose advancing a stern. However, stent
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`deployment is often a necessary treatment for stenotic coronary arteries, 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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`further treating the patient's coronary vessel. The motivation would have been in order to
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`provide the patient with the best standard of care.
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`Regarding claims 49-50, 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 56b) which are located in the tubular structure for use in 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 into the combination in order to
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`provide a treatment to the patient if necessary. The combination would. have yielded predictable
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`results in providing an extension to a guide catheter for placement of a treatment catheter,
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`Allowable Subject Matter
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`Claim 43 is objected to as being dependent upon a rejected base claim, but would be
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`allowable if rewritten in independent form including all 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 reasons for 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 15 cm,
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`Application/Control Number: 14/195,435 (cid:9)
`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. WILLIAMS whose telephone number is
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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 number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`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
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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.
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`/Catherine S. Williams/
`Primary Examiner
`Central Reexamination Unit 3993
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`Conferees: /ple/ and /GAS/
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`Page 13
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`Medtronic Exhibit 1469
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`(cid:9)
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