`
`In re the application of:
`
`Attorney Docket No.: 2005.86US02
`
`PATENT APPLICATION
`
`Root et al.
`
`Application No.:
`
`of even date
`
`Filed:
`
`of even date
`
`For: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`PRELIMINARY AMENDMENT
`
`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`INTRODUCTORY COMMENTS
`
`Prior to examination, please amend the above-identified application as follows:
`
`The present amendment comprises the following sections:
`
`A. Amendments to the Specification
`
`B. Listing of Claims
`
`C. Remarks
`
`Please grant any extension of time necessary for entry; charge any fee due to Deposit Account No. 16-0631.
`
`Page 1
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`Medtronic Exhibit 1403
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`
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`Attorney Docket No. 2005.86US02
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`AMENDMENTS TO THE SPECIFICATION
`
`In the Specification
`
`Please substitute the following amended paragraph(s) and/or section(s) (deleted matter is
`
`shown by strikethrough and added matter is shown by underlining):
`
`Page 1, prior to line 6, please insert the following:
`
`Related Application
`
`This application is a division of Application No. 11/416.629 filed May 3, 2006, which is
`
`hereby fully incorporated herein by reference.
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`2
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`Page 2
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`Medtronic Exhibit 1403
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`
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`Attorney Docket No. 2005.86US02
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`AMENDMENTS TO THE CLAIMS
`
`A detailed listing of all claims that are, or were, in the present application, irrespective of
`
`whether the claim(s) remain(s) under examination in the application is presented below. The
`
`claims are presented in ascending order and each includes one status identifier. Those claims not
`
`cancelled or withdrawn but amended by the current amendment utilize the following notations
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`for amendment: 1. deleted matter is shown by strikethrough for six or more characters and
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`double brackets for five or fewer characters; and 2. added matter is shown by underlining.
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`3
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`Page 3
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`Medtronic Exhibit 1403
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`
`
`Attorney Docket No. 2005.86US02
`
`I.
`
`(Original)
`
`A method of providing backup support for an interventional cardiology
`
`device for use in the coronary vasculature, the interventional cardiology device being adapted to
`
`be passed through a guide catheter, the method comprising:
`
`inserting the guide catheter into the first blood vessel, the guide catheter having a first
`
`lumen and a distal end;
`
`positioning the distal end of the guide catheter in a second blood vessel that branches off
`
`from the first blood vessel;
`
`inserting a coaxial guide catheter over the guidewire and into the first lumen of the guide
`
`catheter, the coaxial guide catheter having a second lumen and
`
`a flexible distal tip portion,
`
`a reinforced portion proximal to the distal tip portion, and
`
`a substantially rigid portion proximal to the reinforced portion, the substantially rigid
`
`portion having an opening along a side thereof,
`
`advancing the distal tip portion of the coaxial guide catheter into the second blood vessel
`
`such that the flexible distal tip portion and at least a portion of the reinforced portion extend out
`
`of the distal end of the guide catheter and into the second blood vessel; and
`
`inserting the interventional cardiology device through the lumen of the coaxial guide
`
`catheter and into contact with or past a lesion in the second blood vessel.
`
`2.
`
`(Original)
`
`The method as claimed in claim 1, further comprising applying a force to a
`
`proximal portion of the coaxial guide catheter such that the distal tip portion of the coaxial guide
`
`4
`
`Page 4
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`Medtronic Exhibit 1403
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`
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`catheter remains seated in the second blood vessel in response to an opposing backward force
`
`exerted by the interventional cardiology device.
`
`Attorney Docket No. 2005.86US02
`
`3.
`
`(Original)
`
`The method as claimed in claim 1, further comprising:
`
`keying the tapered inner catheter to the coaxial guide catheter at a proximal portion
`
`thereof;
`
`inserting a guidewire having a tip into a first blood vessel; and
`
`inserting the tip of the guidewire into a second blood vessel that branches off of the first
`
`blood vessel.
`
`4.
`
`(Original)
`
`The method as claimed in claim 1, further compnsmg selecting the
`
`substantially rigid portion of the coaxial guide catheter such that it comprises a cylindrical
`
`portion and a partially cylindrical portion defining the opening along a side thereof.
`
`5.
`
`(Original)
`
`The method as claimed in claim 1, further comprising selecting the guide
`
`catheter to further comprise a Y-adapter and the method further comprising injecting a fluid
`
`through the Y -adapter into the second lumen.
`
`6.
`
`(Original)
`
`The method as claimed in claim 1, further comprising inserting a
`
`guidewire having a tip into a first blood vessel; and
`
`inserting the tip of the guidewire into a second blood vessel that branches off of the first
`
`blood vessel.
`
`5
`
`Page 5
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`Medtronic Exhibit 1403
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`
`
`Attorney Docket No. 2005.86US02
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`7.
`
`(Original)
`
`The method as claimed in claim 6, further comprising placing a tapered
`
`inner catheter inside the second lumen of the coaxial guide catheter, the tapered inner catheter
`
`including a tapered distal portion, the tapered distal portion being positioned to extend beyond
`
`the distal tip of the coaxial guide catheter;
`
`removing the tapered inner catheter from the coaxial guide catheter; and
`
`removing the guidewire from the coaxial guide catheter.
`
`8-20.
`
`(Canceled).
`
`6
`
`Page 6
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`Medtronic Exhibit 1403
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`
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`Attorney Docket No. 2005.86US02
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`REMARKS
`
`Claims 1-20 are pending. By this Amendment 8-20 are canceled.
`
`In view of the foregoing, it is submitted that this application is in condition for allowance.
`
`Favorable consideration and prompt allowance of the application are respectfully requested.
`
`The Examiner is invited to telephone the undersigned if the Examiner believes it would
`
`be useful to advance prosecution.
`
`Brad Pedersen
`Registration No. 32,432
`
`Customer No. 24113
`Patterson Thuente Christensen Pedersen, P.A.
`4800 IDS Center
`80 South 8th Street
`Minneapolis, Minnesota 55402-2100
`Telephone: (612) 349-5774
`
`7
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`Page 7
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`Medtronic Exhibit 1403
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`
`
`Electronic Patent Application Fee Transmittal
`
`Application Number:
`
`Filing Date:
`
`Title of Invention:
`
`COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`First Named Inventor/Applicant Name:
`
`Howard Root
`
`Filer:
`
`Bradley Pedersen/Michelle Arcand
`
`Attorney Docket Number:
`
`2005.86US02
`
`Filed as Small Entity
`
`Utility under 35 USC 111 (a) Filing Fees
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
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`
`Utility filing Fee (Electronic filing)
`
`Utility Search Fee
`
`Utility Examination Fee
`
`4011
`
`2111
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`2311
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`82
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`270
`
`110
`
`82
`
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`
`110
`
`Pages:
`
`Claims:
`
`Miscellaneous-Filing:
`
`Petition:
`
`Patent-Appeals-and-Interference:
`
`Page 8
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`Medtronic Exhibit 1403
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`
`
`Description
`
`Fee Code
`
`Quantity
`
`Amount
`
`Sub-Total in
`USO($)
`
`Post-Allowance-and-Post-Issuance:
`
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`
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`
`Total in USD ($)
`
`462
`
`Page 9
`
`Medtronic Exhibit 1403
`
`
`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`7906131
`
`12824734
`
`International Application Number:
`
`Confirmation Number:
`
`1416
`
`Title of Invention:
`
`COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`First Named Inventor/Applicant Name:
`
`Howard Root
`
`Customer Number:
`
`24113
`
`Filer:
`
`Bradley Pedersen/Michelle Arcand
`
`Filer Authorized By:
`
`Bradley Pedersen
`
`Attorney Docket Number:
`
`2005.86US02
`
`Receipt Date:
`
`28-JUN-2010
`
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`
`Time Stamp:
`
`15:45:09
`
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`
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`
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`
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`
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`
`Authorized User
`
`yes
`
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`
`$462
`
`2382
`
`160631
`
`PEDERSEN,BRADLEY D.
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
`
`Page 10
`
`Medtronic Exhibit 1403
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`
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`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
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`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
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`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
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`Medtronic Exhibit 1403
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Page 12
`
`Medtronic Exhibit 1403
`
`
`
`Electronic Acknowledgement Receipt
`
`EFSID:
`
`Application Number:
`
`7906131
`
`12824734
`
`International Application Number:
`
`Confirmation Number:
`
`1416
`
`Title of Invention:
`
`COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
`
`First Named Inventor/Applicant Name:
`
`Howard Root
`
`Customer Number:
`
`24113
`
`Filer:
`
`Bradley Pedersen/Michelle Arcand
`
`Filer Authorized By:
`
`Bradley Pedersen
`
`Attorney Docket Number:
`
`2005.86US02
`
`Receipt Date:
`
`28-JUN-2010
`
`Filing Date:
`
`Time Stamp:
`
`15:45:09
`
`Application Type:
`
`Utility under 35 USC 111 (a)
`
`Payment information:
`
`Submitted with Payment
`
`Payment Type
`
`Payment was successfully received in RAM
`
`RAM confirmation Number
`
`Deposit Account
`
`Authorized User
`
`yes
`
`Credit Card
`
`$462
`
`2382
`
`160631
`
`PEDERSEN,BRADLEY D.
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.16 (National application filing, search, and examination fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.17 (Patent application and reexamination processing fees)
`
`Page 13
`
`Medtronic Exhibit 1403
`
`
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.19 (Document supply fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.20 (Post Issuance fees)
`
`Charge any Additional Fees required under 37 C.F.R. Section 1.21 (Miscellaneous fees and charges)
`
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`
`Document
`Number
`
`Document Description
`
`File Name
`
`File Size(Bytes)/
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`
`Multi
`Part /.zip
`
`Pages
`(if appl.)
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`Medtronic Exhibit 1403
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`6
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`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable. It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`New A~~lications Under 35 U.S.C. 111
`If a new application is being filed and the application includes the necessary components for a filing date (see 37 CFR
`1.53(b)-(d) and MPEP 506), a Filing Receipt (37 CFR 1.54) will be issued in due course and the date shown on this
`Acknowledgement Receipt will establish the filing date of the application.
`
`National Stage of an International A~~lication under 35 U.S.C. 371
`If a timely submission to enter the national stage of an international application is compliant with the conditions of 35
`U.S.C. 371 and other applicable requirements a Form PCT/DO/E0/903 indicating acceptance of the application as a
`national stage submission under 35 U.S.C. 371 will be issued in addition to the Filing Receipt, in due course.
`
`New International A~~lication Filed with the USPTO as a Receiving Office
`If a new international application is being filed and the international application includes the necessary components for
`an international filing date (see PCT Article 11 and MPEP 181 O), a Notification of the International Application Number
`and of the International Filing Date (Form PCT/R0/1 OS) will be issued in due course, subject to prescriptions concerning
`national security, and the date shown on this Acknowledgement Receipt will establish the international filing date of
`the application.
`
`Page 15
`
`Medtronic Exhibit 1403
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`
`
`PTO/SB/14 (07-07)
`Approved for use through 06/3012010. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required lo respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`2005.86US02
`
`Application Number
`
`Title of Invention
`
`Coaxial Guide Catheter for lnterventional Cardiology Procedures
`
`The application data sheet is part of the provisional or nonprovisional application for which it is being submitted. The following form contains the
`bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR 1. 76.
`This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System (EFS) or the
`document may be printed and included in a paper filed application.
`
`Secrecy Order 37 CFR 5.2
`D Portions or all of the application associated with this Application Data Sheet may fall under a Secrecy Order pursuant to
`37 CFR 5.2 (Paper filers only. Applications that fall under Secrecy Order may not be filed electronically.}
`r
`(PP 1can t I f
`n orma 10n:
`f
`A
`Aoolicant 1
`Applicant Authority ®Inventor I QLegal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`
`I Remove I
`I QParty of Interest under 35 U.S.C. 118
`Family Name
`Suffix
`
`Howard
`Root
`Residence Information (Select One) @ US Residency 0 Non US Residency O Active US Military Service
`I Country of Residence i I us
`State/Province I MN
`City
`Excelsior
`us
`
`Citizenship under 37 CFR 1.41(b} i
`Mailing Address of Applicant:
`Address 1
`Address 2
`I
`Postal Code
`
`City
`
`Aoolicant2
`Applicant Authority ®Inventor I QLegal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`
`I State/Province
`I Countryi I
`
`I
`
`I Remove I
`I QParty of Interest under 35 U.S.C. 118
`Family Name
`Suffix
`
`Gregg
`Sutton
`Residence Information (Select One) @ US Residency 0 Non US Residency O Active US Military Service
`I Country of Residence i I us
`State/Province I MN
`City Maple Grove
`us
`
`Citizenship under 37 CFR 1.41(b} i
`Mailing Address of Applicant:
`Address 1
`Address 2
`I
`Postal Code
`
`City
`
`Annlicant3
`Applicant Authority ®Inventor I QLegal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`
`I State/Province
`I Countryi I
`
`I
`
`I Remove I
`I QParty of Interest under 35 U.S.C. 118
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`Suffix
`
`M.
`Jeffrey
`Welch
`Residence Information (Select One) @ US Residency 0 Non US Residency O Active US Military Service
`State/Province I MN
`I Country of Residence i I US
`City Maple Grove
`
`EFS Web 2.2.2
`
`Page 16
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`Medtronic Exhibit 1403
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`
`
`PTO/SB/14 (07-07)
`Approved for use through 06/3012010. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required lo respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`2005.86US02
`
`Application Number
`
`Title of Invention
`
`Coaxial Guide Catheter for lnterventional Cardiology Procedures
`
`us
`
`Citizenship under 37 CFR 1.41(b} i
`Mailing Address of Applicant:
`Address 1
`Address 2
`I
`Postal Code
`
`City
`
`Annlicant4
`Applicant Authority ®Inventor I QLegal Representative under 35 U.S.C. 117
`Prefix Given Name
`Middle Name
`
`I State/Province
`I Countryi I
`
`I
`
`I Remove I
`I QParty of Interest under 35 U.S.C. 118
`Family Name
`Suffix
`
`Garrity
`Jason
`M.
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`24113
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`pedersen@ptslaw.com
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`Application Information:
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`Title of the Invention
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`Attorney Docket Number 2005.86US02
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`Coaxial Guide Catheter for lnterventional Cardiology Procedures
`I Small Entity Status Claimed
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`[81
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`Page 17
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`Medtronic Exhibit 1403
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`
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`PTO/SB/14 (07-07)
`Approved for use through 06/3012010. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required lo respond to a collection of information unless it contains a valid 0MB control number.
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`Application Data Sheet 37 CFR 1.76
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`Attorney Docket Number
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`2005.86US02
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`Application Number
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`Title of Invention
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`Coaxial Guide Catheter for lnterventional Cardiology Procedures
`
`Pub I ication Information:
`D Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`Request Not to Publish. I hereby request that the attached application not be published under 35 U.S.
`D C. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of
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`11416629
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`2006-05-03
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`Page 18
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`Medtronic Exhibit 1403
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`
`
`PTO/SB/14 (07-07)
`Approved for use through 06/3012010. 0MB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required lo respond to a collection of information unless it contains a valid 0MB control number.
`
`Application Data Sheet 37 CFR 1.76
`
`Attorney Docket Number
`
`2005.86US02
`
`Application Number
`
`Title of Invention
`
`Coaxial Guide Catheter for lnterventional Cardiology Procedures
`
`If the Assignee is an Organization check here.
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`Signature
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`/Brad Pedersen/
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`First Name
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`Brad
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`I Last Name I Pedersen
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`Date (YYYY-MM-DD) 2010-06-28
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`Registration Number
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`32432
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`EFS Web 2.2.2
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`Page 19
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`Medtronic Exhibit 1403
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`
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`EFS Web 2.2.2
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`Page 20
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`Medtronic Exhibit 1403
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`
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`Attorney Docket No. 2005.86US02
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`COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`PROCEDURES
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`Field of the Invention
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`The present invention relates generally to catheters used in interventional cardiology
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`procedures. More particularly the present invention relates to methods and apparatus for
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`increasing backup support for catheters inserted into the coronary arteries from the aorta.
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`Background of the Invention
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`Interventional cardiology procedures often include inserting guidewires or other
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`instruments through catheters into coronary arteries that branch off from the aorta. For the
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`purposes of this application, the term "interventional cardiology devices" is to be understood to
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`include but not be limited to guidewires, balloon catheters, stents and stent catheters.
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`In
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`coronary artery disease the coronary arteries may be narrowed or occluded by atherosclerotic
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`plaques or other lesions. These lesions may totally obstruct the lumen of the artery or may
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`dramatically narrow the lumen of the artery. Narrowing is referred to as stenosis. In order to
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`diagnose and treat obstructive coronary artery disease it is commonly necessary to pass a
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`guidewire or other instruments through and beyond the occlusion or stenosis of the coronary
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`artery.
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`In treating a stenosis, a guide catheter is inserted through the aorta and into the ostium of
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`the coronary artery. This is sometimes accomplished with the aid of a guidewire. A guide
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`catheter is typically seated into the opening or ostium of the artery to be treated and a guidewire
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`Page 21
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`Medtronic Exhibit 1403
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`
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`Attorney Docket No. 2005.86US02
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`or other instrument is passed through the lumen of the guide catheter and inserted into the artery
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`beyond the occlusion or stenosis. Crossing tough lesions can create enough backward force to
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`dislodge the guide catheter from the ostium of the artery being treated. This can make it difficult
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`or impossible for the interventional cardiologist to treat certain forms of coronary artery disease.
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`Prior attempts to provide support to the guiding catheter to prevent backward
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`dislod