PATENT APPLICATION
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re the application of:
`
`Attorney Docket No.: 2005.86US01
`
`Howard Root et al.
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`Confirmation No.: 5061
`
`Application No.:
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`11/416,629
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`Examiner: Bradley Osinski
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`Filed:
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`May 3, 2006
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`Group Art Unit: 3767
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`For: COAXIAL GUIDE CATHETER FOR INTERVENTION AL CARDIOLOGY
`PROCEDURES
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`AMENDMENT
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`Mail Stop Amendment
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
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`INTRODUCTORY COMMENTS
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`In response to the Office Action of December 5, 2008, amendment to the above(cid:173)
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`identified patent application is requested.
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`The present amendment comprises the following sections:
`
`A. Amendments to the Claims
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`B. Remarks
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`Please grant any extension of time necessary for entry; charge any fee due to Deposit Account No. 16-0631.
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`Application No. 11/416,629
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`AMENDMENTS TO THE CLAIMS
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`A detailed listing of all claims that are, or were, in the present application, irrespective of
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`whether the claim(s) remain(s) under examination in the application is presented below. The
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`claims are presented in ascending order and each includes one status identifier. Those claims not
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`cancelled or withdrawn but amended by the current amendment utilize the following notations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 less characters; and 2. added matter is shown by underlining.
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`2
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`Application No. 11/416,629
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`1. (Withdrawn-Currently Amended) A method of providing backup support for an interventional
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`cardiology device for use in the coronary vasculature, the interventional cardiology device being
`
`adapted to be passed through a guide catheter, the method comprising:
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`inserting the guide catheter into the first blood vessel, the guide catheter having a
`
`first lumen and a distal end;
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`positioning the distal end of the guide catheter in a second blood vessel that
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`branches off from the first blood vessel;
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`inserting a coaxial guide catheter over the guidewire and into the first lumen of
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`the guide catheter, the coaxial guide catheter having a second lumen along at least part of a
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`length thereof; and
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`a flexible distal tip portion;
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`a flexible reinforced portion proximal to the flexible distal tip portion;
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`a sttbstantially rigid an intermediate portion proximal to the reinforced portion, the
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`substantially
`
`rigid portion intermediate portion including a partially cylindrical portion defining an opening
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`along and accessible from a longitudinal side thereof, the longitudinal side being
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`generally parallel to a long axis of the second lumen, the opening extending substantially
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`along at least a portion of a length of the rigid intermediate portion; and
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`inserting the interventional cardiology device through the lumen of the coaxial guide
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`catheter and into contact with or past a lesion in the second blood vessel.
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`3
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`Application No. 11/416,629
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`2. (Withdrawn) The method as claimed in claim 1, further comprising applying a force to a
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`proximal portion of the coaxial guide catheter such that the distal tip portion of the coaxial guide
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`catheter remains seated in the second blood vessel in response to an opposing backward force
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`exerted by the interventional cardiology device.
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`3. (Withdrawn) The method as claimed in claim 1, further comprising:
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`keying the tapered inner catheter to the coaxial guide catheter at a proximal
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`portion thereof;
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`inserting a guidewire having a tip into a first blood vessel; and
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`inserting the tip of the guidewire into a second blood vessel that branches off of
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`the first blood vessel.
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`4.
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`(Withdrawn-Currently Amended) The method as claimed in claim [[ 1 ]] 26, further
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`comprising selecting the substantially rigid portion of the coaxial guide catheter such that it
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`comprises a cylindrical portion and a partially cylindrical portion defining the opening along a
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`side thereof.
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`5.
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`(Withdrawn) The method as claimed in claim 1, further comprising selecting the guide
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`catheter to further comprise a Y-adapter and the method further comprising injecting a fluid
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`through the Y-adapter into the second lumen.
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`4
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`Application No. 11/416,629
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`6. (Withdrawn) The method as claimed in claim 1, further comprising inserting a guidewire
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`having a tip into a first blood vessel; and
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`inserting the tip of the guidewire into a second blood vessel that branches off of
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`the first blood vessel.
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`7. (Withdrawn) The method as claimed in claim 6, further comprising placing a tapered inner
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`catheter inside the second lumen of the coaxial guide catheter, the tapered inner catheter
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`including a tapered distal portion, the tapered distal portion being positioned to extend beyond
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`the distal tip of the coaxial guide catheter;
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`removing the tapered inner catheter from the coaxial guide catheter; and
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`removing the guidewire from the coaxial guide catheter.
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`8. (Currently Amended) A device to be passed through guide catheter having a first lumen, for
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`use with interventional cardiology devices that are insertable into a branch artery that branches
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`off from a first artery, the device comprising:
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`an elongate structure defining a second lumen along at least part of a length
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`thereof and being sized to pass through the first lumen of the guide catheter, the elongate
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`structure including:
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`a flexible distal tip portion;
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`a flexible reinforced portion proximal to the flexible distal tip portion;
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`5
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`Application No. 11/416,629
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`a substantially rigid an intermediate portion proximal to the flexible reinforced portion,
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`the substantially
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`rigid portion intermediate portion including a partially cylindrical portion defining an opening
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`along and accessible from a longitudinal side thereof, the longitudinal side being
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`generally parallel to a long axis of the second lumen, the opening extending substantially
`
`along at least a portion of a length of the rigid intermediate portion; and
`
`such that when the device is extended through the lumen of the guide catheter and
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`beyond the distal end of the guide catheter and inserted into the branch artery, the device assists
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`in resisting axial and shear forces exerted by an interventional cardiology device passed through
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`the second lumen and beyond the flexible distal tip portion that would otherwise tend to dislodge
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`the guide catheter from the branch artery.
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`9. (Currently Amended)
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`The device as claimed in claim [[8]] 25, further comprising:
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`a radiopaque marker proximate the distal tip;
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`wherein the reinforced portion comprises a braid or coil formed of metal; and
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`wherein the substantially rigid portion defines a plurality of relief cuts therein, the relief
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`cuts controlling the rigidity of at least a portion of the substantially rigid portion.
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`6
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`Application No. 11/416,629
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`10. (Original) The device as claimed in claim 8, further comprising a tapered inner catheter
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`proportioned to pass through the second lumen and to extend outwardly from the flexible distal
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`tip, the tapered inner catheter defining a third lumen through which the tapered inner catheter
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`may be passed over a guidewire to facilitate insertion of the device, the tapered inner catheter
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`being removable prior to insertion of the interventional cardiology device.
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`11. (Original) The device as claimed in claim 10, wherein the tapered inner catheter has a first
`
`portion and a second portion, the first portion defining a lumen therethrough and the second
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`portion defining a concave track.
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`12. (Original) The device as claimed in claim 8, wherein portions of the device intended for
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`passage into the guide catheter have a size selected from a group consisting of about eight
`
`French, about seven French and about six French.
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`13. (Original) The device as claimed in claim 8, further comprising, starting at a distal end, a
`
`polymer exterior having a first portion having a first flexural modulus, a second portion having a
`
`second flexural modulus greater than the first flexural modulus, a third portion having a third
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`flexural modulus greater than the second flexural modulus and a fourth portion having a fourth
`
`flexural modulus greater than the third flexural modulus.
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`7
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`Application No. 11/416,629
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`14. (Original) The device as claimed in claim 13, in which the first flexural modulus is about
`
`13,000 PSI plus or minus 5000 PSI, the second flexural modulus is about 29,000 PSI plus or
`
`minus 10,000 PSI, the third portion flexural modulus is about 49,000 PSI plus or minus 10,000
`
`PSI and the fourth flexural modulus is about 107,000 PSI plus or minus 20,000 PSI.
`
`15. (Original) The device as claimed in claim 13, in which the first portion is about 0.1 cm in
`
`length, the second portion is about three cm in length, the third portion is about five cm in length
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`and the fourth portion is about twenty seven cm in length.
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`16. (Original) The device as claimed in claim 10, wherein the coaxial guide catheter and the
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`tapered inner catheter are keyed at their respective distal ends to allow releasable connection of
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`the coaxial guide catheter and the tapered inner catheter to each other.
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`17. (Withdrawn-Currently Amended) A kit for performing interventional cardiology procedures
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`that include insertion of a treatment catheter into a blood vessel, for use with a guide catheter
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`having a first lumen, the kit comprising:
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`a coaxial guide catheter comprising an elongate structure defining a second lumen and
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`being sized to pass through the first lumen of the guide catheter, the coaxial guide catheter
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`including:
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`a flexible distal tip portion;
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`a flexible reinforced portion proximal to the flexible distal tip portion;
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`8
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`a substantially rigid an intermediate portion proximal to the reinforced portion, the
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`Application No. 11/416,629
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`substantially
`
`rigid portion intermediate portion including a partially cylindrical portion defining an opening
`
`along and accessible from a longitudinal side thereof, the longitudinal side being
`
`generally parallel to a long axis of the second lumen, the opening extending substantially
`
`along at least a portion of a length of the Figid intermediate portion; and
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`18. (Withdrawn) The kit as claimed in claim 17, further comprising a tapered inner catheter
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`sized to fit within the second lumen having a tapered distal tip and defining a third lumen
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`through which a guidewire may be passed.
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`19. (Withdrawn) The kit as claimed in claim 17, the coaxial guide catheter further comprising,
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`starting at a distal end, a polymer exterior having a first portion having a first flexural modulus, a
`
`second portion having a second flexural modulus greater than the first flexural modulus, a third
`
`portion having a third flexural modulus greater than the second flexural modulus and a fourth
`
`portion having a fourth flexural modulus greater than the third flexural modulus.
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`20. (Withdrawn) The kit as claimed in claim 19, in which the first flexural modulus is about
`
`13,000 PSI plus or minus 5000 PSI, the second flexural modulus is about 29,000 PSI plus or
`
`minus 10,000 PSI, the third portion flexural modulus is about 49,000 PSI plus or minus 10,000
`
`PSI and the fourth flexural modulus is about 107,000 PSI plus or minus 20,000 PSI.
`
`9
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`21.
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`(Previously Presented) The device as claimed in claim 8, wherein the reinforced portion
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`comprises a braid or coil formed of metal.
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`Application No. 11/416,629
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`22.
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`(Withdrawn-Currently Amended) The device as claimed in claim 8, wherein the
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`substantially rigid intermediate portion comprises a full circumference portion, a greater than one
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`hundred eighty degree portion and a less than one hundred eighty degree portion.
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`23. (Withdrawn- Previously Presented) The device as claimed in claim 8, wherein the opening is
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`bounded by a beveled border.
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`24. (Withdrawn- Currently Amended) The kit as claimed in claim 17, further comprising:
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`instructions to insert the guide catheter into the first blood vessel, the guide catheter
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`having a distal end;
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`positioning the distal end of the guide catheter in a second blood vessel that branches off
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`from the first blood vessel;
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`inserting a coaxial guide catheter over the guidewire and into the first lumen of the guide
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`catheter advancing the distal tip portion of the coaxial guide catheter into the second blood vessel
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`such that the flexible distal tip portion and at least a portion of the flexible reinforced portion
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`extend out
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`of the distal end of the guide catheter and into the second blood vessel; and
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`inserting the interventional cardiology device through the lumen of the coaxial guide
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`catheter and into contact with or past a lesion in the second blood vessel.
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`10
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`Application No. 11/416,629
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`25.
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`(New) The device as claimed in claim 8, wherein the intermediate portion further
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`comprises:
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`a substantially rigid portion proximal to the reinforced portion, the substantially rigid
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`portion including the partially cylindrical portion defining an opening along the side thereof.
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`26.
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`(New) The method as claimed in claim 1, wherein the intermediate portion of the guide
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`catheter further comprises:
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`a substantially rigid portion proximal to the reinforced portion, the substantially rigid
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`portion including the partially cylindrical portion defining an opening along the side thereof.
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`27.
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`(New) The kit as claimed in claim 17, wherein the intermediate portion of the guide
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`catheter further comprises:
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`a substantially rigid portion proximal to the reinforced portion, the substantially rigid
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`portion including the partially cylindrical portion defining an opening along the side thereof.
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`11
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`Application No. 11/416,629
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`REMARKS
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`Claims 1-24 are pending. Claims 1-7, 17-20 and claims 22-24 are withdrawn from
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`consideration. By this Amendment, no claims are canceled, claims 1, 8, 9 and 17 are amended
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`and new claims 25-27 are added
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`Election/Restriction
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`Initially, Applicants note that the disposition of claims in the Office Action Summary is
`
`incomplete. The disposition of claims indicates that claims 8-16 and 21 are pending in the
`
`application but makes no comment on the status of claims 1-7, 17-20 and 22-24 which also
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`remain pending. As indicated above, claims 1-24 remain pending in the application, while
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`Applicants have requested that claims 1-7, 17-20 and 22-24 be withdrawn from consideration.
`
`Applicants respectfully request that the Examiner correct the record to reflect the disposition of
`
`the claims in the case as it currently stands. In particular, Applicant respectfully requests that the
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`Examiner indicate that claims 1-7, 17-20 and 22-24 are withdrawn from consideration and have
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`not been canceled from the application.
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`Claim Reiections - 35 U.S.C. § 103
`
`The Office Action rejected claims 9 and 12-15 under 35 U.S.C. § 103(a) as being
`
`unpatentable over Niazi (U.S. 6,638,268) in view of Solar (U.S. Publication 2003/0195546).
`
`Initially, while the Office Action states that claims 9 and 12-15 are so rejected, the Office Action
`
`then continues on to address the limitations of claim 8. Applicant therefore assumes that a
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`typographical error was made and the Examiner intended to refer to claims 8 and 12-15.
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`Applicants respectfully traverse the rejection.
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`12
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`Application No. 11/416,629
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`Claim 8 and new claim 25
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`Amended claim 8 recites the limitations "the intermediate portion including a partially
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`cylindrical portion defining an opening along and accessible from a longitudinal side thereof, the
`
`longitudinal side being generally parallel to a long axis of the second lumen, the opening
`
`extending substantially along at least a portion of a length of the intermediate portion."
`
`The Office Action admits that Niazi does not disclose an elongate structure with a
`
`cylindrical portion defining an opening along a side thereof." However, the Office Action
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`asserts that Solar discloses such a structure. Applicants respectfully traverse the assertion and
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`the rejection.
`
`33
`
`34
`
`)
`
`i
`\_ 7
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`FIG. 8
`
`As can be seen in representative Fig. 8 of Solar, reproduced above, Solar discloses no
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`"opening along a side" of a portion as recited in claim 8 and described, depicted and claimed in
`
`the application. Note that the side is defined as being generally parallel to the long axis of the
`
`second lumen. Arrows have been added to indicate openings only on the ends of the device
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`disclosed by Solar. These ends are not generally parallel to a long axis of the second lumen as
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`recited in claim 8. Amended Claim 8 further recites "the opening extending substantially along
`
`at least a portion of a length of the intermediate portion." Solar does not disclose or suggest this
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`13
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`Application No. 11/416,629
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`limitation either. Rather, Solar discloses that "[t]racking member 7 has an open proximal end 11
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`and an open distal end 7." Paragraph 0026. However, Solar does not disclose or suggest "the
`
`intermediate portion including a partially cylindrical portion defining an opening along a
`
`longitudinal side thereof, the longitudinal side being generally parallel to a long axis of the
`
`second lumen, the opening extending substantially along at least a portion of a length of the
`
`intermediate portion" as recited in claim 8.
`
`~·'I
`
`,- ,S'
`
`~ *
`
`~ L..,s
`l'-·
`
`~·4./~
`
`...
`
`''-
`
`.itY
`,-,•
`lJ
`~~ I
`L.. ,c
`~
`y~ 7
`~
`
`;z.O
`
`81
`
`f~
`
`·™·
`
`... i .... ,t..
`
`An example structure can be seen, for example, in Figs. 13, 15 and 16 of the present
`
`application. In particular, Figs. 15 and 16 depict an example opening and partially cylindrical
`
`portion identified by the arrows added. Thus, at least this limitation of claim 8 is not disclosed or
`
`suggested by the cited prior art and the Office Action does not make out a prima facie case of
`
`obviousness for at least this reason.
`
`Claim 8 previously recited the limitations:
`
`"an elongate structure defining a second lumen along at least part of a length thereof and
`
`being sized to pass through the first lumen of the guide catheter, the elongate structure
`
`including:
`
`a flexible distal tip portion;
`
`14
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`a flexible reinforced portion proximal to the flexible distal tip portion."
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`These limitations are now partially contained in new claim 25.
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`Application No. 11/416,629
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`The Office Action indicates that "Niazi also discloses an elongate structure 52 defining a
`
`second lumen along its length and being sized to pass through the first lumen of the guide
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`catheter 51." The Office Action goes on to state that "the elongate structure has flexible tip"
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`citing Col. 5, line 14. Niazi recites:
`
`"Inner guiding catheter 52 made of a soft, pliable material such as silicone, and in this
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`example is 2.6 mm in outer diameter and 2.3 mm in inner diameter. It has no
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`longitudinal braiding, which makes it extremely flexible and able to conform to various
`
`shapes. Inner catheter 52 is designed to advance over a guide wire into a side branch of
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`the coronary sinus, in conjunction with the obturator 53. Its flexibility allows it to
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`negotiate tortuous vessels and side branches that originate from the coronary sinus at an
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`acute angle." Column 5, Lines 15-22.
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`Thus, Niazi clearly indicates that the flexible tip referred to at Col. 5, line 14 is the tip of
`
`inner guide catheter 52 which is a separate structure from guide catheter 51 which is not
`
`indicated to have a flexible tip portion.
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`The Office Action goes on to state that a flexible reinforced portion proximal to the
`
`flexible tip portion is described at Col. 6, lines 46-54. Applicant respectfully traverses the
`
`assertion, Col. 6, lines 46-54 of Niazi describes an alternate version of the inner catheter 52
`
`which is depicted in Figure 6, and reference to Figure 6 clearly shows that the reinforced portion
`
`is not proximal to the flexible portion that is described at Column 5, Lines 15-22 but that in the
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`described alternate embodiment the reinforced portion extends all the way to the distal end of the
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`depicted inner guide catheter 52. The alternate embodiment has no distal portion that is "soft
`
`and pliable" as is the embodiment disclosed at Column 5, Lines 14-27, which is described as
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`having "no longitudinal braiding." Instead, the alternate embodiment is reinforced all the way to
`
`its distal end.
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`Application No. 11/416,629
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`56
`
`FIG. 6
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`Thus, the flexible tip is part of one version of the inner guide catheter while the depicted
`
`reinforced portion is the tip of another embodiment of the inner guide catheter. In particular,
`
`Niazi does not disclose or suggest "a flexible distal tip portion" and "a flexible reinforced portion
`
`proximal to the flexible distal tip portion" as recited in independent claim 8. Thus, aside from
`
`potential hindsight reasoning based on the Applicants' disclosure, the Niazi reference does not
`
`disclose or suggest the limitations recited in the claims of the present application and no reason is
`
`presented as to why one would arrange the flexible distal tip portion and the and the flexible
`
`reinforced portion relative to each other as recited in the presently pending claims. For these
`
`further reasons, the present invention as claimed is not rendered obvious over Niazi in view of
`
`Solar. Applicants respectfully request that the Examiner withdraw the rejection.
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`16
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`Application No. 11/416,629
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`The Office Action goes on to indicate "the elongate structure 52 when extended through
`
`the lumen guide catheter 50, and beyond the distal end of the guide catheter, it is capable (sic) of
`
`assisting in resisting shear forces exerted by any device passed through the second lumen and
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`beyond the flexible tip that would dislodge the guide catheter from the branch artery." The
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`Office Action cites no evidence in Niazi to support this conclusory assertion and Applicant finds
`
`no indication of this limitation being disclosed or suggested in the Niazi reference. Absent
`
`supporting evidence, Applicant respectfully takes the position that the office action does not
`
`make out a prima facie case of obviousness for at least this additional reason because the Office
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`Action does not show that this limitation is disclosed or suggested in the cited prior art.
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`Applicants respectfully request that the Examiner withdraw the rejection.
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`With regard to claim 8 and limitations that are now, in part, presented in dependent claim
`
`25, the Office Action cites to paragraph 25 of Solar as supporting the assertion that the tracking
`
`member 7 of Solar is rigid and becomes more flexible as it moves distally. Paragraph 25 of
`
`Solar states:
`
`"Preferably, advancement member 5 (also depicted in Fig. 8 of Solar above) is rigid
`
`at its proximal end and becomes increasingly more flexible as it extends distally.
`
`This may be accomplished by a number of ways known in the art, including, but not
`
`limited to, tapering, selective heat treatment and/or forming advancement member 5
`
`from a composite of materials with various properties."
`
`According to Solar, it is only "advancement member 5" that is described as being "rigid
`
`at its proximal end" and "increasingly more flexible as it extends distally." Thus, Solar does not
`
`disclose or suggest the claimed limitations "a flexible distal tip portion; a flexible reinforced
`
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`portion proximal to the flexible distal tip portion; and a substantially rigid portion proximal to
`
`the reinforced portion" as recited in claim 8 in combination with new claim 25. Therefore, the
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`Office Action does not make out a prima facie case of obviousness for at least this additional
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`Application No. 11/416,629
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`reason.
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`The Office Action further asserts that the device of Solar has "partially cylindrical
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`portion 7 with an opening in the circular sides that extends substantially discloses the apparatus
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`as claimed, it does not disclose along a length of a rigid portion." Applicant respectfully notes,
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`that as demonstrated above, Solar does not disclose or suggest a partially cylindrical portion as
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`recited in claim 8 and defined in the specification of the present application nor does it disclose
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`any openings in the side of a partially cylindrical portion as recited in claim 8. The indicated
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`portion of Niazi is a full cylinder. An example partially cylindrical portion is depicted for
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`example in Figs. 15 and 16 of the present application which are reproduced above.
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`Thus, the cited prior art Office Action does not anticipate or render obvious amended
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`claim 8 because the prior art cited does not disclose or suggest all of the elements recited in
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`claim 8. Applicants respectfully request that the Examiner withdraw the rejection.
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`Claims 9-16, 21 and new claim 25 depend directly or indirectly from claim 8 and should
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`be patentable for at least the same reasons as claim 8. Applicants respectfully request that the
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`Examiner withdraw the rejections.
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`Claim 9
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`Claim 9 recites the limitations "wherein the substantially rigid portion defines a plurality
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`of relief cuts therein, the relief cuts controlling the rigidity of at least a portion of the
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`substantially rigid portion." With regard to claim 9, the Office Action cites to Adams (US
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`Application No. 11/416,629
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`2004/0127927) which in turn cites to Fucci (US 5,601,586 and 5,411,514) as disclosing relief
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`cuts. However, the single "spiral relief cut" of Adams and Fucci would not create the invention
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`as claimed and would destroy the function of the present invention because there would be
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`nothing in the present invention as claimed in claim 9 to hold a spiral cut tube together and
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`facilitate the passage of another device through the lumen of the spiral cut tube as compared to
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`the multiple staggered relief cuts claimed and depicted for example in Figs. 10 and 11.
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`Applicants respectfully request that the Examiner withdraw the rejection.
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`Claim 13
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`With regard to claim 13, the Office Action indicates "Niazi and Solar further disclose
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`decreasing the rigidity (directly related to flexural modulus) as one moves distally down the
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`device. Applicant respectfully traverses this assertion. While the statement regarding Niazi and
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`Solar may be true, Claim 13 recites "further comprising, starting at a distal end, a polymer
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`exterior" and then goes on to define the polymer exterior as "having a first portion having a first
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`flexural modulus, a second portion having a second flexural modulus greater than the first
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`flexural modulus, a third portion having a third flexural modulus greater than the second flexural
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`modulus and a fourth portion having a fourth flexural modulus greater than the third flexural
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`modulus." The Office Action provides no citation to the references as to where this disclosure is
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`allegedly found and Applicants cannot identify any such disclosure in either the Niazi or the
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`Solar reference other than the comments related to the advancement member discussed above.
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`The advancement member is not a polymer exterior as recited in claim 13. As such, neither the
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`Niazi reference nor the Solar reference discloses or suggests a device with a polymer exterior
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`meeting the recited limitations related to flexural modulus. Thus, Applicant respectfully takes
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`the position that the Office Action has not made out a prima facie case of obviousness with
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`regard to claim 13 for this additional reason. Applicants respectfully request that the Examiner
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`Application No. 11/416,629
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`withdraw the rejection.
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`With regard to claims 14 and 15, the Office Action asserts "it would have been an
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`obvious matter of design choice to a person of ordinary skill in the art to assign specific flexural
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`modulus and length to each section of Niazi, because Applicant has not disclose if the lengths
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`and modulus provide an advantage, is used for a particular purpose or solves a stated problem."
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`Applicant respectfully traverses the assertion. The Board of Patent Appeals and Interferences
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`has an addressed the issue of rejections based on "obvious matter of design choice" in ex parte
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`Roger Massey. Appeal No. 2003-1660, slip op. at 6. The Board stated with regard to rejections
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`under § 103 of the patent statute "It is not enough to merely allege that something is 'well
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`known,' is an 'obvious matter of design choice,' or 'lacks criticality."' The Board then cited In re
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`Lee, which indicates "The factual inquiry whether to combine the references must be thorough
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`and searching.
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`It must be based on objective evidence of record. This precedent has been
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`reinforced in myriad decisions and cannot be dispensed with." 277 F.3d 1338, 1343, 61 USPQ
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`2d 1430, 1433 (Fed. Cir. 2002). The patent office must not only assure that the requisite findings
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`to support a conclusion of obviousness are made, based on evidence of record, but must also
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`explain the reasoning by which the findings are deemed to support the agency's conclusion. In
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`re Lee at 1434. Thus the Office Action does not make out a prima facie case of obviousness
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`with relation to claims 14 and 15 for at least this additional reason. Applicants respectfully
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`request that the Examiner withdraw the rejection.
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`Application No. 11/416,629
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`Applicant has also amended withdrawn independent claims 1 and 1 7 to recite the
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`limitation of claim 8. Thus, claims 1-8 and 17-24, 26 and 27 should be allowable as well.
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`Applicants, respectfully request that these claims be rejoined in the application upon a finding of
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`allowable subject matter in claim 8.
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`In view of the foregoing, it is submitted that this application is in condition for allowance.
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`Favorable consideration and prompt allowance of the application are respectfully requested.
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`The Examiner is invited to telephone the undersigned if the Examiner believes it would
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`be useful to advance prosecution.
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`~ectfully submitte
`
`Paul C. Onderick
`Registration No. 45,354
`
`Customer No. 24113
`Patterson, Thuente, Skaar & Christensen, P.A.
`4800 IDS Center
`80 South 8th Street
`Minneapolis, Minnesota 55402-2100
`Telephone: (612) 349-5766
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`Medtron