Paul Onderick 6123499266
`
`(1/31) 12/01/2015 08:39:22 AM -0600
`
`S/N_14/195,435
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Applicants:
`Serial No.:
`Filed:
`Title:
`
`Examiner: Catherine Serke Williams
`HOWARD C. ROOT ET AL.
`Group Art Unit: 3993
`14/195,435
`Docket: 2005.86USREI6
`March3, 2014
`COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY
`
`PROCEDURES
`
`PROPOSED AMENDMENTS AND REMARKS UNDER37 C.E.R.§1.111 — FOR
`DISCUSSION DURING UPCOMING TELEPHONIC INTERVIEW
`
`Dear Examiner Williams,
`
`These Proposed Amendments & Remarksare intended to help facilitate discussion during
`
`an upcoming telephone discussion.
`
`I understand that you will give me a call at (612) 349-5766
`
`to initiate the interview to discuss the Proposed Amendments & Remarks at 10:00 ET, 9:00CT
`
`on Wednesday, December 2, 2015.
`
`I would like to discuss the proposed amendments and
`
`arguments below as well as any suggestions that you may have to movethe application forward.
`
`Please confirm receipt by telephone or email. onderick@ptslaw.com
`
`Thank you.
`
`Best Regards,
`
`Paul
`
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`* DURATION (mm-ss):26-51
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`

`

`Paul Onderick 6123499266
`
`(24/31) 12/01/2015 08:39:48 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 2
`Dkt: 2005.86USREI6
`
`AMENDMENTS TO THE CLAIMS
`
`The following listing of claims replaces all prior versions of the claimsin the present
`
`application. Amended and new claimsutilize the following notations: deleted matter is enclosed
`
`in brackets and added matter is underlined.
`
`LISTING OF CLAIMS
`
`1-24.
`
`(Cancelled)
`
`25.
`
`(Amended) A method, comprising:
`
`advancing a distal end of a guide catheter having a lumen through a mainblood vessel to an
`
`ostium of a coronary artery;
`
`advancing a distal end of a guide extension catheter through, and beyondthe distal end of, the
`
`guide catheter, including advancing a distal end portion of a tubular structure of the guide
`
`extension catheter beyond the distal end of the guide catheter while a segment defining a
`
`side opening of the guide extension catheter[ and a proximal end of a tubular structure of
`
`the guide extension catheter remain] remains within the guide catheter, the side opening
`
`extending for a distance along a longitudinal axis of the guide extension catheter and
`
`accessible from a longitudinal side defined transverse to the longitudinal axis, the tubular
`
`structure having a cross-sectional inner diameterthat is not more than one Frenchsize
`
`smaller than a cross-sectional inner diameter of the lumenof the guide catheter; and
`
`with the distal end of the guide extension catheter positioned beyond the distal end of the guide
`
`catheter, advancing a[ treatment] balloon catheter_or stent at least partially through the
`
`guide catheter and the guide extension catheter and into the coronary artery, including
`
`advancing] a distal portion of] the[ treatment]_balloon catheter or stent through a
`
`hemostatic valve associated with a proxumal end of the guide catheter, along a
`
`substantially rigid segment of the guide extension catheter, through the side opening, and
`
`throughthe tubular structure.
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(3/31) 12/01/2015 08:40:25 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 3
`Dkt: 2005.86USREI6
`
`20.
`
`The method of claim 25, further comprising injecting one or more fluids into the
`
`coronary artery via the proximalend of the guide catheter.
`
`27.
`
`The method of claim 25, wherein advancing the distal end of the guide extension catheter
`
`through, and beyondthe distal end of, the guide catheter includes opening the hemostatic valve
`
`and advancing the distal end of the guide extension catheter through the hemostatic valve and
`
`into the guide catheter.
`
`28.
`
`The method of claim 25, wherein advancing the distal end of the guide extension catheter
`
`through, and beyond the distal end of, the guide catheter includes advancing the distal end of the
`
`guide extension catheter proximal to a location of a lesion to be treated in the coronary artery.
`
`29.
`
`(Amended) The method of claim 25, wherein advancing the distal end of the guide
`
`extension catheter through, and beyond the distal end of, the guide catheter includes
`
`manipulating the substantially rigid segment to advance the segment defining the side opening[
`
`and the proximal end of the tubular structure] to a position within the lumenof the guide
`
`catheter.
`
`30.
`
`(Amended) The method of claim 25, wherein advancing the distal end of the guide
`
`extension catheter through, and beyond the distal end of, the guide catheter includes sealing
`
`aroundthe substantially rigid segment with the hemostatic valve associated with the proximal
`
`end of the guide catheter.
`
`31.
`
`(Amended) The method of claim 25, wherein advancing the distal end of the guide
`
`extension catheter through, and beyondthe distal end of, the guide catheter includes advancing
`
`the substantially rigid segment within the lumen ofthe guide catheter.
`
`32.
`
`(Amended) The method of claim 25, wherein advancing the distal end of the guide
`
`extension catheter through, and beyond the distal end of, the guide catheter includes coaxially
`
`aligning the tubular structure of the guide extension catheter with the lumenof the guide
`
`catheter.
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(4/31) 12/01/2015 08:41:02 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 4
`Dkt: 2005.86USREI6
`
`33.
`
`(Amended) The method of claim 25, wherein advancingthe distal end of the guide
`
`extension catheter through, and beyond the distal end of, the guide catheter includes positioning
`
`the segment defining the side opening| proximal end of the tubular structure] within the guide
`
`catheter for receiving the[ treatment]_balloon catheter_or stent.
`
`34.
`
`(Amended) The method of claim 25, wherein advancingthe distal end of the guide
`
`extension catheter through, and beyond the distal end of, the guide catheter includes establishing
`
`fluid communication between the tubular structure of the guide extension catheter and the lumen
`
`of the guide catheter.
`
`35.
`
`(Amended) The method of claim 25, wherein advancingthe distal end of the guide
`
`extension catheter through, and beyond the distal end of, the guide catheter includes resisting
`
`dislodging of the distal end of the guide catheter from the ostium of the coronary artery when
`
`the[ treatment|_balloon catheter_orstent is at least partially advanced through the guide catheter,
`
`through the guide extension catheter, and into the coronary artery.
`
`36.
`
`(Amended) The method of claim 25, wherein advancing the distal end of the guide
`
`extension catheter through, and beyond the distal end of, the guide catheter includes using the
`
`guide extension catheter to resist axial and shear forces exerted by the[ treatment]_balloon
`
`catheter_or stent when the[ guide extension|_balloon catheter_or stent is advanced at least partially
`
`throughthe guide catheter| and], through the guide extension catheter, and into the coronary
`
`artery.
`
`37.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment]_balloon catheter
`
`or stent at least partially through the guide catheter[ and], through the guide extension catheter,
`
`and into the coronary artery includes advancing[ a stent and] a[ stent] delivery system_including
`
`the stent into the coronaryartery.
`
`
`
` 1 the guideextensioncatheter,
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(2/31) 12/01/2015 08:41:44 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 5
`Dkt: 2005.86USREI6
`
`
`single seal, which is the hemostatic valveassociatedwiththe proximal end oftheguidecatheter.
`
`39.
`
`(Amended) The method of claim 25, wherein, subsequent to advancing the[ treatment]
`
`balloon catheter_or stent at least partially through the hemostatic valve, the method further
`
`comprises at least partially sealing around a proximal end portion of the[ treatment] balloon
`
`catheter_or a delivery system including the stent with the hemostatic valve associated with the
`
`proximal end of the guide catheter.
`
`40.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment]_balloon catheter
`
`or stent at least partially through the side opening includes accessing the side opening of the
`
`guide extension catheter within the lumenof the guide catheter.
`
`41.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment]_balloon catheter
`
`or stent at least partially through the side opening includes advancing the[ treatment|_balloon
`
`catheter_or stent along a concave track of the side opening, the concave track extending for a
`
`length of about 20 cm to about 75 cm.
`
`42.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment] _balloon catheter
`
`or stent at least partially through the side opening includes advancing the[ treatment|_balloon
`
`catheter_or stent through a structure having an arcuate cross-sectional shape.
`
`43,
`
`(Amended) A method, comprising:
`
`advancing a distal end of a guide catheter having a lumen through a main blood vessel to an
`
`ostium of a coronary artery:
`
`advancing a distal end of a guide extension catheter through, and beyondthe distal end of, the
`
`guide catheter while a segment defining a side opening of the guide extension catheter
`
`and a proximal end of a tubular structure of the guide extension catheter remain within
`
`the guide catheter, the side opening extending for a distance along a longitudinal axis of
`
`the guide extension catheter and accessible from a longitudinal side defined transverse to
`
`the longitudinal axis. the tubular structure having a cross-sectional inner diameter that is
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(6/31) 12/01/2015 08:42:25 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 6
`Dkt: 2005.86USREI6
`
`not more than one French size smaller than a cross-sectional inner diameter of the lumen
`
`of the guide catheter: and
`
`with the distal end of the guide extension catheter positioned beyond the distal end of the guide
`
`catheter, advancing a treatment catheter at least partially through the guide catheter and
`
`the guide extension catheter and into the coronary artery, including advancing a distal
`
`portion of the treatment catheter through a hemostatic valve associated with a proximal
`
`end of the guide catheter, along a substantially rigid segment of the guide extension
`
`catheter, through the side opening, and through the tubular structure,
`
`wherein advancing the treatment catheter at least partially through the side opening
`
`includes advancing the treatment catheter through a structure having an[ The method of claim
`
`42, wherein the] arcuate cross-sectional shape[ extends]|_extending for a length of 15 cm.
`
`44.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment]_balloon catheter
`
`or stent at least partially through the side opening includes advancing the[ treatment] balloon
`
`catheter_or stent through a structure having a hemicylindrical cross-sectional shape.
`
`45.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment]_balloon catheter
`
`or stent at least partially through the side opening includes advancing the[ treatment] balloon
`
`catheter_or stent through a_side-opening structure having at least two inclined slopes.
`
`46.
`
`(Amended) The method of any one of claims 25 or 40-45, wherein advancing the[
`
`treatment]_balloon catheter_or stent at least partially through the side opening includes advancing
`
`the[ treatment] balloon catheter_or stent through an opening formed by a material_or material
`
`combination more rigid than_the distal end portion of the tubular structure.
`
`47.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment] balloon catheter
`
`or stent at least partially through the tubular structure includes advancing the[ treatment]_balloon
`
`catheter_or stent through a reinforcing braid or coil having a length of 20 to 30 cm.
`
`48.
`
`(Amended) The method of claim 25, wherein advancing the[ treatment]_balloon catheter
`
`or stent though the side opening and through the tubular structure includes advancing the[
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(7/31) 12/01/2015 08:43:07 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 7
`Dkt: 2005.86USREI6
`
`treatment]_balloon catheter_or stent respectively througha first portion_of the guide extension
`
`catheter having a first flexural modulus and a second portion_of the guide extension catheter
`
`having a second flexural modulus[ greater|_less than the first flexural modulus.
`
`49.
`
`(Amended) The method of any one of claims 25, 33, 37, 40 or 48, wherein advancing
`
`the[ treatment]|_balloon catheter_or stent at least partially through the side opening includes
`
`advancing the[ treatment]_balloon catheter_or stent through a_side-opening structure having one
`
`or moreslits or cuts.
`
`50.
`
`The method of claim 49, whereinat least one cut includes two aligned linear cuts
`
`separated by a section of uncutstructure.
`
`51.
`
`(New) A method, comprising:
`
`advancing a distal end of a guide catheter having a lumen through a main blood vessel to an
`
`ostium of a coronary artery;
`
`advancing a distal end of a guide extension catheter through, and beyondthe distal end of, the
`
`guide catheter, including advancing a distal end portion of a tubular structure of the guide
`
`extension catheter beyond the distal end of the guide catheter while a segment defining an
`
`arcuate cross-sectional shape of the guide extension catheter remains within the guide
`
`catheter, the arcuate cross-sectional shape extending for a length of at least about 15 cm:
`
`and
`
`with the distal end of the guide extension catheter positioned beyond the distal end of the guide
`
`catheter, advancing a treatment catheter at least partially through the guide catheter and
`
`the guide extension catheter and into the coronary artery, including advancing a distal
`
`portion of the treatment catheter through a hemostatic valve associated with a proximal
`
`end of the guide catheter, along a substantially rigid segment of the guide extension
`
`catheter, along the arcuate cross-sectional shape, and through the tubular structure.
`
`52.
`
`(New) A method, comprising:
`
`advancing a distal end of a guide catheter having a lumen through a mainblood vessel to an
`
`ostium of a coronary artery:
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(8/31) 12/01/2015 08:43:44 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 8
`Dkt: 2005.86USREI6
`
`
`
`advancingadistalendofaguidethroughtheguidecatheter,includngcatheterextension
`
`
`
`
`
`advancing a distal end portion of a tubular structure of the guide extension catheter
`
`beyond the distal end of the guide catheter while a segment defining a side opening ofthe
`
`guide extension catheter remains within the guide catheter, wherein the segment defining
`
`the side opening comprises a portion of the guide extension catheter that is more rigid
`
`thanthe distal end portion of the tubular structure; and
`
`with the distal end of the guide extension catheter positioned beyond the distal end of the guide
`
`catheter, advancing a treatment catheter at least partially through the guide catheter and
`
`the guide extension catheter and into the coronary artery, including advancing a distal
`
`portion of the treatment catheter through a hemostatic valve associated with a proximal
`
`end of the guide catheter, along a substantially rigid segment of the guide extension
`
`catheter, through the side opening, and through the tubular structure.
`
`53.
`
`(New) The method of claim 52, wherein advancing the distal end of the guide extension
`
`catheter through the guide catheter includes positioning the segment defining the side opening
`
`within the guide catheter for receiving the treatment catheter.
`
`34.
`
`(New) The method of claim 52, wherein advancing the treatment catheter at least
`
`partially through the side opening includes advancing the treatment catheter along a concave
`
`track of the side opening, the concave track extending for a length of about 20 cm to about 75
`cm.
`
`55.
`
`(New) The method of claim 52, wherein advancing the treatment catheter at least
`
`partially through the side opening includes advancing the treatment catheter through a structure
`
`having an arcuate cross-sectional shape, the arcuate cross-sectional shape extending for a length
`
`of at least about 15 cm.
`
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`* DURATION (mm-ss):26-51
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`

`

`Paul Onderick 6123499266
`
`(9/31) 12/01/2015 08:44:20 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.F.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 9
`Dkt: 2005.86USREI6
`
`REMARKS
`
`Applicants have carefully reviewed the Non-Final Office Action mailed on October6,
`
`2015 (hereinafter “Office Action’) and, in response, respectfully submit this proposed
`
`communication. Claims 25 and 29-49 are proposed to be amended, claims 1-24 were previously
`
`cancelled, and claims 51-55 are added; as a result, claims 25-55 are now pending in this
`
`application.
`
`Examination and reconsideration of this application in view of the above claim
`
`amendments, claim additions, andfollowing remarks are respectfully requested.
`
`1.
`
`Support for the substantively amended and new claims 25, 29, 33, 35-49 and 51-55 can
`
`Claim Support
`
`be found in the originally-filed patent application, as presented in the followingtable:
`
`Claim Language [Deleted] or Added
`
`Example(s) of Support in U.S.
`Application Serial No.
`13/359,059, filed on Jan. 26,
`
`2012
`
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`* DURATION (mm-ss):26-51
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`

`

`Paul Onderick 6123499266
`
`(10/31) 12/01/2015 08:45:35 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 10
`Dkt: 2005.86USREI6
`
`the coronary artery.
`
`The method of claim 25, wherein advancing the
`distal end of the guide extension catheter
`through, and beyond the distal end of, the
`guide catheter includes manipulating the
`substantially rigid segment to advance the
`segment defining the side opening and the
`proximal end of the tubular structure] to a
`position within the lumen of the guide
`catheter.
`
`Page 15, lines 1-18
`
`Page 19, lines 12-14
`
`Page 22, original claim 2
`
`Page 15, lines 9-18
`
`The method of claim 25, wherein advancing the
`distal end of the guide extension catheter
`through, and beyond the distal end of, the
`guide catheter includes using the guide
`extension catheter to resist axial and shear
`forces exerted by the[ treatment] balloon
`catheter_or stent when the[ guide extension]
`balloon catheter_or stent is advancedat least
`partially through the guide catheter[ and],
`through the guide extension catheter, and into
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(11/31)
`
`12/01/2015 08:47:39 AM
`
`-0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.F.R § 1.111
`Serial Number: 14/195435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 11
`Dkt: 2005.86USREI6
`
`Page 15, lines 9-18
`
`The method of claim 25, wherein, subsequent to
`advancing the[ treatment] balloon catheter_or
`stent at least partially through the hemostatic
`valve, the method further comprises at least
`partially sealing around a proximalend
`portion of the[ treatment] balloon catheter_or a
`delivery system including the stent with the
`hemostatic valve associated with the proximal
`end of the guide catheter.
`
`Page 5, lines 3-18
`
`Page 7, line 14 — page8, line 2
`
`Page 9, lines 11-14
`
`Page 12, lines 14-16
`
`Page 13, lines 1 and 2
`
` Page 6, lines 1-4 and 16-22
`
`and 15
`
`A method, comprising:
`advancing a distal end ofa guide catheter having
`a lumen through a main blood vessel to an
`ostium of a coronary artery:
`advancing a distal end of a guide extension
`catheter through, and beyond the distal
`end of, the guide catheter while a segment
`defining a side opening of the guide
`extension catheter and a proximal end ofa
`tubular structure of the guide extension
`catheter remain within the guide catheter,
`the side opening extending for a distance
`along a longitudinal axis of the guide
`extension catheter and accessible from a
`longitudinal side defined transverse to the
`longitudinal axis. the tubular structure
`having a cross-sectional inner diameter
`that is not more than one French size
`
`Page 15, lines 1-18
`
`Page 19, lines 12-14
`
`Onginal claims 1-3, 8, 9, 12, 14
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(14/31) 12/01/2015 08:49:14 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 12
`Dkt: 2005.86USREI6
`
`FIGS. 2, 4, 8, 9, 14, 16 and 18:
`Fig. 2
`
`smaller than a cross-sectional inner
`diameter of the lumenof the guide
`catheter; and
`with the distal end of the guide extension catheter
`positioned beyond the distal end of the
`guide catheter, advancing a treatment
`catheter at least partially through the
`guide catheter and the guide extension
`catheter and into the coronary artery.
`including advancing a distal portion of the
`treatment catheter through a hemostatic
`valve associated with a proximal end of
`the guide catheter, along a substantially
`rigid segment of the guide extension
`catheter, through the side opening, and
`through the tubular structure,
`wherein advancing the treatment catheter
`at least partially through the side opening
`includes advancing the treatment catheter through
`a structure having an| The methodof claim 42,
`wherein the] arcuate cross-sectional shape[
`extends] extending for a length of about 15 cm.
`
`
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`* DURATION (mm-ss):26-51
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`

`

`Paul Onderick 6123499266
`
`(13/31) 12/01/2015 08:30:04 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 13
`Dkt: 2005.86USREI6
`
`The method of any one of claims 25 or 40-45,
`wherein advancing the[ treatment]_balloon
`catheter_or stent at least partially through the
`side opening includes advancing the[
`treatment] balloon catheter_or stent through an
`opening formed by a material_or material
`combination more rigid than _the distal end
`portion of the tubular structure
`
`Page 6, lines 15 and 17
`
`Page 13, line 15 — page 14, line 8
`
`
`
`The method of any one of claims 25, 33, 37, 40 or|Page 7, lines 3 and 4
`48, wherein advancing the[ treatment|_balloon
`catheter_or stent at least partially through the|Page 10, lmes 15-17
`side opening includes advancing the[
`treatment]_balloon catheter_or stent througha|Page 15, line 19 — page 16,line
`side-opening structure having one or more
`14
`slits or cuts.
`
`FIGS. 10 and 11:
`
`Fig. 11
`wreoy
`
`ttno.
`
`aol
`
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`* DURATION (mm-ss):26-51
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`

`

`Paul Onderick 6123499266
`
`(14/31) 12/01/2015 08:31:44 AM -0600
`
`Page 14
`Dkt: 2005.86USREI6
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(15/31) 12/01/2015 08:33:38 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 15
`Dkt: 2005.86USREI6
`
`Page 5, lines 3-18
`
`Page 7, line 14 — page8, line 2
`
`Page 9, lines 11-14
`
`Page 13, line 15 — page 14, line 8
`
`
`
`A method, comprising:
`advancing a distal end of a guide catheter having
`a lumenthrough a main blood vessel to an|Page 6, lines 1-4, 15 and 17
`ostium of a coronary artery:
`advancing a distal end of a guide extension
`catheter through the guide catheter,
`including advancing a distal end portion
`of a tubular structure of the guide
`extension catheter beyond the distal end
`of the guide catheter while a segment
`defining a side opening of the guide
`extension catheter remains within the
`guide catheter, wherein the segment
`defining the side opening comprises a
`portion of the guide extension catheter
`that is more rigid than the distal end
`portion of the tubular structure; and
`with the distal end of the guide extension catheter|FIGS. 2, 4, 8, 9, 14 and 18:
`positioned beyond the distal end of the
`Fig. 2
`guide catheter, advancing a treatment
`at
`catheter at least partially through the
`guide catheter and the guide extension
`catheter and into the coronary artery.
`including advancing a distal portion of the
`treatment catheter through a hemostatic
`valve associated with a proximal end of
`the guide catheter, along a substantiall
`
`Page 15, lines 1-18
`
`Page 19, lines 12-14
`
`Oniginal claims 1-3, 8, 12, 14 and
`15
`
`me.
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(16/31) 12/01/2015 08:33:05 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 16
`Dkt: 2005.86USREI6
`
`rigid segment of the guide extension
`catheter, through the side opening, and
`through the tubular structure.
`
`
`
`
`
`
`The method of claim 52, wherein advancing the
`treatment catheter at least partially through
`the side opening includes advancing the
`treatment catheter along a concave track of
`the side opening, the concave track extending|FIG.6:
`for a length of about 20 cm to about 75 cm.
`Fig. &
`
`Page 12, lines 19 and 20
`
`Page 13, lines 10 and 11
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`* DURATION (mm-ss):26-51
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`

`

`Paul Onderick 6123499266
`
`(17/31) 12/01/2015 08:33:56 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 17
`Dkt: 2005.86USREI6
`
`
`
`Amendments to claims 30-32, 34, 38, 40, 42, 44 and 47 relate to punctuation and/or antecedent
`
`basis only.
`
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`* DURATION (mm-ss):26-51
`
`

`

`Paul Onderick 6123499266
`
`(18/31) 12/01/2015 08:36:32 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.E.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 18
`Dkt: 2005.86USREI6
`
`The Rejection of Claims under§103
`
`2.
`
`Claims 25, 27, 28, 30-35, 37, 38 and 47 stand rejected under pre-AJA 35 U.S.C. § 103(a)
`
`as bemg unpatentable over U.S. Publication No. 2004/0010280 to Adamset al. (hereinafter
`
`“Adams ‘280”) in view of U.S. Patent No. 5,120,323 to Shockeyet al. (hereinafter “Shockey’).
`
`(Office Action at pages 4-7.) This basis of rejection is respectfully traversed to the extentit
`
`applies to the amended claims.
`The U.S. Supreme Court’s decision ofKSR v. Teleflex’ provided a multi-prongtest to
`
`evaluate obviousness. This multi-prong test set forth a list of requirements to support a
`
`conclusion of obviousness, including—among other things—a finding that all claimedfeatures
`were knownin the prior art in combinableform.’ As set-forth below, the undersigned
`
`respectfully submits that Adams ‘280 does not teach or suggest each and every feature of
`
`Applicants’ present claims and provides no reason for modification to include the missing
`
`features.
`
`Claim 25:
`
`Independentclaim 25 presently recites*:
`
`A method, comprising:
`advancing a distal end of a guide catheter having a lumen through a main blood vessel to
`an ostium of a coronary artery;
`advancing a distal end of a guide extension catheter through, and beyond the distal end
`of, the guide catheter, including advancing a distal end portion of a tubular
`structure of the guide extension catheter beyond the distal end of the guide
`catheter while a segment defining a side opening of the guide extension catheter[
`and a proximalend ofa tubular structure of the guide extension catheter remain]
`remains within the guide catheter, the side opening extending for a distance along
`a longitudinal axis of the guide extension catheter and accessible from a
`longitudinal side defined transverse to the longitudinal axis, the tubular structure
`having a cross-sectional inner diameter that is not more than one Frenchsize
`smaller than a cross-sectional mner diameter of the lumen of the guide catheter;
`and
`with the distal end of the guide extension catheter positioned beyond the distal end of
`the guide catheter, advancing af treatment]_balloon catheter_or stent at least
`partially through the guide catheter and the guide extension catheter and into
`
`' KSR International Co. v. Teleflex Inc., 127 8. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007).
`? See also, Manual of Patent Examining Procedure §§ 706.02(), 2143(A) (2008); MPEP § 2142 (2006) (citing Jn re
`Vaeck, 947 F.2d, 488 (Fed. Cir. 1991)). Cited approvingly in Ex parte Wen Wen and Patricia NG at 7; Appeal No.
`2009-000776; decided September 25, 2009.
`’ Text deleted from claim 25 as originally presented is enclosed in brackets, and text added to the claim is
`underlined.
`
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`* DURATION (mm-ss):26-51
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`

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`Paul Onderick 6123499266
`
`(19/31) 12/01/2015 08:57:22 AM -0600
`
`PROPOSED AMENDMENTS AND RESPONSE UNDER37 C.F.R § 1.111
`Serial Number: 14/195,435
`Filing Date: March 3, 2014
`Title: COAXIAL GUIDE CATHETER FOR INTERVENTIONAL CARDIOLOGY PROCEDURES
`
`Page 19
`Dkt: 2005.86USREI6
`
`the corenary artery, including advancing|[ a distal portion of] the[ treatment]
`balloon catheter_or stent through a hemostatic valve associated with a proximal
`end of the guide catheter, along a substantially rigid segment of the guide
`extension catheter, through the side opening, and through the tubular structure.
`
`The present application recognizes that the claimed method of positioning the distal end of the
`
`guide extension catheter beyondthe distal end of the guide catheter “provides additional back up
`
`support to resist dislodging of guide catheter 56 from ostium 60 .
`
`.
`
`. in the positioning ofa
`
`treating cat