DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 27 April 2022, has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites “wherein the sheath distal end portion extends entirely through the handle assembly”. However, the sheath distal end portion is described in claim 7 as being the end of the sheath with the balloon attached, and the end of the sheath with the balloon does not extend into the handle. For the purpose of examination, this is being interpreted as “wherein the sheath proximal end portion extends entirely through the handle assembly”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2004/0215139 A1) in view of George (US 4861337 A).
Regarding claim 1, Cohen discloses a steerable intravascular catheter (Fig 1), comprising: a) a handle assembly (14 Fig 1) having opposed proximal (44 Fig 3) and distal (Fig 1) end portions and defining a longitudinal axis therebetween (the long axis of the handle 14 Fig 1); b) an elongated sheath (12 Fig 1) extending from the distal end portion of the handle assembly and having opposed sheath proximal (22 Fig 1) and distal ([0051] “distal section 18”) end portions, wherein the sheath distal end portion is deflectable relative to the sheath proximal end portion ([0055] “distal portion 18 and intermediate portion 20 to bend or straighten”), the elongated sheath including: i) a tubular body wall (the wall of sheath 12 Fig 1) having an inner wall surface (the inner surface of lumen 34 Fig 2) spaced from an outer wall surface (the outer surface of 30 Fig 2), wherein the inner wall surface defines a central lumen (34 Fig 2) having a central lumen axis (the axis of 34 is perpendicular with the cross section shown in Fig 2); and ii) a first lumen in the tubular body wall (36 on the top of Fig 2), the first lumen having a first lumen axis that is radially outward from and parallel to the central lumen axis (see the spacing of the top 36 relative to 34 in Fig 2); and c) a rotatable actuation assembly operatively associated with the handle assembly for controlling deflection of the sheath distal end portion ([0055] “rotational or other movement of hub or handle 14 causes longitudinal member 12 to rotate and/or distal portion 18 and intermediate portion 20 to bend or straighten.”, “hub or handle 14 has a distal section 64 that may function to rotate longitudinally extending member 12 and/or engage steering or pull wire(s) or cord(s) 42 to "steer" distal section 18.”).
However, Cohen fails to disclose wherein the inner wall surface adjacent to the first lumen has a first partial elliptical shape comprising a first ellipse with a first semi-minor axis of the first ellipse extending from a first center point coincident with the first lumen axis to the inner wall surface.
George teaches an inner wall surface (30 Fig 5) adjacent to the first lumen (24 Fig 5) has a first partial elliptical shape comprising a first ellipse (the thickened wall portion 38 forms an ellipse as outlined in annotated Fig 5) with a first semi-minor axis of the first ellipse extending from a first center point coincident with the first lumen axis to the inner wall surface (See the axes of the elliptical shape in annotated Fig 5 below). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner wall surface of Cohen to be shaped as taught by George to provide the central lumen with a greater diameter (Col 1 lines 66-67) while providing a thickened wall portion for the first lumen to extend through, and since George teaches the shape of the thickened wall portion can be changed (Col 4 lines 26-42, see the alternative shapes in Figs 7 and 8).
Regarding claim 3, modified Cohen teaches the catheter of claim 1. Modified Cohen further teaches wherein the first ellipse comprises opposed first and second semi-major axes extending from the first center point to opposed first and second vertex points located in the tubular body wall between the inner and outer surfaces thereof (See the vertices and the semi-major axes in annotated Fig 5 of George).
Regarding claim 6, modified Cohen teaches the catheter of claim 1. Cohen further teaches wherein the first lumen is a pull-wire lumen and the second lumen is a fluid lumen, or the first lumen (36 on the top of Fig 2) is a fluid lumen and the second lumen is a pull- wire lumen (36 on the bottom of Fig 2 is shown with a wire, [0034] “The steering or pull wire(s) or cord(s) preferably extends through a lumen, optionally the same lumen through which each wire for an electrode extends.”, [0053] “One of ancillary lumens 36 is an inflation lumen for, and in fluid communication with, balloon 28, and the other lumen 36 is for the wires 38 extending from the electrodes 28 and a steering or pull wire or cord 42 that extends to distal section 18.”).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2004/0215139 A1) in view of George (US 4861337 A) and Bourang et al. (US 2008/0255447 A1).
Regarding claim 2, modified Cohen teaches the catheter of claim 1. While a first radial distance from the first lumen axis to the inner wall surface appears equal to a second radial distance from the first lumen axis to the outer wall surface in Fig 5 of George, this ratio is not explicitly described.
Bourang et al. teaches wherein a first radial distance from the first lumen axis to the inner wall surface (124 Fig 2) is equal to a second radial distance from the first lumen axis to the outer wall surface (122 Fig 4, [0033] “each contrast lumen 120 is positioned at a distance 122 of about 0.003 inches from the outer circumference of the body 108 and positioned at a distance 124 of about 0.003 inches from the guidewire lumen 110”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the first lumen of modified Cohen to include the limitations as taught by Bourang et al. to minimize kinking of the lumens [0033].
Claim(s) 4-5, 7-11, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2004/0215139 A1) in view of George (US 4861337 A) and Tegg et al. (US 2019/0160256 A1).
Regarding claim 4, modified Cohen teaches the catheter of claim 1. Cohen further teaches further including a second lumen (36 on the bottom of Fig 2) in the tubular body wall, the second lumen having a second lumen axis that is radially outward from and parallel to the central lumen axis (see the spacing of the bottom 36 relative to 34 in Fig 2). Cohen further teaches the second lumen is symmetrical with the first lumen.
However, modified Cohen fails to teach wherein the inner wall surface adjacent to the second lumen has a second partial elliptical shape comprising a second ellipse with a second semi-minor axis of the second ellipse extending from a second center point coincident with the second lumen axis to the inner wall surface. Because George only teaches one lumen within a thickened wall portion, it is not clear that a modification with George would result in the second lumen also be positioned within a similarly shaped thickened portion as the first lumen.
Tegg et al. teaches wherein the inner wall surface adjacent to the second lumen (top 84 Fig 4A) has a thickened wall shape symmetrical ([0042] “the symmetrical shape of the first lumen 82”) and opposite to the inner wall surface adjacent to the first lumen (bottom 84 Fig 4A) across the central lumen (82 Fig 4A). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner wall surface adjacent to the second lumen to have the same shape as the inner wall surface adjacent to the first lumen because “This cross-sectional shape can maximize the size of the first lumen 82 while still maintaining sufficient wall thickness around the exterior of the catheter and between adjacent lumens (e.g., the first lumen 82 and the plurality of second lumens 84).” [0041] and “The symmetry of the first lumen 82 can also provide for more desirable bending properties of the distal end portion of the catheter” [0042]. The resulting shape of the inner wall surface would include the ancillary lumens of Cohen both being positioned within a partial elliptical shape as taught by George.
Accordingly, George teaches the inner wall surface (30 Fig 5) adjacent to an ancillary lumen (24 Fig 5) has a partial elliptical shape comprising an ellipse (the thickened wall portion 38 forms an ellipse as outlined in annotated Fig 5) with a semi-minor axis of the second ellipse extending from a center point coincident with the lumen axis to the inner wall surface (See the axes of the elliptical shape in annotated Fig 5 below). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner wall surface of modified Cohen to be shaped as taught by George to provide the central lumen with a greater diameter (Col 1 lines 66-67) while providing a thickened wall portion for the first lumen to extend through, and since George teaches the shape of the thickened wall portion can be changed (Col 4 lines 26-42, see the alternative shapes in Figs 7 and 8). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner wall surface of Cohen to be shaped as taught by George to provide the central lumen with a greater diameter (Col 1 lines 66-67) while providing a thickened wall portion for the second lumen to extend through, and since George teaches the shape of the thickened wall portion can be changed (Col 4 lines 26-42, see the alternative shapes in Figs 7 and 8).
Regarding claim 5, modified Cohen teaches the catheter of claim 4. Modified Cohen further teaches wherein the second ellipse comprises opposed third and fourth semi-major axes extending from the second center point to opposed third and fourth vertex points located in the tubular body wall between the inner and outer surfaces thereof (See the vertices and the semi-major axes in annotated Fig 5 of George).
Regarding claim 7, Cohen discloses a steerable intravascular catheter (Fig 1), comprising: a) a handle assembly (14 Fig 1) having opposed proximal (44 Fig 3) and distal (Fig 1) end portions and defining a longitudinal axis therebetween (the long axis of the handle 14 Fig 1); b) an elongated sheath (12 Fig 1) extending from the distal end portion of the handle assembly and having opposed sheath proximal (22 Fig 1) and distal ([0051] “distal section 18”) end portions, wherein the sheath distal end portion is deflectable relative to the sheath proximal end portion ([0055] “distal portion 18 and intermediate portion 20 to bend or straighten”), the elongated sheath including: i) a tubular body wall (the wall of sheath 12 Fig 1) having an inner wall surface (the inner surface of lumen 34 Fig 2) spaced from an outer wall surface (the outer surface of 30 Fig 2), wherein the inner wall surface defines a central lumen (34 Fig 2) having a central lumen axis (the axis of 34 is perpendicular with the cross section shown in Fig 2); ii) a fluid lumen (36 on the top of Fig 2) in the tubular body wall, the fluid lumen having a fluid lumen axis that is radially outward from and parallel to the central lumen axis (see the spacing of the top 36 relative to 34 in Fig 2); and iii) a pull-wire lumen (36 on the bottom of Fig 2) spaced from the fluid lumen in the tubular body wall, the pull-wire lumen being radially outward from and having a pull-wire axis that is parallel to the central lumen axis (see the spacing of the bottom 36 relative to 34 in Fig 2), and c) a rotatable actuation assembly operatively associated with the handle assembly for controlling deflection of the sheath distal end portion ([0055] “rotational or other movement of hub or handle 14 causes longitudinal member 12 to rotate and/or distal portion 18 and intermediate portion 20 to bend or straighten.”, “hub or handle 14 has a distal section 64 that may function to rotate longitudinally extending member 12 and/or engage steering or pull wire(s) or cord(s) 42 to "steer" distal section 18.”); and d) an inflatable balloon (26 Fig 1) positioned on an outer surface of the sheath distal end portion (Fig 1), wherein the fluid lumen of the elongated sheath is in fluid communication with an interior of the balloon (top lumen 36 Fig 2 [0053] “One of ancillary lumens 36 is an inflation lumen for, and in fluid communication with, balloon 28”).
However, Cohen fails to disclose wherein the inner wall surface adjacent to the fluid lumen has a first partial elliptical shape comprising a first ellipse with a first semi-minor axis of the first ellipse extending from a first center point coincident with the fluid lumen axis to the inner wall surface and with opposed first and second semi-major axes of the first ellipse extending from the first center point to opposed first and second vertex points located in the tubular body wall between the inner and outer surfaces thereof, and wherein the inner wall surface adjacent to the pull-wire lumen has a second partial elliptical shape comprising a second ellipse with a second semi-minor axis of the second ellipse extending from a second center point coincident with the pull-wire axis to the inner wall surface and with opposed third and fourth semi-major axes of the second ellipse extending from the second center point to opposed third and fourth vertex points located in the tubular body wall between the inner and outer surfaces thereof.
Tegg et al. teaches wherein an inner wall surface adjacent to a first lumen (top 84 Fig 4A) has a first thickened wall shape symmetrical ([0042] “the symmetrical shape of the first lumen 82”) and opposite to an inner wall surface adjacent to a second lumen (bottom 84 Fig 4A) across the central lumen (82 Fig 4A). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner wall surfaces adjacent to the ancillary lumens to have the same thickened wall shape because “This cross-sectional shape can maximize the size of the first lumen 82 while still maintaining sufficient wall thickness around the exterior of the catheter and between adjacent lumens (e.g., the first lumen 82 and the plurality of second lumens 84).” [0041] and “The symmetry of the first lumen 82 can also provide for more desirable bending properties of the distal end portion of the catheter” [0042].
George teaches the inner wall surface (30 Fig 5) adjacent to an ancillary lumen (24 Fig 5) has a partial elliptical shape comprising an ellipse (the thickened wall portion 38 forms an ellipse as outlined in annotated Fig 5) with a semi-minor axis of the second ellipse extending from a center point coincident with the lumen axis to the inner wall surface (See the axes of the elliptical shape in annotated Fig 5 below). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner wall surface of modified Cohen to be shaped as taught by George to provide the central lumen with a greater diameter (Col 1 lines 66-67) while providing a thickened wall portion for the first lumen to extend through, and since George teaches the shape of the thickened wall portion can be changed (Col 4 lines 26-42, see the alternative shapes in Figs 7 and 8). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the inner wall surface of Cohen to be shaped as taught by George to provide the central lumen with a greater diameter (Col 1 lines 66-67) while providing a thickened wall portion for the second lumen to extend through, and since George teaches the shape of the thickened wall portion can be changed (Col 4 lines 26-42, see the alternative shapes in Figs 7 and 8).
Regarding claim 8, modified Cohen teaches the catheter of claim 7. Cohen further discloses further comprising an inflation port (52, 58 Fig 3) positioned on the handle assembly (14 Fig 3) in fluid communication with the fluid lumen ([0054] “access 52 in fluid communication with an inflation lumen 36”) allowing the inflatable occlusion balloon to be inflated and deflated.
Regarding claim 9, modified Cohen teaches the catheter of claim 7. Cohen further discloses wherein the pull-wire lumen is diametrically opposed to the fluid lumen across from the central lumen (See the positioning of lumens 36 across from 34 in Fig 2).
Regarding claim 10, modified Cohen teaches the catheter of claim 7. Cohen further teaches further comprising an elongated pull-wire extending through the pull-wire lumen of the elongated sheath and terminating within the sheath distal end portion ([0052] “internal steering or pull wire(s) or cord(s)”, [0053] “and the other lumen 36 is for the wires 38 extending from the electrodes 28 and a steering or pull wire or cord 42 that extends to distal section 18.”).
Regarding claim 11, modified Cohen teaches the catheter of claim 10. Cohen further teaches wherein the elongated pull-wire has a proximal end operatively connected to the handle assembly ([0055] “More particularly, hub or handle 14 has a distal section 64 that may function to rotate longitudinally extending member 12 and/or engage steering or pull wire(s) or cord(s) 42 to "steer" distal section 18.”) and a distal end anchored to the sheath distal end portion ([0034] “a steering or pull wire(s) or cord(s) extends from a position at or adjacent to the distal end of the catheter”).
Regarding claim 15, modified Cohen teaches the catheter of claim 7. Cohen further discloses wherein the elongated sheath defines a circumference (Fig 2) and a predetermined usable length (UL) extending from the sheath proximal end portion substantially to the sheath distal end portion (22 Fig 3), wherein the predetermined UL ranges from 30 cm to 120 cm ([0057] “80-140cm” Fig 1).
Regarding claim 18, modified Cohen teaches the catheter of claim 7. Cohen further discloses wherein the handle assembly includes a flush port (50 Fig 3) in fluid communication with the central lumen ([0054] the access to the central lumen is fully capable of being used for a flush fluid).
Claim(s) 12-13, 16-17, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2004/0215139 A1) in view of George (US 4861337 A), Tegg et al. (US 2019/0160256 A1) and Osypka et al. (US 2015/0335861 A1), hereinafter Osypka ‘861.
Regarding claim 12, modified Cohen teaches the catheter of claim 10. Cohen further teaches wherein the rotatable actuation assembly includes a control knob operatively connected to a proximal end of the 15elongated pull-wire [0034], wherein actuation of the control knob pulls or releases the elongated pull-wire ([0034] “tightening and loosening said deflection”) and causes the sheath distal end portion to deflect away from the longitudinal axis or back toward the longitudinal axis ([0034], [0052] Fig 1).
However, modified Cohen is silent to wherein the control knob is rotatable and 15wherein rotation of the rotatable control knob pulls or releases the elongated pull-wire.
Osypka ‘861 teaches wherein the rotatable actuation assembly ([0032], 'drive mechanism ... 50') includes a rotatable control knob ([0039], 'knob 38'), wherein rotation ([0039], 'angularly rotated in a clockwise direction') of the rotatable control knob (knob 38) pulls ([0039], 'will be drawn in a proximal direction (rearwardly)') or releases the elongated pull-wire (pull wire 20) and causes the sheath distal end portion ([0031] 'distal end portion 18', [0027] 'sheath 12') to deflect away ([0039], 'angular deflection ... in a first direction') from the longitudinal axis (see Fig. 1, line 5-5) or back toward the longitudinal axis (Fig. 1, line 5-5). It would have been obvious to one of ordinary skill at the time of effective filing for the device of modified Cohen to include the limitations as taught by Osypka ‘861 to provide sufficient structure to actuate the knob pull wire assembly of Cohen.
Regarding claim 13, modified Cohen teaches the catheter of claim 12. Osypka ‘861 further discloses wherein the handle assembly (Fig. 2; [0030], 'handle assembly 24') includes a drive mechanism ([0032], 'internal drive mechanism designated generally by reference numeral 50') for actuating ([0032] 'for actuating') the elongated pull-wire (20 Fig 2) in response to bi-directional angular rotation of the rotatable control knob ([0032], 'in response to the bi-directional angular rotation of the control knob 38'), and wherein bi-directional angular rotation of the rotatable control knob ([0031] 'bi-directional angular rotation of the control knob 38') about the longitudinal axis (see Fig. 1, line 5-5) of the handle assembly ([0031] 'about the longitudinal axis of the handle assembly 24 (i.e., clockwise and counter-clockwise rotation)') effectuates reciprocal axial movement of the elongated pull-wire ([0031] 'effectuates corresponding reciprocal axial movement of the two pull wires 20 and 22 in opposed axial directions') and corresponding angular deflection ([0031], 'causes the corresponding bi-directional angular deflection') of the sheath distal end portion ([0031], 'of the distal end portion 18', 'sheath 12').
Regarding claim 16, modified Cohen teaches the catheter of claim 7. However, modified Cohen is silent to wherein the handle assembly includes a hemostatic valve operatively connected to the central lumen.
Osypka ‘861 teaches wherein the handle assembly includes a hemostatic valve (28 Fig 2) operatively connected to the central lumen ([0030] 16 Fig 5) designed to minimize blood loss and prevent air embolisms. It would have been obvious to one of ordinary skill at the time of effective filing for the handle assembly of Cohen to include the limitations as taught by Osypka ‘861 to “minimize blood loss and prevent air embolism” through the central lumen [0030]. The motivation would be to improve safety of the catheter. Additionally, another embodiment of Cohen teaches a hemostatic valve designed to minimize blood loss and prevent air embolisms “to prevent blood backbleeding” [0133].
Regarding claim 17, modified Cohen teaches the catheter of claim 7. Cohen further teaches wherein the handle assembly (14 Fig 3) 20includes an access (50 Fig 3) on a proximal end of the central lumen ([0054]). However, modified Cohen is silent to wherein the access is of a luer type locking connection.
Osypka ‘861 teaches wherein the access is a luer type locking connection (32 Fig 2, [0030]). It would have been obvious to one of ordinary skill at the time of effective filing for the access of modified Cohen to be a luer type locking connection as taught by Osypka ‘861 to provide a standardized connector that is compatible with other standard devices.
Regarding claim 19, modified Cohen teaches the catheter of claim 7. However, modified Cohen fails to teach wherein the sheath distal end portion extends entirely through the handle assembly and terminates at a sealed access port communicating with the central lumen defined by the tubular body wall.
Osypka ‘861 teaches wherein a sheath proximal (see the interpretation presented the rejection under 112b above) end portion ([0030] 'the proximal end portion 25 of sheath 12') extends entirely through the handle assembly ([0030] 'extends entirely through the handle assembly 24') and terminates at a sealed access port ([0030] 'terminates at a sealed access port 26') communicating with the central lumen ([0030] 'communicates with the central lumen 16') defined by the tubular body wall ([0030] 'defined by the tubular body wall 14'). It would have been obvious to one of ordinary skill at the time of effective filing for the device of modified Cohen to include the limitations as taught by Osypka ‘861 “to minimize blood loss and prevent air embolisms” [0030].
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2004/0215139 A1) in view of George (US 4861337 A), Tegg et al. (US 2019/0160256 A1), and Osypka et al. (US 2010/0106141 A1), hereinafter Osypka ‘141.
Regarding claim 14, modified Cohen teaches the catheter of claim 7. However, modified Cohen fails to teaches wherein the sheath distal end portion is made from a softer material than the sheath proximal end portion to accommodate deflection.
Osypka ‘141 teaches a sheath distal end portion ([0045], 'distal portion 140') being made from a softer material ([0045], 'a flexible, relatively soft and compliant material') than a sheath proximal end portion ([0042] 'a portion 141 of the shaft 130 proximal the distal portion 140 thereof, is preferably formed of a relatively stiff biocompatible material') to accommodate deflection ([0045], 'to allow the distal portion 140 to bend in response to control inputs'). It would have been obvious to one of ordinary skill in the art at the time of effective filing to modify modified Cohen with the teaching of Osypka ‘141 for the purpose of enabling the catheter tip to bend more easily and to a greater degree when navigating the arterial system. Motivation for doing so would have been to extend the life of the device and to improve patient safety by reducing the amount of injury caused to the patient during the surgical procedure.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cohen (US 2004/0215139 A1) in view of George (US 4861337 A), Tegg et al. (US 2019/0160256 A1) and Yokoyama et al. (US 2006/0195136 A1).
Regarding claim 20, modified Cohen teaches the catheter of claim 7. Cohen discloses the diameters of the lumens can vary “and the lumens 34, 36 within catheter 10 are each about 0.01 to about 0.4 inches, preferably from about 0.01 to about 0.25 inches, in diameter” and “it is believed that one skilled in the art could determine appropriate parameters” [0057]. However, modified Cohen is silent to wherein a diameter of the central lumen is larger than a diameter of the fluid lumen.
Yokoyama at al. teaches wherein a diameter of the central lumen (5 Fig 2) is larger than a diameter of the fluid lumen (6 Fig 2, [0027] “a guide lumen 5 which is the largest lumen formed approximately in the center,”). It would have been obvious to one of ordinary skill at the time of effective filing for the diameter of the central lumen of the device of modified Cohen to be a larger lumen as taught by Yokoyama et al. to allow larger tools into the central lumen.
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Annotated Fig 5 of George (US 4861337 A)
Conclusion
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783