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 .
Claim Rejections - 35 USC § 103
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.
Claim(s) 1 and 3-16 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,709,462 (Nguyen ‘462) in view of US Patent App. Pub. No. 2021/0085347 (Phan et al.) and as evidenced by US Patent No. 10,555,744 (Nguyen ‘744).
In regards to claims 1 and 14:
Nguyen ‘462 discloses a catheter (100) for treating occlusions that comprises a sealed balloon (102) filled with conductive fluid and cylindrical conductive sheaths (112, 114, and 116) mounted on an elongate tube (104) located within the balloon (see Figure 1 and column 5, lines 13-26). As best shown in Figure 2D, a conductive sheath (214) defines two opposed slots (213) in which uninsulated portions (236a and 232b) of two insulated wires are positioned to define first and second electrode pairs for generating shockwaves (column 6, lines 14-58). Shock waves are created when a voltage pulse is supplied to the wires.
Nguyen ‘462 fails to disclose that the slots (213) extend distally from a proximal end of the sheath, and the wires extend into the slots. Phan discloses another catheter (200) for treating occlusions that comprises a sealed balloon (280) filled with conductive fluid [0045] and two electrode pairs located within the balloon (see Figures 2A-2B; [0060-0062]). A cylindrical conductive sheath (220) is circumferentially mounted around the elongate tubular catheter (210) and defines a slot (224) that extends from a proximal end of the sheath toward the distal end. Similar to Nguyen, Phan discloses a first insulated wire (242) extending along the elongated tube (210) with an uninsulated portion (243) positioned within a cutout (222) to form a first electrode pair (Figure 2B; [0069]; [0071]). Phan teaches that an electrode pair can have a tongue and groove configuration [0061], wherein a conductive wire (emitter portion 234) extends into a slot (224) that extends distally from a proximal end of a conductive sheath (220) (Fig. 2C; [0072-0075]). Similar to the other forms of electrode pairs in Nguyen, the uninsulated wire (234) is spaced proximally from the distal end of the sheath to form a spark gap, such that shock waves are created when a voltage pulse is supplied to the wire [0075].
Nguyen ‘462 explains that varying the size and shape of the uninsulated portions of wire to control the shockwave (column 6, lines 21-30) and that the particular shape of the outer electrode (cut-out/slot of conductive sheath) effects the size and expansion/collapse of a gas bubble that creates the shock wave (column 7, lines 42-55). It would have been an obvious matter of design choice to one of ordinary skill in the art before the effective filing date of the claimed invention to configure both of the electrode pairs of Nguyen ‘462 such that the wires extend into slots that extend distally from a proximal end of the sheath, as taught by Phan, as such a modification merely involves a substitution of one known electrode pair configuration for another that obtains a predictable result of a spark gap for generating cavitation bubbles/ shockwaves within a balloon. Additionally, the modification provides optimization of the magnitude and direction of a corresponding shockwave to treat a particular patient’s needs.
In regards to claim 3, Phan discloses the sheath (210) has a lumen sized to receive a guidewire of a diameter in the range of 0.014 – 0.035 inch [0065] and the conductive wires having a diameter of 0.003-0.007 inch [0065]. Both Nguyen and Phan illustrate the length of the conductive sheath is several times as large as the width of the slot, but fails to disclose the particular length of the conductive sheath. Phan sets forth that the size of the slot (which relates to the size of the sheath) is a result effective variable, as the location, size and shape of the slot (222) of a conductive sheath can be varied to control the location, direction and/or magnitude of the shockwave [0070]. One of ordinary skill in the art would have found it obvious to configure the sheath to have a length in the range of 0.02 – 0.12 inch for the purpose of optimizing the location, direction and/or magnitude of the shockwave for a particular procedure, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In regards to claim 4, Nguyen clearly shows two slots (236a, 236b) offset by 180 degrees (See Figure 2D; column 7, lines 9-28). Phan also discloses that two electrode pairs may be offset by 180 degrees, wherein a first electrode pair (243/222) shown in Figure 2B is offset 180 degrees from a second electrode pair (234/224) shown in Figure 2C [0072].
In regards to claim 5, Nguyen teaches that the magnitude, duration and distribution of force impinging on surrounding tissue from the shockwaves depends on the location and distance between the shock wave source and tissue portion. Nguyen goes on to explain that electrodes can be distributed across the device to minimize the distance between shock wave sources and tissue location being treated (column 8, lines 35-55). Nguyen discloses an embodiment in Figure 3B having electrodes 330a and 332b positioned 90 degrees circumferentially from one another (column 10, lines 10-30). Additionally, Nguyen teaches that four slots can be positioned about a circumference that are spaced 90 degrees from one another (column 13, lines 60-65). Therefore, it would have been obvious to configure the first and second slots of modified Nguyen to be spaced less than 180 degrees from each other in order to tailor the device for optimizing magnitude, direction of shockwaves for a particular application.
In regards to claim 6, Phan incorporates by reference 10,555,744 (Nguyen ‘744 at [0005]). Nguyen ‘744 discloses that a slot (504 or 608) in a conductive sheath for forming an electrode pair may have a helical configuration (see Figures 5 and 6; column 15, lines 16-56). Nguyen ‘462 teaches the concept of varying the size and shape of the uninsulated portions of wire to control the shockwave (column 6, lines 21-30) and that the particular shape of the outer electrode (cut-out/slot of conductive sheath) effects the size and expansion/collapse of a gas bubble that creates the shock wave (column 7, lines 42-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure at least one slot of modified Nguyen ‘462 to have a helical configuration, in order to optimize the direction and magnitude of an associated shockwave for a particular surgical procedure and/or patient anatomy. The modification results in a slot having a length greater than a proximal to distal length of the conductive sheath.
In regards to claim 7, Nguyen explains the plasma arcs cause the sheath and wire to erode, wherein the wires resembled a candle wick over time (column 14, lines 55-65). Since the free end of the wire has the conductive spot (631) and is the location of the plasma arc, the wires are capable of eroding from the distal end toward the proximal end.
In regards to claim 8, Although Nguyen ‘462 fails to disclose the slot extends the entire length of the conductive sheath, Nguyen ‘462 teaches the concept of varying the size and shape of the uninsulated portions of wire to control the shockwave (column 6, lines 21-30) and that the particular shape of the outer electrode (cut-out/slot of conductive sheath) effects the size and expansion/collapse of a gas bubble that creates the shock wave (column 7, lines 42-55). Nguyen ‘462 further teaches that the location of a spark gap relative to a tissue portion varies the force applied to the tissue by the associated shock wave (column 8, lines 40-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure at least one slot of modified Nguyen ‘462 to extend from the proximal end to the distal end, in order to optimize the direction and magnitude of an associated shockwave for a particular surgical procedure and/or patient anatomy. The modification merely involves a change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
In regards to claim 9, Nguyen ‘462 fails to explicitly disclose the wires have a diameter equal to the thickness of the sheath (212), but Nguyen ‘462 teaches that a wire may be flat for reducing the crossing profile of the electrode assembly (column 6, lines 28-30). Phan illustrates a conductive wire (234) has a thickness similar to the thickness of the conductive sheath (220) (see Figure 2A). Phan also teaches that the wire can have a flattened shape [0065]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the wires of modified Nguyen to have a diameter equal to the thickness of the sheath, as such a modification would have involved a mere change in size of a component, which is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
In regards to claim 10, Phan incorporates by reference 10,555,744 (Nguyen ‘744 at [0005]). Nguyen ‘744 discloses that a slot (504 or 608) in a conductive sheath for forming an electrode pair may have a helical configuration (see Figures 5 and 6; column 15, lines 16-56). Nguyen ‘462 teaches the concept of varying the size and shape of the uninsulated portions of wire to control the shockwave (column 6, lines 21-30) and that the particular shape of the outer electrode (cut-out/slot of conductive sheath) effects the size and expansion/collapse of a gas bubble that creates the shock wave (column 7, lines 42-55). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure at least one slot of modified Nguyen ‘462 to have a helical configuration, in order to optimize the direction and magnitude of an associated shockwave for a particular surgical procedure and/or patient anatomy. The modification results in a slot extending partially in both longitudinal and circumferential directions.
In regards to claim 11, the cylindrical sheath of Nguyen is symmetrical about a longitudinal plane (consistent diameter/thickness).
Regarding claim 12, Nguyen ‘462 teaches that a wire may be flat for reducing the crossing profile of the electrode assembly (column 6, lines 28-30). Phan discloses flattened wires [0065].
In regards to claim 13, Nguyen ‘462 teaches that a wire may be flat for reducing the crossing profile of the electrode assembly (column 6, lines 28-30). Phan discloses flattened wires [0065]. It is considered to be an obvious matter of design choice to use one flattened wire and one round wire, as the modification merely involves a combination of known wire shapes that allows one of ordinary skill in the art to tailor the Nguyen device for a particular application.
In regards to claim 14: modified Nguyen ‘462 discloses all the claimed components as discussed above with reference to claim 1, except fails to specify the pressure and diameter to which the balloon is inflated. Phan teaches that the inflatable member (cap 280)(which corresponds to the balloon of Nguyen ‘462) expands a small amount to retain a low profile (diameter less than 1mm) when inflated to pressure in a range of 1 – 6 atm, wherein the maximum inflated diameter of the flexible cap (280) is no more than 10% greater than in the deflated state [0048; 0062]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the balloon of Nguyen ‘462 to have an inflated diameter of no more than 10% of the deflated diameter, as taught by Phan, in order to maintain a low profile of the balloon after inflation.
In regards to claim 15: Phan teaches that the inflatable member (cap 280)(which corresponds to the balloon of Nguyen ‘462) expands a small amount to retain a low profile (diameter less than 1mm) when inflated to pressure in a range of 1 – 6 atm, wherein the maximum inflated diameter of the flexible cap (280) is no more than 10% greater than in the deflated state [0048; 0062]. Phan additionally teaches that the inflated size of the balloon can be tailored by wall thickness, durometer, and/or inflation pressure. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to configure the balloon of Nguyen ‘462 to have a diameter when pressurized that is the same as the deflated pressure, since Phan teaches that a low profile of less than 10% is ideal for passage through small diameter lumens.
In regards to claim 16: Phan teaches that the inflatable member (cap 280)(which corresponds to the balloon of Nguyen ‘462) expands to a diameter less than 1mm [0062]. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to configure the balloon of Nguyen ‘462 to have a diameter in the range of less than 1.5 mm, as Phan teaches that a low profile is ideal for passage through occluded lumens.
Claim(s) 2 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,709,462 (Nguyen ‘462) in view of US Patent App. Pub. No. 2021/0085347 (Phan et al.), and further in view of 10,966,737 (Nguyen ‘737).
Regarding claim 2, Nguyen ‘462 fails to disclose that the conductive sheath is configured to generate forward biased shockwaves. Phan teaches that the location, size and shape of the slot (222) of a conductive sheath can be varied to control the location, direction and/or magnitude of the shockwave [0070]. Nguyen ‘737 teaches that a conductive sheath of a shockwave generation device in a balloon can be configured to generate forward-biased shockwaves, in order to aid in crossing total occlusions (column 2, lines 19-31). Applicant admits in [0008] that this configuration is taught by 10,966,737 (Nguyen ‘737). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nguyen ‘462 conductive sheath to be generate forward-biased shockwaves in order to aid in penetrating and crossing total occlusions.
In regards to claim 17, the modified Nguyen ‘462 device as discussed with reference to claim 1 discloses all the structural requirements of the catheter. Nguyen ‘462 discloses the steps of advancing the catheter through a body lumen imaging the treatment site during a method of use, pressuring the balloon, applying a voltage pulse across the electrodes, and further advancing the catheter in the body lumen to continue breaking up calcification (column 15, lines 18-54).
Nguyen ‘462 fails to disclose that the shockwaves generated are forward-biased shockwaves having a voltage up to 10kV and a pulse width of 2-6 microseconds. Nguyen ‘737 teaches that a conductive sheath of a shockwave generation device in a balloon can be configured to generate forward-biased shockwaves, in order to aid in crossing total occlusions (column 2, lines 19-31). Applicant admits in [0008] that this configuration is taught by 10,966,737 (Nguyen ‘737). Nguyen ‘737 further teaches a voltage in a range of less than 10kV with a time of a few microseconds (column 4, lines 26-55). Phan teaches a pulse width of 2-6 microseconds [0054]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Nguyen ‘462 method such that forward biased shockwaves are applied up to a voltage of up to kV with a pulse width of 2-6 microsecond. As taught by Nguyen ‘737, in order to aid in achieving the method disclosed in Nguyen ‘462 of penetrating and crossing a total occlusion.
In regards to claim 18, Phan teaches the balloon is depressurized after treatment [0049].
In regards to claim 19, Phan teaches controlling the voltage, current, duration, and repetition rate of the voltage pulse [0054].
Regarding claim 20, Nguyen ‘462 discloses a total chronic occlusion. Phan also discloses crossing a total chronic occlusion [0058].
Conclusion
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/SARAH W ALEMAN/
Primary Examiner, Art Unit 3774
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