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 Objections
Claims 75, 83-84, and 92 are objected to because of the following informalities:
Claims 75 (line 1) and 83 (line 1): “the shape” should recite “a shape”.
Claim 84 (line 2): "the central longitudinal axis of the catheter" should recite "a central longitudinal axis of the catheter".
Claim 92 (line 7): “to again to advance” should recite “to again advance”.
Appropriate correction is required.
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.
Claims 76-84 and 92 are 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 76 recites the limitation "an artery" in line 3. It is unclear to the examiner if “an artery” is meant to further define the artery introduced in the preamble or an additional, new artery. For examination purposes, “an artery” is interpreted as “the artery”.
Claim 82 recites the limitation "the focus" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, "the focus" is interpreted as "a focus".
Claim 92 recites the limitation “at least a portion of the calcified region” in line 6. It is unclear to the examiner if “at least a portion of the calcified region” is meant to be the same portion of the calcified region defined in claim 91 (claim 91 states “after the breaking of at least the portion of the calcified region”) or a different portion of the calcified region. For examination purposes, “at least a portion of the calcified region” is interpreted as “at least the portion of the calcified region”.
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) 71-72, 76, and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US 20150342625) [hereinafter Shimizu] in view of Brisken et al. (US 20030069525) [hereinafter Brisken].
Regarding claim 71, Shimizu discloses a method for fracturing a calcified occlusion from a body lumen adjacent to an artery containing the calcified occlusion (Figs. 5A-B, para. 0071: “the ultrasonic oscillation sections 30 of the medical instrument 10 are positioned in the vicinity of the pulmonary artery a in which the thrombus b as the object to be treated is present…In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a”), the method comprising:
inserting a catheter 10 with an energy emitter 30 into an airway (Figs. 4-5A, para. 0070-0071: “The introduction into the living body can be carried out in the manner of pushing in a distal end of the medical instrument 10 into the airway p either perorally or transnasally…Then, as shown in FIG. 5A, the ultrasonic oscillation sections 30 of the medical instrument 10 are positioned in the vicinity of the pulmonary artery a in which the thrombus b as the object to be treated is present”);
actuating the energy emitter 30 to generate a shockwave within the airway (Fig. 5B, para. 0071: “Thereafter, as shown in FIG. 5B, the expansion member 50 is expanded to press the ultrasonic oscillation sections 30 against the inner wall w of the airway p, thereby retaining the ultrasonic oscillation sections 30 in situ. In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a.”); and
directing the shockwave through a wall of the airway and through a wall of the artery to deposit energy in the artery and fragment the calcified occlusion (Fig. 5B, para. 0071: “Thereafter, as shown in FIG. 5B, the expansion member 50 is expanded to press the ultrasonic oscillation sections 30 against the inner wall w of the airway p, thereby retaining the ultrasonic oscillation sections 30 in situ. In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a”.).
Shimizu further discloses that the method for treating the thrombus in an artery can be done from a blood vessel (para. 0073: “As a treating method for pulmonary embolism, there is a technique of treating the thrombus from the blood vessel side. However, with this approach, when a catheter is introduced up to that portion of a pulmonary artery a, which is clogged with the thrombus b, by way of the aorta, the catheter must be passed through the left ventricle, the left atrium, and the pulmonary vein”).
However, Shimizu fails to explicitly disclose that the catheter is inserted into a vein.
Brisken in the same field of endeavor of shockwave device methods teaches that it is known in the art to treat a calcified occlusion from a vein adjacent to an artery containing the calcified occlusion (Fig. 5, para. 0049: “plaque P within an artery A can be treated by introducing a catheter 40 having a suitable vibratory interface surface 42 thereon into a vein V adjacent to the artery”), wherein a catheter 40 with an energy emitter 42 is inserted into the vein (Fig. 5, para. 0049).
Since Shimizu expressly states that the method of fracturing the calcified occlusion may be done in a blood vessel, one skilled in the art would have readily recognized that inserting the shockwave catheter within a vein, as taught by Brisken, would provide an alternative way to treat the occlusion in the artery as desired by Shimizu (para. 0073 of Shimizu); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 72, modified Shimizu discloses wherein the catheter comprises an adjustable reflector (interpreted as the acoustic lens discussed in para. 0058 of Shimizu: “the method for controlling the angle of beam spread of the ultrasonic vibration is not limited to the method of regulating the delays of the pulse signals, but may include a method wherein an acoustic lens is used”) and the reflector reflects and focuses the shockwave on the calcified occlusion (para. 0057 of Shimizu: “A specific example of the control is a control wherein the pulse signal transmitted to each piezoelectric element unit 31 is provided with a delay time, and vibrators are driven sequentially so that the ultrasonic vibrations are radiated in a sector shape as a whole (the angle of beam spread of the ultrasonic vibration is widened). An example of the control is a control wherein, contrary to the above, the pulse signal is provided with a delay time, and the ultrasonic vibrations are radiated so that the vibrations are converged into a predetermined focal point (the angle of beam spread of the ultrasonic vibration is narrowed”. Since the beam spread of the ultrasonic vibration is adjustable by way of the reflector, the reflector is also adjustable.).
Regarding claim 76, Shimizu discloses a method of treating calcified plaque in an artery (Figs. 5A-B, para. 0071: “the ultrasonic oscillation sections 30 of the medical instrument 10 are positioned in the vicinity of the pulmonary artery a in which the thrombus b as the object to be treated is present…In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a”), the method comprising:
advancing a catheter 10 through an airway and positioning a shockwave emitting portion 30 of the catheter 10 in the airway adjacent a calcified region of an artery (Figs. 4-5A, para. 0070-0071: “The introduction into the living body can be carried out in the manner of pushing in a distal end of the medical instrument 10 into the airway p either perorally or transnasally…Then, as shown in FIG. 5A, the ultrasonic oscillation sections 30 of the medical instrument 10 are positioned in the vicinity of the pulmonary artery a in which the thrombus b as the object to be treated is present”), generating a shockwave within the airway by a shockwave emitter at the shockwave emitting portion 30 of the catheter (para. 0071: “Thereafter, as shown in FIG. 5B, the expansion member 50 is expanded to press the ultrasonic oscillation sections 30 against the inner wall w of the airway p, thereby retaining the ultrasonic oscillation sections 30 in situ. In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a);
directing at least a portion of the shockwave towards the calcified region of the artery, and breaking at least a portion of the calcified plaque in the calcified region of the artery (Fig. 5B, para. 0071: “Thereafter, as shown in FIG. 5B, the expansion member 50 is expanded to press the ultrasonic oscillation sections 30 against the inner wall w of the airway p, thereby retaining the ultrasonic oscillation sections 30 in situ. In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a”).
Shimizu further discloses that the method for treating the thrombus in an artery can be done from a blood vessel (para. 0073: “As a treating method for pulmonary embolism, there is a technique of treating the thrombus from the blood vessel side. However, with this approach, when a catheter is introduced up to that portion of a pulmonary artery a, which is clogged with the thrombus b, by way of the aorta, the catheter must be passed through the left ventricle, the left atrium, and the pulmonary vein”).
However, Shimizu fails to explicitly disclose that the catheter is inserted into a vein.
Brisken in the same field of endeavor of shockwave device methods teaches that it is known in the art to treat a calcified occlusion from a vein adjacent to an artery containing the calcified occlusion (Fig. 5, para. 0049: “plaque P within an artery A can be treated by introducing a catheter 40 having a suitable vibratory interface surface 42 thereon into a vein V adjacent to the artery”), wherein a catheter 40 with an energy emitter 42 is inserted into the vein (Fig. 5, para. 0049).
Since Shimizu expressly states that the method of fracturing the calcified occlusion may be done in a blood vessel, one skilled in the art would have readily recognized that inserting the shockwave catheter within a vein, as taught by Brisken, would provide an alternative way to treat the occlusion in the artery as desired by Shimizu (para. 0073 of Shimizu); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 84, modified Shimizu discloses wherein the shockwave is directed in a direction that is radially oriented relative to the central longitudinal axis of the catheter (Fig. 5B, para. 0071 of Shimizu).
Claim(s) 73-75 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US 20150342625) [hereinafter Shimizu] in view of Brisken et al. (US 20030069525) [hereinafter Brisken] as applied to claim 72 above, and further in view of Emery et al. (US 20110112400) [hereinafter Emery].
Regarding claims 73-74, modified Shimizu discloses all of the limitations set forth above in claim 72. As stated above, modified Shimizu discloses that acoustic lenses are used to manipulate an intensity and location of a zone of concentrated energy of the shockwave (see cited paras. 0057-0058 above). However, modified Shimizu does not explicitly disclose adjusting a curvature of the reflector to do so/ wherein the reflector is positioned within a fluid container and divides the fluid container into a first chamber and a second chamber (claim 74).
Shimizu further teaches that the interpreted energy emitter 30 is an ultrasonic oscillation section that may be positioned either on an outside or an inside of an expansion member i.e. balloon (see Figs. 6, 9A, 11A for example, para. 0082 of Shimizu: “Thus, in a form wherein the expansion member 50 is used in the retaining section 40, the position in which to dispose the ultrasonic oscillation sections 30 may be on the outer surface of the expansion member 50 or in the inside of the expansion member 50, or may be both on the outer surface and in the inside. In any of these cases, the ultrasonic vibrations can be favorably applied to the thrombus present in the pulmonary artery”).
Emery in the same field of endeavor of ultrasonic balloon catheters teaches that it is known in the art to provide an ultrasonic balloon with an inner chamber 136 (Fig. 9B, para. 0132: “balloon 136, filled with conductive medium 138”) within an outer chamber 140 (Fig. 9B, para. 0132: “a balloon 140 that may be filled with a less conductive medium 142, such as gas”, and reflector 144 (Fig. 9B, para. 0132), wherein adjusting a curvature of the reflector 144 by way of inflating the inner and outer chambers works as an acoustic lens to manipulate an intensity and a location of a zone of concentrated energy of the shockwave a predetermined focal point 60 (see Fig. 9B, para. 0132-0133).
Since Shimizu teaches that providing the ultrasonic emitter inside the balloon is known alternative to being positioned on the outside of the balloon and that acoustic lens are known in the art to focus and direct shockwave energy, one skilled in the art would have recognized that the inner and outer compartments and adjustable reflector used in Emery would provide a way to focalize the shockwave energy created inside the balloon to a predetermined focal point directed at the calcified occlusion (para. 0132 of Emery) which is desired by modified Shimizu (para. 0057 of Shimizu); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 75, modified Shimizu discloses wherein the shape of the reflector 144 is manipulated by adjusting a pressure difference between the first chamber and the second chamber (Fig. 9B, para. 0132 of Emery: “The reflective interface 144 between the balloons 136 and 140 creates a focusing (e.g. parabolic) mirror surface that focuses the ultrasonic waves, depicted by arrows 146”. Para. 0133 of Emery further states that “The resulting focalization forms an annular focal region 152 in the region where the conducting balloon 150 is in the contact with the wall of the renal artery”. Therefore, the step of inflating or expanding the inner and outer compartments of Emery to the point of contacting the wall is manipulating the shape of the reflective membrane by adjusting the pressure differential between the inner chamber and the outer chamber).
Claim(s) 77-80 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US 20150342625) [hereinafter Shimizu] in view of Brisken et al. (US 20030069525) [hereinafter Brisken] as applied to claim 76 above, and further in view of Gustus et al. (US 20100076299) [hereinafter Gustus].
Regarding claim 77, modified Shimizu discloses all of the limitations set forth above in claim 76. Modified Shimizu further discloses wherein energy from a portion of the shockwave reaching the artery fractures a thrombus (Fig. 5B, para. 0071).
However, modified Shimizu fails to explicitly disclose fracturing calcium deposits in the artery.
Gustus in the same field of endeavor of inflatable ultrasonic devices teaches that it is known in the art for shockwaves to fracture calcium deposits in an artery (Fig. 4, para. 0070) or thrombus (para. 0075: “a transducer wire/core may be positioned near a center of the balloon and be tuned to pass through saline and into tissue, preferably targeting disease or other unwanted components, e.g., calcium or thrombus”).
In light of this teaching, one skilled in the art would have readily recognized that utilizing shockwave energy to fracture calcium in the artery, as taught by Gustus, could be done using the shockwave device of modified Shimizu (para. 0070, 0075 of Gustus); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 78, modified Shimizu discloses wherein the shockwave emitter is located at a distal region of the catheter 20 (Fig. 1, para. 0052 of Shimizu: “a retaining section 40 disposed on a distal end of the main body section 20, ultrasonic oscillation sections 30 disposed on the retaining section 40).
Regarding claim 79, modified Shimizu discloses further comprising adjusting the shockwave emitter so that a focus of the shockwave is located at the calcified plaque (para. 0058 of Shimizu discloses that the beam of the ultrasonic vibration may be adjusted from a widened state or a narrowed state to fracture thrombus; para. 0071 of Shimizu).
Regarding claim 80, modified Shimizu discloses wherein the focus is located at a cap of the calcified plaque (The instant application states that the cap of the calcified plaque is hardened concave or convex surfaces of the plaque in para. 0008. The examiner notes that calcified plaque is known to include concave/concave surfaces and is not completely planar. Therefore, the combination of modified Shimizu and Gustus as discussed in claims 76 and 79 would result in a product wherein the focus of the shockwave is located at the cap of the calcified plaque, since the combination results in a shockwave device that breaks calcified plaque having a curved outer surface).
Claim(s) 81-83 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US 20150342625) [hereinafter Shimizu] in view of Brisken et al. (US 20030069525) [hereinafter Brisken] and Gustus et al. (US 20100076299) [hereinafter Gustus] as applied to claim 76 above, and further in view of Emery et al. (US 20110112400) [hereinafter of Emery].
Regarding claim 81, modified Shimizu discloses all of the limitations set forth above in claim 76. However, modified Shimizu fails to disclose wherein the shockwave emitter comprises an inner compartment filled with a first fluid and an outer compartment filled with a second fluid, and wherein the compartments are separated by a reflective membrane.
Shimizu further teaches that the interpreted energy emitter 30 is an ultrasonic oscillation section that may be positioned either on an outside or an inside of an expansion member i.e. balloon (see Figs. 6, 9A, 11A for example, para. 0082 of Shimizu: “Thus, in a form wherein the expansion member 50 is used in the retaining section 40, the position in which to dispose the ultrasonic oscillation sections 30 may be on the outer surface of the expansion member 50 or in the inside of the expansion member 50, or may be both on the outer surface and in the inside. In any of these cases, the ultrasonic vibrations can be favorably applied to the thrombus present in the pulmonary artery”).
The reference further discusses ways to control and direct the shockwave energy emitted from the device during use such as regulating delays of pulse signals (para. 0057: “A specific example of the control is a control wherein the pulse signal transmitted to each piezoelectric element unit 31 is provided with a delay time, and vibrators are driven sequentially so that the ultrasonic vibrations are radiated in a sector shape as a whole (the angle of beam spread of the ultrasonic vibration is widened). An example of the control is a control wherein, contrary to the above, the pulse signal is provided with a delay time, and the ultrasonic vibrations are radiated so that the vibrations are converged into a predetermined focal point (the angle of beam spread of the ultrasonic vibration is narrowed)”) or utilizing an acoustic lens (para. 0058: “the method for controlling the angle of beam spread of the ultrasonic vibration is not limited to the method of regulating the delays of the pulse signals, but may include a method wherein an acoustic lens is used”).
Emery in the same field of endeavor of ultrasonic balloon catheters teaches that it is known in the art to provide an ultrasonic balloon with an inner compartment 136 filled with a first fluid (Fig. 9B, para. 0132: “balloon 136, filled with conductive medium 138”) within an outer compartment 140 filled with a second fluid (Fig. 9B, para. 0132: “a balloon 140 that may be filled with a less conductive medium 142, such as gas”, and wherein the compartments are separated by a reflective membrane 144 (Fig. 9B, para. 0132). The reflective membrane 144 works as an acoustic lens to reflect and focus shockwave emitted from an ultrasonic transducer 24 inside the balloons 136, 140 to a predetermined focal point 60 (see Fig. 9B, para. 0132-0133).
Since Shimizu teaches that providing the ultrasonic emitter inside the balloon is known alternative to being positioned on the outside of the balloon and that acoustic lens are known in the art to focus and direct shockwave energy, one skilled in the art would have recognized that the inner and outer compartments and adjustable reflector used in Emery would provide a way to focalize the shockwave energy created inside the balloon to a predetermined focal point directed at the calcified occlusion (para. 0132 of Emery) which is desired by modified Shimizu (para. 0057 of Shimizu); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 82, modified Shimizu discloses further comprising adjusting a shape of the reflective membrane to adjust a position of the focus (Fig. 9B, para. 0132 of Emery: “The reflective interface 144 between the balloons 136 and 140 creates a focusing (e.g. parabolic) mirror surface that focuses the ultrasonic waves, depicted by arrows 146”. Para. 0133 of Emery further states that “The resulting focalization forms an annular focal region 152 in the region where the conducting balloon 150 is in the contact with the wall of the renal artery”. Therefore, the step of inflating or expanding the balloon to the point of contacting the wall is adjusting the shape of the reflective membrane to adjust the position of the focus).
Regarding claim 83, modified Shimizu discloses wherein the shape of the reflective membrane is manipulated by adjusting a pressure differential between the inner compartment and the outer compartment (Fig. 9B, para. 0132 of Emery: “The reflective interface 144 between the balloons 136 and 140 creates a focusing (e.g. parabolic) mirror surface that focuses the ultrasonic waves, depicted by arrows 146”. Para. 0133 of Emery further states that “The resulting focalization forms an annular focal region 152 in the region where the conducting balloon 150 is in the contact with the wall of the renal artery”. Therefore, the step of inflating or expanding the inner and outer compartments of Emery to the point of contacting the wall is manipulating the shape of the reflective membrane by adjusting the pressure differential between the inner compartment and the outer compartment).
Claim(s) 85-88 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US 20150342625) [hereinafter Shimizu] in view of Brisken et al. (US 20030069525) [hereinafter Brisken] and Brouillette et al. (US 20200383692) [hereinafter Brouillette].
Regarding claim 85, Shimizu discloses a method (Figs. 4-5B, para. 0070-0071) comprising:
advancing a distal region 40 of a catheter 10 (Fig. 1, para. 0052) through an airway to a region of the airway adjacent to a calcified region of an artery (Figs. 4-5A, para. 0070-0071: “The introduction into the living body can be carried out in the manner of pushing in a distal end of the medical instrument 10 into the airway p either perorally or transnasally…Then, as shown in FIG. 5A, the ultrasonic oscillation sections 30 of the medical instrument 10 are positioned in the vicinity of the pulmonary artery a in which the thrombus b as the object to be treated is present”);
generating a shockwave within the airway using the distal region (Fig. 5B, para. 0071: “Thereafter, as shown in FIG. 5B, the expansion member 50 is expanded to press the ultrasonic oscillation sections 30 against the inner wall w of the airway p, thereby retaining the ultrasonic oscillation sections 30 in situ. In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a.”);
directing at least a portion of the shockwave from the airway towards the calcified region of the artery, and breaking at least a portion of the calcified region with the shockwave (Fig. 5B, para. 0071: “Thereafter, as shown in FIG. 5B, the expansion member 50 is expanded to press the ultrasonic oscillation sections 30 against the inner wall w of the airway p, thereby retaining the ultrasonic oscillation sections 30 in situ. In this condition, ultrasonic vibrations are oscillated from the ultrasonic oscillation sections 30, thereby crushing the thrombus b present in the pulmonary artery a”.).
Shimizu further discloses that the method for treating the thrombus in an artery can be done from a blood vessel (para. 0073: “As a treating method for pulmonary embolism, there is a technique of treating the thrombus from the blood vessel side. However, with this approach, when a catheter is introduced up to that portion of a pulmonary artery a, which is clogged with the thrombus b, by way of the aorta, the catheter must be passed through the left ventricle, the left atrium, and the pulmonary vein”).
However, Shimizu fails to explicitly disclose that the catheter is inserted into a vein.
Brisken in the same field of endeavor of shockwave device methods teaches that it is known in the art to treat a calcified occlusion from a vein adjacent to an artery containing the calcified occlusion (Fig. 5, para. 0049: “plaque P within an artery A can be treated by introducing a catheter 40 having a suitable vibratory interface surface 42 thereon into a vein V adjacent to the artery”), wherein a catheter 40 with an energy emitter 42 is inserted into the vein (Fig. 5, para. 0049).
Since Shimizu expressly states that the method of fracturing the calcified occlusion may be done in a blood vessel, one skilled in the art would have readily recognized that inserting the shockwave catheter within a vein, as taught by Brisken, would provide an alternative way to treat the occlusion in the artery as desired by Shimizu (para. 0073 of Shimizu); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Shimizu further discusses ways to control and direct the shockwave energy emitted from the device during use such as regulating delays of pulse signals (para. 0057: “A specific example of the control is a control wherein the pulse signal transmitted to each piezoelectric element unit 31 is provided with a delay time, and vibrators are driven sequentially so that the ultrasonic vibrations are radiated in a sector shape as a whole (the angle of beam spread of the ultrasonic vibration is widened). An example of the control is a control wherein, contrary to the above, the pulse signal is provided with a delay time, and the ultrasonic vibrations are radiated so that the vibrations are converged into a predetermined focal point (the angle of beam spread of the ultrasonic vibration is narrowed)”) or utilizing an acoustic lens (para. 0058: “the method for controlling the angle of beam spread of the ultrasonic vibration is not limited to the method of regulating the delays of the pulse signals, but may include a method wherein an acoustic lens is used”).
However, modified Shimizu fails to disclose advancing the distal region of the catheter to a region of the vein proximate the calcified region of the artery such that the shockwaves are directed from the distal region of the catheter at a proximal location to the calcified region.
Brouillette in the same field of endeavor of ultrasonic devices teaches that it is known in the art to advance a distal region of catheter 18 (para. 0072: “the wave directing device 18 may be securable at the distal end of a catheter or a balloon”) proximate a calcified region 12 (Fig. 1, para. 0071) for the purpose of directing shockwaves distally by way of an acoustic lens to treat the calcified region (para. 0068, para. 0076: “In this case, the wave directing device 18 may be an acoustic lens”) as a known alternative to positioning the distal region of the catheter directly adjacent to the calcified region 12 (see Fig. 4, para. 0086).
Since Shimizu discloses that the use of the acoustic lens to focus the shockwave to the calcified region as discussed above, one skilled in the art would have readily recognized that advancing the distal region of the catheter to the region proximal of the calcified region as taught by Brouillette, would provide an alternative way to position the catheter in order to direct the shockwave energy to the calcified region by way of the acoustic lens (para. 0068 of Brouillette); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding claim 86, modified Shimizu discloses further comprising identifying the calcified region by imaging the artery in conjunction with the advancing the distal region of the catheter (para. 0070 of Shimizu: “an operation of determining the object to be treated by use of a predetermined imaging diagnostic apparatus can be carried out concurrently with the introduction of the medical instrument 10 into the living body”).
Regarding claim 87, modified Shimizu discloses all of the limitations set forth above in claim 85. Modified Shimizu further discloses imaging the vein during the advancing of the distal region by way of an imaging diagnostic apparatus (para. 0070 of Shimizu: “an operation of determining the object to be treated by use of a predetermined imaging diagnostic apparatus can be carried out concurrently with the introduction of the medical instrument 10 into the living body”).
However, Shimizu fails to disclose imaging the artery as well during the advancing the distal region.
Brouillette further teaches that it is known in the art to image the artery 14 during advancement of the distal region of the catheter 18 using an imaging device (Fig. 1, para. 0074) for the purpose visualizing the catheter during insertion (para. 0074 of Brouillette).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the method in modified Shimizu to include imaging the distal region of the catheter during the advancing of the distal region, as taught by Brouillette in order to adequately position and/or orient the distal region of the catheter relative to the calcified region to be treated (para. 0074 of Brouillette).
Regarding claim 88, modified Shimizu discloses wherein the distal region includes a reflector (interpreted as the acoustic lens discussed above in para. 0057-0058 of Shimizu in the rejection of claim 85) and the method further comprises moving the reflector to orient the reflector to reflect the shockwave towards the calcified region of the artery (see Fig. 5B, see cited para. 0057 of Shimizu above).
Claim(s) 89 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US 20150342625) [hereinafter Shimizu] in view of Brisken et al. (US 20030069525) [hereinafter Brisken] and Brouillette et al. (US 20200383692) [hereinafter Brouillette], as applied to claim 88 above, and in further view of Emery et al. (US 20110112400) [hereinafter Emery].
Regarding claim 89, modified Shimizu discloses all of the limitations set forth above in claim 88. However, modified Shimizu fails to disclose wherein the moving of the reflector includes turning the reflector about a longitudinal axis of the distal region.
Emery in the same field of endeavor of ultrasonic balloon catheters teaches that it is known in the art to rotate a reflector 144 by way of rotating the catheter 16 for the purpose of creating multiple focal points (Fig. 9B, para. 0132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the method in modified Shimizu to include the step of rotating the catheter, thereby turning the reflector about the longitudinal axis of the distal region, as taught by Emery in order to increase the treatment area if needed during the procedure (para. 0132 of Emery).
Regarding claim 90, modified Shimizu discloses all of the limitations set forth above in claim 88. However, modified Shimizu fails to disclose adjusting a shape of the reflector to align a focus of the reflector at the calcified region of the artery.
Shimizu further teaches that the interpreted energy emitter 30 is an ultrasonic oscillation section that may be positioned either on an outside or an inside of an expansion member i.e. balloon (see Figs. 6, 9A, 11A for example, para. 0082 of Shimizu: “Thus, in a form wherein the expansion member 50 is used in the retaining section 40, the position in which to dispose the ultrasonic oscillation sections 30 may be on the outer surface of the expansion member 50 or in the inside of the expansion member 50, or may be both on the outer surface and in the inside. In any of these cases, the ultrasonic vibrations can be favorably applied to the thrombus present in the pulmonary artery”).
Emery in the same field of endeavor of ultrasonic balloon catheters teaches that it is known in the art to provide an ultrasonic balloon with an inner compartment 136 filled with a first fluid (Fig. 9B, para. 0132: “balloon 136, filled with conductive medium 138”) within an outer compartment 140 filled with a second fluid (Fig. 9B, para. 0132: “a balloon 140 that may be filled with a less conductive medium 142, such as gas”, and a reflector 144 (Fig. 9B, para. 0132). The reflector 144 works as an acoustic lens to reflect and focus shockwave emitted from an ultrasonic transducer 24 inside the balloons 136, 140 to a predetermined focal point 60 (see Fig. 9B, para. 0132-0133). The reference further teaches adjusting a shape of the reflector 144 to align a focus of the reflector at the calcified region of the artery (Fig. 9B, para. 0132 of Emery: “The reflective interface 144 between the balloons 136 and 140 creates a focusing (e.g. parabolic) mirror surface that focuses the ultrasonic waves, depicted by arrows 146”. Para. 0133 of Emery further states that “The resulting focalization forms an annular focal region 152 in the region where the conducting balloon 150 is in the contact with the wall of the renal artery”. Therefore, the step of inflating or expanding the balloon to the point of contacting the wall is adjusting the shape of the reflective membrane to adjust the position of the focus).
Since Shimizu teaches that providing the ultrasonic emitter inside the balloon is known alternative to being positioned on the outside of the balloon and that acoustic lens are known in the art to focus and direct shockwave energy, one skilled in the art would have recognized that the inner and outer compartments and adjustable reflector used in Emery would provide a way to focalize the shockwave energy created inside the balloon to a predetermined focal point directed at the calcified occlusion (para. 0132 of Emery) which is desired by modified Shimizu (para. 0057 of Shimizu); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 91 and 92 are rejected under 35 U.S.C. 103 as being unpatentable over Shimizu et al. (US 20150342625) [hereinafter Shimizu] in view of Brisken et al. (US 20030069525) [hereinafter Brisken] and Brouillette et al. (US 20200383692) [hereinafter Brouillette], as applied to claim 85 above, and further in view of Shabtay et al. (US 20200238107) [hereinafter Shabtay].
Regarding claim 91, modified Shimizu discloses all of the limitations set forth above in claim 85. However, modified Shimizu fails to disclose after the breaking of at least the portion of the calcified region, attempting to advance a second catheter into the calcified region to further break the calcified region.
Shabtay in the same field of endeavor of ultrasonic devices teaches that it is known in the art after utilizing a first ultrasonic catheter to treat a target area, a user may assess the treatment at the target area (see steps 105-111 of Fig. 1, para. 0205, 0213, and 0216). Para. 0400 of Shabtay teaches that when treatment efficacy is evaluated, a decision can be made to introduce a second catheter into the target area to complete the treatment if a change in electrical parameters is required.
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method in modified Shimizu to include the step of advancing the second catheter, as taught by Shabtay, into the calcified region to further break the calcified plaque in order to provide a secondary mode of treatment to complete the treatment if a change in electrical parameters is required (para. 0400 of Shabtay), thereby increasing the efficacy of the treatment.
Regarding claim 92, modified Shimizu discloses all of the limitations set forth above in claim 91. As stated above in the combination of claim 91, modified Shimizu discloses the advancement of a second catheter to further treat and complete the breaking of the calcified plaque. However, modified Shimizu fails to disclose in response to resistance to the advancement of the second catheter into the calcified region, generating a second shockwave using the distal region (of the initial catheter); directing at least a portion of the second shockwave towards the calcified region of the artery; breaking at least a portion of the calcified region with the second shockwave; and after the second shockwave, attempting to again to advance the second catheter into the calcified region.
There are only a finite number of ways to position further treat the calcified region with a first and second catheter as described in modified Shimizu above such as advancing the second catheter into the calcified region and utilizing a shockwave from the second catheter to further break the calcified region or utilizing the initial catheter to direct a second shockwave from the vein to the calcified region of the artery to further break the calcified region. Each possibility yields the predictable result of complete destruction of the calcified region to clear the interior of the artery. Therefore, it would be obvious to one of ordinary skill to modify the method step of modified Shimizu to utilize the initial catheter to direct the second shockwave to the calcified region, in order to achieve the predictable result of completely destroying the calcified region using shockwave energy to clear the interior of the artery; KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Conclusion
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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