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 .
Status of Claims
Claims 15-16, 18 are currently pending.
All claims are rejected.
Response to Arguments
Applicant’s arguments with respect to claim 15 in Applicant’s responses filed 12/02/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 15 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer, A., US 20130197555 A1 in view of Mantell, R., US 20140257323 A1 and Brink, et al., US 20160120598 A1.
Regarding claim 15, Schaer teaches a method for applying pressure pulses to an inner wall of a cavity of a patient (see paragraphs 8 and 101 and fig. 2a for the intraluminal pulsed ultrasound to produce shockwaves), the method comprising:
employing a shockwave system (paragraph 7 states that “The present application discloses various devices, systems and methods of ablating tissue surrounding vein, arteries and other anatomical vessels or conduits (e.g., sphincters) using ultrasound energy”, and paragraph 8 discloses generating shock waves by the ablating system) which comprises
a shockwave transducer (ablation transducer 32 of fig. 2a) comprising a shockwave generating portion (transducer 34 of figs. 2a and 3 and paragraph 8) operable to generate shockwaves (paragraph 101) and
a transducer interface (expandable balloon 46 of figs. 2a and 3 and paragraph 111) comprising a container (expandable balloon 46 of figs. 2a and 3 and paragraph 111 comprises a container as it includes a chamber 50) whose outer contour is configured to directly contact an inner wall of a cavity of a patient (see fig. 2a and paragraph 121 states that “In some embodiments, prior to ablation, the balloon 46 is inflated with a fluid such as saline or water, or an acoustic coupling gel, until it contacts the adjacent tissue (e.g., inner wall of a renal artery, an esophagus or other vessel) over a length exceeding the transducer length”),
wherein said container is at least partially filled with a shockwave-transmissive liquid capable of transmitting the shockwaves from said shockwave generating portion to the inner wall of said cavity (paragraph 121 indicates that the chamber is filed with coupling gel until the balloon 46 contacts the inner wall of the artery, as shown in fig. 2a and that the fluid is acoustic coupling gel) and
wherein said container completely surrounds said shockwave generating portion (paragraph 25 states that “the balloon partially or completely surrounds the ultrasonic transducer”);
introducing said shockwave transducer into a cavity of a patient (see fig. 2a and paragraph 108 which states that “Depending on the specific anatomical location of the patient being targeted, the device can be advanced minimally-invasively through the subject (e.g., delivered transorally to the region of the LES 18, intravascularly to a target artery, vein or other body sphincter or vessel”);
using said shockwave generating portion (transducer 34 of figs. 2a and 3 and paragraph 8) to generate shockwaves (paragraph 8 states that “Ultrasound may also be used (continuously or in pulsed mode) to create shock waves that cause mechanical disruption through cavitation that create the desired tissue effects”) through said shockwave-transmissive liquid and said transducer interface (balloon 46 of fig. 2a and paragraph 114 which states that “A fluid pump 80 delivering cooling fluid 82 to and from the balloon interior. In some embodiments, the balloon is inflated and deflated with the delivery and circulation of cooling fluid through the balloon (e.g., without the need for a separate syringe or other inflating fluid)”) to an inner wall of the cavity (paragraph 25 states that “The method further comprises electrically activating the ultrasonic transducer to deliver acoustic energy radially outwardly from the ultrasonic transducer through the balloon and toward a wall of the vessel”), wherein said shockwave-transmissive liquid is in communication with a pressure sensor (Paragraph 121 states that a means of detecting and displaying balloon inflation volume and/or pressure, and cooling flow rate/pressure may also be incorporated into the generator) and a pump for controlling pressure applied to said inner wall of the cavity (paragraph 121 further states that prior to ablation, the balloon 46 is inflated with a fluid such as saline or water, or an acoustic coupling gel, until it contacts the adjacent tissue (e.g., inner wall of a renal artery, an esophagus or other vessel) over a length exceeding the transducer length. In other embodiments, once the balloon is inflated, it does not contact the adjacent the vessel, hence at least suggesting the use of a pump to regulate the internal pressure of the balloon such that the balloon may be inflated to an internal pressure of the balloon where the outer surface of the balloon is in contact with the inner surface of the tissue/organ of interest or inflated to an internal pressure of the balloon where the outer surface of the balloon does not contact the inner surface of the tissue/organ of interest).
Schaer does not teach monitoring and changing a volume of said shockwave-transmissive liquid in said container in accordance with a treatment plan.
However, within the same field of endeavor, Mantell teaches generation of shockwaves for both intracorporeal and extracorporeal (paragraph 33) using unfocused electrohydraulic lithotripsy ("EHL") probes disposed in a fluid environment (paragraph 5). Paragraph 40 indicates that “at least a portion of the EHL probe tip 101 including the first electrode 104 and the second electrode 106 is surrounded by a flexible encapsulating member 118, such as a balloon, comprising a water-tight flexible material, such as Mylar. The flexible encapsulating member 118 encapsulates a liquid, such as saline. However, other liquids can be used” and paragraph 41 states that “When an electrical arc occurs between the first electrode 104 and the second electrode 106 as described above, the electrical arc causes a steam bubble in the liquid of the flexible encapsulating member 118. The steam bubble rapidly expands and contracts back on itself. As the steam bubble contracts, a pressure wave (a shockwave) is created in the liquid of the flexible encapsulating member 118 that radiates away from the EHL probe tip 101”. Paragraph 41 also includes that a native fluid in a fluid-filled body cavity could be implemented as the wave radiating/propagating medium. Paragraph 59 then states that “In embodiments having a flexible encapsulating member, the strength of the shockwave(s) delivered to a tissue may be selectively adjusted by changing the volume of fluid in the flexible encapsulating member. Because the strength of a shockwave delivered to a tissue is dependent on the distance from the distal end of the EHL probe(s) to the tissue, the strength of a shockwave may be increased or decreased by increasing or decreasing the volume of the fluid in the flexible encapsulating member”, hence teaching the limitation “monitoring and changing a volume of said shockwave-transmissive liquid in said container in accordance with a treatment plan”. Paragraph 34 also states that “The administration of unfocused EHL may be advantageous, for example, in the creation of various shockwave strengths, wave front sizes, wave shapes, or to vary the frequency of shockwaves, as desired, for the treatment of tissues. Such treatments could range, for example, from lightly "massaging" a tissue, to tissue oblation, or cellular disturbance, and potential cellular modification”, hence The Office notes that by the disclosure of selectively adjusting the strength, shape and patterns of the shockwave delivered to the tissue (paragraphs 58 and 59), an inherent monitoring step is being performed to ascertain conditions for changing the fluid volume in the flexible encapsulating member.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Schaer for monitoring and changing a volume of said shockwave-transmissive liquid in said container in accordance with a treatment plan, as taught by Mantell, as such modification would provide a robust way of shaping shockwaves (paragraph 4) to increase the versatility of the method in clinical applications (paragraph 34), with reasonable expectation of success as Schaer also strives to provide measures for effectively propagating waves to the target tissue (paragraph 232).
Schaer in view of Mantell does not teach wherein the method comprising using said pump to control the pressure applied to said inner wall of the cavity in accordance with pressure sensed by said pressure sensor.
However, within the same field of endeavor, Brink teaches devices, systems, and techniques for identifying and treating bladder dysfunction. In one example, a method includes identifying one or more focal points at respective locations of bladder tissue of a bladder of a patient, the one or more focal points initiating coordinated contractions of a detrusor muscle. The method may also, or alternatively, include ablating, for each of the one or more focal points, a respective portion of the bladder tissue at the respective location of the focal point according to the abstract. Brinks further teaches in paragraph 74 that As described in FIG. 1, electrodes 24 may be disposed on the exterior of balloon 20 and as a part of expandable device 18. Sensor 80 may be a pressure sensor that detects the pressure within balloon 20 as it is expanded to place electrodes 24 in contact within the inner surface of bladder 14. Processor 70 may monitor the pressure output by sensor 80 and compare the pressure to a threshold. Responsive to determining that the pressure exceeds the threshold, processor 70 may provide an alert to the clinician that balloon 20 is sufficiently expanded. In other examples, processor 70 may control a pump that inflates balloon 20 and may automatically terminate inflation in response to determining that the pressure sensed by sensor 80 exceeds the threshold, and hence the limitation “wherein the method comprising using said pump to control the pressure applied to said inner wall of the cavity in accordance with pressure sensed by said pressure sensor”.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Schaer as modified by Mantell, wherein the method comprising using said pump to control the pressure applied to said inner wall of the cavity in accordance with pressure sensed by said pressure sensor, as taught by Brinks, as such modification would improve the efficacy of ablation therapy and minimize the volume of treated tissue. See paragraph 24.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer, A., US 20130197555 A1 in view of Mantell, R., US 20140257323 A1 and Brink, et al., US 20160120598 A1, as applied to claim 15, and further in view of Heine, et al., US 20100137752 A1.
Regarding claim 16, Schaer in view of Mantell and Brink teaches all the limitations of claim 15 above.
Schaer in view of Mantell and Brink fails to teach using another energy that cooperates with said pressure pulses to treat the inner wall of the cavity, said other energy comprising at least one of optical energy, ultrasonic energy, radio-frequency energy, magnetic energy, microwave energy and mechanical energy impedance.
However, within the same field of endeavor, Heine teaches a medical apparatus for treatment of the human or animal body by mechanical pressure waves or shock waves, comprises a device designed to generate the pressure waves or shock waves (see abstract), the medical apparatus further configured for using another energy that cooperates with said pressure pulses to treat the inner wall of the cavity, said other energy comprising at least one of optical energy, ultrasonic energy, radio-frequency energy, magnetic energy, microwave energy and mechanical energy impedance (Paragraph 20 disclose that the apparatus includes at least one light source such as a LED, laser or laser-LED for providing “more intensive circulation of blood and stimulation of cells in the tissue of the area to be treated” according to paragraph 22. So that, according to paragraphs 22 and 23, “By combining light with the mechanical pressure waves or shock waves in the area of the body to be treated, it is also possible to achieve better treatment results than with mechanical pressure or shock waves alone”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Schaer, as modified by Mantell and Brink, for using another energy that cooperates with said pressure pulses to treat the inner wall of the cavity, said other energy comprising at least one of optical energy, ultrasonic energy, radio-frequency energy, magnetic energy, microwave energy and mechanical energy impedance, as taught by Heine, to achieve better treatment results than with mechanical pressure or shock waves alone (paragraph 22), with a reasonable expectation of success, as modified Schaer similarly discloses tissue ablation/interruption methods and systems to provide improved therapeutic benefits to the patient according to paragraph 6.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer, A., US 20130197555 A1 in view of Mantell, R., US 20140257323 A1 and Brink, et al., US 20160120598 A1, as applied to claim 15, and further in view of Geva, et al., US 20180104455 A1.
Regarding claim 18, Schaer in view of Mantell and Brink teaches all the limitations of claim 15 above.
Schaer in view of Mantell fails to teach wherein said cavity is a bladder.
However, Brinks further teaches wherein said cavity is a bladder (see abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Schaer as modified by Mantell, wherein the method comprising using said pump to control the pressure applied to said inner wall of the cavity in accordance with pressure sensed by said pressure sensor, as taught by Brinks, as such modification would improve the efficacy of ablation therapy and minimize the volume of treated tissue. See paragraph 24.
Schaer in view of Mantell and Brink fails to teach wherein an outer wall of said container comprises medication, and the method further comprises combining applying said pressure pulses to the bladder and transferring the medication to the bladder for treating bladder cancer.
However, within the same field of endeavor, Geva teaches a kit and method for increasing the permeability of the urinary bladder (or simply ‘bladder’) tissue and/or prostate tissue to therapeutic agents such as drugs (paragraph 59), the kit comprising a urinary catheter 110 of fig. 1 and paragraph 102, wherein said cavity is a bladder (paragraph 101 states that “Reference is now made to FIG. 1, which shows a top view and partially transparent of an exemplary device 100 disposed within a urinary bladder 190 according to an embodiment. Device 100 may be configured such that it may be introduced into urinary bladder 190 (or simply ‘bladder 190’)”) wherein an outer wall of said container comprises medication ([0102] states that “Second opening 150 may be disposed in second longitudinal lumen 140 in the distal portion of catheter 110. Second opening 150 may be disposed outside of balloon 130. Second opening 150 may be configured to deliver the therapeutic fluid (i.e., therapeutic agent 145) into bladder 190, around balloon 130” and [0172] states that “therapeutic fluid may be delivered to the urinary bladder, around the balloon and via a second longitudinal lumen and a second opening of the urinary catheter)”, and the method further comprises combining applying said pressure pulses to the bladder and transferring the medication to the bladder for treating bladder cancer (paragraph 164 discloses generation of shockwaves. As can be seen reproduced fig. 1 below, the outer surface of the balloon 130 is covered entirely by the therapeutic agent 145 (also see paragraphs 101-103), with paragraph 102 stating that “Second opening 150 may be configured to deliver the therapeutic fluid (i.e., therapeutic agent 145) into bladder 190, around balloon 130”. Further, paragraph 110 states that “Ultrasound energy may desirably irradiate the entire internal surface of bladder 190 in order to achieve a uniform transfer of therapeutic agent 145 to bladder 190 (i.e., entirely)”. Paragraph 83 also states that “the device, kit and methods are utilized for treating urinary tract cancer, such as bladder cancer and prostate cancer”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure modified Schaer, wherein an outer wall of said container comprises medication, and the method further comprises combining applying said pressure pulses to the bladder and transferring the medication to the bladder for treating bladder cancer, as taught by Geva, to provide an efficient means (the kits and systems) for penetration and delivery of a therapeutic agent into a bladder without causing prolonged and/or terminal damage to the bladder tissue ([0090]), with a reasonable expectation of success, as modified Schaer similarly discloses tissue ablation/interruption methods and systems to provide improved therapeutic benefits to the patient according to paragraph 6.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
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/FAROUK A BRUCE/Examiner, Art Unit 3793
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797