Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendments
Applicant's amendments and remarks, filed 10/23/2025, are acknowledged. Applicant's arguments have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.
Status of Claims
Claims 15-19, 21-27 are currently under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application discloses and claims only subject matter disclosed in prior application no 14/765,765, filed 08/04/2015, now abandoned, and names the inventor or at least one joint inventor named in the prior application.
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) to PCT371 of PCT/US2014/014728, filed 02/04/2014, is acknowledged.
Priority claiming the benefit of US Provisional Application 61/760,539, filed 02/04/2013 and US Provisional Application 61/772,318, filed 03/04/2013, are acknowledged.
Response to Arguments
Applicant’s responses and arguments filed 10/23/2025 regarding claim rejections under 35 USC 103 have been fully considered.
Applicant amended the independent claims with subject matter appearing to change the scope of the claim therefore necessitating new grounds of rejection.
Applicant argues that the reference Diedrich teaching is contradicting the amended limitations in view of paragraph [0088] such that the independent control of each sector for the tubular transducer is not performed according to that paragraph since multiple “elements” may be needed to achieve a longitudinal control and apparently teaching away from the claimed invention.
In response, the examiner is reading the claim language as the tubular transducer as being claimed by “the catheter having at least one multi-sectored transducer” and one of the at least one multi-sectored transducer” defined “wherein each of the plurality of angular transducer energy zones within the single tubular transducer is independently operable” without considering the other possible multi-sectored tubular transducer. The examiner is considering the teaching of Diedrich teaching each sector as being independently energized (“[0094] As shown in FIG. 7B, section 142 is configured to emit a 120.degree. distribution beam. Each segment may be operated independently and/or concurrently, and adjusted according to different levels (e.g. power from 0 to max, frequency, and emission time) for desired coagulation or distribution”) wherein the transducer in Fig.7B is a 120° three-sectored transducer for ablation with each sector being independently activated with independent power at independent frequency for independent time of activation, and [0090]-[0095]) and a cooling system ([0026], [0081] Fig.6),) wherein the additional multi-sectored tubular transducer are placed longitudinally to ensure the propagation and longitudinal coverage of the heat as needed as described in Figs. 12A-C with one or two or three of the tubular transducer, wherein one of the tubular transducer has his own sector independently energized within its own sectors. Therefore the examiner is considering the Applicant as not persuasive and Diedrich is teaching he amended limitations.
Claim Rejections - 35 USC§ 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
For the purpose of clarity of the rejection, the text provided within bracket as followed is representing limitation or part of it which is not taught by the reference is will be addressed later in the rejection ,e.g. [...Limitation not taught...].
Claims 15-18, 21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (USPN 20030139790 A1; Pub.Date 07/04/2003; Fil.Date 01/07/2003) in view of Diederich et al. (USPN 2007/0255267 A1; Pub.Date 11/01/2007; Fil.Date 04/20/2007), Keidar (USPN 7670335 B2; Pub.Date 03/02/2010; Fil.Date 07/21/2003), Azhari et al. (USPN US 20120296240 A1; Pub.Date 11/22/2012; Fil.Date 05/20/2011), Mathew (2011 PhD. thesis Cochin University of Science Kerela India pages 123; Pub.Date 2011), Cioanta et al. (USPN 6796960 B2; Pat.Date 09/28/2004; Fil.Date 05/01/2002), Lacoste et al. (USPN 20050085726 A1; Pub.Date 04/21/20005; Fil.Date 01/15/2004), Prakash et al. (2010 AIP Conference Proceedings 1215 396–399; Pub.Date 2010), Butty et al. (USPN 20070185483 A1; Pub.Date 08/09/2007; Fil.Date 03/03/2005) and in view of Sterzer et al. (2000 IEEE Trans. Microwave Theory and Techniques 48:1885-1891; Pub.Date 2000).
Regarding claim 15, Ingle teaches A method of thermally remodeling a collagenous structure of a target urethral supporting tissue structure (Title, abstract “methods, and systems for shrinking collagenated tissues” and “Cooled electrodes may be used to chill an intermediate engaged tissue so as to cause the maximum temperature difference between the target tissue and the intermediate tissue prior to initiating RF heating. This allows the dimensions of tissue reaching the treatment temperature to be controlled and/or minimized, the dimensions of protected intermediate tissue to be maximized, and the like), comprising:
inserting a catheter of a catheter-based ultrasound applicator into a urethra, (Figs.13A-13M and [0116], [0143] using catheter for cooling the transducer, with [0031] inserting, via transurethral insertion, the catheter/probe into the bladder into a urethra wherein the probe uses a low power density ultrasound transducer [0040])
[...the catheter having at least one multi-sectored transducer, the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided...];
positioning the catheter in the urethra longitudinally and rotationally under real-time image guidance so as to place the catheter longitudinally in a mid-urethral position and rotationally so the [...at least one multi-sectored...] transducer does not treat a vaginal wall adjacent to the urethra (Fig.13 with focused heating selectively targeting EF endopelvic fascia with Fig.13A-M ultrasonic transducer as in [0143] wherein [0145] allowing translation and rotation of the ultrasound transducer 308, and [0146] to treat selected tissue at different depths by translation or by dynamic focusing the treatment, with [0152] the use of a cooling control system “which can protect intermediate tissues outside the treatment zone” therefore reading the system orienting and focusing the treatment so as not to treat the tissue outside the endopelvic fascia therefore the vaginal wall adjacent the urethra),
[...wherein the at least one multi-sectored transducer produces energy that is electrically subdivided into a plurality of angular transducer energy zones extending radially and longitudinally from the multi- sectored transducer...];
[...inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position and provide cooling to the bladder and nearby tissue...];
circulating a coolant through a cooling system coupled to the catheter, the cooling system comprising an inlet configured to introduce a coolant into the catheter and an outlet configured to allow the coolant to exit the catheter, the coolant configured to cool the catheter-based ultrasound applicator (Fig. 13D and [0152] with the cooling system with the flow of water as the coolant fluid within the catheter with an inlet #318 to introduce the coolant inside the catheter 300 and circulate the coolant through the inside catheter as 316 around the transducer 308 and an outlet as in Fig. 10 and [0121] with cooling fluid conduits #78 for fluid inlet and outlet) and acoustically couple the [...at least one multi-sectored...] transducer to a tissue ([0123] cooling liquid being water which on of ordinary skill in the art would recognize that water is commonly used as a matching liquid between ultrasound transducer and tissue of patient);
[...disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose...];
Ingle teaches propagating acoustic energy through the urethra and into the target urethral supporting tissue structure to affect immediate tightening and remodeling of the target urethral supporting tissue structure wherein the propagation of acoustic energy through the urethra wall to the target EF (Fig.13 with focused heating selectively targeting EF endopelvic fascia with Fig.13A-M ultrasonic transducer as in [0143] wherein [0145] allowing translation and rotation of the ultrasound transducer 308, and [0146] to treat selected tissue at different depths by translation or by dynamic focusing the treatment); and
[...stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter...];
deactivating one or more of the at least one multi-sectored transducer after a desired temperature and a desired ultrasound dose are achieved ([0016] “A control system will often selectively energize the electrode and/or cooling system in response to the monitored temperature” with a control system to energize the probe in response to the monitored temperature to reach maximum temperature and [0073] “The temperature will usually not drop instantaneously when the heating energy stops, so that the tissue may remain at or near the therapy temperature for a time from about 10 seconds to about 2 minutes, and will often cool gradually back to body temperature” teaching implicitly to stop heated when reaching the maximum treatment temperature);
wherein each of the plurality of angular transducer energy zones is independently operable ([0025] “The control system is adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature while the cooling system maintains the intermediate tissue (which is disposed between the electrode array and the target zone) at or below a maximum safe tissue temperature”) […a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone…].
Ingle does not specifically teach the catheter having at least one multi-sectored transducer, the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided, wherein the at least one multi-sectored transducer produces energy that is electrically subdivided within the single tubular transducer into a plurality of angular transducer energy zones defined radially and longitudinally; acoustically couple the at least one multi-sectored transducer to a tissue and wherein each of the plurality of angular transducer energy zones is independently operable, inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position and provide cooling to the bladder and nearby tissue; disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose; stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter, and wherein each energy zone is independently operable, a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone as in claim 15.
However, Diederich teaches within the same field of endeavor of catheter with ultrasonic probe to thermal treatment of tissue (Title and abstract) an apparatus for ultrasound treatment (Title and abstract) comprising: a catheter ([0025], [0080] and Fig.6 #102), with at least one multi-sectored transducer, the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided (Figs.3 and 6 transducer #64, with [0083] tubular piezoelectric transducer and [0090] with multi-sectors and wherein Fig.7B [0093]-[0094] shows one embodiment of a single transducer with notches 130 with each sector 140, 142 and 144 activated separately but not mechanically separated or divided) in communication with the catheter (Fig.6 #64 at the tip of the catheter), wherein the at least one multi-sectored transducer not mechanically subdivided [...is electrically coupled to a power source and...] produces energy that is electrically subdivided within the single tubular transducer into a plurality of angular transducer energy zones defined radially and longitudinally from the at least multi-sectored transducer to the target treatment region ([0090]-[0095] and Fig.7B angular sectors from 60 to 180 degrees individually wired with Diederich teaching also the multi-element transducer alone or stacked longitudinally (Figs. 12A-C) with the energy zones mostly directional as radially oriented but presenting also a longitudinal component due to the natural heat conduction of the matter (Figs.12A-C). Therefore, teaching also “energy that is electrically subdivided into a plurality of angular transducer energy zones extending radially and longitudinally from the multi-sectored transducer” regarding the direction of the propagation of the thermal energy); wherein each sector of the multi-sectored transducer within the single tubular transducer is independently operable, a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone (“[0094] As shown in FIG. 7B, section 142 is configured to emit a 120.degree. distribution beam. Each segment may be operated independently and/or concurrently, and adjusted according to different levels (e.g. power from 0 to max, frequency, and emission time) for desired coagulation or distribution”) wherein the transducer in Fig.7B is a 120° three-sectored transducer for ablation with each sector being independently activated with independent power at independent frequency for independent time of activation, and [0090]-[0095]) and a cooling system ([0026], [0081] Fig.6),) with the coolant configured to acoustically couple the at least one transducer to a tissue ([0110], [0125] coolant is water and “to couple the ultrasound energy to the tissue”).
Additionally, Keidar teaches within the same field of endeavor of catheter with ultrasonic probe to thermal treatment of tissue (Title and abstract) that it is common knowledge to design and use in the art of ablation of tissue a tubular transducer as a sectorized single unit (Fig.2 and col.12 3rd ¶ “the ablation element 120 located circumferentially about an axial centerline” or transducer 120) with the same structure that that of Diederich (Fig. 3C and col.13 4th ¶ with the notching grooves and an internal electrode 302 external electrodes 304 around the single piece of tubular piezo-electric transducer 303 that electrically separate each sector with “By controlling the driving power and operating frequency to each individual sector, the ultrasonic driver 340 can enhance the uniformity of the acoustic energy beam around the transducer 300, as well as can vary the degree of heating (i.e., lesion control) in the angular dimension”) therefore describing wherein the at least one multi-sectored transducer not mechanically subdivided is electrically coupled to a power source and produces energy that is electrically subdivided into a plurality of angular transducer energy zones extending radially from the at least multi-sectored transducer to the target treatment region wherein each sector of the multi-sectored transducer within the single tubular transducer is independently operable as claimed in claim 15. Additionally, Azhari teaches the use of the same ultrasound transducer for high intensity focused ultrasound (HIFU) and for low intensity focused ultrasound (LIFU) ([0065]-[0066]) for different applications.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle such that the method comprises: the catheter having at least one multi-sectored transducer, the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided, wherein the at least one multi-sectored transducer produces energy that is electrically subdivided within the single tubular transducer into a plurality of angular transducer energy zones extending radially and longitudinally from the multi-sectored transducer; acoustically couple the at least one multi-sectored transducer to a tissue and wherein each of the plurality of angular transducer energy zones within the single tubular transducer is independently operable, a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone, since one of ordinary skill in the art would recognize that using a single tubular ultrasonic transducer with multiple sectors not mechanically subdivided independently controlled emitting radially from the catheter longitudinal axis was routine and conventional in the art, as taught by Diederich, and since each sector of the not mechanically subdivided transducer is known in the art to be configured to be electrically separated for activation for emitting sectored ultrasonic heat treatment as taught by Keidar and since water was known in the art to be a commonly used coupling liquid for ultrasonic transducer for medical application as taught by Diederich. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since while Diederich uses the transducer for high intensity focused ultrasound and Keidar teaches similar prior art with electrically subdivided transducer and Ingle uses the transducer for low intensity focused ultrasound, Azhari teaching the same transducer being used for high and low intensity focused ultrasounds. The motivation would have been to improve the control of the treatment for wide region of interest to be treated, as suggested by Diederich ([0088]-[0089]).
Ingle, Diederich, Keidar and Azhari do not specifically teach inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position and provide cooling to the bladder and nearby tissue; disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose, stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter as in claim 15.
Diederich teaches also a plurality of multi-sectored transducers in communication with the catheter ([0124]-[0125]), and the plurality of multi-sectored transducers are stacked (Fig.6 #64) to provide differential control along a length of the catheter ([0125]-[0128] and Fig.19 for monitoring the thermal control) reading on stacking the at least one multi-sectored transducer [...end-to-end...] to provide differential control along a length of the catheter.
Additionally, Mathew teaches the design of the cylindrical array transducer as placed side by side that the cylindrical array transducer is a stacked of transducer elements as considered as transducer set placed end-to-end (Fig. 2-1) along the longitudinal axis and therefore configured to perform the same function than the stacking of transducers along that axis as the configuration of Diederich transducer set without the spacing of Diederich.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle Diederich, Keidar and Azhari such that the method comprises: stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter, since one of ordinary skill in the art would recognize that using several ultrasonic transducers with multiple sector independently controlled emitting radially from the catheter longitudinal axis placed along the axis of the catheter to transmit ultrasonic energy along a predetermined length of the catheter was routine and conventional in the art, as taught by Diederich and placing transducer arrays end-to-end to perform the same function would have been merely an engineering design consideration as taught by Mathew. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Diederich uses the transducer for high intensity focused ultrasound and Ingle uses the transducer for low intensity focused ultrasound, Azhari teaches the same transducer being used for high and low intensity focused ultrasounds. The motivation would have been to improve the control of the treatment for wide region of interest to be treated, as suggested by Diederich ([0088]-[0089]).
Regarding the dependent claims 16-18, 21 all the elements of these claims are instantly disclosed or fully envisioned by the combination of Ingle, Diederich, Keidar, Azhari, Mathew, Cioanta, Lacoste, Prakash, Butty and Sterzer.
Regarding claims 16, 17, Ingle does not specifically teach deploying a second thermal sensor to monitor a temperature in the target urethral supporting tissue structure as in claim 16, and monitoring the temperature and an ultrasound dose in the target urethral supporting tissue structure as in the dependent claim 17 from claim 16.
However, as discussed above, Butty teaches the use of a plurality of thermocouples for accessing to the temperature distribution within the treated tissue and accessing to the thermal dose for the treatment ([0019]) therefore teaching deploying a second thermal sensor in the tissue to measure the temperature in the target treatment region. Diederich teaches also the use of a deployable thermocouple ([0076] “designed to deploy into the target zone”) wherein Ingle teaches that the target zone is the EF (Fig.13 with focused heating selectively targeting EF endopelvic fascia with Fig.13A-M ultrasonic transducer as in [0143] wherein [0145] allowing translation and rotation of the ultrasound transducer 308, and [0146] to treat selected tissue at different depths by translation or by dynamic focusing the treatment) with the thermocouple providing feedback of temperature treatment ([0076] “sensor array 66 provides treatment verification and feedback so that only the desired treatment region or target zone is affected or monitoring the temperature and ultrasound dose in the target). Therefore as discussed above, Diederich and Butty teach deploying a second thermal sensor to monitor a temperature in the target urethral supporting tissue structure as in claim 16, and monitoring the temperature and an ultrasound dose in the target urethral supporting tissue structure.
Regarding claim 18, Ingle teaches the heating of the target being performed from 60°C to 80°C as previously discussed for a heat time of about 5 minutes ([0071]) while Diederich teaches the heating time of 5 to 10 minutes for creating substantial size thermal lesions ([0113]) therefore both anticipating the claimed limitation of raising the temperature of the endopelvic fascia to between 50 degrees Celsius and 75 degrees Celsius for a period of 30 seconds to 10 minutes as in claim 18.
Regarding claim 21, Ingle does not teach specifically the anchor balloon is positioned distal to the at least one multi-sectored transducer as in claim 21.
However, as discussed for claim 15, Cioanta teaches the anchor balloon is positioned distal to the at least one multi-sectored transducer (Fig.2A with the bladder anchoring balloon 22 placed within the bladder distal from the treatment region and the treatment balloon 23 the transurethral catheter being locked along the urethra).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari, Mathew, Cioanta, Lacoste, Prakash, Butty and Sterzer such that the method comprises the step: the anchor balloon is positioned distal to the at least one multi-sectored transducer, since one of ordinary skill in the art would recognize that providing and inflating a bladder anchoring balloon to settle the treatment catheter region within the urethra to treat tissue along the urethra of the patient was routine and conventional in the art, as taught by Cioanta and since thermal ablation using multi-sectored transducers was also known in the art as taught by Diederich. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Ingle, Diederich and Cioanta teach the use of ultrasonic transducers for thermal ablation. The motivation would have been to stabilize the treating region of the catheter to target the right region surrounding the urethra, as suggested by Cioanta (Fig. 2A).
Claims 22-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (USPN 20030139790 A1; Pub.Date 07/04/2003; Fil.Date 01/07/2003) in view of Diederich et al. (USPN 2007/0255267 A1; Pub.Date 11/01/2007; Fil.Date 04/20/2007), Keidar (USPN 7670335 B2; Pub.Date 03/02/2010; Fil.Date 07/21/2003), Azhari et al. (USPN US 20120296240 A1; Pub.Date 11/22/2012; Fil.Date 05/20/2011), Cioanta et al. (USPN 6796960 B2; Pat.Date 09/28/2004; Fil.Date 05/01/2002), Lacoste et al. (USPN 20050085726 A1; Pub.Date 04/21/20005; Fil.Date 01/15/2004), Mathew (2011 PhD. thesis Cochin University of Science Kerela India pages 123; Pub.Date 2011), Prakash et al. (2010 AIP Conference Proceedings 1215 396–399; Pub.Date 2010), Butty et al. (USPN 20070185483 A1; Pub.Date 08/09/2007; Fil.Date 03/03/2005) and in view of Sterzer et al. (2000 IEEE Trans. Microwave Theory and Techniques 48:1885-1891; Pub.Date 2000).
Regarding claim 22, Ingle teaches A method for treating stress urinary incontinence, (Title, abstract “methods, and systems for shrinking collagenated tissues” and “Cooled electrodes may be used to chill an intermediate engaged tissue so as to cause the maximum temperature difference between the target tissue and the intermediate tissue prior to initiating RF heating. This allows the dimensions of tissue reaching the treatment temperature to be controlled and/or minimized, the dimensions of protected intermediate tissue to be maximized, and the like) comprising:
inserting a catheter of a catheter-based ultrasound applicator into a urethra, (Figs.13A-13M and [0116], [0143] using catheter for cooling the transducer, with [0031] inserting, via transurethral insertion, the catheter/probe into the bladder into a urethra wherein the probe uses a low power density ultrasound transducer [0040])
[...the catheter having at least one multi-sectored transducer and an anchor balloon, the anchor balloon positioned distal with respect to the at least one multi-sectored transducer, the anchor balloon to provide cooling to the bladder and nearby tissue,
the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided...] ;
[...positioning the catheter by inflating the anchor balloon within a bladder...] and
rotationally orienting the at least one multi-sectored transducer so as to avoid treating a vaginal wall adjacent to the urethra (Fig.13 with focused heating selectively targeting EF endopelvic fascia with Fig.13A-M ultrasonic transducer as in [0143] wherein [0145] allowing translation and rotation of the ultrasound transducer 308, and [0146] to treat selected tissue at different depths by translation or by dynamic focusing the treatment, with [0152] the use of a cooling control system “which can protect intermediate tissues outside the treatment zone” therefore reading the system orienting and focusing the treatment so as not to treat the tissue outside the endopelvic fascia therefore the vaginal wall adjacent the urethra),
[...wherein the at least one multi-sectored transducer produces energy that is electrically subdivided into a plurality of angular transducer energy zones extending radially and longitudinally from the multi-sectored transducer and... ];
circulating a coolant through a cooling system coupled to the catheter, the cooling system comprising an inlet configured to introduce a coolant into the catheter and an outlet configured to allow the coolant to exit the catheter, the coolant configured to cool the catheter-based ultrasound applicator (Fig. 13D and [0152] with the cooling system with the flow of water as the coolant fluid within the catheter with an inlet #318 to introduce the coolant inside the catheter 300 and circulate the coolant through the inside catheter as 316 around the transducer 308 and an outlet as in Fig. 10 and [0121] with cooling fluid conduits #78 for fluid inlet and outlet) and acoustically couple the [...at least one multi-sectored...] transducer to a tissue ([0123] cooling liquid being water which on of ordinary skill in the art would recognize that water is commonly used as a matching liquid between ultrasound transducer and tissue of patient);
[...disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose ...];
propagating acoustic energy through the urethra into a target urethral supporting tissue structure to affect immediate tightening and remodeling of a collagenous structure of the target urethral supporting tissue structure wherein the propagation of acoustic energy through the urethra wall to the target EF (Fig.13 with focused heating selectively targeting EF endopelvic fascia with Fig.13A-M ultrasonic transducer as in [0143] wherein [0145] allowing translation and rotation of the ultrasound transducer 308, and [0146] to treat selected tissue at different depths by translation or by dynamic focusing the treatment); and;
[...and stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter...];
wherein each of the plurality of angular transducer energy zones is independently operable ([0025] “The control system is adapted to selectively energize the electrode surface segments so as to heat the target tissue to a treatment temperature while the cooling system maintains the intermediate tissue (which is disposed between the electrode array and the target zone) at or below a maximum safe tissue temperature”) […a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone...]
Ingle does not specifically teach the catheter having at least one multi-sectored transducer and an anchor balloon, the anchor balloon to provide cooling to the bladder and nearby tissue, the anchor balloon positioned distal with respect to the at least one multi-sectored transducer, the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided, positioning the catheter by inflating the anchor balloon within a bladder, wherein the at least one multi-sectored transducer produces energy that is electrically subdivided within the single tubular transducer into a plurality of angular transducer energy zones defined radially and longitudinally and, acoustically couple the at least one multi-sectored transducer to a tissue, stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter and disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose and each of the energy zone are independently operable within the single tubular transducer, a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone as in claim 22.
However, Diederich teaches within the same field of endeavor of catheter with ultrasonic probe to thermal treatment of tissue (Title and abstract) an apparatus for ultrasound treatment (Title and abstract) comprising: a catheter ([0025], [0080] and Fig.6 #102), with at least one multi-sectored transducer, the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided (Figs.3 and 6 transducer #64, with [0083] tubular piezoelectric transducer and [0090] with multi-sectors and wherein Fig.7B [0093]-[0094] shows one embodiment of a single transducer with notches 130 with each sector 140, 142 and 144 activated separately but not mechanically separated or divided) in communication with the catheter (Fig.6 #64 at the tip of the catheter), wherein the at least one multi-sectored transducer not mechanically subdivided [...is electrically coupled to a power source and...] produces energy that is electrically subdivided within the single tubular transducer into a plurality of angular transducer energy zones defined radially and longitudinally ([0090]-[0095] and Fig.7B angular sectors from 60 to 180 degrees individually wired with Diederich teaching also the multi-element transducer alone or stacked longitudinally (Figs. 12A-C) with the energy zones mostly directional as radially oriented but presenting also a longitudinal component due to the natural heat conduction of the matter (Figs.12A-C). Therefore, teaching also “energy that is electrically subdivided into a plurality of angular transducer energy zones extending radially and longitudinally from the multi-sectored transducer” regarding the direction of the propagation of the thermal energy);; wherein each sector of the multi-sectored transducer within the single tubular transducer is independently operable, a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone (“[0094] As shown in FIG. 7B, section 142 is configured to emit a 120.degree. distribution beam. Each segment may be operated independently and/or concurrently, and adjusted according to different levels (e.g. power from 0 to max, frequency, and emission time) for desired coagulation or distribution”) wherein the transducer in Fig.7B is a 120° three-sectored transducer for ablation with each sector being independently activated with independent power at independent frequency for independent time of activation, and [0090]-[0095]) and a cooling system ([0026], [0081] Fig.6),) with the coolant configured to acoustically couple the at least one transducer to a tissue ([0110], [0125] coolant is water and “to couple the ultrasound energy to the tissue”).
Additionally, Keidar teaches within the same field of endeavor of catheter with ultrasonic probe to thermal treatment of tissue (Title and abstract) that it is common knowledge to design and use in the art of ablation of tissue a tubular transducer as a sectorized single unit (Fig.2 and col.12 3rd ¶ “the ablation element 120 located circumferentially about an axial centerline” or transducer 120) with the same structure that that of Diederich (Fig. 3C and col.13 4th ¶ with the notching grooves and an internal electrode 302 external electrodes 304 around the single piece of tubular piezo-electric transducer 303 that electrically separate each sector with “By controlling the driving power and operating frequency to each individual sector, the ultrasonic driver 340 can enhance the uniformity of the acoustic energy beam around the transducer 300, as well as can vary the degree of heating (i.e., lesion control) in the angular dimension”) therefore describing wherein the at least one multi-sectored transducer not mechanically subdivided is electrically coupled to a power source and produces energy that is electrically subdivided into a plurality of angular transducer energy zones extending radially from the at least multi-sectored transducer to the target treatment region wherein each sector of the multi-sectored transducer is independently operable as claimed in claim 22. Additionally, Azhari teaches the use of the same ultrasound transducer for high intensity focused ultrasound and for low intensity focused ultrasound ([0065]-[0066]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle such that the method comprises: the catheter having at least one multi-sectored transducer, the multi-sectored transducer is a single tubular transducer such that the multi-sectored transducer is not mechanically subdivided, wherein the at least one multi-sectored transducer produces energy that is electrically subdivided within the single tubular transducer into a plurality of angular transducer energy zones defined radially and longitudinally from the multi-sectored transducer; acoustically couple the at least one multi-sectored transducer to a tissue and wherein each of the plurality of angular transducer energy zones is independently operable within the single tubular transducer, a first frequency and/or power of ultrasound energy delivered to a first angular transducer energy zone different than a second frequency and/or power of ultrasound energy delivered to a second angular transducer energy zone, since one of ordinary skill in the art would recognize that using a single tubular ultrasonic transducer with multiple sectors not mechanically subdivided independently controlled emitting radially from the catheter longitudinal axis was routine and conventional in the art, as taught by Diederich, and since each sector of the not mechanically subdivided transducer is known in the art to be configured to be electrically separated for activation for emitting sectored ultrasonic heat treatment as taught by Keidar and since water was known in the art to be a commonly used coupling liquid for ultrasonic transducer for medical application as taught by Diederich. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since while Diederich uses the transducer for high intensity focused ultrasound and Keidar teaches similar prior art with electrically subdivided transducer and Ingle uses the transducer for low intensity focused ultrasound, Azhari teaching the same transducer being used for high and low intensity focused ultrasounds. The motivation would have been to improve the control of the treatment for wide region of interest to be treated, as suggested by Diederich ([0088]-[0089]).
Ingle, Diederich, Keidar and Azhari do not specifically teach positioning the catheter by inflating the anchor balloon within a bladder, the anchor balloon to provide cooling to the bladder and nearby tissue, stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter and disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose as in claim 22.
However, Cioanta teaches within the same field of endeavor of thermal ablation of tissue such as prostate tissue surrounding the patient’s urethra (Title, abstract and Figs.1-3 and col.2 2nd ¶) the known design of an anchoring balloon inflated within the patient’s bladder (Fig.2A col.2 3rd ¶ “bladder anchoring balloon 22” and “through the urethra 5, the anchoring balloon 22 is inflated via a fluid (or other inflation media) introduced through the shaft 25 to the distal portion of the catheter 20 to cause the anchoring balloon 22 to take on an expanded configuration and reside against the bladder neck 12a of the subject (FIG. 1). Thus, when expanded, the anchoring balloon 22 is adapted to position the treatment balloon 23 in the prostate relative to the bladder 12. When deflated, the catheter 20, including the anchoring and treatment balloons 22, 23, can be removed from the urethra 5 of the subject” which clearly describes “inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position”) placed distally from the thermal treatment zone of the catheter within the urethra (Fig.2A col.2 3rd ¶ “catheter 20” with a treatment balloon 23 proximate to the desired treatment site). Additionally, Lacoste teaches within the same field of endeavor of urethral catheter (Title and abstract) the design of the anchoring balloon within the patient bladder with a cooling fluid in order to protect thermally the bladder and the sphincter ([0052]) therefore with Cioanta and Lacoste teaching positioning the catheter by inflating the anchor balloon within a bladder, the anchor balloon to provide cooling to the bladder and nearby tissue, as claimed.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari and Mathew such that the method comprises the step: positioning the catheter by inflating the anchor balloon within a bladder, the anchor balloon to provide cooling to the bladder and nearby tissue since one of ordinary skill in the art would recognize that providing and inflating a bladder anchoring balloon to settle the treatment catheter region within the urethra to treat tissue along the urethra of the patient was routine and conventional in the art, as taught by Cioanta since the anchoring balloon was also known to be cooled as taught by Lacoste and since thermal ablation using multi-sectored transducers was also known in the art as taught by Diederich. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Ingle, Diederich and Cioanta teach the use of ultrasonic transducers for thermal ablation and Cioanta and Lacoste both teach the use of anchoring balloon within the patient bladder. The motivation would have been to stabilize the treating region of the catheter to target the right region surrounding the urethra, as suggested by Cioanta (Fig. 2A) and protect the bladder and surrounding tissue, as suggested by Lacoste ([0052]).
Ingle, Diederich, Keidar, Azhari, Cioanta and Lacoste, do not specifically teach stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter and disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose as in claim 22.
Diederich teaches also a plurality of multi-sectored transducers in communication with the catheter ([0124]-[0125]), and the plurality of multi-sectored transducers are stacked (Fig.6 #64) to provide differential control along a length of the catheter ([0125]-[0128] and Fig.19 for monitoring the thermal control) reading on stacking the at least one multi-sectored transducer [...end-to-end...] to provide differential control along a length of the catheter.
Additionally, Mathew teaches the design of the cylindrical array transducer as placed side by side that the cylindrical array transducer is a stacked of transducer elements as considered as transducer set placed end-to-end (Fig. 2-1) along the longitudinal axis and therefore configured to perform the same function than the stacking of transducers along that axis as the configuration of Diederich transducer set without the spacing of Diederich.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modifies by Diederich, Keidar, Azhari, Cioanta, Lacoste such that the method comprises: stacking the at least one multi-sectored transducer end-to-end to provide differential control along a length of the catheter, since one of ordinary skill in the art would recognize that using several ultrasonic transducers with multiple sector independently controlled emitting radially from the catheter longitudinal axis placed along the axis of the catheter to transmit ultrasonic energy along a predetermined length of the catheter was routine and conventional in the art, as taught by Diederich and placing transducer arrays end-to-end to perform the same function would have been merely an engineering design consideration as taught by Mathew. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Diederich uses the transducer for high intensity focused ultrasound and Ingle uses the transducer for low intensity focused ultrasound, Azhari teaches the same transducer being used for high and low intensity focused ultrasounds. The motivation would have been to improve the control of the treatment for wide region of interest to be treated, as suggested by Diederich ([0088]-[0089]).
Ingle, Diederich, Keidar, Azhari, Cioanta, Lacoste and Matthew do not specifically teach disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose as in claim 22.
However, Prakash teaches within the same field of endeavor of performing interstitial and transurethral catheter-based ultrasound treatment/ablation of tissue surrounding the urethra (Title, abstract and catheter in Fig. 1a) the use of a urethral cooling balloon (Fig. 1a) disposed about the at least one multi-sectored transducer with an inlet and outlet for the cooling fluid to circulated therefore allowing its use with the cooling system of Inge invention discussed above, therefore teaching disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system as claimed.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari Cioanta, Lacoste and Matthew such that the method comprises the step: disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system, since one of ordinary skill in the art would recognize that using a cooling balloon in communication with the transducer was routine and conventional in the art, as taught by Prakash. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since while Prakash uses the transducer for high intensity focused ultrasound and Ingle uses the transducer for low intensity focused ultrasound for similar purposes, Azhari teaches the same transducer being used for high and low intensity focused ultrasounds. The motivation would have been to allow the setting of the ultrasound transducer at a fixed centered position within the urethra of the patient for using a higher cooling mass for cooling the ultrasound transducer elements and better control of the rotating transducer and easy repeatable modeling of the heating pattern especially for patient-specific modeling, planning, as suggested by Prakash (Fig. 1a and p. 398 ¶ Conclusion).
Additionally, Prakash teaches the patient-specific thermal distribution and thermal dose modelling for the use of the catheter with a cooling balloon for properly monitoring the thermal treatment (abstract and Introduction and conclusion) with the use of MRI for thermal imaging of the treated tissue to lead to optimum patient-specific treatments.
Ingle, Diederich, Keidar, Azhari, Cioanta, Lacoste, Matthew and Prakash do not specifically teach including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose as in claim 22.
However, Butty teaches within the same field of endeavor of performing catheter based treatment/ablation of tissue (Title and abstract) the use of a plurality of thermocouples slidably mounted in the catheter and insertable within a given depth within the tissue surrounding the catheter to access to the temperature distribution within this tissue for controlling the amount of energy or thermal dose supplied during the treatment ([0019]) while Sterzer teaches within the same field of endeavor the placement of one thermocouple close to the cooled urethra wall to monitor the temperature profile of the urethra wall (p.1887 col.2 3rd ¶ and thermal probes specifically placed for Fig. 3 with curve 4) therefore, since the catheter is already placed within the urethra with the taught balloon according to Ingle, Diederich, Keidar, Azhari, Cioanta, Matthew and Prakash, teaching including a first thermal sensor to monitor the temperature profile of an urethra wall and calculate thermal dose as claimed.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari, Matthew, Cioanta, Lacoste and Prakash such that the method comprises the step: including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose since one of ordinary skill in the art would recognize that using thermocouples slidably mounted in the catheter and insertable within the targeted tissue when deployed for monitoring the ablation treatment was routine and conventional in the art, as taught by Butty with in particular accessing the temperature profile of the urethra wall during the treatment as taught by Sterzer. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since both Ingle and Butty teach the use of catheter-based treatments for tissue surrounding the urethra. The motivation would have been to better and cheaper controlling the amount of energy delivered to the tissue without the use of external imaging device as suggested by Butty ([0019]).
Ingle, Diederich, Keidar, Azhari and Mathew do not specifically teach inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position and provide cooling to the bladder and nearby tissue; disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose as in claim 15.
However, Cioanta teaches within the same field of endeavor of thermal ablation of tissue such as prostate tissue surrounding the patient’s urethra (Title, abstract and Figs.1-3 and col.2 2nd ¶) the known design of an anchoring balloon inflated within the patient’s bladder (Fig.2A col.2 3rd ¶ “bladder anchoring balloon 22” and “through the urethra 5, the anchoring balloon 22 is inflated via a fluid (or other inflation media) introduced through the shaft 25 to the distal portion of the catheter 20 to cause the anchoring balloon 22 to take on an expanded configuration and reside against the bladder neck 12a of the subject (FIG. 1). Thus, when expanded, the anchoring balloon 22 is adapted to position the treatment balloon 23 in the prostate relative to the bladder 12. When deflated, the catheter 20, including the anchoring and treatment balloons 22, 23, can be removed from the urethra 5 of the subject” which clearly describes “inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position”) placed distally from the thermal treatment zone of the catheter within the urethra (Fig.2A col.2 3rd ¶ “catheter 20” with a treatment balloon 23 proximate to the desired treatment site). Additionally, Lacoste teaches within the same field of endeavor of urethral catheter (Title and abstract) the design of the anchoring balloon within the patient bladder with a cooling fluid in order to protect thermally the bladder and the sphincter ([0052]) therefore with Cioanta and Lacoste teaching inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position and provide cooling to the bladder and nearby tissue, as claimed.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari and Mathew such that the method comprises the step: inflating an anchor balloon of the catheter within a bladder connected to the urethra to maintain the catheter in the mid-urethral position and provide cooling to the bladder and nearby tissue, since one of ordinary skill in the art would recognize that providing and inflating a bladder anchoring balloon to settle the treatment catheter region within the urethra to treat tissue along the urethra of the patient was routine and conventional in the art, as taught by Cioanta, since the anchoring balloon was also known to be cooled as taught by Lacoste and since thermal ablation using multi-sectored transducers was also known in the art as taught by Diederich. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Ingle, Diederich and Cioanta teach the use of ultrasonic transducers for thermal ablation and Cioanta and Lacoste both teach the use of anchoring balloon within the patient bladder. The motivation would have been to stabilize the treating region of the catheter to target the right region surrounding the urethra, as suggested by Cioanta (Fig. 2A) and protect the bladder and surrounding tissue, as suggested by Lacoste ([0052]).
Ingle, Diederich, Keidar, Azhari, Mathew, Cioanta and Lacoste do not specifically teach disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system and including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose as in claim 15.
However, Prakash teaches within the same field of endeavor of performing interstitial and transurethral catheter-based ultrasound treatment/ablation of tissue surrounding the urethra (Title, abstract and catheter in Fig. 1a) the use of a urethral cooling balloon (Fig. 1a) disposed about the at least one multi-sectored transducer with an inlet and outlet for the cooling fluid to circulated therefore allowing its use with the cooling system of Inge invention discussed above, therefore teaching disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system as claimed.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari, Cioanta and Lacoste such that the method comprises the step: disposing a cooling balloon about the at least one multi-sectored transducer, the cooling balloon in communication with the cooling system, since one of ordinary skill in the art would recognize that using a cooling balloon in communication with the transducer was routine and conventional in the art, as taught by Prakash. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since while Prakash uses the transducer for high intensity focused ultrasound and Ingle uses the transducer for low intensity focused ultrasound for similar purposes, Azhari teaches the same transducer being used for high and low intensity focused ultrasounds. The motivation would have been to allow the setting of the ultrasound transducer at a fixed centered position within the urethra of the patient for using a higher cooling mass for cooling the ultrasound transducer elements and better control of the rotating transducer and easy repeatable modeling of the heating pattern especially for patient-specific modeling, planning and , as suggested by Prakash (Fig. 1a and p. 398 ¶ Conclusion).
Additionally, Prakash teaches the patient-specific thermal distribution and thermal dose modelling for the use of the catheter with a cooling balloon for properly monitoring the thermal treatment (abstract and Introduction and conclusion) with the use of MRI for thermal imaging of the treated tissue to lead to optimum patient-specific treatments.
Ingle, Diederich, Keidar, Azhari, Matthew, Cioanta, Lacoste and Prakash do not specifically teach including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose as in claim 15.
However, Butty teaches within the same field of endeavor of performing catheter based treatment/ablation of tissue (Title and abstract) the use of a plurality of thermocouples slidably mounted in the catheter and insertable within a given depth within the tissue surrounding the catheter to access to the temperature distribution within this tissue for controlling the amount of energy or thermal dose supplied during the treatment ([0019]) while Sterzer teaches within the same field of endeavor the placement of one thermocouple close to the cooled urethra wall to monitor the temperature profile of the urethra wall (p.1887 col.2 3rd ¶ and thermal probes specifically placed for Fig. 3 with curve 4) therefore, since the catheter is already placed within the urethra with the taught balloon according to Ingle, Diederich, Keidar, Azhari, Matthew, Cioanta and Prakash, teaching including a first thermal sensor to monitor the temperature profile of an urethra wall and calculate thermal dose as claimed.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari, Matthew, Cioanta, Lacoste and Prakash such that the method comprises the step: including a first thermal sensor to monitor the temperature profile of a urethra wall and calculate thermal dose since one of ordinary skill in the art would recognize that using thermocouples slidably mounted in the catheter and insertable within the targeted tissue when deployed for monitoring the ablation treatment was routine and conventional in the art, as taught by Butty with in particular accessing the temperature profile of the urethra wall during the treatment as taught by Sterzer. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since both Ingle and Butty teach the use of catheter-based treatments for tissue surrounding the urethra. The motivation would have been to better and cheaper controlling the amount of energy delivered to the tissue without the use of external imaging device as suggested by Butty ([0019]).
Regarding the dependent claims 23-25, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Ingle, Diederich, Keidar, Azhari, Cioanta, Lacoste, Mathew, Prakash, Butty and Sterzer.
Regarding claims 23 and 24, Ingle does not specifically teach deploying a second thermal sensor to monitor a temperature in the target urethral supporting tissue structure as in claim 23, and monitoring the temperature and an ultrasound dose in the target urethral supporting tissue structure as in the dependent claim 24 from claim 23.
However, as discussed above, Butty teaches the use of a plurality of thermocouples for accessing to the temperature distribution within the treated tissue and accessing to the thermal dose for the treatment ([0019]) therefore teaching deploying a second thermal sensor in the tissue to measure the temperature in the target treatment region. Diederich teaches also the use of a deployable thermocouple ([0076] “designed to deploy into the target zone”) wherein Ingle teaches that the target zone is the EF (Fig.13 with focused heating selectively targeting EF endopelvic fascia with Fig.13A-M ultrasonic transducer as in [0143] wherein [0145] allowing translation and rotation of the ultrasound transducer 308, and [0146] to treat selected tissue at different depths by translation or by dynamic focusing the treatment) with the thermocouple providing feedback of temperature treatment ([0076] “sensor array 66 provides treatment verification and feedback so that only the desired treatment region or target zone is affected or monitoring the temperature and ultrasound dose in the target). Therefore as discussed above, Diederich and Butty teach deploying a second thermal sensor to monitor a temperature in the target urethral supporting tissue structure as in claim 23, and monitoring the temperature and an ultrasound dose in the target urethral supporting tissue structure.
Regarding claim 25, Ingle teaches the heating of the target being performed from 60°C to 80°C as previously discussed for a heat time of about 5 minutes ([0071]) and Diederich teaches the heating time of 5 to 10 minutes for creating substantial size thermal lesions ([0113]) therefore both anticipating the claimed limitation of raising the temperature of the endopelvic fascia to between 50 degrees Celsius and 75 degrees Celsius for a period of 30 seconds to 10 minutes as in claim 25.
Claims 19, 26-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al. (USPN 20030139790 A1; Pub.Date 07/04/2003; Fil.Date 01/07/2003) in view of Diederich et al. (USPN 2007/0255267 A1; Pub.Date 11/01/2007; Fil.Date 04/20/2007), Keidar (USPN 7670335 B2; Pub.Date 03/02/2010; Fil.Date 07/21/2003), Azhari et al. (USPN US 20120296240 A1; Pub.Date 11/22/2012; Fil.Date 05/20/2011), Cioanta et al. (USPN 6796960 B2; Pat.Date 09/28/2004; Fil.Date 05/01/2002), Lacoste et al. (USPN 20050085726 A1; Pub.Date 04/21/20005; Fil.Date 01/15/2004), Mathew (2011 PhD. thesis Cochin University of Science Kerela India pages 123; Pub.Date 2011), Prakash et al. (2010 AIP Conference Proceedings 1215 396–399; Pub.Date 2010), Butty et al. (USPN 20070185483 A1; Pub.Date 08/09/2007; Fil.Date 03/03/2005) and in view of Sterzer et al. (2000 IEEE Trans. Microwave Theory and Techniques 48:1885-1891; Pub.Date 2000) as applied to claims 15-18 and 22-25 and further in view of Diederich et al. (1999 IEEE Trans. Ultrason. Ferroelec. Freq. Cont. 46:1218-1228; Pub.Date 1999).
Ingle, Diederich, Keidar, Azhari, Cioanta, Lacoste, Mathew, Prakash, Butty and Sterzer teach a method as set forth above.
Ingle, Diederich, Keidar, Azhari, Cioanta, Lacoste, Mathew, Prakash, Butty and Sterzer do not specifically teach each sector of the multi-sectored transducer to produce energy in a range of 2 Watts to 10 Watts as in claims 19, 26.
However Diederich’1999 teaches within the same field of endeavor of hyperthermia treatments with sectored transducers (Title and abstract) the in vivo thermal profile for one 180° sectored transducer reaching an angular temperature profile between 50 and 75°C (Fig.7 and Fig.8) when one 180° sector of the transducer is to produce 3W or 5.5W acoustic power output (p.1226 col.1 2nd ¶) which is a similar behavior of having a two 180° sectored transducer utilizing only one of the sector to provide a specific thermal profile on the direction of the activated sector with a distribution of temperature between 50 and 75°C therefore reading on each sector of the multi-sectored transducer to produce energy in a range of 2 Watts to 10 Watts as claimed.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to have modified the method of Ingle modified by Diederich, Keidar, Azhari, Cioanta, Lacoste, Mathew, Prakash, Butty and Sterzer such that method comprises: each sector of the multi-sectored transducer to produce energy in a range of 2 Watts to 10 Watts, since one of ordinary skill in the art would recognize that powering one angular segment of the multi-sectored transducer to produce energy in a range of 2 Watts to 10 Watts in order to provide a thermal profile within 50 to 75°C in the corresponding angular sector was routine and conventional in the art, as taught by Diederich’1999. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since while Diederich and Diederich’1999 both use sectored ultrasonic transducers in vivo for hyperthermia treatments. The motivation would have been to achieve different angular heat distribution and angular level of level of coagulation or thermal treatment, as suggested by Diederich ([0094]) and Diederich (Fig.7 and Fig.8).
Regarding the dependent claim 27, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Ingle, Diederich, Keidar, Azhari, Cioanta, Lacoste, Mathew, Prakash, Butty and Sterzer and Diederich’1999.
Regarding claim 27, Ingle teaches also after a desired temperature and a desired ultrasound dose are achieved, deactivating one or more angular transducer energy zones of the at least one multi-sectored transducer ([0016] control system to energize the probe in response to the monitored temperature to reach maximum temperature and [0082] maximum power delivered) as in claim 27.
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 PATRICK M MEHL whose telephone number is (571)272-0572. The examiner can normally be reached Monday-Friday 9AM-6PM.
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/PATRICK M MEHL/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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