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 .
Response to Amendment
The proposed reply filed on 03/19/2026 has been entered. Claims 1-20 remain pending in the current application. The amendments to the claims have overcome the claims objections and 35 USC 112 rejections.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kinsey et al. (NPL: “Transurethral ultrasound applicators with dynamic multi-sector control for prostate thermal therapy: In vivo evaluation under MR guidance”, 2008).
Regarding claim 1, Kinsey teaches an ultrasound probe comprising (page 2083, left col; The transurethral heating applicators):
a shaft having a proximal end, a tip, and a length measured between the proximal end and the tip with respect to an axis (figure 1, page 2083, left col; The catheter was designed in this study to contain the applicator and provide return water cooling flow through a urethral cooling balloon. The main portion of the catheter consisted of TPX tubing 4.3 mm OD secured to a large bore, Touhy-Borst hub at the proximal end. The examiner notes that the catheter comprise a distal and proximal end as shown in figure 1);
a plurality of channels defined in the shaft and extending from the proximal end of the shaft along at least a portion of the length of the shaft, the plurality of channels including an ultrasound channel and a balloon channel (figure 1, page 2083, left col; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. The examiner notes that the catheter comprise an inner tube for water flow for inflating the balloon and an outer tube that surrounds the inner tube and houses the transducer. Thus, the shaft comprise two tubes/channels that extend along at least portion of the length of the catheter, one for ultrasound transducers and one for balloon. );
one or more ultrasound transducers disposed in the ultrasound channel (figure 1, page 2083, left col; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. The examiner notes that the ultrasound applicator comprise two transducers disposed inside of an outer tube.); and
an offset balloon attached to a distal portion of the shaft and disposed at a predetermined distance from the one or more ultrasound transducer(s), the offset balloon fluidly coupled to the balloon channel to receive or withdraw a fluid to adjust an inflation state of the offset balloon, the offset balloon having a deflated state and an inflated state (figure 1, pages 2083-0248; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that the bladder balloon is positioned at a distance from the distal end of the transducer and is connected to a filling system for providing fluids to inflate the balloon after placement of the device and deflate it for removal of the device.);
wherein:
in the inflated state the offset balloon has an inflated size that is larger than a target anatomical opening such that an inflated offset balloon is configured to mechanically engage the target anatomical opening when the shaft is retracted with respect to the target anatomical opening (page 2084, right col; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that the catheter is retracted with respect to the bladder neck until the inflated balloon is firmly engaged with the bladder neck), and
the one or more ultrasound transducer(s) is/are aligned with respect to a target volume when the inflated offset balloon mechanically engages the target anatomical opening (figure 2, pages 2084-2085; the transducer assembly was rotated and translated within the catheter for positioning in relation to the predetermined target region. The examiner notes one positioning the catheter inside the target region by inflating the bladder placement balloon and firmly positioning it in the bladder neck the transducers are rotated for aligning the transducer with the target region, see figure 2.).
Regarding claim 4, Kinsey teaches the ultrasound probe of claim 1, wherein the offset balloon is attached to a distal end of the shaft (page 2083; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip.).
Regarding claim 19, Kinsey teaches a method for performing thermal therapy, comprising (page 2083, left col; The transurethral heating applicators):
inserting a distal portion of a shaft of an ultrasound probe into a target anatomical opening, the shaft having a proximal end, a tip, and a length measured between the proximal end and the tip with respect to an axis, the ultrasound probe further comprising (figure 1, pages 2083-2084; The catheter was designed in this study to contain the applicator and provide return water cooling flow through a urethral cooling balloon. The main portion of the catheter consisted of TPX tubing 4.3 mm OD secured to a large bore, Touhy-Borst hub at the proximal end. The distal portion of the catheter consisted of a PET urethral cooling balloon 10 mm OD, 40 mm length, Advanced Polymers secured to a PEBAX tip 4 mm OD, Danforth Biomedical, Santa Clara, CA. A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. A 20 French introducer sheath was inserted into the urethra. The animals were positioned supine, headfirst into the 0.5 T interventional scanner, and the bottom part of the abdomen was secured to minimize movement due to breathing. The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that the catheter comprise a distal and proximal end as shown in figure 1 which is inserted into an anatomical target opening.):
a plurality of channels defined in the shaft and extending from the proximal end of the shaft along at least a portion of the length of the shaft, the plurality of channels including an ultrasound channel and a balloon channel (figure 1, page 2083, left col; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. The examiner notes that the catheter comprise an inner tube for water flow for inflating the balloon and an outer tube that surrounds the inner tube and houses the transducer. Thus, the shaft comprise two tubes/channels that extend along at least portion of the length of the catheter, one for ultrasound transducers and one for balloon. );
one or more ultrasound transducers disposed in the ultrasound channel (figure 1, page 2083, left col; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. The examiner notes that the ultrasound applicator comprise two transducers disposed inside of an outer tube.); and
an offset balloon attached to the distal portion of the shaft, the offset balloon fluidly coupled to the balloon channel to receive or withdraw a fluid to adjust an inflation state of the offset balloon, the offset balloon in a deflated state (figure 1, pages 2083-0248; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that the bladder balloon is positioned at a distance from the distal end of the transducer and is connected to a filling system for providing fluids to inflate the balloon after placement of the device and deflate it for removal of the device.);
inflating the offset balloon while the distal portion of the shaft, including the offset balloon, is disposed in the target anatomical opening (page 2084; Due to differences between human and canine anatomy, an urethrostomy was performed to access the urethra, and a 20 French introducer sheath was inserted into the urethra. The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution.);
retracting the shaft until the offset balloon mechanically engages the target anatomical opening, the offset balloon in the inflated state and having an inflated size that is larger than the target anatomical opening, the one or more ultrasound transducer(s) disposed at a predetermined distance from the offset balloon (figure 1, page 2084; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner note that the transducer is disposed proximal to the bladder balloon as shown in figure 1. Further, the catheter is retracted with respect to the bladder neck until the inflated balloon is firmly engaged with the bladder neck);
aligning the one or more ultrasound transducer(s) with respect to a target volume (figure 2, pages 2084-2085; the transducer assembly was rotated and translated within the catheter for positioning in relation to the predetermined target region. The examiner notes one positioning the catheter inside the target region by inflating the bladder placement balloon and firmly positioning it in the bladder neck the transducers are rotated for aligning the transducer with the target region, see figure 2.); and
applying ultrasound energy, with the one or more ultrasound transducer(s), to the target volume while the one or more ultrasound transducer(s) are aligned with the target volume (pages 2085-2086; RF power was applied to the applicator by two custom, fourchannel RF amplifiers Advanced Surgical Systems, Tucson, AZ located outside the suite. Coaxial cables from the amplifier were connected to the applicator through a shielded access panel.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kinsey et al. (NPL: “Transurethral ultrasound applicators with dynamic multi-sector control for prostate thermal therapy: In vivo evaluation under MR guidance”, 2008) in the view of Kalorin et al. (US 2021/0113819).
Regarding claim 2, Kinsey teaches the ultrasound probe of claim 1, however, fails to explicitly teach a coating on the offset balloon.
Kalorin, in the same field of endeavor, teaches a coating on the offset balloon (para. 0115; a system 401 having a specially modified Foley-type catheter 410 and a medicament-delivery coating 420 on the balloon portion 412. catheter 410 has an inflatable and deflatable balloon section 412 configured to keep the catheter in place by inflating the balloon section 412 via lumen 413 and input port 403 with a fluid (such as saline, carbon dioxide gas or nitrogen gas) once the appropriate length of catheter 410 is inserted through the urethra of the patient so that the balloon section 412 is at the point of bleeding of the patient. The outer surface of balloon section 412 is coated with a medicament 415, such as a hemostatic agent, that is activated by the expansion of the balloon in the urethra or bladder.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the bladder placement balloon of Kinsey with the medicament coated balloon of Kalorin to provide an offset balloon coated with medication. Doing so would avoid the need for a medicament injection sheath, since the medicament is on the balloon section as disclosed within Kalorin in para. 0115.
Regarding claim 3, Kinsey teaches the ultrasound probe of claim 2, however, fails to explicitly teach wherein the coating comprises a medication, an antibacterial agent, and/or a lubricant.
Kalorin, in the same field of endeavor, teaches wherein the coating comprises a medication, an antibacterial agent, and/or a lubricant (para. 0115; a system 401 having a specially modified Foley-type catheter 410 and a medicament-delivery coating 420 on the balloon portion 412. catheter 410 has an inflatable and deflatable balloon section 412 configured to keep the catheter in place by inflating the balloon section 412 via lumen 413 and input port 403 with a fluid (such as saline, carbon dioxide gas or nitrogen gas) once the appropriate length of catheter 410 is inserted through the urethra of the patient so that the balloon section 412 is at the point of bleeding of the patient. The outer surface of balloon section 412 is coated with a medicament 415, such as a hemostatic agent, that is activated by the expansion of the balloon in the urethra or bladder.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the bladder placement balloon of Kinsey with the medicament coated balloon of Kalorin to provide an offset balloon coated with medication. Doing so would avoid the need for a medicament injection sheath, since the medicament is on the balloon section as disclosed within Kalorin in para. 0115.
Regarding claim 15, Kinsey teaches the ultrasound probe of claim 14, however, fails to explicitly teach a coating on the offset balloon.
Kalorin, in the same field of endeavor, teaches a coating on the offset balloon (para. 0115; a system 401 having a specially modified Foley-type catheter 410 and a medicament-delivery coating 420 on the balloon portion 412. catheter 410 has an inflatable and deflatable balloon section 412 configured to keep the catheter in place by inflating the balloon section 412 via lumen 413 and input port 403 with a fluid (such as saline, carbon dioxide gas or nitrogen gas) once the appropriate length of catheter 410 is inserted through the urethra of the patient so that the balloon section 412 is at the point of bleeding of the patient. The outer surface of balloon section 412 is coated with a medicament 415, such as a hemostatic agent, that is activated by the expansion of the balloon in the urethra or bladder.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the bladder placement balloon of Kinsey with the medicament coated balloon of Kalorin to provide an offset balloon coated with medication. Doing so would avoid the need for a medicament injection sheath, since the medicament is on the balloon section as disclosed within Kalorin in para. 0115.
Regarding claim 16, Kinsey teaches the ultrasound probe of claim 15, however, fails to explicitly teach wherein the coating comprises a medication, an antibacterial agent, and/or a lubricant.
Kalorin, in the same field of endeavor, teaches wherein the coating comprises a medication, an antibacterial agent, and/or a lubricant (para. 0115; a system 401 having a specially modified Foley-type catheter 410 and a medicament-delivery coating 420 on the balloon portion 412. catheter 410 has an inflatable and deflatable balloon section 412 configured to keep the catheter in place by inflating the balloon section 412 via lumen 413 and input port 403 with a fluid (such as saline, carbon dioxide gas or nitrogen gas) once the appropriate length of catheter 410 is inserted through the urethra of the patient so that the balloon section 412 is at the point of bleeding of the patient. The outer surface of balloon section 412 is coated with a medicament 415, such as a hemostatic agent, that is activated by the expansion of the balloon in the urethra or bladder.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the bladder placement balloon of Kinsey with the medicament coated balloon of Kalorin to provide an offset balloon coated with medication. Doing so would avoid the need for a medicament injection sheath, since the medicament is on the balloon section as disclosed within Kalorin in para. 0115.
Claim(s) 5, 14, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kinsey et al. (NPL: “Transurethral ultrasound applicators with dynamic multi-sector control for prostate thermal therapy: In vivo evaluation under MR guidance”, 2008) in the view of Mccaffrey et al. (US 2015/0112234).
Regarding claim 5, Kinsey teaches the ultrasound probe of claim 1, wherein:
the offset balloon is a first offset balloon (figure 1, page 2083; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip.),
the balloon channel is a first balloon channel (figure 1, page 2083; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip.),
the predetermined distance is a first predetermined distance (figure 1, page 2083; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. The examiner notes that the transducers are placed at a distance proximally from the balloon as shown in figure 1),
the fluid is a first fluid (page 2084; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck.), and
the balloon in the inflated state having a size that is larger than the target anatomical opening (page 2084; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that when the balloon is inflated and the applicator is retracted the size of the inflated balloon enables a firm fitting of the device within the bladder neck.),
whereby an alignment with respect to the target volume can be adjusted by transitioning the first offset balloon to the inflated state (page 2084; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that when the balloon is inflated and the applicator is retracted the size of the inflated balloon enables a firm fitting of the device within the bladder neck.).
however, Kinsey fails to explicitly teach the plurality of channels includes a second balloon channel, the ultrasound probe further comprises a second offset balloon attached to the distal portion of the shaft and disposed at a second predetermined distance from the one or more ultrasound transducer(s), the second offset balloon fluidly coupled to the second balloon channel to receive or withdraw a second fluid to adjust the inflation state of the second offset balloon, the second offset balloon having the deflated state and the inflated state.
Mccaffrey, in the same field of endeavor, teaches the plurality of channels includes a second balloon channel (para. 0050; The shaft 116 can include inflation openings (not shown) for each balloon of the balloon assembly 106. The balloons can be laser-bonded or adhered by other suitable methods to an outer surface of the shaft 116 at radially spaced apart locations about the shaft 116. As best seen in the cross-sectional end view of the shaft 116 shown in FIG. 2D, individual inflation openings can connect to inflation lumens 214, 216 that extend proximally along the shaft 116 from the first and second balloon 206, 208 inflation openings, respectively, to the handle 112 (FIG. 1).), the ultrasound probe further comprises a second offset balloon attached to the distal portion of the shaft and disposed at a second predetermined distance from the one or more ultrasound transducer(s), the second offset balloon fluidly coupled to the second balloon channel to receive or withdraw a second fluid to adjust the inflation state of the second offset balloon, the second offset balloon having the deflated state and the inflated state (paras. 0050 and 0056-0057; The shaft 116 can include inflation openings (not shown) for each balloon of the balloon assembly 106. The balloons can be laser-bonded or adhered by other suitable methods to an outer surface of the shaft 116 at radially spaced apart locations about the shaft 116. As best seen in the cross-sectional end view of the shaft 116 shown in FIG. 2D, individual inflation openings can connect to inflation lumens 214, 216 that extend proximally along the shaft 116 from the first and second balloon 206, 208 inflation openings, respectively, to the handle 112 (FIG. 1). A distal portion 418 of a therapeutic assembly having a first balloon assembly 450 and a second balloon assembly 460 configured in accordance with embodiments of the present technology. In some embodiments, the first and second balloon assemblies 450, 460 may both be positioned distal and/or proximal to the therapeutic assembly 404. In other embodiments, the first balloon assembly 450 and the second balloon assembly 460 can be circumferentially offset by more or less than 90 degrees such that expanding the first balloon 452, first balloon 462, second balloon 454 and/or second balloon 464 to different volumes selectively repositions the transducer 404 within the vessel. In one embodiment, the first balloon assembly 450 and the second balloon assembly 460 are not offset and are substantially aligned. The examiner notes that the catheter comprises a shaft with a first and second balloons that are positioned at a distance distally to the ultrasound transducer and they are aligned and inflated to different sized to facilitate positioning of the transducer within the anatomical target.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Mccaffrey to include a second offset balloon fluidly connected to a second balloon channel positioned at a distance from the transducer. Doing so would ensure accurate positioning of the ultrasound transducer relative to the target anatomy. Controlling the inflation volumes of each balloon separately by providing different amounts of inflation fluids using separate inflation channels would allow precisely positioning of the transducer relative to the treatment volume and prevent other areas from thermal damage as disclosed within Mccaffrey in paras. 0054 and 0057.
Regarding claim 14, Kinsey teaches an ultrasound probe comprising (page 2083, left col; The transurethral heating applicators):
a shaft having a proximal end, a tip, and a length measured between the proximal end and the tip with respect to an axis (figure 1, page 2083, left col; The catheter was designed in this study to contain the applicator and provide return water cooling flow through a urethral cooling balloon. The main portion of the catheter consisted of TPX tubing 4.3 mm OD secured to a large bore, Touhy-Borst hub at the proximal end. The examiner notes that the catheter comprise a distal and proximal end as shown in figure 1);
a plurality of channels defined in the shaft and extending from the proximal end of the shaft along at least a portion of the length of the shaft, the plurality of channels including an ultrasound channel and a balloon channel (figure 1, page 2083, left col; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. The examiner notes that the catheter comprise an inner tube for water flow for inflating the balloon and an outer tube that surrounds the inner tube and houses the transducer. Thus, the shaft comprise two tubes/channels that extend along at least portion of the length of the catheter, one for ultrasound transducers and one for balloon. );
one or more ultrasound transducers disposed in the ultrasound channel (figure 1, page 2083, left col; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. The examiner notes that the ultrasound applicator comprise two transducers disposed inside of an outer tube.); and
an offset balloon attached to a portion of the shaft and disposed at a predetermined distance from the one or more ultrasound transducer(s), the offset balloon fluidly coupled to the balloon channel to receive or withdraw a fluid to adjust an inflation state of the offset balloon, the offset balloon having a deflated state and an inflated state (figure 1, pages 2083-0248; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that the bladder balloon is positioned at a distance from the distal end of the transducer and is connected to a filling system for providing fluids to inflate the balloon after placement of the device and deflate it for removal of the device.);
wherein:
in the inflated state the offset balloon has an inflated size that is larger than a target anatomical opening such that an inflated offset balloon is configured to mechanically engage the target anatomical opening when the shaft is retracted with respect to the target anatomical opening (page 2084, right col; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The examiner notes that the catheter is retracted with respect to the bladder neck until the inflated balloon is firmly engaged with the bladder neck), and
the one or more ultrasound transducer(s) is/are aligned with respect to a target volume when the inflated offset balloon mechanically engages the target anatomical opening (figure 2, pages 2084-2085; the transducer assembly was rotated and translated within the catheter for positioning in relation to the predetermined target region. The examiner notes one positioning the catheter inside the target region by inflating the bladder placement balloon and firmly positioning it in the bladder neck the transducers are rotated for aligning the transducer with the target region, see figure 2.).
However, Kinsey fails to explicitly teach an offset balloon attached to a middle portion of the shaft.
Mccaffrey, in the same field of endeavor, teaches an offset balloon attached to a middle portion of the shaft (figure 2A, para. 0047; the balloon assembly 106 is positioned at a location along the elongated shaft 116 proximal to the therapeutic assembly 104.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the location of the offset balloon of Kinsey to incorporate the teaching of Mccaffrey to include an offset balloon attached to a middle portion of the shaft. Doing so would allow more distal shaft length to enter the target anatomy to deliver fluids through the tip or guidewires, thus it would free more distal shaft length for fluid delivery or instrumentation as disclosed within Mccaffrey in para. 0047.
Regarding claim 17, Kinsey teaches the ultrasound probe of claim 14, wherein:
the offset balloon is a first offset balloon (figure 1, page 2083; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip.),
the balloon channel is a first balloon channel (figure 1, page 2083; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip.),
the predetermined distance is a first predetermined distance (figure 1, page 2083; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. The examiner notes that the transducers are placed at a distance proximally from the balloon as shown in figure 1),
the fluid is a first fluid (page 2084; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck.).
however, Kinsey fails to explicitly teach the plurality of channels includes a second balloon channel, the ultrasound probe further comprises a second offset balloon attached to the distal portion of the shaft and disposed at a second predetermined distance from the one or more ultrasound transducer(s), the second offset balloon fluidly coupled to the second balloon channel to receive or withdraw a second fluid to adjust the inflation state of the second offset balloon, the second offset balloon having the deflated state and the inflated state.
Mccaffrey, in the same field of endeavor, teaches the plurality of channels includes a second balloon channel (para. 0050; The shaft 116 can include inflation openings (not shown) for each balloon of the balloon assembly 106. The balloons can be laser-bonded or adhered by other suitable methods to an outer surface of the shaft 116 at radially spaced apart locations about the shaft 116. As best seen in the cross-sectional end view of the shaft 116 shown in FIG. 2D, individual inflation openings can connect to inflation lumens 214, 216 that extend proximally along the shaft 116 from the first and second balloon 206, 208 inflation openings, respectively, to the handle 112 (FIG. 1).), the ultrasound probe further comprises a second offset balloon attached to the distal portion of the shaft and disposed at a second predetermined distance from the one or more ultrasound transducer(s), the second offset balloon fluidly coupled to the second balloon channel to receive or withdraw a second fluid to adjust the inflation state of the second offset balloon, the second offset balloon having the deflated state and the inflated state (paras. 0050 and 0056-0057; The shaft 116 can include inflation openings (not shown) for each balloon of the balloon assembly 106. The balloons can be laser-bonded or adhered by other suitable methods to an outer surface of the shaft 116 at radially spaced apart locations about the shaft 116. As best seen in the cross-sectional end view of the shaft 116 shown in FIG. 2D, individual inflation openings can connect to inflation lumens 214, 216 that extend proximally along the shaft 116 from the first and second balloon 206, 208 inflation openings, respectively, to the handle 112 (FIG. 1). A distal portion 418 of a therapeutic assembly having a first balloon assembly 450 and a second balloon assembly 460 configured in accordance with embodiments of the present technology. In some embodiments, the first and second balloon assemblies 450, 460 may both be positioned distal and/or proximal to the therapeutic assembly 404. In other embodiments, the first balloon assembly 450 and the second balloon assembly 460 can be circumferentially offset by more or less than 90 degrees such that expanding the first balloon 452, first balloon 462, second balloon 454 and/or second balloon 464 to different volumes selectively repositions the transducer 404 within the vessel. In one embodiment, the first balloon assembly 450 and the second balloon assembly 460 are not offset and are substantially aligned. The examiner notes that the catheter comprises a shaft with a first and second balloons that are positioned at a distance distally to the ultrasound transducer and they are aligned and inflated to different sized to facilitate positioning of the transducer within the anatomical target.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Mccaffrey to include a second offset balloon fluidly connected to a second balloon channel positioned at a distance from the transducer. Doing so would ensure accurate positioning of the ultrasound transducer relative to the target anatomy. Controlling the inflation volumes of each balloon separately by providing different amounts of inflation fluids using separate inflation channels would allow precisely positioning of the transducer relative to the treatment volume and prevent other areas from thermal damage as disclosed within Mccaffrey in paras. 0054 and 0057.
Regarding claim 20, Kinsey teaches the method of claim 19, wherein:
the offset balloon is a first offset balloon (figure 1, page 2083; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip.),
the balloon channel is a first balloon channel (figure 1, page 2083; A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip.),
the predetermined distance is a first predetermined distance (figure 1, page 2083; To construct an applicator, the two transducers were aligned with the same orientation and mounted onto an inner polyimide tubing with a silicone adhesive NuSil, Carpinteria, CA. The lumen of this inner tubing would also provide input of water flow cooling to the delivery catheter and urethral cooling balloon described later. The outer surface of the transducer assembly was coated with a thin layer of mineral oil and covered with thin-walled 0.025 mm PET polyester tubing Advanced Polymers, Salem, NH. Another polyimide tube was placed over the inner polyimide lumen to protect the lead wires from damage and applicator cooling flow. A polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. The examiner notes that the transducers are placed at a distance proximally from the balloon as shown in figure 1),
the fluid is a first fluid (page 2084; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck.), and
the method further comprises:
retracting the shaft until the offset balloon mechanically engages the target anatomical opening, the offset balloon in the inflated state and having an inflated size that is larger than the target anatomical opening, the one or more ultrasound transducer(s) disposed at a predetermined distance from the offset balloon, wherein the ultrasound transducer(s) is/are aligned with respect to the target volume (pages 2084-2085; The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. the transducer assembly was rotated and translated within the catheter for positioning in relation to the predetermined target region. The examiner notes that the applicator is inserted into the anatomical opening, then the bladder balloon is inflated to a size larger than the anatomical opening, after the applicator is retracted to firmly anchor the balloon to the anatomical opening; finally, the transducer is rotated for alignment with the target.).
however, Kinsey fails to explicitly teach the plurality of channels includes a second balloon channel, the ultrasound probe further comprises a second offset balloon attached to the distal portion of the shaft and disposed at a second predetermined distance from the one or more ultrasound transducer(s), inflating a second offset balloon attached to the distal portion of the shaft, the second offset balloon fluidly coupled to the second balloon channel to receive or withdraw a second fluid to adjust the inflation state of the second offset balloon.
Mccaffrey, in the same field of endeavor, teaches the plurality of channels includes a second balloon channel (para. 0050; The shaft 116 can include inflation openings (not shown) for each balloon of the balloon assembly 106. The balloons can be laser-bonded or adhered by other suitable methods to an outer surface of the shaft 116 at radially spaced apart locations about the shaft 116. As best seen in the cross-sectional end view of the shaft 116 shown in FIG. 2D, individual inflation openings can connect to inflation lumens 214, 216 that extend proximally along the shaft 116 from the first and second balloon 206, 208 inflation openings, respectively, to the handle 112 (FIG. 1).), the ultrasound probe further comprises a second offset balloon attached to the distal portion of the shaft and disposed at a second predetermined distance from the one or more ultrasound transducer(s), inflating a second offset balloon attached to the distal portion of the shaft, the second offset balloon fluidly coupled to the second balloon channel to receive or withdraw a second fluid to adjust the inflation state of the second offset balloon (paras. 0050, 0054, 0056-0057, 0062, and 0065; The shaft 116 can include inflation openings (not shown) for each balloon of the balloon assembly 106. The balloons can be laser-bonded or adhered by other suitable methods to an outer surface of the shaft 116 at radially spaced apart locations about the shaft 116. As best seen in the cross-sectional end view of the shaft 116 shown in FIG. 2D, individual inflation openings can connect to inflation lumens 214, 216 that extend proximally along the shaft 116 from the first and second balloon 206, 208 inflation openings, respectively, to the handle 112 (FIG. 1). A distal portion 418 of a therapeutic assembly having a first balloon assembly 450 and a second balloon assembly 460 configured in accordance with embodiments of the present technology. In some embodiments, the first and second balloon assemblies 450, 460 may both be positioned distal and/or proximal to the therapeutic assembly 404. In other embodiments, the first balloon assembly 450 and the second balloon assembly 460 can be circumferentially offset by more or less than 90 degrees such that expanding the first balloon 452, first balloon 462, second balloon 454 and/or second balloon 464 to different volumes selectively repositions the transducer 404 within the vessel. In one embodiment, the first balloon assembly 450 and the second balloon assembly 460 are not offset and are substantially aligned. the first and/or second balloon volumes V.sub.1, V.sub.2 can be decreased so that the clinician may reposition the distal portion 118 to target previously untargeted nerves, or to adjust the approach for the same targeted nerve. The clinician may reposition the distal portion 118 by rotating the therapeutic assembly 104 about the longitudinal axis of the shaft, longitudinally moving the distal portion 118 distally or proximally relative to the vessel wall, and/or by any change in position of the therapeutic assembly 104 with respect to the vessel wall. After repositioning, the clinician may re-inflate the first and/or second balloons 206, 208 so that the focal length FL is generally equivalent to the radial distance between for the therapeutic assembly 104 to the targeted nerves N and re-activate the therapeutic assembly 104 to modulate the nerves N. The examiner notes that the catheter comprises a shaft with a first and second balloons that are positioned at a distance distally to the ultrasound transducer and they are aligned and inflated to different sized to facilitate positioning of the transducer within the anatomical target. Additionally, the balloons can be inflated or deflated separately to reposition the device.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Mccaffrey to include a second offset balloon fluidly connected to a second balloon channel positioned at a distance from the transducer. Doing so would ensure accurate positioning of the ultrasound transducer relative to the target anatomy. Controlling the inflation volumes of each balloon separately by providing different amounts of inflation fluids using separate inflation channels would allow precisely positioning of the transducer relative to the treatment volume and prevent other areas from thermal damage as disclosed within Mccaffrey in paras. 0054 and 0057.
Claim(s) 6-13 and 18 rejected under 35 U.S.C. 103 as being unpatentable over Kinsey et al. (NPL: “Transurethral ultrasound applicators with dynamic multi-sector control for prostate thermal therapy: In vivo evaluation under MR guidance”, 2008) in the view of Arevalos et al. (US 2022/0362509).
Regarding claim 6, Kinsey teaches the ultrasound probe of claim 1, however, fails to explicitly teach a handle attached to the proximal end of the shaft; and a fluid-collection ring disposed on a distal side of the handle, the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape and configured to direct a liquid away from the handle.
Arevalos, in the same field of endeavor, teaches a handle attached to the proximal end of the shaft; and a fluid-collection ring disposed on a distal side of the handle, the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape and configured to direct a liquid away from the handle (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a handle and a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 7, Kinsey teaches the ultrasound probe of claim 6, however fails to explicitly teach wherein the inner edge and the shaft define a fluid-collection channel and the ultrasound probe further comprises a fluid-collection reservoir that is fluidly coupled to the fluid-collection channel.
Arevalos, in the same field of endeavor, teaches the inner edge and the shaft define a fluid-collection channel and the medical device further comprises a fluid-collection reservoir that is fluidly coupled to the fluid-collection channel (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that connects to the shaft and runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 8, Kinsey teaches the ultrasound probe of claim 6, however fails to explicitly teach wherein a drainage hole is defined through a proximal side and the distal side of the fluid-collection ring and a drainage tube is fluidly coupled to the drainage hole on the proximal side of the fluid-collection ring.
Arevalos, in the same field of endeavor, teaches a drainage hole is defined through a proximal side and the distal side of the fluid-collection ring and a drainage tube is fluidly coupled to the drainage hole on the proximal side of the fluid-collection ring (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that connects to the shaft and runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 9, Kinsey teaches the ultrasound probe of claim 6, wherein: however, fails to explicitly teach the axis is a first axis, the fluid-collection ring is elongated with respect to a second axis compared to with respect to a third axis, and the first, second, and third axes are mutually orthogonal.
Arevalos, in the same field of endeavor, teaches the axis is a first axis, the fluid-collection ring is elongated with respect to a second axis compared to with respect to a third axis, and the first, second, and third axes are mutually orthogonal (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the funnel fluid collector is elongated with respect to a vertical axis and extends with respect to a horizontal axis.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 10, Kinsey teaches the ultrasound probe of claim 1, however fails to explicitly teach a handle attached to the proximal end of the shaft; and a fluid-collection ring disposed on a distal side of the handle, the fluid-collection ring having an inner edge, an outer edge, and a fluid-collection channel defined on a distal side of the fluid-collection ring.
Arevalos, in the same field of endeavor, teaches a handle attached to the proximal end of the shaft; and a fluid-collection ring disposed on a distal side of the handle, the fluid-collection ring having an inner edge, an outer edge, and a fluid-collection channel defined on a distal side of the fluid-collection ring (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a handle and a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 11, Kinsey teaches the ultrasound probe of claim 10, however fails to explicitly teach wherein the fluid-collection channel is defined only on a distal surface of the fluid-collection ring.
Arevalos, in the same field of endeavor, teaches the fluid-collection channel is defined only on a distal surface of the fluid-collection ring (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that connects to the shaft and runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 12, Kinsey teaches the ultrasound probe of claim 11, however, fails to explicitly teach wherein the fluid-collection channel extends to a hole defined in the outer edge of the fluid-collection ring.
Arevalos, in the same field of endeavor, teaches the fluid-collection channel extends to a hole defined in the outer edge of the fluid-collection ring (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that connects to the shaft and runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 13, Kinsey teaches the ultrasound probe of claim 12, however, fails to explicitly teach wherein the hole is oriented at a bottom of the fluid- collection channel when the shaft is oriented parallel to a horizontal axis.
Arevalos, in the same field of endeavor, teaches the hole is oriented at a bottom of the fluid- collection channel when the shaft is oriented parallel to a horizontal axis (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that connects to the shaft and runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Regarding claim 18, Kinsey teaches the ultrasound probe of claim 14, however, fails to explicitly teach a handle attached to the proximal end of the shaft; and a fluid-collection ring disposed on a distal side of the handle, the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape and configured to direct a liquid away from the handle.
Arevalos, in the same field of endeavor, teaches a handle attached to the proximal end of the shaft; and a fluid-collection ring disposed on a distal side of the handle, the fluid-collection ring having an inner edge and an outer edge, the inner edge defining a hole through which the shaft extends, a distal side of the fluid-collection ring having a concave shape and configured to direct a liquid away from the handle (para. 0268 and 0293; a bladder management system disposed only externally to the body of the user, and selectively couple to a conventional indwelling urinary catheter. Body 6820 may include (and may support and enclose) any one or more of a valve include including a body 6820 and an external controller 6830, electronics 6860, and a power source 6870. Body 6820 includes a fluid inlet 6822 at an inlet, or distal, end thereof and a fluid outlet 6824 at an outlet, or proximal, end thereof. The body 6820 has a lumen 6821 extending from the fluid inlet 6822 to the fluid outlet 6824, through which fluid (e.g., urine) from the user may pass. Urine originating from the user bladder UB may pass through the user urethra UU via a conventional indwelling urinary catheter IC (such as a Foley catheter) having a catheter outlet CO. The fluid inlet 6822 may be selectively coupled to the catheter outlet CO to receive urine therefrom. Urine (or other fluid) received at the fluid inlet 6822 may be passed through lumen 6821 and discharged directly from fluid outlet 6824 into a suitable receptacle (bag, toilet, etc.). the funnel 7801 can be configured to be physically and/or operably coupled to a separate urinary catheter (e.g., such as those described in previous embodiments herein) such that fluid from a user's bladder can be transferred into the funnel 7801. In some implementations, the funnel 7801 can include a lip 7802 or similar structure such that when fluid (e.g., urine) is introduced into the funnel 7801 the fluid is redirected towards the middle of the funnel to discourage fluid from spilling out from the funnel 7801 or splashing back to the user. Funnel 7801 is fluidically coupled to a lumen 7804 (e.g., similar to lumen 6821 or lumen 6921) that is configured to route the fluid from funnel 7801 to an outport or outlet 7903 (e.g., similar to fluid outlet 6824 or fluid outlet 6924). The examiner note the external bladder management system comprise a funnel that is coupled to a shaft of a catheter and comprise a body (handle). The proximal end of the funnel is connected to the body and comprise a lumen that runs through the body to bag to collect drained fluids.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the ultrasound applicator of Kinsey to incorporate the teaching of Arevalos to include a handle and a fluid collection ring. Doing so would prevent the fluids from spilling out from the funnel or splashing back to the user and allow drain the fluids from the patient through the catheter safely as disclosed within Arevalos in para. 0293.
Response to Arguments
Applicant's arguments filed 03/19/2026 have been fully considered but they are not persuasive. The applicant argues that Kinsey fails to disclose “an offset balloon attached to a distal portion of the shaft … where the one or more transducers is/are aligned with respect to a target volume when the inflated offset balloon mechanically engages the target anatomical opening”. The examiner respectfully disagree. Kinsey teaches a polyimide tubing lumen ran the down the center of the catheter to provide a filling system for a C-Flex urinary bladder balloon Extrusioneering, Placentia, CA that was secured to the PEBAX tip. The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The multisectored transurethral applicator being tested was inserted into the introducer sheath, which was subsequently removed. The bladder placement balloon was then filled with 8–10 ml of a 4% gadolinium solution and the applicator was gently retracted until firmly seated within the bladder neck. The endorectal imaging coil with a water cooling jacket was inserted within the rectum and positioned adjacent to the prostate. Based upon pretreatment MR images and integrated fiducial markers that marked the position of the applicator, the transducer assembly was rotated and translated within the catheter for positioning in relation to the predetermined target region. The examiner notes that the balloon is offset from the transducer and it is secured to the distal tip of the catheter. Upon insertion of the catheter, the balloon is inflated and the catheter is retracted until the balloon is firmly seated within the bladder neck. Then based on MRI images the transducer is translated and aligned with the target treatment region. Thus, Kinsey teaches an offset balloon for securing the catheter in place and aligning the transducer with target treatment region.
The applicant arguments regarding McCaffrey fails to disclose the one or more transducers are aligned with respect to a target volume when the inflated offset balloon mechanically engages the target anatomical opening”. The examiner respectfully disagrees. McCaffrey was relied on for teaching the placement/position of the balloon on the shaft. Kinsey disclose the alignment of the transducers with the target treatment region after the balloon engaged the anatomical opening. Further, McCaffrey disclose that the balloon assembly 106 can be configured to position the distal portion 118 within the blood vessel V so that the emitted ultrasound waves W are focused on target depths where neural fibers N are likely to be located within the wall of the blood vessel V to induce thermal neuromodulation. Therefore, McCaffrey disclose that the inflation of the balloon enables the alignment of the transducers with the treatment region. Finally, the examiner notes that the current claim limitation does not limit the alignment of the transducers to be based on the predetermined distance between the balloon and the transducers.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2023/0097230, Geva et al., Systems and methods for ultrasonic bladder therapeutic agent delivery.
THIS ACTION IS MADE FINAL. 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.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
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