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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 7, 2026 has been entered.
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, in line 2, --- the --- should be inserted before “plurality”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, it is assumed that the limitations following the phrase are not part of the claimed invention.
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.
Claim(s) 1-2, 4, 6-7, 13-14, 16-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov et al. (US Pub No. 2020/0093505) in view of Fjield et al. (WO 02/05868), as cited by Applicant in the IDS filed on July 24, 2025.
With regards to claim 1, Sinelnikov et al. disclose an apparatus for use with tissue of a subject, the apparatus comprising:
a transluminal ablation catheter (“ultrasound carotid body ablation catheter”) comprising: at least one ultrasound transducer (i.e. at least one diagnostic ultrasound transducer and an ultrasound treatment transducer) configured to be inserted into a chamber of the subject's heart, and: (a) to ablate tissue of the subject by applying ultrasound energy to the tissue, and (b) to image tissue of the subject by applying non-ablating ultrasound energy to the tissue (paragraph [0107], referring to the ultrasound carotid body ablation catheter comprising at least one diagnostic ultrasound transducer and an ultrasound treatment transducer; paragraphs [101]-[0103], referring to the ultrasound transducer (255) which includes an acoustic insulator (257) which ensures an imaging or ablation beam is directed in a direction (259); paragraph [0144]; paragraph [0243], referring to imaging and ablation section (651); paragraph [0159], referring to a transducer assembly that is configured for both imaging and ablation; paragraph [0316]; paragraph [0089]; Figures 1, 5-8, 9-10, 20, 22A, 43); and
an expandable element configured to be disposed around the at least one ultrasound transducer (paragraph [0099], referring to the balloon (145), which surrounds the transducer (146, 230) as depicted in Figure 4A,B; paragraph [0072], referring to “any of the ultrasonic transducers herein may be incorporated in a carotid body ablation catheter having a deployable or expandable structure (e.g., a balloon, cage, basket, mesh, or coil) to position, align, and maintain stable position of the transducer in a vessel…”; paragraph [0093], referring to rotating a diagnostic transducer, which can occur within a balloon; paragraph [0104], referring to the catheter may further comprise a deployable structure such as a balloon, cage, mesh or helix; Figures 4, 9, 35, 43, wherein, as depicted in Figure 4, the transducer (230) is disposed within the balloon (145));
the at least one ultrasound transducer being configured to rotate and axially translate back and forth within the expandable element to generate a three- dimensional image of the tissue (paragraph [0093], referring to rotating a diagnostic transducer, which can occur within a balloon; paragraph [0176], referring to moving the imaging transducer along with the ablation transducer, wherein the motion may be accomplished by rotating the transducer within a catheter or translational motion of the transducer along a length of a vessel, wherein the motion of the transducer in a catheter may be accomplished manually by a user or automatically by a servomotor connected to a rotatable transducer mount that is computer controlled with a desired speed and distance and may comprise a feedback signal such as edge detection to identify a target zone; paragraph [0241], referring to the imaging and ablation section of the catheter being rotationally adjustable and longitudinal translation is allowed which allows the position of the imaging and ablation section to be adjustable with respect to the integrated shaft; Figures 13, 20-21, 42).
With regards to the limitations concerning the tissue including specifically “tissue of an ostium of a lumen that extends from the chamber of a subject’s heart” and wherein the rotation and axial translation of the at least one ultrasound transducer is “to generate a three-dimensional image of the tissue of the ostium of the lumen”, these limitations are directed to an intended use and/or manner of operating the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the at least one ultrasound transducer is sized such that it can transvers the body (see Figure 1) such that it is capable of ablating any tissue, including the claimed tissue of an ostium and the ultrasound transducer is capable of rotating (paragraph [0241], referring to the imaging and ablation section of the catheter being rotationally adjustable and longitudinal translation is allowed which allows the position of the imaging and ablation section to be adjustable with respect to the integrated shaft; Figures 13, 20-21, 42) such that it is capable of acquiring three-dimensional data that can be used to generate a 3D image, Sinelnikov et al. meet the above limitations.
However, though Sinelnikov et al. do disclose that an expandable element can comprise of a cage (paragraph [0072], referring to the deployable/expandable structure comprising of a cage as an alternative to using a balloon), Sinelnikov et al. do not specifically disclose the expandable element comprises an expandable cage comprising a plurality of struts, and wherein the expandable cage is configured to temporarily anchor a distal portion of the transluminal ablation catheter in the lumen by a portion of the plurality of struts contacting a wall of the lumen.
Fjield et al. disclose a probe structure comprising a catheter carrying a cylindrical ultrasonic transducer (1120) for performing cardiac ablation, such as for ablating tissue of the wall of the atrium encircling the ostium of a pulmonary vein (Abstract; pg. 11, lines 22-30; pg. 6, lines 28-30; pg. 31, lines 24-28; Figures 1, 12). An expansible reflector structure (1127) is surrounded by an expansible basket (1102) formed from a set of wires (i.e. “struts”) (pg. 31, lines 24-32; Figure 12, note that the basket structure formed with a set of wires/struts has the equivalent structure of what would be called a “cage” [defined as an enclosure having some openwork for confinement]). The basket structure holds the expansible reflector structure (1127) at a predetermined distance from the surface of the cardiac wall and thus, serves as a standoff, so as to provide a space (1112) between the transmissive wall and the tissue (pg. 32, lines 2-10; Figure 12).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the expandable element of Sinelnikov et al. comprise an expandable cage comprising a plurality of struts, and wherein the expandable cage is configured to temporarily anchor a distal portion of the transluminal ablation catheter in the lumen by a portion of the plurality of struts contacting a wall of the lumen, as taught by Fjield et al., in order to hold the expandable cage/element at a predetermined distance from the surface of the cardiac wall and thus provide a space between the transmissive wall and the tissue, thus serving as a standoff (pg. 32, lines 2-10) and/or the substitution of one known expandable element for another yields predictable results (i.e. providing space between the transducer and tissue) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
With regards to claim 2, Sinelnikov et al. disclose that the at least one ultrasound transducer is configured to be inserted into a left atrium in a vicinity of a pulmonary vein ostium and is configured to ablate tissue of the pulmonary vein ostium, to thereby electrically isolate the pulmonary vein (paragraphs [0053], [0101]-[0103], [0107], [0267], Figures 1, 2). Note that the limitations directed to the at least one ultrasound transducer being specifically configured “to be inserted into a left atrium…” and to specifically ablate “tissue of the pulmonary vein ostium…” is directed to an intended use and/or manner of operating the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the at least one ultrasound transducer is sized such that it is capable of being inserted into the left atrium and capable of ablating the specific tissue claimed, Sinelnikov et al. meet the above limitations.
With regards to claim 4, Fjield e tal. disclose that at least a portion of the struts are curved outwardly at at least two locations along the strut to temporarily anchor a distal portion of the transluminal ablation catheter in the lumen by the portion of the struts contacting a wall of the lumen (pg. 32, lines 2-10; Figure 12, wherein the wires/struts of the cage (1102) are curved at at least two location (i.e. locations corresponding to where the wires curves away from the transducer and then curves towards the transducer).
With regards to claim 6, Sinelnikov et al. disclose that the at least one ultrasound transducer is configured to generate ultrasound energy at a frequency of 8-20 MHz (paragraphs [0071], [0162], referring to ultrasonic transducers being energized to produced acoustic energy in a range from about 10 Mhz to about 30 MHz).
With regards to claim 7, as discussed above, the above combined references meet the limitations of claim 1. Further, Sinelnikov et al. disclose wherein the at least one ultrasound transducer is shaped to define a convex surface facing outwardly from a longitudinal axis of the transducer, and having a width of 0.5 - 3 mm (paragraph [0073], referring to the transducer aperture shape being round or oval, and thus having a convex shape and/or the ultrasound aperture shape being rectangular with a slightly convex shape; paragraph [0176], referring to the transducer having a convex curved surface; paragraph [0076], referring to the width of the transducer having a width of about 2 mm, and thus within the claimed 0.5-3 mm width range). With regards to the limitation of the transducer having a radius of curvature of 0.75 - 5 mm, although Sinelnikov et al. do disclose a transducer having a curvature (paragraphs [0073], [0176]), Sinelnikov et al. do not specifically disclose that the curvature has a radius of curvature of 0.75-5mm. However, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to adopt a radius of curvature of 0.75-5mm in order to determine the optimal radius of curvature to fit within an ablation device (i.e. catheter or probe) and/or provide a desired focus.
With regards to claim 13, Sinelnikov et al.. disclose that the transluminal ablation catheter comprises an elongated shaft comprising a proximal portion comprising a handle (i.e. 544), and a distal portion to which the at least one ultrasound transducer is coupled (paragraph [0083], referring to the ultrasound transducer positioned near an axis of the catheter shaft, wherein an actuator in a handle may control a deflection of the catheter; paragraph [0126], referring to, at the proximal region of the ablation catheter, the shaft may be connected to a proximal ablation transducer support, which may also function as a handle (544); Figures 1, 12G, 14A,B, 27, 45E).
With regards to claim 14, Sinelnikov et al. disclose that the elongated shaft is configured to be rotatable, such as to rotate the ultrasound transducer, and the transluminal ablation catheter comprises one or more sensors coupled to the distal portion of the elongated shaft and configured to detect a rotational position of the distal portion of the elongated shaft (paragraphs [0093], [0098], [0104], [0107]-[0108], referring to the rotation of the catheter; paragraph [0213], referring to detecting potential movement of the directed ablation energy from the target tissue by a sensor such as an accelerometer or multiple accelerometers positioned in an ablation catheter or a 3D orientation and tracking system to detect a magnetic coil or electrode position in an ablation catheter to track the device within a patient’s body, and thus a rotational position of the distal portion of the elongated shaft is detected).
With regards to claim 16, Sinelnikov et al. disclose wherein the at least one ultrasound transducer is configured to apply the non-ablating ultrasound energy to the tissue such that at least a portion of the non-ablating ultrasound energy is reflected and received by the ultrasound transducer; and wherein the apparatus further comprises a computer processor configured to assess a parameter of the reflected energy to determine a parameter of the ultrasound energy to be applied by the at least one ultrasound transducer to ablate the tissue; and wherein the at least one ultrasound transducer is configured to apply the ultrasound energy to the tissue based on the determined parameter (paragraph [0176], referring to “Motion may be preformed while imaging wherein a user may identify boundaries of a desired target zone or an ablation may be computer controlled by detecting target zone boundaries and applying ablation energy only within the boundaries. Boundaries may include for example anatomical structures such as boundaries of a carotid septum. Motion of a transducer in a catheter may be accomplished manually by a user or automatically by a servomotor connected to a rotatable transducer mount that is computer controlled with a desired speed and distance and may comprise a feedback signal such as edge detection to identify a target zone”).
With regards to claim 17, Sinelnikov et al. disclose that their apparatus further comprises an inflatable element configured to be disposed around the ultrasound transducer (paragraphs [0101]-[0102] referring to a membrane (250) being inflated with coolant (252) creating a lens shape that focuses an ultrasound beam (253) on a target region (254); paragraph [0221], referring to a balloon (495) surrounding an ablation transducer (496); paragraph [0072], referring to the catheter having a deployable or expandable structure, such as a balloon; Figures 9A, 10, 35).
With regards to claim 19, Sinelnikov et al. disclose that the at least one ultrasound transducer comprises: a first ultrasound transducer (i.e. 401)) configured to ablate the tissue of the subject by transmitting ablative ultrasound energy toward the tissue (paragraph [0144], referring to the ablation transducer (401); Figure 20A,B); and a second ultrasound transducer (355) configured to image the tissue of the subject by transmitting one or more pulses of pulse-echo ultrasound energy toward the tissue and receiving a reflection of the transmitted pulse-echo ultrasound energy (paragraph [0144], referring to the imaging transducer (355); Figure 20A,B), and the second ultrasound transducer is configured to rotate and axially translate back and forth within the expandable element such as to generate a three-dimensional image of the tissue (paragraph [0176], referring to moving the imaging transducer along with the ablation transducer, wherein the motion may be accomplished by rotating the transducer within a catheter or translational motion of the transducer along a length of a vessel, wherein the motion of the transducer in a catheter may be accomplished manually by a user or automatically by a servomotor connected to a rotatable transducer mount that is computer controlled with a desired speed and distance and may comprise a feedback signal such as edge detection to identify a target zone; paragraph [0241], referring to the imaging and ablation section of the catheter being rotationally adjustable and longitudinal translation is allowed which allows the position of the imaging and ablation section to be adjustable with respect to the integrated shaft; ; paragraph [0159], Figures 13, 20-21, 22A, 42).
Claim(s) 1-2, 4, 13-14, 16-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti et al. (US Pub No. 2018/0353203) in view of Fjield et al..
With regards to claim 1, Lupotti et al. disclose an apparatus for use with tissue of an ostium of a lumen that extends from a chamber of a subject's heart, the apparatus comprising:
a transluminal ablation catheter (10) (Abstract; paragraphs [0030], [0033]-[0034], referring to the catheter (10) which includes an ablation element (22) which can include one or more ultrasound transducers (24); Figures 1-4) comprising:
at least one ultrasound transducer (24) configured to be inserted into the chamber of the subject's heart, and: (a) to ablate tissue of the ostium by applying ultrasound energy to the tissue, and (b) to image tissue of the ostium by applying non-ablating ultrasound energy to the tissue (paragraph [0034], referring to the ablation element (22) including one or more ultrasound transducers (24) that can be used both for ablation and imaging; paragraph [0006], referring to producing a circumferential lesion at or near the ostium of one or more of the pulmonary veins; paragraph [0052], referring to the catheter being introduced into a patient’s vasculature and can be positioned within a pulmonary vein (32); Figures 1-4, 6-7); and
an expandable element (i.e. balloon (28)) configured to be disposed around the at least one ultrasound transducer (24), wherein the expandable element/balloon (28) is configured to temporarily anchor a distal portion of the transluminal ablation catheter in the lumen by a portion of the expandable element/balloon contacting a wall of the lumen (Abstract; paragraphs [0048]-[0051], referring to the balloon, when expanded, is shaped such that it can engage the interior wall of a blood vessel (32) in a manner that holds catheter (10) stable relative to vessel (32), wherein the balloon (28) will press against the interior wall of blood vessel (32) along sufficient interfacing surface to hold catheter (10) stable, wherein it is desirable for the balloon (28) to be positioned such that the ablation element (22/24) are positioned therein; Figures 1-4, 6-7);
the at least one ultrasound transducer (24) being configured to rotate and axially translate back and forth within the expandable cage, to generate a three-dimensional image of the tissue of the ostium of the lumen (Abstract, referring to the ablation element rotating and/or sliding along the longitudinal axis of the catheter body; paragraphs [0041]-[0042], referring to the ultrasound transducers being mounted such that they can rotate about longitudinal axis (L) of catheter body (12), following arrow A-B; paragraph [0047], referring to the ultrasound transducers (24) mounted such that they can move back and forth along the longitudinal axis of the catheter body (12) (e.g., parallel to arrow C-D in Figs. 2 and 4; paragraph [0044], referring to the transducer (24) providing information to provide two-dimensional image slices that can be assembled as a three-dimensional volumetric image of a blood vessel; Figures 1-4, 6-7, in particular, see Figure 2, wherein arrow A-B depicts the rotation of the ultrasound transducers (24) and arrow C-D depicts the back and forth movement of the ultrasound transducers (24), wherein such a movement occurs within the expandable element (28)).
However, Lupotti et al. do not specifically disclose that the expandable element is an expandable cage, wherein the expandable cage comprises a plurality of structs.
Fjield et al. disclose a probe structure comprising a catheter carrying a cylindrical ultrasonic transducer (1120) for performing cardiac ablation, such as for ablating tissue of the wall of the atrium encircling the ostium of a pulmonary vein (Abstract; pg. 11, lines 22-30; pg. 6, lines 28-30; pg. 31, lines 24-28; Figures 1, 12). An expansible reflector structure (1127) is surrounded by an expansible basket (1102) formed from a set of wires (i.e. “struts”) (pg. 31, lines 24-32; Figure 12, note that the basket structure formed with a set of wires/struts has the equivalent structure of what would be called a “cage” [defined as an enclosure having some openwork for confinement]). The basket structure holds the expansible reflector structure (1127) at a predetermined distance from the surface of the cardiac wall and thus, serves as a standoff, so as to provide a space (1112) between the transmissive wall and the tissue (pg. 32, lines 2-10; Figure 12).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the expandable element of Sinelnikov et al. comprise an expandable cage comprising a plurality of struts, as taught by Fjield et al., in order provide an alternative structure to hold the expandable cage/element at a predetermined distance from the surface of the cardiac wall and thus provide a space between the transmissive wall and the tissue, thus serving as a standoff (pg. 32, lines 2-10) and/or the substitution of one known expandable element for another yields predictable results (i.e. providing space between the transducer and tissue) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
With regards to claim 2, Lupotti et al. disclose that the at least one ultrasound transducer (24) is configured to be inserted into a left atrium in a vicinity of a pulmonary vein ostium and is configured to ablate tissue of the pulmonary vein ostium, to thereby electrically isolate the pulmonary vein (paragraph [0006], referring to producing a circumferential lesion at or near the ostium of one or more of the pulmonary veins; Note that the limitations directed to the at least one ultrasound transducer being specifically configured “to be inserted into a left atrium…” and to specifically ablate “tissue of the pulmonary vein ostium…” is directed to an intended use and/or manner of operating the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Since the at least one ultrasound transducer is sized such that it is capable of being inserted into the left atrium and capable of ablating the specific tissue claimed, Lupotti et al. meet the above limitations).
With regards to claim 4, Fjield et al. disclose that at least a portion of the struts are curved outwardly at at least two locations along the strut to temporarily anchor a distal portion of the transluminal ablation catheter in the lumen by the portion of the struts contacting a wall of the lumen (pg. 32, lines 2-10; Figure 12, wherein the wires/struts of the cage (1102) are curved at at least two location (i.e. locations corresponding to where the wires curves away from the transducer and then curves towards the transducer).
With regards to claim 13, Lupotti et al. disclose that the transluminal ablation catheter comprises an elongated shaft comprising a proximal portion comprising a handle (20), and a distal portion to which the at least one ultrasound transducer (24) is coupled (paragraph [0032], referring to the proximal end (14) of the tubular body (12) is attached to a catheter control handle (20); paragraphs [0033]-[0034], referring to the distal region (16) of the catheter body (12) including an ablation element (22) including ultrasound transducers (24); Figures 1-2).
With regards to claim 14, Lupotti et al. disclose that the elongated shaft is configured to be rotatable, such as to rotate the ultrasound transducer, and the transluminal ablation catheter comprises one or more sensors coupled to the distal portion of the elongated shaft and configured to detect a rotational position of the distal portion of the elongated shaft (paragraph [0044], referring to a sensor (e.g., magnetic coil) being provided on shaft (26) in order to determine the rotational attitude of ultrasound transducers (24); paragraph [0041], referring to the ultrasound transducers (24) being mounted such that they can rotate about the longitudinal axis L of the catheter body (12), such as by attaching ultrasound transducers (24) to a rotatable shaft (26); Figures 1-4).
With regards to claim 16, Lupotti et al. disclose wherein the at least one ultrasound transducer is configured to apply the non-ablating ultrasound energy to the tissue such that at least a portion of the non-ablating ultrasound energy is reflected and received by the ultrasound transducer; and wherein the apparatus further comprises a computer processor configured to assess a parameter of the reflected energy to determine a parameter of the ultrasound energy to be applied by the at least one ultrasound transducer to ablate the tissue; and wherein the at least one ultrasound transducer is configured to apply the ultrasound energy to the tissue based on the determined parameter (paragraph [0044], referring to obtaining 2D image slices to assemble a three-dimensional volumetric image; paragraphs [0053]-[0054], referring to the ultrasound transducers being activated to image pulmonary vein (32), wherein based on the image, ablation parameters can be selected and then the ultrasound trasducers can be active according to the parameters, for example under excitation by ablation energy generator (120); paragraphs [0063]-[0064], referring to a processor carrying out the foregoing methods, which including imaging; Figures 1-4, 6-7).
With regards to claim 17, Fjield et al. disclose that the apparatus further comprises an inflatable element configured to be disposed around the ultrasound transducer (Abstract, referring to the device comprising a gasfilled reflector balloon (50) and a liquid-filled structural balloon (28), wherein the transducer (20) is disposed within the structural balloon; Figures 1, 12).
With regards to claim 19, Lupotti et al. disclose that the at least one ultrasound transducer comprises: a first ultrasound transducer configured to ablate the tissue of the subject by transmitting ablative ultrasound energy toward the tissue; and a second ultrasound transducer configured to image the tissue of the ostium by transmitting one or more pulses of pulse-echo ultrasound energy toward the tissue and receiving a reflection of the transmitted pulse-echo ultrasound energy, and the second ultrasound transducer is configured to rotate and axially translate back and forth within the expandable cage, to generate a three-dimensional image of the tissue (paragraphs [0034]-[0035], referring to the one “or more” ultrasound transducers (24), each of which can be used both for ablation and for imaging, wherein “pinging” can be performed which means transmitting acoustic energy and then receiving the reflected or echoed acoustic energy such as in the case of imaging, and therefore one of the plural transducers can be viewed as corresponding to the “first ultrasound transducer” and a second one of the plural transducers can be viewed as corresponding to the “second ultrasound transducer”; paragraph [0044], referring obtaining a plurality of two-dimensional image slices that can be assembled into a three-dimensional volumetric image; Figures 1-4, 6-7).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov et al. in view of Fjield et al. as applied to claim 1 above, and further in view of Lim (US Pub No. 2017/0071664).
With regards to claim 5, as discussed above, the above combined references meet the limitations of claim 1. Sinelnikov et al. further disclose that the expandable element comprises an expandable cage having a central portion and a distal portion (paragraph [0072], referring to “any of the ultrasonic transducers herein may be incorporated in a carotid body ablation catheter having a deployable or expandable structure (e.g., a balloon, cage, basket, mesh, or coil) to position, align, and maintain stable position of the transducer in a vessel…”).
However, the above combined references do not specifically disclose that the expandable cage is shaped to define a nipple-like structure by the central portion having a diameter that is greater than a diameter of the distal portion such that the distal portion is shaped and sized to be inserted into an ostium of the lumen to temporarily anchor the distal in the lumen by the contacting a wall of the lumen.
Lim discloses an ablation lesion monitoring method comprising a catheter (1000) that is adapted to fit the targeted anatomy, wherein the basket catheter may take a shape that is not a normal oblong shape, but rather forms a basket that has a more narrow distal region and a wider proximal region which allows the basket to securely fit the targeted anatomy (Abstract; paragraph [0188], Figures 2-4). As depicted 4, an alternate shape for the basket configuration includes the basket/cage having a shape defining a nipple-like structure by the central portion having a diameter that is greater than a diameter of the distal portion (Abstract; paragraph [0033], [0188]; Figure 4). Note that such a shape of the basket/cage is capable of being shaped and sized to be inserted into an ostium of the lumen.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the expandable cage of the above combined references be shaped to define a nipple-like structure by the central portion having a diameter that is greater than a diameter of the distal portion such that the distal portion is shaped and sized to be inserted into an ostium of the lumen to temporarily anchor the distal in the lumen by the contacting a wall of the lumen, as taught by Lim, in order to securely fit the targeted anatomy (paragraph [0188]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov et al. in view of Fjield et al. as applied to claim 1 above, and further in view of Steinke et al. (US Pub No. 2005/0096647).
With regards to claim 8, as discussed above, the above combined references meet the limitations of claim 1. Sinelnikov et al. further disclose that the expandable element comprises an expandable cage comprising a plurality of struts (paragraph [0072], referring to “any of the ultrasonic transducers herein may be incorporated in a carotid body ablation catheter having a deployable or expandable structure (e.g., a balloon, cage, basket, mesh, or coil) to position, align, and maintain stable position of the transducer in a vessel…”, wherein such a cage/basket would inherently comprise a plurality of struts).
However, the above combined references do not specifically disclose that at least a portion of the plurality of struts comprise electrically conductive struts that are configured to contact tissue of an ostium of the lumen and to ablate tissue of the ostium of the lumen that is in contact with the electrically conductive struts by driving current into the tissue of the ostium of the lumen.
Steinke et al. disclose a catheter for removal of material of a blood vessel, wherein the catheter comprises a radially expandable basket comprising a plurality of flexible struts, wherein electrodes comprising of conductive surfaces may be mounted to a separately formed basket struct and/or may be formed as part of the expandable structure (Abstract; paragraph [0016]). The electrode may comprise a localized widening of an associated strut, wherein the expandable structure may comprise Nitinol and a remaining surface of the Nitinol strut may be insulated (paragraph [0016]). The array of electrodes engage adjacent atherosclerotic material when the basket is expanded within the blood vessel (paragraph [0016]; Figure 3). Current is carried from an energy source to the electrodes (paragraph [0131]). Note that the electrically conductive struts are capable of contacting tissue of an ostium of the lumen and ablating tissue of the ostium of the lumen that is in contact with the electrically conductive struts (See Figure 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have at least a portion of the plurality of struts of the above combined references comprise electrically conductive struts that are configured to contact tissue of an ostium of the lumen and to ablate tissue of the ostium of the lumen that is in contact with the electrically conductive struts by driving current into the tissue of the ostium of the lumen, as taught by Steinke et al., in order to engage and remove adjacent atherosclerotic material or unwanted material when the basket is expanded within the desired anatomy (paragraph [0016]; Figure 3).
With regards to claim 9, Steinke et al. disclose that at least a portion of the electrically conductive struts comprise an insulated portion and an electrically conductive portion, and wherein the electrically conductive portion is configured to contact tissue of the ostium of the lumen and to ablate tissue of the ostium of the lumen (paragraph [0016], referring to the electrode may comprise a localized widening of an associated strut, wherein the expandable structure may comprise conductive Nitinol and a remaining surface of the Nitinol strut may be insulated).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov et al. in view of Fjield et al. as applied to claim 1 above, and further in view of Shanley (CA 2 571 791).
With regards to claim 10, as discussed above, the above combined references meet the limitations of claim 1. However, the above combined references do not specifically disclose that at least some of plurality of struts are shaped to define an aperture formed in the strut through which ultrasound energy is transmitted from the ultrasound transducer to the tissue.
Shanley discloses an expandable medical device (10) having a plurality of elongated struts (14), wherein at least one of the plurality of struts includes at least one opening (24, 26) extending at least partially through a thickness of said strut (Abstract; pg. 10, 1st-2nd paragraphs). A beneficial agent is loaded into the opening within the strut to achieve desired temporal release kinetics of the agent, wherein the beneficial agent can be an ablative agent to create a lesion to treat atrial fibrillation, such as ultrasound energy (Abstract; pg. 11, 1st paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have at least some of plurality of struts of the above combined references be shaped to define an aperture formed in the strut [wherein such an aperture formed would allow ultrasound energy of the above combined references to be transmitted through in the above combined references], as taught by Shanley, in order to provide a desired temporal release kinetics of a beneficial agent that can create a lesion to treat atrial fibrillation (Abstract; pg. 11, 1st paragraph).
With regards to claims 11-12, as discussed above, the above combined references meet the limitations of claim 10. The above combined references do not specifically disclose that wherein within the portion of plurality of the struts each of the struts has a width of 0.5 - 1 mm, and the aperture in the strut has a width of 0.25 -0.5 mm or that a thickness of the strut is 0.1-0.25 mm. However, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to adopt a width of 0.5-1 mm for each of the struts and a width of 0.25-.05mm for the aperture in the strut and have a thickness of the strut be 0.1-0.25mm in order to determine the optimal width size, aperture size and strut thickness that optimizes the transmission of the ultrasound energy.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti et al. in view of Fjield et al. as applied to claim 1 above, and further in view of Shanley (CA 2 571 791).
With regards to claim 10, as discussed above, the above combined references meet the limitations of claim 1. However, the above combined references do not specifically disclose that at least some of plurality of struts are shaped to define an aperture formed in the strut through which ultrasound energy is transmitted from the ultrasound transducer to the tissue.
Shanley discloses an expandable medical device (10) having a plurality of elongated struts (14), wherein at least one of the plurality of struts includes at least one opening (24, 26) extending at least partially through a thickness of said strut (Abstract; pg. 10, 1st-2nd paragraphs). A beneficial agent is loaded into the opening within the strut to achieve desired temporal release kinetics of the agent, wherein the beneficial agent can be an ablative agent to create a lesion to treat atrial fibrillation, such as ultrasound energy (Abstract; pg. 11, 1st paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have at least some of plurality of struts of the above combined references be shaped to define an aperture formed in the strut [wherein such an aperture formed would allow ultrasound energy of the above combined references to be transmitted through in the above combined references], as taught by Shanley, in order to provide a desired temporal release kinetics of a beneficial agent that can create a lesion to treat atrial fibrillation (Abstract; pg. 11, 1st paragraph).
With regards to claims 11-12, as discussed above, the above combined references meet the limitations of claim 10. The above combined references do not specifically disclose that wherein within the portion of plurality of the struts each of the struts has a width of 0.5 - 1 mm, and the aperture in the strut has a width of 0.25 -0.5 mm or that a thickness of the strut is 0.1-0.25 mm. However, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to adopt a width of 0.5-1 mm for each of the struts and a width of 0.25-.05mm for the aperture in the strut and have a thickness of the strut be 0.1-0.25mm in order to determine the optimal width size, aperture size and strut thickness that optimizes the transmission of the ultrasound energy.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov et al. in view of Fjield et al. as applied to claim 13 above, and further in view of Edwards et al. (US Patent No. 5,471,982).
With regards to claim 15, as discussed above, the above combined references meet the limitations of claim 15. Further, Sinelnikov et al. disclose that the elongated shaft is configured to be rotatable, such as to rotate the ultrasound transducer (paragraphs [0093], [0098], [0104], [0107]-[0108], referring to the rotation of the catheter).
However, the above combined references do not specifically disclose that the transluminal ablation catheter further comprises a rotational-force reduction mechanism configured to reduce rotational force applied to the expandable cage by the elongated shaft upon rotation of the elongated shaft, such as to hold the expandable cage stationary during rotation of the ultrasound transducer.
Edwards et al. disclose an improved probe for cardiac diagnosis and/or treatment comprising a basket (70), wherein a user can lock the basket (70) in the desired shape, while conducting other control or mapping operations, by using an external locking nut (166) (column 7, lines 15-15; column 13, line 59-column 14, line 5, note that such a lock would serve as a “rotational-force reduction mechanism” as it locks the shape of the basket and thus would reduce rotational force applied to the basket/cage upon operation of the transducer, including rotation of the transducer; Figures 1-8).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the transluminal ablation catheter of the above combined references further comprise a rotational-force reduction mechanism configured to reduce rotational force applied to the expandable cage by the elongated shaft upon rotation of the elongated shaft, such as to hold the expandable cage stationary during rotation of the ultrasound transducer, as taught by Edwards et al., in order to effectively lock the shape of the expandable cage into a desired shape (column 13, line 59-column 14, line 5).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti et al. in view of Fjield et al. as applied to claim 13 above, and further in view of Edwards et al. (US Patent No. 5,471,982).
With regards to claim 15, as discussed above, the above combined references meet the limitations of claim 13. Further, Lupotti et al. disclose that the elongated shaft is configured to be rotatable, such as to rotate the ultrasound transducer (paragraph [0041]; Figures 1-4, 6-7).
However, the above combined references do not specifically disclose that the transluminal ablation catheter further comprises a rotational-force reduction mechanism configured to reduce rotational force applied to the expandable cage by the elongated shaft upon rotation of the elongated shaft, such as to hold the expandable cage stationary during rotation of the ultrasound transducer.
Edwards et al. disclose an improved probe for cardiac diagnosis and/or treatment comprising a basket (70), wherein a user can lock the basket (70) in the desired shape, while conducting other control or mapping operations, by using an external locking nut (166) (column 7, lines 15-15; column 13, line 59-column 14, line 5, note that such a lock would serve as a “rotational-force reduction mechanism” as it locks the shape of the basket and thus would reduce rotational force applied to the basket/cage upon operation of the transducer, including rotation of the transducer; Figures 1-8).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the transluminal ablation catheter of the above combined references further comprise a rotational-force reduction mechanism configured to reduce rotational force applied to the expandable cage by the elongated shaft upon rotation of the elongated shaft, such as to hold the expandable cage stationary during rotation of the ultrasound transducer, as taught by Edwards et al., in order to effectively lock the shape of the expandable cage into a desired shape (column 13, line 59-column 14, line 5).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinelnikov et al. in view of Fjield et al. as applied to claim 19 above, and further in view of Seip et al. (WO 2007/006034).
With regards to claim 20, as discussed above, the above combined references meet the limitations of claim 19. Further, Sinelnikov et al. disclose that the transluminal ablation catheter comprises a first support (i.e. backing material) configured to support the first ultrasound transducer (i.e. ablation transducer) and enable transmitting of the ablative ultrasound energy toward the tissue (paragraphs [0112], [0119], Figure 12B).
However, the above combined references do not specifically disclose that the catheter further comprises a second damping support that is configured to support the second ultrasound transducer and provide a higher level of damping than damping provided by the first support, such as to enable the second ultrasound transducer to receive the reflection of the transmitted pulse-echo ultrasound energy, while the first ultrasound transducer is transmitting the ablative ultrasound energy toward the tissue.
Seip et al. disclose a transducer member (105) that includes a first transducer element (102) for imaging and a second transducer element (104) for HIFU therapy (paragraphs [0028]-[0029]; Figures 1-2). The transducer (102) may be improved to compensate for the overall/global therapy optimization of matching layer 112 by placing a thicker/heavier backing (140) on transducer element 102 than traditionally employed, wherein the heavier the backing, the more damping is provided by the backing (140) (paragraphs [0063]-[0064]; note that there is thus a backing that has a higher level of damping associated with the imaging transducer (102) than for the HIFU transducer (104); Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the catheter of the above combined references further comprise a second damping support that is configured to support the second ultrasound transducer and provide a higher level of damping than damping provided by the first support, such as to enable the second ultrasound transducer to receive the reflection of the transmitted pulse-echo ultrasound energy, while the first ultrasound transducer is transmitting the ablative ultrasound energy toward the tissue, as taught by Seip et al., in order to optimize the transducer for both imaging and therapy applications and compensate for the overall/global therapy optimization of matching layer (paragraphs [0063]-[0064]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti et al. in view of Fjield et al. as applied to claim 1 above, and further in view of Lim (US Pub No. 2017/0071664).
With regards to claim 5, as discussed above, the above combined references meet the limitations of claim 1. Lupotti et al. further disclose that the expandable element has a central portion and a distal portion (Figures 1-4, 6-7).
However, the above combined references do not specifically disclose that the expandable cage is shaped to define a nipple-like structure by the central portion having a diameter that is greater than a diameter of the distal portion such that the distal portion is shaped and sized to be inserted into an ostium of the lumen to temporarily anchor the distal in the lumen by the contacting a wall of the lumen.
Lim discloses an ablation lesion monitoring method comprising a catheter (1000) that is adapted to fit the targeted anatomy, wherein the basket catheter may take a shape that is not a normal oblong shape, but rather forms a basket that has a more narrow distal region and a wider proximal region which allows the basket to securely fit the targeted anatomy (Abstract; paragraph [0188], Figures 2-4). As depicted 4, an alternate shape for the basket configuration includes the basket/cage having a shape defining a nipple-like structure by the central portion having a diameter that is greater than a diameter of the distal portion (Abstract; paragraph [0033], [0188]; Figure 4). Note that such a shape of the basket/cage is capable of being shaped and sized to be inserted into an ostium of the lumen.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the expandable cage of the above combined references be shaped to define a nipple-like structure by the central portion having a diameter that is greater than a diameter of the distal portion such that the distal portion is shaped and sized to be inserted into an ostium of the lumen to temporarily anchor the distal in the lumen by the contacting a wall of the lumen, as taught by Lim, in order to securely fit the targeted anatomy (paragraph [0188]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lipotti et al. in view of Fjield et al. as applied to claim 1 above, and further in view of Steinke et al. (US Pub No. 2005/0096647).
With regards to claim 8, as discussed above, the above combined references meet the limitations of claim 1. Fjield et al. further disclose that the expandable element comprises an expandable cage comprising a plurality of struts (pg. 31, lines 24-32; Figure 12, referring to the basket/cage structure formed with a set of wires/struts).
However, the above combined references do not specifically disclose that at least a portion of the plurality of struts comprise electrically conductive struts that are configured to contact tissue of an ostium of the lumen and to ablate tissue of the ostium of the lumen that is in contact with the electrically conductive struts by driving current into the tissue of the ostium of the lumen.
Steinke et al. disclose a catheter for removal of material of a blood vessel, wherein the catheter comprises a radially expandable basket comprising a plurality of flexible struts, wherein electrodes comprising of conductive surfaces may be mounted to a separately formed basket struct and/or may be formed as part of the expandable structure (Abstract; paragraph [0016]). The electrode may comprise a localized widening of an associated strut, wherein the expandable structure may comprise Nitinol and a remaining surface of the Nitinol strut may be insulated (paragraph [0016]). The array of electrodes engage adjacent atherosclerotic material when the basket is expanded within the blood vessel (paragraph [0016]; Figure 3). Current is carried from an energy source to the electrodes (paragraph [0131]). Note that the electrically conductive struts are capable of contacting tissue of an ostium of the lumen and ablating tissue of the ostium of the lumen that is in contact with the electrically conductive struts (See Figure 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have at least a portion of the plurality of struts of the above combined references comprise electrically conductive struts that are configured to contact tissue of an ostium of the lumen and to ablate tissue of the ostium of the lumen that is in contact with the electrically conductive struts by driving current into the tissue of the ostium of the lumen, as taught by Steinke et al., in order to engage and remove adjacent atherosclerotic material or unwanted material when the basket is expanded within the desired anatomy (paragraph [0016]; Figure 3).
With regards to claim 9, Steinke et al. disclose that at least a portion of the electrically conductive struts comprise an insulated portion and an electrically conductive portion, and wherein the electrically conductive portion is configured to contact tissue of the ostium of the lumen and to ablate tissue of the ostium of the lumen (paragraph [0016], referring to the electrode may comprise a localized widening of an associated strut, wherein the expandable structure may comprise conductive Nitinol and a remaining surface of the Nitinol strut may be insulated).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lupotti et al. in view of Fjield et al. as applied to claim 19 above, and further in view of Seip et al. (WO 2007/006034).
With regards to claim 20, as discussed above, the above combined references meet the limitations of claim 19. Further, Lupotti et al. disclose that the transluminal ablation catheter comprises a first support configured to support the first ultrasound transducer (i.e. ablation transducer (24)) and enable transmitting of the ablative ultrasound energy toward the tissue (Figures 1-4, 6-7; see rejection of claim 1).
However, the above combined references do not specifically disclose that the catheter further comprises a second damping support that is configured to support the second ultrasound transducer and provide a higher level of damping than damping provided by the first support, such as to enable the second ultrasound transducer to receive the reflection of the transmitted pulse-echo ultrasound energy, while the first ultrasound transducer is transmitting the ablative ultrasound energy toward the tissue.
Seip et al. disclose a transducer member (105) that includes a first transducer element (102) for imaging and a second transducer element (104) for HIFU therapy (paragraphs [0028]-[0029]; Figures 1-2). The transducer (102) may be improved to compensate for the overall/global therapy optimization of matching layer 112 by placing a thicker/heavier backing (140) on transducer element 102 than traditionally employed, wherein the heavier the backing, the more damping is provided by the backing (140) (paragraphs [0063]-[0064]; note that there is thus a backing that has a higher level of damping associated with the imaging transducer (102) than for the HIFU transducer (104); Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the catheter of the above combined references further comprise a second damping support that is configured to support the second ultrasound transducer and provide a higher level of damping than damping provided by the first support, such as to enable the second ultrasound transducer to receive the reflection of the transmitted pulse-echo ultrasound energy, while the first ultrasound transducer is transmitting the ablative ultrasound energy toward the tissue, as taught by Seip et al., in order to optimize the transducer for both imaging and therapy applications and compensate for the overall/global therapy optimization of matching layer (paragraphs [0063]-[0064]).
Response to Arguments
Applicant's arguments filed January 7, 2026 have been fully considered but they are not persuasive.
With regards to Sinelnikov, Applicant argues that Sinelnikov describes a cage disposed on the catheter distally to the transducer and not an expandable cage that is disposed “around” the ultrasound transducer.
However, the above rejection refers to the balloon/expandable element (145), wherein balloon (145) is formed around the ultrasound transducers (230) (paragraphs [0099]-[0100]; Figure 4B). Further, paragraph [0093] refers to rotating a diagnostic transducer, which can occur within a balloon. Paragraph [0104] further sets forth that the deployable structure can be a “balloon, cage…”. One of ordinary skill in the art would recognize that a “cage” is viewed as known alternative to using a balloon. However, even if this were not clear to one of ordinary skill in the art, Examiner notes that the claim is rejected under the combination of Sinelnikov in view of Fjield, wherein Fjield is used to modify the expandable element of Sinelnikov, which is disposed around the at least one ultrasound transducer as depicted in Figure 4B of Sinelnikov, to comprise of an expandable cage, as set forth in the above rejection.
Applicant further argues that Sinelnikov does not disclose an expandable cage comprising a plurality of struts, configured to be disposed around the ultrasound transducer, in the context of a transducer configured to rotate and axially translate back and forth within the expandable cage.
However, Examiner notes that the above limitation is rejected under the combination of Sinelnikov in view of Fjield, wherein Fjield is relied upon to teach the use of an expandable “cage” comprising a plurality of struts, wherein such a teaching is used to modify the balloon of Sinelnikove which surrounds the transducer and further allows the transducer to rotate and axially translate within the balloon. The above argument is therefore unpersuasive.
With regards to Fjield, Applicant argues that Fjield does not describe the expansible basket in the context of a rotational and translational ultrasound transducer.
However, claim 1 is rejected under the combination of Sinelnikov in view of Fjield, wherein Fjield is not relied upon to teach the rotational and translation ultrasound transducer, but rather Sinelnikove discloses this limitation. Fjield is solely relied upon for teaching that the expandable element can be an expandable cage that comprises a plurality of struts and is configured to temporarily anchor the distal portion of the transluminal catheter in the lumen by a portion of the plurality of struts contacting a wall of the lumen.
Claim 1 therefore remains rejected under the previously applied references.
With regards to claims 10 and 15, Applicant’s arguments have been found to be persuasive. Shanley has been introduced to teach claim 10 and Edwards has been introduced to teach claim 15.
Further, if Applicant does not consider the above response persuasive with regards to the combination of Sinelnikove and Fjield, an alternative rejection has been introduced for claim 1, etc. under newly introduced Lupotti in view of Fjield.
Conclusion
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/KATHERINE L FERNANDEZ/ Primary Examiner, Art Unit 3798