DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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).
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 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 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 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 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 June 10, 2026 have been fully considered but they are not persuasive.
With regards to the 35 USC 112(b) rejection, Applicant argues that the rejection is moot as claim 15 has been amended to delete “such as”.
However, claim 15 still contains the phrase “such as” (see line 2 of claim 15) and therefore claim 15 remains rejected under 35 USC 112(b).
With regards to Sinelnikov, Applicant argues that Sinelnivo’s device is structurally configured to transmit energy through the vessel wall without ablating it and to ablate tissue beyond the vessel wall, which is opposite of claim 1 which requires ablating tissue of the ostium (i.e. the vessel wall structure itself). Applicant asserts that a device specifically designed to avoid ablation of the vessel tissue to protect the vessel wall from ablation is not “configured to ablate tissue of the ostium”.
Examiner respectfully disagrees and first notes that, as set forth in the above rejection, the limitation concerning the tissue including specifically “tissue of an ostium of a lumen that extends from the chamber of a subject’s heart” 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 can transverse the body (see Figure 1) such that it is capable of ablating any tissue, including the claimed tissue of an ostium, Sinelnikov et al. meet the above limitations.
With regards to Applicant’s assertion that the device of Sinelnikov is specifically designed to avoid ablation of the vessel wall, Examiner respectfully disagrees that the device of Sinelnikov is limited to specific targets, such as the septum or targets other than a vessel wall structure. Paragraph [0057] sets forth that “An ablation may be focused exclusively on targeted tissue, or be focused on the targeted tissue while safely ablating tissue proximate to the targeted tissue (e.g., to ensure the targeted tissue is ablated or as an approach to gain access to the targeted tissue). An ablation region may be as big as a peripheral chemoreceptor (e.g., carotid body or aortic body) itself, somewhat smaller, or bigger and can include one or more tissues surrounding the chemoreceptor such as blood vessels, adventitia, fascia, small blood vessels perfusing the chemoreceptor, and nerves connected to and innervating the glomus cells..”. The device of Sinelnikov is thus capable of ablating various targets, including having the ablation be focused on targeted tissue or focused on the targeted tissue while safely ablating tissue proximate to the targeted tissue, and therefore the device of Sinelnikov is capable of ablating tissue of the ostium.
Applicant further argues that Sinelnikov does not describe rotation and translation capabilities in the context of generating a three-dimensional image, nor is there any indication that the device described in Sinelnikov that is designed for Doppler detection and directional ablation aiming has the structural features needed for 3D volumetric imaging.
However, Examiner notes that 3D imaging is not required for the claimed apparatus. As set forth in the above rejection, the limitation “to generate a three-dimensional image of the tissue of the ostium of the lumen” is directed to an intended use and/or manner of operating the claimed system. Examiner emphasizes that claim 1 is directed to an apparatus, the apparatus comprising structurally of a transluminal ablation catheter comprising at least one ultrasound transducer and an expandable cage. The apparatus comprises no further structure, such as a processor/computer, that would be capable of generating a three-dimensional image. As such, the limitation concerning generating a 3D image is directed to an intended use. Since the above combined references do disclose that the at least one ultrasound transducer is configured to rotate and axially translate back and forth within the expandable cage (i.e. see Sinelnikov, 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), and therefore the ultrasound transducer is capable of gathering three-dimensional data that could be used to generate a three-dimensional image, the above combined references do meet the above limitation.
Applicant additionally argues that the Office Action’s position of taking the balloon’s location around the transducer and substituting the cage’s structures (struts) [of Fjield] ignores Sinelnikov’s own teaching that these elements occupy different positions and serves different purposes.
However, Fjield provides motivation for modifying the apparatus of Sinelnikov to use the expandable element comprising an expandable cage, etc., specifically 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 transmission wall and the tissue (see pg. 32, lines 2-10 of Fjield) and/or alternatively, based on the rationale or substitution of one known expandable element for another yields predictable results. See MPEP 2143, IB.. One of ordinary skill in the art would thus find it obvious to modify the apparatus of Sinelnikov to the adopt the expandable element comprising of an expandable cage comprising a plurality of structs, etc., as taught by Fjield.
Applicant further argues that Fjield does not teach or suggest a cage disposed around a transducer in which the transducer rotates and axially translates back and forth to generate a three-dimensional image.
However, Examiner notes that the limitation is rejected under the combination of Sinelnikov and Fjield, wherein Sinelnikov is relied upon to teach a transducer that rotates and axially translates back and forth, etc. and an expandable element in the form of a balloon (145) which surrounds the transducer (146, 230). Fjield is relied upon to teach an expandable element comprising an expandable cage comprising a plurality of struts, etc.. Therefore, the combined references meet the above limitation. Further, with regards to Applicant’s assertion that Fjield does not teach or suggest a cage disposed around a transducer, Examiner respectfully disagrees and refers Applicant to Fjield’s Figure 12 which depicts the a cage (1102) surrounding the transducer (1120) and reflector balloon (1150). Therefore, Fjield does teach a cage disposed around a transducer, etc..
Applicant further argues that replacing the balloon of Sinelnikov with the cage of Fjield would eliminate the very functionality upon which Sinelnikov’s device depends. Applicant asserts that a proposed modification that renders the cited art unsatisfactory for its intended purpose cannot support an obviousness rejection. Applicant additionally argues that the Office Action’s stated motivation for the combination --- to hold the expandable element at a predetermined distance from the surface of the cardiac wall --- does not justify eliminating the balloon’s functions. Applicant provides similar arguments with regards to the rejection of the claims over Lupotti in view of Fjield, noting that Lupotti’s balloon serves critical functions that a cage does not provide and replacing Lupotti’s balloon with a cage would eliminate functions that are integral to the operation of Lupotti’s device, etc.
However, Examiner notes that the above rejection does not suggest replacing the balloon of Sinelnikov (or Lupotti) with the cage of Fjield. Rather, the above rejection proposes having the expandable element of Sinelnikov et al. (or Lupotti) 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). The proposed modification would provide the balloon expandable element of Sinelnikov (or Fjield) to further comprise an expandable cage comprising a plurality of struts, etc. Note that this structure of a balloon combined with an expandable cage, together forming an expandable element, is taught by Fjield (i.e. see Figure 12 of Fjield, which teaches an expansable reflector structure (1127) with a balloon having a transmissive surface (1130) and with a reflector balloon (1150), as well as a sonic transducer (1120), all of which are surrounded by an expansible basket (1102) formed from a set of wires (i.e. expandable cage comprising a plurality of struts/wires). Further, with regards to the motivation being that of substitution of one known expandable element for another, the “expandable element” of Fjield is viewed as corresponding to the expansible basket (1102) combined with the expansible balloon structure (i.e. 1150, 1127). Examiner emphasizes that the modification of the apparatus of Sinelnikov (or Lupotti) in view of the teachings of Fjield would not eliminate the balloon (145) of Sinelnikov (or the balloon of Lupotti) or its functions but rather modify the balloon (145) of Sinelnikov (or the balloon of Lupotti) to be further surrounded by the expandable cage as taught by Fjield, and therefore the proposed modification would not render the cited art unsatisfactory for its intended purpose.
Applicant further argues that neither Sinelnikov nor Fjield, alone or in combination, teaches or suggests an ultrasound transducer configured to rotate and axially translate back and forth within an expandable cage to generate a three-dimensional image of the tissue of the ostium.
Examiner respectfully disagrees and refers Applicant to the above rejection, as well as the above response to Applicant’s arguments, as to how the combination of Sinelnikov and Fjield does meet the above limitation.
The claims therefore remain rejected under the previously applied prior art.
Conclusion
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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/KATHERINE L FERNANDEZ/Primary Examiner, Art Unit 3798
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