DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
The previous objection of claim 1 due to minor informalities has been withdrawn in light of applicant’s amendments made 8/07/2025.
Applicant's arguments filed 8/07/2025 have been fully considered but they are not persuasive. Applicant argues Willard (US 2013/0116687 A1) teaches an individual ablation element 58 and does not disclose “each elongated support having mounted thereon a linear array of separate, individual ablation elements” and that while Tran et al. (US 2014/0088630 A1) depicts multiple transducers 416 on a bar element 408 (Fig. 6), and generally refers to an array of ultrasound ablation elements, it does not teach an ablation unit having a plurality of elongated supports.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Tran is the primary reference which discloses a linear array of separate, individual ablation elements (416) for radiating energy on a single elongated support, wherein each individual ablation element in the array radiates energy in a direction generally parallel to other ablation elements in the respective linear array because the array is linear. While Tran does not disclose a plurality of elongated supports, Willard is brought in to teach an ablation catheter having a plurality of elongated supports. Therefore, modifying Tran to include a plurality of elongated struts that expand as taught by Willard would not take away the linear array of ablation elements of Tran. In other words, the modification would still include a plurality of individual ablation elements in a linear array on each elongated strut of the cage 80 of Willard.
Willard further teaches the thermal elements 58 may be positioned on or connected to struts 82 at any position, including at or near the largest diameter portion of cage 80 and distal of the largest diameter portion of the cage 80 when cage 80 is in the second position i.e. expanded ([0050]). Thus, Willard also contemplates a plurality of individual ablation elements on a single elongated support.
Accordingly, applicants arguments are not found persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 6 and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (US 2014/0088630 A1 in view of Willard (US 2013/0116687 A1).
Regarding claim 1, Tran discloses a catheter system (Fig. 6) comprising: a first catheter (catheter shaft 402) having: a directional non-contact ablation unit (portion of 400 including at least 408 and 416 extending out of 402 and electrical means 424; Fig. 6), the ablation unit having an elongated support (bar element 408), each elongated support (408) having mounted thereon a linear array of separate, individual ablation elements (ablation transducers 416; Fig. 6) for radiating energy (acoustic energy; [0077]), wherein the individual ablation elements radiate energy generally perpendicular to the elongated support (as the acoustic energy may be directed from the ablation transducers 416 in a direction generally perpendicular to the radiating surfaces of the transducers 416; [0077]), wherein the elongated support (408) is connected at a fixed distal end and is movable to adjust positions of the individual ablation elements relative to the ablation unit (as 408 is movable in the direction of arrows 422 and 426 relative to the electrical means 424, which is part of the ablation unit; [0078]-[0079]); and a deformer (tension member 412), wherein the deformer (412) is coupled to the ablation unit (Fig. 6), wherein the deformer (412) is controllable to move the elongated support between a first position in which the ablation elements are in a contracted position and a second position in which the deformer pushes the elongated support radially outward from an axis of the ablation unit to an expanded position (as tension member 412 may be manually actuated to move the bare element 408 and transducers 416 relative to the electrical means 424; [0078]; [0080]; as the orientation of transducers 416 is changed via movement of the bar element 408 in directions 422 and 426), wherein adjustment of the positions of the elongated support and the corresponding individual ablation elements adjusts a pattern in which the radiated energy is radiated from the ablation unit to surrounding tissue (as the angle of the transducers 416 changes by movement of the tension member 412; Fig. 6; [0077]), and wherein individual ablation elements (416) in a respective linear array radiate energy in a direction generally parallel to other ablation elements in the respective linear array (because 416 are in a line, they radiate energy parallel; Fig. 6).
Tran fails to disclose the ablation unit having a plurality of elongated supports, each elongated support having mounted thereon a corresponding plurality of separate, individual elements for radiating energy, wherein each of the elongated supports is connected at a first end to a fixed band, and wherein in the first position the ablation elements are in a contracted position which has a generally cylindrical shape and in the second position the deformer pushes the elongated supports radially outward from an axis of the ablation unit to an expanded position in which the ablation elements have a generally conic section shape.
However, Willard teaches a catheter system (Figs. 5A-5C) comprising: a first catheter (elongated member 52) having: a directional non-contact ablation unit (expandable feature 51 for ablating tissue; [0058]), the ablation unit having a plurality of elongated supports (struts 82), each elongated support having mounted thereon an individual ablation element (thermal elements 58) for radiating energy (via emitting thermal energy 66 or RF energy, or ultrasound heating; [0043]-[0044]), wherein each of the elongated supports (82) is connected at a first end (distal end) to a fixed band (at 53a) and the elongated supports are movable to adjust positions of the individual ablation elements (Figs. 5A-5B) relative to the ablation unit (as the struts 82 expand and move relative at least to the terminal end 53a, which is a part of the expandable feature 51 or ablation unit; Figs. 5A-5B); and a deformer (sheath 72), wherein the deformer (72) is coupled to the ablation unit (at least in the collapsed configuration of Fig. 5A), wherein the deformer (72) is controllable (via retraction) to move the elongated supports between a first position (Fig. 5A) in which the ablation elements (58) are in a contracted position which has a generally cylindrical shape (Fig. 5A) and a second position (Fig. 5B) in which the deformer (72) pushes the elongated supports radially outward from an axis of the ablation unit to an expanded position in which the ablation elements (58) have a generally conic section shape (see annotated Fig. 5B, below), the elongated supports move relative to the ablation unit (Figs. 5A-5B) to thereby adjust the positions of the individual ablation elements (Figs. 5A-5B) to change a direction of the individual ablation elements (as elements 58 may be positioned at or near the largest diameter portion of the cage and distal to the largest diameter portion of the cage 80; [0050]; see for example, annotated Fig. 5B below), thus, in a linear array, wherein adjustment of the positions of the individual ablation elements adjusts a pattern in which the ablation elements are positioned (as the spacing and angle of the elements 58 expands in Fig. 5B, changing their position and a pattern in which energy is radiated).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter system of Tran to include a plurality of elongated supports spaced circumferentially around a longitudinal axis of the first catheter and fixed to each other at a first end with a fixed band as taught by Willard, each elongated support comprising a plurality of ablation elements (as disclosed by Tran), such that the plurality of elongated supports have a contracted position which is generally cylindrical and an expanded position which is generally conic in shape as taught by Willard in order to place multiple linear arrays of ablation elements of Tran circumferentially around the first catheter to increase the area of ablation and/or to effectively use the ablation elements on an ostium.
Regarding claim 6, Tran discloses the invention as claimed above, and Tran further discloses wherein the first catheter (402) has a lumen (lumen 404; [0073]).
Regarding claim 11, Tran discloses the invention as claimed above, and Tran further discloses wherein the individual ablation elements (416) are electrically coupled (via electrical connection 424) to a controller (control unit 418) which is configured to independently control the individual ablation elements (as ultrasound sensor information can be used to selectively turn on and off the ablation transducers; [0085]).
Regarding claim 12, Tran discloses the invention as claimed above, and Tran further discloses wherein the controller (418) is configured to generate electrical signals (via electrical connection 424) which are provided to the individual ablation elements (416), wherein the electrical signals provided to at least one of the individual ablation elements are different from the electrical signals provided to others of the individual ablation elements (as transducers 416 have similar form and function as previous embodiments and separate transducers may be supplied that are tuned to different frequencies; [0076]; [0037]), wherein in response to receiving the generated electrical signals, each of the individual ablation elements radiates corresponding energy (as the transducers radiate acoustic energy; [0077]).
Regarding claim 13, Tran discloses the invention as claimed above, and Tran further discloses wherein the controller (418) is configured to alter the generated electrical signals (via electrical connection 424) which are provided to the individual ablation elements (416) and thereby alter a pattern of radiated energy produced by the ablation unit (as the frequencies may be alter from low to high and vice versa; [0081]).
Regarding claim 14, Tran discloses the invention as claimed above, and Tran further discloses wherein the individual ablation elements (416) comprise individual ultrasound transducers (as the transducers 416 use ultrasound energy; [0027]).
Claim(s) 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tran et al. (US 2014/0088630 A1) in view of Willard (US 2013/0116687 A1), as applied to claim 6 above, and further in view of Shih (US 2019/0274561 A1).
Regarding claims 7-10, Tran modified discloses the invention as claimed above, and Tran further discloses the first catheter (402) has a lumen (404) and/or one or more auxiliary lumens for medical use ([0073]) and wherein the first catheter (404) may further include a measurement electrode (temperature sensor/wire; [0073]) to enable measurement of electrical characteristics of target tissue irradiated by energy emitted from the individual ablation elements (via temperature), but fails to disclose a second catheter configured to fit within the lumen of the first catheter, wherein at least one of the first and second catheters is a positioning catheter, wherein at least one of the first and second catheters includes one or more measurement electrodes configured to measure electrical characteristics of tissue proximal to the at least one of the first and second catheters, and wherein the second catheter includes one or more measurement electrodes, wherein the one or more measurement electrodes are positioned to enable measurement of electrical characteristics of target tissue irradiated by energy emitted from the individual ablation elements of the ablation unit.
However, Shih teaches a catheter system (Fig. 4) comprising: a first catheter (ablation catheter 410) having an ablation unit (ultrasound transducer 411), the first catheter having a lumen (lumen through 410) and a second catheter (positioning catheter 420) configured to fit within the lumen of the first catheter (Fig. 4), wherein the second catheter is a positioning catheter (positioning catheter 420; [0063]), wherein the first catheter (410) has one or more measurement electrodes (electrodes 412) and the second catheter (420) has one or more measurement electrodes (array of electrodes 421) configured to measure electrical characteristics of tissue proximal to the at least one of the first and second catheters and characteristics of target tissue irradiated by energy emitted from the ablation element (as recordings and measurements from the electrodes are made before, during, and after application of ultrasound energy for ablation to make assessments of the disease state and treatment effect; Fig. 4; [0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first catheter of modified Tran to include one or more measurement electrodes and to insert the second catheter having one or more measurement electrodes as taught by Shih into the one or more lumens of the first catheter of Tran in order to not only allow for positioning for accurate placement of the catheter system, but to also take measurements before, during, and after an application of ultrasound energy to make assessments of the disease state and of the treatment effect.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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/SARAH A LONG/Primary Examiner, Art Unit 3771