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 . Claims 1-20 are currently pending with claims 1-10 being previously withdrawn. The previous 112 rejections/interpretations have been withdrawn due to the Applicant’s amendments.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ludwin et al. US Publication 2019/0350489 (hereinafter Ludwin) in view of Bar-Tal US Publication 2020/0155224 (hereinafter Bar-Tal) in further view of Tegg et al. US Publication 2022/0054198 (hereinafter Tegg).
Regarding claims 11 and 14, Ludwin discloses an electro-anatomical mapping system utilizing a catheter having a distal assembly (Figure 2), the system comprising one or more processors ([0009]), non-transitory computer-readable medium containing instructions ([0040]) that when executed by the one or more processors cause them to: calculate a center of mass of said distal assembly as a centroid derived from the locations of the electrodes (all of the electrodes 55 have center points around the equator of the balloon which the electrical data is then used to estimate the center as per [0047]-[0049] and Figure 3); a tilt angle calculator to receive output from a sensor (50) having a sensor longitudinal axis aligned along a shaft longitudinal axis of a shaft to which said distal assembly is attached (50 as per Figure 2), to check whether or not said shaft longitudinal axis extends through said center of mass and ([0050]-[0052] and shown in Figure 4, where the off axis can be determined), and though the processor of Ludwin combined with the magnetic sensors and electrodes are fully capable of performing the claimed functional language it is not taught explicitly.
Bar-Tal teaches a similar balloon catheter that calculates a tilt angle of said center of mass from said sensor longitudinal axis and a line extending from a position of said sensor and said center of mass ([0045] and Figure 2 at center of mass 47 and angle 59); said tilt angle calculator to determine an angle between said longitudinal axis and said line ([0045][0053] which details determining an angle between the two, see also Figure 2 at 45). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the tilt angle detection as taught by Bar-Tal with the device of Ludwin in order to make adjustments to maintain good electrode contact affording more uniform energy delivery and improved sensing accuracy.
Though Ludwin teaches electrodes (55) on the balloon, these are for ablation only. Tegg teaches a catheter monitoring system that includes an expandable portion on a catheter including electrodes (electrodes 102 on expandable portions 103 on catheter 101), where those electrode’s locations are received by the processor ([0052]-[0053][0055][0057][0083]). Therefore it would have been obvious to the skilled artisan before the effective filing date to utilize the additional functionality as taught by Tegg with the device of Ludwin in order to further aid in determining the distal assembly’s location. The resultant combination of Ludwin, Bar-Tal, and Tegg would have included a processor that corrects the locations ([0038] as per Ludwin, which details correcting the positions using the ACL), with electrodes on the expandable portion providing the pertinent location/positional data as detailed by Tegg above), according to the tilt angle (tilt angle is rendered obvious above via Bar-Tal). Each of these aspects of the limitation are taught by the combination above.
Regarding claim 12, Ludwin discloses that the instructions further cause the processor(s) to generate an average value of said tracked locations ([0047]-[0049][0051] where the processor estimates the center location based on electrode signals). The electrodes on the expandable portion is taught above via Tegg, and is combined for the same rationale above.
Regarding claim 13, Ludwin discloses that the sensor is a magnetic sensor (50, see also [0038]).
Regarding claim 15, Ludwin discloses that the distal assembly is one of: a basket distal assembly and a balloon distal assembly (Figure 2).
Regarding claims 16-17, Ludwin discloses that the system also comprises a display to display at least one of: corrected said tracked locations and said center of mass on a map of said electro-anatomical mapping system (display 27, see also the Carto 3 system is detailed as per [0019]-[0020] which can provide real-time viewing of the device in the anatomy).
Regarding claim 18, Ludwin discloses that the instructions further cause the processor to track at least one of: corrected said tracked locations and said center of mass ([0021] which details the real-time displaying of information and [0047]-[0049] which details utilizing the estimated data to calculate the center of mass). The corrected signals and locations are determined by Ludwin, while the electrode positioning rendered obvious by Tegg.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ludwin in view of Bar-Tal and Tegg, and in further view of Beeckler et al. US Publication 2021/0187254 (hereinafter Beeckler).
Regarding claims 19-20, Ludwin, as modified by Bar-Tal and Tegg, is silent on the flexible portion at the distal end of the flexible section along said shaft. Beeckler teaches a balloon catheter that includes such a section including a helical spring (28, 38). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the helical spring as taught by Beeckler with the device of Ludwin in order to afford force sensing which can aid in determining the force of contact with the desired tissue.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/05/2026, with respect to the rejection(s) of claim(s) 11-20 under Ludwin in view of Bar-Tal have been fully considered and are persuasive as the electrodes used for position information (to determine the center of mass) are not located on the expandable portion as is now claimed. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tegg (above), who discloses that the position information can come from the electrodes on the expandable portion.
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.
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/B.M.A/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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