DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 11 December 2025 has been entered. Claims 1, 7, 10, and 18 are currently amended. Claims 2-6 and 9 are canceled, and claims 21-26 are new. Claims 1, 7-8, and 10-26 are pending in the application. Applicant’s amendments to claim 7 have overcome the objection previously set forth in the Non-Final Office Action mailed 26 September 2025.
Claim Objections
Applicant is advised that should claims 19-20 be found allowable, claims 25-26 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1, 7-8, 10-15, and 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Stewart et al. (US PGPub No. 2018/0325586), hereinafter Stewart, in view of Govari (US PGPub No. 2021/0113263), and further in view of Curran et al. (US PGPub No. 2021/0220047), hereinafter Curran.
Regarding claims 1, 7, and 18, Stewart teaches a medical probe comprising: an insertion tube extending along a longitudinal axis (Fig. 1: shaft 202 and longitudinal axis 214);
an end effector disposed at a distal end of the insertion tube, the end effector comprising: a spine member (Fig. 1: distal end portion 212), and an electrode assembly disposed along at least a portion of the spine member (Fig. 1: electrode sets 217),
the electrode assembly comprising: a flexible substrate; a plurality of electrical leads extending along at least a portion of the flexible substrate; and a plurality of electrodes disposed on the flexible substrate, each electrode of the plurality of electrodes electrically connected to at least one electrical lead of the plurality of electrical leads, the plurality of electrodes wrapped around the spine member (Figs. 1-2: electrodes 218 wrapped around spine 212; par. 0076: “the mini-electrodes 218, 318 and 358 can be formed on flex circuits that may comprise one or more than one of the mini-electrode sets 217, 317 or 357 on the respective catheter”),
at least some of the electrodes of the plurality of electrodes positioned facing away from the longitudinal axis, the plurality of electrodes arranged on the flexible substrate such that at least three electrodes are aligned around a circumference of the spine member at each location where an electrode is positioned facing away from the longitudinal axis (Fig. 2: electrode sets 217 containing electrodes 218 and par. 0071: “the ablation catheters 100, 300 can have between two and four mini-electrode sets 217, 318 disposed about the circumference of the respective catheter shaft 202, 302”).
Stewart teaches wherein the distal end portion of the probe can be deflected into a curve (Fig. 6; par. 0061: “The deflection region 220 is configured to bend in a pre-determined direction, e.g., by manipulation of the control element 226, so as to change the trajectory of the distal end portion 212 of the shaft 202, and in particular, the mapping region thereof containing the mini-electrode sets 217. This ability to change the shape of the shaft 202 within or proximate the mapping region is useful in allowing the user to urge the mini-electrodes 218 into direct contact with target tissue, particularly when the target tissue is within a body lumen such as a pulmonary vein”) but does not explicitly teach wherein the end effector is configured to bow radially outward from the longitudinal axis generally perpendicular to the longitudinal axis to define a lasso catheter, or wherein at least some of electrodes of the plurality of electrodes are positioned on a side of a lasso catheter facing away from the longitudinal axis extending through a lasso catheter. However, in an analogous art, Govari teaches a mapping/ablation catheter with an arcuate lasso shape and electrodes disposed on the outer circumference of the lasso shape (Fig. 2: electrodes 53 facing away from the longitudinal axis of the lasso catheter), which help to engage a circumference of an opening in the heart and minimize unwanted interference from stray electrophysiological signals (par. 0023: “the arcuate shape should enable, in principle, electrodes disposed over the arcuate end section to engage some or all of the circumference of an opening in the heart, such as an ostium of a pulmonary vein” and par. 0030: “the electrodes are disposed on the outer (tissue-facing) circumference of the inflatable sleeve, and are not fully cylindrical, i.e., do not fully surround the inflatable sleeve to reach the inner circumference that faces away from the tissue. This configuration helps minimizing unnecessary exposure of the electrodes to blood. The accommodating properties of the inflatable sleeve, together with electrode shape and location, thus assist in minimizing unwanted interference from stray electrophysiological signals”).
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 medical probe and electrode assembly of Stewart by configuring the distal end to deflect into an arcuate (i.e., lasso) shape and placing the electrodes on the outer circumference of the lasso shape, as taught by Govari, in order to help engage a circumference of an opening in the heart and minimize unwanted interference from stray electrophysiological signals, as taught by Govari.
The combination does not explicitly teach wherein the flexible substrate is wrapped helically around the spine member. However, in an analogous art, Curran teaches a flexible substrate with a plurality of electrodes disposed thereon and wrapped helically around a spine member (Figs. 3-4: flexible circuit 220 and plurality of electrodes 221; par. 0054: “it may be desirable to have a number of electrodes radially positioned about the catheter shaft at one or more longitudinal positions along the catheter shaft. In such an application, a single flexible circuit may be helically wound about the catheter shaft, two or more times, to position radially offset electrodes along the catheter shaft”).
The substitution of one known element (helically wrapped flexible substrate as shown in Curran) for another (flexible substrate wrapped in rings as shown in Stewart) would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since the substitution of the helically wrapped flexible substrate shown in Curran would have yielded predictable results, namely, radially offset electrodes at multiple longitudinal positions along the catheter shaft using a single flexible circuit rather than multiple flexible circuits.
The combination further teaches the method of claim 18, since the method merely recites steps for forming the device as claimed.
Regarding claims 8 and 21, the combination teaches the medical probe of claim 7 and method of claim 18 as described previously. Stewart further teaches wherein each of the electrodes of the plurality of electrodes is configured to detect electroanatomical signals (par. 0060: “the mini-electrodes 217 can facilitate high-density mapping of target tissue both before and after the application of ablation energy using the same catheter through which the ablation energy itself is applied”).
Regarding claims 10-11 and 22-23, the combination teaches the medical probe of claim 7 and method of claim 18 as described previously. Stewart further teaches wherein the at least three electrodes are spaced approximately 120 degrees apart from each other around the circumference of the lasso catheter and wherein at least one electrode of the at least three electrodes is configured to face tissue and at least another electrode of the at least three electrodes being configured to face blood when the lasso catheter is inserted into a lumen of a body (Figs. 2 and 6; par. 0065: “the various mini-electrode sets 217 can be arranged such that they are equally spaced from one another about the circumference of the shaft 202;” examiner notes that spacing three sets equally about the circumference of the shaft would result in the electrodes 218 being spaced approximately 120 degrees apart from each other).
Regarding claims 12 and 24, the combination teaches the medical probe of claim 7 and method of claim 18 as described previously. Stewart teaches a spacing of 0.5 – 2 millimeters between electrodes and does not explicitly teach wherein each electrode of the plurality of electrodes is spaced approximately 9 millimeters from an adjacent electrode of the plurality of electrodes. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the electrodes to be spaced 9 millimeters apart, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 13-15, 19-20, and 25-26, the combination teaches the medical probe of claim 12 and method of claim 18 as described previously. Stewart further teaches further comprising an insulative sleeve disposed over the electrode assembly and a plurality of apertures extending through the insulative sleeve, the plurality of apertures configured to align with the plurality of electrodes (par. 0065: “electrically insulative material of the shaft 202 is disposed between the mini-electrodes 218 so as to electrically isolate the mini-electrodes 218 from one another”), the plurality of apertures comprising multiple apertures extending through the insulative sleeve at each electrode of the plurality of electrodes (par. 0073: “portions of the respective mini-electrodes 218, 318 may be masked or otherwise covered such that only the exposed portions of the mini-electrodes 218, 318 are exposed to the external environment. This configuration may advantageously provide for directional mapping capability”).
Regarding claim 17, the combination teaches the medical probe of claim 7 as described previously. Stewart further teaches further comprising a position sensor configured to generate a current when subjected to an electromagnetic field (par. 0058: “the catheter 100 can include navigation sensors (e.g., electromagnetic coil or magneto-resistive sensors) to facilitate accurate localization of the distal end portion 212 within the subject anatomy”).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Stewart in view of Govari and Curran and further in view of Rao et al. (US PGPub No. 2020/0030024), hereinafter Rao.
Stewart in view of Govari and Curran teaches the medical probe of claim 13 as described previously. Stewart further teaches a fluid delivery system (Fig. 1: fluid delivery system 164) but does not explicitly teach wherein the insulative sleeve comprises a plurality of irrigation holes extending through the insulative sleeve, the plurality of irrigation holes configured to permit an irrigation fluid to flow therethrough. However, in an analogous art, Rao teaches a catheter end with an insulative sleeve comprising a plurality of irrigation holes extending through the insulative sleeve, the plurality of irrigation holes configured to permit an irrigation fluid to flow therethrough, in order to provide irrigation out of a particular portion of the catheter (Fig. 3: irrigation ports 134; par. 0041: “Flexible circuit 100 may further comprise various layers, e.g., formed via a lithographic process. […] An additional layer may also comprise an insulator” and par. 0042: “Ports 134 may be provided through flexible circuit 100. These ports may be used to provide irrigation out of tip 200”). 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 medical probe of the combined reference by including a plurality of irrigation holes through the insulative sleeve, as suggested by Rao, in order to provide irrigation out of a particular portion of the catheter, i.e., the electrode assembly, as taught by Rao.
Response to Arguments
Applicant’s arguments, filed 11 December 2025, with respect to the rejection(s) of claim(s) 1, 7, and 18 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Curran. As described previously, Curran teaches wrapping a flexible substrate helically around a catheter shaft as a means for positioning radially offset electrodes at multiple longitudinal positions along the catheter shaft.
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 DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794