DETAILED ACTION
Applicant’s amendments and remarks, filed April 16, 2026, are fully acknowledged by the Examiner. Currently, claims 1-26 are pending with claims 15-20 cancelled, and claim 1 and 10 amended. The following is a complete response to the April 16, 2026 communication.
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 § 103
Claims 1-5, 7-14, 21, 23, 25 and 26are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (US Pat. Pub. 2021/0330372 A1) further in view of Govari (US Pat. Pub. 2005/0033135 A1) hereinafter “Govari ‘135” and Wang et al. (CN 215960235 U).
Regarding claim 1, Govari provides for a medical probe comprising an elongated shaft that extends along a longitudinal axis and is dimensioned to be inserted into a vein of Marshall (32), the elongated shaft comprising a distal tip and defining a lumen (lumen within 32 as in [0045]),
a guidewire that extends through the lumen (26),
a plurality of electrodes connected to the distal tip along the longitudinal axis, each electrode being configured to (i) sense anatomical signals in the vein of Marshall and provide electrical signals which are indicative of the anatomical signals or (ii) convey ablation energy to a target tissue region proximal the vein of Marshall (electrodes 64, see[0047] providing for the disclosed ablation functionality; the Examiner is of the position that the electrodes 64 would further be functionally capable of operating to sense signals of contacted tissue).
Govari, while providing for a single coil functioning to provide a current and to indicate a position of the coil (34 is capable of functioning as such as in [0046]), fails to provide for a plurality of coils connected to the distal tip along the longitudinal axis, each coil being configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil. Govari ‘135 provides for a similar device as that of Govari and specifically contemplates the inclusion of a plurality of coils connected to the distal tip of a shaft of a medical probe (see figure 2 with coils 30/32, see also [0074]), each coil being configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil (as in [0076])
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of spaced-apart locating coils as in Govari ‘135 to the distal end of the elongated shaft of Govari to provide for additional position detection and orientation within the body. Such would allow for the user to determination location as well as curves, bends or other changes in direction and location of the distal tip of the device within the body.
Both Govari and Govari ‘135 fail to provide for an inflatable balloon connected to the elongated shaft proximal of the plurality of electrodes configured to be in an inflated configuration in the vein of Marshall. Wang discloses a similar device as that of both Govari and Govari ‘135 and specifically contemplates the inclusion of an inflatable balloon proximal to an ablation structure and which is configured to be in an inflated configuration in the vein of Marshall (103). Therefore, it is he Examiner’s position hat it would have been obvious to have utilized an inflatable balloon as in Wang to the elongate shaft of Govari to provide for a manner of anchoring the elongate shaft at a desired location in the body during treatment.
Regarding claim 2, Govari provides that each electrode comprising a ring electrode comprising an electrode axis coaxial with the longitudinal axis (see figures 2, 4D and 5 with the ring/circular electrodes at 64 as in figures 2/4D or 68d/p as in figure 5).
Regarding claim 3, in view of the combination in the rejection of claim 1 above, the combined device would provide that a first coil of the plurality of coils bis disposed within the distal tip and positioned so as to overlap with a distalmost electrode of the plurality of electrodes along the longitudinal axis. The Examiner is of the position that the distal-most electrode (see figures 4C and 4D in Govari is configured to overlap with the first coil per the combination with Govari ‘135 given that the distal electrode 64 can be placed in a longitudinally-aligned arrangement with the distal-most coil).
Regarding claim 4, in view of the combination in the rejections of claims 1/3 above, the plurality of coils further comprise a second coil and a third coil (per the combination with Govari ‘135, there are at least three coils), the second coil and the third coil being positioned away from a distal end of the distal tip such that the second coil and the third coil are non-overlapping with each electrode of the plurality of electrodes (with such non-overlapping with the distal electrode 64).
Regarding claim 5, Govari provides that the elongated shaft comprises an outer wall and a lumen wall that defines the lumen (see, for example, figure 2 where 32 as an outer wall, and then an inner luminal wall to define the lumen passing through 32).
Regarding claim 7, Govari provides that the elongated shaft having an outer diameter between approximately .04 inches and .05 inches (see [0046] providing for an outer diameter of 1 mm which is approx. 0.04 inches).
Regarding claim 8, in view of the combination with Govari ‘135 above, the combined arrangement further provides that each coil comprises a single axis sensor selected from a group consisting of a flat spiral coil, cylindrical coil or combination thereof (See at least [0074] and [0077] providing for 30 to be a single-coil sensor).
Regarding claim 9, Govari provides that each electrode is configured to (i) sense the anatomical signals in the vein of Marshall and provide the electrical signals which are indicative of the anatomical signals and (ii) convey the ablation energy to the target tissue region proximal the vein of Marshall (via the electrodes 64; The Examiner is of the position that the electrodes 64 are functional capable of providing both sensing and ablating as claimed with such functionality failing to provide for a structural difference between the claimed electrodes and those in the Govari reference).
Regarding claim 21, Govari provides that the elongated shaft is coaxial with the longitudinal axis (via 32 being coaxial with a longitudinal axis defined therealong).
Regarding claim 23, Govari provides that the guidewire has a diameter between approximately 0.01 and 0.02 inches (see [0045] providing for a 325 micron diameter guidewire which is approx.. 0.0128 inches).
Regarding claim 10, Govari provides for a system comprising a medical probe comprising an elongated shaft that extends along a longitudinal axis and is dimensioned to be inserted into a vein of Marshall (32), the elongated shaft comprising a distal tip and defining a lumen therethrough (lumen within 32 as in [0045]),
a guidewire that extends through the lumen (26),
a location coil connected to the distal tip along the longitudinal axis the coil being configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil (34),
and a plurality of electrodes connected to the distal tip along the longitudinal axis, each electrode being configured to (i) sense anatomical signals in the vein of Marshall and provide electrical signals which are indicative of the anatomical signals or (ii) convey ablation energy to a target tissue region proximal the vein of Marshall (electrodes 64, see[0047] providing for the disclosed ablation functionality; the Examiner is of the position that the electrodes 64 would further be functionally capable of operating to sense signals of contacted tissue), and
a processor (44) configured to estimate a position of the distal tip based on the generated currents (see [0051]-[0056]) and (i) estimate at least one characteristic of the anatomical signals based on the electrical signals or (ii) provide a signal to convey the ablation energy to the electrodes (see [0070]).
Govari, while providing for a single coil functioning to provide a current and to indicate a position of the coil (34 is capable of functioning as such as in [0046]), fails to provide for a plurality of coils connected to the distal tip along the longitudinal axis, each coil being configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil. Govari ‘135 provides for a similar device as that of Govari and specifically contemplates the inclusion of a plurality of coils connected to the distal tip of a shaft of a medical probe (see figure 2 with coils 30/32, see also [0074]), each coil being configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil (as in [0076])
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of spaced-apart locating coils as in Govari ‘135 to the distal end of the elongated shaft of Govari to provide for additional position detection and orientation within the body. Such would allow for the user to determination location as well as curves, bends or other changes in direction and location of the distal tip of the device within the body.
Both Govari and Govari ‘135 fail to provide for an inflatable balloon connected to the elongated shaft proximal of the plurality of electrodes configured to be in an inflated configuration in the vein of Marshall. Wang discloses a similar device as that of both Govari and Govari ‘135 and specifically contemplates the inclusion of an inflatable balloon proximal to an ablation structure and which is configured to be in an inflated configuration in the vein of Marshall (103). Therefore, it is he Examiner’s position that it would have been obvious to have utilized an inflatable balloon as in Wang to the elongate shaft of Govari to provide for a manner of anchoring the elongate shaft at a desired location in the body during treatment.
Regarding claim 11, Govari provides that each electrode comprising a ring electrode comprising an electrode axis coaxial with the longitudinal axis (see figures 2, 4D and 5 with the ring/circular electrodes at 64 as in figures 2/4D or 68d/p as in figure 5).
Regarding claim 12, in view of the combination in the rejection of claim 1 above, the combined device would provide that a first coil of the plurality of coils bis disposed within the distal tip and positioned so as to overlap with a distalmost electrode of the plurality of electrodes along the longitudinal axis. The Examiner is of the position that the distal-most electrode (see figures 4C and 4D in Govari is configured to overlap with the first coil per the combination with Govari ‘135 given that the distal electrode 64 can be placed in a longitudinally-aligned arrangement with the distal-most coil).
Regarding claim 13, in view of the combination in the rejections of claims 1/3 above, the plurality of coils further comprise a second coil and a third coil (per the combination with Govari ‘135, there are at least three coils), the second coil and the third coil being positioned away from a distal end of the distal tip such that the second coil and the third coil are non-overlapping with each electrode of the plurality of electrodes (with such non-overlapping with the distal electrode 64).
Regarding claim 14, in view of the combination with Govari ‘135 above, the combined arrangement further provides that each coil comprises a single axis sensor selected from a group consisting of a flat spiral coil, cylindrical coil or combination thereof (See at least [0074] and [0077] providing for 30 to be a single-coil sensor).
Regarding claim 25, Govari provides that the guidewire has a diameter between approximately 0.01 and 0.02 inches (see [0045] providing for a 325 micron diameter guidewire which is approx.. 0.0128 inches).
Regarding claim 26, Govari provides that the elongated shaft has an outer diameter between approximately .04 inches and .05 inches (see [0046] providing for an outer diameter of 1 mm which is approx. 0.04 inches).
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (US Pat. Pub. 2021/0330372 A1) in view of Govari (US Pat. Pub. 2005/0033135 A1) hereinafter “Govari ‘135” and Wang et al. (CN 215960235 U) as applied to claims 1 and 10, respectively above, and further in view of Ben-Haim (EP 0911059 A2).
Regarding claims 22 and 24, Govari, while contemplating the inclusion of a plurality of electrodes (see [0070] setting force “[i]f there are two or more electrodes 64”) fails to specifically contemplate that the plurality of electrodes comprise eight to ten ring electrodes that are positioned, relative to a distal end of the distal tip, in approximately two-millimeter increments from one another along the longitudinal axis. Govari ‘135 provides for the inclusion of at least eight electrodes as shown in figure 2 at 26/28; see also [0084] providing for 10-12 sensing electrodes). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of electrodes in the number of eight to ten electrodes as the “two or more electrodes” in Govari to provide for an alternative number of electrodes that are readily functionable to sense parameters at a tissue site as well as provide bipolar energy delivery to tissue along a lumen within the body.
Neither Govari nor Govari ‘135 sets forth that that the spacing is approximately two-millimeter increments. Ben-Haim provides for a similar probe as that of each of Govari and Govari ‘135 and specifically contemplates for a plurality of electrodes that are spaced in approximately two-millimeter increments from one another along the longitudinal axis (see [0057] providing for a “gap of about 1-2mm between electrodes”). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the spacing arrangement in Ben-Haim to the combined electrode arrangement of Govari and Govari ‘135 given that it have been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205, USPQ 215 (CCPA 1980).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (US Pat. Pub. 2021/0330372 A1) in view of Govari (US Pat. Pub. 2005/0033135 A1) hereinafter “Govari ‘135” and Wang et al. (CN 215960235 U) as applied to claim 5 above, and further in view of Saad (US Pat. No. 5,727,553).
Regarding claim 6, neither Govari nor Govari ‘135 provide that each coil being disposed between the outer wall and the lumen wall. Saad discloses a similar probe as each of Govari and Govari ‘135 and specifically contemplates the encapsulating of a location coil within the wall of a probe between an outer wall and a lumen wall (see figure 6A with the coil 70 located within the wall; see also col. 6; 17-19). Therefore, it is the Examiner’s position that it would have been further obvious to one of ordinary skill in the art at the time of filing to have utilized a mounting of each of the plurality of coils per the combination of Govari and Govari ‘135 to provide for a known manner of structurally arranging the coils relative to the walls of the probe. Such a provision further provides a known manner of structurally arranging the coils relative to the walls of the probe. Such further provides protection and electrical isolation to the fine wires of the coils during navigation and operation within the body.
Response to Arguments
Applicant’s arguments, see pages 7-9 of the Remarks filed April 16, 2026, with respect to the rejection of claims 1 and 10 under 35 U.S.C. 103 as unpatentable over the combination of Govari and Govari ‘ 372 have been fully considered and are persuasive. In particular, the prior combination fails to provide for each and every limitation set forth in each of independent claims 1 and 10 including the newly-added limitation of “an inflatable balloon”. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-5, 7-14, 21, 23, 25 and 26are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (US Pat. Pub. 2021/0330372 A1) further in view of Govari (US Pat. Pub. 2005/0033135 A1) hereinafter “Govari ‘135” and Wang et al. (CN 215960235 U).
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (US Pat. Pub. 2021/0330372 A1) in view of Govari (US Pat. Pub. 2005/0033135 A1) hereinafter “Govari ‘135” and Wang et al. (CN 215960235 U) as applied to claims 1 and 10, respectively above, and further in view of Ben-Haim (EP 0911059 A2).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Govari et al (US Pat. Pub. 2021/0330372 A1) in view of Govari (US Pat. Pub. 2005/0033135 A1) hereinafter “Govari ‘135” and Wang et al. (CN 215960235 U) as applied to claim 5 above, and further in view of Saad (US Pat. No. 5,727,553).
The Examiner notes that the newly proffered rejection of independent claims 1 and 10 presents a new combination of the prior cited Govari references and further rely upon the newly cited Wang reference. The Examiner has failed to find any other rationale set forth in the April 16, 2026 Remarks that would preclude the newly proffered interpretation and combination of references set forth in the rejections above.
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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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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