DETAILED ACTION
Applicant’s amendments and remarks, filed December 29, 2025, are fully acknowledged by the Examiner. Currently, claims 1-14 and 21-26 are pending with claims 21-26 newly added, claims 15-20 cancelled, and claim 4 amended. The following is a complete response to the December 29, 2025 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 .
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.
Election/Restrictions
Applicant’s election without traverse of Species A (figures 2-11B) in the reply filed on December 29, 2025 is acknowledged. Claims 1-14 and 21-26 are directed to this elected species and will be examined on the merit.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 5, 7-11, 14, 21, 23, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Pat. Pub. 2005/0033135 A1) further in view of Govari et al. (US Pat. Pub. 2021/0330372 A1) hereinafter “Govari ‘372”.
Regarding claim 1, Govari provides for a medical probe comprising an elongated shaft that extends along a longitudinal axis (catheter 20 with a shaft and having a longitudinal axis defined therealong), the elongated shaft comprising a distal tip (the tip section defined along the portion at 22),
a plurality of coils connected to the distal dip along the longitudinal axis (see figure 2 with the plurality of coils at 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 (see [0076], and
a plurality of electrodes connected to the distal tip along the longitudinal axis (the plurality of electrodes as in figure 2 at 26 and 28), 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 (via the electrodes as in [0082] being provided that “sensing electrodes 26 are adapted to additionally perform ablation” and “preferably, each element adapted to perform ablation (whether a sensing electrode 26 or an ablation electrode 28)”).
Govari fails to provide for elongated shaft to be dimensioned to be inserted into a vein of Marshall, or for the shaft to define a lumen where a guidewire extends through the lumen. Govari ‘372 discloses a similar probe as that of Govari the includes an elongated shaft (tube 32) that includes at least one coil configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil (at least one 34 thereon), and at least one 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 (at least one 76). Govari ‘372 further provides that its elongated shaft is specifically configured to be dimensioned to be inserted into a vein of Marshall (see at least 0060]), and to define a lumen wherein a guidewire extends through the lumen (tube 32 has a lumen therein for receiving the guidewire 26 as in [0046]).
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 first have utilized a lumen and guidewire therein as in Govari ‘372 with the probe of Govari to provide for an exemplary manner of directing the probe of Govari to a desired location with the body. Govari readily provides that steering or otherwise directing catheters are known in the art to place the probe at a desired location within the body (see at least [0008] of Govari) with the guidewire arrangement in Govari ‘372 providing a known manner of such guiding that also provides for a internal force to guide the probe including the curved portion at 22 through the vasculature to the desired location for deployment. The Examiner further finds that the utilization of a sizing of the probe as contemplated Govari ‘372 at [0046] would have been a further obvious consideration to one of ordinary skill in the art given that both probes of Govari and Govari ‘372 are directed towards probes for treating within the vasculture of the body and that further include similar electrode and coil structure defined thereon. The Examiner further notes that such a change in size as taught in the prior would generally be recognized as being within the level of ordinary skill in the art. see In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 2, Govari provides that each electrode comprising a ring electrode (each of the electrodes 26/28 are ring electrodes as in [0083]). The Examiner is further of the position that each electrode would include an electrode axis coaxial with the longitudinal axis when in the straight position in view of the combination in the rejection of claim 1 with the shaping guidewire in the guidewire lumen). Specifically, Govari ‘372 further provides for a longitudinal axis defined along a portion of the shaft that contains the coil and the electrode to be coaxial with an axis of the electrode contained thereon.
Regarding claim 5, in view of the combination in the rejection of claim 1 above, the elongated shaft comprises an outer wall (outer wall of the tube per the combination) and a lumen wall that defines the lumen (inner wall of the tube to define the lumen for the guidewire to pass therethrough).
Regarding claim 7, in view of the combination in the rejection of claim 1 above to provide the sizing per Govari ‘372, the combination further provides that the elongated shaft having an outer diameter between approximately .04 inches and .05 inches (see [0046] of Govari ‘372 providing for an outer diameter of 1mm which is approx. .04 inches).
Regarding claim 8, Govari provides that each coil comprising 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 the sensor 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 26 as in [0082] being provided that “sensing electrodes 26 are adapted to additionally perform ablation”; the Examiner is of the position that the sensing electrodes 26 would be capable of providing for both the claimed sensing and ablation).
Regarding claim 21, in view of the combination in the rejection of claim 1 above, the elongated shaft would be coaxial with the longitudinal axis along at least one portion of the shaft that is straight due to the guidewire placed therein..
Regarding claim 23, in view of the combination in the rejection of claim 1 above to provide the sizing per Govari ‘372 as well as the guidewire, the combination would include the guidewire to have a diameter between approximately 0.01 and 0.02 inches (see [0045 of Govari ‘372 providing for a 325 micron diameter guidewire which is approx. .0128 inches).
Regarding claim 10, Govari provides for a system comprising a medical probe comprising an elongated shaft that extends along a longitudinal axis (catheter 20 with a shaft and having a longitudinal axis defined therealong), the elongated shaft comprising a distal tip (the tip section defined along the portion at 22),
a plurality of coils connected to the distal dip along the longitudinal axis (see figure 2 with the plurality of coils at 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 (see [0076]), and
a plurality of electrodes connected to the distal tip along the longitudinal axis (the plurality of electrodes as in figure 2 at 26 and 28), 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 (via the electrodes as in [0082] being provided that “sensing electrodes 26 are adapted to additionally perform ablation” and “preferably, each element adapted to perform ablation (whether a sensing electrode 26 or an ablation electrode 28)”),
and a processor configured to estimate a position of the distal tip based on the generated currents 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 at least [0078] providing for the console 34 to include a processor and to provide for the use of signals to derive a maps; [0079] further provides for ECG monitoring; see also [0081]-[0082] to provide for the ablating via 26/28 under control of console including the processor).
Govari fails to provide for elongated shaft to be dimensioned to be inserted into a vein of Marshall, or for the shaft to define a lumen where a guidewire extends through the lumen. Govari ‘372 discloses a similar probe as that of Govari the includes an elongated shaft (tube 32) that includes at least one coil configured to generate a current when subjected to a magnetic field, the current being indicative of a position of the respective coil (at least one 34 thereon), and at least one 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 (at least one 76). Govari ‘372 further provides that its elongated shaft is specifically configured to be dimensioned to be inserted into a vein of Marshall (see at least 0060]), and to define a lumen wherein a guidewire extends through the lumen (tube 32 has a lumen therein for receiving the guidewire 26 as in [0046]).
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 first have utilized a lumen and guidewire therein as in Govari ‘372 with the probe of Govari to provide for an exemplary manner of directing the probe of Govari to a desired location with the body. Govari readily provides that steering or otherwise directing catheters are known in the art to place the probe at a desired location within the body (see at least [0008] of Govari) with the guidewire arrangement in Govari ‘372 providing a known manner of such guiding that also provides for a internal force to guide the probe including the curved portion at 22 through the vasculature to the desired location for deployment. The Examiner further finds that the utilization of a sizing of the probe as contemplated Govari ‘372 at [0046] would have been a further obvious consideration to one of ordinary skill in the art given that both probes of Govari and Govari ‘372 are directed towards probes for treating within the vasculture of the body and that further include similar electrode and coil structure defined thereon. The Examiner further notes that such a change in size as taught in the prior would generally be recognized as being within the level of ordinary skill in the art. see In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 11, Govari provides that each electrode comprising a ring electrode (each of the electrodes 26/28 are ring electrodes as in [0083]). The Examiner is further of the position that each electrode would include an electrode axis coaxial with the longitudinal axis when in the straight position in view of the combination in the rejection of claim 1 with the shaping guidewire in the guidewire lumen). Specifically, Govari ‘372 further provides for a longitudinal axis defined along a portion of the shaft that contains the coil and the electrode to be coaxial with an axis of the electrode contained thereon.
Regarding claim 14, Govari provides that each coil comprising 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 the sensor 30 to be a single-coil sensor).
Regarding claim 25, in view of the combination in the rejection of claim 1 above to provide the sizing per Govari ‘372 as well as the guidewire, the combination would include the guidewire to have a diameter between approximately 0.01 and 0.02 inches (see [0045 of Govari ‘372 providing for a 325 micron diameter guidewire which is approx. .0128 inches).
Regarding claim 26, in view of the combination in the rejection of claim 1 above to provide the sizing per Govari ‘372, the combination further provides that the elongated shaft having an outer diameter between approximately .04 inches and .05 inches (see [0046] of Govari ‘372 providing for an outer diameter of 1mm which is approx. .04 inches).
Claims 3, 4, 12, 13, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Govari (US Pat. Pub. 2005/0033135 A1) in view of Govari et al. (US Pat. Pub. 2021/0330372 A1) hereinafter “Govari ‘372” as applied to claims 1 and 10 respectively above, and further in view of Ben-haim (EP 0911059 A2).
Regarding claims 3 and 12, while Govari provides for a first coil of the plurality of coils being disposed within the distal tip (a distal one of 30), neither Govari nor Govari ‘372 provides that the first coil is positioned so as to overlap with a distalmost electrode of the plurality of electrodes along the longitudinal axis. Ben-hain discloses a similar probe as that of Govari and specifically provides for a distal coil (32) to located so as to overlap with a distal electrode (26 as in figures 2/4). 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 an overlapping placement of the first coil and the distal-most electrode in Govari as taught by Ben-haim. Such would provide for the user to accurately locate the position of both the distal tip of the device as well as the location of the distal-most electrode during treatment.
Regarding claims 4 and 13, Govari further provides that the plurality of coils further comprise a second coil and a third coil, 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 a second and third of the coils 30/32 being non-overlapping with the remainder of the electrodes 26/28).
Regarding claims 22 and 24, Govari provides that the plurality of electrodes comprising eight to ten ring electrodes that are positioned, relative to a distal end of the distal tip (see figure 2 with at least 8 electrodes shown at 26/28, see also [0084] providing for 10-12 sensing electrodes). The combination fails to provide that the spacing is in approximately two-millimeter increments from one another along the longitudinal axis. Ben-haim provides for a similar probe as that of Govari where a plurality of electrodes are provided in a plurality of configurations (see [0082]) including for a plurality of electrodes to be spaced in approximately two-millimeter increments from one another along the longitudinal axis (see [0057] providing for “a gap of about 1-2 mm 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 a spacing between the plurality of eletrodes in Govari to have a spacing of two-millimeter increments from one another as taught by Ben-haim. Ben-haim readily provides that such a spacing is an exemplary spacing value that provides for sensing via its electrodes at a target location within the body in addition to the application of energy and locating using at least one coil of the probe. Thus, the selection of the claimed spacing would have been an obvious consideration to one of ordinary skill in the art to provide for the disclosed sensing/ablation by the electrodes of Govari. The Examiner further notes that the selection of such a value from the spacing would have been further obvious since it has 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 (US Pat. Pub. 2005/0033135 A1) in view of Govari et al. (US Pat. Pub. 2021/0330372 A1) hereinafter “Govari ‘372” as applied to claim 5 above, and further in view of Saad (US Pat. No. 5,727,553).
Regarding claim 6, while Govari provides for the plurality of coils, and Govari ‘372 provides for the outer wall and lumen wall, neither Govari nor Govari ‘372 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 ‘372 and specifically contemplates the encapsulating a location coil within the wall of a probe between an outer wall and a lumen wall (see figure 6A with the coil at 70 located within the wall; see also col. 6; 17-19). Therefore, it is the Exmainer’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 between the outer and lumen walls of the combined device of Govari and Govari ‘372 to provide for 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794