DETAILED ACTION
Applicant’s amendments and remarks, filed July 8, 2026, are fully acknowledged by the Examiner. Currently, claims 1-20 are pending with claims 1, 3, 5, 7-10, 14 and 16-20 amended. The following is a complete response to the July 8, 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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the requirement in claim 20 of the elongated electrode to comprise a width and a length such that “the length being shorter than the width”. The Examiner notes that this requirement only appears in claim 20 and the Specification only sets forth in filed [0053] that “the elongated electrodes have respective lengths 94 that are at least twice as long as their respective widths 96”.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the requirement in claim 20 of the elongated electrode to comprise a width and a length such that “the length being shorter than the width” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hareland (US Pat. Pub. 2018/0064495 A1).
Regarding claim 20, Hareland provides for a computer software product, operated in conjunction with a medical probe configured to be inserted into a body cavity and comprising a distal end having at least one elongated electrode disposed along the distal end (the Examiner notes that the software of Hareland is readily capable of being used in conjunction with a suitable medical probe and at least one elongated electrode as claimed; the claimed “a medical probe” is set forth in the preamble of the claim to define the intended use of the software product; see MPEP 2111.02), the product comprising a non-transitory computer-readable medium, in which program instructions are stored, which instructions, when read by a computer, cause the computer:
to generate a three-dimensional (3D) model of a body cavity (see [0052]),
to receive, from a position transducer associated with the medical probe, signals indicative of orientation and location coordinates of the distal end within the body cavity (one of the navigation electrodes 38a/b of the device 12 functioning as in [0040]-[0042]),
to identify, based on the 3D model and the signals, including the orientation and location coordinates of the distal end within the body cavity, a segment disposed at a position along a length of a given elongated electrode that is in contact with tissue at at least one respective site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity (see paragraphs [0054]-[0058] disclosing the determination of contact assessment between portions of the expandable treatment element 30 having at least one treatment electrode thereon to a tissue surface; figures 3/4 display a surface of 30 with the map displaying a segment of 30 that is in contact at 78/80 and portions not in contact at 76),
and to render to the display a graphical representation of the 3D model with a visual marker at a location on the 3D model corresponding to the at least one respective site contacted by the segment of the at least one given elongated electrode (via the displaying of the surface map 72 to the user as in [0060]-[0061]).
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 1-6 and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hareland (US Pat. Pub. 2018/0064495 A1) further in view of Avitall (US 2012/0143179 A1).
Regarding claim 1, Hareland provides for an apparatus, comprising:
a medical probe configured to be inserted into a body cavity and comprising a distal end having at least one elongated electrode disposed along the distal end (device 12 with the expandable treatment element 30; see [0038] providing for an electrode to be considered a treatment element 30), wherein the at least one elongated electrode comprises a length and a width, (an electrode of Hareland would have an inherent length and width),
a position transducer associated with the medical probe (one of the navigation electrodes 38a/b functioning as in [0040]-[0042]),
a memory configured to store a three-dimensional (3D) model of the body cavity (memory within the processing unit 58 as in [0047]), a display (54), and
a processor configured: to receive, from the position transducer, signals indicative of orientation and location coordinates of the distal end within the body cavity (processor of the processing unit 58 as in [0047]),
to identify, based on the 3D model and the signals, including the orientation and location coordinates of the distal end within the body cavity, a segment disposed at a position along a length of a given elongated electrode that is in contact with tissue at least one respective site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity (see paragraphs [0054]-[0058] disclosing the determination of contact assessment between portions of the expandable treatment element 30 having at least one treatment electrode thereon to a tissue surface; figures 3/4 display a surface of 30 with the map displaying a segment of 30 that is in contact at 78/80 and portions not in contact at 76), and
to render to the display a graphical representation of the 3D model with a visual marker at a location on the 3D model corresponding to the at least one respective site contacted by the segment of the at least one given elongated electrode (via the displaying of the surface map 72 to the user as in [0060]-[0061]).
While Hareland contemplates that the device can include one or more electrodes with various different structural arrangements, Hareland fails to specifically contemplate that the “at least one elongated electrode comprising a width and a length, the length being longer than the width”. Avitall discloses a similar device as that of Hareland with an expandable distal end and at least one electrode thereon (see figures 18A/B with the electrodes 606 disposed on an expandable element) wherein each electrode comprises a length and a width, and with the length being longer than the width (see [0050] providing that the expandable balloon has a length of 30mm, a diameter of 15mm, and each of the electrodes 606 only covering a portion of the circumferent of the balloon). 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 at in Avitall as the electrodes of the expandable distal end of Hareland to provide for an exemplary manner of transferring energy to tissue. Hareland, again, readily contemplates for a number of electrodes to be on its treatment element as in [0038] with Avitall providing an exemplary manner of accomplishing such.
In view of the combination with Avitall, the Examiner is of the position that the identification of the portions of the treatment element 30 in Hareland would then readily function to provide the indicatin that “a segment disposed at a position along the length of at least one given elongated electrode that is in contact with tissue at at least one respective site on an inner surface … while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity” given that the indentifcation per Hareland would indicate which portions of at least one of the electrode structures provided by the combination with the electrodes 606 of Avital would be in contact with tissue and which portions are not.
Regarding claim 2, in view of the combination with Avitall above and the direction therein to provide for a plurality of circumferential electrodes 606 on an expandable member, and further in view of the exemplary ratio of dimensions of the length and diameter of the expandable member, that it would have been further obvious to utilize a length of the at least one elongated electrode that is at least twice as long as the width of the at least one elongated electrode. In particular, the disclosed 30mm length in Avitall and multiple circumferential electrodes thereon would result in a width less than half its length.
Regarding claim 3, Hareland provides for an inflatable balloon that extends from a lumen in the distal end of the medical probe (30 is formed as a balloon as in [0038]).
Regarding claim 4, the combined arrangement of Hareland and Avitall provides that that at least one electrode is a surface electrode that would be disposed longitudinally on a surface of the balloon, and that the length of the at least one elongated electrode is at least twice as long as the width of the at least one elongated electrode. In particular, Avitall displays that the electrodes 606 are surface electrodes. Additionally, in view of the combination with Avitall above and with the direction therein to provide for a plurality of circumferential electrodes 606 on an expandable member, and further in view of the exemplary ratio of dimensions of the length and diameter of the expandable member, the Examiner is of the position that it would have been further obvious to utilize a length of the at least one elongated electrode that is at least twice as long as the width of the at least one elongated electrode. In particular, the disclosed 30mm length in Avitall and multiple circumferential electrodes thereon would result in a width less than half its length.
Regarding claim 5, Hareland provides for an ablation module configured to deliver ablation energy to the at least one given elongated electrode, thereby ablating the tissue that is in contact with the at least one given electrode (see [0045] providing for the radiofrequency generator to provide power for ablating tissue).
Regarding claim 6, Hareland provides that the processor is further configured, to receive, prior to receiving the signals, 3D model data for the body cavity wherein the 3D model data comprises a first set of voxels, and to generate, using the first set of voxels, the 3D model (as in [0052] with the uploaded map provided in step 100).
Regarding claim 10, Hareland provides for a method, comprising: generating a three-dimensional (3D) model of a body cavity (as in [0052]),
receiving, from a position transducer associated with a medical probe configured to be inserted into the body cavity and comprising a distal end having at least one elongated electrode disposed along the distal end, signals indicative of orientation and location coordinates of the distal end within the body cavity (one of the navigation electrodes 38a/b of the device 12 functioning as in [0040]-[0042]; the device 12 has an expandable treatment element 30 with [0038] providing for an electrode to be considered a treatment element 30), wherein the at least one elongated electrode comprises a length and a width, (an electrode of Hareland would have an inherent length and width),
identifying, based on the 3D model and the signals, including the orientation and location coordinates of the distal end within the body cavity, a segment disposed at a position along a length of a given elongated electrode that is in contact with tissue at least one respective site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity (see paragraphs [0054]-[0058] disclosing the determination of contact assessment between portions of the expandable treatment element 30 having at least one treatment electrode thereon to a tissue surface; figures 3/4 display a surface of 30 with the map displaying a segment of 30 that is in contact at 78/80 and portions not in contact at 76),
and rendering to the display a graphical representation of the 3D model with a visual marker at a location on the 3D model corresponding to the site contacted by the segment of the given elongated electrode (via the displaying of the surface map 72 to the user as in [0060]-[0061]).
While Hareland contemplates that the device can include one or more electrodes with various different structural arrangements, Hareland fails to specifically contemplate that the “at least one elongated electrode comprising a width and a length, the length being longer than the width”. Avitall discloses a similar device as that of Hareland with an expandable distal end and at least one electrode thereon (see figures 18A/B with the electrodes 606 disposed on an expandable element) wherein each electrode comprises a length and a width, and with the length being longer than the width (see [0050] providing that the expandable balloon has a length of 30mm, a diameter of 15mm, and each of the electrodes 606 only covering a portion of the circumferent of the balloon). 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 at in Avitall as the electrodes of the expandable distal end of Hareland to provide for an exemplary manner of transferring energy to tissue. Hareland, again, readily contemplates for a number of electrodes to be on its treatment element as in [0038] with Avitall providing an exemplary manner of accomplishing such.
In view of the combination with Avitall, the Examiner is of the position that the identification of the portions of the treatment element 30 in Hareland would then readily function to provide the indicatin that “a segment disposed at a position along the length of at least one given elongated electrode that is in contact with tissue at at least one respective site on an inner surface … while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity” given that the indentifcation per Hareland would indicate which portions of at least one of the electrode structures provided by the combination with the electrodes 606 of Avital would be in contact with tissue and which portions are not.
Regarding claim 11, in view of the combination with Avitall above and the direction therein to provide for a plurality of circumferential electrodes 606 on an expandable member, and further in view of the exemplary ratio of dimensions of the length and diameter of the expandable member, that it would have been further obvious to utilize a length of the at least one elongated electrode that is at least twice as long as the width of the at least one elongated electrode. In particular, the disclosed 30mm length in Avitall and multiple circumferential electrodes thereon would result in a width less than half its length.
Regarding claim 12, Hareland provides for an inflatable balloon that extends from a lumen in the distal end of the medical probe (30 is formed as a balloon as in [0038]).
Regarding claim 13, the combined arrangement of Hareland and Avitall provides that that at least one electrode is a surface electrode that would be disposed longitudinally on a surface of the balloon, and that the length of the at least one elongated electrode is at least twice as long as the width of the at least one elongated electrode. In particular, Avitall displays that the electrodes 606 are surface electrodes. Additionally, in view of the combination with Avitall above and with the direction therein to provide for a plurality of circumferential electrodes 606 on an expandable member, and further in view of the exemplary ratio of dimensions of the length and diameter of the expandable member, the Examiner is of the position that it would have been further obvious to utilize a length of the at least one elongated electrode that is at least twice as long as the width of the at least one elongated electrode. In particular, the disclosed 30mm length in Avitall and multiple circumferential electrodes thereon would result in a width less than half its length.
Regarding claim 14, Hareland provides delivering, via an ablation module, ablation energy to the at least one elongated electrode, thereby ablating the tissue that is in contact with the at least one given electrode (see [0045] providing for the radiofrequency generator to provide power for ablating tissue).
Regarding claim 15, Hareland provides that the visual marker corresponds to the site ablated by the segment of the given elongated electrode (via such a location of the electrode in contact with tissue to be the location that ablation is generated).
Regarding claim 16, Hareland receiving, prior to receiving the signals, 3D model data for the body cavity wherein the 3D model data comprises a first set of voxels, and generating, using the first set of voxels, the 3D model (as in [0052] with the uploaded map provided in step 100).
Allowable Subject Matter
Claims 7-9 and 17-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to the prior rejections of independent claims 1 and 10 under 35 U.S.C. 102(a)(1) as anticipated by Hareland on pages 8-10 of the Remarks filed July 8, 2026 have been fully considered and are persuasive. In particular, the Examiner finds Applicant argument therein that the Examiner’s prior characterization of the treatment element 30 being considered as the claimed “electrode” in view of the disclosure in [0038], and then for such to provide for the length of the electrode to be greater than the width of the electrode has been found as perausisve upon further review of the broadest reasonable interpretation of each claim and in light of Applicant’s comments regarding [0038] of Hareland. Therefore, the rejections of each of idnepednent claims 1 and 10 have been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hareland (US Pat. Pub. 2018/0064495 A1).
Claims 1-6 and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hareland (US Pat. Pub. 2018/0064495 A1) further in view of Avitall (US 2012/0143179 A1).
The Examiner notes that Applicant has submitted additional arguments with respect to various aspects of each of independent claims 1, 10 and 20 in view of the Hareland reference on pages 10-12 of the Remarks. Applicant specifically contends that Hareland fails to provide “a processor configured ‘to identify, based on the 3D model and the signal, including the orientation and location coordinates of the distal end within the body cavity, a segment disposed at a position along the length of at least one given elongated electrode that is in contact with tissue at at least one respective site on an inner surface of the body cavity’”. Applicant alleges that Hareland only provides for the spatial location of the navigation electrodes 38 and the calculation of the surface geometry of the element(s) 30 relative to these electrodes 38 thereby failing to provide disclosure of the orientation of the distal end within a body cavity or for the use of such an orientation to determine a segment “disposed at a position along the length of at least one give electrode that is in contact with tissue at at least one respective site on an inner surface of the body cavity”. This is not persuasive.
The Examiner readily maintains that Hareland’s processor does indeed function to identify, based on the 3D model and the signals, including the orientation and location coordinates of the distal end within the body cavity, a segment disposed at a position along a length of a given elongated electrode that is in contact with tissue at least one respective site on an inner surface of the body cavity, while parts of the given elongated electrode other than the identified segment are not in contact with the inner surface of the body cavity. The Examiner takes the position that the disclosure in paragraphs [0054]-[0058] of Hareland provides adequate disclosure to show such a teaching. Hareland readily displays the determination of contact assessment between portions of the expandable treatment element 30 having at least one treatment electrode thereon to a tissue surface with the depiction in figures 3 and 4 displaying a surface of 30 with the map displaying a segment of 30 that is in contact (at 78/80) and portions not in contact (at 76).
The Examiner is of the position that this determination discussed above is further based on the orientation and location of the device 12 including the surface of the element 30 within the body relative to the endocardial surface . The claim only requires that the signals received from the position transducer “are indicative of orientation and location coordinates of the distal end with the body cavity” with the subsequent identification being “based on the 3D models and the signals, including orientation and location coordinates of the distal end within the body cavity”. Thus, the Examiner is of the position that the signals and subsequent identification only need to indicative of the location/orientation of the distal end of the medical probe within the body, which the display as shown in figures 3/4 of Hareland with the location and orientation of of body 30 relative to the tissue surface indeed qualifies as. The Examiner then further finds, in view of the combination with Avitall, that the showing of the contacted vs. contacted locations in Hareland would provide for the showing of a segment at least one electrode that is in contact with tissue as required by the claim.
Applicant’s arguments, see pages 13-14 of the Remarks with respect to the prior rejections of claims 7-9 and 17-19 under 35 U.S.C. 103 as being unpatentable over Hareland (US Pat. Pub. 2018/0064495 A1) further in view of Hareland (US Pat. Pub. 2018/0064494 A1) have been fully considered and are persuasive. In particular, Applicant persuasively argues that the prior-cited Hareland ‘494 reference fails to disclose, fairly suggest, or make obvious, the determination of location coordinates for “respective centroids of the two or more elongated electrodes” in light of the disclosure of Hareland ‘494 only being particularly concerned with the determination of the centroid of the entirety of the treatment element 30 and not of any manner of electrode contained on a surface thereof. Thus, the prior rejections of claims 7-9 and 17-19 under 35 U.S.C. 103 have been withdrawn.
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.
/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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