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 October 28th, 2025 has been entered. Claims 1 & 4-6 are amended. Claims 1-7 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; as necessitate by amendment.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Harlev et al. (previously presented-US 20230012307 A1), hereinafter “Harlev”, in view of Ehrenreich et al. (US 20150359432 A1), hereinafter “Ehrenreich”.
Regarding claim 1, Harlev discloses a catheter, comprising: an elongated body at least a distal end side of which is to be inserted into a body ([0034]; Figure 2—element 122); and an electrode provided around an axis of the elongated body and expandable in a direction intersecting the axis ([0036]; Figures 3A & 3B—element 250), wherein the electrode in an expanded state includes an intermediate portion at least partially including a portion in which element wires spread like a mesh ([0040], & [0053]-[0055]; Figure 3B & 8D—element 352; the examiner is considering the intermediate portion to be the active body portion 352 of the expandable electrode 250 located in between the nose portion 355 and neck portion 357 ), a proximal end portion which is located closer to a proximal end side of the elongated body than the intermediate portion and in which the element wires gather ([0040], [0041], & [0056]; Figures 3B & 8D—element 357; the examiner is considering the proximal end portion to be the neck portion 357), and a distal end portion which is located closer to the distal end side than the intermediate portion and in which the element wires gather ([0040], [0041], & [0057]; Figures 3B & 8D—element 355; the examiner is considering the distal end portion to be the nose portion 355), the intermediate portion includes a maximum portion where an outer dimension of the electrode is maximized, and the maximum portion is located closer to the proximal end side than a center of the electrode in an axial direction of the elongated body ([0040] & [0073]; Figures 3A, 3B, & 8D—element 352; the expandable electrode comprises a pear-shape; the examiner is considering the maximum portion to be the proximal portion of the intermediate portion 352, which is shown in figures 3A, 3B, & 8D as having a maximum diameter and being location closer to the proximal end side than the center of the electrode is).
Harlev does not disclose wherein the electrode is comprised of a pipe in which a cut is made.
Ehrenreich teaches a catheter comprising an expandable member, wherein the expandable member is comprised of a pipe in which a cut is made ([0045]; Figure 2—element 450).
A person of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to modify the expandable electrode, as disclosed by Harlev, to include wherein the wherein the expandable electrode is comprised of a pipe in which a cut is made, as taught by Ehrenreich, as both references and the claimed invention are directed toward ablation devices comprising expandable members. As disclosed by Harlev, the expandable electrode may be formed by a plurality of panels that are each formed by a tube that is laser cut ([0027] & [0054]). As disclosed by Ehrenreich, the expandable member may be configured as a unitary member cut from a single tubular member or the expandable member may be embodied as a plurality of separate members ([0045]). 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 expandable electrode, as disclosed by Harlev, to include wherein the wherein the expandable electrode is comprised of a pipe in which a cut is made, as taught by Ehrenreich, as providing an expandable member that is configured as a unitary member cut from a single tubular member is a known and suitable alternative in the art to providing an expandable member that is embodied as a plurality of separate members; further the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the electrode is comprised of a pipe in which a cut is made, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 2, Harlev in view of Ehrenreich disclose all of the limitations of claim 1, as described above.
Harlev further discloses wherein in a distal end-side region from the maximum portion to the distal end portion ([0040] & [0073]; Figures 3B & 8D—elements 352 & 355; the examiner is considering the distal end-side region as comprising the portion of electrode 250 between the maximum portion of the intermediate portion 352 and the distal end of the distal end portion 355), an outer dimension of the electrode at a first position in the axial direction of the elongated body is smaller than an outer dimension of the electrode at a second position closer to the proximal end side than the first position ([0040] & [0073]; Figure 3B & 8D—elements 352 & 355; the electrode 250 is pear-shaped and tapers from a larger diameter in the proximal end of intermediate portion 352 to a smaller diameter in the distal end portion 355; as shown in figures 3B & 8D, an outer dimension of the electrode at a first position distally (e.g. at the distal region of the intermediate portion 352 or in the distal end portion 355) is smaller than an outer dimension of the electrode at a second position (e.g. in the proximal region of the intermediate portion 352)).
Regarding claim 3, Harlev in view of Ehrenreich disclose all of the limitations of claim 2, as described above.
Harlev further discloses wherein the electrode includes, in the distal end-side region, a tapered portion whose outer dimension gradually decreases toward the distal end portion ([0040] & [0073]; Figure 3B & 8D—elements 352 & 355; the intermediate portion 352 is shown, in Figures 3B & 8D, as tapering from a proximal larger outer diameter to a distal smaller outer diameter).
Regarding claim 4, Harlev discloses a catheter, comprising: an elongated body at least a distal end side of which is to be inserted into a body ([0034]; Figures 2, 3A, 3B, & 8D—element 122); and an electrode provided around an axis of the elongated body and expandable in a direction intersecting the axis ([0036]; Figures 3A & 3B—element 250), wherein the electrode in the expanded state includes an intermediate portion at least partially including a portion in which element wires spread like a mesh ([0040], & [0053]-[0055]; Figure 3B & 8D—element 352; the examiner is considering the intermediate portion to be the active body portion 352 of the expandable electrode 250 located in between the nose portion 355 and neck portion 357), a proximal end portion which is located closer to a proximal end side of the elongated body than the intermediate portion and in which the element wires gather ([0040], [0041], & [0056]; Figures 3B & 8D—element 357; the examiner is considering the proximal end portion to be the neck portion 357), and a distal end portion which is located closer to the distal end side than the intermediate portion and in which the element wires gather ([0040], [0041], & [0057]; Figures 3B & 8D—element 355; the examiner is considering the distal end portion to be the nose portion 355), the intermediate portion including a maximum portion where an outer dimension of the electrode is maximized ([0040] & [0073]; Figures 3A, 3B, & 8D—element 352; the expandable electrode comprises a pear-shape; the examiner is considering the maximum portion to be the proximal portion of the intermediate portion 352, which is shown in figures 3A, 3B, & 8D as having a maximum diameter), the electrode includes a proximal end-side region from the proximal end portion to the maximum portion ([0040]; Figures 3B & 8D—element 357; the examiner is considering the proximal end-side region as comprising the proximal end portion 357) and a distal end-side region from the maximum portion to the distal end portion ([0040] & [0073]; Figures 3B & 8D—elements 352 & 355; the examiner is considering the distal end-side region as comprising the portion of electrode 250 between the maximum portion of the intermediate portion 352 and the distal end of the distal end portion 355), and in a first region continuing from the proximal end portion in the axial direction of the elongated body within the proximal end-side region and a second region continuing from the maximum portion in an axial direction within the distal end-side region ([0040]; the examiner is considering the first region as comprising the proximal end portion 357 and the second region as comprising the intermediate portion 352 and the distal end portion 355), a number of the element wires in the first region is less than a number of the element wires in the second region ([0053]; Figures 7A & 8D—elements 751, 755, & 757), and a thickness of the element wires in the first region is larger than a thickness of the element wires in the second region ([0053]; Figures 3B & 8D—elements 751, 755, & 757; the element wires 757 in the first region 357 may comprise an insulating PTFE sleeve, whereas the element wires 751 & 755 in the second region 352 & 355 may not comprise the insulating PTFE sleeve so as to be capable of conducting electrosurgical energy to tissue; it is the examiners position that the thickness of the element wires 757 in the first region 357 containing the insulating PTFE sleeve would be larger than the thickness of the element wires 750 & 755 in the second region 352 & 355 that do not contain the insulating PTFE sleeve).
Harlev does not disclose wherein the electrode is comprised of a pipe in which a cut is made.
Ehrenreich teaches a catheter comprising an expandable member, wherein the expandable member is comprised of a pipe in which a cut is made ([0045]; Figure 2—element 450).
A person of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to modify the expandable electrode, as disclosed by Harlev, to include wherein the wherein the expandable electrode is comprised of a pipe in which a cut is made, as taught by Ehrenreich, as both references and the claimed invention are directed toward ablation devices comprising expandable members. As disclosed by Harlev, the expandable electrode may be formed by a plurality of panels that are each formed by a tube that is laser cut ([0027] & [0054]). As disclosed by Ehrenreich, the expandable member may be configured as a unitary member cut from a single tubular member or the expandable member may be embodied as a plurality of separate members ([0045]). 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 expandable electrode, as disclosed by Harlev, to include wherein the wherein the expandable electrode is comprised of a pipe in which a cut is made, as taught by Ehrenreich, as providing an expandable member that is configured as a unitary member cut from a single tubular member is a known and suitable alternative in the art to providing an expandable member that is embodied as a plurality of separate members; further the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the electrode is comprised of a pipe in which a cut is made, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 5, Harlev in view of Ehrenreich disclose all of the limitations of claim 4, as described above.
Harlev further discloses wherein the electrode includes a plurality of opening portions defined by the element wires ([0055]; & [0075] Figure 8D—elements 753; with said openings being the cells 753 defined between each element wire), and at least some of the plurality of opening portions located in the proximal end-side region extend to the proximal end portion and each of the at least some of the plurality of opening portions has an open end at the proximal end portion ([0075]; Figures 8D, 10A, & 10B—elements 357 & 753; with said at least some of the plurality of oping portions 753 in the proximal end-side region being defined between adjacent element wires 757 in the proximal end portion 357).
Regarding claim 6, Harlev discloses a catheter for pulsed electric field ablation ([0034] & [0134]), comprising: an elongated body at least a distal end side of which is to be inserted into a body ([0034]; Figures 2, 3A, 3B, & 8D—element 122); and an electrode that is provided on the elongated body and generates a pulsed electric field ([0034] & [0036]; Figures 3A & 3B—element 250), wherein the electrode includes a core wire and a coating covering the core wire ([0054] & [0055]; Figures 7A & 8D—elements 750/751; the struts 751 of the mesh electrode panel 750 may be formed of a material, such as nitinol, and may be coated with one or more of gold, tantalum, iridium oxide, or other materials), the core wire contains a first metal whose standard electrode potential is lower than a standard electrode potential of hydrogen ([0054]; the struts 751 of the mesh electrode panel 750 may be formed of a material, such as nitinol; as nitinol is a nickel-titanium alloy and as it is known that both nickel and titanium have a more negative electrode potential than hydrogen, it is the examiners position that nitinol would have a standard electrode potential that is lower than a standard electrode potential of hydrogen), and the coating contains a second metal whose standard electrode potential is higher than the standard electrode potential of hydrogen and which is less likely to occlude hydrogen than the first metal ([0054]; the struts may be coated with gold; it is known in the art that gold has a higher electrode potential than hydrogen).
Harlev does not disclose wherein the electrode is comprised of a pipe in which a cut is made.
Ehrenreich teaches a catheter comprising an expandable member, wherein the expandable member is comprised of a pipe in which a cut is made ([0045]; Figure 2—element 450).
A person of ordinary skill in the art, before the effective filing date of the claimed invention would have been motivated to modify the expandable electrode, as disclosed by Harlev, to include wherein the wherein the expandable electrode is comprised of a pipe in which a cut is made, as taught by Ehrenreich, as both references and the claimed invention are directed toward ablation devices comprising expandable members. As disclosed by Harlev, the expandable electrode may be formed by a plurality of panels that are each formed by a tube that is laser cut ([0027] & [0054]). As disclosed by Ehrenreich, the expandable member may be configured as a unitary member cut from a single tubular member or the expandable member may be embodied as a plurality of separate members ([0045]). 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 expandable electrode, as disclosed by Harlev, to include wherein the wherein the expandable electrode is comprised of a pipe in which a cut is made, as taught by Ehrenreich, as providing an expandable member that is configured as a unitary member cut from a single tubular member is a known and suitable alternative in the art to providing an expandable member that is embodied as a plurality of separate members; further the examiner notes it would have been obvious to one having ordinary skill in the art at the time the invention was made to include wherein the electrode is comprised of a pipe in which a cut is made, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 7, Harlev in view of Ehrenreich disclose all of the limitations of claim 6, as described above.
Harlev further discloses wherein the first metal contains Ni and/or Ti, and the second metal contains Au and/or Pt ([0054]; the first metal comprises nitinol (e.g. Ni and Ti) and the second metal comprises gold (Au); the examiner notes the rest are in the alternative).
Conclusion
Accordingly, claims 1-7 are rejected.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Reo et al. (US 20230040877 A1) discloses an expandable electrode ([0054]; Figures 1A-1D—element 124), the electrode is comprised of a pipe in which a cut is made ([0064] & [0076]; the electrode is made of a unitary nitinol tube that is laser cut, this manufacture of electrodes is less expensive, less prone to failure than other types of deployable electrodes that require numerous solder points to manufacture making them difficult, more expensive, and more prone to failure).
THIS ACTION IS MADE FINAL. 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 MARINA D TEMPLETON whose telephone number is (571)272-7683. The examiner can normally be reached M-F 8:00am to 5:00pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.D.T./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794