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 .
Claims 11-19 are cancelled. A complete action on the merits of pending claims 1-10, and 20-29 appears herein.
Response to Arguments
Applicant's arguments filed 10/17/2025 have been fully considered but they are not persuasive.
Applicant argues “Ditter teaches a helical lasso catheter with electrodes arranged in a circular, spiral pattern around pulmonary vein ostia for circumferential ablation. Ditter discloses a helical form 22 extends distally from the transverse section 21 and generally spirals about a longitudinal axis and describes a distal assembly with a helical form or a crescent form carrying a plurality of irrigated ablation ring electrodes. In contrast, amended claim 1 recites a linear point electroporation catheter where the "first pair of electrodes is disposed linearly along the longitudinal axis" and "the second pair of electrodes is disposed linearly along the longitudinal axis." This describes electrodes arranged in a straight line along the catheter shaft, not spiraling around it. Ditter's helical arrangement supports circumferential pulmonary vein isolation, requiring electrodes to follow a circular path around anatomical structures. The claimed linear arrangement addresses the entirely different technical problem of focal pulsed field ablation, requiring precise electrode spacing and alignment for directional energy delivery.”
Examiner respectfully contends that, as further discussed in the rejection to claim 1 below, Ditter teaches the helical form (22) is flexible and capable of moving to a straight configuration when desired. (e.g. during insertion into a guide sheath) (Par. [0051])
Applicant further argues “Additionally, claims 1, 20, and 25 recite, in part, "a first side view of the first edge portion along the longitudinal axis is rounded at a first corner with a first edge radius; and ... a second side view of the second edge portion is rounded at a second corner with a second edge radius." Emphasis added. The Office takes the position that the curved transitional regions (67) shown in FIG. 14, reproduced below, "comprise a rounded edge/corner and would comprise a first edge radius." Office Action at 5. However, as discussed in paragraph [0076], "transitional regions 67 are provided between the side wall 65 and the end portions 66." Simply put, the transitional regions (67) are not located at a first or second corner as required by the claims. Rather, the transitional regions (67) are spaced from the corners.”
Examiner respectfully contends that, as further discussed in the rejections to claims 1, 20, and 25 below, curved transitional regions (67) comprise rounded corners between a surface parallel to the longitudinal axis and a surface angled relative to the longitudinal axis. The rounded corners of curved transitional regions would have a radius of their respective curvatures.
Applicant further argues “Additionally, claims 1, 20, and 25 recite, in part, "wherein the first electrode comprises a first edge portion generally perpendicular to the longitudinal axis; wherein the second electrode comprises a second edge portion generally perpendicular to the longitudinal axis and a third edge portion generally perpendicular to the longitudinal axis." In rejecting the claims, the Office correctly determines that Ditter is silent regarding the first, second, and third edge portions being generally perpendicular to the longitudinal axis. However, the Office incorrectly concludes that "it would have been an obvious matter of design choice to one of ordinary skill in the art...to have modified Ditter... to make the different portions of the first, second, and third edge portions of whatever form or shape was desired or expedient, including being generally perpendicular to the longitudinal axis. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Office Action at 6. Applicant respectfully disagrees. As discussed in MPEP §2144(III), "legal precedent can provide the rational supporting obviousness only if the facts in the case are sufficiently similar to those in the application ...facts are sufficiently similar when they can be analogized to each other such that they present the same legal issue... [i]f the applicant has demonstrated the criticality of a specific limitation, it would not be appropriate to rely solely on the rationale used by the court to support an obviousness rejection." In the present case, the Office cites In re Dailey, 357F.2d 669, 149 USPQ 47 (CCPA 1966). However, the facts of In re Dailey are not at all similar to the present application. In re Dailey is directed to a disposable infant bottle having a nipple opening claimed as being "less than a hemisphere" configuration. This is not at all "sufficiently similar" to the present application and does not present the same legal issue.”
Examiner respectfully contends that In re Dailey is sufficiently similar to the present application, as the limitations of the first, second, and third edge portions each being generally perpendicular to the longitudinal axis are ultimately limitations directed towards the shape of the electrodes comprising said first, second, and third edge portions. In re Dailey is directed towards a change of shape absent persuasive evidence that the claimed shape was significant. Applicant has not provided persuasive evidence that the claimed shape was significant. (A statement of criticality AND unexpected results.) Therefore, In re Dailey is "sufficiently similar" to the present application and does present the same legal issue.
Applicant further argues “Furthermore, paragraph [0074] of the present applications states, "the first and second edge 220, 222 are generally parallel to each other, and perpendicular to the longitudinal axis 204 such that the electrodes 212, 214 are aligned co-axially with each other. Electrodes disposed out of alignment may increase chances of arc formation."”
Examiner respectfully contends that, as best understood by examiner, the electrodes being in “alignment” refers to the electrodes being in coaxial alignment with each other. The first and second edges being generally perpendicular to the longitudinal axis is not required for said alignment with each other. (e.g. the first and second edges can be at any angle relative to the longitudinal axis, as long as said angle is the same for both edges.)
Applicant’s arguments with respect to claim(s) 20 and 25, regarding the claimed force sensor 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.
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 force sensor disposed between the second electrode and the second pair of electrodes of claims 20 and 25 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 § 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.
Claim(s) 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ditter (US 2013/0006238 A1).
Regarding claim 1, Ditter teaches
a linear shaft (Fig. 1, Char. 12: catheter body) having an elongated body defining a longitudinal axis, the elongated body having a distal end and a proximal end; (Fig. 15)
an electrode assembly disposed on the linear shaft (Fig. 15: the AR and IR/RR electrodes; Par. [0051]: Due to the flexible construction of the distal assembly 17, the helical form 22 readily straightens for insertion into the guiding sheath.) comprising:
a first pair of electrodes comprising a first electrode disposed proximate to the distal end of the elongated body (Attached “Annotated Ditter Fig 15A” below: AR electrode labelled “First Electrode”//Attached “Annotated Ditter Fig 15B” below: IR/RR electrode labelled “First Electrode”) and a second electrode, (Attached “Annotated Ditter Fig 15A” below: AR electrode labelled “Second Electrode”//Attached “Annotated Ditter Fig 15B” below: IR/RR electrode labelled “First Electrode”) wherein the first pair of electrodes is disposed linearly along the longitudinal axis; (Par. [0051]: Due to the flexible construction of the distal assembly 17, the helical form 22 readily straightens for insertion into the guiding sheath; The IR/RR and AR electrodes of Ditter would be disposed linearly along the longitudinal axis at least when distal assembly (17) is arranged in a linear configuration, such as during insertion into the guiding sheath.)
a second pair of electrodes disposed adjacent to the first pair of electrodes and comprising a third electrode and a fourth electrode, (Attached “Annotated Ditter Fig 15A” below: IR/RR electrodes labelled “Third Electrode” and “Fourth Electrode” respectively// Attached “Annotated Ditter Fig 15B” below: AR electrodes labelled “Third Electrode” and “Fourth Electrode” respectively) wherein the second pair of electrodes is disposed linearly along the longitudinal axis; (Par. [0051]: Due to the flexible construction of the distal assembly 17, the helical form 22 readily straightens for insertion into the guiding sheath; The IR/RR and AR electrodes of Ditter would be disposed linearly along the longitudinal axis at least when distal assembly (17) is arranged in a linear configuration, such as during insertion into the guiding sheath.)
wherein the first electrode comprises a first edge portion; (Attached “Annotated Ditter Fig 15A” below: Portion of AR electrode labelled “First Edge Portion”//Attached “Annotated Ditter Fig 15B” below: Portion of IR/RR electrode labelled “First Edge Portion”)
wherein the second electrode comprises a second edge portion (Attached “Annotated Ditter Fig 15A” below: Portion of AR electrode labelled “Second Edge Portion”//Attached “Annotated Ditter Fig 15B” below: Portion of IR/RR electrode labelled “Second Edge Portion”) and a third edge portion (Attached “Annotated Ditter Fig 15A” below: Portion of AR electrode labelled “Third Edge Portion”//Attached “Annotated Ditter Fig 15B” below: Portion of IR/RR electrode labelled “Third Edge Portion”);
wherein the first edge portion is closer to the second edge portion than the third edge portion; (Attached “Annotated Ditter Fig 15A” below//Attached “Annotated Ditter Fig 15B” below)
wherein a first side view of the first edge portion along the longitudinal axis is rounded at a first corner with a first edge radius; (Fig. 13-14: Curved transitional regions (67) of AR electrodes comprise a rounded edge/corner and would comprise a first edge radius//Fig. 15: IR/RR electrodes are rounded on both the distal and proximal ends of said electrodes and would comprise a first edge radius) and
wherein a second side view of the second edge portion is rounded at a second corner with a second edge radius. (Fig. 13-14: Curved transitional regions (67) of AR electrodes comprise a rounded edge/corner and would comprise a second edge radius//Fig. 15: IR/RR electrodes are rounded on both the distal and proximal ends of said electrodes and would comprise a second edge radius)
Annotated Ditter Fig 15A Annotated Ditter Fig 15B
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Regarding claims 2 and 3, modified Ditter, as applied to claim 1 above, teaches the first electrode has a first electrode surface area and wherein the second electrode has a second electrode surface area. (Attached “Annotated Ditter Fig 15A” above, the AR electrodes labelled “First Electrode” and “Second Electrode” have surface areas.)
Modified Ditter, as applied to claim 1 above, is silent regarding a difference between the first electrode surface area and the second electrode surface area is less than 10% of the first electrode surface area.
However, absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to configure the sizes of the AR electrodes labelled “First Electrode” and “Second Electrode” in attached “Annotated Ditter Fig 15A” above to differ such that a difference between the first electrode surface area and the second electrode surface area is less than 10% of the first electrode surface area, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Regarding claim 4, modified Ditter, as applied to claim 1 above, teaches a distance between the first edge portion and the second edge portion is in the range of 1 millimeter and 2 millimeter. (Attached “Annotated Ditter Fig 15B” above; Par. [0089]: IR/RR electrodes can have a spacing of 1.0mm between each other)
Regarding claim 5, modified Ditter, as applied to claim 1 above, teaches a distance between the first edge portion and the second edge portion. (Attached “Annotated Ditter Fig 15B” above; Par. [0089]: IR/RR electrodes can have a spacing of 1.0mm between each other)
Modified Ditter, as applied to claim 1 above, is silent regarding the distance between the first edge portion and the second edge portion being in the range of 1.4 millimeter and 1.8 millimeter.
However, absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Ditter, as applied to claim 1 above, to make the spacing between the IR/RR electrodes of Ditter in the range of 1.4 millimeter and 1.8 millimeter since applicant has not disclosed that the claimed range of 1.4 mm to 1.8 mm solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a spacing between IR/RR electrodes of 1mm as the invention would with a spacing of 1.4mm.
Regarding claim 6, modified Ditter, as applied to claim 1 above, teaches the second pair of electrodes are sensing electrodes configured to measure an electrical signal. (Attached “Annotated Ditter Fig 15A” above; Par. [0084]: IR/RR electrodes are configured to record impedance)
Regarding claim 7, modified Ditter, as applied to claim 6 above, teaches the second pair of electrodes are disposed between the first electrode and the second electrode. (Attached “Annotated Ditter Fig 15A” above: IR/RR electrodes labelled “Third Electrode” and “Fourth Electrode” are disposed between AR electrodes labelled “First Electrode” and “Second Electrode”)
Regarding claim 8, modified Ditter, as applied to claim 1 above, teaches the electrode assembly further comprises a fifth ring electrode disposed further away from the distal end of the elongated body than each electrode of the first pair of electrodes. (Fig. 15: The proximal most AR electrode)
Regarding claim 9, modified Ditter, as applied to claim 1 above, teaches the first electrode comprises a conductive material having a first thickness, wherein the first edge radius is associated with the first thickness. (Attached “Annotated Ditter Fig 15A” below, and Fig. 14, Char. 65: side wall: Side wall (65) has a thickness that is associated with the radius of curved regions (67); Side wall would be conductive due to side wall (65) being the contact portion of the AR electrodes.)
Annotated Ditter Fig 15A Annotated Ditter Fig 15B
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Regarding claim 10, modified Ditter, as applied to claim 1 above, teaches the second electrode comprises a conductive material having a second thickness, wherein the second edge radius is associated with the second thickness. (Attached “Annotated Ditter Fig 15A” above, and Fig. 14, Char. 65: side wall: Side wall (65) has a thickness that is associated with the radius of curved regions (67); Side wall would be conductive due to side wall (65) being the contact portion of the AR electrodes.)
Claim(s) 20, 22, 23, 25, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Ditter (US 2013/0006238 A1) in view of Shachar (US 2010/0130854 A1) in view of Stewart (US 2016/0166310 A1).
Regarding claims 20 and 25, Ditter teaches
an electroporation ablation device (Fig. 1) comprising:
a shaft (Fig. 1, Char. 12: catheter body) having an elongated body defining a longitudinal axis, the elongated body having a distal end and a proximal end; (Fig. 15)
an electrode assembly disposed on the shaft (Fig. 15: the AR and IR/RR electrodes) comprising:
a first pair of electrodes comprising a first electrode disposed proximate to the distal end of the elongated body Attached “Annotated Ditter Fig 15A” below: AR electrode labelled “First Electrode”//Attached “Annotated Ditter Fig 15B” below: IR/RR electrode labelled “First Electrode”) and a second electrode; (Attached “Annotated Ditter Fig 15A” below: AR electrode labelled “Second Electrode”//Attached “Annotated Ditter Fig 15B” below: IR/RR electrode labelled “First Electrode”) and
a second pair of electrodes disposed adjacent to the first pair of electrodes and comprising a third electrode and a fourth electrode; (Attached “Annotated Ditter Fig 15A” below: IR/RR electrodes labelled “Third Electrode” and “Fourth Electrode” respectively//Attached “Annotated Ditter Fig 15B” below: AR electrodes labelled “Third Electrode” and “Fourth Electrode” respectively)
an electroporation generator operatively coupled to the electrode assembly and the controller (Par. [0104] and [0106])
wherein the first electrode comprises a first edge portion; (Attached “Annotated Ditter Fig 15A” below: Portion of AR electrode labelled “First Edge Portion”//Attached “Annotated Ditter Fig 15B” below: Portion of IR/RR electrode labelled “First Edge Portion”)
wherein the second electrode comprises a second edge portion (Attached “Annotated Ditter Fig 15A” below: Portion of AR electrode labelled “Second Edge Portion”//Attached “Annotated Ditter Fig 15B” below: Portion of IR/RR electrode labelled “Second Edge Portion”) and a third edge portion; (Attached “Annotated Ditter Fig 15A” below: Portion of AR electrode labelled “Third Edge Portion”//Attached “Annotated Ditter Fig 15B” below: Portion of IR/RR electrode labelled “Third Edge Portion”)
wherein the first edge portion is closer to the second edge portion than the third edge portion; (Attached “Annotated Ditter Fig 15A” below//Attached “Annotated Ditter Fig 15B” below)
wherein a first side view of the first edge portion along the longitudinal axis is rounded at a first corner with a first edge radius; (Fig. 13-14: Curved transitional regions (67) of AR electrodes comprise a rounded edge/corner and would comprise a first edge radius//Fig. 15: IR/RR electrodes are rounded on both the distal and proximal ends of said electrodes and would comprise a first edge radius) and
wherein a side view of the second edge portion is rounded at a second corner with a second edge radius. (Fig. 13-14: Curved transitional regions (67) of AR electrodes comprise a rounded edge/corner and would comprise a second edge radius//Fig. 15: IR/RR electrodes are rounded on both the distal and proximal ends of said electrodes and would comprise a second edge radius)
Annotated Ditter Fig 15A Annotated Ditter Fig 15B
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Ditter, as applied to claim 20 above, is silent regarding a controller configured to receive one or more signals from the one or more mapping electrodes; and wherein the first, second, and third edge portions being generally perpendicular to the longitudinal axis; a force sensor; and wherein the force sensor is disposed between the second electrode and the second pair of electrodes.
However, absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Ditter, as applied to claim 1 above, to make the different portions of the first, second, and third edge portions of whatever form or shape was desired or expedient, including being generally perpendicular to the longitudinal axis. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Modified Ditter, as applied to claim 20 above, is silent regarding a controller configured to receive one or more signals from the one or more mapping electrodes; a force sensor; and wherein the force sensor is disposed between the second electrode and the second pair of electrodes.
Shachar, in a similar field of endeavor, teaches a controller configured to receive one or more signals from one or more mapping electrodes. (Par. [0027]: The feedback controller receives impedance measurements and uses said measurements to create an impedance map.)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Ditter, as applied to claim 20 above, to incorporate the teachings of Shachar, and include the feedback controller of Shachar, such that the feedback controller uses the impedance values sensed by the IR/RR electrodes of Ditter to construct an impedance map usable to help navigate the device to the target tissue location. Doing so would ensure proper positioning and navigation to the treatment site.
The combination of Ditter/Shachar, as applied to claim 20 above, is silent regarding a force sensor; wherein the force sensor is disposed between the second electrode and the second pair of electrodes.
Stewart, in a similar field of endeavor, teaches a flexible electrode array (Fig. 1, Char. 48: electrode array) comprising a force sensor (Par. [0042]: Sensors (20) may comprise piezoelectric or capacitive sensors configured to measure force) configured to sense the force/contact of said array with surrounding tissue. (Par. [0042])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combination of Ditter/Shachar, as applied to claim 20 above, to incorporate the teachings of Stewart, and configure distal assembly (17) of Ditter to comprise a force sensor configured to sense a force applied to the distal assembly (17). Doing so would allow for the determination that distal assembly (17) has come into contact with a tissue, as suggested in Par. [0042] of Stewart.
In this combination, the force sensors may be placed anywhere along distal assembly (17), including between the second electrode and second pair of electrodes.
Regarding claims 22 and 27, the combination of Ditter/Shachar/Stewart, as applied to claims 20 and 25 respectively above, teaches the force sensor is configured to measure a force when the distal end is in contact with tissue of a patient. (In the rejection to claim 20 above, the force sensor (20) of Stewart was placed in the distal assembly (17) of Ditter)
Regarding claims 23 and 28, the combination of Ditter/Shachar/Stewart, as applied to claims 20 and 25 respectively above, teaches a fifth electrode. (Ditter: Fig. 2: The proximal most ring electrode (19))
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 21, 24, 26, and 29 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claims 21 and 26, the prior art of record fails to explicitly teach all of the limitations of claims 20 or 25 and further teach the limitation “the force sensor is configured to sense a force of local electric fields.”
Regarding claims 24 and 29, the prior art of record fails to explicitly teach all of the limitations of claims 23 or 28 and further teach the limitation “wherein the fifth electrode is configured as a steering ring.”
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 NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at 5712724764. 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
/N.S.B./Examiner, Art Unit 3794