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 on May 19th 2026, has been entered. Claims 1, 2, 5-7, 9-12, 13-15 and 30 remain pending in the application. Claims 4, 8, 16-17, 19-21 are withdrawn and claims 3, 18, 22-29 have been cancelled.
Response to Arguments
Applicant’s arguments filed May 19th 2026, have been fully considered but they are moot.
Regarding the 102 rejections, applicant amended claim 1 to recite “wherein the elongated tool includes a pointed tip configured to penetrate a target tissue”. Applicant argues that Koop does not disclose or suggest at least these features. However, the amendment changed the scope of the claims and therefore allowed for a new interpretation. Therefore, the claim is rejected over Sundquist which does describe a pointed tip configured to penetrate a target tissue. See rejection below.
Regarding the 102 rejections, applicant amended claim 10 to now be in independent form and to recite “A system comprising: an elongated tool through which a lumen extends; and a stylet including an expandable electrode portion, the expandable electrode portion having a collapsed configuration within the lumen and having an expanded configuration outside of the lumen, a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration, wherein in the expanded configuration, the expandable electrode portion is configured to create a plurality of path segments in a target tissue, wherein each path segment in the plurality of path segments is extended in a different direction wherein the expandable electrode portion in the expanded configuration is configured to deliver energy to ablate the target tissue wherein the stylet includes a cannulated shaft and wherein the expandable electrode portion includes a plurality of electrode tines that extend from the cannulated shaft and”. Applicant argues that Koop does not disclose or suggest the features of “the electrode tines are straight,” “the plurality of path segments in the target tissue are generally straight” and “in a distal direction”. However, the amendment changed the scope of the claims and therefore allowed for a new interpretation. Therefore, the claim is rejected over Sundquist which does describe the electrode tines being straight and in a distal direction. See rejection below.
Regarding the 102 rejections, applicant amended claim 14 to now be in independent form and to recite “A system comprising: an elongated tool through which a lumen extends; and a stylet including an expandable electrode portion, the expandable electrode portion having a collapsed configuration within the lumen and having an expanded configuration outside of the lumen, a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration, wherein in the expanded configuration, the expandable electrode portion is configured to create a plurality of path segments in a target tissue, wherein each path segment in the plurality of path segments is extended in a different direction wherein the expandable electrode portion in the expanded configuration is configured to deliver energy to ablate the target tissue wherein the stylet includes a cannulated shaft and wherein the expandable electrode portion includes a plurality of electrode tines that extend from the cannulated shaft and”. Applicant argues that Koop does not disclose or suggest the features of “the electrode tines are straight,” “the plurality of path segments in the target tissue are generally straight” and “in a proximal direction”. However, the amendment changed the scope of the claims and therefore allowed for a new interpretation. Therefore, the claim is rejected over Sundquist which does describe the electrode tines being straight and in a proximal direction. See rejection below.
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, 2, 5-7, 9-15 and 30 are rejected under 35 U.S.C 103 as being unpatentable over Sundquist et al (US20110106072A1) herein referred to as “Sundquist” in view of Koop et al (US20220015826A1) herein referred to as “Koop.”
Regarding claim 1, Sundquist discloses: A system ([Abstract] a system) comprising: an elongated tool through which a lumen extends; ([See FIG 2B] where 14, the catheter is seen as the elongated tool; See FIG 4B where the catheter 44, contains a lumen), and a stylet including an expandable electrode portion, ([0114] the support structure within the catheter which the electrodes are coupled to is seen as the stylet) wherein the elongated tool includes a pointed tip configured to penetrate a target tissue; ([0252] the electrode contains a pointed tip to penetrate the target tissue; See also [0115] where the electrode tip may be sharp enough to penetrate the urethra, which is seen as the target tissue) and having an expanded configuration outside of the lumen, (See FIG 2B where the electrodes, 18, have an expanded configuration), wherein in the expanded configuration, the expandable electrode portion is configured to create a plurality of path segments in a target tissue, (See FIG 12 where the electrodes, 80 and 82, create a plurality of paths in the target tissue) wherein each path segment in the plurality of path segments is extended in a different direction (See FIG 12 where each of the path created by each electrode is in a different direction) and wherein the expandable electrode portion in the expanded configuration is configured to deliver energy to ablate the target tissue ([0112] the electrodes deliver DC current, which is seen as energy, to ablate the tissue), however, Sundquist does not explicitly disclose: the expandable electrode portion having a collapsed configuration within the lumen, and a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration.
Koop discloses: the expandable electrode portion having a collapsed configuration within the lumen, (See FIG 5A where the electrode is collapsed within the lumen) and a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration (See FIG 5B where the tines extend distally forming a diameter greater than that of the outer diameter of the tool body).
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 elongate tool of Sundquist to include the diameter of the expandable portion being larger in the expanded configuration as disclosed in Koop. The motivation being that the strength and size of the electrical field can be tuned and the electrical field can be steered to provide more targeted ablation of the tissue (Koop [0067]).
Regarding claim 2, Sundquist discloses: The system of claim 1, wherein the elongated tool and the stylet are flexible ([0119] the catheter which is seen as the elongated tool, is flexible).
Regarding claim 5, Sundquist discloses: The system of claim 1, however, Sundquist does not explicitly disclose: wherein the expandable electrode portion is expandable to a diameter greater than an outer diameter of the elongated tool when extended distally of the lumen.
Koop discloses: wherein the expandable electrode portion is expandable to a diameter greater than an outer diameter of the elongated tool when extended distally of the lumen. (See FIG 5B where the tines extend distally forming a diameter greater than that of the outer diameter of the tool body).
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 elongate tool of Sundquist to include the diameter of the expandable portion being larger in the expanded configuration as disclosed in Koop. The motivation being that the strength and size of the electrical field can be tuned and the electrical field can be steered to provide more targeted ablation of the tissue (Koop [0067]).
Regarding claim 6, Sundquist discloses: The system of claim 5, wherein the expandable electrode portion is formed of nitinol. ([0218] the electrode portion is made from Nitinol).
Regarding claim 7, Sundquist discloses: The system of claim 5, however, Sundquist does not explicitly disclose: wherein the expandable electrode portion has a straightened configuration in the lumen.
Koop discloses: wherein the expandable electrode portion has a straightened configuration in the lumen (FIG 5A and [0056] can be in a linear configuration when restrained within the lumen).
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 elongate tool of Sundquist to include the expandable portion having a straightened configuration in the lumen as disclosed in Koop. The motivation being that this allows the catheter to be withdrawn safely (Koop [0039]).
Regarding claim 9, Sundquist discloses: The system of claim 1, wherein the stylet includes a cannulated shaft and wherein the expandable electrode portion includes a plurality of electrode tines that extend from the cannulated shaft. (See annotated FIG 2B above showing the cannulated shaft and the electrodes, 18 extending from the shaft).
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Regarding claim 10, Sundquist discloses: A system ([Abstract] a system) comprising: an elongated tool through which a lumen extends; ([See FIG 2B] where 14, the catheter is seen as the elongated tool; See FIG 4B where the catheter 44, contains a lumen), and a stylet including an expandable electrode portion, ([0114] the support structure within the catheter which the electrodes are coupled to is seen as the stylet) having an expanded configuration outside of the lumen, (See FIG 2B where the electrodes, 18, have an expanded configuration), wherein in the expanded configuration, the expandable electrode portion is configured to create a plurality of path segments in a target tissue, (See FIG 12 where the electrodes, 80 and 82, create a plurality of paths in the target tissue) wherein each path segment in the plurality of path segments is extended in a different direction (See FIG 12 where each of the path created by each electrode is in a different direction) wherein the expandable electrode portion in the expanded configuration is configured to deliver energy to ablate the target tissue ([0112] the electrodes deliver DC current, which is seen as energy, to ablate the tissue), wherein the stylet includes a cannulated shaft and wherein the expandable electrode portion includes a plurality of electrode tines that extend from the cannulated shaft (See annotated FIG 2B above showing the cannulated shaft and the electrodes extending from the shaft), and, wherein the electrode tines are straight and extend outward from the cannulated shaft in a distal direction and the plurality of path segments in the target tissue are generally straight. ([See annotated FIG 2B above] where the electrode tines are in a distal direction). However, Sundquist does not explicitly disclose: the expandable electrode portion having a collapsed configuration within the lumen and a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration.
Koop discloses: the expandable electrode portion having a collapsed configuration within the lumen, (See FIG 5A where the electrode is collapsed within the lumen) and a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration (See FIG 5B where the tines extend distally forming a diameter greater than that of the outer diameter of the tool body).
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 elongate tool of Sundquist to include the diameter of the expandable portion being larger in the expanded configuration as disclosed in Koop. The motivation being that the strength and size of the electrical field can be tuned and the electrical field can be steered to provide more targeted ablation of the tissue (Koop [0067]).
Regarding claim 11, Sundquist discloses: The system of claim 9, wherein the electrode tines extend from a distal end of the cannulated shaft ([See annotated FIG 2B above] where the electrodes extend from the shaft).
Regarding claim 12, Sundquist discloses: The system of claim 9, wherein the electrode tines extend through openings along the cannulated shaft (See annotated FIG 2B above showing electrode tines (18) extending through openings in canulated shaft).
Regarding claim 13, Sundquist discloses: The system of claim 9, wherein the electrode tines are collapsible into the elongated tool by proximal motion of the stylet. ([0141] the support structure, which is seen as the stylet, retracts the electrodes when moved in a proximal direction since moving in a distal direction deploys the electrodes).
Regarding claim 14, Sundquist discloses: A system ([Abstract] a system) comprising: an elongated tool through which a lumen extends; ([See FIG 2B] where 14, the catheter is seen as the elongated tool; See FIG 4B where the catheter 44, contains a lumen), and a stylet including an expandable electrode portion, ([0114] the support structure within the catheter which the electrodes are coupled to is seen as the stylet) having an expanded configuration outside of the lumen, (See FIG 2B where the electrodes, 18, have an expanded configuration), wherein in the expanded configuration, the expandable electrode portion is configured to create a plurality of path segments in a target tissue, (See FIG 12 where the electrodes, 80 and 82, create a plurality of paths in the target tissue) wherein each path segment in the plurality of path segments is extended in a different direction (See FIG 12 where each of the path created by each electrode is in a different direction) wherein the expandable electrode portion in the expanded configuration is configured to deliver energy to ablate the target tissue ([0112] the electrodes deliver DC current, which is seen as energy, to ablate the tissue), wherein the stylet includes a cannulated shaft and wherein the expandable electrode portion includes a plurality of electrode tines that extend from the cannulated shaft (See annotated FIG 2B above showing electrode tines (18) extending through openings in canulated shaft), and wherein the electrode tines are straight and extend outward from the cannulated shaft (See FIG 12 where the electrode tines are straight an extend out of the shaft) in a proximal direction (See FIG 43B where the electrodes, 418 [0275], are in a proximal direction) and the plurality of path segments in the target tissue are generally straight (See FIG 12 where the electrode path segments within the target tissue is straight). However, Sundquist does not explicitly disclose: the expandable electrode portion having a collapsed configuration within the lumen and a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration.
Koop discloses: the expandable electrode portion having a collapsed configuration within the lumen, (See FIG 5A where the electrode is collapsed within the lumen) and a diameter of the expandable electrode portion being larger in the expanded configuration than the collapsed configuration (See FIG 5B where the tines extend distally forming a diameter greater than that of the outer diameter of the tool body).
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 elongate tool of Sundquist to include the diameter of the expandable portion being larger in the expanded configuration as disclosed in Koop. The motivation being that the strength and size of the electrical field can be tuned and the electrical field can be steered to provide more targeted ablation of the tissue (Koop [0067]).
Regarding claim 15, Sundquist discloses: The system of claim 9, further comprising an actuator configured to move the electrode tines relative to the cannulated shaft ([0141] deployment of the electrodes may be triggered using a push button or sliding mechanism using the catheter handle which is seen as the actuator).
Regarding claim 30, Sundquist discloses: The system of claim 1, wherein the elongated tool is electrically conductive, and wherein the elongated tool and the stylet form a bipolar energy delivery assembly ([0143] the tool is electrically conductive; [0279] the electrodes can be bipolar and therefore deliver bipolar energy).
Conclusion
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 CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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