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 6, 13, 14, 16, 17, 20, 23, 24, and 28-37 are cancelled. A complete action on the merits of pending claims 1-5, 7-12, 15, 18, 19, 21, 22, and 25-27 appears herein.
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive.
Applicant argues “McGaffigan discloses some impedance sensing capabilities, "impedance sensing is provided to determine when the capsule of the prostate has been perforated" (McGaffigan, column 5 lines 40-42), this disclosure is limited to capsule perforation detection, not comprehensive electrode location identification”
Examiner respectfully disagrees and contends that by using impedance to determine prostate capsule perforation, McGaffigan would be determining the locations of the plurality of needle electrodes at least in that, while all the needle electrodes are perforating the prostate capsule, the locations of the plurality of needle electrodes would be identified as “in the perforated prostate capsule.”
Applicant further argues “McGaffigan does describe electrode deactivation when destroyed, "[a]nother object of the invention is to provide an apparatus and method of the above character in which when the two proximal needles have been deactivated, the filaments used for deactivation of those two proximal needles are destroyed to facilitate deployment of the remaining intact distal pair of needle electrodes" (McGaffigan, column 2 lines 11-16) but lacks the specific impedance-based location identification”
Examiner respectfully contends that, as discussed above, McGaffigan teaches impedance-based location identification, at least in that McGaffigan identifies when the needle electrodes are in the location “in the perforated prostate capsule.”
Applicant further argues “McGaffigan's impedance sensing is narrowly focused on capsule perforation detection and does not teach or suggest using impedance measurements to comprehensively identify electrode locations. The claimed combination of impedance-based location identification is not disclosed or suggested by McGaffigan.”
Examiner respectfully contends that the current claim language doesn’t require the identification of electrode locations to be “comprehensive.” Furthermore, as best understood by examiner, there does not appear to be support in the present specification for “comprehensive” electrode location identification. As discussed above, McGaffigan teaches impedance-based location identification, at least in that McGaffigan identifies when the needle electrodes are in the location “in the perforated prostate capsule.”
Applicant’s arguments, see Remarks, filed 10/06/2025, with respect to the rejection(s) of claim(s) 1 and 19 under 35 U.S.C. 102(a)(1) regarding the amended claim limitations directed towards identifying whether at least one of the needle electrodes is located within a blood vessel or within tissue, and selectively energizing only the needle electrodes disposed within the tissue have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of McGaffigan (US 6638275 B1), in view of Sahay (US 2017/0209218 A1), in view of Byrd (US 2021/0161582 A1).
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, 5, 11, 12, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Sahay (US 2017/0209218 A1), in view of Byrd (US 2021/0161582 A1).
Regarding claim 1, McGaffigan teaches
a sheath; (Fig. 9, Char. 76 and 86)
a plurality of needle electrodes (Fig. 9, Char. 106, 107, 108, and 109) that are each extendible from a distal end of the sheath; (Col. 4, Lines 60-64) and
a controller (Fig. 1, Char. 16: RF generator and controller) that is configured to:
identify locations of the plurality of needle electrodes when said plurality of needle electrodes is in contact with a tissue, using impedance measurements; (Col. 5, Lines 40-42)
selectively apply a power signal between specified pairs of needle electrodes of the plurality of needle electrodes, when the plurality of needle electrodes are in contact with a tissue, so as to ablate a desired region of said tissue. (Col. 12, Lines 12-44; and Col. 8, Lines 63-65)
McGaffigan, as applied to claim 1 above, is silent regarding identifying whether at least one needle electrode from said plurality of needle electrodes is located within a blood vessel or in the tissue; and the selective application of power occurring only to needle electrodes which are properly placed in said tissue.
Sahay, in a similar field of endeavor, teaches an electrosurgical device comprising needle electrodes configured to ablate tissue in a plurality of various tissue, including the prostate and the cardiovascular system. (Par. [0029])
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 McGaffigan, as applied to claim 1 above, to incorporate the teachings of Sahay, and configure the device of Sahay to treat the plurality of other tissues taught by Sahay in addition to the prostate, including the cardiovascular system. Doing so would increase the number of treatments the device of McGaffigan can be used in.
The combination of McGaffigan/Sahay, as applied to claim 1 above, is silent regarding identifying whether at least one needle electrode from said plurality of needle electrodes is located within a blood vessel or in the tissue; and the selective application of power occurring only to needle electrodes which are properly placed in said tissue.
Byrd, in a similar field of endeavor, teaches identifying whether at least one electrode from a plurality of electrodes are in contact with a target tissue; and selectively energizing only the electrodes which are properly placed in contact with said tissue. (Par. [0029]: If the basket catheter is inserted into the antrum of a pulmonary vein, electroporation generator (26) and/or computer system (32) may determine which electrodes to activate based on contact with tissue (16) or even the specific anatomical location within the heart.)
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 McGaffigan/Sahay, as applied to claim 1 above, to incorporate the teachings of Byrd and configure the RF generator and controller of McGaffigan to, at least when used to treat the cardiovascular system, determine when the needle electrodes of McGaffigan are located within a blood vessel or in the tissue, and selectively energize only the needle electrodes which are properly placed in said tissue. Doing so would minimize the risk of applying electrosurgical energy to locations other than the target tissue when the needle electrodes are not properly placed in said target tissue. (e.g. delivering electrosurgical energy when a needle electrode is completely in the lumen of a blood vessel and not in a target tissue)
Regarding method claim 19, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 1, since operation of the prior art relied on to reject apparatus claim 1 would naturally result in the step of method claim 19 being satisfied.
Regarding claim 5, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches said specified pairs of needle electrodes are selected based on a desired pattern of ablation. (McGaffigan: Col. 12, Lines 12-44)
Regarding claim 11, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches the sheath comprises an elongated shaft. (McGaffigan: Fig. 9, Char. 76: elongate probe)
Regarding claim 12, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches the elongated shaft is flexible. (McGaffigan: Col. 4, Line 1: Probe (76) is a flexible elongate rigid tubular probe)
Regarding claim 15, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches a needle electrode of the plurality of needle electrodes comprises a sensor. (McGaffigan: Fig. 9, Char. 121, 122, 123, and 124: thermocouples)
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Sahay (US 2017/0209218 A1), in view of Byrd (US 2021/0161582 A1), as applied to claim 1 above, in view of Hester (US 2017/0252089 A1).
Regarding claim 2, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches said power signal is a radiofrequency (RF) current. (McGaffigan: Col. 10, Lines 7-11)
The combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, is silent regarding the RF current being an alternating current.
Hester, in a similar field of endeavor, teaches an electrosurgical system comprising needle electrodes configured to deliver radio frequency alternating current. (Par. [0064] and [0112])
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 McGaffigan/Sahay/Byrd, as applied to claim 1 above, to incorporate the teachings of Hester, and configure the RF generator of McGaffigan to comprise an RF alternating current mode. Doing so would provide more energy modalities available to the user.
Claim(s) 3, 4, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Sahay (US 2017/0209218 A1), in view of Byrd (US 2021/0161582 A1), as applied to claim 1 above, in view of Manstein (US 2008/0082090 A1).
Regarding claim 3, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches said applying comprises applying said power signal to each of said specified pairs of needle electrodes. (McGaffigan: Col. 12, Lines 12-44)
The combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, is silent regarding the application of said power signal to each of said specified pairs of needle electrodes occurring simultaneously.
Manstein, in a similar field of endeavor, teaches an electrosurgical system configured to deliver ablative energy to a plurality of needle electrodes simultaneously, individually, to specific groups, or to any combination of individual electrodes in a variety of temporal sequences. (Par. [0041])
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 McGaffigan/Sahay/Byrd, as applied to claim 1 above, to incorporate the teachings of Manstein, and configure the RF generator of McGaffigan to energize the needle electrodes of McGaffigan simultaneously, individually, to specific groups, or to any combination of individual electrodes in a variety of temporal sequences, as taught by Manstein. Doing so would increase the possible energy modalities, thereby increasing possible treatment options and results.
Regarding method claim 21, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 3, since operation of the prior art relied on to reject apparatus claim 3 would naturally result in the step of method claim 21 being satisfied.
Regarding claim 4, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches said applying comprises applying said power signal between said specified pairs of needle electrodes. (McGaffigan: Col. 12, Lines 12-44)
The combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, is silent regarding the application of said power signal occurring sequentially, in a predetermined sequence of pairs of needle electrodes of said specified pairs of needle electrodes.
Manstein, in a similar field of endeavor, teaches an electrosurgical system configured to deliver ablative energy to a plurality of needle electrodes simultaneously, individually, to specific groups, or to any combination of individual electrodes in a variety of temporal sequences. (Par. [0041])
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 McGaffigan/Sahay/Byrd, as applied to claim 1 above, to incorporate the teachings of Manstein, and configure the RF generator of McGaffigan to energize the needle electrodes of McGaffigan simultaneously, individually, to specific groups, or to any combination of individual electrodes in a variety of temporal sequences, as taught by Manstein. Doing so would increase the possible energy modalities, thereby increasing possible treatment options and results.
Regarding method claim 22, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 4, since operation of the prior art relied on to reject apparatus claim 4 would naturally result in the step of method claim 22 being satisfied.
Claim(s) 7-10, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Sahay (US 2017/0209218 A1), in view of Byrd (US 2021/0161582 A1), as applied to claims 1 and 19 above respectively, in view of Schomacker (US 2012/0158100 A1).
Regarding claim 7, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, is silent regarding said plurality of needle electrodes comprises a central first needle electrode and at least two second needle electrodes arranged in a predetermined pattern relative to said first needle electrode.
Schomacker, in a similar field of endeavor, teaches a plurality of needle electrodes (Fig. 2, Char. 50: needle; Par. [0039]) comprises a central first needle electrode and at least two second needle electrodes arranged in a predetermined pattern relative to said first needle electrode. (Fig. 5: Second needle electrodes (the eight needle electrodes disposed around the central needle electrode) are arranged in a predetermined pattern around a first needle electrode (the central needle electrode))
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 McGaffigan/Sahay/Byrd, as applied to claim 1 above, to incorporate the teachings of Schomacker, and configure the device of McGaffigan to comprise nine needle electrodes disposed in the pattern of Schomacker since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Furthermore, doing so would provide for a wider range of possible ablation patterns.
Regarding method claim 25, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 7, since operation of the prior art relied on to reject apparatus claim 7 would naturally result in the step of method claim 25 being satisfied.
Regarding claim 8, the combination of McGaffigan/Sahay/Byrd/Schomacker, as applied to claim 7 above, teaches said predetermined pattern comprises said at least two second needle electrodes arranged in a surrounding pattern relative to said first needle electrode. (Schomacker: Fig. 5 – it is implicit that this feature be present in the McGaffigan/Sahay/Byrd/Schomacker combination based on the rejection to claim 7 above.)
Regarding method claim 26, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 8, since operation of the prior art relied on to reject apparatus claim 8 would naturally result in the step of method claim 26 being satisfied.
Regarding claim 9, the combination of McGaffigan/Sahay/Byrd/Schomacker, as applied to claim 7 above, teaches at least one of said specified pairs of needle electrodes comprises said first needle electrode and one of said second needle electrodes. (McGaffigan: Col. 12, Lines 12-44: The RF generator and controller (16) can energize a pair of needle electrodes comprising any two needle electrodes)
Regarding method claim 27, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 9, since operation of the prior art relied on to reject apparatus claim 9 would naturally result in the step of method claim 27 being satisfied.
Regarding claim 10, the combination of McGaffigan/Sahay/Byrd/Schomacker, as applied to claim 7 above, teaches at least one of said specified pairs of needle electrodes comprises a pair of said second needle electrodes. (McGaffigan: Col. 12, Lines 12-44: The RF generator and controller (16) can energize a pair of needle electrodes comprising any two needle electrodes)
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Sahay (US 2017/0209218 A1), in view of Byrd (US 2021/0161582 A1), as applied to claim 1 above, in view of Larson (US 2019/0388073 A1).
Regarding claim 18, the combination of McGaffigan/Sahay/Byrd, as applied to claim 1 above, teaches a needle electrode of the plurality of needle electrodes comprises a hollow core. (Col. 4, Lines 64-67)
McGaffigan, as applied to claim 1 above, is silent regarding a needle electrode of the plurality of needle electrodes being a biopsy needle.
Larson, in a similar field of endeavor, teaches a needle electrode being a biopsy needle with a hollow core configured to collect a tissue sample. (Claim 7 and 12)
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 McGaffigan/Sahay/Byrd, as applied to claim 1 above, to incorporate the teachings of Larson and configure at least one needle electrode of McGaffigan to be a biopsy needle configured to collect a tissue sample in a hollow core. Doing so would allow for the device to be used in a broader range of procedures, and would allow tissue samples to be collected for testing and examination without the need for insertion of a second device.
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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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794