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, 18-22, and 25-27 appears herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/19/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/21/2026, with respect to the rejection(s) of claim(s) 1 and 19 under U.S.C. 103 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 Therefore, the rejection has been withdrawn.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 Cao (US 2011/0152712 A1), in view of Fahey (US 2018/0344411 A1).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-12, 15, 18-22, and 25-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 19, the limitations “a plurality of needle electrodes” and “deactivate misplaced electrodes and conduct ablation using only properly placed electrodes” renders the claims unclear as to if the “misplaced” and “properly placed” electrodes are the same electrodes as the needle electrodes or separate electrodes. For the purpose of examination, the “misplaced” and “properly placed” electrodes are interpreted as referring to the needle electrodes. Claims 2-5, 7-12, 15, 18, 20-22, and 25-27 are rejected due to their respective dependencies on claims 1 and 19.
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, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Cao (US 2011/0152712 A1), in view of Fahey (US 2018/0344411 A1).
Regarding claim 1, McGaffigan teaches an ablation device, (Fig. 1) the device comprising:
a sheath; (Fig. 9, Char. 76 and 86)
a plurality of needle electrodes that are each extendible from a distal end of the sheath; (Fig. 9, Char. 106, 107, 108, and 109) 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, so as to ablate a desired region of said tissue. (Col. 12, Lines 12-44)
McGaffigan further teaches measuring tissue impedance to determine when the capsule of the prostate has been perforated. (Col. 5, Lines 40-42)
McGaffigan, as applied to claim 1 above, is silent regarding the controller being configured to identify whether at least one needle electrode from said plurality of needle electrodes is located within a blood vessel or in the tissue; deactivate misplaced electrodes and conduct ablation using only properly placed electrodes based on the impedance measurements identifying electrode locations within blood vessels versus tissue; and that the selectively applied power is only delivered to needle electrodes which are properly placed in said tissue.
Cao, in a similar field of endeavor, teaches using impedance measurements to differentiate tissue type, such as blood, muscle, vessel, or plaque. (Par. [0021])
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 Cao, and configure the RF generator and controller (16) of McGaffigan to use the impedance measurements of McGaffigan to differentiate/identify the tissue types in which each of the needle electrodes have been inserted. Doing so would provide a user with greater awareness of the placement of each needle electrode and would minimize the risk of delivering ablative energy to the wrong tissue type.
McGaffigan, as applied to claim 1 above, is silent regarding the controller being configured to deactivate misplaced electrodes and conduct ablation using only properly placed electrodes based on the impedance measurements identifying electrode locations within blood vessels versus tissue; and that the selectively applied power is only delivered to needle electrodes which are properly placed in said tissue.
Fahey, in a similar field of endeavor, teaches an ablation system configured to detect blood vessels located within potential ablation zones and prevent ablation from being initiated in the region containing said blood vessels. (Par. [0094] and [0153])
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/Cao, as applied to claim 1 above, to incorporate the teachings of Fahey, and configure the RF generator and controller (16) of McGaffigan to deactivate the needle electrodes disposed within a blood vessel such that ablative energy is only delivered via needle disposed within non-vessel tissue. Doing so would minimize the risk of ablating a blood vessel, thereby causing unintentional complications during the procedure, as suggested in Fahey. (Abstract and Par. [0004])
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/Cao/Fahey, 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/Cao/Fahey, as applied to claim 1 above, teaches the sheath comprises an elongated shaft. (McGaffigan: Fig. 9, Char. 76: elongate probe)
Regarding claim 15, the combination of McGaffigan/Cao/Fahey, 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 Cao (US 2011/0152712 A1), in view of Fahey (US 2018/0344411 A1), as applied to claim 1 above, in view of Hester (US 2017/0252089 A1).
Regarding claim 2, the combination of McGaffigan/Cao/Fahey, 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/Cao/Fahey, 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/Cao/Fahey, 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 Cao (US 2011/0152712 A1), in view of Fahey (US 2018/0344411 A1), as applied to claim 1 above, in view of Manstein (US 2008/0082090 A1).
Regarding claim 3, the combination of McGaffigan/Cao/Fahey, 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/Cao/Fahey, 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/Cao/Fahey, 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/Cao/Fahey, 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/Cao/Fahey, 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/Cao/Fahey, 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, 12, and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Cao (US 2011/0152712 A1), in view of Fahey (US 2018/0344411 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/Cao/Fahey, 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/Cao/Fahey, 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/Cao/Fahey/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/Cao/Fahey/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/Cao/Fahey/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/Cao/Fahey/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)
Regarding claim 12, the combination of McGaffigan/Cao/Fahey/Schomacker, as applied to claim 10 above, teaches the elongated shaft is flexible. (McGaffigan: Col. 4, Line 1: Probe (76) is a flexible elongate rigid tubular probe)
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over McGaffigan (US 6638275 B1), in view of Cao (US 2011/0152712 A1), in view of Fahey (US 2018/0344411 A1), as applied to claim 1 above, in view of Larson (US 2019/0388073 A1).
Regarding claim 18, the combination of McGaffigan/Cao/Fahey, 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/Cao/Fahey, 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
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
