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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 4-13 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch et al. (WO 2011/146498) in view of Deem et al. (US 2005/0261672).
Regarding claim 1, Deutsch discloses a pulse generator system (see Fig. 1a), comprising: a pulse generator (see at least elements 140, 150, 160 and 170, Fig. 1a); a power supply (see 130, Fig. 1a); and a controller communicatively coupled to the pulse generator and the power supply (see controller 110 connected to the pulse generation and power supply circuits, Fig. 1a) and configured to: generate control values corresponding to one or more desired pulse characteristic values (see [00162]), tune output pulses of the pulse generator to reflect the one or more desired pulse characteristic values (see [0094]), wherein to tune the output pulses, the controller is configured to: transmit first control signals to the power supply to charge the pulse generator to a charging voltage determined based on the control values (see [0090]); transmit second control signals to the pulse generator to generate the output pulses based on the control values (see [0094], [00146], and [00148]); receive a measured or sensed pulse characteristic value of the output pulses, the measured or sensed pulse characteristic value is based on applying the output pulses to a subject (see [00150]); and adjust the control values based on a comparison of the measured or sensed pulse characteristic value to a corresponding one of the one or more desired pulse characteristic values (see [00150]), and repeat tuning the output pulses using the adjusted control values (see process being repeated for additional pulses, [00150], see also Fig. 15), however Deutsch fails to further disclose wherein the output pulses have sub-microsecond duration and a voltage of at least 5 kV.
Deem teaches a pulse generation system (see Fig. 8) for generation electrical pulses to cardiac tissue (see [0052], [0057]-[0058]) including applying ultrashort pulses, or nanosecond pulsed electrical fields to create electrical fields ranging from 10 V/cm to 10,000 V/cm (see [0058]). Therefore, it would have been obvious to one having ordinary skill in the art before the time of filing to have modified the amplitudes and durations as disclosed by Deutsch such that the output pulses have a sub-microsecond duration and a voltage of at least 5 kV in order to provide the additional functionality of targeting and/or ablate cardiac tissue in order to correct nerve conduction issues in light of Deem (see Deem [0038] and [0052]), and further since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. See MPEP 2144.05.
Regarding claim 4, Deutsch further discloses wherein the pulse generator comprises a plurality of pulse generator stages (see multiple stages comprising the different components that make up the pulse generation circuits 140, 150, and 160 that each generate high voltage output, Fig. 1a, [0081]-[0082]).
Regarding claim 5, Deutsch further discloses wherein the controller is configured to receive the one or more desired pulse characteristic values via a user interface (see [00134]-[00135]).
Regarding claim 6, Deutsch further discloses wherein the pulse generator comprises multiple pulse generator circuits, each of the multiple pulse generator circuit configured to generate high voltage output (see multiple circuits comprising the different components that make up the pulse generation circuits 140, 150, and 160 that each generate high voltage output, Fig. 1a, [0081]-[0082]).
Regarding claim 7, Deutsch further discloses one or more electrodes coupled to the pulse generator, wherein the output pulses are applied to the subject via the one or more electrodes (see [00131]).
Regarding claim 8, Deutsch further discloses wherein the one or more electrodes further comprise a sensor configured to obtain the measured or sensed pulse characteristic value (see impedance sensing circuit and relay 190, [00132]).
Regarding claim 9, Deutsch further discloses a sensor communicatively coupled to the controller and configured to obtain the measured or sensed pulse characteristic value (see 170; [0083], Fig. 1a).
Regarding claim 10, Deutsch further discloses wherein the one or more desired pulse characteristic values comprise an amplitude, a pulse width, a frequency, current, pulse shape, polarity, a rise time, a fall time, power, energy, or a combination thereof (see [0034] and [00146]).
Regarding claim 11, Deutsch further discloses wherein to tune the output pulses the controller is further configured to: receive other measured or sensed values based on applying the output pulses to the subject, wherein the adjusting the control values is further based in part on the other measured or sensed values (see reconfiguration based one or more received characteristics of the targeted tissue in [00162]-[00164]).
Regarding claim 12, Deutsch further discloses wherein the other measured or sensed values comprise one or more of a conductivity of the tissue of the subject (see impedance of the tissue, [00132]), and presence of arcing at a delivery electrode (see [00130]), and an environmental characteristic (impedance is considered an environmental characteristic of the environment surrounding the electrodes, [0033]).
Regarding claims 13, 17-18 and 20, Deutsch in view of Deem teaches the limitations of these claims under the same rationale and citations as applied in the rejections of claims
Regarding claim 19, Deutsch discloses the limitations of claim 18, however fails to further teach wherein the other measured or sensed characteristic values comprise an environmental characteristic including one or more of a temperature, a humidity, and a chemical concentration.
Deem teaches a pulse generation system (see Fig. 8) for generation electrical pulses to cardiac tissue (see [0052], [0057]-[0058]) including applying ultrashort pulses, or nanosecond pulsed electrical fields to create electrical fields ranging from 10 V/cm to 10,000 V/cm (see [0058]), and wherein certain factors effect how a delivered electric field will effect a targeted cell, including cell size, cell shape, cell orientation with respect to the applied electric field, cell temperature, distance between cells (cell-cell separation), cell type, tissue heterogeneity, properties of the cellular membrane and the like (see [0059]). Therefore, 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 other measured or sensed characteristic value as disclosed by Deutsch to have included at least a temperature of the target cardiac tissue as the other measured or sensed characteristic in light of Deem, the motivation being to provide the additional functionality of accurately targeting and/or ablate cardiac tissue in order to correct nerve conduction issues (see Deem [0038] and [0052]).
Claims 2-3 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Deutsch in view of Deem and in further view of Dimalanta, Jr. et al. (US 2003/0191510).
Regarding claims 2-3 and 14-15, Deutsch in view of Deem teaches the limitations of claims 1 and 13, respectively, however Deutsch in view of Deem fails to further teach wherein the output pulses have a rise time, a fall time, or both rise and fall times of about 75 nanoseconds or less; or wherein the output pulses have a rise time, a fall time, or both rise and fall times of about 25 nanoseconds or less.
Dimalanta teaches an apparatus and method for the dissociation and removal of highly hydrated macroscopic volumes of proteinaceous tissues (see [0035]) comprising the use of high-intensity pulsed electric fields via pulses with rise and fall times of less than five nanoseconds (see [0043]). Therefore, 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 rise and fall times of the output pulses as taught by Deutsch and Deem such that the output pulses have a rise time, a fall time, or both rise and fall times of about 75 nanoseconds or less, and/or about 25 nanoseconds or less in light of Dimalanta, the motivation being to provide the additional benefit of avoiding development of detrimental thermal effects (see Dimalanta [0043]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Deutsch in view of Deem and in further view of Ochs et al. (US 2003/0191510).
Regarding claim 16, Deutsch in view of Deem teaches the limitations of claim 13, however fails to further teach using a lookup table to determine a next value based on the measured or sensed characteristic value.
Ochs teaches a method applying electrical pulses to a patient (see [0026]) comprising measuring patient impedance and comparing the measured impedance value to a lookup table to determine an adjusted value for the duration of the electrotherapy waveform (see [0033]-[0034]). Therefore, 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 adjustment of the control values as disclosed by Deutsch in view of Deem to use a lookup table to determine a next value based on the measured or sensed characteristic value in light of Ochs, the motivation being to provide the advantage of permitting patients having wide ranges of impedances to receive optimal levels of energy in a consistent manner (see Ochs [0037]).
Response to Arguments
Applicant's arguments filed 27 July 2026 with respect to the combination of Deutsch and Deem have been fully considered but they are not persuasive.
To the extent that applicant argues that there is no proper motivation to modify Deutsch with features of the pulse generator as taught by Deem (see Remarks pgs. 9-14), the examiner respectfully disagrees. Applicant argues that one of ordinary skill in the art would not have modified the defibrillation system of Deustch to instead produce output pulses that cause ablation when modified in light of Deem. The examiner contends that the above modification to Deutsch would not replace or modify the defibrillation pulses as disclosed by Deutsch in the manner that applicant argues since they would also be included in the modified device. Instead, the above modification adds additional functionality to the system as taught by Deutsch in order to enable the system to selectively target and/or ablate cardiac tissue in order to correct nerve conduction issues as necessary. The examiner notes that defibrillation of Deutsch comprises electrical cardiac stimulation, and Deem includes electrical cardiac stimulation, targeting, and permanent atrial defibrillation via electrodes in its capabilities in addition to creation of lesions in order to selectively denervate nerve bundles which make up conduction pathways responsible for atrial fibrillation and other cardiac dysrhythmias (see Deem [0038] and [0053]). One of ordinary skill in the art would have recognized that the defibrillation pulses of Deutsch would still be suitable for defibrillation on their own as well as use during the stimulation and targeting functions of the approach when modified in view of Deem to include ablation procedure capability when considered in combination. Therefore, providing additional functionality to the stimulation only device of Deutsch would have motivated one of ordinary skill to combine such functionalities when considering the stimulation, targeting, and ablation capabilities of Deem, and the modification in light of Deem would not render the principle of operation of Deutch because the combined device would still be fully functional for defibrillation via stimulation. Simply put, there is nothing of record that necessitates that lower voltage defibrillation pulses could not be outputted after the above combination or that the combined device could not produce both types of pulses since the combined device would be required to produce both stimulation and ablative type pulses.
To the extent that applicant argues that Deutsch teaches away from the modification in view of Deem (see Remarks pgs. 14-15), the examiner respectfully disagrees. Applicant argues that because Deutsch only contemplates stimulation level pulses for defibrillation, Deutsch teaches away from applying ablation techniques for the purpose of defibrillation. The examiner contends that this amounts to a disclosure of one alternative to providing defibrillation, and "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023) ("a reference does not teach away if it merely expresses a general preference for an alternative invention but does not criticize, discredit or otherwise discourage investigation into the invention claimed.") (internal quotations omitted) (quoting DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)) (MPEP 2145(X)(D)(1)). The remainder of applicant’s argument is believed to already be addressed above.
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 SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
