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 .
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1 & 15 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 & 15 of prior U.S. Patent No. 12,017,074. This is a statutory double patenting rejection.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jaax (US 2014/0276707) in view of one having ordinary skill in the art.
1.
A system, comprising: a stimulator device comprising a plurality of electrodes each configured to be electrically coupled in contact with a patient's tissue;
E.G. via the disclosed ablation system 10 comprising a stent catheter 12 having a plurality of electrodes 24 {[0022]-[0023] & (Figs. 1-2)}.
and a machine-implementable algorithm, wherein the algorithm when executed is configured to
control stimulation circuitry in the stimulator device to generate a stimulation waveform pursuant to a stimulation program at a first configuration of the electrodes defining a center point of stimulation (CPS) in a patient's tissue,
E.G. via the disclosed controller/processor 18/30 configured for performing processes/techniques for prompting a stimulation output circuitry 110 to activate ‘selected’ electrodes of the plurality of electrodes 24 via a tripolar delivery ([0008] & [0033]-[0034]), wherein said controller is further configured to be ‘reconfigurable’ at appropriate times via stimulation parameters including an electrode combination parameter based on a first and a second technique ([0031]-[0032] & [0038]-[0041])., wherein the first technique activates the stimulation electrodes located on one of the rings A,B,C of electrodes E1- E24 {[0023], [0038] & (Fig. 2)}.
*Note that the examiner is interpreting the disclosed first technique used by the controller/processor 30 as being the stimulation program at a first configuration.
determining an Evoked Compound Action Potential (ECAP) generated in response to the stimulation waveform or at least one feature of the ECAP at least one electrode of the plurality of electrodes,
E.G. via the disclosed monitoring circuitry 106 that sense an evoked CAP, i.e. ECAP, in response to the activation of the plurality of electrodes {[0008], [0030] & (Fig. 1)}.
and based on the determined ECAP or the at least one feature, adjust the stimulation program so that it is generated at a second configuration of the electrodes different from the first electrode configuration.
E.G. via the disclosed controller/processor 18/30 utilizing a second technique to activate stimulation electrodes based on the sensed ECAP, wherein the response is based on a different one of the rings A,B , C {[0023], [0041] & (Fig. 2)}.
Jaax discloses the claimed invention having ablation system configured to perform processes/techniques for prompting a stimulation output circuitry to activate ‘selected’ electrodes of a plurality of electrodes via a tripolar delivery ([0008] & [0033]-[0034]), wherein said controller is further configured to be ‘reconfigurable’ at appropriate times via stimulation parameters including an electrode combination parameter based on a first and a second technique ([0031]-[0032] & [0038]-[0041]) except wherein said first technique explicitly defines the stimulation parameters as utilizing a center point of stimulation (CPS) in a patient's tissue.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to configure the activated plurality of electrodes in a tripolar arrangement to achieve a focused stimulation region, i.e. the claimed center point of stimulation (CPS). As is well understood in the art, tripolar stimulation utilizes a central activate electrode with flanking return electrodes to shape and concentrate the electric field, i.e. the disclosed anode and cathode electrodes, thereby producing a localized region of maximum stimulation at or about the central electrode, in order to affectively transmit a multipolar electrical energy to a selected group of electrodes adjacent to tissue {[0033]-[0034] & (Fig 2)}.
2.
The system of claim 1, wherein the algorithm is stored on a non-transitory machine- readable medium within the stimulator device, and wherein algorithm is configured to be executed within the stimulator device.
E.G. [0031].
3.
The system of claim 1, further comprising an external system configured to communicate with the stimulator device.
E.G. via the disclosed control unit 18 being external {[0022] & (Fig.1 )}.
4.
The system of claim 3, wherein a portion of the algorithm is stored on a non-transitory machine-readable medium within the external system.
E.G. [0031].
5.
The system of claim 4, wherein the portion of the algorithm in the external system is configured to: receive the determined ECAP or the at least one feature of the ECAP from the stimulator device, determine the at least one feature from the ECAP if the at least one feature was not received from the stimulator device,
and based on the determined ECAP or the at least one feature, adjust the stimulation program and transmit the adjusted stimulation program to the stimulator device.
E.G. ([0031]-[0033]).
6.
The system of claim 5, wherein the portion of the algorithm in the external system is configured to allow for the input of the CPS via a user interface.
E.G. via the disclosed external control unit 18 being inherently capable of programing and executing the disclosed stored-suitable program via user interface in order to perform the disclosed functions of the controller/processor 30 ([0031]-[0033]).
*Note that the examiner is interpreting the claim language “configured to allow for the input of the CPS via a user interface” as being intended use language, which the disclosed controller/processor 18/30 is capable of providing the claimed limitation.
7.
The system of claim 6, wherein the portion of the algorithm in the external system is configured to compute the stimulation program and the adjusted stimulation program using the input CPS.
E.G. {[0033]-[0034] & (Fig 2)}.
8.
The system of claim 1, wherein the first and second electrode configurations define which of the plurality of electrodes should be active, whether each active electrode comprises an anode electrode or a cathode electrode, a percentage of a total anodic current for each active anode electrode, and a percentage of a total cathodic current for each active cathode electrode.
E.G. {[0033]-[0034] & (Fig 2)}.
9.
The system of claim 1, wherein the total anodic and total cathodic current of the second electrode configuration equals the total anodic and total cathodic current of the first electrode configuration.
E.G. {[0033]-[0034] & (Fig 2)}.
10.
The system of claim 1, wherein the at least one feature is indicative of the shape and/or size of the ECAP.
E.G. via utilizing the magnitude of the ECAP response [0042].
11.
The system of claim 1, wherein the at least one feature comprises a time defining a duration of any portion of the ECAP, or a time delay from stimulation to issuance of the ECAP.
E.G. ([0041]-[0042]).
12.
The system of claim 1, wherein the algorithm is configured to determine in the stimulator device the neural response to the stimulation waveform at at least one non-active electrode of the plurality of electrodes.
E.G. ([0033] & [0041]-[0042])
13.
The system of claim 1, wherein the stimulation program comprises a pulse width, frequency, duty cycle, and waveform shape, and wherein the adjusted stimulation program comprises the same pulse width, frequency, duty cycle and waveform shape as the stimulation program.
E.G. [0032].
14.
The system of claim 1, wherein the stimulation program and the adjusted stimulation program comprise the same energy.
([0038] & [0041]-[0042]).
15.
A method for controlling a stimulator device comprising a plurality of electrodes each configured to be electrically coupled in contact with a patient's tissue,
E.G. ([0010]-[0011])
the method comprising: (a) generating a stimulation waveform pursuant to a stimulation program at a first configuration of the electrodes defining a center point of stimulation (CPS) in a patient's tissue,
E.G. via the disclosed controller/processor 18/30 configured for performing processes/techniques for prompting a stimulation output circuitry 110 to activate ‘selected’ electrodes of the plurality of electrodes 24 via a tripolar delivery ([0008] & [0033]-[0034]), wherein said controller is further configured to be ‘reconfigurable’ at appropriate times via stimulation parameters including an electrode combination parameter based on a first and a second technique ([0031]-[0032] & [0038]-[0041])., wherein the first technique activates the stimulation electrodes located on one of the rings A,B,C of electrodes E1- E24 {[0023], [0038] & (Fig. 2)}.
*Note that the examiner is interpreting the disclosed first technique used by the controller/processor 30 as being the stimulation program at a first configuration.
(b) determining an Evoked Compound Action Potential (ECAP) generated in response to the stimulation waveform or at least one feature of the ECAP at at least one electrode of the plurality of electrodes,
E.G. via the disclosed monitoring circuitry 106 that sense an evoked CAP, i.e. ECAP, in response to the activation of the plurality of electrodes {[0008], [0030] & (Fig. 1)}.
and (c) based on the determined ECAP or the at least one feature, adjusting the stimulation program so that it is generated at a second configuration of the electrodes different from the first electrode configuration, wherein the second electrode configuration is defined by a CPS in the patient's tissue that equals the CPS defined by the first electrode configuration.
E.G. via the disclosed controller/processor 18/30 utilizing a second technique to activate stimulation electrodes based on the sensed ECAP, wherein the response is based on a different one of the rings A, B, C {[0023], [0041] & (Fig. 2)}.
16.
The method of claim 15, wherein the method is configured to be executed within the stimulator device.
E.G. [0031].
17.
The method of claim 15, wherein step (c) is executed in an external system in communication
E.G. [0022].
18.
The method of claim 17, wherein step (b) is executed in the external system in communication with the stimulator device.
E.G. [0022].
19.
The method of claim 15, wherein the first and second electrode configurations define which of the plurality of electrodes should be active, whether each active electrode comprises an anode electrode or a cathode electrode, a percentage of a total anodic current for each active anode electrode, and a percentage of a total cathodic current for each active cathode electrode.
E.G. {[0033]-[0034] & (Fig 2)}.
20.
The method of claim 15, wherein the CPS is input by a user via a user interface.
E.G. via the disclosed external control unit 18 being inherently capable of programing and executing the disclosed stored-suitable program via user interface in order to perform the disclosed functions of the controller/processor 30 ([0031]-[0033]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796