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 .
Status of Claims
Claims 1-20 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Nov. 20, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-9, 11-13, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 20120239109 A1, published Sept. 20, 2012, hereinafter referred to as “Lee”).
Regarding claims 1 and 13, Lee teaches a system (“FIG. 1, an exemplary SCS system 10” ¶[0071]) and method for modulating a volume of tissue (“in accordance with the stimulation parameters programmed by the external control device, electrical pulses can be delivered from the neurostimulator to the stimulation electrode(s) to stimulate or activate a volume of tissue in accordance with a set of stimulation parameters and provide the desired efficacious therapy to the patient.” ¶[0007]), the system comprising: a plurality of physical electrodes (Fig. 1 “plurality of electrodes 26” ¶[0072]); a neural modulation generator configured to deliver energy using active physical electrodes from the plurality of physical electrodes (Fig. 1 “implantable pulse generator (IPG) 14” ¶[0071] and “the IPG 14 includes pulse generation circuitry that delivers electrical stimulation energy in the form of a pulsed electrical waveform (i.e., a temporal series of electrical pulses) to the electrode array 26 in accordance with a set of stimulation parameters.” ¶[0072] and “any functions described herein with respect to the IPG 14 can likewise be performed with respect to the ETS 20.” ¶[0073]); and a programming system (“CP 18 provides clinician detailed stimulation parameters for programming the IPG 14 and ETS 20” ¶[0075]) configured to: use a target multipole with target poles to determine physical electrode fractionalizations for the active physical electrodes that emulate the target poles (“a stimulation target in the form of an ideal target pole (e.g., an ideal bipole or tripole) is defined and the stimulation parameters, including the fractionalized current values on each of the electrodes, are computationally determined in a manner that emulates these ideal target poles” ¶[0021] and Fig. 7 “the control circuitry 80, in response to the actuation of the control elements 116, 118, first defines a series of ideal multipoles, and computationally determines the stimulation parameters, including the fractionalized current values on each of the electrodes, in a manner that emulates these ideal multipoles.” ¶[0100]), and program the neural modulation generator to deliver the energy according to the determined physical electrode fractionalizations for the active physical electrodes (Fig. 7 “control circuitry 80 is further configured for generating, based on the modification, stimulation parameter values defining relative amplitude values for the respective electrodes 12 to emulate the selected poles of the ideal multipole 250, and instructing the IPG 14 to convey electrical energy to the electrode array 26 in accordance with the stimulation parameter values” ¶[0114]).
Lee does not explicitly teach wherein the target multipole is configured to provide a linear electric field to modulate the volume of tissue; and delivering the energy to provide the linear electric field.
Lee does teach that the control circuitry 80 may steer current in a particular direction by modifying the values defining the generalized ideal multipole 250 in response to the continual generation of the directional control signals, and instructing the IPG 14 to convey the electrical energy to the electrode array 26 in accordance with stimulation parameter values generated based on the modified values (¶[0115]). The control circuitry 80 may be configured for sequentially defining a plurality of different ideal bipole/tripole configurations relative to electrode array 26 in response to the directional control signals (¶[0116]). The best stimulus parameter set will typically be one that delivers stimulation energy to the volume of tissue that must be stimulated in order to provide the therapeutic benefit (e.g., treatment of pain), while minimizing the volume of non-target tissue that is stimulated (¶[0007]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to provide an appropriate field such as a linear electric field to treat the tissue in order to minimize the volume of non-target tissue that is stimulated.
Regarding claims 6 and 16, Lee teaches wherein the programming system includes a user interface (Fig. 7 “The control circuitry 80 is configured for modifying at least one of the sets of values that define the ideal multipole 250 in response to the directional control signals generated by the user interface.” ¶[0113]) with a focus (“focus” ¶[0107] and [0112]) user control element for adjusting a focus of the target multipole to change a length of the linear electric field (“the control circuitry 80 may modify … the vertical focuses VF1, VF2 and horizontal focuses HF1, HF2” ¶[0113]).
Regarding claims 7 and 17, Lee teaches wherein the programming system includes a user interface (Fig. 7 “The control circuitry 80 is configured for modifying at least one of the sets of values that define the ideal multipole 250 in response to the directional control signals generated by the user interface.” ¶[0113]) with a spread user control element for adjusting a spread of the target multipole to change a width of the linear electric field (“the control circuitry 80 may modify the polarities of the central ideal pole 252 and surrounding ideal poles 254, the rectilinear position of the central ideal pole 252 relative to the electrode array 26, the vertical focuses VF1, VF2 and horizontal focuses HF1, HF2, the fractionalized values A1-A4 of the surrounding ideal poles 254, and/or any of the angles alpha, beta, phi” ¶[0113] changing the spread changes the width).
Regarding claims 8 and 18, Lee teaches wherein the programming system includes a user interface (Fig. 7 “The control circuitry 80 is configured for modifying at least one of the sets of values that define the ideal multipole 250 in response to the directional control signals generated by the user interface.” ¶[0113]) with an angle user control element for changing an angle of the linear electric field (“the control circuitry 80 may modify … any of the angles alpha, beta, phi” ¶[0113] changing the angles adjust the electrical field).
Regarding claims 9 and 19, Lee teaches wherein the programming system includes a user interface (Fig. 7 “The control circuitry 80 is configured for modifying at least one of the sets of values that define the ideal multipole 250 in response to the directional control signals generated by the user interface.” ¶[0113]) with a therapy strength user control element for adjusting a total amount of delivered energy (“parameters that may be controlled or varied include the amplitude, width, and rate of the electrical pulses provided through the electrode array” ¶[0005]).
Regarding claim 11, Lee teaches wherein the plurality of physical electrodes includes electrodes on a paddle lead (“FIG. 3, the neurostimulation lead 12 takes the form of a surgical paddle lead 12 on which the electrodes 26 (in this case, electrodes E1-E22) are carried.” ¶[0079]).
Regarding claim 12, Lee teaches wherein the plurality of physical electrodes includes electrodes on at least two leads (“FIG. 4, the neurostimulation lead 12 takes the form of a percutaneous stimulation lead on which the electrodes 12 (in this case, electrodes E1-E8) are disposed as ring electrodes. Although only one percutaneous stimulation lead 12 is shown, multiple percutaneous stimulation leads (e.g., two), can be used with the SCS system 10. The actual number and shape of leads and electrodes will, of course, vary according to the intended application.” ¶[0080] Therefore, it would have been obvious to have electrodes on at least two leads depending on the application).
Claims 2-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, as applied to claims 1 and 13 above, in view of Rochat et al. (US 20120290034 A1, published Nov. 15, 2012, hereinafter referred to as “Rochat”).
Regarding claims 2-3 and 14, Lee teaches the system and method of claims 1 and 13. Lee discloses the claim 3 and 14 limitation of wherein the target poles are in-line (Fig. 14, longitudinal tri-pole).
Although Lee teaches multipoles with anodes and cathodes and that the poles can be configured to a desired orientation, Lee does not disclose wherein: the target poles for the target multipole include a first target anode, a second target anode, a first target cathode and a second target cathode; the first target anode is between the second target anode and the first target cathode, and the first target cathode is between the second target cathode and the first target anode; the second target cathode has a larger emulated cathodic fractionalization magnitude than the first target cathode; and the second target anode has a larger emulated anodic fractionalization magnitude than the first target anode.
Rochat’s invention, concerned with the common goal of modulating a volume of tissue, relates to programming of implantable medical devices and, more particularly, to representation of cardiac leads in the user interface of a programmer (¶[0001]). The vectors in Rochat’s invention may include any number of bipolar vectors including that IMD 16 may utilize a vector that includes two anodes to two cathodes on the LV lead 20. For example, LV1 and LV 2 may be anodes and LV3 and LV4 may be cathodes (¶[0051]). As shown in Fig.’s 5A-C, LV1-LV4 are in-line.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the target poles for the target multipole include a first target anode, a second target anode, a first target cathode and a second target cathode; where the first target anode is between the second target anode and the first target cathode, and the first target cathode is between the second target cathode and the first target anode as taught by Rochat in the system and method of Lee as Lee’s system is able to be programmed for optimization and this is a results-effective way of setting up the different poles.
Regarding the limitation of the second target cathode has a larger emulated cathodic fractionalization magnitude than the first target cathode; and the second target anode has a larger emulated anodic fractionalization magnitude than the first target anode, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to try as there are a finite number of solutions that could have a reasonable expectation of success.
Further, the specification discloses the appropriate ranges that apply to the claimed invention in ¶[00127] as percentages may be used to progressively increase the percentage moving away from the center of the target multipole. However, the specification does not disclose that the specifically claimed range(s) that the outer anode and cathode having larger magnitude than the inner anode and cathode is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Lee teaches that the fractionalization is included in a way to optimize the stimulation parameters in order to provide benefit and minimize non-target tissue stimulation (Lee ¶[0009] and [0013]), the prior art therefore provides teaching that the magnitude of the cathode and anodes are a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Since Applicants fail to disclose that the claimed range(s) that the second anode and cathode having higher magnitudes than the first one provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that adjusting the fractionalizations absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of the second target cathode has a larger emulated cathodic fractionalization magnitude than the first target cathode; and the second target anode has a larger emulated anodic fractionalization magnitude than the first target anode by normal optimization procedures known in the electrical stimulation arts.
Regarding claim 4, Lee does not teach wherein the target poles for the target multipole include more than four in-line target poles.
Moffitt teaches the multipolar lead may have more or less the four electrodes of a quadripolar lead. For example, a lead may have three or five electrodes (¶[0019]). The instant specification discloses the appropriate ranges that apply to the claimed invention in ¶[00117] as anywhere from 3-6 or more. However, the specification does not disclose that the specifically claimed range(s) of more than four is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to include more than four in-line target poles as taught by Moffitt in the system of Lee as is it a results-effective way to alter the stimulation effects.
Regarding claims 5 and 15, Lee teaches wherein the programming system includes a user interface (Fig. 7 “The control circuitry 80 is configured for modifying at least one of the sets of values that define the ideal multipole 250 in response to the directional control signals generated by the user interface.” ¶[0113]) with an edge guarding user control element (“the fractionalized current values on each of the electrodes, are computationally determined in a manner that emulates these ideal target poles” ¶[0021]) for adding to the target multipole an edge guard target cathode and an edge guard target anode, the edge guard target cathode has a smaller emulated cathodic fractionalization than the second target cathode, and the edge guard target anode has a smaller emulated anodic fractionalization than the second target anode.
Regarding the limitation for adding to the target multipole an edge guard target cathode and an edge guard target anode, the edge guard target cathode has a smaller emulated cathodic fractionalization than the second target cathode, and the edge guard target anode has a smaller emulated anodic fractionalization than the second target anode, the recitation of functional language must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim. In this case, the device of Lee contains all of the structural components of the claim and is capable of assigning the electrodes these fractionalizations; see MPEP 2114(I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2s at 1432.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, as applied to claims 1 and 13 above, in view of Moffitt (US 20110106215 A1, published May 5, 2011, hereinafter referred to as “Moffitt”).
Regarding claim 10, Lee teaches the system of claim 1. Lee also teaches wherein the programming system includes a user interface (Fig. 7 “The control circuitry 80 is configured for modifying at least one of the sets of values that define the ideal multipole 250 in response to the directional control signals generated by the user interface.” ¶[0113]).
Lee does not teach the system having a user input for identifying an anatomical region with the volume of tissue to be modulated, and the programming system is configured to determine the target multipole based on the identified anatomical region.
Moffitt’s invention relates to tissue stimulation systems, and more particularly, to a system and method for programming an implantable tissue stimulator (¶[0002]). The navigation session may be used to pinpoint the stimulation region or areas correlating to the pain. Such programming ability is particularly advantageous after implantation should the leads gradually or unexpectedly move, or in the case of a single-source system if the relative impedances of the contacts should change in a clinically significant way, thereby relocating the paresthesia away from the pain site. By reprogramming the external control device, the stimulation region can often be moved back to the effective pain site without having to reoperate on the patient in order to reposition the lead and its electrode array (¶[0010]). The locations of the ideal current source poles may be determined in a manner that places the resulting electrical field over an identified region of the patient to be stimulated. The locations of the ideal current source poles may be defined by the user, and may be displayed to the user along with the electrode locations, which as briefly discussed above, may be determined based on electrical measurements taken at the electrodes (¶[0063]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to identify the anatomical region with the volume of tissue to be modulated and determine the target multipole based on this identified region as taught by Moffitt in the system of Lee in order to effectively treat the patient without having to reposition the leads.
Regarding claim 20, Lee teaches the method of claim 13. Lee also teaches the method further comprising using a user interface (Fig. 7 “The control circuitry 80 is configured for modifying at least one of the sets of values that define the ideal multipole 250 in response to the directional control signals generated by the user interface.” ¶[0113])
Lee does not teach the method having a user input to identify an anatomical region with the volume of tissue to be modulated and using the programming system to determine the target multipole based on the identified anatomical region; or move the target multipole and using the programming system to determine physical electrode fractionalizations to emulate the target poles for the moved target multipole.
See USC 103 claim 10 rejection (for a user input to identify an anatomical region with the volume of tissue to be modulated and using the programming system to determine the target multipole based on the identified anatomical region). Moffitt additionally teaches the location of the target bipole can be steered (or otherwise selected) up, down, left, or right relative to the electrode arrays, such that (1) as the simple target bipole moves up in the electrode array, the assigned cathodic and anodic electrical current will be shifted up in the electrode array; (2) as the simple target bipole moves down in the electrode array, the assigned cathodic and anodic electrical current will be shifted down in the electrode array; (3) as the simple target bipole moves left in the electrode array, the assigned cathodic and anodic electrical current will be shifted to the left side of the electrode array; and (4) as the simple target bipole moves right in the electrode array, the assigned cathodic and anodic electrical current will be shifted down in the electrode array (¶[0072]). Further, claim 1 is a method of stimulating tissue using a plurality of electrodes, comprising: determining desired electrical parameter values at a plurality of spatial points; selecting a plurality of constituent current sources adjacent the locations of the electrodes; determining the relative strengths of the constituent current sources that, when combined, result in estimated electrical parameter values at the spatial points that best matches the desired electrical parameter values at the spatial points; selecting the polarity and percentage of electrical current to be associated with each of the electrodes based on the determined strengths of the constituent current sources; and conveying electrical current through the plurality of electrodes in accordance with the selected electrical current magnitudes to stimulate the tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to determine the physical electrode distributions that emulate the target poles for the moved target multipole as taught by Moffitt in the method of Lee in order to stimulate the target tissue.
Conclusion
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/E.N.C./Patent Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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