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 .
Specification
The disclosure is objected to because of the following informalities:
Par. [0002], line 3: “patent input” should be changed to “patient input”.
Par. [0055], line 15: “on behave of the patient” should be “on behalf of the patient”.
Par. [0056], lines 4-10: The sentence “For example, in the neurostimulation system can including … the external patient device.” needs revision.
Par. [0057], lines 5-6: “causing the discomfortable” should be changed to “causing the discomfort”.
Par. [0069], line 8: “external 502” should be “external system 502”.
Par. [0080], line 5: “can one or more physiological signals” should be changed to “can sense one or more physiological signals”.
Par. [0098], line 2: “wireless communication link 904A” should be changed to “wireless communication link 940a”.
Par. [0098], lines 3-4: “communication link 904C” should be changed to “communication link 940C”.
Par. [0101], line 6: “Interface control circuit 1020” should be changed to “Interface control circuit 1054”.
Par. [0103], line 1: “CP 1130” should be “CP 1132”.
Par. [0103], line 3: “CP 1130” should be “CP 1132”.
Par. [0104], line 2: “CP 1130” should be “CP 1132”.
Par. [0104], line 3: “CP 1130” should be “CP 1132”.
Par. [0105], line 1: “CP programming control circuit 1118” should be changed to “CP programming control circuit 1116”.
Par. [0105], line 2: “CP 1030” should be “CP 1132”.
Par. [0105], lines 3-4: “CP programming control circuit 1118” should be changed to “CP programming control circuit 1116”.
Par. [0106], line 2: “CP 1130” should be “CP 1132”. (2 instances)
Par. [0106], line 3: “CP 1130” should be “CP 1132”.
Par. [0107], line 6: “Interface control circuit 1120” should be changed to “Interface control circuit 1154”.
Par. [0107], line 9: “Interface control circuit 1120” should be changed to “Interface control circuit 1154”.
Par. [0107], line 11: “CP 1130” should be “CP 1132”.
Par. [0108], line 2: “CP 1130” should be “CP 1132”. (2 instances)
Par. [0108], lines 2-3: “to programming” should be “to program”.
Par. [0108], line 5: “CP 1130” should be “CP 1132”.
Par. [0108], line 6: “to programming” should be changed to “to program”.
Par. [0108], line 11: “CP 1130” should be “CP 1132”.
Par. [0108], line 12: “CP 1130” should be “CP 1132”.
Par. [0109], line 9: “RC figuration” should be changed to “RC configuration”.
Par. [0110], lines 9-10: “CP 1130” should be “CP 1132”.
Appropriate correction is required.
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 Interpretation
In Par. [0092] of the Applicant’s specification, “stimulation configuration” is explained to include stimulation parameters defining one or more stimulation waveforms and one or more stimulation fields. In Par. [0114] of the Applicant’s specification, “metric” is explained to be a parameter measured from neural responses evoked by neurostimulation pulses.
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
“an RC programming control circuit/system configured to generate the stimulator adjustment information based on patient adjustment instructions” in claim 1 (lines 13-14) and claim 20 (lines 15-16).
“a stimulator programming circuit/system configured to determine the patient adjustment instructions by interpreting the patient input according to an RC configuration” in claim 1 (lines 17-19) and claim 20 (lines 11-12).
“an RC configuration that is programmable for modifying capabilities of the RC in adjusting the stimulation configuration and adjusting the closed-loop control algorithm” in claim 1 (lines 19-21), claim 11 (lines 10-12), and claim 20 (lines 12-14).
“an RC programming circuit configured … to determine the RC configuration based on the RC programming information for enabling the RC user input device to receive the patient input for at least one of adjusting the stimulation configuration or adjusting the closed-loop control algorithm” in claim 3 (lines1-5).
“the RC is configured … to program the RC configuration using the received RC programming information” in claim 5 (lines 1-3).
“the stimulator programming circuit is configured to adjust the stimulation configuration directly using the one or more metrics” in claim 8 (lines 3-5).
“the stimulator programming circuit is configured to adjust the stimulation configuration directly using the each parameter and the respective at least one of the weighting factor or the scaling factor” in claim 9 (lines 4-6).
“the stimulator programming circuit is configured to adjust at least one of the stimulation configuration or the closed-loop control algorithm based on the response to the survey” in claim 10 (lines 3-5).
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The Examiner notes that for a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function (MPEP 2181(II)(B)). Evidence of such an algorithm for covering the corresponding structure, material, or acts are found in these locations of the specification:
Figs. 12-19 and Fig. 20, # 2074; Par. [0109-0126]; Par. [0130]; - For example, see Fig. 13 and Par. [0115]. In Par. [0115], it is explained that the SET screen allows the user to select a “Referencing Policy” for presented options (functions that can be enabled for the RC) including the following: Ignore, no adjustment to the closed-loop control algorithm; Move Setpoint: adjustment of setpoint allowed; Scale TW: adjustment of therapy window (TW) allowed; and Adaptive: adjustment of the closed-loop control algorithm allowed.
Figs. 12-19; Par. [0109-0126]; Fig. 20, # 2073; Par. [0129]; – For example, in Par. [0111-0112] the example of toggling is disclosed. In Par. [0111], it is explained that “The RC programming circuit can allow the RC configuration to be programmed to enable the user input device of the RC to receive the patient input for producing the direct control instructions (for direct adjustment of the stimulation configuration) and/or the adaptation instructions (also referred to indirect control instructions, including the adjustment of the closed-loop algorithm). For example, Par. [0112] explains that “For example, under “How should RC input be Interpreted?”, the user can select options from the following: * “Direct Control, No Adaptation”: allowing for the direct control without adaptation, to be applied instantly when selected…”
Figs. 12-19; Par. [0109-0126]; - For example, it is explained in Par. [0113] that the RC programming circuit can allow the RC configuration to be programmed to enable the user input device of the RC to receive the patient input for causing gradual shifts in a setpoint and/or a tolerance range around the setpoint.
Figs. 12-19; Par. [0109-0126]; - For example, see Par. [0112] where it is explained that the user can select a “TOGGLE” screen, a “SCALE” screen, or a “SET” screen, for example. These screens each allow the user to program various aspects of the RC configuration.
Figs. 12-19; Par. [0109-0126]; - For example, see Par. [0112] where it is explained that within the TOGGLE screen, the user can enable and disable features related to the direct control (direct adjustment of the stimulation configuration) and adaptation (adjustment of the closed-loop control algorithm).
Fig. 13; Par. [0114-0115]
Fig. 15, Fig. 17; Par. [0120]; Par. [0122-0123]
Figs. 19A-B; Par. [0125-0126]
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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.
The limitation “a remote controller (RC) configured for use by the patient” renders claim 1 (line 6) indefinite. It is unclear why/how the “patient” is using the controller, when earlier in the claim it is disclosed that neurostimulation is controlled by “a user” (lines 1-2). Was this limitation supposed to say “user” instead of “patient”?
Claim 2 recites the limitation "the user input" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is noted that “a patient input” was introduced in claim 1, but not a “user input”.
The limitation “a remote controller (RC) configured for use by the patient” renders claim 11 (line 6) indefinite. It is unclear why/how the “patient” is using the controller, when earlier in the claim it is disclosed that neurostimulation is controlled by “a user” (lines 1-2). Was this limitation supposed to say “user” instead of “patient”?
The limitation “a remote controller (RC) configured for use by the patient” renders claim 20 (line 9) indefinite. It is unclear why/how the “patient” is using the controller, when earlier in the claim it is disclosed that neurostimulation is controlled by “a user” (line 3). Was this limitation supposed to say “user” instead of “patient”?
*All other claims are rejected due to their dependency on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Esteller (U.S. PGPub No. 2022/0370808).
Regarding claim 1, Esteller teaches (Figs. 6, 9, and 10) a system for delivering neurostimulation to a patient and controlling the neurostimulation by a user (Par. [0068]; Par. [0087]; Par. [0089]), (Fig. 6, # 604 – implantable pulse generator (IPG), i.e. implantable stimulator; Fig. 13) the neurostimulation delivered from an implantable stimulator configured to control the delivery of the neurostimulation according to a stimulation configuration and to adjust the stimulation configuration by using a closed-loop control algorithm (Title, Abstract, Par. [0068] – neurostimulation system 600 includes IPG 604; Par. [0070]; Par. [0113] – method 1300 for delivering neurostimulation to a patient, including closed-loop steering of a stimulation field of the neurostimulation), the system comprising:
(Fig. 6, # 632 – remote controller (RC)) a remote controller (RC) configured for use by the patient (Par. [0068] – neurostimulation system 600 includes an external remote controller (RC)), the RC comprising:
(Fig. 6, # 604 – Implantable Pulse Generator (IPG), i.e. implantable stimulator; 640 – wireless communication link; Fig. 8, # 852 – telemetry circuit) an RC telemetry circuit configured to provide wireless communication between the RC and the implantable stimulator (Par. [0073] – RC 632 communicates with IPG 604 using a wireless link 604) and (Fig. 6, # 604, 632, 640; Fig. 10, # 1020; Fig. 13, # 1333-1334) to transmit stimulator adjustment information to the implantable stimulator (Par. [0073] – RC 632 communicates with IPG 604 using a wireless link 640; Par. [0078-0079]; Par. [0094] – stimulation control circuit 1020 can control the delivery of the neurostimulation using stimulation parameters; Par. [0137-0138]), (Fig. 9, # 960; Fig. 10, # 1060; Fig. 13, # 1333-1334) the stimulator adjustment information including direct control adjustment information for adjusting the stimulation configuration and adaptation adjustment information for adjusting the closed-loop control algorithm (Par. [0089] – Fig. 10 illustrates an embodiment of a system 1060 for closed-loop steering of a stimulation field; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands (i.e., direct control adjustment); Par. [0137-0138] – At 1334, one or more parameters of the stimulation parameters is adjusted to move the stimulation field according to the user commands while maintaining a value of the response parameter between an upper threshold and a lower threshold (i.e., adaptation adjustment));
(Fig. 6, # 632; Fig. 8, # 816 – programming control circuit; Fig. 13) an RC programming control circuit configured to generate the stimulator adjustment information based on patient adjustment instructions (Par. [0078-0079] – external programming device 802 may be implemented on RC 632. External programming device 802 includes a programming control circuit 816; Par. [0082] – programming control circuit 816 generates the plurality of stimulation parameters; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands (i.e., direct control adjustment); Par. [0137-0138] – At 1334, one or more parameters of the stimulation parameters is adjusted to move the stimulation field according to the user commands while maintaining a value of the response parameter between an upper threshold and a lower threshold (i.e., adaptation adjustment))); and
(Fig. 8, # 810 – user interface, 858 – user input device; Fig. 6, # 632; Fig. 9, # 960, 964) an RC user interface including an RC user input device configured to receive a patient input (Par. [0078]; Par. [0083] – user interface 810 includes a user input device 858; Par. [0087-0088] – steering module 964 can receive user commands (i.e., patient input). System 960 can be implemented on RC 632) and (Fig. 8, # 820 – stimulation control circuit, i.e. stimulator programming circuit; Fig. 9, # 960; Fig. 10, # 1060; Fig. 13, # 1333-1334) a stimulator programming circuit configured to determine the patient adjustment instructions by interpreting the patient input according to an RC configuration that is programmable for modifying capabilities of the RC in adjusting the stimulation configuration and adjusting the closed-loop control algorithm (Par. [0086] – Stimulation control circuit 820 can be configured to provide for closed-loop control of steering of stimulation field; Par. [0089] – Fig. 10 illustrates an embodiment of a system 1060 for closed-loop steering of a stimulation field; Par. [0092] – user interface 1010 can include a presentation device 1056; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands; Par. [0137-0138]).
Therefore, claim 1 is unpatentable over Esteller.
Regarding claim 2, Esteller teaches the system of claim 1, wherein (Fig. 8, # 820 – stimulator programming circuit; Fig. 10, # 1020; Fig. 13) the stimulator programming circuit is configured to enable and disable each function of RC functions using the user input according to the RC configuration, the RC functions allowing the delivery of the neurostimulation from the implantable stimulator to be adjusted using the RC and including one or more functions each allowing one or more aspects of the closed-loop control algorithm to be adjusted using the RC (Par. [0086] – Stimulation control circuit 820 can be configured to provide for closed-loop control of steering of stimulation field; Par. [0094]; Par. [0137-0138]).
Therefore, claim 2 is unpatentable over Esteller.
Regarding claim 3, Esteller teaches the system of claim 1, further comprising (Fig. 8, # 820 and 854 – interface control circuit, i.e. RC programming circuit; Fig. 10, # 1020 and 1054; Fig. 13) an RC programming circuit configured to receive RC programming information and to determine the RC configuration based on the RC programming information for enabling the RC user input device to receive the patient input for at least one of adjusting the stimulation configuration or adjusting the closed-loop control algorithm (Par. [0084] – Interface control circuit 854 controls the operation of user interface 810 including responding to various inputs received by user input device 858 and defining the one or more stimulation waveforms; Par. [0092]; Par. [0094]; Par. [0137-0138]).
Therefore, claim 3 is unpatentable over Esteller.
Regarding claim 4, Esteller teaches the system of claim 3, wherein (Fig. 8, # 810 – user interface, 854 – RC programming circuit) the RC user interface comprises the RC programming circuit (Par. [0083]), and (Fig. 8, # 858 – input device; Fig. 10, # 1058) the RC user input device is configured to receive the RC programming information (Par. [0084]; Par. [0093]).
Therefore, claim 4 is unpatentable over Esteller.
Regarding claim 5, Esteller teaches the system of claim 3, wherein (Fig. 8, # 852 – RC telemetry circuit) the RC is configured to receive the RC programming information using the RC telemetry circuit (Par. [0079-0080]) and (Fig. 8, # 854; Fig. 10, # 1054) to program the RC configuration using the received RC programming information (Par. [0084] – interface control circuit defines the one or more stimulation waveforms; Par. [0094]).
Therefore, claim 5 is unpatentable over Esteller.
Regarding claim 6, Esteller teaches the system of claim 3, wherein (Fig. 8, # 854 and 858; Fig. 10, # 1058) the RC programming circuit is configured to allow the RC configuration to be defined to allow the RC user input device to receive the patient input for adjusting the stimulation configuration while overriding the closed-loop control algorithm (Par. [0084] – Interface control circuit 854 controls the operation of user interface 810 including responding to various inputs received by user input device 858 and defining the one or more stimulation waveforms; Par. [0093] – user input device 1058 can receive user commands for moving the stimulation field (i.e., overriding the closed-loop control algorithm)).
Therefore, claim 6 is unpatentable over Esteller.
Regarding claim 7, Esteller teaches the system of claim 3, wherein (Fig. 13, # 1334) the RC programming circuit is configured to allow the RC configuration to be defined to enable the RC user input device to receive the patient input for causing gradual shifts in at least one of a setpoint or a tolerance range around that setpoint, the setpoint being a parameter of the closed-loop control algorithm associated with a measurable result of the delivery of the neurostimulation (Par. [0138] – At 1334, one or more parameters of the stimulation parameters is adjusted to move the stimulation field according to the user commands while maintaining a value of the response parameter between an upper threshold and a lower threshold. The upper threshold and lower threshold can be adjusted (i.e. tolerance range around the setpoint)).
Therefore, claim 7 is unpatentable over Esteller.
Regarding claim 8, Esteller teaches the system of claim 3, wherein (Fig. 13, # 1334) the RC programming circuit is configured to allow the RC configuration to be defined to enable the RC user input device to receive the patient input as one or more metrics, and the stimulator programming circuit is configured to adjust the stimulation configuration directly using the one or more metrics (Par. [0138] – In one embodiment, the upper threshold is adjusted based on a DT, and the lower threshold is adjusted based on a NT. The DT is the value of the response parameter corresponding to the stimulation intensity at which the patient starts to feel discomfort resulting from the neurostimulation. The NT is the minimum value of the response parameter corresponding to the minimum stimulation intensity at which the patient starts to feel the neurostimulation.; - DT and NT are metrics).
Therefore, claim 8 is unpatentable over Esteller.
Regarding claim 9, Esteller teaches the system of claim 8, wherein (Fig. 10, # 1064 – steering module part of RC programming circuit; Fig. 13, # 1334) the RC programming circuit is configured to allow the RC configuration to be defined to enable the RC user input device to receive at least one of a weighting factor or a scaling factor for each parameter of the one or more metrics, and the stimulator programming circuit is configured to adjust the stimulation configuration directly using the each parameter and the respective at least one of the weighting factor or the scaling factor (Par. [0130] – In one embodiment, steering module 1064 sets the upper threshold to aDT and sets the lower threshold to bNT, where a and b are programmable to allow adjustment depending on, for example, whether the user or the patient is to drive the steering. In one specific example, a is programmed to 0.5, and b is programmed to 1.1.; Par. [1038] – In one embodiment, the upper threshold is set to aDT, and the lower threshold is set to bNT, where a and b having programmable values (i.e., weighting factor/scaling factor).
Therefore, claim 9 is unpatentable over Esteller.
Regarding claim 10, Esteller teaches the system of claim 3, wherein (Fig. 10, # 1058; Fig. 13, # 1334) the RC programming circuit is configured to allow the RC configuration to be defined to enable the RC user input device to receive the patient input as a response to a survey, and the stimulator programming circuit is configured to adjust at least one of the stimulation configuration or the closed-loop control algorithm based on the response to the survey (Par. [0125] – Optionally, the user can mark (e.g., using user input device 1058) when the patient stops feeling the stimulation, and/or mark when the patient starts feeling discomfort; - This is representative of the DT threshold and also representative of a patient responding to a survey of when the patient starts feeling discomfort.; Par. [0128-0129]; Par. [0138]).
Therefore, claim 10 is unpatentable over Esteller.
Regarding claim 11, Esteller teaches (Fig. 6, # 600, 604 – implantable pulse generator (IPG), i.e. implantable stimulator; Fig. 13) a method for delivering neurostimulation to a patient and controlling the neurostimulation by a user, the neurostimulation delivered from an implantable stimulator configured to control the delivery of the neurostimulation according to a stimulation configuration and to adjust the stimulation configuration by using a closed-loop control algorithm (Title, Abstract, Par. [0068] – neurostimulation system 600 includes IPG 604; Par. [0070]; Par. [0113] – method 1300 for delivering neurostimulation to a patient, including closed-loop steering of a stimulation field of the neurostimulation), the method comprising:
(Fig. 6, # 604 – Implantable pulse generator (IPG), i.e. implantable stimulator, 632 – remote controller (RC), 640) providing a remote controller (RC) configured to be used by the patient and to wirelessly communicate with the implantable stimulator (Par. [0073] – RC 632 communicates with IPG 604 using a wireless link 604);
(Fig. 6, # 632; Fig. 9, # 960, 964) receiving a patient input using the RC (Par. [0087-0088] – steering module 964 can receive user commands (i.e., patient input). System 960 can be implemented on RC 632);
(Fig. 9, # 960; Fig. 10, # 1060; Fig. 13, # 1333-1334) determining patient adjustment instructions by interpreting the patient input according to an RC configuration that is programmable for modifying capabilities of the RC in adjusting the stimulation configuration and adjusting the closed-loop control algorithm (Par. [0089] – Fig. 10 illustrates an embodiment of a system 1060 for closed-loop steering of a stimulation field; Par. [0092] – user interface 1010 can include a presentation device 1056; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands; Par. [0137-0138]);
(Fig. 9, # 960; Fig. 10, # 1060; Fig. 13, # 1333-1334) generating stimulator adjustment information based on the patient adjustment instructions, the stimulator adjustment information including direct control adjustment information for adjusting the stimulation configuration directly and adaptation adjustment information for adjusting the closed-loop control algorithm (Par. [0089] – Fig. 10 illustrates an embodiment of a system 1060 for closed-loop steering of a stimulation field; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands (i.e., direct control adjustment); Par. [0137-0138] – At 1334, one or more parameters of the stimulation parameters is adjusted to move the stimulation field according to the user commands while maintaining a value of the response parameter between an upper threshold and a lower threshold (i.e., adaptation adjustment)); and
(Fig. 6, # 604, 632, 640; Fig. 10, # 1020; Fig. 13, # 1333-1334) transmitting the stimulator adjustment information from the RC to the implantable stimulator (Par. [0073] – RC 632 communicates with IPG 604 using a wireless link 640; Par. [0094] – stimulation control circuit 1020 can control the delivery of the neurostimulation using stimulation parameters; Par. [0137-0138]).
Therefore, claim 11 is unpatentable over Esteller.
Regarding claim 12, Esteller teaches the method of claim 11, further comprising (Fig. 13, # 1333, 1334) tracking a usage of the RC in generating the direct control adjustment information and a usage of the RC in generating the adaptation adjustment information (Par. [0133]; Par. [0137-0138]).
Therefore, claim 12 is unpatentable over Esteller.
Regarding claim 13, Esteller teaches the method of claim 11, further comprising:
(Fig. 8, # 810 – user interface, 858 – user input device; Fig. 6, # 632; Fig. 9, # 960, 964) receiving RC user input using a user interface of the RC (Par. [0078]; Par. [0083] – user interface 810 includes a user input device 858; Par. [0087-0088] – steering module 964 can receive user commands (i.e., patient input). System 960 can be implemented on RC 632); and
(Fig. 13, # 1333, 1334) adjusting the RC configuration using the RC user input (Par. [0092] – user interface 1010 can include a presentation device 1056; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands; Par. [0137-0138]).
Therefore, claim 13 is unpatentable over Esteller.
Regarding claim 14, Esteller teaches the method of claim 11, further comprising:
(Fig. 8, # 852 – telemetry circuit) receiving RC programming information using a telemetry circuit of the RC (Par. [0079-0080]); and
(Fig. 8, # 854; Fig. 10, # 1054) adjusting the RC configuration using the RC programming information (Par. [0084] – interface control circuit defines the one or more stimulation waveforms; Par. [0094]).
Therefore, claim 14 is unpatentable over Esteller.
Regarding claim 15, Esteller teaches the method of claim 14, further comprising:
(Fig. 6, # CP) providing a clinician’s programmer (CP) configured for use by the user (Par. [0070]);
(Fig. 6, # CP) receiving a CP user input using a user interface of the CP (Par. [0072-0073] – CP 630 can be used to set modulation parameters for the neurostimulation after IPG 604 has been implanted); and
(Fig. 6, # CP) generating the RC programming information based on the CP user input (Par. [0072-0073] – RC 632 may be programmed by CP 630).
Therefore, claim 15 is unpatentable over Esteller.
Regarding claim 16, Esteller teaches the method of claim 11, further comprising (Fig. 8, # 820 and 854; Fig. 10, # 1020 and 1054; Fig. 13) adjusting the RC configuration to enable the RC to receive the patient input for at least one of adjusting the stimulation configuration or adjusting the closed-loop control algorithm (Par. [0084] – Interface control circuit 854 controls the operation of user interface 810 including responding to various inputs received by user input device 858 and defining the one or more stimulation waveforms; Par. [0092]; Par. [0094]; Par. [0137-0138]).
Therefore, claim 16 is unpatentable over Esteller.
Regarding claim 17, Esteller teaches the method of claim 11, further comprising (Fig. 13, # 1334) adjusting the RC configuration to enable the RC to receive the patient input for causing gradual shifts in at least one of a setpoint or a tolerance range around that setpoint, the setpoint being a parameter of the closed-loop control algorithm associated with a measurable result of the delivery of the neurostimulation (Par. [0138] – At 1334, one or more parameters of the stimulation parameters is adjusted to move the stimulation field according to the user commands while maintaining a value of the response parameter between an upper threshold and a lower threshold. The upper threshold and lower threshold can be adjusted (i.e. tolerance range around the setpoint)).
Therefore, claim 17 is unpatentable over Esteller.
Regarding claim 18, Esteller teaches the method of claim 11, further comprising (Fig. 13, # 1334) adjusting the RC configuration to enable the RC to receive the patient input as one or more metrics that are used to directly adjust the stimulation configuration (Par. [0138] – In one embodiment, the upper threshold is adjusted based on a DT, and the lower threshold is adjusted based on a NT. The DT is the value of the response parameter corresponding to the stimulation intensity at which the patient starts to feel discomfort resulting from the neurostimulation. The NT is the minimum value of the response parameter corresponding to the minimum stimulation intensity at which the patient starts to feel the neurostimulation.; - DT and NT are metrics).
Therefore, claim 18 is unpatentable over Esteller.
Regarding claim 19, The method of claim 11, further comprising (Fig. 10, # 1058; Fig. 13, # 1334) adjusting the RC configuration to enable the RC to receive the patient input as a response to a survey, the response used to adjust at least one of the stimulation configuration or the closed-loop control algorithm (Par. [0125] – Optionally, the user can mark (e.g., using user input device 1058) when the patient stops feeling the stimulation, and/or mark when the patient starts feeling discomfort; - This is representative of the DT threshold and also representative of a patient responding to a survey of when the patient starts feeling discomfort.; Par. [0128-0129]; Par. [0138]).
Therefore, claim 19 is unpatentable over Esteller.
Regarding claim 20, Esteller teaches (Fig. 9, # 960; Fig. 13) a non-transitory computer-readable storage medium including instructions, which when executed by a system (Par. [0133] – a non-transitory computer-readable storage medium includes instructions, which when executed by a system, such as system 960 or 970, cause the system to perform method 1300), cause the system to perform (Fig. 6, # 600, 604 – implantable pulse generator (IPG), i.e. implantable stimulator; Fig. 13) a method for delivering neurostimulation to a patient and controlling the neurostimulation by a user, the neurostimulation delivered from an implantable stimulator configured to control the delivery of the neurostimulation according to a stimulation configuration and to adjust the stimulation configuration by using a closed-loop control algorithm (Title, Abstract, Par. [0068] – neurostimulation system 600 includes IPG 604; Par. [0070]; Par. [0113] – method 1300 for delivering neurostimulation to a patient, including closed-loop steering of a stimulation field of the neurostimulation), the method comprising:
(Fig. 6, # 604 – Implantable pulse generator (IPG), i.e. implantable stimulator, 632 – remote controller (RC), 640) communicating with the implantable stimulator wirelessly using a remote controller (RC) configured for use by the patient (Par. [0073] – RC 632 communicates with IPG 604 using a wireless link 604);
(Fig. 6, # 632; Fig. 9, # 960, 964) receiving a patient input using the RC (Par. [0087-0088] – steering module 964 can receive user commands (i.e., patient input). System 960 can be implemented on RC 632);
(Fig. 9, # 960; Fig. 10, # 1060; Fig. 13, # 1333-1334) determining patient adjustment instructions by interpreting the patient input according to an RC configuration that is programmable for modifying capabilities of the RC in adjusting the stimulation configuration and adjusting the closed-loop control algorithm (Par. [0089] – Fig. 10 illustrates an embodiment of a system 1060 for closed-loop steering of a stimulation field; Par. [0092] – user interface 1010 can include a presentation device 1056; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands; Par. [0137-0138]);
(Fig. 9, # 960; Fig. 10, # 1060; Fig. 13, # 1333-1334) generating stimulator adjustment information based on the patient adjustment instructions, the stimulator adjustment information including direct control adjustment information for adjusting the stimulation configuration directly and adaptation adjustment information for adjusting the closed-loop control algorithm (Par. [0089] – Fig. 10 illustrates an embodiment of a system 1060 for closed-loop steering of a stimulation field; Par. [0093] – User input device 1058 can receive user commands for moving the stimulation field, and presentation device 1056 can graphically show movement of the stimulation field in response to user commands (i.e., direct control adjustment); Par. [0137-0138] – At 1334, one or more parameters of the stimulation parameters is adjusted to move the stimulation field according to the user commands while maintaining a value of the response parameter between an upper threshold and a lower threshold (i.e., adaptation adjustment)); and
(Fig. 6, # 604, 632, 640; Fig. 10, # 1020; Fig. 13, # 1333-1334) transmitting the stimulator adjustment information from the RC to the implantable stimulator (Par. [0073] – RC 632 communicates with IPG 604 using a wireless link 640; Par. [0094] – stimulation control circuit 1020 can control the delivery of the neurostimulation using stimulation parameters; Par. [0137-0138]).
Therefore, claim 20 is unpatentable over Esteller.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sharma, et al. (WO2022/183198)
Sun, et al. (“Closed-loop Neurostimulation: The Clinical Experience”
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796