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 .
Information Disclosure Statement
The Information Disclosure Statements filed 03/14/2025 and 08/04/2025 have been considered by the Examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 6. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
*Note: Reference character 6 is shown in Figs. 1-4, but is not included in the specification.
The drawings are objected to because Figs. 3-4 include the terms “Ein” and “Aus” which appear to be the terms for on/activated and off/deactivated. Please translate into English. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
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 limitation is:
“determining device being configured for determining an axial dislocation of the stimulator shaft” in claim 1.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The claim limitation above covers the corresponding structure, material, or acts described in the specification at specific citations listed below (references are made to the PGPub – US 2025/0170405):
Par. [0005] – In principle, any measurement principle suitable for detecting length or position changes can be used for this, for example a capacitive, inductive or resistive measurement principle. In one embodiment, the determining device has at least one sensor which is arranged on or in the body of the patient or in the vicinity of the body and generates a signal representing the axial dislocation; Par. [0006] – the determining device is connected to the plurality of electrodes and configured for determining impedances between the electrodes and therefore an impedance pattern of the surrounding body tissue along the longitudinal axis of the stimulator shaft, for determining a temporal change of the impedance pattern and for determining the axial dislocation depending on the determined temporal change of the impedance pattern. Preferably, the determining device is configured for determining impedances between respectively adjacent electrodes. Alternatively or additionally, the determining device is configured for determining impedances between at least one of the electrodes and a skin electrode. The stimulator, more precisely: the plurality of electrodes, function in this embodiment as a sensor, as it were, for generating a signal representing the axial dislocation, so that no separate sensor is necessary for determining the dislocation
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 § 102
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 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 1-9 and 16-19 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Bradley, et al. (US 2006/0224222 – cited on IDS).
Regarding claim 1, Bradley teaches (Fig. 1, # 100) a system for electrical neurostimulation (Title; Abstract; Par. [0032] – Referring first to FIGS. 1 and 1A, an exemplary implantable neurostimulation system 100 includes first and second implantable leads 102 and 104), the system comprising:
(Figs. 1 and 6A-B, # 102 – lead, i.e. stimulator, 108 – flexible body, i.e. stimulator shaft) a stimulator that has a stimulator shaft (Par. [0032] – The exemplary leads 102 and 104 are in-line leads and, to that end, both of the leads consist of a plurality of in-line electrodes 106 carried on a flexible body 108);
(Figs. 1-2, # 110 – IPG, 128 – current control circuit, i.e. control device) a control device (Par. [0037] – the IPG 110 is provided with a programmable current control circuit 128 that causes selected dual current sources 124 to operate as an anode or a cathode, at specified times, to source or sink current having predetermined amplitude); and
(Fig. 1, # 118) a determining device (Par. [0034]; Par. [0037] – The control circuit 128, which typically operates in accordance with stored control data that is received from the programmer 118, also turns off the selected dual current sources 124 at specified times; Par. [0044] – The data gleaned from the measurements may be stored and processed by the IPG control circuit 128 (or 128'), by the external programmer 118, by some combination thereof, or the like),
(Fig. 1, # E1-E8, 102) the stimulator shaft having a distal stimulator end with electrodes arranged adjacently along a longitudinal axis of the stimulator shaft and configured for outputting electrical stimuli to a body tissue surrounding the stimulator shaft (Par. [0032] – there are eight (8) electrodes on lead 102, which are labeled E1-E8 … Once in place, the electrodes 106 may be used to supply stimulation energy to the target neural elements or other target tissue.),
(Figs. 1-2, # 128) the control device connected to the electrodes, the control device configured for controlling an output of the electrical stimuli (Par. [0037]; Par. [0039] – Referring to FIG. 2, the control circuit 128 may be used to simultaneously turn on (or enable) the positive current sources in the dual current sources 124 connected to lead electrodes E1 and E2 during time T1),
(Figs. 1-2, # 128) the electrodes configured to be activated and deactivated independently of one another by the control device and activated for forming different electrode activation patterns along the longitudinal axis (Par. [0037] – To that end, the IPG 110 is provided with a programmable current control circuit 128 that causes selected dual current sources 124 to operate as an anode or a cathode, at specified times, to source or sink current having predetermined amplitude… The control circuit 128, which typically operates in accordance with stored control data that is received from the programmer 118, also turns off the selected dual current sources 124 at specified times.),
(Figs. 6A-B and 7) the determining device being configured for determining an axial dislocation of the stimulator shaft (Par. [0044] – Generally speaking, the present migration detection processes employ artifactual tissue measurements, such as tissue impedance measurements or evoked potential measurements, to detect migration of the leads 102 and 104. The data gleaned from the measurements may be stored and processed by the IPG control circuit 128 (or 128'), by the external programmer 118, by some combination thereof, or the like; Par. [0050] – This difference provides an indication that the lead 102 may have moved relative to the tissue in the vicinity of the lead; Par. [0053]),
(Figs. 6A-B) the control device being connected to the determining device and configured for axially moving an electrode activation pattern by a change of activation and deactivation of the electrodes as a function of the axial dislocation, in order to locally adapt the output of the electrical stimuli to the axial dislocation of the stimulator shaft (Pars. [0066-0068] – Assuming for example that the leads 102 and 104 illustrated in FIG. 6A were employed in a therapeutic regimen that involve sourcing and sinking stimulation pulses from electrodes E4, E5 and E6 on lead 102 and electrodes E13 and E14 on lead 104. After lead 102 moved to the position illustrated in FIG. 6B, and it was determined by the present inventions that only lead 102 moved and that lead 102 moved toward the IPG 110 a distance corresponding to two electrodes, the therapeutic regimen may reprogrammed by simply substituting electrodes E2, E3 and E4, respectively, for electrodes E4, E5 and E6 … Automatic reprogramming, which is especially useful when lead migration is being continuously monitored, could be truly automatic (i.e. it would happen without the patient's knowledge). Alternatively, the IPG 110 could provide the patient with an indication that at least one lead has moved and give the patient the option of trying the automatically reprogrammed stimulation regimen or simply reporting the lead migration to the clinician. Reprogramming by the clinician, either in response to a notification from the IPG 110 or patient complaint, would typically involve allowing the external programmer 118 to modify (or simply suggest a modification of) the therapeutic regimen based on the lead migration data from the IPG 110).
Therefore, claim 1 is unpatentable over Bradley, et al.
Regarding claim 2, Bradley teaches the system according to claim 1, wherein (Fig. 1, # 110, 118 – external programmer, i.e. determining device, 128) the determining device is connected to the electrodes (Par. [0034]; Par. [0037]) and configured for:
(Figs. 6A-B and 7) determining impedances between electrodes and therefore an impedance pattern of the body tissue along the longitudinal axis of the stimulator shaft (Pars. [0044-0045]; Par. [0047] – Exemplary plots of the impedance at each electrode E1-E8 on lead 102 and each electrode E9-E16 on lead 104 are shown with solid lines in FIG. 7; Par. [0050] – Exemplary positions of the leads 102 and 104 at the time of a subsequent impedance measurement are illustrated in FIG. 6B and the corresponding plots of the subsequent impedance measurement at each of the electrode E1-E16 is shown with dashed lines in FIG. 7),
(Figs. 6A-B and 7) determining a temporal change of the impedance pattern (Par. [0048] – impedance measurements may be taken at a periodic check-up or in response to an indication from the patient that the neurostimulation system is no longer providing the same level of therapeutic effect that it did when the baseline impedance measurement was taken. Such an impedance measurement is referred to herein as a "subsequent impedance measurement" and may consist of a single set of measurements at electrodes E1-E16 or a number of sets of measurements at the electrodes that are averaged together on an electrode-by-electrode basis. The subsequent impedance measurement is compared to the baseline impedance measurement to determine whether or not the measurements have changed. A change may indicate that the associated lead has migrated; Par. [0050] – Exemplary positions of the leads 102 and 104 at the time of a subsequent impedance measurement are illustrated in FIG. 6B and the corresponding plots of the subsequent impedance measurement at each of the electrode E1-E16 is shown with dashed lines in FIG. 7. Referring first to lead 102, the plot of the subsequent impedance measurement is clearly different than the plot of the baseline impedance measurement. This difference provides an indication that the lead 102 may have moved relative to the tissue in the vicinity of the lead), and
(Figs. 6A-B and 7) determining the axial dislocation depending on the temporal change of the impedance pattern (Par. [0050] – the subsequent tissue impedance measurements taken at electrodes E2 and E3 are essentially the same as the baseline tissue impedance measurements taken at electrodes E4 and E5, respectively. From this, it may be inferred that the electrodes E2 and E3 have moved to the locations originally occupied by electrodes E4 and E5, respectively, and that the lead 102 has moved a distance corresponding to two electrodes 106. If, for example, there is a 4 mm electrode-to-electrode spacing, it could be inferred that the lead 102 moved 8 mm.).
Therefore, claim 2 is unpatentable over Bradley, et al.
Regarding claim 3, Bradley teaches the system according to claim 2, wherein (Fig. 1, # 102, 118; Figs. 6A-B and 7, # 102, E1-E8) the determining device is configured for determining impedances between respectively adjacently arranged electrodes (Par. [0050] – Exemplary positions of the leads 102 and 104 at the time of a subsequent impedance measurement are illustrated in FIG. 6B and the corresponding plots of the subsequent impedance measurement at each of the electrode E1-E16 is shown with dashed lines in FIG. 7).
Therefore, claim 3 is unpatentable over Bradley, et al.
Regarding claim 4, Bradley teaches the system according to claim 2, wherein (Figs. 6A-B and 7) the determining device is configured for determining the temporal change of an impedance spectrum of the impedances (Par. [0048] – Impedance measurements are also taken at each of the electrodes E1-E16 at various times after the baseline impedance measurement has been established. For example, impedance measurements may be taken at a periodic check-up or in response to an indication from the patient that the neurostimulation system is no longer providing the same level of therapeutic effect that it did when the baseline impedance measurement was taken; Par. [0049] – Additionally, or alternatively, as additional subsequent impedance measurements are taken over time, a moving average process may be used to establish the trended baseline impedance value).
Therefore, claim 4 is unpatentable over Bradley, et al.
Regarding claim 5, Bradley teaches the system according to claim 2, wherein (Figs. 6A-B and 7) the determining device is configured for determining the temporal change of the impedance pattern, taking account of a real part and/or an imaginary part of the impedances that are determined (Par. [0048] – Impedance measurements are also taken at each of the electrodes E1-E16 at various times after the baseline impedance measurement has been established. For example, impedance measurements may be taken at a periodic check-up or in response to an indication from the patient that the neurostimulation system is no longer providing the same level of therapeutic effect that it did when the baseline impedance measurement was taken; Par. [0049] – Additionally, or alternatively, as additional subsequent impedance measurements are taken over time, a moving average process may be used to establish the trended baseline impedance value).
Therefore, claim 5 is unpatentable over Bradley, et al.
Regarding claim 6, Bradley teaches the system according to claim 2, wherein (Figs. 6A-B and 7) the determining device is configured for determining the temporal change of the impedance pattern, taking account of a magnitude and/or a phase of the impedances that are determined (Par. [0048] – Impedance measurements are also taken at each of the electrodes E1-E16 at various times after the baseline impedance measurement has been established. For example, impedance measurements may be taken at a periodic check-up or in response to an indication from the patient that the neurostimulation system is no longer providing the same level of therapeutic effect that it did when the baseline impedance measurement was taken; Par. [0049] – Additionally, or alternatively, as additional subsequent impedance measurements are taken over time, a moving average process may be used to establish the trended baseline impedance value; Par. [0050] – Exemplary positions of the leads 102 and 104 at the time of a subsequent impedance measurement are illustrated in FIG. 6B and the corresponding plots of the subsequent impedance measurement at each of the electrode E1-E16 is shown with dashed lines in FIG. 7. Referring first to lead 102, the plot of the subsequent impedance measurement is clearly different than the plot of the baseline impedance measurement. This difference provides an indication that the lead 102 may have moved relative to the tissue in the vicinity of the lead).
Therefore, claim 6 is unpatentable over Bradley, et al.
Regarding claim 7, Bradley teaches the system according to claim 2, wherein (Figs. 6A-B and 7) the determining device is configured for determining the temporal change of the impedance pattern, taking account of a spectrum of the impedances that are determined (Par. [0048] – Impedance measurements are also taken at each of the electrodes E1-E16 at various times after the baseline impedance measurement has been established. For example, impedance measurements may be taken at a periodic check-up or in response to an indication from the patient that the neurostimulation system is no longer providing the same level of therapeutic effect that it did when the baseline impedance measurement was taken; Par. [0049] – Additionally, or alternatively, as additional subsequent impedance measurements are taken over time, a moving average process may be used to establish the trended baseline impedance value).
Therefore, claim 7 is unpatentable over Bradley, et al.
Regarding claim 8, Bradley teaches the system according to claim 2, wherein (Fig. 2, # 110, 124) the electrodes are configured for outputting a measuring current for determination of the impedances (Par. [0036-0038] – dual current sources 124… the control circuit 128 may be used to measure the electrode voltage VE1, VE2, VE3 . . . VE16 at the output node 126 of each dual current source 124, whether the electrode is activated or non-activated. This allows the electrode voltage at the electrode to be measured which, in turn, facilitates impedance measurements; Par. [0046] – impedance may be determined by sourcing current from the IPG outer case 116, which functions as electrode Ecase (FIG. 2), and sinking current at a selected one of the electrodes E1-E16 at a predetermined voltage), and wherein (Figs. 1-2 and 6A, # 116, # 124, Ecase) the control device is configured for controlling the output of the measuring current (Par. [0036]; Par. [0046] – impedance may be determined by sourcing current from the IPG outer case 116, which functions as electrode Ecase (FIG. 2), and sinking current at a selected one of the electrodes E1-E16 at a predetermined voltage. Given that most of the drop will occur at the smaller electrode, and that the lead electrodes 106 are much smaller than the IPG outer case 116, it can be assumed that the measured impedance between the selected lead electrode and the outer case is primarily due to the impedance of the tissue adjacent to the selected lead electrode).
Therefore, claim 8 is unpatentable over Bradley, et al.
Regarding claim 9, Bradley teaches the system according to claim 8, wherein the measuring current has a current intensity of at most 10 mA (Par. [0046] – It should be noted that the current used for impedance measurements is a sub-threshold current pulse (e.g. 1 mA for 20 μs) that will not cause stimulation or substantially drain the IPG battery).
Therefore, claim 9 is unpatentable over Bradley, et al.
Regarding claim 16, Bradley teaches the system according to claim 1, wherein (Figs. 6A-B and 7) the determining device is configured for determining impedances based on the electrical stimuli (Par. [0046]).
Therefore, claim 16 is unpatentable over Bradley, et al.
Regarding claim 17, Bradley teaches the system according to claim 16, wherein:
(Figs. 1-2, # 102, 106, 116/Ecase, E1-E8) the electrodes comprise a first group of electrodes and a second group of electrodes (Par. [0032] – there are eight (8) electrodes on lead 102; Par. [0137] – IPG case 116 can function as an electrode (Ecase); the electrodes can be arbitrarily grouped as desired, for instance the first group is electrodes E1-E8 and the second group is Ecase), and
(Figs. 6A-B and 7) the determining device is configured for determining impedances across the first group of electrodes when an electrical stimulus is output by the second group of electrodes (Par. [0044] – Additionally, the artifactual tissue measurements (e.g., tissue impedance measurements and evoked potential measurements) allow lead migration to be detected on an individual basis relative to the underlying tissue, as opposed to detecting migration of one lead relative to the other. Accordingly, the processes described herein may be employed in neurostimulation systems with a single lead as well as neurostimulation systems, such as the exemplary system 100, with a plurality of leads.; Par. [0046] - impedance may be determined by sourcing current from the IPG outer case 116, which functions as electrode Ecase (FIG. 2), and sinking current at a selected one of the electrodes E1-E16 at a predetermined voltage … This process may be repeated for each of the electrodes E1-E16. Alternatively, an electrode that is sutured anywhere in or on the patient's body and, preferably, that is larger than the lead electrodes, may be used in place of the case IPG outer case for these measurements; Par. [0050]).
Therefore, claim 17 is unpatentable over Bradley, et al.
Regarding claim 18, Bradley teaches the system according to claim 17, wherein (Figs. 1-2, # 102, 106, 116/Ecase, E1-E8) electrodes of the first group of electrodes are not contained in the second group of electrodes (Par. [0032] – there are eight (8) electrodes on lead 102; Par. [0137] – IPG case 116 can function as an electrode (Ecase); the electrodes can be arbitrarily grouped as desired, for instance the first group is electrodes E1-E8 and the second group is Ecase).
Therefore, claim 18 is unpatentable over Bradley, et al.
Regarding claim 19, Bradley teaches (Fig. 1, # 100) a method for operating a system for electrical neurostimulation (Title; Abstract; Par. [0002]), the system having (Figs. 1 and 6A-B, # 102 – lead, i.e. stimulator, 108 – flexible body, i.e. stimulator shaft) a stimulator with an elongated stimulator shaft (Par. [0032] – The exemplary leads 102 and 104 are in-line leads and, to that end, both of the leads consist of a plurality of in-line electrodes 106 carried on a flexible body 108) having (Fig. 1, # E1-E8, 102) a distal stimulator end with electrodes (Par. [0032] – there are eight (8) electrodes on lead 102, which are labeled E1-E8 … Once in place, the electrodes 106 may be used to supply stimulation energy to the target neural elements or other target tissue.), the method comprising the steps of:
(Figs. 1-2, # 128) activating the electrodes to form an electrode activation pattern with activated and non-activated electrodes (Par. [0037] – To that end, the IPG 110 is provided with a programmable current control circuit 128 that causes selected dual current sources 124 to operate as an anode or a cathode, at specified times, to source or sink current having predetermined amplitude… The control circuit 128, which typically operates in accordance with stored control data that is received from the programmer 118, also turns off the selected dual current sources 124 at specified times.);
(Figs. 6A-B and 7) determining an axial dislocation of the elongated stimulator shaft (Par. [0044] – Generally speaking, the present migration detection processes employ artifactual tissue measurements, such as tissue impedance measurements or evoked potential measurements, to detect migration of the leads 102 and 104. The data gleaned from the measurements may be stored and processed by the IPG control circuit 128 (or 128'), by the external programmer 118, by some combination thereof, or the like; Par. [0050] – This difference provides an indication that the lead 102 may have moved relative to the tissue in the vicinity of the lead; Par. [0053]);
(Figs. 6A-B) activating the electrodes such that the electrode activation pattern is moved axially depending on the axial dislocation by a changed activation and deactivation of the electrodes, in order to compensate for the axial dislocation of the elongated stimulator shaft (Pars. [0066-0068] – Assuming for example that the leads 102 and 104 illustrated in FIG. 6A were employed in a therapeutic regimen that involve sourcing and sinking stimulation pulses from electrodes E4, E5 and E6 on lead 102 and electrodes E13 and E14 on lead 104. After lead 102 moved to the position illustrated in FIG. 6B, and it was determined by the present inventions that only lead 102 moved and that lead 102 moved toward the IPG 110 a distance corresponding to two electrodes, the therapeutic regimen may reprogrammed by simply substituting electrodes E2, E3 and E4, respectively, for electrodes E4, E5 and E6 … Automatic reprogramming, which is especially useful when lead migration is being continuously monitored, could be truly automatic (i.e. it would happen without the patient's knowledge). Alternatively, the IPG 110 could provide the patient with an indication that at least one lead has moved and give the patient the option of trying the automatically reprogrammed stimulation regimen or simply reporting the lead migration to the clinician. Reprogramming by the clinician, either in response to a notification from the IPG 110 or patient complaint, would typically involve allowing the external programmer 118 to modify (or simply suggest a modification of) the therapeutic regimen based on the lead migration data from the IPG 110).
Therefore, claim 19 is unpatentable over Bradley, et al.
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 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley, et al. (US 2006/0224222 – cited on IDS).
Regarding claims 10 and 11, Bradley teaches the system according to claim 8, as indicated hereinabove. Bradley does not explicitly teach the limitations of instant claims 10-11, that is wherein the measuring current has a current intensity of at most 0.5 mA or of at most 0.01 mA.
Bradley does teach that the current used for impedance measurements is a sub-threshold current pulse (e.g. 1 mA for 20 μs) that will not cause stimulation or substantially drain the IPG battery (Par. [0046]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize and arrive at a current intensity of at most 0.5 mA or of at most 0.01 mA, recognizing that Bradley’s teaching of 1mA was exemplary and that the current intensity is directly correlated to preventing causing stimulation or substantially draining the IPG battery, which is a desirable characteristic, 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. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Therefore, claims 10 and 11 are unpatentable over Bradley, et al.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bradley, et al. (US 2006/0224222 – cited on IDS) in view of Gerber, et al. (US 2012/0277833).
Regarding claims 12 and 13, Bradley teaches the system according to claim 8, as indicated hereinabove. It is noted that Bradley also teaches that the current used for impedance measurements is a sub-threshold current pulse (e.g. 1 mA for 20 μs) that will not cause stimulation or substantially drain the IPG battery (Par. [0046]). While electrical impedance is specifically a measure of opposition to the flow of alternating current (AC), Bradley appears to teach using a current pulse instead of a continuous wave in order to prevent stimulation or draining the IPG battery. Therefore, Bradley does not explicitly teach the limitation of instant claim 12, that is wherein the measuring current is an alternating current which has a frequency of at least 10 Hz or at least 1 kHz.
Gerber, directed to analogous art, teaches implantable medical devices for delivery of electrical stimulation therapy (Par. [0002]). Gerber also teaches the limitation of instant claim 12, that is wherein (Fig. 5A) the measuring current is an alternating current (Par. [0100] – FIG. 5A illustrates exemplary sensing module 40A that includes impedance measurement circuit 70 configured to measure one or more impedance values between electrode 18 and sensing element 20A, which may be indicative of the head position of patient 12; Par. [0101]; Par. [0107] – impedance measurement circuit 70 may control delivery of an alternating current (AC) measurement current and subsequently measure complex impedance between sensing element 20A and electrode 18. In some examples, impedance measurement circuit 70 may apply the AC signal at various frequencies such that the frequency-dependent portion of the complex impedance (due to capacitive and/or inductive components of the impedance measurement circuit 70) may be measured by impedance measurement circuit 70 or another component of system 10. In some examples, impedance measurement circuit 70 may apply the AC signal in periodic bursts to facilitate periodic sensing of impedance values while, in other examples, impedance measurement circuit 70 may apply the AC signal substantially continuously to facilitate substantially continuous sensing of impedance values).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Gerber’s teaching of the measuring current being an alternating current into Bradley’s system because doing so would be an example of simple substitution of one known element for another to obtain predictable results. Gerber discloses, like Bradley, that an impedance measurement can apply an AC signal in periodic bursts to facilitate periodic sensing of impedance values (Par. [0107] of Gerber). Gerber also discloses that alternatively, impedance measurement can apply the AC signal substantially (Par. [0107] of Gerber). One of ordinary skill in the art would desire applying the AC signal continuously to facilitate substantially continuous sensing of impedance values (Par. [0107] of Gerber). Therefore, both processes are viable and substitutable options for measuring impedance.
Bradley, in view of Gerber, discloses the claimed invention except for the alternating current having a frequency of at least 10 Hz or at least 1 kHz. Gerber does teach that the impedance measurement circuit may apply the AC signal at various frequencies such that the frequency-dependent portion of the complex impedance (due to capacitive and/or inductive components of the impedance measurement circuit) may be measured by impedance measurement circuit or another component of system (Par. [0107]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to optimize and arrive at a frequence of at least 10 Hz or at least 1 kHz, recognizing that frequency is directly correlated to impedance measurement, which is a desirable characteristic, 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. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Therefore, claims 12 and 13 are unpatentable over Bradley, et al. and Gerber, et al.
Regarding claim 14, Bradley teaches the system according to claim 8, as indicated hereinabove. It is noted that Bradley also teaches that the current used for impedance measurements is a sub-threshold current pulse (e.g. 1 mA for 20 μs) that will not cause stimulation or substantially drain the IPG battery (Par. [0046]). While electrical impedance is specifically a measure of opposition to the flow of alternating current (AC), Bradley appears to teach using a current pulse instead of a continuous wave in order to prevent stimulation or draining the IPG battery. Therefore, Bradley does not explicitly teach the limitation of instant claim 14, that is wherein the measuring current is an alternating current which has a frequency spectrum.
Gerber, directed to analogous art, teaches implantable medical devices for delivery of electrical stimulation therapy (Par. [0002]). Gerber also teaches the limitation of instant claim 12, that is wherein (Fig. 5A) the measuring current is an alternating current which has a frequency spectrum (Par. [0100] – FIG. 5A illustrates exemplary sensing module 40A that includes impedance measurement circuit 70 configured to measure one or more impedance values between electrode 18 and sensing element 20A, which may be indicative of the head position of patient 12; Par. [0101]; Par. [0107] – impedance measurement circuit 70 may control delivery of an alternating current (AC) measurement current and subsequently measure complex impedance between sensing element 20A and electrode 18. In some examples, impedance measurement circuit 70 may apply the AC signal at various frequencies such that the frequency-dependent portion of the complex impedance (due to capacitive and/or inductive components of the impedance measurement circuit 70) may be measured by impedance measurement circuit 70 or another component of system 10. In some examples, impedance measurement circuit 70 may apply the AC signal in periodic bursts to facilitate periodic sensing of impedance values while, in other examples, impedance measurement circuit 70 may apply the AC signal substantially continuously to facilitate substantially continuous sensing of impedance values).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have implemented Gerber’s teaching of the measuring current being an alternating current into Bradley’s system because doing so would be an example of simple substitution of one known element for another to obtain predictable results. Gerber discloses, like Bradley, that an impedance measurement can apply an AC signal in periodic bursts to facilitate periodic sensing of impedance values (Par. [0107] of Gerber). Gerber also discloses that alternatively, impedance measurement can apply the AC signal substantially (Par. [0107] of Gerber). One of ordinary skill in the art would desire applying the AC signal continuously to facilitate substantially continuous sensing of impedance values (Par. [0107] of Gerber). Therefore, both processes are viable and substitutable options for measuring impedance.
Therefore, claim 14 is unpatentable over Bradley, et al. and Gerber, et al.
Regarding claim 15, Bradley, in view of Gerber, renders obvious the system according to claim 14, as indicated hereinabove. Gerber also teaches the limitation of instant claim 15, that is wherein (Fig. 5A) the alternating current has a sweep (Par. [0107] – impedance measurement circuit 70 may apply the AC signal at various frequencies such that the frequency-dependent portion of the complex impedance (due to capacitive and/or inductive components of the impedance measurement circuit 70) may be measured by impedance measurement circuit 70 or another component of system 10).
Therefore, claim 15 is unpatentable over Bradley, et al. and Gerber, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Skelton, et al. (US 2009/0018617)
Moffit (US 7,831,307)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
Prosecution Insights