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 23, 28, 34-35, 38, and 45 are rejected. Claims 1-22 and 37 are canceled. Claims 24-27, 29-33, 36, and 39-44 are withdrawn.
Response to Arguments
Drawing Objection
The previous drawing objection has been withdrawn in view of the Replacement Sheet to the specification.
Specification Objection
The previous specification objection has been withdrawn in view of the Replacement Sheet to the specification.
Claim Rejections - 35 USC § 112
Some of the previous 112(b) rejections have been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 102
Applicant's arguments filed 6/27/25 have been fully considered but they are not persuasive.
Applicant asserts that Zellmer fails to teach or suggest that the algorithm is configured to determine a stimulation paradigm for stimulating one or more target locations of the patient based on the predetermined information. However, the Examiner disagrees. Zellmer teaches: ¶126-setting the stimulation configuration can include setting the electrode stimulation state and/or the potential magnitude. Stimulation state can include active/non-active state, polarity (e.g., anode or cathode if active), set current/voltage magnitude, a current/voltage signal if used, and/or any suitable characteristic of how current flows through the electrode when active. The stimulation configuration additionally involves determining the mapping of electrode states (i.e., how the set of electrodes are stimulated as a group). Different electrodes can be driven at different settings to create a different net effect. The stimulation profile can be automatically determined within the implantable device; ¶127-for example, during a first instance, the set of electrodes are driven in a first electrical stimulation state, and in second state, the set of electrodes are driven in a second electrical stimulation state as shown in FIGS. 24A and 24B. The electrical stimulation state is preferably updated according to a new stimulation profile that targets different effects. In the first state a first stimulation profile can be used that promotes or targets a set of osteolysis and/or osteoinduction regions. These regions can be changed, wherein in the second state, a second stimulation profile promotes or targets a second set of osteolysis and/or osteoinduction regions, wherein the first and second regions are not the same.
Applicant asserts that Zellmer fails to teach or suggest a library of predetermined information. However, Zellmer teaches ¶104-through the UI, physicians or technicians may adjust the setting of the stimulator (current amplitude, choice of channels, stimulation frequency if AC is used, frequency of impedance measurements etc.) based on feedback from imaging or from the implant itself. If the feedback is provided by the system itself, the output may be adjusted by a preprogrammed algorithm; ¶83-the implant circuitry could be configured to operate according to a complex state machine enable intelligent modifications and updates to the mode of operation. For example, various timing conditions, data thresholds, power thresholds, and/or other conditions could be used in automatically determining operating state; ¶85-a stimulation configuration profile can define the desired characteristics of stimulation for a set of electrodes (e.g., specifying which electrodes are active, the polarity, and magnitude)).
Claim Rejections - 35 USC § 103
Applicant's arguments filed 6/27/25 have been fully considered but they are not persuasive.
Applicant asserts that Kent fails to teach or suggest a library of predetermined information. However, Kent was not relied upon to teach this limitation.
Applicant asserts that Kent fails to teach wherein the algorithm is further configured to correlate one or both of implant locations or implant geometries of the one or more leads to the predetermined information. However, the Examiner disagrees. Kent teaches wherein the algorithm is further configured to correlate one or both of implant locations or implant geometries of the one or more leads to the predetermined information (¶8-the method may further adjust the NS parameters based on the neuronal system response; ¶41- embodiments herein have applications in various neural stimulation areas such as deep brain stimulation, spinal cord stimulation, cortical stimulation, and peripheral nerve stimulation; ¶60-the NS system 100 delivers NS therapy based on a preprogrammed sequence. The therapy parameters of the sequence may include, among other things, pulse amplitude, pulse polarity, pulse width, pulse frequency, interpulse interval, inter burst interval, electrode combinations, firing delay and the like. Optionally, the NS system 100 may represent a closed loop neurostimulation device that is configured to provide real-time sensing functions from a lead. The configuration of the lead sensing electrodes may be varied depending on the neuronal anatomy of the sensing site(s) of interest. The size and shape of electrodes is varied based on the implant location. The electronic components within the NS system 100 are designed with both stimulation and sensing capabilities, including alternative stimulation therapy, such as burst mode and the like).
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 23, 28, 34-35, 38, and 45 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.
Claim 23 recites the limitation "the stimulation element" in line 9. There is insufficient antecedent basis for this limitation in the claim. Dependent claims 28, 34-35, 38, and 45 are rejected for the same deficiency in claim 23.
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 23, 28, 34-35, and 45 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zellmer (US 20190247198 filed on 11/30/18 as cited in the IDS).
Regarding claim 23, Zellmer teaches a system for delivering stimulation energy to a patient (¶42-the system and method may provide dynamic and controllable stimulation while implanted within a patient) comprising: a controller (In Fig. 4 of Zellmer, microcontroller 113); a memory coupled to the controller and storing instructions for the controller to perform an algorithm and a library of predetermined information (¶104-through the UI, physicians or technicians may adjust the setting of the stimulator (current amplitude, choice of channels, stimulation frequency if AC is used, frequency of impedance measurements etc.) based on feedback from imaging or from the implant itself. If the feedback is provided by the system itself, the output may be adjusted by a preprogrammed algorithm; ¶83-the implant circuitry could be configured to operate according to a complex state machine enable intelligent modifications and updates to the mode of operation. For example, various timing conditions, data thresholds, power thresholds, and/or other conditions could be used in automatically determining operating state; ¶85-a stimulation configuration profile can define the desired characteristics of stimulation for a set of electrodes (e.g., specifying which electrodes are active, the polarity, and magnitude); ¶148-other systems and methods of the embodiment can be embodied and/or implemented at least in part as a machine configured to receive a computer-readable medium storing computer-readable instructions. The instructions can be executed by computer-executable components integrated by computer-executable components integrated with apparatuses and networks of the type described above. The computer-readable medium can be stored on any suitable computer readable media such as RAMs, ROMs, flash memory, EEPROMs, optical devices (CD or DVD), hard drives, floppy drives, or any suitable device. The computer-executable component can be a processor but any suitable dedicated hardware device can (alternatively or additionally) execute the instructions; ¶44-stimulating electrodes based on preprogrammed embedded algorithms) one or more leads for implantation inside a human body (¶62-such medical implant bodies may house some or all circuit elements, PCB, leads, antennas etc. included as part of the implantable component 12), wherein each lead comprises a plurality of stimulation elements (Fig. 6A of Zellmer shows one lead with plural electrodes 13), wherein each stimulation element is configured to be in at least one of a first configuration state comprising the stimulation element sourcing or sinking current or, a second configuration state comprising the stimulation element in an electrically passive state (¶72-in some embodiments the implant control circuitry 15 may be effective to control one or more of said electrodes with respect to the polarity (current source or current sink) and/or state (current source/sink, or passive) of the electrode during stimulation, wherein the algorithm is configured to determine a stimulation paradigm for stimulating one or more target locations of the patient based on the predetermined information (¶126-setting the stimulation configuration can include setting the electrode stimulation state and/or the potential magnitude. Stimulation state can include active/non-active state, polarity (e.g., anode or cathode if active), set current/voltage magnitude, a current/voltage signal if used, and/or any suitable characteristic of how current flows through the electrode when active. The stimulation configuration additionally involves determining the mapping of electrode states (i.e., how the set of electrodes are stimulated as a group). Different electrodes can be driven at different settings to create a different net effect. The stimulation profile can be automatically determined within the implantable device; ¶127-for example, during a first instance, the set of electrodes are driven in a first electrical stimulation state, and in second state, the set of electrodes are driven in a second electrical stimulation state as shown in FIGS. 24A and 24B. The electrical stimulation state is preferably updated according to a new stimulation profile that targets different effects. In the first state a first stimulation profile can be used that promotes or targets a set of osteolysis and/or osteoinduction regions. These regions can be changed, wherein in the second state, a second stimulation profile promotes or targets a second set of osteolysis and/or osteoinduction regions, wherein the first and second regions are not the same), and wherein the stimulation paradigm assigns each of the plurality of the stimulation elements of a first lead of the one or more leads to the first or second configuration state (¶126-setting the stimulation configuration can include setting the electrode stimulation state and/or the potential magnitude. Stimulation state can include active/non-active state, polarity (e.g., anode or cathode if active), set current/voltage magnitude, a current/voltage signal if used, and/or any suitable characteristic of how current flows through the electrode when active. The stimulation configuration additionally involves determining the mapping of electrode states (i.e., how the set of electrodes are stimulated as a group). Different electrodes can be driven at different settings to create a different net effect. The stimulation profile can be automatically determined within the implantable device; ¶127-for example, during a first instance, the set of electrodes are driven in a first electrical stimulation state, and in second state, the set of electrodes are driven in a second electrical stimulation state as shown in FIGS. 24A and 24B. The electrical stimulation state is preferably updated according to a new stimulation profile that targets different effects. In the first state a first stimulation profile can be used that promotes or targets a set of osteolysis and/or osteoinduction regions. These regions can be changed, wherein in the second state, a second stimulation profile promotes or targets a second set of osteolysis and/or osteoinduction regions, wherein the first and second regions are not the same).
Regarding claim 28, Zellmer teaches the system of claim 23, wherein the algorithm is configured to cause at least one of the plurality of stimulation elements of each lead in the first configuration state configured to cause any remaining stimulation elements of the plurality of stimulation elements of each lead to be in a floating state (¶74-the plurality of electrodes 13 of a preferred embodiment function as sites driven to various electric potentials to induce electric current into the regions around the implantable component 3; ¶75-an electrode can be controlled to act as a source (e.g., cathode) or sink (e.g., anode) during electrical stimulation or to be passive in order to steer the current density in different parts of the intervertebral space. In some variations, a subset of electrodes may only be controllable between one or two states. For example, one electrode may only act as an anode and another electrode may only be driven as a cathode or be passive).
Regarding claim 34, Zellmer teaches the system of claim 23, wherein the algorithm utilizes one or more constraints to determine the stimulation paradigm (¶75-an electrode can be controlled to act as a source (e.g., cathode) or sink (e.g., anode) during electrical stimulation or to be passive in order to steer the current density in different parts of the intervertebral space. In some variations, a subset of electrodes may only be controllable between one or two states. For example, one electrode may only act as an anode and another electrode may only be driven as a cathode or be passive; Based on the description of ¶75, assigning certain number of electrodes as a sink, source, and passive places constraints on the system).
Regarding claim 35, Zellmer teaches the system of claim 34, wherein the algorithm limits a number of the plurality of stimulation elements of the first lead that are in the first configuration state based on the one or more constraints (¶75-an electrode can be controlled to act as a source (e.g., cathode) or sink (e.g., anode) during electrical stimulation or to be passive in order to steer the current density in different parts of the intervertebral space. In some variations, a subset of electrodes may only be controllable between one or two states. For example, one electrode may only act as an anode and another electrode may only be driven as a cathode or be passive; Based on the description of ¶75, assigning certain number of electrodes as a sink, source, and passive places constraints on the system).
Regarding claim 45, Zellmer teaches the system of claim 23, wherein the predetermined information comprises impedance data for the plurality of electrodes of each of the one or more leads recorded prior to implantation of the one or more leads (Zellmer, ¶104-through the UI, physicians or technicians may adjust the setting of the stimulator (current amplitude, choice of channels, stimulation frequency if AC is used, frequency of impedance measurements etc.; ¶84-a diagnostics mode functions to check the operational condition of the implantable component 3. The diagnostics mode can be performed prior to use in a surgery, the electrode check verifies the conductive state of each electrode. The electrode check can be performed in a manner substantially similar to the impedance measurements of the bone growth monitoring; ¶120).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Zellmer in view of Kent (US 20180140843 filed on 11/18/16).
Regarding claim 38, Zellmer teaches the invention of claim 23, but does not expressly teach wherein the algorithm is further configured to correlate one or both of implant locations or implant geometries of the one or more leads to the predetermined information.
Kent teaches wherein the algorithm is further configured to correlate one or both of implant locations or implant geometries of the one or more leads to the predetermined information (¶8-the method may further adjust the NS parameters based on the neuronal system response; ¶41- embodiments herein have applications in various neural stimulation areas such as deep brain stimulation, spinal cord stimulation, cortical stimulation, and peripheral nerve stimulation; ¶60-the NS system 100 delivers NS therapy based on a preprogrammed sequence. The therapy parameters of the sequence may include, among other things, pulse amplitude, pulse polarity, pulse width, pulse frequency, interpulse interval, inter burst interval, electrode combinations, firing delay and the like. Optionally, the NS system 100 may represent a closed loop neurostimulation device that is configured to provide real-time sensing functions from a lead. The configuration of the lead sensing electrodes may be varied depending on the neuronal anatomy of the sensing site(s) of interest. The size and shape of electrodes is varied based on the implant location. The electronic components within the NS system 100 are designed with both stimulation and sensing capabilities, including alternative stimulation therapy, such as burst mode and the like).
Kent generally relates to neurostimulation (NS) systems, and more particularly to systems and methods for analyzing evoked waveforms to determine a neuronal system response (¶1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Zellmer to include wherein the algorithm is further configured to correlate one or both of implant locations or implant geometries of the one or more leads to the predetermined information of Kent in order to detect migration of a lead following implant and/or changes in the physiologic responsiveness of a patient over time (Kent, ¶135).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20200147388 teaches the following:
¶7-determine an indication of efficacy of the provided stimulation, based on the indication of efficacy, automatically determining via an evaluation algorithm in the external controller, whether to perform a reprogramming algorithm in the external controller to adjust one or more stimulation parameters; and
¶73-an example of a module (algorithm) that may use sub-perception stimulation is the anatomical location schedule (ALS). The anatomical location schedule (ALS) is a schedule of preprogrammed stimulation programs that provide stimulation (typically sub-perception stimulation) directed to different anatomical locations. By cycling through preprogrammed anatomical locations, the patient may find a location that effectively treats their pain.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UNSU JUNG can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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