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 statement (IDS) submitted on 02/19/2026 is being considered by the examiner.
Status of Claims
Claims 1-4, 7-8, 10-18, and 21-29 are currently pending and under examination. Claims 5-6, 9, 19-20, and 30-34 are canceled. As per the amendments filed on 03/11/2026, claims 1 and 17 are amended.
Response to Arguments
Applicant's arguments, see Remarks pages 9-13 (Response to the § 103 Rejections), filed
03/11/2026, with respect to the rejections of claims 1-29 under 35 USC § 103 been fully considered. Claims 5-6, 9, and 19-20 are canceled. Regarding independent claims 1 and 17, Applicant argues:
Carroll and Zhang do not describe all features of independent claims
The combination of Carroll and Zhang does not describe all features of independent claims
1 and 17 including (as recited in claim 1)
• wherein the implantable electrodes are positioned in a substantially linear configuration along a same axis such that the first electrical field and the second electrical field are in an axial bias configuration, whereby the first electrical field and the second electrical field are longitudinally superposed along the same axis, and
• wherein the first electrical field and the second electrical field interfere with each other at an area of overlap to produce a beat signal; and
• independently controlling the implantable electrodes to alter a selection of at least one electrode in the first circuit to shift a longitudinal positioning of the beat signal along the same axis while maintaining the axial bias configuration. Claim 17 recites similar features.
The Office stated, "Carroll does not disclose wherein the implantable electrodes are positioned in a substantially linear configuration along a same axis such that the first electrical field and the second electrical field are in an axial bias configuration." (Office Action, p. 7).
The Office cited to Zhang for this feature, and stated, "in the same field of endeavor of providing interferential stimulation of nervous tissue ([0002]), teaches the use of an interferential system to provide peripheral nerve stimulation in addition to spinal cord stimulation ([0056]) using multiple electrodes pairs to shape electric fields ([0059]). The electrodes can be implanted around the nervous tissue target ([0088]). In one embodiment presented in Figure 10, a single lead is used to provide interferential stimulation where electrodes are arranged linearly and can be segmented or non-segmented (Figures 12-14). The configurations in Figures 10 and 11 are seen by Zhang as one of a number of possible configurations which can be used for stimulation when generating symmetric or asymmetric electrical fields ([0103-0104])." (Office Action, p. 7-8).
Thus, the Office acknowledged that Carroll does not disclose electrodes positioned such that the fields are in an axial bias configuration, and the Office attempted to bridge this gap using Zhang's Figure 10, which shows electrodes on a single lead. However, "axial bias configuration" as claimed is not merely presence of electrodes a single lead; it is a specific functional arrangement where the fields are directed along the same axis to produce a beat signal through overlap rather.
Use of a single linear lead as described in Zhang at Figure 10 within Carroll lacks description of "independently controlling the implantable electrodes to alter a selection of at least one electrode in the first circuit to shift a longitudinal positioning of the beat signal along the same axis while maintaining the axial bias configuration," as in amended claim 1. (03/11/2026 Remarks, pages 9-10)
This argument is not persuasive. Carroll discloses electrodes placed in cross (Fig. 3, [0052]) or parallel (Fig. 4, [0053-0054]) configurations. It should be noted the parallel configuration involves electrode pairs on the same lead (Fig. 5, [0057-0058] - with any number of electrodes on a lead) where the resultant electric fields are controlled to form beat frequency signals ([0037-0039]).
Zhang similarly teaches a pair of leads in Figure 11 for which are able to interact in parallel and cross configurations for producing asymmetric fields ([0102-0104]). However, Zhang also teaches an embodiment where electrodes pairs positioned on one lead (along a single axis centrally-aligned relative to the spine) are used to provide symmetrical fields (i.e. symmetrical between electrodes positioned along the lead’s longitudinal axis, similar to the electrodes pairs seen in Carroll Fig. 4) for inferential stimulation (Fig. 10, [0102-0104]). Zhang reinforces that selection of electrode pairs and waveform properties determine the location and properties of the beat frequency ([0059]). Zhang elaborates further on this control feature, as being applicable to one or more leads:
Lead system 208 includes one or more leads each configured to be electrically connected to stimulation device 204 and a plurality of electrodes 206 distributed in the one or more leads. The plurality of electrodes 206 includes electrode 206-1, electrode 206-2, ... electrode 206-N, each a single electrically conductive contact providing for an electrical interface between stimulation output circuit 212 and tissue of the patient, where N2>2. The neurostimulation pulses are each delivered from stimulation output circuit 212 through a set of electrodes selected from electrodes 206. In various embodiments, the neurostimulation pulses may include one or more individually defined pulses, and the set of electrodes may be individually definable by the user for each of the individually defined pulses or each of collections of pulse intended to be delivered using the same combination of electrodes. [0068]
Applicant additionally argues:
In Zhang, a space-domain modulation is described to create "irregular" beat frequencies. This is achieved through "Counter-clock" or "Clock" shifts that rotate the field around the lead. Thus, while Zhang discusses "shifting" geometries, Zhang's method for doing so involves rotating fields using electrodes to achieve lateral or focal selectivity. In contrast, claim 1 recites "independently controlling the implantable electrodes to alter a selection of at least one electrode in the first circuit to shift a longitudinal positioning of the beat signal along the same axis while maintaining the axial bias configuration," as in amended claim 1. This defines a method of "electronic steering" where the beat signal moves up or down the axis, such as along the spine, without rotating or changing the axial bias. The combination of Carroll and Zhang does not describe using a linear axial bias specifically to steer a beat signal longitudinally by switching electrode selection as claimed.
Thus, based on the reasoning provided by the Office, where Zhang provides the "single lead" and Carroll provides the "IFS", there is still a lack of description to operate the system as claimed. Carroll provides no description of an axial bias configuration, and Zhang's complex, time-varying fields would inherently break the stable axial bias as claimed. Claim 1 recites "independently controlling the implantable electrodes to alter a selection ... while maintaining the axial bias configuration." By requiring the axial bias to be maintained during steering, claim 1 excludes Zhang's "Counter-Clock" or "Clock" rotating field types which by definition change the axial orientation of the fields (see Zhang [0137]). The description in Zhang of steering is designed for asynchronous activation through rotation, whereas the claimed steering is designed for longitudinal coverage of the spinal tracts while maintaining the signal.
If a person of ordinary skill in the art followed Zhang's teaching to create "non-regular activation," they would purposefully avoid the stable, axial field recited by claim 1, as a stable field would lead to the very habituation Zhang seeks to prevent. Zhang describes use of drift or weave to effect asynchronous and non-regular activation-essentially making the signal "irregular" so the body does not habituate to it (see Zhang [0060]). As a result, the description in Zhang results in a functional incompatibility with claim 1. (03/11/2026 Remarks, pages 10-11)
This argument is not persuasive. The clock and counter-clock in Zhang [0128-0133] are presented as options to move the electrode geometry and beat location while an option for a static electric field is also presented. As stated previously, Zhang teaches an embodiment where electrodes pairs positioned on one lead (aligned central to the spine where electrode pairs share an axis) are used to provide symmetrical fields for inferential stimulation (Fig. 10, [0102-0104]).
Applicant additionally argues:
B. Functional Incompatibility by Combining Carroll and Zhang
The Office provided reasoning that "[i]t would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lead configuration in Carroll with the single linear lead configuration in Zhang. Given a number of lead configuration options are presented in both Carroll (multiple leads, single lead with parallel electrodes) and Zhang (multiple leads, single lead with electrodes axially aligned on the lead, and other combinations needed to produce certain field shapes and properties) it would have been obvious to try the lead with axially-aligned electrodes in Zhang. A person of ordinary skill in the art would have a reasonable expectation of successfully using the single lead with axial electrodes for interferential stimulation with Carroll based on the disclosure of Zhang." (Office Action, p. 8).
The Examiner's combination of Carroll and Zhang relies on the improper assumption that a Person of Ordinary Skill in the Art (PHOSITA) would combine the "IFS" of Carroll with the "single lead" of Zhang to arrive at the claimed invention. The objective in Carrol is to achieve deep penetration into the spinal cord by lowering activation thresholds. The objective in Zhang is to create "irregular" beat frequencies through time-varying modulation to prevent habituation. If a PHOSITA modified Zhang' s shifting geometry to maintain the stable axial bias required by Claim 1, they would defeat Zhang's stated purpose of providing "non-regular activation". Conversely, adopting Zhang's rotating fields into Carroll's system would destroy the directional control Carroll requires for deep tract penetration.
The claimed method provides a unique functionality-longitudinal electronic steering of a stable beat signal along a single axis in an axial bias configuration-which the combination of Carroll and Zhang does not contemplate. Thus, because the combination of Carroll and Zhang does not describe all features of independent claims 1 and 17, the combination of Carroll and Zhang does not render any of claims 1-29 obvious. (03/11/2026 Remarks, pages 12-13)
This argument is not persuasive. The obviousness rejections over Carroll in view of Zhang in claims 1 and 17 use an obvious to try rationale. Both Carroll and Zhang disclose two lead axis systems capable of producing a beat frequency by the interaction of electric fields between leads. However, Zhang teaches an alternative embodiment where electrode pairs positioned on one lead (aligned central to the spine where electrode pairs share an axis) are used to provide symmetrical fields (i.e. symmetrical between electrodes positioned along the lead’s longitudinal axis, similar to the electrodes pairs seen in Carroll Fig. 4) for inferential stimulation (Zhang, Fig. 10, [0102-0104]).
In this manner, Zhang provides an axial bias configuration between electrode pairs with electrodes sequentially placed along a single lead (where either the single or paired leads are presented as alternatives for producing different electric field orientations as a solution to the problem of producing an effective beat stimulation pattern). While different features are emphasized in Carroll and Zhang, as presented by the Applicant, the feature in Zhang combined with Carroll is the specific spatial pattern of symmetrical stimulation along a single lead axis (as opposed to an asymmetrical pattern of a two lead system along multiple axes). The rejections of claims 1-4, 7-8, 10-18, and 21-29 are maintained because the Examiner did not find Applicant’s arguments persuasive.
Summary: The 35 U.S.C. § 103 rejections of claims 1-4, 7-8, 10-18, and 21-29 are maintained.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-4, 7-8, 10-18, and 21-29 are rejected under U.S.C 103 as being unpatentable over Carroll (US PG Pub 2017/0036029 A1, see IDS filed on 11/29/2023) in view of Zhang (US PG Pub 2020/0324119 A1, see IDS filed on 11/29/2023).
Regarding Claim 1, Carroll discloses a method for electrical stimulation of a subject ([0001]), the method comprising:
• creating multiple circuits using implantable electrodes positioned in the subject ([0069] – multiple circuits created by pairs of electrodes);
• transmitting a signal of a first frequency through a first circuit of the multiple circuits ([0073] – first circuit has first frequency), wherein the first circuit generates a first electrical field ([0069] – first electric field generated by first circuit);
• transmitting a signal of a second frequency through a second circuit of the multiple circuits ([0073] – second circuit has second frequency), wherein the second circuit generates a second electrical field ([0069] – second electric field generated by second circuit);
• pairings between electrodes are established on the same lead in a parallel configuration or between different leads in a crossing configuration ([0058] – the electrode pairs can be positioned along a single lead; [0069] – parallel configuration mentioned), and
• wherein the first electrical field and the second electrical field interfere with each other at an area of overlap to produce a beat signal ([0069] – “the first pair of implantable electrodes and the second pair of implantable electrodes are positioned such that the first field and the second field overlap to produce the at least one beat signal”)
Carroll discloses electrodes placed in cross (Fig. 3, [0052]) or parallel (Fig. 4, [0053-0054]) configurations. While both the parallel and cross configurations are predicated on interactions between electrodes pairs along different axes, it should be noted the parallel configuration involves electrode pairs formed on the same lead (Fig. 5, [0057-0058] - with any number of electrodes on a lead) where the resultant electric fields are controlled to form beat frequency signals ([0037-0039]). However, Carroll does not disclose (1) wherein the implantable electrodes are positioned in a substantially linear configuration along a same axis such that the first electrical field and the second electrical field are in an axial bias configuration, whereby the first electrical field and the second electrical field are longitudinally superposed along the same axis and (2) independently controlling the implantable electrodes to alter a selection of at least one electrode in the first circuit to shift a longitudinal positioning of the beat signal along the same axis while maintaining the axial bias configuration.
Zhang, in the same field of endeavor of providing interferential stimulation of nervous tissue ([0002]), teaches the use of an interferential system to provide peripheral nerve stimulation in addition to spinal cord stimulation ([0056]) using multiple electrodes pairs to shape electric fields ([0059]). The electrodes can be implanted around the nervous tissue target ([0088]). In one embodiment presented in Figure 10, a single lead is used to provide interferential stimulation where electrodes are arranged linearly and can be segmented or non-segmented (Figures 12-14).
The configurations in Figures 10 and 11 are seen by Zhang as one of a number of possible configurations which can be used for stimulation when generating symmetric or asymmetric electrical fields ([0102-0104]). Zhang reinforces that selection of electrode pairs and waveform properties determine the location and properties of the beat frequency ([0059]). Zhang elaborates further on this control feature, as applicable to one or more leads with any number of electrodes or combination of electrodes along the at least one lead ([0068]).
An axial bias configuration, though not apparently a standard term represented in interferential stimulation literature as assessed via the Examiner’s search, is defined by the Applicant “as implantable electrodes 108 are positioned in a substantially linear configuration along a same axis such that the first electrical field of the first circuit and the second electrical field of the second circuit are in an axial bias configuration” (Specification [0031]) and the configuration in Figure 5 (Specification [0059]). For this reason, the linear configuration with respect to claim 1 is interpreted as electrodes being linearly arranged on the same axis and creating an interferential signal between electrode pairs in this linear arrangement.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lead configuration in Carroll with the single linear lead configuration in Zhang. Given a number of lead configuration options are presented in both Carroll (multiple leads, single lead with parallel electrodes) and Zhang (multiple leads, single lead with electrodes axially aligned on the lead, and other combinations needed to produce certain field shapes and properties) it would have been obvious to try the lead with axially-aligned electrodes in Zhang. A person of ordinary skill in the art would have a reasonable expectation of successfully using the single lead with axially-aligned electrodes for interferential stimulation with Carroll based on the disclosure of Zhang.
Therefore, Claim 1 is obvious over Carroll in view of Zhang.
Regarding Claim 2, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein creating multiple circuits using implantable electrodes positioned in the subject ([0069]) comprises:
• creating the first circuit between a first implantable electrode and a second implantable electrode ([0069] – first circuit created between a pair of electrodes); and
•creating the second circuit between the first implantable electrode and a third implantable electrode ([0069] – second circuit created between a pair of electrodes), wherein the first circuit and the second circuit have a common implantable electrode (The electrodes form any number of pairs in [0069], which is interpreted as being able to form pairs using three distinct electrodes with one electrode being shared between the pairs).
Therefore, Claim 2 is obvious over Carroll in view of Zhang.
Regarding Claim 3, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein creating multiple circuits using implantable electrodes positioned in the subject ([0069]) comprises:
• creating the first circuit between a first implantable electrode and a second implantable electrode ([0069] – first circuit created between a pair of electrodes); and
• creating the second circuit between a third implantable electrode and a fourth implantable electrode ([0069] – second circuit created between a pair of electrodes).
The electrodes form any number of pairs in [0069], which is interpreted as being able to form pairs between four distinct electrodes.
Therefore, Claim 3 is obvious over Carroll in view of Zhang.
Regarding Claim 4, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein creating multiple circuits using implantable electrodes positioned in the subject ([0069]) comprises:
• creating the first circuit and the second circuit using the implantable electrodes on a single lead ([0058] – the electrode pairs can be positioned along a single lead: “Thus, in FIG. 5, leads 409 are shown to include four electrodes each, although any number of electrodes may be included such as six, eight, ten, ..., or up to thirty or thirty-two, for example. Pairs of implantable electrodes are created between the electrodes on the leads 409. Pairs may be created between electrodes on the same lead (so as to create a parallel configuration), or between electrodes on different leads, as shown in FIG. 5 to create a crossing configuration”; Fig. 4 – electrode pairs are established along each lead).
Therefore, Claim 4 is obvious over Carroll in view of Zhang.
Regarding Claim 7, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein the implantable electrodes are provided on a first lead and a second lead (Figure 5, [0057]), and wherein creating multiple circuits using implantable electrodes positioned in the subject comprises (Figure 5, [0058] – “leads 409 are shown to include four electrodes each, although any number of electrodes may be included such as six, eight, ten, ..., or up to thirty or thirty-two, for example. Pairs of implantable electrodes are created between the electrodes on the leads 409”):
• creating the first circuit using the implantable electrodes on the first lead ([0058] – electrode pairs can be selected on the same lead); and
• creating the second circuit using the implantable electrodes on the second lead ([0058] – electrode pairs can be selected on the same lead);
Therefore, Claim 7 is obvious over Carroll in view of Zhang.
Regarding Claim 8, the method for electrical stimulation of a subject according to Claim 7 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein the first lead and the second lead are positioned in the substantially linear configuration approximately end-to-end (Figure 5, [0057-0058] – two leads positioned parallel to each other), wherein a distance, measured perpendicular to the same axis, between the first lead and the second lead is less than 2mm ([0056] - “A horizontal distance between the two channels may be about between 1 mm and 5 mm, for example” where channels are defined as longitudinally-aligned circuits as in [0054]). The distance between the channels on each lead is interpreted as the distance between leads. MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for distance between leads. The “substantially linear configuration approximately end-to-end” is interpreted as two leads placed in parallel next to each other (as seen in Figures 10 and 11 and described in [0076], [0077], and [0080], all from the Specification in the instant application) less than 2 mm apart.
Therefore, Claim 8 is obvious over Carroll in view of Zhang.
Regarding Claim 10, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein:
• transmitting the signal of the first frequency comprises transmitting the signal at a frequency between 1,000 Hz to 20,000 Hz ([0073] – “Frequencies of signals may be transmitted through the first and second pair of implantable electrodes within ranges of about 0 to about 20,000 Hz”); and
• transmitting the signal of the second frequency comprises transmitting the signal at a frequency between 1,000 Hz to 20,000 Hz ([0073] – “Frequencies of signals may be transmitted through the first and second pair of implantable electrodes within ranges of about 0 to about 20,000 Hz”), wherein the first frequency is different from the second frequency ([0047] – “The signal generating source 104 may be an interferential current generator that generates an interferential output including first and second signal having different first and second frequencies”).
MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for either of the first or second signals.
Therefore, Claim 10 is obvious over Carroll in view of Zhang.
Regarding Claim 11, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein the beat signal has a frequency within a range of more than 0 Hz to 5,000 Hz ([0073] – the frequencies of the first and second signals “result in a beat signal having a frequency in a range of more than 250 Hz to about 15,000 Hz”). The total range of frequencies for the beat signal are 250 Hz to 15,000 Hz, but other sub-ranges within this overall range are listed in [0074]. MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for the beat signal.
Therefore, Claim 11 is obvious over Carroll in view of Zhang.
Regarding Claim 12, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses:
• positioning the implantable electrodes to space proximate to nervous tissue of the subject
([0010] – “The first ends are connected to the interferential current generator and the second ends are configured to be implanted to a dura matter in an epidural space at predetermined locations proximate to a subject's spinal cord”). The electrodes are proximate the nervous tissue in the spinal cord.
Therefore, Claim 12 is obvious over Carroll in view of Zhang.
Regarding Claim 13, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses:
• positioning the implantable electrodes to space proximate to vertebral nerves of the subject
([0010] – “The first ends are connected to the interferential current generator and the second ends are configured to be implanted to a dura matter in an epidural space at predetermined locations proximate to a subject's spinal cord”, [0107] – spinal nerve roots stimulated). The electrodes are proximate the spinal cord and, thereby, the vertebral nerves originating in the spinal cord.
Therefore, Claim 13 is obvious over Carroll in view of Zhang.
Regarding Claim 14, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses:
• positioning the implantable electrodes to space proximate to spinal nerves and spinal nerve roots of the subject ([0107] – “Other applications include highly precise neurostimulation of the nerve roots and the Dorsal Root Ganglia themselves, all from an intraspinal, epidural location”).
Therefore, Claim 14 is obvious over Carroll in view of Zhang.
Regarding Claim 15, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll discloses positioning implantable electrodes proximate the spinal cord ([0010]). Carroll does not disclose positioning the implantable electrodes to space proximate to peripheral nerves of the subject.
Zhang, in the same field of endeavor of providing interferential stimulation of nervous tissue ([0002]), teaches the use of an interferential system to provide peripheral nerve stimulation in addition to spinal cord stimulation ([0056]). The electrodes can be implanted around the nerve tissue target ([0088]). Therefore, electrodes can be implanted proximate the peripheral nerves.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carroll’s interferential stimulator method proximate to the spinal cord by incorporating the positioning of electrode leads proximate to the peripheral nerves in Zhang. This would have been obvious because both Carroll and Zhang discuss spinal cord stimulation with interferential electrode pairs and Zhang provides a solution/improvement for applying interferential stimulation to targets in sites more peripheral to the spinal cord, thereby expanding the medical applications of implantable interferential stimulation electrodes. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carroll by incorporating the positioning of electrode leads proximate to the peripheral nerves in Zhang.
Therefore, Claim 15 is obvious over Carroll in view of Zhang.
Regarding Claim 16, the method for electrical stimulation of a subject according to Claim 1 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll discloses positioning implantable electrodes proximate to the spinal cord ([0010]). Carroll does not disclose positioning the implantable electrodes to space proximate sympathetic and parasympathetic nerves.
Zhang, in the same field of endeavor of providing interferential stimulation of nervous tissue ([0002]), teaches the use of an interferential system to provide Vagus and peripheral nerve stimulation in addition to spinal cord stimulation ([0056]). The electrodes can be implanted around the nerve tissue target ([0088]). Therefore, it would be reasonable to interpret implantable electrodes which can be applied to Vagus and peripheral nerve stimulation as being applicable to sympathetic and parasympathetic nerves (which are both part of the peripheral nervous system) as well.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carroll’s interferential stimulator method proximate to the spinal cord by incorporating the positioning of electrode leads proximate to more peripheral nerves in Zhang. This would have been obvious because both Carroll and Zhang discuss spinal cord stimulation with interferential electrode pairs and Zhang provides a solution/improvement for applying interferential stimulation to targets in sites more peripheral to the spinal cord, thereby expanding the medical applications of implantable interferential stimulation electrodes. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carroll by incorporating the positioning of electrode leads proximate to more peripheral nerves in Zhang.
Therefore, Claim 16 is obvious over Carroll in view of Zhang.
Regarding Claim 17, Carroll discloses a method for electrical stimulation of a subject ([0001]), the method comprising:
• transmitting a signal of a first frequency through a first circuit ([0073] – first circuit has first frequency) created between a first pair of implantable electrodes ([0069] – first circuit created between a pair of electrodes) positioned in the subject ([0010] – electrodes are implantable near spine), wherein the first circuit generates a first electrical field ([0069] – first electric field generated by first circuit);
• transmitting a signal of a second frequency ([0073] – second circuit has second frequency) through a second circuit created between a second pair of implantable electrodes ([0069] – second circuit created between a pair of electrodes) positioned in the subject ([0010] – electrodes are implantable near spine), wherein the second circuit generates a second electrical field ([0069] – second electric field generated by second circuit);
• pairings between electrodes are established on the same lead in a parallel configuration or between different leads in a crossing configuration ([0058] – the electrode pairs can be positioned along a single lead: “Thus, in FIG. 5, leads 409 are shown to include four electrodes each, although any number of electrodes may be included such as six, eight, ten, ..., or up to thirty or thirty-two, for example. Pairs of implantable electrodes are created between the electrodes on the leads 409. Pairs may be created between electrodes on the same lead (so as to create a parallel configuration), or between electrodes on different leads, as shown in FIG. 5 to create a crossing configuration”; [0069] – parallel configuration mentioned), and
• wherein the first electrical field and the second electrical field interfere with each other at an area of overlap to produce a beat signal ([0069] – “the first pair of implantable electrodes and the second pair of implantable electrodes are positioned such that the first field and the second field overlap to produce the at least one beat signal”).
Carroll discloses electrodes placed in cross (Fig. 3, [0052]) or parallel (Fig. 4, [0053-0054]) configurations. While both the parallel and cross configurations are predicated on interactions between electrodes pairs along different axes, it should be noted the parallel configuration involves electrode pairs formed on the same lead (Fig. 5, [0057-0058] - with any number of electrodes on a lead) where the resultant electric fields are controlled to form beat frequency signals ([0037-0039]). However, Carroll does not disclose (1) wherein the first pair of implantable electrodes and the second pair of implantable electrodes are positioned in a substantially linear configuration along a same axis such that the first electrical field and the second electrical field are in an axial bias configuration, whereby the first electrical field and the second electrical field are longitudinally superposed along the same axis and (2) independently controlling the implantable electrodes to alter a selection of at least one electrode in the first circuit to shift a longitudinal positioning of the beat signal along the same axis while maintaining the axial bias configuration.
Zhang, in the same field of endeavor of providing interferential stimulation of nervous tissue ([0002]), teaches the use of an interferential system to provide peripheral nerve stimulation in addition to spinal cord stimulation ([0056]) using multiple electrodes pairs to shape electric fields ([0059]). The electrodes can be implanted around the nervous tissue target ([0088]). In one embodiment presented in Figure 10, a single lead is used to provide interferential stimulation where electrodes are arranged linearly and can be segmented or non-segmented (Figures 12-14).
The configurations in Figures 10 and 11 are seen by Zhang as one of a number of possible configurations which can be used for stimulation when generating symmetric or asymmetric electrical fields ([0102-0104]). Zhang reinforces that selection of electrode pairs and waveform properties determine the location and properties of the beat frequency ([0059]). Zhang elaborates further on this control feature, as applicable to one or more leads with any number of electrodes or combination of electrodes along the at least one lead ([0068]).
An axial bias configuration, though not apparently a standard term represented in interferential stimulation literature as assessed via the Examiner’s search, is defined by the Applicant “as implantable electrodes 108 are positioned in a substantially linear configuration along a same axis such that the first electrical field of the first circuit and the second electrical field of the second circuit are in an axial bias configuration” (Specification [0031]) and the configuration in Figure 5 (Specification [0059]). For this reason, the linear configuration with respect to claim 17 is interpreted as electrodes being linearly arranged on the same axis and creating an interferential signal between electrode pairs in this linear arrangement.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lead configuration in Carroll with the single linear lead configuration in Zhang. Given a number of lead configuration options are presented in both Carroll (multiple leads, single lead with parallel electrodes) and Zhang (multiple leads, single lead with electrodes axially aligned on the lead, and other combinations needed to produce certain field shapes and properties) it would have been obvious to try the lead with axially-aligned electrodes in Zhang. A person of ordinary skill in the art would have a reasonable expectation of successfully using the single lead with axially-aligned electrodes for interferential stimulation with Carroll based on the disclosure of Zhang.
Therefore, Claim 17 is obvious over Carroll in view of Zhang.
Regarding Claim 18, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll discloses the electrode pairs can be positioned along a single or multiple leads ([0058]). Carroll does not disclose wherein the first pair of implantable electrodes and the second pair of implantable electrodes are aligned vertically along a longitudinal axis of a spinal cord to form the first circuit and the second circuit and the first circuit is positioned on the same axis as the second circuit.
Zhang, in the same field of endeavor of providing interferential stimulation of nervous tissue ([0002]), teaches the use of an interferential system to provide peripheral nerve stimulation in addition to spinal cord stimulation ([0056]) using multiple electrodes pairs to shape electric fields ([0059]). The electrodes can be implanted around the nervous tissue target ([0088]). In one embodiment presented in Figure 10, a single lead is used to provide interferential stimulation where electrodes are arranged linearly and can be segmented or non-segmented (Figures 12-14). The configurations in Figures 10 and 11 are seen by Zhang as one of a number of possible configurations which can be used for stimulation when generating symmetric or asymmetric electrical fields ([0103-0104]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the lead configuration in Carroll with the single linear lead configuration in Zhang. Given a number of lead configuration options are presented in both Carroll (multiple leads, single lead with parallel electrodes) and Zhang (multiple leads, single lead with electrodes axially aligned on the lead, and other combinations needed to produce certain field shapes and properties) it would have been obvious to try the lead with axially-aligned electrodes in Zhang. A person of ordinary skill in the art would have a reasonable expectation of successfully using the single lead with axial electrodes for interferential stimulation with Carroll based on the disclosure of Zhang.
Therefore, Claim 18 is obvious over Carroll in view of Zhang.
Regarding Claim 21, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein the first pair of implantable electrodes are included on a first lead and the second pair of implantable electrodes are included on a second lead (Figure 5, [0058] – electrode pairs can be selected on the same lead of the two separate leads discussed), wherein the first lead and the second lead are positioned in the substantially linear configuration approximately end-to-end (Figure 5, [0057-0058] – two leads positioned parallel to each other), wherein a distance, measured perpendicular to the same axis, between the first lead and the second lead is less than 2mm ([0056] - “A horizontal distance between the two channels may be about between 1 mm and 5 mm, for example” where channels are defined as longitudinally-aligned circuits as in [0054]). The distance between channels is interpreted as the distance between leads. MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for distance between leads. The “substantially linear configuration approximately end-to-end” is interpreted as two leads placed in parallel next to each other (as seen in Figures 10 and 11 and described in [0076], [0077], and [0080], all from the Specification in the instant application) less than 2 mm apart.
Therefore, Claim 21 is obvious over Carroll in view of Zhang.
Regarding Claim 22, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein the substantially linear configuration approximately end-to-end comprises at least one electrode on the first lead positioned adjacent to at least one electrode on the second lead (Figure 5, [0057-0058] - Electrodes in separate leads 409 can be adjacent to each other). The “substantially linear configuration approximately end-to-end” is interpreted as two leads with electrodes placed in parallel next to each other (as seen in Figures 10 and 11 and described in [0076], [0077], and [0080], all from the Specification in the instant application).
Therefore, Claim 22 is obvious over Carroll in view of Zhang.
Regarding Claim 23, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein:
• transmitting the signal of the first frequency comprises transmitting the signal at a frequency between 1,000 Hz to 20,000 Hz ([0073] – “Frequencies of signals may be transmitted through the first and second pair of implantable electrodes within ranges of about 0 to about 20,000 Hz”); and
• transmitting the signal of the second frequency comprises transmitting the signal at a frequency between 1,000 Hz to 20,000 Hz ([0073] – “Frequencies of signals may be transmitted through the first and second pair of implantable electrodes within ranges of about 0 to about 20,000 Hz”), wherein the first frequency is different from the second frequency ([0047] – “The signal generating source 104 may be an interferential current generator that generates an interferential output including first and second signal having different first and second frequencies”).
MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for either of the first or second signals.
Therefore, Claim 23 is obvious over Carroll in view of Zhang.
Regarding Claim 24, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses wherein the beat signal has a frequency within a range of more than 0 Hz to 5,000 Hz ([0073] – the frequencies of the first and second signals “result in a beat signal having a frequency in a range of more than 250 Hz to about 15,000 Hz”). The total range of frequencies for the beat signal are 250 Hz to 15,000 Hz, but other sub-ranges within this overall range are listed in [0074]. MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations for the beat signal.
Therefore, Claim 24 is obvious over Carroll in view of Zhang.
Regarding Claim 25, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses:
• positioning the first pair of implantable electrodes to a dura matter in an epidural space proximate to a spinal cord of the subject ([0009] – “The method comprises positioning a first pair of implantable electrodes to a dura matter in an epidural space proximate to a subject's spinal cord at predetermined locations”); and
• positioning the second pair of implantable electrodes to the dura matter in the epidural space proximate to the spinal cord of the subject ([0009] – “The method comprises … positioning a second pair of implantable electrodes to the dura matter in the epidural space proximate to the subject's spinal cord at predetermined locations”).
Therefore, Claim 25 is obvious over Carroll in view of Zhang.
Regarding Claim 26, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses:
• positioning the first pair of implantable electrodes and positioning the second pair of implantable electrodes to space proximate to nervous tissue of the subject ([0010] – “The first ends are connected to the interferential current generator and the second ends are configured to be implanted to a dura matter in an epidural space at predetermined locations proximate to a subject's spinal cord”). The electrodes are proximate the nervous tissue in the spinal cord.
Therefore, Claim 26 is obvious over Carroll in view of Zhang.
Regarding Claim 27, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses:
• positioning the first pair of implantable electrodes and positioning the second pair of implantable electrodes to space proximate to vertebral nerves of the subject ([0010] – “The first ends are connected to the interferential current generator and the second ends are configured to be implanted to a dura matter in an epidural space at predetermined locations proximate to a subject's spinal cord”, [0107] – spinal nerve roots stimulated). The electrodes are proximate the spinal cord and, thereby, the vertebral nerves originating in the spinal cord.
Therefore, Claim 27 is obvious over Carroll in view of Zhang.
Regarding Claim 28, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll further discloses:
• positioning the first pair of implantable electrodes and positioning the second pair of implantable electrodes to space proximate to spinal nerves and spinal nerve roots of the subject ([0107] – “Other applications include highly precise neurostimulation of the nerve roots and the Dorsal Root Ganglia themselves, all from an intraspinal, epidural location”).
Therefore, Claim 28 is obvious over Carroll in view of Zhang.
Regarding Claim 29, the method for electrical stimulation of a subject according to Claim 17 is obvious over Carroll in view of Zhang, as indicated hereinabove. Carroll discloses positioning implantable electrodes proximate to the spinal cord ([0010]). Carroll does not disclose positioning implantable electrodes to space proximate to Vagus nerves of the subject.
Zhang, in the same field of endeavor of providing interferential stimulation of nervous tissue ([0002]), teaches the use of an interferential system to Vagus nerve stimulation in addition to spinal cord stimulation ([0056]). The electrodes can be implanted around the nerve tissue target ([0088]). Therefore, electrodes can be implanted proximate the Vagus nerves.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Carroll’s interferential stimulator method proximate to the spinal cord by incorporating the positioning of electrode leads proximate to the Vagus nerves in Zhang. This would have been obvious because both Carroll and Zhang discuss spinal cord stimulation with interferential electrode pairs and Zhang provides a solution/improvement for applying interferential stimulation to targets in sites more peripheral to the spinal cord, thereby expanding the medical applications of implantable interferential stimulation electrodes. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Carroll by incorporating the positioning of electrode leads proximate to the Vagus nerves in Zhang.
Therefore, Claim 29 is obvious over Carroll in view of Zhang.
Conclusions
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.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights