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 .
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12 December 2025 has been entered.
Status of Claims
Claims 1-23 are pending and currently under consideration for patentability; claims 1, 8, and 14 have been amended.
Response to Arguments
Applicant’s arguments dated 12 December 2005 have been fully considered, but they are not persuasive or moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant has amended the independent claims to recite further the position of the neurostimulation lead, in particular “parallel to a sagittal plane” (independent claim 1), “in a transverse plane to a coronal plane” (independent claim 8), and “parallel to a sagittal plane and transverse to a coronal plane” (independent claim 14). Applicant argues that the prior art reference of Kast discloses paddles which are “in a transverse plane to the sagittal plane” (Arguments, p. 7). The Examiner has addressed the amended limitations in the updated text of the rejection below. In an effort to avoid repetition in the text of the rejection, the Examiner offers the following analysis of Kast’s lead positioning.
Specifically regarding the position of the neurostimulation lead, although the Examiner agrees that the specific embodiment provided in Kast’s figure 1 depicts paddles 17A and 17B as laying in a transverse plane (or “in a transverse plane to a coronal plane” as recited in amended claim 8), the Examiner respectfully submits that the neurostimulation leads described by Kast are not limited to laying only in a transverse plane. For example, Kast describes that the paddles “deliver stimulation therapy to a therapy region, which generally encompasses occipital nerve sites and trigeminal nerve sites…nerve sites may include, for example, an occipital nerve (e.g., a greater occipital nerve, lesser occipital nerve, third occipital nerve and suboccipital nerves), a trigeminal nerve, tissue adjacent to the trigeminal or occipital nerves, or a nerve branching from the occipital and/or trigeminal nerves” ([0025]). Kast further describes a variety of different lead and electrode configurations which may be utilized ([0025]: “paddle electrodes including a two-dimensional array of electrodes…axial leads with ring electrodes, segmented electrodes…other lead and/or electrode configurations may be used”). Kast also describes that the therapy system shown in figure 1A is merely an example ([0028]), broadening the description to include that the therapy system “may be useful in other neurostimulation applications” and the tissue target sites “may be at locations proximate to any other suitable nerve in body of patient” ([0031]). Kast goes on to describe that the leads may be implanted proximate to other nerves and/or structures in the head and neck of the patient, or that the system may be implanted at other locations used for “sacral stimulation, pelvic floor stimulation, peripheral nerve field stimulation, spinal cord stimulation, deep brain stimulation, gastric stimulation, or subcutaneous stimulation other than occipital stimulation” ([0031]). As all of these different stimulation sites, both within the patient’s brain and at other locations in the patient’s body, may require different configurations of leads and electrodes, the Examiner respectfully submits that Kast’s paddle electrodes 17A and 17B, though depicted in the specific embodiment in figure 1 as laying in a transverse orientation, maybe positioned as necessary in order to accurately target a desired therapy region. Therefore, the Examiner respectfully submits that Kast, at the very least, suggests the positioning of electrodes “parallel to a sagittal plane,” “in a transverse plane to a coronal plane,” and/or “parallel to a sagittal plane and transverse to a coronal plane” as recited.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8 and 11-23 are rejected under 35 U.S.C. 103 as being obvious over Kast et al. (US 2009/0112282 A1) in view of Bennett et al. (US 2012/0310314 A1), Ackermann et al. (US 2013/0006326 A1), and Kaplan et al. (US 2006/0089691 A1). The Examiner notes that the Bennett reference has a common assignee (SPR Therapeutics, Inc.) with the instant application.
Regarding claim 1, Kast describes a method comprising
positioning a flexible neurostimulation lead ([0067]: “like leads 14, lead [sic] 134 are flexible to conform to the skull of a patient”) having a single electrode proximate to, but not in direct physical contact with a targeted region ([0004] “…at least one stimulation electrode is positioned proximate to a target stimulation site”) of at least one occipital nerve ([0005])
providing an electrical stimulation device in communication with the single electrode ([0023])
delivering pulsed electrical signals via the electrical stimulation device sufficient to activate the occipital nerve ([0026]) to provide pain relief ([0023], [0030])
Regarding claim 1, Kast does not explicitly disclose the use of a “coiled” neurostimulation lead positioned parallel to a sagittal plane, wherein the pulsed electrical signals avoid activation of non-target type III and IV nerve fibers within the occipital nerve due to the single electrode being proximate to but not in physical contact with the targeted region, and the step of verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort through application of a test stimulation.
Regarding positioning the neurostimulation lead parallel to a sagittal plane, the Examiner respectfully refers Applicant to the reasoning provided in the Response to Arguments section above, in which the Examiner describes how Kast suggests this limitation.
Regarding avoiding activation of non-target nerve fibers, Bennett also describes a method of delivering pulsed electrical signals to a targeted region ([0052], [0062] - [0064]), including wherein the electrical signals activate target nerves while avoiding activation of non-target nerves ([0066]: “if stimulus intensity is too low, the lead may be advanced too close to the targeted nerve of passage…possibly leading to…inability to activate the target nerve fiber(s) without activating non-target nerve fiber(s)…”), thereby suggesting that some nerve fibers will be targeted and some will be non-targeted. Bennett also makes frequent mention of targeting type Ia, Ib, and II nerve fibers ([0050]: “A first method according to the present invention includes activating afferent fibers (e.g. type Ia, lb, and/or II, which may also be called Aα and/or Aβ afferent fibers)…as a non-limiting example, stimulation may activate one or more Aβ fibers…”; [0059]: “a third method according to the present invention…comprises the step of activating one or more motor (efferent) axons (type Aα or Aγ)…”), but Bennett does not describe targeting type III (Aδ) or type IV (C) nerve fibers, leading one to conclude that these nerve fibers may be non-targeted nerve fibers. Therefore, the Examiner respectfully submits that, though not explicitly disclosed, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to target type Ia, Ib, and II nerve fibers while avoiding activation of non-target type III and IV nerve fibers, as doing so advantageously allows the resulting stimulation pattern to better target the nerves responsible for the patient’s pain. Configuring the method to target certain nerve fibers while avoiding activation of non-target nerve fibers is also in line with Bennett’s stated goals ([0066]). As Bennett is also directed towards providing neurostimulation therapy to a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a targeted therapy similar to that described by Bennett when using the method described by Kast, as doing so advantageously ensures that only the targeted regions are provide with the stimulation and minimizes the chances of aberrant stimulation of non-targeted regions.
Specifically regarding the step of “verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort through application of a test stimulation,” Bennett describes that “the stimulator is set to an intensity…sufficient to activate the targeted efferent or afferent neural structures, using an electrode that is preferably spaced at some distance (e.g. 1 mm) away from the targeted structure” ([0066]). Bennett further describes that if the stimulus intensity is too great or too low, or if the lead is placed improperly, this can lead to “incorrect guidance, nerve damage, mechanically evoked sensation (e.g. pain and/or paresthesia) and/or muscle contraction, inability to activate the target nerve fiber(s) without activating non-target nerve fiber(s), improper placement, and/or improper anchoring of the lead” ([0066], emphasis added). Bennett expands upon the desire to avoid electrical stimulation to non-targeted nerves and avoid cutaneous discomfort in paragraph [0071], when stating that improper positioning of the lead may lead to stimulation that is unable to evoke the desired responses in the desired regions without evoking undesirable responses, and that “it may be desirable to increase the range stimulus intensities that evoke the desired response(s) without evoking the undesired response(s)” ([0071]). Based at least on the above passages, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate step for verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort, similar to that recited, when using a stimulation scheme as described by Bennett, as doing so advantageously minimizes the chances of unwanted stimulation to non-targeted nerves and unwanted muscle contractions.
Therefore, the Examiner respectfully submits that Bennett suggests the step of “verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort,” but Bennett does not describe wherein this is achieved “through application of a test stimulation.” However, Ackermann also describes a method of providing nerve stimulation ([0189]: “the microstimulator may be positioned to stimulate an occipital nerve (e.g., to treat headache or other pain)”), including application of a test stimulation to verify avoidance of patient discomfort ([0199]: “the physician may assess one or more outcomes of the test signal, such as…discomfort…and may alter stimulation parameters and/or positioning of the device”). As Ackermann is also directed towards providing neurostimulation therapy to a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a test stimulation similar to that described by Ackermann when using the method described by Kast, as doing so advantageously ensures that the therapeutic stimulation does not cause unnecessary patient discomfort, as described by Bennett and Ackermann.
Regarding the use of a coiled neurostimulation lead, Kaplan also describes a method of delivering pulsed electrical signals to a targeted nerve ([0105]), including the use of a flexible, coiled neurostimulation lead ([0050] - [0051]; figure 2) configured to target the occipital nerve ([0004]). As Kaplan is also directed towards methods of nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a coiled neurostimulation lead, similar to that described by Kaplan, when using the method described by Kast and Bennett, as doing so advantageously allows the resulting method to treat a larger number of conditions.
Regarding claim 2, Kast, Bennett, Ackermann, and Kaplan do not explicitly disclose wherein the pulsed electrical signals comprise a 15 - 20 μsec pulse duration. Kast does, however, state that the pulse parameters may be altered as necessary for optimal treatment ([0034]), including wherein the pulse duration may include 20 μsec ([0064]). Similarly, Bennett also states that the pulse parameters may be altered as necessary for optimal treatment ([0052], [0066]) and provides a table of example stimulation parameters which lists a 20 μsec pulse duration. Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the pulsed electrical signals to have a pulse duration of 15 - 20 μsec, as doing so would be a matter of optimizing a result-effective variable via routine experimentation, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.05).
Regarding claim 3, Bennett further describes wherein the pulsed electrical signals comprise a frequency of 100 Hz ([0065]).
Regarding claim 4, Bennett further describes wherein the pulsed electrical signals comprise an amplitude of less than 20 mA ([0066]).
Regarding claim 5, Bennett further describes wherein the electrical stimulation device is an external electrical stimulation device ([0062]).
Regarding claim 6, Bennett further describes wherein the electrical stimulation device is a subcutaneous electrical stimulation device ([0057]).
Regarding claim 7, Kast further describes providing a plurality of leads ([0025], paddle leads 17A and 17B) and positioning each lead so that each lead is operatively associated with a plurality of targeted regions, said plurality of targeted regions each located in separate occipital nerves ([0029]).
Regarding claim 8, Kast describes a method comprising
positioning a flexible neurostimulation lead ([0067]: “like leads 14, lead [sic] 134 are flexible to conform to the skull of a patient”) having a single electrode proximate to, but not in direct physical contact with a targeted region ([0004] “…at least one stimulation electrode is positioned proximate to a target stimulation site”) of at least one occipital nerve ([0005]) and in a transverse plane to a coronal plane (fig 1A, orientation of paddles 17A and 17B is in a transverse plane)
delivering preliminary therapy for a period of time via the lead ([0004], the lead may be implanted on a temporary basis; [0027], the leads may be removed from the connection ports), the preliminary therapy comprising pulsed electrical signals sufficient to activate the occipital nerve ([0026]) to provide pain relief ([0023], [0030])
removing the lead after the period of time ([0004], [0027])
Regarding claim 8, Kast does not explicitly disclose the use of a “coiled” neurostimulation lead, wherein the pulsed electrical signals avoid activation of non-target type III and IV nerve fibers within the occipital nerve due to the single electrode being proximate to but not in physical contact with the targeted region, and the step of verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort through application of a test stimulation.
Regarding avoiding activation of non-target nerve fibers, Bennett also describes a method of delivering pulsed electrical signals to a targeted region ([0052], [0062] - [0064]), including wherein the electrical signals activate target nerves while avoiding activation of non-target nerves ([0066]: “if stimulus intensity is too low, the lead may be advanced too close to the targeted nerve of passage…possibly leading to…inability to activate the target nerve fiber(s) without activating non-target nerve fiber(s)…”), thereby suggesting that some nerve fibers will be targeted and some will be non-targeted. Bennett also makes frequent mention of targeting type Ia, Ib, and II nerve fibers ([0050]: “A first method according to the present invention includes activating afferent fibers (e.g. type Ia, lb, and/or II, which may also be called Aα and/or Aβ afferent fibers)…as a non-limiting example, stimulation may activate one or more Aβ fibers…”; [0059]: “a third method according to the present invention…comprises the step of activating one or more motor (efferent) axons (type Aα or Aγ)…”), but Bennett does not describe targeting type III (Aδ) or type IV (C) nerve fibers, leading one to conclude that these nerve fibers may be non-targeted nerve fibers. Therefore, the Examiner respectfully submits that, though not explicitly disclosed, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to target type Ia, Ib, and II nerve fibers while avoiding activation of non-target type III and IV nerve fibers, as doing so advantageously allows the resulting stimulation pattern to better target the nerves responsible for the patient’s pain. Configuring the method to target certain nerve fibers while avoiding activation of non-target nerve fibers is also in line with Bennett’s stated goals ([0066]). As Bennett is also directed towards providing neurostimulation therapy to a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a targeted therapy similar to that described by Bennett when using the method described by Kast, as doing so advantageously ensures that only the targeted regions are provide with the stimulation and minimizes the chances of aberrant stimulation of non-targeted regions.
Specifically regarding the step of “verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort through application of a test stimulation,” Bennett describes that “the stimulator is set to an intensity…sufficient to activate the targeted efferent or afferent neural structures, using an electrode that is preferably spaced at some distance (e.g. 1 mm) away from the targeted structure” ([0066]). Bennett further describes that if the stimulus intensity is too great or too low, or if the lead is placed improperly, this can lead to “incorrect guidance, nerve damage, mechanically evoked sensation (e.g. pain and/or paresthesia) and/or muscle contraction, inability to activate the target nerve fiber(s) without activating non-target nerve fiber(s), improper placement, and/or improper anchoring of the lead” ([0066], emphasis added). Bennett expands upon the desire to avoid electrical stimulation to non-targeted nerves and avoid cutaneous discomfort in paragraph [0071], when stating that improper positioning of the lead may lead to stimulation that is unable to evoke the desired responses in the desired regions without evoking undesirable responses, and that “it may be desirable to increase the range stimulus intensities that evoke the desired response(s) without evoking the undesired response(s)” ([0071]). Based at least on the above passages, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate step for verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort, similar to that recited, when using a stimulation scheme as described by Bennett, as doing so advantageously minimizes the chances of unwanted stimulation to non-targeted nerves and unwanted muscle contractions.
Therefore, the Examiner respectfully submits that Bennett suggests the step of “verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort,” but Bennett does not describe wherein this is achieved “through application of a test stimulation.” However, Ackermann also describes a method of providing nerve stimulation ([0189]: “the microstimulator may be positioned to stimulate an occipital nerve (e.g., to treat headache or other pain)”), including application of a test stimulation to verify avoidance of patient discomfort ([0199]: “the physician may assess one or more outcomes of the test signal, such as…discomfort…and may alter stimulation parameters and/or positioning of the device”). As Ackermann is also directed towards providing neurostimulation therapy to a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a test stimulation similar to that described by Ackermann when using the method described by Kast, as doing so advantageously ensures that the therapeutic stimulation does not cause unnecessary patient discomfort, as described by Bennett and Ackermann.
Regarding the use of a coiled neurostimulation lead, Kaplan also describes a method of delivering pulsed electrical signals to a targeted nerve ([0105]), including the use of a flexible, coiled neurostimulation lead ([0050] - [0051]; figure 2) configured to target the occipital nerve ([0004]). As Kaplan is also directed towards methods of nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a coiled neurostimulation lead, similar to that described by Kaplan, when using the method described by Kast and Bennett, as doing so advantageously allows the resulting method to treat a larger number of conditions.
Regarding claim 11, Kast, Bennett, Ackermann, and Kaplan do not explicitly disclose wherein the pulsed electrical signals comprise a 15 - 20 μsec pulse duration. Kast does, however, state that the pulse parameters may be altered as necessary for optimal treatment ([0034]), including wherein the pulse duration may include 20 μsec ([0064]). Similarly, Bennett also states that the pulse parameters may be altered as necessary for optimal treatment ([0052], [0066]) and provides a table of example stimulation parameters which lists a 20 μsec pulse duration. Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the pulsed electrical signals to have a pulse duration of 15 - 20 μsec, as doing so would be a matter of optimizing a result-effective variable via routine experimentation, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.05).
Regarding claim 12, Bennett further describes wherein the pulsed electrical signals comprise a frequency of 100 Hz ([0065]).
Regarding claim 13, Bennett further describes wherein the pulsed electrical signals comprise an amplitude of less than 20 mA ([0066]).
Regarding claim 14, Kast describes a method comprising
identifying a targeted region of at least one occipital nerve ([0005])
positioning a flexible neurostimulation lead ([0067]: “like leads 14, lead [sic] 134 are flexible to conform to the skull of a patient”) having a single electrode proximate to and spaced a distance from, but not in direct physical contact with, the targeted region ([0004] “…at least one stimulation electrode is positioned proximate to a target stimulation site”)
delivering therapy for a period of time via the lead ([0004], [0027]), the therapy comprising pulsed electrical signals sufficient to activate the occipital nerve ([0026]) to provide pain relief ([0023], [0030])
Regarding claim 14, Kast does not explicitly disclose the use of a “coiled” neurostimulation lead positioned parallel to a sagittal plane and transverse to a coronal plane, wherein the pulsed electrical signals do not stimulate muscle contractions and are directionally transmitted only to the targeted region while simultaneously preventing the pulsed signals from stimulating non-targeted type III and IV nerve fibers due to the single electrode being spaced the distance from the targeted region, and the step of verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort through application of a test stimulation.
Regarding positioning the neurostimulation lead parallel to a sagittal plane and transverse to a coronal plane, the Examiner respectfully refers Applicant to the reasoning provided in the Response to Arguments section above, in which the Examiner describes how Kast suggests this limitation.
Regarding avoiding activation of non-target nerve fibers, Bennett also describes a method of delivering pulsed electrical signals to a targeted region ([0052], [0062] - [0064]), including wherein the electrical signals activate target nerves while avoiding activation of non-target nerves ([0066]: “if stimulus intensity is too low, the lead may be advanced too close to the targeted nerve of passage…possibly leading to…inability to activate the target nerve fiber(s) without activating non-target nerve fiber(s)…”), thereby suggesting that some nerve fibers will be targeted and some will be non-targeted. Bennett also makes frequent mention of targeting type Ia, Ib, and II nerve fibers ([0050]: “A first method according to the present invention includes activating afferent fibers (e.g. type Ia, lb, and/or II, which may also be called Aα and/or Aβ afferent fibers)…as a non-limiting example, stimulation may activate one or more Aβ fibers…”; [0059]: “a third method according to the present invention…comprises the step of activating one or more motor (efferent) axons (type Aα or Aγ)…”), but Bennett does not describe targeting type III (Aδ) or type IV (C) nerve fibers, leading one to conclude that these nerve fibers may be non-targeted nerve fibers. Therefore, the Examiner respectfully submits that, though not explicitly disclosed, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to target type Ia, Ib, and II nerve fibers while avoiding activation of non-target type III and IV nerve fibers, as doing so advantageously allows the resulting stimulation pattern to better target the nerves responsible for the patient’s pain. Configuring the method to target certain nerve fibers while avoiding activation of non-target nerve fibers is also in line with Bennett’s stated goals ([0066]). As Bennett is also directed towards providing neurostimulation therapy to a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a targeted therapy similar to that described by Bennett when using the method described by Kast, as doing so advantageously ensures that only the targeted regions are provide with the stimulation and minimizes the chances of aberrant stimulation of non-targeted regions.
Specifically regarding the step of “verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort through application of a test stimulation,” Bennett describes that “the stimulator is set to an intensity…sufficient to activate the targeted efferent or afferent neural structures, using an electrode that is preferably spaced at some distance (e.g. 1 mm) away from the targeted structure” ([0066]). Bennett further describes that if the stimulus intensity is too great or too low, or if the lead is placed improperly, this can lead to “incorrect guidance, nerve damage, mechanically evoked sensation (e.g. pain and/or paresthesia) and/or muscle contraction, inability to activate the target nerve fiber(s) without activating non-target nerve fiber(s), improper placement, and/or improper anchoring of the lead” ([0066], emphasis added). Bennett expands upon the desire to avoid electrical stimulation to non-targeted nerves and avoid cutaneous discomfort in paragraph [0071], when stating that improper positioning of the lead may lead to stimulation that is unable to evoke the desired responses in the desired regions without evoking undesirable responses, and that “it may be desirable to increase the range stimulus intensities that evoke the desired response(s) without evoking the undesired response(s)” ([0071]). Based at least on the above passages, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate step for verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort, similar to that recited, when using a stimulation scheme as described by Bennett, as doing so advantageously minimizes the chances of unwanted stimulation to non-targeted nerves and unwanted muscle contractions.
Therefore, the Examiner respectfully submits that Bennett suggests the step of “verifying avoidance of electrical stimulation to cutaneous afferent fibers to eliminate cutaneous discomfort,” but Bennett does not describe wherein this is achieved “through application of a test stimulation.” However, Ackermann also describes a method of providing nerve stimulation ([0189]: “the microstimulator may be positioned to stimulate an occipital nerve (e.g., to treat headache or other pain)”), including application of a test stimulation to verify avoidance of patient discomfort ([0199]: “the physician may assess one or more outcomes of the test signal, such as…discomfort…and may alter stimulation parameters and/or positioning of the device”). As Ackermann is also directed towards providing neurostimulation therapy to a patient and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a test stimulation similar to that described by Ackermann when using the method described by Kast, as doing so advantageously ensures that the therapeutic stimulation does not cause unnecessary patient discomfort, as described by Bennett and Ackermann.
Regarding the use of a coiled neurostimulation lead, Kaplan also describes a method of delivering pulsed electrical signals to a targeted nerve ([0105]), including the use of a flexible, coiled neurostimulation lead ([0050] - [0051]; figure 2) configured to target the occipital nerve ([0004]). As Kaplan is also directed towards methods of nerve stimulation and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a coiled neurostimulation lead, similar to that described by Kaplan, when using the method described by Kast and Bennett, as doing so advantageously allows the resulting method to treat a larger number of conditions.
Regarding claim 15, Kast, Bennett, Ackermann, and Kaplan do not explicitly disclose wherein the pulsed electrical signals comprise a 15 - 20 μsec pulse duration. Kast does, however, state that the pulse parameters may be altered as necessary for optimal treatment ([0034]), including wherein the pulse duration may include 20 μsec ([0064]). Similarly, Bennett also states that the pulse parameters may be altered as necessary for optimal treatment ([0052], [0066]) and provides a table of example stimulation parameters which lists a 20 μsec pulse duration. Therefore, the Examiner respectfully submits that it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to configure the pulsed electrical signals to have a pulse duration of 15 - 20 μsec, as doing so would be a matter of optimizing a result-effective variable via routine experimentation, with such matters having been held by the Courts as being obvious to the skilled artisan (please see MPEP 2144.05).
Regarding claim 16, Bennett further describes wherein the pulsed electrical signals comprise a frequency of 100 Hz ([0065]).
Regarding claim 17, Bennett further describes wherein the pulsed electrical signals comprise an amplitude of less than 20 mA ([0066]).
Regarding claim 18, Kast further describes
wherein the targeted region comprises first and second areas ([0029])
wherein the single electrode includes a length of exposed conductive wires, said length having a first exposed end and a second exposed end with a middle length situated therebetween (figures 1E and 5)
further comprising positioning the first exposed end proximate to and spaced a first exposed distance from, but not in direct physical contact with, the first area and the second exposed end proximate to and spaced a second exposed distance from, but not in direct physical contact with, the second area ([0025])
Regarding claim 19, Kast further describes wherein the pulsed electrical signals are adjusted so that appropriate levels of therapeutic current are delivered at the first and second exposed ends while current delivered by the middle length does not stimulate muscle contractions and sensations of discomfort ([0025] - [0026]).
Regarding claim 20, Kast further describes wherein the first area is located on a first occipital nerve and the second area is located on a second occipital nerve ([0025], [0029]).
Regarding claim 21, Kaplan further describes wherein the lead comprises a flexible, double coiled neurostimulation lead ([0050] - [0051]; figure 2).
Regarding claim 22, Kaplan further describes wherein the lead comprises a flexible, double coiled neurostimulation lead ([0050] - [0051]; figure 2).
Regarding claim 23, Kaplan further describes wherein the lead comprises a flexible, double coiled neurostimulation lead ([0050] - [0051]; figure 2).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being obvious over Kast in view of Bennett, Ackermann, and Kaplan, further in view of Wahlstrand et al. (US 7,676,271 B2).
Regarding claim 9, Kast in view of Bennett, Ackermann, and Kaplan suggests the method of claim 8, but Kast, Bennett, Ackermann, and Kaplan do not explicitly disclose
monitoring pain reported by a patient subsequent to the preliminary therapy
upon a report from the patient of pain that is similar to the preliminary therapy, providing a surgically implanted system comprising a second neurostimulation lead positioned proximate to, but not in direct contact with, the targeted region and a subcutaneous electrical stimulation device located proximate to one of a patient's upper chest, clavicle, skull and neck
connecting the second lead to the electrical stimulation device and subcutaneously fixing the electrical stimulation device within the patient
delivering therapy via the second lead and the electrical stimulation device
However, Wahlstrand also describes providing neurostimulation therapy to a patient (col 1:60-66), including
monitoring pain reported by a patient subsequent to the preliminary therapy (col 6:50-58)
upon a report from the patient of pain that is similar to the preliminary therapy, providing a surgically implanted system comprising a second neurostimulation lead positioned proximate to, but not in direct contact with, the targeted region (col 12:11-17) and a subcutaneous electrical stimulation device located proximate to one of a patient's upper chest, clavicle, skull and neck (col 17:41-48)
connecting the second lead to the electrical stimulation device and subcutaneously fixing the electrical stimulation device within the patient (col 17:41-48)
delivering therapy via the second lead and the electrical stimulation device (col 13:53-56)
As Wahlstrand is also directed towards providing neurostimulation therapy and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate the pain monitoring and permanently implanted system similar to that described by Wahlstrand when using the method described by Kast, Bennett, Ackermann, and Kaplan, as doing so advantageously allows the resulting method to optimize the treatment parameters prior to implantation of a permanent device.
Regarding claim 10, Wahlstrand further describes wherein the electrical stimulation device is attached to a patient’s fascia (col 12:4-21).
Statement on Communication via Internet
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“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796