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 4/15/25 is being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: “the spine” in line 3 should recite –a spine—since a spine is not previously recited. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: the limitations “the spine” in line 2, “the back” in line 3, and “the legs” in line 3 should respectively recite –a spine--, --a back--, and –legs—since these are not previously recited. Appropriate correction is required.
Claims 12 and 19 are objected to because of the following informalities: “MHz” and “mA” are not defined by the claim. Applicant is encouraged to change “MHz” to recite –megahertz (MHz)-- and “mA” to recite –milliampere (mA)--. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the limitation “to apply the electrical signal to the at least one sensory fiber to stimulate the at least one sensory fiber to override the pain signal with non-painful stimulus induced activity to at least partially relieve pain felt by the subject” should recite –configured to apply the electrical signal to the at least one sensory fiber to stimulate the at least one sensory fiber to override the pain signal with non-painful stimulus induced activity to at least partially relieve pain felt by the subject—for clarity purposes. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: “the spine” in line 2, “the back” in line 3, and “the arms” in line 4 should respectively recite –a spine--, --a back--, and –arms—since these are not previously recited. Appropriate correction is required.
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.
Claim 11-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the other electrode" in line 5. There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to change the limitation to recite –the another electrode--, since “another electrode” is recited in line 2 and “other electrode” is not previously recited in the claim.
In claims 12 and 19, the limitation of “0.001” seems unclear. It remains unclear what the unit is for this frequency. For instance, is it also MHz or another unit? For the purpose of examination, the Examiner is interpreting “0.001” to be “0.001 MHz” (see ¶40 on p8 of the specification).
In claim 13, the limitation of “a lateral spinothalamic tract; at least one electrode” seems unclear since it is missing an “and” between the elements of the list. It remains unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022) (each independent claim recites "a selection from the group comprising a person, an animal, an animated character, a creature, an alien, a toy, a structure, a vegetable, and a fruit." … (emphasis added). A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. See MPEP 2173.05(h). Applicant is encouraged to change the limitation of “a lateral spinothalamic tract; at least one electrode” to recite --a lateral spinothalamic tract; and at least one electrode --. Dependent claims 14-20 are rejected for the same deficiency in claim 13.
Claim 15 recites the limitation "the at least the other electrode" in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to change the limitation to recite –the another electrode--, since “another electrode” is recited in line 2 and “other electrode” is not previously recited in the claim.
Claim 15 recites the limitation "the other at least one electrode" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim. Applicant is encouraged to change the limitation to recite –the another electrode--, since “another electrode” is recited in line 2 and “other at least one electrode” is not previously recited in the claim.
In claim 20, the limitation of “one electrode is configured to be implanted on at least one thoracic level of the spine and the pain at least partially relieved comprises a pain of the back and/or legs or on at least one cervical level and the pain at least partially relieved comprises a pain of the arms” seems unclear due to multiple use of conjunctions without separating commas. It remains unclear whether Applicant means: “the pain at least partially relieved comprises a pain of the back and/or legs” or “on at least one cervical level and the pain at least partially relieved comprises a pain of the arms,” or whether Applicant means “the pain at least partially relieved comprises a pain of the back and/or legs or on at least one cervical level” and “the pain at least partially relieved comprises a pain of the arms.” For the purpose of examination, the Examiner is interpreting the limitation as -- one electrode is configured to be implanted: on at least one thoracic level of the spine and the pain at least partially relieved comprises a pain of the back and/or legs; or on at least one cervical level and the pain at least partially relieved comprises a pain of the arms-- to be consistent with ¶37 of the specification on pp7-8.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 8, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Annoni (US 10675469 filed on 1/11/18 as cited in the IDS).
Regarding claim 1, Annoni teaches a method comprising: implanting at least one electrode within a ventral space of a spinal column of a subject, wherein the at least one electrode is positioned near an anterior and/or a lateral spinothalamic tract (col. 13 and lines 20-27-the electrostimulator may deliver spinal cord stimulation (SCS) via electrodes electrically coupled to the electrostimulator. The electrodes may be surgically placed at a region at or near a spinal cord tissue, which may include, by way of example and not limitation, dorsal column, dorsal horn, spinal nerve roots such as the dorsal nerve root, dorsal root entry zone, spinothalamic tract, and dorsal root ganglia); generating, by a signal generator (col. 13 and lines 18-20-the therapy circuit 250 may include an electrostimulator configured to generate electrostimulation energy to treat pain), an electrical signal configured to stimulate at least one sensory fiber carrying a pain signal in the anterior and/or the lateral spinothalamic tract (col. 9 and lines 54-56-the pain management system 200 may assess pain of a subject using at least one physiological signal, and program a pain therapy based on the pain assessment; col. 13 and lines 18-27-the therapy circuit 250 may include an electrostimulator configured to generate electrostimulation energy to treat pain. In an example, the electrostimulator may deliver spinal cord stimulation (SCS) via electrodes electrically coupled to the electrostimulator. The electrodes may be surgically placed at a region at or near a spinal cord tissue, which may include, by way of example and not limitation, dorsal column, dorsal horn, spinal nerve roots such as the dorsal nerve root, dorsal root entry zone, spinothalamic tract, and dorsal root ganglia; Fig. 2); and applying the electrical signal via the at least one electrode to the anterior and/or the lateral spinothalamic tract to stimulate the at least one sensory fiber to override the pain signal with non-painful stimulus induced activity to at least partially relieve pain felt by the subject (col. 9 and lines 54-56-the pain management system 200 may assess pain of a subject using at least one physiological signal, and program a pain therapy based on the pain assessment; col. 13 and lines 18-20-the therapy circuit 250 may include an electrostimulator configured to generate electrostimulation energy to treat pain; col. 6 and lines 37-38-the stimulus may be delivered through sight, hearing, touch, or electrical, mechanical, or pharmacological stimulus; col. 5 and lines 8-10-improve automated patient pain characterization, as well as individualized therapies to alleviate pain or to reduce side effects).
Regarding claim 4, Annoni teaches the method of claim 1, further comprising beginning and/or ending the stimulation after receiving a user input (Annoni, col. 8 and lines 35-38-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; col. 12, line 55-col. 13, line 2-the input circuit 241 may enable a system user to program the parameters used for sensing the physiological signals, generating signal metrics, or generating the pain score, the input circuit 241 may enable a user to confirm, reject, or edit the programming of the therapy unit 250 , such as parameters for electrostimulation).
Regarding claim 5, Annoni teaches the method of claim 1, wherein the pain is chronic pain (¶7-chronic pain management).
Regarding claim 8, Annoni teaches the method of claim 1, wherein the applying further comprises stimulating the at least one sensory fiber carrying the pain signal continuously for a time period (Annoni, col. 15 and lines 41-45-the parameter adjustment or stimulation electrode configuration may be executed continuously, periodically at specific time, duration, or frequency, or in a commanded mode upon receiving from a system user a command or confirmation of parameter adjustment; col. 16 and lines 58-61-the programmer circuit 324 may continuously or periodically provide adjusted stimulation parameters or electrode configuration to the implantable neuromodulator 210).
Regarding claim 13, Annoni teaches a system comprising: a signal generator configured to generate an electrical signal (col. 13 and lines 18-20-the therapy circuit 250 may include an electrostimulator configured to generate electrostimulation energy to treat pain), wherein the electrical signal is configured to stimulate at least one sensory fiber carrying a pain signal in an anterior and/or a lateral spinothalamic tract (col. 9 and lines 54-56-the pain management system 200 may assess pain of a subject using at least one physiological signal, and program a pain therapy based on the pain assessment; col. 13 and lines 18-27-the therapy circuit 250 may include an electrostimulator configured to generate electrostimulation energy to treat pain. In an example, the electrostimulator may deliver spinal cord stimulation (SCS) via electrodes electrically coupled to the electrostimulator. The electrodes may be surgically placed at a region at or near a spinal cord tissue, which may include, by way of example and not limitation, dorsal column, dorsal horn, spinal nerve roots such as the dorsal nerve root, dorsal root entry zone, spinothalamic tract, and dorsal root ganglia; Fig. 2); at least one electrode configured to be implanted within a ventral space of the spinal column of the subject near the anterior and/or the lateral spinothalamic tract (col. 13 and lines 20-27-the electrostimulator may deliver spinal cord stimulation (SCS) via electrodes electrically coupled to the electrostimulator. The electrodes may be surgically placed at a region at or near a spinal cord tissue, which may include, by way of example and not limitation, dorsal column, dorsal horn, spinal nerve roots such as the dorsal nerve root, dorsal root entry zone, spinothalamic tract, and dorsal root ganglia) and to apply the electrical signal to the at least one sensory fiber to stimulate the at least one sensory fiber to override the pain signal with non-painful stimulus induced activity to at least partially relieve pain felt by the subject (col. 9 and lines 54-56-the pain management system 200 may assess pain of a subject using at least one physiological signal, and program a pain therapy based on the pain assessment; col. 13 and lines 18-20-the therapy circuit 250 may include an electrostimulator configured to generate electrostimulation energy to treat pain; col. 6 and lines 37-38-the stimulus may be delivered through sight, hearing, touch, or electrical, mechanical, or pharmacological stimulus; col. 5 and lines 8-10-improve automated patient pain characterization, as well as individualized therapies to alleviate pain or to reduce side effects).
Regarding claim 16, Annoni teaches the system of claim 13, wherein the at least one electrode comprises a plurality of contacts (col. 14 and lines 49-52-pain management via SCS, a plurality of segmented electrodes, such as the electrodes 116 , may be distributed in one or more leads).
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.
Claims 2-3, 9-11, 14-15, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Annoni in view of Li (US 20220111211 filed on 10/9/20 as cited in the IDS).
Regarding claim 2, Annoni teaches the method of claim 1. However, Annoni does not teach wherein the implanting further comprises implanting the at least one electrode on at least one cervical level, at least one thoracic level, and/or at least one lumbar level of the spine.
Li teaches wherein the implanting further comprises implanting the at least one electrode on at least one cervical level, at least one thoracic level, and/or at least one lumbar level of the spine (¶32- leads 116 may be introduced into spinal cord 120 in via any suitable region, such as the thoracic, cervical or lumbar regions; ¶74-in the example of FIG. 2, IMD 102 comprises two leads 116 comprising sets of electrodes 114, 115. In some examples, leads 116 comprise percutaneous SCS leads configured to be implanted within an epidural space of patient 112 of FIG. 1. The epidural space may include, e.g., a thoracic region or a lumbar region of patient 112).
Li relates to electrical stimulation therapy (¶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 Annoni to include wherein the implanting further comprises implanting the at least one electrode on at least one cervical level, at least one thoracic level, and/or at least one lumbar level of the spine of Li in order to deliver electrical stimulation therapy to patient for relief of chronic pain or other symptoms (Li, ¶23).
Regarding claim 3, the combination of Annoni and Li teaches the method of claim 2, wherein the implanting further comprises implanting the at least one electrode at least one thoracic level of the spine (Li, ¶32-leads 116 may be introduced into spinal cord 120 in via any suitable region, such as the thoracic, cervical or lumbar regions; ¶74-in the example of FIG. 2, IMD 102 comprises two leads 116 comprising sets of electrodes 114, 115. In some examples, leads 116 comprise percutaneous SCS leads configured to be implanted within an epidural space of patient 112 of FIG. 1. The epidural space may include, e.g., a thoracic region or a lumbar region of patient 112) and the pain at least partially relieved comprises a pain of the back and/or the legs of the subject (Li, ¶54-the paresthesia serves to mask pain felt in specific regions of the body, such as the lower back or legs).
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 Annoni to include wherein the implanting further comprises implanting the at least one electrode at least one thoracic level of the spine and the pain at least partially relieved comprises a pain of the back and/or the legs of the subject of Li in order to deliver electrical stimulation therapy to patient for relief of chronic pain or other symptoms (Li, ¶23).
Regarding claim 9, Annoni teaches the method of claim 1, further comprising: receiving an input related to the pain being treated (col. 12, line 55-col. 13, line 2-the input circuit 241 may enable a system user to program the parameters used for sensing the physiological signals, generating signal metrics, or generating the pain score. The input circuit 241 may be coupled to one or more input devices such as a keyboard, on-screen keyboard, mouse, trackball, touchpad, touch-screen, or other pointing or navigating devices. In some example, the input device may be incorporated in a mobile device such as a smart phone or other portable electronic device configured to execute a mobile application (“App”). The mobile App may enable a patient to provide pain description or quantified pain scales during the pain episodes).
However, Annoni does not explicitly teach sending a feedback signal to the signal generator based on at least a portion of the input; and modifying one or more parameters of the electrical signal based on the feedback signal.
Li teaches sending a feedback signal to the signal generator based on at least a portion of the input (¶36-external programmer 104 may transmit therapy stimulation programs, ECAP test stimulation programs, stimulation parameter adjustments, therapy stimulation program selections, ECAP test program selections, user input, or other information to control the operation of IMD 110, e.g., by wireless telemetry or wired connection; ¶81-sensor 212 may output patient parameter values that may be used as feedback to control delivery of therapy; ¶98-receive a user input and send a corresponding command to IMD 104); and modifying one or more parameters of the electrical signal based on the feedback signal (¶81-sensor 212 may output patient parameter values that may be used as feedback to control delivery of therapy; ¶45-adjust one or more stimulation parameter that defines the electrical stimulation informed pulses and, in some examples, control pulses, delivered to patient 112; ¶46-the control stimulation parameters and the target ECAP characteristic values may be initially set at the clinic but may be set and/or adjusted at home by patient 112).
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 Annoni to include sending a feedback signal to the signal generator based on at least a portion of the input; and modifying one or more parameters of the electrical signal based on the feedback signal of Li in order to allow the therapy to have long term efficacy, with the ability to keep the intensity of the stimulation consistent (Li, ¶46).
Regarding claim 10, the combination of Annoni and Li teaches the method of claim 9, wherein the input is a manual indication of pain or a recording of at least one ventral column evoked compound action potential (Annoni, col. 19 and lines 19-24-the pain assessment session may be automatically triggered by a sensor indicator, or activated manually by the patient (such as during a spontaneous pain episode) or a clinician (such as during an induced pain episode). The pain assessment session may include evaluating the electrostimulation's pain-relief effect; col. 12 and lines 64-66-the mobile App may enable a patient to provide pain description or quantified pain scales during the pain episodes).
Regarding claim 11, Annoni teaches the method of claim 1, further comprising: implanting at least another electrode within a dorsal column of the spinal column of the subject (col. 13 and lines 22-27-the electrodes may be surgically placed at a region at or near a spinal cord tissue, which may include, by way of example and not limitation, dorsal column, dorsal horn, spinal nerve roots such as the dorsal nerve root, dorsal root entry zone, spinothalamic tract, and dorsal root ganglia); and communicating, by a system comprising a processor (col. 10 and lines 36-38-a microprocessor circuit, which may be a dedicated processor).
However, Annoni does not explicitly teach information from the at least one electrode to the at least the other electrode to indicate where the stimulation should be delivered.
Li teaches information from the at least one electrode to the at least the other electrode to indicate where the stimulation should be delivered (¶19-systems detecting ECAPs can implement cycling as a technique to provide SCS therapy with predetermined periods of “on” and “off” time (e.g., where stimulation is delivered and not delivered, respectively); ¶70-different waveforms may modulate the axon population differently, and may be selected so as to adjust the tissue area of patient 112 that receives electrical stimulation).
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 Annoni to include information from the at least one electrode to the at least the other electrode to indicate where the stimulation should be delivered of Li in order for relief of chronic pain or other symptoms (Li, ¶23), because different waveforms may modulate the axon population differently (Li, ¶70).
Regarding claim 14, Annoni teaches the system of claim 13. However, Annoni does not explicitly teach at least one sensing electrode configured to record one or more evoked compound action potentials related to the pain of the subject; and a controller, comprising a non-transitory memory and a processor, configured to: receive a recording of the one or more evoked compound action potentials; modulate at least one parameter of the electrical signal in response to the one or more evoked compound action potentials to improve pain management; and send the modulated at least one parameter to the signal generator.
Li teaches at least one sensing electrode configured to record one or more evoked compound action potentials related to the pain of the subject (¶19-an SCS system may sense electrical signals, such as evoked compound action potentials (ECAPs), using electrodes carried by a lead implanted in the epidural space next to the spinal cord; ¶115-in response to determining that the cardiac features are trending towards increased pain (e.g., “YES” block of 706), IMD 102 determines whether the sensed ECAP signal is within a targeted ECAP signal range (708)); and a controller (¶73-a controller), comprising a non-transitory memory (¶69-memory 211 may be a storage device or other non-transitory medium.) and a processor (¶69-one or more processors), configured to: receive a recording of the one or more evoked compound action potentials (¶19-elicit a recordable ECAP; ¶55-the resultant ECAP can be detected and recorded); modulate at least one parameter of the electrical signal in response to the one or more evoked compound action potentials to improve pain management (¶58-the IMD detects an ECAP signal that is generated by one or more nerve fibers as a result of the applied stimulation and compares a characteristic value of the ECAP signal to a target characteristic value for the ECAP. Based on the comparison, the IMD may adjust one or more parameters of the stimulation therapy so as to reduce the difference between the characteristic value of the ECAP signal and the target characteristic value for the ECAP. For example, the IMD may lower the amplitude and/or pulse frequency of the applied stimulation pulses to generate a new set of therapy parameters for subsequent therapy; ¶115-in response to determining that the cardiac features are trending towards increased pain (e.g., “YES” block of 706), IMD 102 determines whether the sensed ECAP signal is within a targeted ECAP signal range (708)); and send the modulated at least one parameter to the signal generator (¶52-control the stimulation generator to deliver the electrical stimulation therapy to the patient according to the at least one adjusted parameter value; ¶58-the IMD may then apply the new stimulation therapy to the patient, sense the resulting ECAP generated as a result of the application of the new therapy, and may further generate a new set of therapy parameters for the therapy, in accordance with this closed loop control scheme).
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 Annoni to include at least one sensing electrode configured to record one or more evoked compound action potentials related to the pain of the subject; and a controller, comprising a non-transitory memory and a processor, configured to: receive a recording of the one or more evoked compound action potentials; modulate at least one parameter of the electrical signal in response to the one or more evoked compound action potentials to improve pain management; and send the modulated at least one parameter to the signal generator of Li in order for relief of chronic pain or other symptoms (Li, ¶23).
Regarding claim 15, Annoni teaches the system of claim 13, further comprising: another at least one electrode configured to be implanted within a dorsal column of the spinal column of the subject (col. 13 and lines 22-27-the electrodes may be surgically placed at a region at or near a spinal cord tissue, which may include, by way of example and not limitation, dorsal column, dorsal horn, spinal nerve roots such as the dorsal nerve root, dorsal root entry zone, spinothalamic tract, and dorsal root ganglia); and another system comprising a processor (col. 10 and lines 36-38-a microprocessor circuit, which may be a dedicated processor).
However, Annoni does not explicitly teach to communicate information from the at least one electrode to the at least the other electrode, wherein the information indicates a timing for delivering the stimulation and/or whether the at least one electrode and/or the other at least one electrode is delivering the stimulation.
Li teaches to communicate information from the at least one electrode to the at least the other electrode, wherein the information indicates a timing for delivering the stimulation and/or whether the at least one electrode and/or the other at least one electrode is delivering the stimulation (¶19-systems detecting ECAPs can implement cycling as a technique to provide SCS therapy with predetermined periods of “on” and “off” time (e.g., where stimulation is delivered and not delivered, respectively); ¶77- stimulation generation circuitry 202 cycles between periods of time where electrical stimulation is delivered and periods of time in which no electrical stimulation is delivered; ¶70-different waveforms may modulate the axon population differently, and may be selected so as to adjust the tissue area of patient 112 that receives electrical stimulation).
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 Annoni to include communicating information from the at least one electrode to the at least the other electrode, wherein the information indicates a timing for delivering the stimulation and/or whether the at least one electrode and/or the other at least one electrode is delivering the stimulation of Li in order for relief of chronic pain or other symptoms (Li, ¶23), because different waveforms may modulate the axon population differently (Li, ¶70).
Regarding claim 17, Annoni teaches the system of claim 13. However, Annoni does not teach wherein the at least one electrode comprises at least one percutaneously implanted cylindrical electrode or at least one implantable paddle electrode.
Li teaches wherein the at least one electrode comprises at least one percutaneously implanted cylindrical electrode or at least one implantable paddle electrode (¶26-the electrodes of leads 116 may be electrode pads on a paddle lead, circular (e.g., ring) electrodes surrounding the body of the lead, conformable electrodes, cuff electrodes, segmented electrodes (e.g., electrodes disposed at different circumferential positions around the lead instead of a continuous ring electrode), any combination thereof (e.g., ring electrodes and segmented electrodes) or any other type of electrodes capable of forming unipolar, bipolar or multipolar electrode combinations for therapy; ¶27).
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 Annoni to include wherein the at least one electrode comprises at least one percutaneously implanted cylindrical electrode or at least one implantable paddle electrode of Li in order to deliver electrical stimulation therapy to patient for relief of chronic pain or other symptoms (Li, ¶23).
Regarding claim 20, Annoni teaches the system of claim 13. However, Annoni does not teach wherein the at least one electrode is configured to be implanted on at least one thoracic level of the spine and the pain at least partially relieved comprises a pain of the back and/or legs or on at least one cervical level and the pain at least partially relieved comprises a pain of the arms.
Li teaches wherein the at least one electrode is configured to be implanted on at least one thoracic level of the spine (Li, ¶32- leads 116 may be introduced into spinal cord 120 in via any suitable region, such as the thoracic, cervical or lumbar regions; ¶74-in the example of FIG. 2, IMD 102 comprises two leads 116 comprising sets of electrodes 114, 115. In some examples, leads 116 comprise percutaneous SCS leads configured to be implanted within an epidural space of patient 112 of FIG. 1. The epidural space may include, e.g., a thoracic region or a lumbar region of patient 112) and the pain at least partially relieved comprises a pain of the back and/or legs or on at least one cervical level (Li, ¶54-the paresthesia serves to mask pain felt in specific regions of the body, such as the lower back or legs; ¶32-leads 116 may be introduced into spinal cord 120 in via any suitable region, such as the thoracic, cervical or lumbar regions. Stimulation of spinal cord 120 may, for example, prevent pain signals from traveling through spinal cord 120 and to the brain of patient 112).
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 Annoni to include wherein the at least one electrode is configured to be implanted on at least one thoracic level of the spine and the pain at least partially relieved comprises a pain of the back and/or legs or on at least one cervical level of Li in order to deliver electrical stimulation therapy to patient for relief of chronic pain or other symptoms (Li, ¶23).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Annoni in view of Saab (US 8977362 filed on 4/27/11 as cited in the IDS).
Regarding claim 6, Annoni teaches the method of claim 1. However, Annoni does not explicitly teach wherein the pain is back pain, leg pain, neck pain, and/or arm pain.
Saab teaches wherein the pain is back pain, leg pain, neck pain, and/or arm pain (col. 12 and lines 60-64-the WDR neuron chosen can correspond to the portion of the body which the patient 10 feels chronic pain (e.g., a neuron corresponding to the right leg of a patient suffering from chronic pain in their right leg, technically defined as a "receptive field")).
Saab relates to a solution to the long-standing problem of accurate identification of clinical pain and reliable therapeutic intervention to alleviate such pain (col. 1 and lines 38-40).
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 Annoni to include wherein the pain is back pain, leg pain, neck pain, and/or arm pain of Saab in order for accurate identification of clinical pain and reliable therapeutic intervention to alleviate such pain (Saab, col. 1 and lines 39-40).
Regarding claim 7, Annoni teaches the method of claim 1. However, Annoni does not teach wherein the pain is caused by at least one of complex regional pain syndrome, diabetic neuropathy, small fiber neuropathy, peripheral ischemia, and/or surgery.
Saab teaches wherein the pain is caused by at least one of complex regional pain syndrome, diabetic neuropathy, small fiber neuropathy, peripheral ischemia, and/or surgery (claim 5-wherein chronic pain further comprises one or more of: monoradiculopathies, trigeminal neuralgia, postherpetic neuralgia, phantom limb pain, complex regional pain syndromes, sciatica, and a peripheral neuropathy; col. 1 and lines 40-44-chronic clinical pain includes neuropathic pain such as that associated with direct nerve damage, amputation, chemotherapy, diabetes, HIV infection or AIDS, Multiple Sclerosis, shingles, sciatic nerve compression or injury, as well as spine surgery).
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 Annoni to include wherein the pain is caused by at least one of complex regional pain syndrome, diabetic neuropathy, small fiber neuropathy, peripheral ischemia, and/or surgery of Saab in order for accurate identification of clinical pain and reliable therapeutic intervention to alleviate such pain (Saab, col. 1 and lines 39-40).
Claims 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Annoni in view Stylos (US 20220088389 filed on 7/15/21).
Regarding claim 12, Annoni teaches the method of claim 1. However, Annoni does not explicitly teach wherein the electrical signal comprises at least one of a frequency between 0.001 and 1 MHz and a current between 0.001 mA and 50 mA.
Stylos teaches wherein the electrical signal comprises at least one of a frequency between 0.001 and 1 MHz (¶77-frequencies ranging between about 100 Hz and about 10,000 Hz) and wherein the electrical signal comprises a current between 0.001 mA and 50 mA (¶77-one or more stimulation parameters of the second pain reduction stimulation signals comprise…current ranging between about 0.1 mA and about 30 mA; ¶92-93).
Stylos relates to the field of neurostimulation, and more particularly to delivering electrical stimulation therapy to peripheral nerves of a patient, including, but not limited to, for the purpose of stimulating muscles and alleviating pain (¶2).
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 Annoni to include wherein the electrical signal comprises at least one of a frequency between 100 Hz and 10,000 Hz and a current between 0.1 mA and 30 mA of Stylos in order for reducing pain sensed by the patient through electrical stimulation (Stylos, ¶8). For the electrical signal frequency, the frequency range of 100 Hz to 10,000 Hz taught by Stylos overlaps with claimed range of “0.001 and 1MHz” and the specification does not disclose any criticality associated with the claimed frequency range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 19, Annoni teaches the system of claim 13. However, Annoni does not explicitly teach wherein the electrical signal comprises a frequency between 0.001 and 1 MHz and/or a current between 0.001 mA and 50 mA.
Stylos teaches wherein the electrical signal comprises a frequency between 0.001 and 1 MHz (¶77-frequencies ranging between about 100 Hz and about 10,000 Hz) and/or wherein the electrical signal comprises a current between 0.001 mA and 50 mA (¶77-one or more stimulation parameters of the second pain reduction stimulation signals comprise…current ranging between about 0.1 mA and about 30 mA; ¶92-93).
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 Annoni to include wherein the electrical signal comprises a frequency between 100 Hz and 10,000 Hz and/or a current between 0.1 mA and 30 mA of Stylos in order for reducing pain sensed by the patient through electrical stimulation (Stylos, ¶8). For the electrical signal frequency, the frequency range of 100 Hz to 10,000 Hz taught by Stylos overlaps with claimed range of “0.001 and 1MHz” and the specification does not disclose any criticality associated with the claimed frequency range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Annoni in view of Ackermann (US 20220088374 filed on 7/1/19).
Regarding claim 18, Annoni teaches the system of claim 13. However, Annoni does not teach wherein the at least one electrode comprises platinum-iridium.
Ackermann teaches wherein the at least one electrode comprises platinum-iridium (¶223-the traditional electrode may be made from a material such as…platinum-iridium).
Ackermann relates to facilitating block of biological signals through nerve tissue (¶2).
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 Annoni to include wherein the at least one electrode comprises platinum-iridium of Ackermann in order for safely delivering blocking direct current (DC) to neural tissue by delivering cycled cathodic and anodic current through a high-charge chemistry (Ackermann, ¶214) for management of chronic and acute pain states (Ackermann, ¶214).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2021252766: the IMD may monitor one or more characteristics of the ECAP signals and adjust electrical stimulation based on the one or more characteristics. In some examples, more information regarding the ECAP signals may be useful for further investigation into patient activity, patient symptom and/or patient disease progression, or efficacy of electrical stimulation therapy (¶5).
While Ackermann (US 20220088374) has been used for prior art rejection above for claim 18, it is further noted that Ackermann teaches the pain at least partially relieved comprises a pain of the arms (¶258- specific pain targets include focal pain, phantom limb pain, neuroma pain, and neuralgias, neuralgia in extremities such as the hands, arms, feet, and legs as frequently caused due to diabetes-related neuropathies are also potential targets).
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/L.N.H./Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
