DETAILED ACTION
This action is in response to amendments received on 4/22/2025. Claims 1-25 were previously rejected. Claims 1 and 24 have been amended. A complete action on the merits of claims 1-25 follows below.
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.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
The information disclosure statement (IDS) submitted on 4/22/2025 was filed after the mailing date of the Non-Final rejection on 11/1/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-25 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.
Each of claims 1 and 24 recite the limitation “the pulse generator comprising programming that, when executed, causes electrical stimulation …”. It is at most unclear how a pulse generator is programmed without ever introducing a processor associated with the generator. It is suggested to add the structural limitation (e.g. processor) that is configured to carry the functional recitation of being programmed to perform specific steps such as “the pulse generator comprising a processor programmed to perform electrical stimulation”. Clarification and appropriate correction is required.
Claims 2-23 and 25 are rejected due to dependency over a rejected claim.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-18, 20-21 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bennett (US Pub. No. 2010/0036454) in view of Sachs (US Patent No. 8,428,728).
Regarding Claim 1, Bennett teaches a system to treat back pain ([0035] and [0057]), the system comprising:
a lead 12 having a proximal region and a distal region (Figs. 12A-B), the lead comprising a coiled structure ([0141]-[0145] and Figs. 12A-B);
at least one electrode 14 at the distal region (electrodes 14, Figs. 12A-B and [0147]), the at least one electrode adapted to be placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers innervating a muscle supporting spinal stability of the human ([0028]-[0037], [0058]-[0059], [0158]-[0160] and claim 5);
at least one fixation anchor at the distal region (anchoring element 70), the at least one fixation anchor adapted to be angled relative to a longitudinal axis of the lead in a deployed state to anchor the lead so that the at least one electrode is positioned to stimulate the efferent motor nerve fibers (Figs. 12A-B and [0144]-[0150]); and
a pulse generator 28 configured to be coupled to the at least one electrode via the lead, the pulse generator comprising programming that, when executed, causes electrical stimulation through the at least one electrode to stimulate efferent motor nerve fibers innervating the muscle to cause contraction of the muscle ([0028], [0069]-[0073] and [0144]-[0150], especially [0154] teaching “Control of the stimulator and stimulation parameters may be provided by one or more external controllers. In the case of an external stimulator, the controller may be integrated with the external stimulator. The implanted pulse generator external controller (i.e., clinical programmer) may be a remote unit that uses RF (Radio Frequency) wireless telemetry communications (or an inductively coupled telemetry) to control the implanted pulse generator”);
although examiner takes the position that the lead of Bennett is configured to be placed near a multifidus muscle in order to stimulate the innervating nerves to thereby alleviate or reduce the back pain in a human as shown in Fig. 13 and thus it has a length to extend from the pulse generator to the efferent motor nerve fibers and is sized and shaped such that the at least one electrode is positioned to stimulate the efferent motor nerve fibers innervating the multifidus muscle, Bennett does not in specific show positioning the lead such that it is sized and shaped for the at least one electrode to be positioned to stimulate the efferent motor nerve fibers innervating the multifidus muscle as claimed.
In the same field of invention, Sachs teaches “Target muscles for lead placement include muscles associated with local segmental control of a motion segment, including the deep multifidus, …” in Col. 3, ll. 67-Col. 4, ll. 6 and “One embodiment of a device for facilitation of spinal stabilization would use a sensor of multifidus activity (or activity of another muscle of the local muscle system) that would trigger a piggyback stimulation on top of a patient's native contraction. Stimulus amplitudes may be set to achieve a strong muscle contraction, or may be used simply as a sensory reminder. As the patient's motor control improves, stimulation amplitude may be decreased to provide only a sensory cue as to when the multifidus should contract … embodiments of our device may use stimulation parameters to improve motor control of spine stabilization muscles” in Col. 4, ll. 55-Col. 5, ll. 22, “the implanted pulse generator 10 is shown near the lead system 12 that places electrodes (not shown) within the multifidus muscle structures” Col. 6, ll. 41-43, Figs. 1C-2 and Claims 1, 9, 19, 29, 44 and 58 of Sachs; therefore, in view of the teachings of Sachs, it has been known to place the lead at the multifidus muscle in a human back and therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention that either the lead of Bennett is sized and shaped to be positioned at the multifidus muscle as claimed or alternatively, it would have been obvious to have the lead shaped and sized to be placed at the multifidus muscle such that the electrode of Bennett is positioned near the multifidus muscle to stimulate efferent motor nerve fibers innervating a multifidus muscle supporting spinal stability of the human and applying electrical stimulation through the at least one electrode to stimulate efferent motor nerve fibers innervating the multifidus muscle to cause contraction and thereby alleviating or reducing the back pain of the human at that specific area in light of the teachings of Sachs.
Regarding Claim 2, Bennett in view of Sachs teaches wherein the at least one electrode 14 is configured to be positioned to stimulate efferent motor nerve fibers of a medial branch of a dorsal ramus nerve innervating the multifidus muscle ([0028]-[0037], [0058]-[0059] and [0158]-[0160] of Bennett teaches the lead configured to be used to stimulate efferent motor nerve fibers and therefore, the lead is configured to be placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers of a medial branch of a dorsal ramus nerve innervating the multifidus muscle, also see Col. 2, ll. 34-51, Col. 7, ll. 4-24 and claims 19 & 58 of Sachs).
Regarding Claim 3, Bennett teaches wherein the pulse generator 28 is configured to be programmed to apply the electrical stimulation through the at least one electrode 14 to stimulate the efferent motor nerve fibers without targeting stimulation of afferent nerve fibers ([0028] teaches “applying therapeutic electrical stimulation to the at least one electrode according to predefined therapeutic electrical stimulation parameters to affect afferent and/or efferent nerve stimulation within the skeletal muscle and to provide the therapeutic electrical stimulation to the motor point to alleviate pain without any functional nerve stimulation involving the skeletal muscle”; therefore, depending on the predefined parameters certain nerve fibers are stimulated without target stimulating the others).
Regarding Claim 4, Bennett in view of Sachs teaches wherein the pulse generator 28 is configured to be programmed to apply the electrical stimulation through the at least one electrode 14 to stimulate afferent nerve fibers associated with the multifidus muscle to reduce pain signals traveling towards the human’s brain ([0028] teaches “applying therapeutic electrical stimulation to the at least one electrode according to predefined therapeutic electrical stimulation parameters to affect afferent and/or efferent nerve stimulation within the skeletal muscle and to provide the therapeutic electrical stimulation to the motor point to alleviate pain without any functional nerve stimulation involving the skeletal muscle”; therefore, depending on the predefined parameters certain nerve fibers are stimulated without target stimulating the others, also see [0084] of Bennett, also see Col. 2, ll. 23-51 and Col. 4, ll. 14-Col. 5, ll. 43 of Sachs).
Regarding Claim 5, Bennett in view of Sachs teaches wherein the at least one electrode is configured to be positioned to stimulate a peripheral nerve to reduce the pain signals ([0073] and [0084] of Bennett, also see Figs. 1C-2 and Col. 3, ll. 37-59 and Claims 44 & 58 of Sachs).
Regarding Claim 6, Bennett in view of Sachs teaches wherein the at least one electrode comprises a plurality of electrodes (more than one electrode 14 shown in Fig. 12B of Bennett also see Claims 1, 9, 19, 29, 44 and 58 of Sachs).
Regarding Claim 7, Bennett in view of Sachs teaches wherein the pulse generator 28 is configured to be programmed to apply the electrical stimulation through the at least one electrode to improve neural drive([0125], [0154] and [0163]-[0166] of Bennett, also see Claims 1, 9, 19, 29, 44 and 58 of Sachs).
Regarding Claim 8, Bennett teaches wherein the pulse generator 28 is configured to be programmed to apply the electrical stimulation through the at least one electrode to stimulate the efferent nervous tissue to cause muscle contractions during a predetermined number of sessions ([0028]-[0030], [0058]-[0068], [0078] and [0098]).
Regarding Claim 9, Bennett teaches wherein the predetermined number of sessions is over a period of weeks ([0098]).
Regarding Claim 10, Bennett teaches wherein the pulse generator is configured to be programmed to apply the electrical stimulation through the at least one electrode to stimulate the efferent nervous tissue at a stimulation rate selected from a range of 12-30 Hz ([0157] and [0159]).
Regarding Claim 11, Bennett teaches wherein the pulse generator is configured to be programmed to apply the electrical stimulation through the at least one electrode to stimulate the efferent nervous tissue at an amplitude selected from less than 50 mA ([0158]).
Regarding Claim 12, Bennett in view of Sachs teaches wherein the at least one electrode comprises a first electrode and a second electrode (more than one electrode 14 in Fig. 12B), and wherein the pulse generator is configured to be programmed to apply the electrical stimulation through the first electrode and the second electrode simultaneously ([0012], [0026], [0057], [0074] and [0117]-[0119] of Bennett, also see Claims 9-27 and 44-70 of Sachs).
Regarding Claim 13, Bennett teaches wherein the at least one electrode comprises a first electrode and a second electrode (more than one electrode 14 shown in Fig. 12B), and wherein the pulse generator is configured to be programmed to apply the electrical stimulation through the first electrode and the second electrode in a time-wise interleaved manner([0115]).
Regarding Claim 14, Bennett in view of Sachs teaches further comprising an additional electrode lead configured to be coupled to the pulse generator([0025], [0057], [0074] and Figs. 1B-C of Bennett, also see “lead or leads will likely be placed in muscle and the electrical stimulation will activate the nerves associated with the muscle” in Col. 3, ll. 62-64 of Sachs).
Regarding Claim 15, Bennett in view of Sachs teaches wherein the at least one fixation anchor 70 is at a distal tip of the lead 12, the at least one fixation anchor angled proximally relative to the longitudinal axis of the lead in the deployed state (Figs. 12A-B of Bennett, also see “lead system 12 is placed along the bony structures and in an embodiment is anchored to the bone. Both active and passive fixation anchors are contemplated as well as glue based fixation features” in Col. 7, ll. 66-Col. 8, ll. 2 and Claims 1 and 29 of Sachs).
Regarding Claim 16, Bennett in view of Sachs teaches wherein the at least one fixation anchor consists of a single fixation anchor 70 (Figs. 12A-B of Bennett, also see “lead system 12 is placed along the bony structures and in an embodiment is anchored to the bone. Both active and passive fixation anchors are contemplated as well as glue based fixation features” in Col. 7, ll. 66-Col. 8, ll. 2 and Claims 1 and 29 of Sachs).
Regarding Claim 17, Bennett teaches wherein the at least one fixation anchor is at least one barb (Figs. 11A-B and [0145]).
Regarding Claim 18, Bennett teaches wherein the lead is formed from flexible metal and an outer polymeric cover ([0140]).
Regarding Claim 20, Bennett in view of Sachs teaches wherein the pulse generator is configured to be implanted ([0154] and Fig. 3B of Bennett and Col. 6, ll. 41-43 and Fig. 1c of Sachs).
Regarding Claim 21, Bennett in view of Sachs teaches wherein the pulse generator is configured to be programmed to transmit data associated with the pulse generator to an external control system([0154] of Bennett and Fig. 2 of Sachs).
Regarding Claim 24, Bennett teaches a system to treat back pain ([0035] and [0057]), the system comprising:
a lead having a proximal region and a distal region, the lead comprising a coiled structure([0141]-[0145] and Figs. 12A-B);
at least one electrode at the distal region(electrode(s) 14, Figs. 12A-B and [0147]), the at least one electrode adapted to be placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers associated with a muscle supporting spinal stability of the human and afferent sensory nerve fibers associated with the muscle ([0028]-[0037], [0058]-[0059] and [0158]-[0160] teaches the lead configured to be placed in a muscle of a human and used to stimulate efferent motor nerve fibers and therefore, the lead is configured to be placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers associated with a multifidus muscle supporting spinal stability of the human and afferent sensory nerve fibers associated with the multifidus muscle);
at least one fixation anchor (anchoring element(s) 70) at the distal region(Figs. 12A-B), the at least one fixation anchor adapted to be angled relative to a longitudinal axis of the lead in a deployed state to anchor the lead so that the at least one electrode is positioned to stimulate the efferent motor nerve fibers and the afferent sensory nerve fibers (Figs. 12A-B and [0144]-[0150]); and
a pulse generator 28 configured to be coupled to the at least one electrode via the lead, the pulse generator comprising programming that, when executed, causes electrical stimulation through the at least one electrode to stimulate efferent motor nerve fibers to cause contraction of the muscle and to stimulate the afferent sensory nerve fibers to reduce or block the transmission of pain signals, thereby alleviating or reducing the back pain of the human ([0028], [0069]-[0073] and [0144]-[0150], especially [0154] teaching “Control of the stimulator and stimulation parameters may be provided by one or more external controllers. In the case of an external stimulator, the controller may be integrated with the external stimulator. The implanted pulse generator external controller (i.e., clinical programmer) may be a remote unit that uses RF (Radio Frequency) wireless telemetry communications (or an inductively coupled telemetry) to control the implanted pulse generator”);
although examiner takes the position that the lead of Bennett is configured to be placed near a multifidus muscle in order to stimulate the innervating nerves to thereby alleviate or reduce the back pain in a human, Bennett does not in specific show wherein the lead has a length to extend from the pulse generator to the efferent motor nerve fibers and is sized and shaped such that the at least one electrode is positioned to stimulate the efferent motor nerve fibers innervating the multifidus muscle as claimed.
In the same field of invention, Sachs teaches “Target muscles for lead placement include muscles associated with local segmental control of a motion segment, including the deep multifidus, …” in Col. 3, ll. 67-Col. 4, ll. 6 and “One embodiment of a device for facilitation of spinal stabilization would use a sensor of multifidus activity (or activity of another muscle of the local muscle system) that would trigger a piggyback stimulation on top of a patient's native contraction. Stimulus amplitudes may be set to achieve a strong muscle contraction, or may be used simply as a sensory reminder. As the patient's motor control improves, stimulation amplitude may be decreased to provide only a sensory cue as to when the multifidus should contract … embodiments of our device may use stimulation parameters to improve motor control of spine stabilization muscles” in Col. 4, ll. 55-Col. 5, ll. 22, “the implanted pulse generator 10 is shown near the lead system 12 that places electrodes (not shown) within the multifidus muscle structures” Col. 6, ll. 41-43, Figs. 1C-2 and Claims 1, 9, 19, 29, 44 and 58 of Sachs; therefore, in view of the teachings of Sachs, it has been known to place the lead at the multifidus muscle in a human back and therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention that either the lead of Bennett is sized and shaped to be positioned at the multifidus muscle as claimed or alternatively, it would have been obvious to have the lead shaped and sized to be placed at the multifidus muscle such that the electrode of Bennett is positioned near the multifidus muscle to stimulate efferent motor nerve fibers innervating a multifidus muscle supporting spinal stability of the human and applying electrical stimulation through the at least one electrode to stimulate efferent motor nerve fibers innervating the multifidus muscle to cause contraction and thereby alleviating or reducing the back pain of the human at that specific area in light of the teachings of Sachs.
Regarding Claim 25, Bennett teaches wherein the pulse generator is configured to be programmed to apply the electrical stimulation through the at least one electrode to stimulate the efferent nervous tissue at a stimulation rate selected from a range of 12-30 Hz([0157] and [0159]).
Claims 19 and 22-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bennett in view of Sachs and further in view of Boveja (US Pub. No. 2005/0137644).
Regarding Claim 19, Bennett in view of Sachs teaches wherein the pulse generator is configured to be programmed with a circuitry module to apply the electrical stimulation through the at least one electrode to stimulate the efferent motor nerve fibers ([0028] teaches “applying therapeutic electrical stimulation to the at least one electrode according to predefined therapeutic electrical stimulation parameters to affect afferent and/or efferent nerve stimulation within the skeletal muscle and to provide the therapeutic electrical stimulation to the motor point to alleviate pain without any functional nerve stimulation involving the skeletal muscle”; thereby, the pulse generator is configured to be programmed with a circuitry module to apply a predetermined therapeutic electrical stimulation parameters to affect efferent nerve stimulation within the skeletal muscle, and although teaches in addition, it is also configured to be programmed to affect afferent nerve stimulation “affect afferent and/or efferent nerve stimulation” in [0028], Bennett is silent in teaching wherein the pulse generator is configured to be programmed with at least one additional circuitry module for additional therapeutic modalities.
In the same field of invention, Boveja teaches “A further advantage of the system and method of the current disclosure is that the external stimulator (with an optional telemetry module) can be remotely interrogated and programmed over the internet. This eliminates the need for patient to visit physicians office or clinic every time the device needs to be re-programmed” in [0033] as well as “pre-packaged or "customized" programs are stored in the memory unit 71” [0101 and the use of multiple modules in [0103]; thereby allowing the pulse generator to be programmed with at least one additional circuitry module for additional therapeutic modalities besides those already programmed in the memory in order to allow for a wider range of therapeutic applications using the implantable device.
It would have been obvious to one having ordinary skill in the field of the invention prior to the effective filing date of the current invention to allow the pulse generator be programmed with different circuitry modules for additional therapeutic modalities in order to allow for a wider range of therapeutic applications using the implantable device.
Regarding Claim 22, Bennett teaches wherein the pulse generator is wirelessly in communication with an external controller and passive charging ([0154]); however, does not specifically show or teach receiving power from the external control system to charge a battery of the pulse generator (e.g., a rechargeable battery); however, Boveja teaches a rechargeable battery in [0091], [0101] and [0122].
Regarding Claim 23, Bennett teaches wherein the pulse generator is configured to be programmed to transmit data associated with the pulse generator ([0154] teaches “Control of the stimulator and stimulation parameters may be provided by one or more external controllers. In the case of an external stimulator, the controller may be integrated with the external stimulator. The implanted pulse generator external controller (i.e., clinical programmer) may be a remote unit that uses RF (Radio Frequency) wireless telemetry communications (or an inductively coupled telemetry) to control the implanted pulse generator”; therefore, the external controller (i.e., clinical programmer) and wireless communication is here interpreted to be a computer running monitoring and control software, also see [0149]); however, Bennett is silent in specifically stating or showing a computer running monitoring and control software; however, Boveja teaches the use of a computer running monitoring and control software used to program the implantable device and update/ re-loading of a new set of programs ([0101]-[0103] and [0109]).
Response to Arguments
Applicant's arguments filed 04/22/2025 have been fully considered but they are not persuasive.
Applicant refers to an affidavit or declaration filed in the prior application 18/046,835 dated 05/06/2024. Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of the prior application do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
Applicant further makes a second Supplemental Declaration to address the rejections of the claims of this current application (Affidavit dated 04/22/2025).
First, examiner would like to thank Dr. Christopher Gilligan for his input on the matter.
The evidence and arguments submit have been taken into consideration by the examiner; however, they are not sufficient to overcome the rejection of claims 1-18, 20-21 and 24-25 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Bennett (US Pub. No. 2010/0036454) in view of Sachs (US Patent No. 8,428,728) as set forth in the prior Office action dated 11/01/2024.
According to MPEP 716.01(b) Nexus Requirement and Evidence of nonobviousness stating "The weight attached to evidence of secondary considerations by the examiner will depend upon its relevance to the issue of obviousness and the amount and nature of the evidence. To be given substantial weight in the determination of obviousness or nonobviousness, evidence of secondary considerations must be relevant to the subject matter as claimed, and therefore the examiner must determine whether there is a nexus between the merits of the claimed invention and the evidence of secondary considerations."
In this case after careful reconsideration of the Affidavit, it was determined that there is not a nexus between the secondary consideration and the specific structure of the claimed invention present. The apparatus claims are directed to a lead having a proximal region and a distal region, the lead comprising a coiled structure; at least one electrode at the distal region, the at least one electrode configured adapted to be placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers innervating a multifidus muscle supporting spinal stability of the human; at least one fixation anchor at the distal region, the at least one fixation anchor adapted to be angled relative to a longitudinal axis of the lead in a deployed state to anchor the lead so that the at least one electrode is positioned to stimulate the efferent motor nerve fibers; and a pulse generator configured to be coupled to the at least one electrode via the lead, the pulse generator comprising programming that, when executed, causes electrical stimulation through the at least one electrode to stimulate efferent motor nerve fibers innervating the multifidus muscle to cause contraction of the multifidus muscle, thereby alleviating or reducing the back pain of the human, wherein the lead has a length to extend from the pulse generator to the efferent motor nerve fibers and is sized and shaped such that the at least one electrode is positioned to stimulate the efferent motor nerve fibers innervating the multifidus muscle.
The arguments rely on Exhibit F: Industrial praise received by the Applicant’s invention, the article “Mainslay Medical Announces Positive Outcome from Landmark RESTORE Clinical Trial (Exhibit F) demonstrated statistically significant and clinically meaningful superiority vs. standard care in all primary and secondary measures of disability, pain and quality of life.
Applicant also relies on exhibit G to show that the addition of Reactiv8 Restoration therapy to current standard of care results in superior improvement in back pain related disability, pain and quality of life compared to standard of care treatment alone.
Examiner takes the position that such arguments might satisfy method of using the apparatus in the specific manner; however, the current claims are directed to apparatus claims.
Bennett teaches the use of a lead 12 “such as a coiled fine wire IM lead may be used because it is minimally-invasive and previous studies suggest it will perform well in this location, i.e., in muscle, during use” [0082], having “one or more anchoring element(s) 70. In the illustrated embodiment, the anchoring element 70 takes the form of an array of shovel-like paddles or scallops or tabs 76 distal to the distal-most electrode 14, although a tab 76 or tabs could also be proximal to the distal and/or proximal most electrode 14. The tabs 76 as shown are sized and configured so they will not cut or score the surrounding tissue. The anchoring element 70 is sized and configured so that, when in contact with the muscle tissue, it takes purchase in the muscle, to resist dislodgement or migration of the electrode out of the correct location in the surrounding muscle” [0146]. Furthermore, Figs. 12A-B of Bennett is designed to “resist migration” as explained in [0083], [0106], [0146] since “Lead migration is the most common complication for spinal cord stimulators occurring in up to 45-88% of the cases (North et al. 1991; Andersen 1997; Spincemaille et al. 2000; Sharan et al. 2002). When the lead migrates, the active contact moves farther from the target fibers and loses the ability to generate paresthesias in the target area. SCS systems attempt to address this problem by using leads with multiple contacts so that as the lead travels, the next contact in line can be selected to be the active contact” [0018]. As seen below the structure of lead 12 in Figs. 12A-B of Bennett is very similar to the specially-designed lead from the 2018 publication and not the commercially-available lead from the 2015 publication.
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Therefore, examiner takes the position that the design of the lead of Bennett is very similar to the current invention having a proximal region, a distal region and a coiled structure (Figs. 12A-B). Furthermore, Bennett teaches at least one electrode 14 at the distal region configured to be placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers innervating a specific muscle in the back of the patient (“the at least one electrode according to predefined therapeutic electrical stimulation parameters to affect afferent and/or efferent nerve stimulation within the skeletal muscle and to provide the therapeutic electrical stimulation to the motor point to alleviate pain” [0028] and claim 5 of Bennett). Moreover, Bennett teaches at least one fixation anchor (anchoring element 70/76) at the distal region angled relative to a longitudinal axis of the lead in a deployed state to anchor the lead and the electrode in position (Figs. 12A-B) and the use of a pulse generator 28 to apply electrical stimulation through the at least one electrode (Each of the electrode(s) may be connected to one or more conductors that run the length of the lead 12, proving electrical continuity from the electrode through the lead 12 to the stimulator 26 or 28” [0142]) and wherein the lead has a length to extend from the pulse generator to the efferent motor nerve fibers (Figs. 1A-4B where the disclosure encompasses different lead lengths to reach different muscles and nerve fibers in a human body). Although most of the disclosure is directed to shoulder pain, in [0035] Bennett teaches “the therapeutic electrical stimulation is adapted to provide a therapeutic stimulation function, the therapeutic stimulation function including a function selected from a group comprising the treatment of (i) shoulder pain, (ii) arm pain, (iii) calf pain, (iv) leg pain, (v) neck pain, (vi) head pain, and (vii) back pain”. Therefore, the lead is structured, sized and configured to be used in the claimed manner. In order to show that positioning of a lead with electrodes configured to stimulate efferent and/or afferent nerve fibers in the specific muscle as claimed (multifidus muscle) was known at the time of the invention, examiner turned to Sachs. Since no arguments or evidence directed to Sachs has been provided in the affidavit, examiner concludes that the affidavit does not address the deficiency of the prior art Sachs.
Applicant has not provided adequate evidence for why and how lead 12 of Bennett is different than the current invention and/or inoperable for the intended use.
Bennett clearly teaches the claimed structure shown in Figs. 12A-B including a lead 12 having a proximal region, a distal region and a coiled structure (Figs. 12A-B). Furthermore, Bennett teaches at least one electrode 14 at the distal region configured to be placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers innervating a specific muscle in the back of the patient (“the at least one electrode according to predefined therapeutic electrical stimulation parameters to affect afferent and/or efferent nerve stimulation within the skeletal muscle and to provide the therapeutic electrical stimulation to the motor point to alleviate pain” [0028] and claim 5 of Bennett).
Moreover Bennett teaches at least one fixation anchor (anchoring element 70) at the distal region angled relative to a longitudinal axis of the lead in a deployed state to anchor the lead and the electrode in position (Figs. 12A-B) and the use of a pulse generator 28 to apply electrical stimulation through the at least one electrode (Each of the electrode(s) may be connected to one or more conductors that run the length of the lead 12, proving electrical continuity from the electrode through the lead 12 to the stimulator 26 or 28” [0142]) and wherein the lead has a length to extend from the pulse generator to the efferent motor nerve fibers (Figs. 1A-4B where the disclosure encompasses different lead lengths to reach different muscles and nerve fibers in a human body). Although most of the disclosure is directed to shoulder pain, in [0035] Bennett teaches “the therapeutic electrical stimulation is adapted to provide a therapeutic stimulation function, the therapeutic stimulation function including a function selected from a group comprising the treatment of (i) shoulder pain, (ii) arm pain, (iii) calf pain, (iv) leg pain, (v) neck pain, (vi) head pain, and (vii) back pain”. Therefore, the lead is structured, sized and configured to be used in the claimed manner.
It is noted that there has been no evidence presented in the affidavit to prove the incapability of the use of the lead as disclosed by Bennett in the functional recitation of the claim (ex.g., specific sizes, angles, sensors, ...).
Examiner makes reference to section IV. Probative Value of Commercial Success or Long Felt Need Evidence which states "Objective evidence of commercial success or long felt need and failure of others may be given less weight if the record shows that the applicant or patent owner has a strong market power or blocking patent depending on the facts of record. “A patent has been called a ‘blocking patent’ where practice of a later invention would infringe the earlier patent. The existence of such a blocking patent may deter non-owners and non-licensees from investing the resources needed to make, develop, and market such a later, ‘blocked’ invention, because of the risk of infringement liability and associated monetary or injunctive remedies. If the later invention is eventually patented by an owner or licensee of the blocking patent, that potential deterrent effect is relevant to understanding why others had not made, developed, or marketed that ‘blocked’ invention and, hence, to evaluating objective indicia of the obviousness of the later patent.” Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1337, 128 USPQ2d 1001, 1021(Fed. Cir. 2018). “Such a blocking patent therefore can be evidence that can discount the significance of evidence that nobody but the blocking patent’s owners or licensees arrived at, developed, and marketed the invention covered by the later patent at issue in litigation. But the magnitude of the diminution in incentive in any context—in particular, whether it was great enough to have actually deterred activity that otherwise would have occurred—is ‘a fact-specific inquiry.” Id. At 1339, 128 USPQ2d at 1022. While having record evidence of such a blocking patent may not be common, examiners should be aware of its potential impact in evaluating secondary evidence of nonobviousness. In any Office action, examiners should articulate why there is any discounting of the weight of the secondary consideration evidence when addressing the evidence."
As well as MPEP 716.02 Allegations of Unexpected Results [R-08.2012] which states "Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of “a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree.” Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (“we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense”).
As far as the pending apparatus claims are concerned, it does not appear that the structure of the current invention would result in unexpected results over that of Bennett since they both have the claimed elements and size and configuration of back surgery (as evidenced by Figs. 12A-B and [0035] of Bennett “the therapeutic electrical stimulation is adapted to provide a therapeutic stimulation function, the therapeutic stimulation function including a function selected from a group comprising the treatment of (i) shoulder pain, (ii) arm pain, (iii) calf pain, (iv) leg pain, (v) neck pain, (vi) head pain, and (vii) back pain’).
Applicant argues that the programming language (as amended in claims 1 and 24) “constitutes a structural difference from a genetic pulse generator used to apply electrical stimulation. See, e.g., In re Bernhart, 417 F.2d 1395, 1399-1400, 163 USPQ 611, 615- 16 (CCPA 1969) ("[I]f a machine is programmed in a certain new and unobvious way, it is physically different from the machine without that program; its memory elements are differently arranged.") The foregoing case teaches that programming a previously-known controller/pulse generator to perform a new, useful, and non-obvious function-to cause contraction of the multifidus muscle to thereby alleviate/reduce back pain, as claimed-transforms that pulse generator into aphysically different device, and more importantly, constitutes patentably distinguishable structure that is not taught by generic, previously known pulse generators”.
Examiner respectfully disagrees and maintains that since the generator of Bennett is programmable as evidenced by paragraph [0154] teaching “Control of the stimulator and stimulation parameters may be provided by one or more external controllers. In the case of an external stimulator, the controller may be integrated with the external stimulator. The implanted pulse generator external controller (i.e., clinical programmer) may be a remote unit that uses RF (Radio Frequency) wireless telemetry communications (or an inductively coupled telemetry) to control the implanted pulse generator.” Therefore, in view of the teachings of Sachs, one having ordinary skill in the art prior to the effective filing date of the current invention would have been motivated to program the generator in the claimed manner without departing from the scope of the invention.
Furthermore applicant argues that “Dr. Gilligan explains that an electrode lead must be specifically structured to be implanted to stimulate efferent motor nerve fibers associated with lower back muscles, e.g., medial branch of the dorsal ramus nerve, as the muscles of the lower back are mobile, creating an environment having high risk of lead dislodgement and muscle damage. (Gilligan Oct. 2023 Decl. ¶ 11). Thus, as Dr. Gilligan explains, one of ordinary skill in the art would have understood that the lead of Bennett is not configured to be inserted in the lower back region to 8710188352 stimulate "efferent nervous tissue associated with the multifidus muscle to cause contraction of the multifidus muscle" as recited in independent claim 1, and to simply insert the lead of Bennett in the lower back as suggested by the Office action would be unsafe andpotentially catastrophic for the patient. (Id.). Further, independent claims 1 and 24 state that "the lead has a length to extend from the pulse generator to the efferent motor nerve fibers and is sized and shaped such that the at least one electrode is positioned to stimulate the efferent motor nerve fibers innervating the multifidus muscle." These are structural limitations as confirmed by the PTAB. In Snyders Heart Valve, LLC v. St. Jude Medical, LLC', the Federal Circuit explained that it focused its opinion in St. Jude Med., LLC v. Snyders Heart Valve LLC, 977 F.3d 1232 (Fed. Cir. 2020) "on the limitation 'a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region,' and, particularly, the 'sized and shaped' requirement." Accordingly, in Snyders, the Federal Circuit made clear that the "sized and shaped" limitation is structurally limiting, finding that U.S. Patent No. 6,540,782 to Snyders, which claimed "a flexibly resilient frame sized and shaped for insertion in a position between the upstream region and the downstream region [of an intact heart valve]," was not anticipated by U.S. Patent No. 5,855,601 to Bessler, which teaches an artificial heart valve that is inserted in larger space where the native valve has been excised and removed, as "[t]he requirement that the frame be 'sized and shaped' a certain way suggests a focus on how the frame is fitted to the surrounding material." Thus, in Snyders, the Federal Circuit found that the Bessler patent did not anticipate the claims of Snyders because Bessler failed to teach that its artificial heart valve is "sized and shaped" to be inserted in a position between the upstream region and the downstream region of an intact heart valve-a structural limitation of the claims of Snyder. Thus, like the "sized and shaped" limitation in the claims of Snyders, the "sized and shaped" limitations of claims 1 and 24 of the instant application must be construed as structurally limiting because the requirement that the lead be "sized and shaped" a certain way-with a length to extend from the pulse generator to the efferent motor nerve fibers and sized and shaped such that the at least one electrode is positioned to stimulate the efferent motor nerve fibers 1 See, Snyders Heart Valve, LLC v. St. Jude Medical, LLC, Appeal No. 2019-2111 (Fed. Cir. October 5, 2021) 9710188352v2 innervating the multifidus muscle-suggests a focus on how the lead is structured to be positioned to stimulate the efferent motor nerve fibers innervating the multifidus muscle. As such, under recent Federal Circuit precedent, which is controlling, the rejections must be withdrawn.”
Examiner respectfully disagrees and maintains that although examiner takes the position that the lead of Bennett has a length to extend from the pulse generator to the efferent motor nerve fibers and is sized and shaped such that the at least one electrode is positioned to stimulate the efferent motor nerve fibers innervating the multifidus muscle and is programmable, Examiner agrees that Bennett does not teach the specific limitation of programming the generator to stimulate efferent motor nerve fibers innervating the multifidus muscle to cause contraction of the multifidus muscle, by positioning the at least one electrode in the multifidus muscle; however, this limitation has been rejected under 35 U.S.C. § 103(a) in view of Sachs.
In order to show that positioning of a lead with electrodes configured to stimulate efferent and/or afferent nerve fibers in the specific muscle as claimed (multifidus muscle) was known at the time of the invention, examiner turned to Sachs.
Since no arguments or evidence directed to Sachs has been provided in the affidavit nor the arguments presented by the applicant, examiner concludes that the affidavit does not address the deficiency of the prior art Sachs.
Moreover, Sachs specifically teaches “the implanted pulse generator 10 is shown near the lead system 12 that places electrodes (not shown) within the multifidus muscle structures” Col. 6, ll. 41-43, Figs. 1C-2 and Claims 1, 9, 19, 29, 44 and 58 of Sachs; therefore, in view of the teachings of Sachs, it has been known to place the lead at the multifidus muscle in a human back and therefore, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention that either the lead of Bennett is sized and shaped to be positioned at the multifidus muscle as claimed or alternatively, it would have been obvious to have the lead shaped and sized to be placed at the multifidus muscle such that the electrode of Bennett is positioned near the multifidus muscle to stimulate efferent motor nerve fibers innervating a multifidus muscle supporting spinal stability of the human and applying electrical stimulation through the at least one electrode to stimulate efferent motor nerve fibers innervating the multifidus muscle to cause contraction and thereby alleviating or reducing the back pain of the human at that specific area in light of the teachings of Sachs.
Therefore, Examiner maintained that the claims are directed to apparatus and not the method of using the apparatus, hence, the prior art is only required to be configured to operate in the functional manner claimed. Without any reasons provided to prevent the probe of Bennett from being placed within a human such that the at least one electrode is positioned to stimulate efferent motor nerve fibers innervating a multifidus muscle supporting spinal stability of the human nor providing any physical differences between the current invention's probe and the prior art (e.g. length, width, flexibility,… differences), it would appear that the probe of Bennett is shaped and configured to operate in the claimed manner (in view of the teachings of Sachs) since it includes a lead 12 comprising a coiled structure with at least one electrode 14 and at least one fixation anchor 76 as seen in figs. 12A-B. Furthermore, Bennett teaches a programmable generator for applying therapeutic electrical stimulation to the at least one electrode according to predefined therapeutic electrical stimulation parameters to affect afferent and /or efferent nerve stimulation within the skeletal muscle in [0028] to treat back pain [0035], also see [0154].
Conclusion
THIS ACTION IS MADE FINAL. 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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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
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