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 .
Response to Arguments
Regarding the 112b indefiniteness rejections, applicant’s amendments and related arguments have overcome these rejections and they are hereby withdrawn. However, applicant’s amendments have created new 112b indefiniteness rejection and 112a written description rejection; see below.
Regarding the 101 related to claiming the human body, applicant’s amendments have overcome this rejection and it is hereby withdrawn.
Regarding the 101 related to an abstract idea/mental process, applicant’s amendments to claim 1, making it clear that an implantable pulse generator (IPG) is required and the delivery of the neuromodulation signal is achieved by the IPG, overcomes this 101 rejection as prophylaxis is now clearly required.
Regarding the 102 rejection to Bloch, the examiner will address applicant’s specific arguments below. However, it is worth pointing out that the device claims (1-9 and 16) have been amended slightly differently and have a different claim interpretation compared to the method claims (10-15). Therefore, the examiner’s position related to the device claims is separate/distinct from the method claims, as will be clearly differentiated below.
Applicant argues:
Bloch describes neural signals providing features of motion of a patient, kinematic signals, and electromyography signals (see e.g. paragraph [0048]. However, there is absolutely no disclosure of receiving "sensor data... comprising spinal electrophysiological data sensed from the at least one sensing electrical contact" as recited in claim 1 or "detecting sensor data comprising spinal electrophysiological data" as recited in claims 10 and 11
This is not found persuasive, as it’s abundantly clear from applicant’s own specification, specifically Par 0013 of applicant’s specification, that BRI of “sensor data comprising spinal electrophysiological data” can include many different types of data, including EMG. Therefore, the BRI of “sensor data comprising spinal electrophysiological data” is broad enough to include all different types of sensors and sensed data, include the numerous types of sensing taught by Bloch (See Pars 0048-49 and 0124-127) with particular emphasis on the “neurosensor 112 for receiving neural activity data therefrom” (Par 0127). It seems as if applicant’s interpretation of what is encompassed by the claimed “spinal electrophysiological data” is improperly narrow based on the knowledge/understanding within the art, as a whole, as well as applicant’s own specification. Applicant has failed to properly argue why the sensing data taught by Bloch cannot/does not read on the BRI of “spinal electrophysiological data” which clearly includes data from both/either a neurosensor or EMG.
Applicant further argues:
Bloch does describe a stimulation device 111 that can comprise an implantable pulse generator electrically coupled to one or more multi-electrode arrays and that the multi-electrode arrays may be placed epidurally or subdurally. However, nothing in the specification or the figures describes or illustrates the neurosensor being placed epidurally such that spinal electrophysiological data can be collected. In fact, Bloch specifically states that "the neurostimulation system 100 may be used to provide stimulation (e.g., electrical stimulation) to the spinal cord in response to neural activity in the motor cortex of subject 110" (paragraph [0122]) (emphasis added).
This is not found persuasive, specifically with regards to the device claims, as nothing in claim 1 requires the sensor, i.e. sensing electrical contact, to be placed epidurally in order to obtain the spinal electrophysiological data. Specifically, the implantable pulse generator merely has to be “in electrical communication” with the sensing electrical contact, which is not the same as being on/within the IPG. Furthermore, even if there was a limitation that required the sensor to be epidurally implantable, this is purely functional language/intended use, in terms of a device claim. MPEP 2114 states: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim… Functional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Therefore, if the prior art discloses a device that can inherently perform the claimed function, a rejection under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be appropriate. Therefore, applicant’s arguments related to an epidurally placed sensor are 1. Not commensurate in scope with the device claims and 2. Even if such a limitation was required by the device, Bloch seemingly teaches electrodes that are structurally capable of being placed in such a manner. Therefore, in terms of the device claim, this argument is not persuasive. Regarding the method claims, applicant’s amendments to specifically require implanting or positioning a spinal cord stimulator having a sensing electrical contact on an epidural surface of the patient, has overcome the 102 rejection to Bloch. These amendments to the method claims have necessitated a new grounds of rejection; see new 103 rejection, below.
Lastly, applicant argues:
Further, the present application states the disadvantages of using EMGs (which, as stated above, is what Bloch is directed to) in spinal cord stimulation
While this may be true, as noted above, applicant’s claim language is still broad enough to include EMG data. Therefore, applicant’s arguments that seemingly imply that EMG cannot be interpreted/considered “spinal electrophysiological data” are not commensurate in scope with the BRI of the current claim language, as EMG data is not precluded. Applicant’s interpretation of the current claim language is improperly narrow and these arguments are not considered persuasive.
While the examiner is not necessarily convinced/persuaded by the amendments and arguments, as specifically related to the device claim, in order to provide compact prosecution, and based on the amendments and new 112b rejections, the examiner has presented a new grounds of rejection for the device claims, as well as the method claims; see new 103 rejection below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
[Claim 1] The amended limitation “receive sensor data from the at least one stimulating electrical contact, the sensor data comprising spinal electrophysiological data sensed from the at least one sensing electrical contact” is not supported by the originally-filed specification. There is no indication in the specification that the sensor data is ever received from the stimulating electrical contact, as the specification is very clear that the stimulating electrical contact delivers electrical stimulation and the sensing electrical contact receives electrical sensing signals from the tissue.
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 1-9 and 16 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 1] The amended limitation “receive sensor data from the at least one stimulating electrical contact, the sensor data comprising spinal electrophysiological data sensed from the at least one sensing electrical contact” is indefinite. It’s unclear if the sensor data is received/sensed from the stimulating electrical contact, the sensing electrical contact or both. For examination purposes, the examiner interprets this as an electrode, i.e. electrical contact, that can act as both a sensing electrode and a stimulating electrode.
The limitation “the patient’s physiological state” and “the patient’s physiological function”, as recited in claims 1, 3, 4, and 6 lack antecedent basis. Applicant’s amendments deleted the necessary antecedent basis for the term “patient”, therefore these previously recited limitations now lack antecedent basis.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0173326 to Bloch et al. in view of US 2019/0366094 to Esteller et al. or US 2014/0163639 to Zhu.
[Claims 1 and 3] Bloch discloses a system (Fig. 11) comprising:
an implantable pulse generator (stimulation device 111; Par 0121 and Abstract) in electrical communication with at least one stimulating electrical contact (“electrically coupled to one or more multi-electrode arrays” Par 0121) and at least one sensing electrical contact (neurosensor 112, real-time monitoring component 120 and/or electromyogram 130) of a spinal cord stimulator (neurostimulation system 100), the implantable pulse generator comprising:
a processor (signal processing device 150 and/or stimulation controller 114; Pars 0114, 0129); and
a non-transitory computer readable medium storing executable instructions executable by the processor to execute the instructions to at least (Pars 0114 and 0129):
receive sensor data comprising spinal electrophysiological data from the at least one sensing electrical contact (neurosensor 112, real-time monitoring component 120 and/or electromyogram recording system 130; at least Pars 0124-127);
determine the patient's physiological state in response to the sensor data (neural and kinematic activity; Pars 00124-0128 provide examples of various physiological states that can be determined; gait phase is explicitly taught in at least Pars 0045 and 0125);
define neuromodulation parameters for the at least one stimulating electrical contact of the spinal cord stimulator in response to the determination of the patient's physiological state (at least Pars 0084-89, 0205-206, 0222-226 and claim 16 disclose using the sensor data in a closed-loop feedback system to determine/adjust/control the neuromodulation parameters, i.e. stimulation parameter settings); and
wherein the implantable pulse generator delivers a neuromodulation signal via the at least one stimulating electrical contact to the spinal cord based on the neuromodulation parameters to improve the patient's physiological function (at least Pars 0084-88, especially Par 0087).
Regarding the limitation “receiving sensor data from the at least one stimulating electrical contact”, Bloch is silent to such an instruction. However, in the same field of endeavor, either Esteller or Zhu teach such a concept. In particular, Esteller discloses an IPG for spinal cord stimulation system (Fig. 7A) that includes at least one sensing electrical contact (S) and at least one stimulation electrical contact (E1 to E8). Par 0047 of Esteller states “It should also be noted that in the embodiments described herein, any of the electrodes may be usable for sensing and usable for stimulation and may be selectable for either of those functions. Thus, when the disclosure refers to an electrode as a sensing electrode, it simply means that that electrode has been selected for sensing.” Similarly, Zhu discloses a similar IPG for spinal cord stimulation that includes multiple electrodes (26) that can be used for either sensing or stimulation (at least Pars 0048-49 and 0052-53). Therefore, it would have been obvious to one of ordinary skill in the art to configure the sensing electrodes, the stimulation electrodes and the processor of Bloch to receive sensor data from both/either sensing electrodes or stimulation electrodes, as taught by either Esteller or Zhu.
If it is determined that the limitations “an implantable pulse generator in electrical communication with… at least one sensing electrical contact” and “the sensor data comprising spinal electrophysiological data sensed from the at least one sensing electrical contact” somehow require a sensing electrical contact that is capable of being positioned or implanted on an epidural surface of the spinal cord, Bloch is silent to such a sensor capability/configuration. However, in the same field of endeavor, either Esteller or Zhu teach such a concept. Specifically Par 0048 of Zhu discloses “the electrodes 26 fit snugly within the epidural space of the spinal column, and because the tissue is conductive, electrical measurements can be taken from the electrodes 26… the electrical measurements taken by the monitoring circuitry 60 for the purpose of determining the positioning of the leads 12 may be any suitable measurement, e.g., an electrical impedance, an electrical field potential, or an evoked potential”. This data is then used to control stimulation parameters, i.e. reprogramming (at least Pars 0017-18). Similarly, Pars 0052-68, specifically Par 0054, of Esteller disclose sensing electrodes placed on an epidural surface to sense spinal electrophysiological data which is then used as feedback to control electrical stimulation. Therefore, it would have been obvious to one of ordinary skill in the art to modify the sensing electrical contacts of Bloch to be capable/configured of implantation/positioning on an epidural surface of the spine, as taught by Esteller or Zhu, as a known sensor position for obtaining spinal electrophysiological data that is then used to control/adjust the stimulation parameters delivered to the spinal cord.
[Claim 2] Pars 0238, 0242, 0265 and 0280 of Bloch disclose measuring evoked potentials. Additionally, both Esteller (Pars 0045-56 and Figs. 7-8) and Zhu (Pars 0048, 0053) disclose sensor data that includes ECAPs that are used to control the stimulation parameters. Therefore, it would have been obvious to modify Bloch to include ECAP measurements, as taught by either Esteller or Zhu, as a known type of neural activity that is commonly sensed/measured in order to determine effective spinal electrical stimulation and adjust/control the stimulation parameters based on these measurements. It is emphasized that Bloch is specifically concerned with sensing neural signals/activity (at least Pars 0048 and 0127-128)
[Claims 4-6] First, when measuring the neural or motor activity of the spinal cord, there are only two options: activity of ascending afferent fibers or activity of descending efferent fibers, so inherently Bloch encompasses at least one of these. Specifically, ascending afferent fibers transmit sensory information from the body up to the brain through the spinal cord, while descending efferent fibers transmit motor commands from the brain down the spinal cord to the muscles. Regarding the ascending afferent fibers, there are only 4 types of sensory receptors, so any physiological state related to the activity of ascending afferent fibers has to come from one of: mechanoreceptors, nociceptors, proprioceptors or thermoreceptors. For example, the neural signals related to gait (at least Par 0205) is activity of ascending afferent fibers of proprioceptors (Par 0260). Regarding the descending efferent fibers, the kinematic activity, specifically the walking/gait analysis (at least Par 0125), is volitional activation of a skeletal muscle based on an activity of descending efferent fibers that innervate a skeletal muscle.
[Claim 7] Bloch discloses using EMG data as the sensor data (at least Pars 0048-49, 0124-125. Element 130; Fig. 11)
[Claims 8-9] Bloch discloses applying a trained machine learning algorithm to the sensor data which is then used to define the neuromodulation parameters (Pars 0207-208). This is considered a predictive model that determines a clinical parameter representing spinal cord injury and the delivery of the neuromodulation signal.
[Claim 10] This claim is the normal/inherent operation of the device of claim 1; see explanation above.
[Claims 11-12] Bloch disclose a real-time, continuous closed-loop feedback (at least Pars 0084-0088), this by definition, i.e. inherently, includes delivering an initial stimulation, adjusting the initial stimulation parameters based on the sensed data and delivering a second stimulation. Specifically, in real-time, continuous closed-loop feedback system, the delivery of stimulation and the sensing of a response to this stimulation, i.e. sensing of both neural and kinematic activity, is repeated indefinitely, over and over again.
[Claim 13] Bloch discloses generating spatiotemporal maps based on the sensor data and stimulation (at least Pars 0106, 0290 and 292)
[Claims 14 and 15] Bloch discloses detecting sensor data from both the rostral and caudal side of a spinal cord lesion/injury (Pars 0228 and 0283 discuss spinal cord injuries and Par 0240 discloses “To visualize a roots and motoneuron activation map, electromyographic signals were mapped onto the rostrocaudal distribution of the motorpools”).
[Claim 16] Zhu discloses that it is known to sense epidural field potentials (Pars 0048 and 0052) as spinal electrophysiological data that is then used to control/adjust the electrical stimulation parameters delivered to the spine. Therefore, it would have been obvious to modify Bloch to include efps, as taught by Zhu, as a known type of neural activity that is commonly sensed/measured in order to determine effective spinal electrical stimulation and adjust/control the stimulation parameters based on these measurements. It is emphasized that Bloch is specifically concerned with sensing neural signals/activity (at least Pars 0048 and 0127-128).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/ Primary Examiner, Art Unit 3796