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 .
Claim Objections
Claims 2 & 14 are objected to because of the following informalities: The claim language “…to determine a stimulus threshold at at least two different pulse widths…” should be changed to “…to determine a stimulus threshold at least two different pulse widths...” Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,894,158. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following rationale:
Claim 1: US Appl. 18/583,405
Claim 1: US Pat. 10,894,158
A medical device…the device comprising one or more processors configured to:
An implantable medical device…the device comprising…a processor configured to:
apply a plurality of stimuli…to a spinal nerve, each stimulus having defined stimulus parameters;
process…a plurality of neural measurements of respective compound action potentials evoked by the respective stimuli;
apply from the at least one stimulus electrode to a nerve at least one stimulus having defined stimulus parameters;
process the plurality of neural measurements of at least one compound action potential evoked by the at least one stimulus;
process the plurality of neural measurements and the respective stimulus parameters in order to estimate a rheobase of a single fibre-size of the spinal nerve.
process the plurality of neural measurements in order to estimate an originating state of stimulation…at least one observable characteristic defined by a single fibre size.
As depicted above, the limitations of claim 1 of the present invention differ from claim 1 of US Pat ‘158 in that the device is directed towards the neural measurement of the spinal nerve, which represents an obvious species of the generic medical device of US Pat. ‘158, i.e. the generic medial device is directed to the neural measurement of a nerve. No additional structure or functional limitations between the two claim sets that would render the claims patentably distinct from one another.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-23, specifically independent claims 1, 13 & 23, are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a device, which is a product. Therefore, the claim falls within a statutory category of invention.
Claim 13 is directed to a method. Therefore, the claim falls within a statutory category of invention.
Claim 23 is directed to a computer readable medium executed by one or more processors. Therefore, the claim falls within a statutory category of invention.
Step 2A, prong 1:
Claim 1 recites a medical device comprising one or more processors configured to (method steps of):
“…apply a plurality of stimuli from at least one stimulus electrode…”
“…process from at least one sense electrode a plurality of neural measurements…”
“…process the plurality of neural measurements and the respective stimulus parameters…to estimate a rheobase of a single fibre-size of the spinal nerve…”
Claim 13 recites the method steps of:
“…applying a plurality of stimuli from at least one stimulus electrode…”
“…obtaining a plurality of neural measurements of respective compound action potentials…”
“…processing the plurality of neural measurements and the respective stimulus parameters…to estimate a rheobase of a single fibre-size of the spinal nerve…”
Claim 23 recites a non-transitory computer readable medium comprising instructions causing performance of the following (method steps of):
“…applying a plurality of stimuli from at least one stimulus electrode…”
“…obtaining a plurality of neural measurements of respective compound action potentials…”
“…processing the plurality of neural measurements and the respective stimulus parameters…to estimate a rheobase of a single fibre-size of the spinal nerve…”
Under the broadest reasonable interpretation, claims 1, 13 & 23, recites a series of steps practically performable in the human mind. A human could obtain a plurality of neural measurements and process the plurality of neural measurements and stimulus parameters to estimate a rheobase of single fibre-size of the spinal nerve. Therefore, it would be practical to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed plurality of neural measurements.
Claims 1, 13 & 23 recite method steps comprising mental processes (i.e. obtaining, processing) and mathematical concepts (i.e. processing to estimate). Thus, since claims 1 , 13 & 23 recite limitations that fall within the mental processes and mathematical concepts of abstract ideas, the claims are directed to an abstract idea.
Step 2A, prong 2:
Claim 1 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application:
“…one or more processors configured to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…at least one stimulus electrode…” which is directed to data gathering, see MPEP 2106.05(g).
“…at least one sense electrode…” which is directed to data gathering, see MPEP 2106.05(g).
Claim 13 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application:
“…at least one stimulus electrode…” which is directed to data gathering, see MPEP 2106.05(g).
Claim 23 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application: “…one or more processors configured to…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
“…at least one stimulus electrode…” which is directed to data gathering, see MPEP 2106.05(g).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1, 13 & 23 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The examiner also notes that the above claims are silent in providing any treatment to a patient.
The examiner also notes that the limitations of the dependent claims, claims 2-12 & 14-22, define determining a stimulus threshold, estimating the rheobase, applying a single fibre model to the estimated rheobase, which further limits claim limitations already indicated above as being directed to an abstract idea. Therefore, the above dependent claims are directed to patient-ineligible subject matter.
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)(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.
Claim(s) 1-4, 6-16 & 18-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bornzin et al. (US 2015/0360031)
Bornzin et al. discloses;
1.
A medical device, the device comprising: one or more processors configured to: apply a plurality of stimuli from at least one stimulus electrode to a spinal nerve, each stimulus having defined stimulus parameters; process from at least one sense electrode a plurality of neural measurements of respective compound action potentials evoked by the respective stimuli;
E.G. via the disclosed ECAP-feedback process of automatically adjusting SCS therapy between a stimulation electrode-to-spinal cord distance and a sensing electrode-to-spinal cord distance via the stimulation system 100 {[0032]-[0033], [0049] & (Figs. 1 & 3)}.
and process the plurality of neural measurements and the respective stimulus parameters in order to estimate a rheobase of a single fibre-size of the spinal nerve.
E.G. via the disclosed process to control said SCS therapy including step 302 which measures one or more ECAP responses along distinct types of nerve fibers as a voltage potential which is ultimately used to adjust said therapy based on the calculated rheobase voltage at step 318 {[0049]-[0055], [0078] & (Fig 3)}.
Note: Under the broadest reasonable interpretation consistent with the specification the recitation of “to estimate a rheobase of single fibre-size of the spinal nerve,” does not require direct measurement of an isolated individual nerve fiber, but reasonably encompasses estimating a fiber size characteristic based on signals obtained from one or more nerve fibers or population thereof.
Bornzin et al. discloses measuring ECAP responses from nerve fibers and adjusting therapy based on a calculated rheobase voltage. ECAP measurements inherently reflect electrophysiological properties of the activated nerve fibers, including characteristics correlated with fiber size. Therefore, Bornzin et al. reasonably reds on the claimed estimation of a rheobase of a single fiber-sized of the spinal nerve, as is instantly claimed.
2.
The device of claim 1, wherein the one or more processors are configured to determine a stimulus threshold at at least two different pulse widths, and wherein the rheobase is calculated from the stimulus thresholds.
E.G. via the disclosed rheobase voltage based on the stimulation pulse width ([0077]-[0080]).
3.
The device of claim 2, wherein four stimuli of the plurality of stimuli are applied to determine the stimulus thresholds.
E.G. ([0077]-[0078]).
4.
The device of claim 3, wherein at least two stimuli of the four stimuli are controllable to have a therapeutic level of charge.
E.G. via the disclosed IPG 150 which utilizes a stimulation program using consecutively generated pulses according to a ‘multi-stimset program’ having various sets of parameters in order to control and provide SCS therapy ([0040] & [0048]).
6.
The device of claim 1, wherein the one or more processors are configured to apply a single fibre model to the estimated rheobase and the stimulus parameters to produce a measure of nerve-to-electrode distance comprising a distance between the at least one sense electrode and the spinal nerve.
E.G. ([0077]-[0079]).
7.
The device of claim 6, wherein the single fibre model comprises a fitted relationship between the rheobase and the nerve-to-electrode distance.
E.G. ([0078]-[0079]).
8.
The device of claim 6, wherein the measure of nerve-to-electrode distance is produced by determining a fibre-size of the single fibre-size of the spinal nerve associated with the estimated rheobase, and applying the estimated rheobase and the determined fibre-size to the single fibre model.
E.G. via the disclosed method of determining a baseline stimulation or therapeutic level base on excitation energy and/or ECAP response experienced at target tissue, i.e. the region of the nerve fiber proximate to the stimulating electrode, wherein the energy is the current density at said nerve fibers which is dependent on the distance between the nerve fibers and the excitation electrodes ([0053]-[0054] & [0078]-[0079]).
9.
The device of claim 8, wherein the fibre-size is determined by calculating a conduction velocity associated with the plurality of neural measurements of compound action potentials evoked by the stimuli.
E.G. ([0053]-[0054] & [0078]-[0079]).
10.
The device of claim 1, wherein the one or more processors are further configured to treat a neurological condition by administering or modifying a therapy in a manner responsive to the estimated rheobase, or to a change in the estimated rheobase over time.
E.G. [0049].
11.
The device of claim 1, wherein the device comprises an implantable device that is configured to function intra-operatively, as part of a surgical procedure.
E.G. {[0034]-[0035] & (Fig. 1)}.
12.
The device of claim 1, wherein the device comprises an implantable device configured to function as part of a postoperative fitting procedure of the device.
E.G. {[0034]-[0035] & (Fig. 1)}.
13.
A method of estimating a rheobase of a spinal nerve, the method comprising: applying a plurality of stimuli from a stimulus electrode to the spinal nerve, each stimulus having defined stimulus parameters; obtaining a plurality of neural measurements of respective compound action potentials evoked by the respective stimuli;
E.G. via the disclosed ECAP-feedback process of automatically adjusting SCS therapy between a stimulation electrode-to-spinal cord distance and a sensing electrode-to-spinal cord distance via the stimulation system 100 {[0032]-[0033], [0049] & (Figs. 1 & 3)}.
and processing the plurality of neural measurements and the respective stimulus parameters in order to estimate a rheobase of a single fibre-size of the spinal nerve.
E.G. via the disclosed process to control said SCS therapy including step 302 which measures one or more ECAP responses along distinct types of nerve fibers as a voltage potential which is ultimately used to adjust said therapy based on the calculated rheobase voltage at step 318 {[0049]-[0055], [0078] & (Fig 3)}.
14.
The method of claim 13, wherein the method comprises determining stimulus threshold at at least two different pulse widths, and calculating the rheobase from the stimulus thresholds.
E.G. via the disclosed rheobase voltage based on the stimulation pulse width ([0077]-[0080]).
15.
The method of claim 14, wherein the method comprises applying four stimuli of the plurality of stimuli to determine the stimulus thresholds.
E.G. ([0077]-[0078]).
16.
The method of claim 15, wherein the method comprises controlling at least two stimuli of the four stimuli to have a therapeutic level of charge.
E.G. via the disclosed IPG 150 which utilizes a stimulation program using consecutively generated pulses according to a ‘multi-stimset program’ having various sets of parameters in order to control and provide SCS therapy ([0040] & [0048]).
18.
The method of claim 13, wherein the method comprises applying a single fibre model to the estimated rheobase and the stimulus parameters to produce a measure of nerve-to-electrode distance comprising a distance between the electrode and the spinal nerve.
E.G. ([0077]-[0079]).
19.
The method of claim 18, wherein the single fibre model comprises a fitted relationship between the rheobase and the nerve-to-electrode distance.
E.G. ([0077]-[0079]).
20.
The method of claim 18, wherein the method comprises producing the measure of nerve-to-electrode distance by determining a fibre-size of the single fibre-size of the spinal nerve associated with the estimated rheobase, and applying the estimated rheobase and the determined fibre-size to the single fibre model.
E.G. via the disclosed method of determining a baseline stimulation or therapeutic level base on excitation energy and/or ECAP response experienced at target tissue, i.e. the region of the nerve fiber proximate to the stimulating electrode, wherein the energy is the current density at said nerve fibers which is dependent on the distance between the nerve fibers and the excitation electrodes ([0053]-[0054] & [0078]-[0079]).
21.
The method of claim 20, wherein the method comprises determining the fibre-size by calculating a conduction velocity associated with the plurality of neural measurements of compound action potentials evoked by the stimuli.
E.G. ([0053]-[0054] & [0078]-[0079]).
22.
The method of claim 13, wherein the method further comprises treating a neurological condition by administering or modifying a therapy in a manner responsive to the estimated rheobase, or to a change in the estimated rheobase over time.
E.G. [0049].
23.
A non-transitory computer readable medium for estimating a rheobase of spinal nerve, comprising instructions which, when executed by one or more processors, causesperformance of the following: applying a plurality of stimuli from a stimulus electrode to the spinal nerve, each stimulus having defined stimulus parameters; obtaining a plurality of neural measurements of respective compound action potentials evoked by the respective stimuli;
E.G. via the disclosed ECAP-feedback process of automatically adjusting SCS therapy, via the disclosed computer-readable medium, between a stimulation electrode-to-spinal cord distance and a sensing electrode-to-spinal cord distance via the stimulation system 100 {[0011], [0032]-[0033], [0049] & (Figs. 1 & 3)}.
and processing the plurality of neural measurements and the respective stimulus parameters in order to estimate a rheobase of a single fibre-size of the spinal nerve.
E.G. via the disclosed process to control said SCS therapy including step 302 which measures one or more ECAP responses along distinct types of nerve fibers as a voltage potential which is ultimately used to adjust said therapy based on the calculated rheobase voltage at step 318 {[0049]-[0055], [0078] & (Fig 3)}.
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.
Claim(s) 5 & 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bornzin et al. (US 2015/0360031) in view of Ward et al. (WO 2013063111).
Bornzin et al. discloses a process to control said SCS therapy including step 302 which measures one or more ECAP responses along distinct types of nerve fibers as a voltage potential which is ultimately used to adjust said therapy based on the calculated rheobase voltage except wherein said rheobase voltage is a slope of a charge duration curve that plots pulse width of the plurality of stimuli against charge delivered by the plurality of stimuli.
Ward et al. teaches that it is known to use a method and apparatus for closed-loop control of nerve activation based on an automated strength-duration curve-mapping algorithm that yields a compound action potential response relative to activate fibers, wherein said algorithm is based on a rheobase current, i.e. a slope of the line, showing data reconstructed from a charge-duration line and relationship between rheobase current and the level of nerve fiber activation ([0034] & [0040]-[0042]).
Therefore, it would have been obvious to one having ordinary skill in the art to have modified the process as disclosed by Bornzin et al. with the curve-mapping algorithm that yields a compound action potential response relative to activate fibers as taught by Ward et al. since such a modification would provide the predictable results pertaining to utilizing a rheobase parameter based on the slope of a line in order to effectively showing data reconstructed from a charge-duration line and relationship between rheobase current and the level of nerve fiber activation (Ward, [0034] & [0040]-[0042]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm 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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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796