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 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 1-39 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.
In claim 1, line 6, “neural stimuli” is vague as this term has also been used previously in line 2. If they are the same element, then “the neural stimuli” should be used in line 6. If they are different elements, then a modifier such as “additional neural stimuli” should be used in line 6. In lines 5-6 and 9, “via one or more…electrodes” is vague as it is unclear if the stimulus and sense electrodes are being positively claimed/recited or are meant as functional/intended use recitations. If they are meant to be positively claimed, it is suggested to first state the system has these electrodes. If they are meant as intended use, it is suggested to use “to provide the neural stimuli through one or more stimulus electrodes to neural tissue of a patient”. In line 12, “each neural stimulus” is vague as it is unclear if this is referencing the stimuli from line 2, line 6, or if this is a new stimulus. If it is the same stimulus, then “to provide each neural stimulus of the neural stimuli” should be used. In line 13, “a stimulus intensity parameter” is inferentially included and vague and it is unclear if it is meant to be positively recited/claimed or is meant as an intended/functional use recitation. If it is meant to be positively recited, then an element should be set forth to provide it. In lines 15-16, “a plurality of neural stimuli” is vague as it is unclear if this is referencing the stimuli of lines 2, 6, or 12. In addition, stimuli is already a “plurality”. In line 16, “stimulus intensity parameters values” is vague and it is unclear if this is referencing the parameter of line 13 or is a new parameter (or a plurality of new parameters). In line 18, “a captures signal window” is vague as this term is also used in line 9 and it is unclear if they are the same element or not. In line 18, “each neural stimulus” is vague as it is unclear if this is the same as any other stimulus previously recited. In line 19, “each captured signal window” is vague as it is unclear if this is the same element as any other window previously recited.
Similarly, claim 36 has these problems.
In claim 3, “a linear prediction model” is vague and inferentially included. To positively recite the model, it is suggested to first state the processor further comprises the model before it is used.
In claim 4, “the lowest stimulus intensity parameter” lacks antecedent basis. In line 3, “evoked neural responses” is vague as this term was used previously.
In claim 5, “an” evoked neural response is present in “a” captured signal window is vague since these terms have been used previously.
Similarly, claims 6, 7, 24-26, and 32 have this problem.
In claim 8, “a subthreshold model” is vague and inferentially included. It is suggested to first state the processor has the model before it is used. In line 2, “stimulus intensity…pairs” is vague as this term has been used previously.
Similarly, claim 9 has these problems.
In claim 10, “neural stimuli” is vague as this term has been used previously.
In claim 13, “an” evoked neural response in “each” captured signal window is vague as these terms have been used previously. In line 3, “using a …detector” is vague and inferentially including the detector. It is suggested to first state the system has the detector.
In claim 14, “one or more parameters” is vague as this term has been used previously.
In claim 16, “upon detecting an adverse side effect” is vague and makes the claim incomplete as no element has been set forth to detect an adverse side effect.
In claim 20, line 3, “a plurality of neural stimuli” is vague since neural stimuli is used in line 1 and it is unclear if they are the same. In addition, it is unclear if “a plurality” is adding anything to the “stimuli” since it is already plural. In line 5, “each delivered neural stimulus” is vague as the stimuli have been previously recited.
Similarly, claim 38 has these problems.
In claim 23, “the lowest stimulus intensity parameter” lacks antecedent basis.
In claims 27-28, “stimulus intensity…pairs” is vague as this term has been used previously.
In claim 29, “neural stimuli” is vague as this term has been used previously.
In claim 33, “one or more parameters” is vague as this term has been used previously.
In claims 37 and 39, “an” evoked neural response is present in “a” captured signal window…”a” neural stimulus is vague since these terms have been used previously.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-21, and 23-39 are rejected under 35 U.S.C. 102a2 as being anticipated by Litvak et al (2024/0293676). Litvak discloses the claimed limitations as follows:
--a neuromodulation device for delivering neural stimulation (e.g. figures 1-3, paras. 43-57, etc.)
--a stimulus source to deliver stimuli through electrodes (e.g. figure 2, elements 202, 230A/B, etc.)
--measurement circuitry to sense neural signals from sense electrodes (e.g. figure 2, elements 206, 230A/B, para. 76, etc.) in signal windows (e.g. paras. 65, 73, 113, etc.)
--control unit to control the stimulation (e.g. figure 2, element 210, para. 78, one or more of controller, etc.)
--processor configured to (e.g. figure 2, element 210, para. 78, one or more of microprocessor, etc.).
--provide sequential stimuli in a ramp of increasing stimulus intensity to a perceptual marker (e.g. paras. 41, 68, 133-134, etc.)
--receive a captured signal window (e.g. paras. 65, 73, 113, etc.)
--detect an evoked response in the signal window (e.g. paras. 65, 73, 113, etc.)
--repeat the instructing, detecting, and incrementing (e.g. paras. 41, 68, 133-134, etc.)
--determine the perceptual marker (e.g. paras. 41, 68, 133-134, etc.)
For claim(s): 2, 21 determine provisional neural response threshold and perceptual marker (e.g. paras. 65, 68, 123, etc.); 4, 23, lowest intensity at which detecting detects evoked neural responses (e.g. paras. 68, 134-135, inflection point when neural response is first detected, etc.); 5, 24, detect response by detecting a statistically unusual difference from noise (e.g. paras. 73-75, etc.); 6, 25, removing artifact (e.g. paras. 112-113, etc.); 7, 26, 37, 39, intensity pairs (e.g. paras. 67, 37, 41, etc.); 8, 27, sub-threshold model (e.g. figure 5A, paras. 68, 124-126, etc.); 9-10, 28-29, supra-threshold model (e.g. figure 5A, para. 68, etc.); 11, 30, point of intersection for determining the neural response (e.g. figure 5A, inflection point, paras. 41, 68, etc.); 12, 31, determine a key parameter by measuring the sensitivity (e.g. paras. 68, 124-126, width of current amplitude of the curvilinear region, radius of curvature, etc.); 13-15, 32-34, measure intensity of evoked response in window (e.g. paras. 113-119, etc.) and updating parameters of the detector to re-measure intensities during using the updated parameters (e.g. paras. 102-110, etc.); 16,35, halt the ramp of stimuli (e.g. stopping of stimuli, para. 68, etc.); 17-19, the processor is part of the neuromodulation device, with external computing device in communication with the neuromodulation device, where the external device can also be the processor (e.g. para. 62, etc.).
Claims 1-39 are rejected under 35 U.S.C. 102a1 as being anticipated by Esteller et al (2019/0209844). Esteller discloses the claimed limitations as follows:
--a neural stimulation system (Abstract, Figs. IA, lB, 2, 3, 8 and 10-12) comprising:
--a neuromodulation device for delivering neural stimuli (Figs. IA, lB, 3, 7A and 8), the neuromodulation device comprising: a plurality of implantable electrodes (16) including one or more stimulus electrodes (para [0004, 5, 9, 48, 54]) and one or more sense electrodes ("E8") (para [0050, 55, 59] see sense electrodes connected to sense amp(s)(l 10), see Figs. 7A, 7B and para [0051]);
--a stimulus source ((IPG) (10)/(100)/ETS (170)) configured to provide neural stimuli to be delivered via the one or more stimulus electrodes to neural tissue of a patient in order to evoke neural responses (ECAP) in the neural tissue (para [0004-10, 40, 51-53, 60-62, 76-78], Fig. 8, 11, 12);
--measurement circuitry configured to capture signal windows (depicted in Fig. 13, see element (1308) and the window showing the detected Nl-Pl-P2 ECAPs signal sensed at one or more sense electrodes subsequent to respective neural stimuli (see Fig. 11 -
Sensing Operations Modes (SOMs) (1100); Fig. 12, element (1108) "MARK ECAP"; see also para [0079-85]); and
--a control unit (control circuitry (102) with microcontroller Fig. 8 with ECAP algo (124a)) configured to control the stimulus source (controlling the stimulus source is via elements (118), (104)-(108)) to provide each neural stimulus according to a stimulus intensity parameter (Fig.12, element (1110); and
--a processor (Figs. 2 and 10, see an external controller (50)/(90)) configured to:
--instruct the control unit to control the stimulus source to sequentially provide a plurality of neural stimuli according to a ramp of stimulus intensity parameter values (para [0051], "sensed ECAP" is used "as a biomarker for directing therapy ... ", see para [0079-97], Fig. 12] up to a perceptual marker (para [008490], see esp. para[0085 , 90], discussing "effective biomarkers" that are part of the identified metrics M as perception Threshold (PT) corresponding to min stim perceptible by the patient, physiological Threshold (PhT) that is the min stim resulting in extracted detectable evoked neural response;
--receive a captured signal window (1309a) -(1309c), para [0083], Fig. 13 - see the windows with captured ECAP responses (1305), subsequent to each neural stimulus - Fig. 9, shows time intervals/window namely: "Delay"/stimulation" in the "ECAP features,"
--detect whether an evoked neural response ("ECAP response" (1305) para[0083]) is present in each captured signal window (Fig.13 in view of Figs. 9 -12, esp. Fig. 9 and detection of "ECAP features" para[0065], note " ... there are ECAP responses not visible by naked eye, on the order of 10% or 14% of the noise floor of the spinal cord sensed signals ...", para [0081-0083] in view of para[0084-97]); and
--determine the perceptual marker based on the detecting ((PT)/(PhT)/motor threshold, Metrics (M), para [0084-92] see the ECAP algorithm (124a) and ECAP features in para [0066-76, 80-87], see para [0087] for relationship between PT and PhT and the constant "C").
Independent claims 20, 35, 37 and 38, similar reasoning applies, mutatis mutandis, to the disclosures in Esteller regarding independent claims 36 and 38 that define claims with same/similar scope - see Esteller disclosures in Abstract, para[ 0004-10, 48, 51-55, 59-62, 76-97] Figs. IA, lB, 2, 3, 7A, 7B, 8-13, elements IPG) (10)/(100)/ETS (170), Sensing Operations Modes (SOMs) (1100), (1108) "MARK ECAP", (102), ECAP algorithm (124a), signal window (1309a)-(1309c), elements (ll8), (104)-(108), Metrics (M), ECAP responses (1305).
For the dependent claims: claims 2, 21 - see para [0084], esp. 4th sentence and para 0087]; claim 3, 22 - formula in para [0087], see para [0065]; claims 4, 23 - para [0080-90]; claims 5, 6, 24, 25 - para [ 0065, 86, 89], Esteller's claim 15; claims 7-9, 26-28 - para [0066-76], Fig. 9, para [0089-94]; para [0080, 83] Esteller's claim l; para [0089-94], see "metric(s) M", para [0090] formula and text related to coefficient K - para [0091-94]; claims 10-19 and 29-35, 37, 39 - para [0089-94], para [0065], para [0066-76], Fig. 9; Figs. 7B-9, see "burst" anon E3 and the ECAP detected by E8; Figs. 9 and 12; Fig. 8, see ECAP algo 124a - para [0052]; Fig. 2, external controller (50) or external trial stimulator (170); Fig. 9.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Litvak et al. Litvak discloses the claimed invention using a prediction model (curvilinear) to determine the perceptual marker from the provisional neural response threshold, but does not disclose the prediction model being a linear prediction model. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Litvak, with using a linear prediction model to determine the perceptual maker from the provisional neural response threshold, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of a simpler model that is easier to implement using less data and less computational power, easier to interpret, and is resistance to overfitting.
Conclusion
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/George R Evanisko/Primary Examiner, Art Unit 3792 6/10/26
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