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 .
Election/Restrictions
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 13 October 2025 of Invention I, directed to Claims 1-14.
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). For example, Paragraphs [0005]-[0009] and [0028] of the instant Specification describe Figure 1 as “Prior Art”.
Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The Claims 1-7 recite a spinal cord stimulation system (machine) and Claims 8-14 a method for spinal cord stimulation (process), which are within the four statutory categories. Claims 1-14 are directed to an abstract idea as described below.
Step 2A, Prong One:
Claim 1 recites:
storing a lower reflectometer current boundary and an upper stimulation current boundary associated with a patient prone position;
storing an upper reflectometer current boundary and a lower stimulation current boundary associated with a patient supine position;
deriving a relationship between the lower reflectometer current boundary, the upper reflectometer current boundary, the lower stimulation current boundary and the upper stimulation current boundary;
adjusting a stimulation current value based on the relationship and a reflectometer current signal; and
sending a stimulation signal to the stimulation electrode based on the stimulation current value
Independent Claim 8 recites similar limitations.
However, these limitations as drafted, under their broadest reasonable interpretation, are merely a mental process, because these are steps are akin to having a doctor or other human actor mentally evaluating and calculating sensed signals. The action of “sending a stimulation signal to the stimulation electrode based on the stimulation current value” fails to provide any specific treatment or action to a patient explicitly, and is merely providing communication signals, which may be performed mentally as evaluating/communicating data. The claims do not explicitly recite providing stimulation therapy to the patient or tissue. Therefore, these limitations are also merely processes to evaluate a sensed signal which may be performed mentally by a human actor, such as by visually comparing data/charts/plots, or by simply using a pen and paper to calculate and evaluate the data. Therefore, these steps may be performed mentally by a human actor.
Additionally, the limitations recited above recite performing mathematical calculations (processing and mathematically analyzing the data) and forming mathematical relationships (“deriving a relationship between the lower reflectometer current boundary, the upper reflectometer current boundary, the lower stimulation current boundary and the upper stimulation current boundary”), and as such, the claims recite limitations which may also fall within the 'mathematical concepts' grouping of abstract ideas. See MPEP 2106.4(a)(2). ‘‘[A] scientific truth, or the mathematical expression of it, is not patentable invention[.]’’ See, e.g., Benson, 409 U.S. at 65, 175 USPQ2d at 674; Flook, 437 U.S. at 589, 198 USPQ2d at 197; Mackay Radio & Telegraph Co. v. Radio Corp. of Am., 306 U.S. 86, 94, 40 USPQ 199, 202 (1939).
Claims 2-7 depend from Claim 1, and Claims 9-14 depend from Claim 8. These dependent claims only recite additional features of the sensed signals and additional evaluation of data steps, including setting/determining mathematical relationships in the data, which may also be performed by a human actor. For example, Claims 2 and 9 recite “wherein the relationship is linear”. Claims 3 and 10 recite, “clipping the reflectometer current signal”. Claims 4 and 11 recite, “monitoring a processor interrupt condition”. Claims 5-7 and 12-14 recite additional settings/instructions related to the evaluation of the sensed signals. However, these are merely additional data collection and evaluation activities performed by the controller/stored instructions.
If claim limitations, under their broadest reasonable interpretation covers the performance of the limitations within the human mind or by a human using a pen and paper, then it falls within “mental processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two:
The judicial exception is not integrated into a practical application.
Claims 1 and 8 only recites “a controller”, “a reflectometer”, “a stimulation electrode”, and “a memory” with “a set of instructions”. As described above, dependent Claims 2-7 and 9-14 only recite other limitations of evaluating the sensed signals and providing generic (“sending a signal”) output, which may be done mentally by a human actor.
These elements merely use generic computer component to evaluate a sensed signal. It is noted that no direct therapy initiation or delivery is explicitly claimed, only “sending a stimulation signal to the stimulation electrode based on the stimulation current value” (emphasis added). The step of “sending a stimulation signal to the stimulation electrode” fails to provide any specific treatment or action explicitly to a patient/tissue, and is merely providing a communication signal, which could also be merely instructions from a human actor.
Furthermore, these additional elements are recited at a high-level of generality (i.e. most generic stimulation systems would be known to have these components), and they amount to no more than mere pre-solution activity of data gathering and evaluation with generic ‘signal’/data output. This pre-solution activity of data gathering using sensors is known in the field of stimulation technology, and not considered integration into a practical application.
For example, see the Pivonka et al. (US Publication No. 2018/0256906), Manbachi et al. (US Publication No. 2023/0372685), Wolf (US Publication No. 2012/0095525, cited in IDS), Lo et al. (Niche Biomedical Inc.; WO 2021/062345 A1, cited in IDS), and Aydemir et al. (Boston Scientific Neuromodulation Corporation, WO 2020/251899 A1, cited in IDS) references described below which describes known stimulation systems with controllers, memories, reflectometers, and/or electrodes. In addition, Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000) which describes known medical signal sensing and processing (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis.
Therefore, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Thus the claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to the integration of the judicial exception into a practical application (Step 2A - Prong Two), the additional elements of using a controller and generic electrodes and signal processing to perform the sensing and evaluation steps and generic output “actions” amounts to no more than mere instruction to apply the exception using known and generic elements. The only structural elements recited in the claims are “a controller”, “a reflectometer”, “a stimulation electrode”, and “a memory” with “a set of instructions”. These additional elements are recited at a high-level of generality (i.e. most generic stimulation/medical systems would be known to have these components), and only provide conventional, well-known sensing and computing functions that do not add meaningful limits to practicing the abstract idea. The signal sensing/storing and derivation steps of Claims 1-14, amount to no more than mere pre-solution activity of data gathering, and this pre-solution activity of data gathering using electrodes and sensors is well-understood, routine, and conventional in the field of stimulation and medical technology.
For example, see the Pivonka et al. (US Publication No. 2018/0256906), Manbachi et al. (US Publication No. 2023/0372685), Wolf (US Publication No. 2012/0095525, cited in IDS), Lo et al. (Niche Biomedical Inc.; WO 2021/062345 A1, cited in IDS), and Aydemir et al. (Boston Scientific Neuromodulation Corporation, WO 2020/251899 A1, cited in IDS) references described below which describes known stimulation systems with controllers, memories, reflectometers, and/or electrodes, as well as Neuman (Neuman, M. R. “Biopotential Electrodes.” The Biomedical Engineering Handbook: Second Ed. Joseph D. Bronzino; Boca Raton: CRC Press LLC, 2000) which describes known medical signal sensing and processing (Table 48.1, Sections 48.1 and 48.4) for further evaluation and diagnosis.
Furthermore, the evaluation steps of Claims 1-14 do not recite any additional structural elements or limitations on practical applications (e.g. specific/explicit treatment). The limitation in Claims 1 and 8 of, “sending a stimulation signal to the stimulation electrode based on the stimulation current value” fails to provide any specific treatment or action to a patient explicitly, and is merely providing communication signals, which may be performed mentally as evaluating/communicating data. Therefore, this is considered generic output. The claims do not explicitly recite providing stimulation therapy to the patient or tissue.
Thus, the claims are not patent eligible.
Therefore, Claims 1-14 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more. It is recommended by the Examiner that additional limitations be added to independent Claims 1 and 8 to explicitly recite that the stimulation signal with the adjusted stimulation current value is directly applied to a patient/tissue.
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 1-14 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.
Regarding Claims 1 and 8, the claims recite “storing a lower reflectometer current boundary and an upper stimulation current boundary associated with a patient prone position” and “storing an upper reflectometer current boundary and a lower stimulation current boundary associated with a patient supine position”. However, it is unclear as to what is intended by the limitations “associated with a patient prone position” and “associated with a patient supine position”, since it is unclear as to whether these are sensed positions of a patient, and/or inputs in the instructions, and/or defining a correlative relationship. Particularly, it is unclear as to whether “a patient” is referring to the current position of the human/animal in which the stimulation system is implanted, or a separate meaning. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting these limitations as “storing a lower reflectometer current boundary and an upper stimulation current boundary corresponding to a patient prone position, wherein the patient prone position is any posture of the patient in which the stimulation electrode is implanted wherein the spinal cord is in its most ventral position and further away from the reflectometer” and “storing an upper reflectometer current boundary and a lower stimulation current boundary corresponding to a patient supine position, wherein the patient supine position is any posture of the patient in which the stimulation electrode is implanted wherein the spinal cord is in its most dorsal position and nearest the reflectometer”. It is suggested by the Examiner that similar amendments be made to the independent Claims 1 and 8 in order to clarify these limitations and the claimed invention (see Paragraph 0019 and Abstract of the instant Specification). Claims 2-7 and 9-14 are rejected for depending on Claims 1 and 8. Appropriate correction or clarification is required.
Regarding Claims 1 and 8, the claims recite “deriving a relationship”. However, the term ‘relationship’ is unclear as to whether this refers to a mathematical relationship and/or another type of algorithm. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting these limitations as “deriving a mathematical relationship”. Claims 2-7 and 9-14 are rejected for depending on Claims 1 and 8. Appropriate correction or clarification is required.
Regarding Claims 7 and 14, the claims recite “just a noticeable difference”. However, “just a noticeable difference” is relative term/phrase which renders the claim indefinite. The term/phrase “just a noticeable difference” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, it is unclear as to what “noticeable” is referring – a parameter felt by the patient, a stimulation level, or another meaning. Therefore, these limitations are indefinite. For purposes of examination, the Examiner is interpreting this limitation as “a minimal difference”. Appropriate correction or clarification is required.
Prior Art
The prior art made of record and not relied upon is considered pertinent to the Applicant's disclosure:
Pivonka et al. (US Publication No. 2018/0256906) discloses a spinal cord stimulation system (Paragraph 0026, 0033, see stimulators of 260, 265, Figs. 3A-3B) comprising a reflectometer/directional coupler (Paragraph 0493), stimulation electrodes (Paragraph 0132, 0465; see elements 260, Fig. 3A-3B), body position sensors (Paragraph 0101, 0124, 0357, 0500, 0501), and adjusting a stimulation current value and sending a stimulation signal to the stimulation electrode (Paragraph 0095, 0345, 0465, 0491). However, Pivonka et al. does not explicitly teach storing a lower reflectometer current boundary and.an upper stimulation current boundary associated with a patient prone position; storing an upper reflectometer current boundary and a lower stimulation current boundary associated with a patient supine position; deriving a relationship between the lower reflectometer current boundary, the upper reflectometer current boundary, the lower stimulation current boundary and the upper stimulation current boundary; adjusting a stimulation current value based on the relationship and a reflectometer current signal; and sending a stimulation signal to the stimulation electrode based on the stimulation current value as required by independent Claims 1 and 8.
Manbachi et al. (US Publication No. 2023/0372685) discloses a spinal cord stimulation system (Paragraph 0037, 0062, 0069, see stimulator system 500, Fig. 5) comprising a reflectometer/directional coupler (Paragraph 0009, 0099, Claim 11), stimulation electrodes (Paragraph 0062, 0069, 0072), body position sensors (e.g. accelerometers, Paragraph 0045, 0072, 0060), and adjusting a stimulation current value and sending a stimulation signal to the stimulation electrode (Paragraph 0069, 0071-0072). However, Manbachi et al. does not explicitly teach storing a lower reflectometer current boundary and.an upper stimulation current boundary associated with a patient prone position; storing an upper reflectometer current boundary and a lower stimulation current boundary associated with a patient supine position; deriving a relationship between the lower reflectometer current boundary, the upper reflectometer current boundary, the lower stimulation current boundary and the upper stimulation current boundary; adjusting a stimulation current value based on the relationship and a reflectometer current signal; and sending a stimulation signal to the stimulation electrode based on the stimulation current value as required by independent Claims 1 and 8.
Wolf (US Publication No. 2012/0095525, cited in IDS) discloses a spinal cord stimulation system (A spinal cord stimulation apparatus and method for automatic — adjustments of SCS using near-infrared (NIR) reflectometry, Abstract), comprising a reflectometer (A spinal cord stimulation apparatus and method for automatic adjustments of SCS using near-infrared (NIR) reflectometry, Abstract), a stimulation electrode (A positionally sensitive system for spinal cord stimulation including an electrode assembly with integrated optical components for sensing spinal cord position relative to a stimulating electrode array and an SCS controller for controlling electrode stimulation parameters is provided, Abstract), a patient prone position (RF transceiver 1002 receives a signal indicative of a request to move the patient to a prone position and passes it to processor 1000. At step 352, the patient is positioned in a prone position, Paragraph 0131), a patient supine position (RF transceiver 1002 receives a signal indicative of a request to move the patient to a supine position and passes it to processor 1000. At step 372, the patient is positioned in a supine position, Paragraph 0133), adjusting a stimulation current value and sending a stimulation signal to the stimulation electrode (The detected current signals are used to vary the stimulation current delivered to the electrodes based on a calibration. table. The varying current adjusts the induced electric field of each electrode to compensate for changes in the position of the spinal cord to achieve a constant electric field, Paragraph 0015). However, Wolf does not explicitly teach storing a lower reflectometer current boundary and.an upper stimulation current boundary associated with a patient prone position; storing an upper reflectometer current boundary and a lower stimulation current boundary associated with a patient supine position; deriving a relationship between the lower reflectometer current boundary, the upper reflectometer current boundary, the lower stimulation current boundary and the upper stimulation current boundary; adjusting a stimulation current value based on the relationship and a reflectometer current signal; and sending a stimulation signal to the stimulation electrode based on the stimulation current value as required by independent Claims 1 and 8.
Lo et al. (Niche Biomedical Inc.; WO 2021/062345 A1, cited in IDS) teaches a spinal cord stimulation system (integrating physiological feedforward and feedback signals into a control loop for spinal cord stimulation, Paragraph 0105), a stimulation electrode (A transcutaneous electrical stimulation system is provided, comprising a plurality of electrodes configured to be in contact with a skin surface of a patient, Paragraph 0034; see Fig. 14 with electrode arrays 1402, 1404), a patient prone position and a patient supine position (spinal cord neural circuits significantly shift due to variations in both electrode to spinal cord distance caused by skin movement and thickness of cerebral spinal fluid [e.g., 50-100% as human body moves from supine to prone], Paragraph 0126-0127, 0129; variation in spine curvature that would normally occur if the user were not restricted to a single position, such as supine, prone, sitting or standing, Paragraph 0018), adjusting a stimulation current value (the current intensity, polarity, arid firing timing at each electrode can be independently adjusted to steer the stimulation current to the target [e.g., spinal column and spinal ganglion], Paragraph 0110). However, Lo et al. does not explicitly teach storing a lower reflectometer current boundary and an upper stimulation current boundary associated with a patient prone position; storing an upper reflectometer current boundary and a lower stimulation current boundary associated with a patient supine position; deriving a relationship between the lower reflectometer current boundary, the upper reflectometer current boundary, the lower stimulation current boundary and the upper stimulation current boundary; adjusting a stimulation current value based on the relationship and a reflectometer current signal; and sending a stimulation signal to the stimulation electrode based on the stimulation current value, as required by independent Claims 1 and 8.
Aydemir et al. (Boston Scientific Neuromodulation Corporation, WO 2020/251899 A1, cited in IDS) teaches a spinal cord stimulation system (Spinal Cord Stimulator (SCS) pulse generator systems, Paragraph 0034), a stimulation electrode (stimulator device comprising a plurality of electrodes configured to contact a patient's tissue, Paragraph 0016; see stimulators in Figs. 5A-B), a patient prone position and a patient supine position (provided stimulation in both prone and supine positions, Paragraph 0052, 0055, 0057), adjusting a stimulation current value (using the determined at least one neural response feature to adjust the stimulation, Paragraph 0017, 0058-0060), sending a stimulation signal to the stimulation electrode (sensing a signal over time at a sensing electrode comprising one of the electrodes different from the at least two electrodes that provide the stimulation, wherein the signal comprises a stimulation artifact formed by the electric field and the neural response; and processing the sensed signal to determine at least one feature of the stimulation artifact and to determine at least one feature of the neural response, Paragraph 0020, 0059, 0068). However, Aydemir et al. does not explicitly teach storing a lower reflectometer current boundary and an upper stimulation current boundary associated with a patient prone position; storing an upper reflectometer current boundary and a lower stimulation current boundary associated with a patient supine position; deriving a relationship between the lower reflectometer current boundary, the upper reflectometer current boundary, the lower stimulation current boundary and the upper stimulation current boundary; adjusting a stimulation current value based on the relationship and a reflectometer current signal; and sending a stimulation signal to the stimulation electrode based on the stimulation current value as required by independent Claims 1 and 8.
Conclusion
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796
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