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
Claim 6 is objected to because of the following informalities: line 7 recites, “less than or equal to than the maximum selectable value” and should instead state, “less than or equal to the maximum selectable value”. Appropriate correction is required.
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 5-6, 9, 15-16 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 5 recites the limitation "the presently selected value for the second electrical parameter" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the presently selected value for the second electrical parameter" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitations, “determining, an electrical characteristic of a stimulation system” (in line 2) and “an electrical stimulation program” (line 4). However claim 1, for which claim 9 directly depends, previously introduced “an electrical characteristic of a stimulation system” (line 5) and “an electrical stimulation program” (lines 2-3). Therefore it is unclear if claim 9 is referencing what was previously introduced in claim 1 or if it is requiring a separate and distinct electrical characteristic, a stimulation system, and an electrical stimulation program.
Claim 9 recites, “for which the maximum selectable value for the second electrical stimulation parameter is the greatest” (lines 4-6). The relative term “greatest” is not defined by the claim in a manner where the maximum selectable value would be compared against another value to evaluate if it is “the greatest”.
Claim 15 recites the limitation "the presently selected value for the second electrical parameter" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the presently selected value for the second electrical parameter" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 defines the headroom amount to be the difference between the maximum selectable value and the presently selected value, “wherein the presently selected value is less than or equal to the maximum selectable value” (lines 3-5). However, lines 6-7 then recite, output, for display by the user interface and based on “the presently selected value being greater than the maximum selectable value, the headroom amount”. This limitation is indefinite because the headroom amount was initially defined as incorporating a presently selected value as less than or equal to the maximum selectable value, but is then later defined as incorporating a presently selected value as being greater than the maximum selectable value. For purposes of examination, the limitation recited in lines 6-7 would be regarded as intending to state, “the presently selected value being less than or equal to the maximum selectable value” as is similarly recited in claim 6.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-20 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p. 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019).
Regarding claim 1:
Step 1: Claim 1 is directed to a method.
Step 2A – Prong 1: Claim 1 is directed to an abstract idea in the form of an apparatus that, under its broadest reasonable interpretation, covers emphasized limitations performed in the mind as the following:
obtaining, by processing circuitry, at least one first electrical stimulation parameter of an electrical stimulation program that defines an electrical stimulation therapy deliverable to a patient
determining, by processing circuitry, an electrical characteristic of a stimulation system configured to deliver the electrical stimulation therapy according to the electrical stimulation program;
determining, by processing circuitry and based on the electrical characteristic and the at least one first electrical stimulation parameter, a maximum selectable value for a second electrical stimulation parameter of the electrical stimulation program; and
outputting, for display by a user interface, the maximum selectable value
The above bolded emphasized limitations are drawn to an abstract idea because they are, under their broadest reasonable interpretation, mere steps that are capable of being mentally performed or with a pen and paper. For example determining a maximum selectable value for a second electrical stimulation parameter based on an obtained electrical characteristic and an obtained at least one first electrical stimulation parameter are a matter of observation, evaluation, judgement and opinion recognized by the courts as mental processes. See MPEP 2106.04(a)(2).
Step 2A – Prong 2: The above underlined emphasized limitations do not integrate the exception into a practical application of the exception because the elements are directed to insignificant extra-solution activity. Processing circuitry, a generic stimulation system and a user interface are recited at a high level of generality to perform the abstract idea and are merely regarded as including instructions to implement the abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Obtaining at least one first electrical stimulation parameter of an electrical stimulation program, determining an electrical characteristic of a stimulation system and outputting a maximum selectable value (the value determined via the abstract idea identified above) on a display does not integrate the exception into a practical application of the exception because it does not amount to more than generally linking the use of the exception to a particular technological environment or field of use. See MPEP 2106.05(h). The judicial exception does not integrate the claim as a whole into a practical application because the claimed invention does not improve another technology or technical field.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. The processing circuitry, stimulation system and user interface are recited at a high level of generality to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Furthermore the processing circuitry, stimulation system and user interface are well-understood, routine, and conventional elements as evidenced by and not limited to Kroll (US 7,006,867) disclosing, “The microcontroller 52 may be provided by a conventional microprocessor” (col. 5, lines 23-24); Chen (US 2020/0139106) disclosing, “Conventional electrical stimulation systems typically have a control unit hard-wired to a set of electrodes” ([0005]); Moffitt et al. (US 2018/0178021) disclosing, “the display screen 76 is a conventional screen” ([0055]). Obtaining at least one first electrical stimulation parameter of an electrical stimulation program, determining an electrical characteristic of a stimulation system and outputting a maximum selectable value (the value determined via the abstract idea identified above) on a display is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). The underlined emphasized elements do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)).
In view of the above, the underlined additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Claims 2-10 depend on and recite the same abstract idea as claim 1. Claims 2-4 only further limit the type of first electrical stimulation parameter or electrical characteristic that is obtained or specify the type of second electrical stimulation parameter that the maximum selectable value is determined for. Claims 5-7 are directed to displaying further information on the user interface- this further information regarded as a judicial exception as it is directed to a mental process of observation, evaluation or judgement. Claim 8 is directed to determining an efficiency of an anode and cathode of the stimulation system and displaying the efficiency, regarded as a field of use or technological environment in which to apply the judicial exception. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016). Claim 9 similarly recites the judicial exception and additional elements identified for claim 1, specifying in further detail the first electrical stimulation parameter. Claim 10 is directed to determining an amplitude threshold and displaying this threshold, regarded as a field of use or technological environment in which to apply the judicial exception. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016).
Regarding claim 11:
Claim 11 is directed to an apparatus that recites the same abstract idea in Step 2A – Prong 1 and the same additional elements in Step 2A – Prong 2/Step 2B as identified above for claim 1 and are therefore rejected to for the same reasons as identified above.
Claims 2-18 depend on and recite the same abstract idea as claim 11, and recite the same limitations and are rejected to for the same reasons as claims 2-10 above.
Claim 19 depends on claim 11 and recites the additional element of an external programmer but does not integrate the exception into a practical application of the exception because the external programmer is directed to insignificant extra-solution activity. The generic external programmer is recited at a high level of generality to perform the abstract idea and are merely regarded as including instructions to implement the abstract idea on a computer, or merely using a computer as a tool to perform the abstract idea. See MPEP 2106.04(d) and 2106.05(f). Claim 19 does not recite additional elements that amount to significantly more than the judicial exception itself. The external programmer is well-understood, routine, and conventional elements as evidenced by and not limited to Poore (US 5,620,473) disclosing, “the external programmer 20 are of conventional design” (col. 5, lines 39-40) and disclosing processing circuitry 62 and a user interface 70, 72, 78 in Figure 3.
Regarding claim 20:
Claim 20 is directed to an apparatus that recites the same abstract idea in Step 2A – Prong 1 and the same additional elements in Step 2A – Prong 2/Step 2B as identified above for claim 1 and are therefore rejected to for the same reasons as identified above.
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.
Claim(s) 1-4, 9, 11-14, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0401730) in view of Young-Dixon et al. (US 2021/0154480).
Regarding claims 1, 11 and 20, Lee et al. discloses a method and system and non-transitory computer-readable medium comprising instructions comprising: obtaining, by processing circuitry 107, at least one first electrical stimulation parameter (“The electrode information can contain the electrode material, the surface area of the electrodes, and/or the number of electrodes (e.g., the number of anodes and the number of cathodes)” or “pulse width” [0045]) of an electrical stimulation program (“therapy programs” [0033]) that defines electrical stimulation therapy deliverable to a patient (“the therapy signal 300a” [0045]), determining, by processing circuitry 107, an electrical characteristic (“impedance value” [0045]) of a stimulation system (“patient treatment system” [0045]) configured to deliver the electrical stimulation therapy according to the electrical stimulation program; determining, by processing circuitry 107 and based on the electrical characteristic and the at least one first electrical stimulation parameter, a maximum selectable value (“maximum amplitude” [0045]) for a second electrical stimulation parameter (“amplitude”) of the electrical stimulation program (“Based at least in part on the selected pulse width and the electrode information, the algorithm can determine the upper limit of the programmable amplitude (e.g., the “maximum amplitude”) based upon a calculation of maximum allowed charge density. For example, if a user inputs and/or the system determines that the electrodes are polished platinum iridium electrodes, the electrodes have a specific impedance value and/or surface area, and the pulse width is 30 ms, the algorithm can calculate the maximum amplitude that can be used without exceeding a charge density of 300 μC/cm2, which as reflected in Table 1 is about 1.27 mA.” [0045]).
Lee et al. discloses a graphical user interface for the user to program values for electrical stimulation parameters ([0045], [0063]) but does not expressly disclose outputting, for display by the user interface, the maximum selectable value. Young-Dixon et al. teaches an electrical stimulation system configured to deliver electrical stimulation therapy according to an electrical stimulation program where the maximum electrical current amplitude selectable value for any given electrode is output, for display by a user interface 59 (fig. 3; [0041], [0054]) in order to display information for reference to a user when adjusting electrical current amplitudes for various electrodes ([0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee et al. to output and display by the user interface, the maximum selectable value as taught by Young-Dixon et al. in order to provide a reference to the user that is helpful when determining which values to select for the second electrical stimulation parameter that can be chosen within the boundaries of the maximum selectable value, such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claims 2 and 12, Lee et al. discloses wherein the at least one first electrical stimulation parameter comprises a number of anodes, a number of cathodes, a pulse width, or a pulse frequency (“The electrode information can contain the electrode material, the surface area of the electrodes, and/or the number of electrodes (e.g., the number of anodes and the number of cathodes)” or “pulse width” [0045]).
Regarding claims 3 and 13, Lee et al. discloses wherein the electrical characteristic comprises an impedance of each of the anodes and cathodes of the electrical stimulation program (“the surface area of the electrodes can be estimated from an impedance value associated with the electrode, which may be automatically detected by the system” [0045]).
Regarding claims 4 and 14, Lee et al. discloses wherein the second electrical stimulation parameter is at least one of an electrical current amplitude or a voltage amplitude (“the algorithm can determine the upper limit of the programmable amplitude (e.g., the “maximum amplitude”)… the algorithm can calculate the maximum amplitude that can be used without exceeding a charge density of 300 μC/cm2, which as reflected in Table 1 is about 1.27 mA.” [0045]).
Regarding claim 9, Lee et al. discloses determining, an electrical characteristic (“impedance value” [0045]) of a stimulation system (“patient treatment system” [0045]) configured to deliver the electrical stimulation therapy via a plurality of anodes and cathodes (“For example, in some embodiments, three electrodes are programmed as anodic and three electrodes are programmed as cathodic” [0044]); determining, based on the electrical characteristic, an electrical stimulation program for which the maximum selectable value for the second electrical stimulation parameter is the greatest (“the upper limit of the programmable amplitude (e.g., the “maximum amplitude”)” [0045]), wherein the at least one first electrical stimulation parameter comprises at least one of a combination of anodes and cathodes, a pulse width, or a pulse frequency (“The electrode information can contain the electrode material, the surface area of the electrodes, and/or the number of electrodes (e.g., the number of anodes and the number of cathodes)” or “pulse width” [0045]); and Lee et al. in view of Young-Dixon et al. discloses outputting, for display by the user interface 59 one or more parameter values of the electrical stimulation program (fig. 3; [0041], [0054]).
Regarding claim 19, Lee et al. discloses an external programmer 106, 117 ([0033]) comprises a graphical user interface ([0045]) but discloses an implantable signal generator 101 comprises the processing circuitry 107 and does not expressly disclose the external programmer comprises the processing circuitry. Young-Dixon et al. teaches it is known in the art for an external programmer 40 to comprise processing circuitry 53 to perform processing functions in addition to a user interface 59. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee et al. such that the external programmer comprised the processing circuitry as known and taught by Young-Dixon et al. for performing the claimed invention as it would reduce the computing strain on an implantable device, the results of such a modification being reasonably predictable and would not alter the overall operation of the device.
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0401730) in view of Young-Dixon et al. (US 2021/0154480) and further in view of Roy et al. (US 2012/0221077).
Regarding claims 5 and 15, Lee et al. does not expressly disclose determining, based on the maximum selectable value and the presently selected value for the second electrical parameter, that the presently selected value is greater than the maximum selectable value; and response to determining that the presently selected value is greater than the maximum selectable value, outputting, for display by the user interface, an alert indicating that the presently selected value is greater than the maximum selectable value. Roy et al. teaches an electrical stimulation system with selectable stimulation values where after determining based on a maximum selectable value and a presently selected value of a current amplitude parameter, that the presently selected value is greater than the maximum selected value; an alert is displayed (“’Message’ panel”) to the user on a user interface that indicates the presently selected value of the parameter is greater than the maximum selectable value (“This message is generated if the maximum/minimum current amplitude is reached (as allowed by the maximum charge per phase safety limit) and the subject continues to turn the jog dial to increase/decrease the amplitude” [0113]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee et al. to make a determination based on a comparison between the maximum selectable value and a presently selected value for the second electrical parameter, that the presently selected value is greater than the maximum selectable value; and in response to this determination, outputting for display by the user interface, an alert of this determination as taught by Roy et al. in order to better inform the user that the presently selected value exceeds the boundaries of the maximum selectable value, such a modification being reasonably predictable and would not alter the overall operation of the device.
Claim(s) 6-7 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0401730) in view of Young-Dixon et al. (US 2021/0154480) and further in view of Kim et al. (US 8,977,360).
Regarding claims 6 and 16, Lee et al. does not expressly disclose determining, based on the maximum selectable value and the presently selected value for the second electrical parameter, a headroom amount that is the difference between the maximum selectable value and the presently selected value, wherein the presently selected value is less than or equal to the maximum selectable value; and outputting, for display by the user interface and based on the presently selected value being less than or equal to the maximum selectable value, the headroom amount. Kim et al. teaches an electrical stimulation device comprising a user interface (fig. 9a-e) and determining a headroom amount (the anode at 100% in fig. 9a-d adjusts to 50% in fig. 9e after programming anode electrode 26’ to 50%) that is the difference between a maximum selectable value (“100%”) and a presently selected value (“the stimulation amplitude control element 124b has been actuated to increase the fractionalized electrical current value from 0% to 50%, thereby programming the associated electrode 26 with a fractionalized current of 50%” col. 13, lines 61-64; fig. 9e), wherein the presently selected value is less than or equal to the maximum selectable value; and outputting, for display by the user interface and based on the presently selected value being less than or equal to the maximum selectable value, the headroom amount (fig. 9e). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee et al. to display the headroom amount that is the difference between the maximum selectable value and the presently selected value, the presently selected value being less than or equal to the maximum selectable value as taught by Kim et al. in order to provide a display that easily communicates to the user what how the presently selected value compares to the maximum selectable value, and how much more headroom the user has in selecting a different selected value, such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claims 7 and 17, Lee et al. in view of Kim et al. disclose wherein the headroom amount includes a headroom amount for each anode and cathode of the electrical stimulation program, and wherein the method further comprises outputting, for display by the user interface, the headroom amount for each anode and cathode (fig. 9a-e; interpreted as if other anodes and cathodes are programmed in the same manner as what is disclosed for electrode 26’ in fig. 9a-e).
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0401730) in view of Young-Dixon et al. (US 2021/0154480) and further in view of Torgerson (US 2010/0274320).
Regarding claims 8 and 18, Lee et al. discloses determining, by processing circuitry and based on the electrical characteristic, an efficiency of an anode and a cathode of the stimulation system (“charge density” [0045]) but does not expressly disclose outputting, for display by the user interface, the efficiency of the anode and the cathode. Torgerson teaches displaying the charge density of active electrodes on a graphical user interface 90 ([0067-0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee et al. and display the efficiency (charge density) of the anode and cathode of the stimulation system as taught by Torgerson as it is a known characteristic to display for active electrodes in a stimulation system, the basis for the determination of the programmed intensity of stimulation ([0067]) and would be useful to the user to keep aware of such a parameter.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 2022/0401730) in view of Young-Dixon et al. (US 2021/0154480) and further in view of Torgerson (US 2020/0038660).
Regarding claim 10, Lee et al. does not expressly disclose determining, for the electrical stimulation program, an amplitude threshold at which respective evoked compound action potential (ECAP) signals are detectable; and outputting, for display by the user interface, an indication of a relationship between the amplitude threshold and the maximum selectable value. Torgerson teaches an example electrical stimulation program where an amplitude threshold at which respective evoked compound action potential (ECAP) signals are detectable is determined ([0113-0114]); and outputting, for display by a user interface ([0088]), an indication of a relationship between the amplitude threshold and a maximum selectable value (“if IMD 102 determines that electrical stimulation therapy according to an amplitude that is 80% of a previous maximum amplitude evokes a compound action potential, IMD 102 may deliver electrical stimulation therapy according to an amplitude that is 60% of a previous maximum amplitude and determine whether this electrical stimulation therapy evokes a compound action potential” [0116]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee et al. to output an indication of a relationship between the amplitude threshold at which respective ECAP signals are detectable and the maximum selectable value as taught by Torgerson as it is a known relationship for electrical stimulation therapy programs to consider and would be useful to present to the user via display, the results of such a modification being reasonably predictable and would not alter the overall operation of the device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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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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/ERICA S LEE/Primary Examiner, Art Unit 3796