ETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed 04 May 2026 have been entered. Claims 1 – 15 and 23 – 46 are pending. Applicant’s amendments have not overcome each and every claim objection previously applied in the office action dated 09 February 2026. Applicant’s amendments have not overcome each and every rejection under 35 U.S.C. 112 previously applied in the office action dated 09 February 2026.
Claim Objections
Claims 4 and 43 are each objected for the term “wherein the spinal cord was stimulated at each of the set of stimulation times using an electrode positioned via percutaneous access to the spinal cord.” There is a change of tense from Claim 1 and 40 from which these Claim depend. For the purposes of readability, it is suggested to modify the term to be “wherein a spinal cord of the subject is stimulated at each of the set of stimulation times using an electrode configured to be positioned via percutaneous access to the spinal cord.” Appropriate correction is required.
Claim 15 recites the term “wherein the remyelination therapy is a particular remyelination therapy that uses a particular active ingredient”. It is suggested to revise the term to be “wherein the remyelination therapy uses a particular active ingredient” for conciseness and readability in the claim. Appropriate correction is required.
Claim Interpretation
Applicant has not made an amendment regarding the 112(f) Claim Interpretations applied in the Office Action dated 09 February 2026. Applicant has not provided any reason to withdraw the 112(f) claim interpretation, so the interpretation detailed in the Office Action dated 09 February 2026 is maintained for the terms “recording device” in Claim 38.
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 – 15 and 23 – 46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 (line 11 -12), Claim 23 (line 15 – 16), Claim 36 (line 16 – 17), Claim 39 (line 17 – 18), and Claim 40 (line 13 – 14) each recite the limitation “latency and one or more features”. It is unclear if this is intended to be the same or different than the previously-recited one or more features. For the purposes of examination, the term “latency and one or more features” is deemed to claim “latency and the one or more features”. Claims 2 – 15, 24 – 35, 37 – 38, and 41 – 46 are similarly rejected due to their dependence on claims 1, 23, 36, 39, and 40.
Claim 4 (line 3) and Claim 43 (line 3) each recite the limitation "to the spinal cord". It is unclear if this is intended to be the same or different than the previously-recited spinal cord of the subject. For the purposes of examination, the term “to the spinal cord” is deemed to claim “to the spinal cord of the subject.”
Line 1 of each of Claims 8 - 10, 12 – 14, 27 – 28, and 31 – 35 recites the term “the result”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is intended to be the same or different than the previously-recited location specific imaging result. For the purposes of examination, the term “the result” is deemed to claim “the location-specific result”. Claim 15 is similarly rejected due to its dependence on Claim 14.
Claim 23 (line 17) and Claim 39 (line 19) each recite the term “in a subject”. It is unclear if this is intended to be the same or different than the previously-recited subject. For the purposes of examination, the term “in a subject” is deemed to claim “in the subject.” Claims 24 – 35 are similarly rejected due to their dependence on Claim 23.
As previously-applied, Claim 24 (line 1), Claim 25 (line 1), Claim 26 (line 3), Claim 27 (line 2), and Claim 28 (line 2), each recite the limitation "the stimulation device". It is unclear if this is intended to be the same or different than the “wearable or implanted stimulation device” previously recited in Claim 23, from which these claims depend. For the purposes of examination, the term “the stimulation device” is deemed to claim “the wearable or implanted stimulation device”.
As previously-applied, Claim 38 recites the term “record evoked compound action potentials” in lines 1 – 2. It is unclear if this is intended to be the same or different than the “set of evoked compound action potentials” previously recited in Claim 36, from which this claim depends. For the purposes of examination, the term “record evoked compound action potentials” is deemed to claim “record the set of evoked compound action potentials”
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 – 15 and 23 – 46 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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4 and 43 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims each recite “a spinal cord of the subject was stimulated at each of the set of stimulation times using an electrode positioned via percutaneous access to the spinal cord.” The claim should be amended to recite “wherein the one or more electrodes are configured to be positioned via percutaneous access to a spinal cord of the subject and are configured to stimulate the spinal cord of the subject.” The forthcoming 101 analysis regarding Claims 4 and 43 is provided assuming that this amendment is made.
Claims 7 and 46 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims each recite “wherein the set of evoked compound action potentials include signals from a brain of the subject”. The claims should be amended to recite “wherein the set of evoked compound action potentials are configured to be collected from signals from a brain of the subject.” The forthcoming 101 analysis regarding Claims 7 and 46 is provided assuming that this amendment is made.
Claim 11 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claim recites “stimulating a spinal cord of the subject using one or more electrodes at each of the set of stimulation times.” The claim should be amended to recite “using one or more electrodes configured to stimulate a spinal cord of the subject at each of the set of stimulation times.” The forthcoming 101 analysis regarding Claim 11 is provided assuming that this amendment is made.
Regarding Claims 1 and 23 the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claims 36, 39, and 40, the claims each recite an apparatus, which is one of the statutory categories of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 15 and 23 – 46 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 15 and 23 – 46 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 15 and 23 – 46 recites an abstract idea.
Specifically, Independent Claims 1, 23, 36, 39, and 40 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim
A method comprising:
detecting a set of evoked compound action potentials, wherein each of the set of evoked compound action potentials is defined to start at a corresponding stimulation time of a set of stimulation times;
generating an average evoked response using the set of evoked compound action potentials;
extracting one or more features from the average evoked response, the one or more features including one or more signal characteristics;
determining a latency of the average evoked response relative to the corresponding stimulation time by using the one or more signal characteristics;
generating a location-specific imaging result based on the latency and one or more features, wherein the location-specific imaging result identifies:
a location of demyelination or remyelination in a subject; and
outputting the location-specific imaging result.
Claim 23
A method comprising:
detecting a set of stimulation times at which a wearable or implanted stimulation device delivered a stimulation to a subject, wherein the wearable or implanted stimulation device is positioned to trigger or amplify nerve signals to facilitate partly or fully negating a disability of the subject;
detecting a set of evoked compound action potentials, wherein each of the set of evoked compound action potentials is defined to start at a corresponding stimulation time of the set of stimulation times;
generating an average evoked response using the set of evoked compound action potentials;
extracting one or more features from the average evoked response, the one or more features including one or more signal characteristics;
determining a latency of the average evoked response relative to the corresponding stimulation time by using the one or more signal characteristics; and
generating a location-specific imaging result based on the latency and one or more features, wherein the location-specific imaging result identifies a location of demyelination or remyelination in a subject.
Claim 36
A system comprising:
one or more data processors; and
a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform a set of actions including:
detecting a set of evoked compound action potentials, wherein each of the set of evoked compound action potentials is defined to start at a corresponding stimulation time of a set of stimulation times; generating an average evoked response using the set of evoked compound action potentials; extracting one or more features from the average evoked response, , the one or more features including one or more signal characteristics; determining a latency of the average evoked response relative to the corresponding stimulation time by using the one or more signal characteristics; and generating a location-specific imaging result based on the latency and one or more features, wherein the location-specific imaging result identifies a location of demyelination or remyelination in a subject; and outputting the location-specific imaging result.
Claim 39
A computer-program product tangibly embodied in a non- transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform a set of actions including:
detecting a set of stimulation times at which a wearable or implanted stimulation device delivered a stimulation to a subject, wherein the wearable or implanted stimulation device is positioned to trigger or amplify nerve signals to facilitate partly or fully negating a disability of the subject;
generating an average evoked response using the set of stimulation times;
extracting one or more features from the average evoked response, the one or more features including one or more signal characteristics;
determining a latency of the average evoked response relative to a corresponding stimulation time of the set of stimulation times by using the one or more signal characteristics;
generating a location-specific imaging result based on the latency and one or more features, wherein the location-specific imaging result identifies: a location of demyelination or remyelination in a subject
and outputting the location-specific result.
Claim 40
A computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform a set of actions including:
detecting a set of evoked compound action potentials, wherein each of the set of evoked compound action potentials is defined to start at a corresponding stimulation time of a set of stimulation times;
generating an average evoked response using the set of evoked compound action potentials;
extracting one or more features from the average evoked response, the one or more features including one or more signal characteristics;
determining a latency of the average evoked response relative to the corresponding stimulation time by using the one or more signal characteristics;
generating a location-specific imaging result based on the latency and one or more features, wherein the location-specific imaging result identifies a location of demyelination or remyelination in a subject; and outputting the location-specific imaging result
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claims 1, 23, 36, 39, and 40, these limitations include:
Observation and judgment of a set of evoked compound action potentials
each of the set of evoked compound action potentials is observed and judged to start at a corresponding stimulation time of a set of stimulation times;
Observation and judgment to evaluate an average evoked response using the set of evoked compound action potentials;
Observation and judgment of one or more features from the average evoked response, the one or more features including one or more signal characteristics;
Observation and judgment of a latency of the average evoked response relative to the corresponding stimulation time by using the one or more signal characteristics;
Observation and judgment of a location-specific imaging result based on the one or more features, wherein the result identifies a location of demyelination or remyelination in a subject;
Observation and judgment to communicate the result.
Observation and judgment of a set of stimulation times at which a wearable or implanted stimulation device delivered a stimulation to a subject
Similarly, Dependent Claims 2 – 15, 24 – 35, and 41 – 46 include the following abstract limitations, in addition to the aforementioned limitations in Independent Claims 1, 23, 36, 39, and 40 (underlined are certain methods of directing human activity and observation, judgment or evaluation, which are grouped as a mental process , and under the 2019 PEG ):
generating the result includes using a look-up table that associates various feature values with quantitative or qualitative predicted degrees of inflammation or of myelination.
Observation and judgment of a look-up table that associates various feature values with quantitative or qualitative predicted degrees of inflammation or of myelination.
generating the result includes using a function that relates feature values with quantitative or qualitative predicted degrees of inflammation or of myelination.
Observation and judgment of a function that relates feature values with quantitative or qualitative predicted degrees of inflammation or of myelination.
the result further identifies a predicted degree of inflammation.
the result is an Observation and judgment of a predicted degree of inflammation.
the result identifies a predicted degree of myelination or demyelination.
the result is an Observation and judgment of a predicted degree of myelination or demyelination.
the result identifies a predicted degree to which a symptom or disease of the subject would be effectively treated by a remyelination therapy.
the result is an Observation and judgment of the predicted degree to which the symptom or disease of the subject would be effectively treated by a remyelination therapy.
automatically adjusting an intensity or frequency of stimulations that the stimulation device delivers based on the result.
Observation and judgment to adjust without hesitation an intensity or frequency of stimulations that the stimulation device delivers based on the result.
all of which are grouped as mental processes, or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 1, 23, 36, 39, and 40 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1 – 31 and 50), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“one or more electrodes”, “an electrode”
“look-up table”
“wearable or implanted stimulation device”, “stimulation device”
“Functional Electrical Stimulation Device”
“one or more data processors”
”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”
“recording device”
“computer-program product”
Additional elements recited include “one or more electrodes”, “an electrode”, “look-up table”, “wearable or implanted stimulation device”, “stimulation device”, “Functional Electrical Stimulation Device”, “one or more data processors”, ”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”, “recording device”, and “computer-program product” in Independent Claims 1, 23, 36, 39, and 40 (and their respective Dependent Claims). These components are recited at a high level of generality, , i.e., as a processor performing a generic function of processing data (the acquiring, generating, and correcting); a memory performing a generic function of storing data (the storing). These generic hardware component limitations for “one or more electrodes”, “an electrode”, “look-up table”, “wearable or implanted stimulation device”, “stimulation device”, “Functional Electrical Stimulation Device”, “one or more data processors”, ”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”, “recording device”, and “computer-program product” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 1, 23, 36, 39, and 40 and their dependent claims includes pre-solution activity limitations, such as:
each of the set of evoked compound action potentials includes an antidromic or a dromic compound action potential.
a spinal cord of the subject was stimulated at each of the set of stimulation times using an electrode positioned via percutaneous access to the spinal cord.
the one or more features includes a time of a peak or trough in the average evoked response.
the one or more features includes a magnitude or relative magnitude of a peak or trough in the average evoked response.
the result is a category.
wherein the one or more features includes a magnitude or relative magnitude of a peak or trough in the average evoked response.
wherein the set of evoked compound action potentials include signals from a brain of the subject.
stimulating the spinal cord of the subject using the one or more electrodes at each of the set of stimulation times
measuring the set of evoked compound action potentials.
the remyelination therapy is a particular remyelination therapy that uses a particular active ingredient.
the stimulation device is a Functional Electrical Stimulation device that is configured and positioned to deliver stimulation to a paretic peroneal nerve.
the stimulation device is configured and positioned to deliver stimulation to a sacral nerve of the subject or a cochlear nerve of the subject
a stimulation device configured to deliver stimulation pulses.
a recording device configured to record evoked compound action potentials.
A computer-program product tangibly embodied in a non- transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform a set of actions
a non-transitory computer readable storage medium containing instructions which, when executed on the one or more data processors, cause the one or more data processors to perform a set of actions
The “one or more electrodes”, “an electrode”, “look-up table”, “wearable or implanted stimulation device”, “stimulation device”, “Functional Electrical Stimulation Device”, “one or more data processors”, ”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”, “recording device”, and “computer-program product” as recited in Independent Claims 1, 23, 36, 39, and 40 (and their respective Dependent Claims) are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 1, 23, 36, 39, and 40 (and their dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 1, 23, 36, 39, and 40 (and their dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 1, 23, 36, 39, and 40 (and their dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 15 and 23 – 46 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “one or more electrodes”, “an electrode”, “look-up table”, “wearable or implanted stimulation device”, “stimulation device”, “Functional Electrical Stimulation Device”, “one or more data processors”, ”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”, “recording device”, and “computer-program product” as recited in Independent Claims 1, 23, 36, 39, and 40 (and their dependent claims).
The additional elements of the “one or more electrodes”, “an electrode”, “look-up table”, “wearable or implanted stimulation device”, “stimulation device”, “Functional Electrical Stimulation Device”, “one or more data processors”, ”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”, “recording device”, and “computer-program product” in Independent Claims 1, 23, 36, 39, and 40 (and their dependent claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, the “one or more electrodes”, “an electrode” is described generically at [0041] with “a non-invasive electrode, such as an electroencephalography (EEG) electrode, or a minutely invasive electrode that does not require an incision, such as an electromyography (EMG) electrode” and [0079] as anode and cathode stimulating electrodes and recording electrodes. The “one or more electrodes” or “an electrode” is shown as “Recording Electrodes, Stimulating Electrodes” in Figure 5 and “contacts 5 and 13 on the spinal cord electrode leads” and “active and reference electrodes” in figure 5.
Per Applicant’s specification, the “look-up table” is described generically in [0015] “Generating the result may include using a look-up table that associates various feature values with quantitative or qualitative predicted degrees of inflammation or of myelination. “ and [0059] “The mapping may be performed using a look-up table.” The “look-up table” is not shown in a figure.
Per Applicant’s specification, the “wearable or implanted stimulation device”, “stimulation device”, and “Functional Electrical Stimulation Device” is described by its use position in [0019] and [0067] as stimulating either the paretic peroneal nerve, sacral nerve, or auditory nerve; at [0020] as a stimulation device that is configure to deliver stimulation pulses; and at [0078] as “a separate stimulation device was connected to the implanted percutaneous spinal cord electrode leads.”
Per Applicant’s specification, the , “one or more data processors” is described generically in [0020] – [0024] as being part of the system and can be used to “perform part or all of one or more methods or processes disclosed herein.” The “one or more data processors” are not shown in a figure.
Per Applicant’s specification, the “non-transitory computer readable storage medium”, “non-transitory machine readable storage medium” is described generically in [0020] – [0024] as being part of the system and can be used to store instructions that can be executed by one or more data processors. The “non-transitory computer readable storage medium” or “non-transitory machine readable storage medium” are not shown in a figure.
Per Applicant’s specification, “recording device” is described generically at [0020] as “a recording device configured to record evoked compound action potentials.” It is potentially shown in a figure as “recording electrodes” in Figure 7.
Per Applicant’s specification, the “computer-program product” is described generically at [0088] as “a computer-program product tangibly embodied in a non-transitory machine-readable storage medium, including instructions configured to cause one or more data processors to perform part or all of one or more methods and/or part or all of one or more processes disclosed herein.” The “computer-program product” is not shown in a figure.
Accordingly, in light of Applicant’s specification, the claimed terms “one or more electrodes”, “an electrode”, “look-up table”, “wearable or implanted stimulation device”, “stimulation device”, “Functional Electrical Stimulation Device”, “one or more data processors”, ”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”, “recording device”, and “computer-program product” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “one or more electrodes”, “an electrode”, “look-up table”, “wearable or implanted stimulation device”, “stimulation device”, “Functional Electrical Stimulation Device”, “one or more data processors”, ”non-transitory computer readable storage medium”, “non-transitory machine readable storage medium”, “recording device”, and “computer-program product”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Independent Claims 1, 23, 36, 39, and 40 (and their dependent claims) amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatuses and methods of Claims 1 – 15 and 23 – 46 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1 – 15 and 23 – 46 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 1, 23, 36, 39, and 40 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1 – 15 and 23 – 46 apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1 – 15 and 23 – 46 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 15 and 23 – 46 are not patent eligible and rejected under 35 U.S.C. 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5 – 6, 9, 13 – 14, 23, 26, 29 - 30, 32, 34 - 40, and 44 - 45 are rejected under 35 U.S.C. 103 as being unpatentable over Cholette, (United States Patent Application Publication US 2008/0300655 A1), hereinafter Cholette in view of Hughes, “Fundamental of Clinical ECAP Measures in Cochlear Implants Part 2: Measurement Techniques and Tips”.
Regarding Claims 1, 23, 36, 39, and 40, Cholette discloses
For Claim 1: A method ([Abstract]) comprising:
outputting the location-specific imaging result (Figure 7, “latency”; [0030] “Various techniques include presenting information in graphical form to thereby allow a clinician to monitor or assess nerve condition.”)(Examiner notes that a graphical form is broadly an imaging result that visually presents the information about the latency between electrodes at the particular locations on the subject. The instant specification describes the “imaging” at [0060] with “locations of various recording electrodes (e.g., and of one or more stimulating electrodes) can be used to generate an image that illustrates where in a subject’s body the nervous system is predicted to be demyelinated (e.g., an extent of the demyelination).” Given this description, presenting this information of latency at locations labeled in graphical form would broadly be an imaging result of the location-specific information.),
For Claim 23: A method ([Abstract]) comprising:
detecting a set of stimulation times (Fig 3, “Stimulus”; Fig 6, [0067] “square wave pulses at periodic intervals”; Fig 7) at which a wearable or implanted stimulation device (Fig 2, [0008] “an exemplary implantable device”) delivered a stimulation to a subject ([0067] “delivering therapeutic stimulation energy to a nerve...”), wherein the wearable or implanted stimulation device is positioned to trigger or amplify nerve signals to facilitate partly or fully negating a disability of the subject ([0029] “Various neurostimulation devices electrically stimulate peripheral nerves (e.g., vagus for the treatment of obesity, phrenic for the treatment of sleep apnea, pudendal for urinary incontinence)…“);
For Claim 36: A system ([Abstract]) comprising:
one or more data processors ([0035] “exemplary device 200 includes a programmable microprocessor 210 “); and
a non-transitory computer readable storage medium containing instructions which ([0073] “control logic 830 may be in the form of instructions stored on a digital data storage medium accessible by the processor 810”), when executed on the one or more data processors ([0035]; [0073] “the processor 810”)), cause the one or more data processors to perform a set of actions including ([0073] “…instructions cause the processor to perform various actions…”):
outputting the location-specific imaging result (Figure 7, “latency”; [0030] “Various techniques include presenting information in graphical form to thereby allow a clinician to monitor or assess nerve condition.”)(See examiner note above for more detail regarding that that a graphical form is broadly an imaging result that visually presents the information about the latency between electrodes at the particular locations on the subject.)
For Claim 39:
A computer-program product tangibly embodied in a non- transitory machine-readable storage medium ([0073] “control logic 830 may be in the form of instructions stored on a digital data storage medium accessible by the processor 810”), including instructions configured to cause one or more data processors to perform a set of actions ([0073] “…instructions cause the processor to perform various actions…”) including:
detecting a set of stimulation times (Fig 3, “Stimulus”; Fig 6, [0067] “square wave pulses at periodic intervals”; Fig 7) at which a wearable or implanted stimulation device (Fig 2, [0008] “an exemplary implantable device”) delivered a stimulation to a subject ([0067] “delivering therapeutic stimulation energy to a nerve...”), wherein the wearable or implanted stimulation device is positioned to trigger or amplify nerve signals to facilitate partly or fully negating a disability of the subject ([0029] “Various neurostimulation devices electrically stimulate peripheral nerves (e.g., vagus for the treatment of obesity, phrenic for the treatment of sleep apnea, pudendal for urinary incontinence)…“);
outputting the location-specific imaging result (Figure 7, “latency”; [0030] “Various techniques include presenting information in graphical form to thereby allow a clinician to monitor or assess nerve condition.”)(See examiner note above for more detail regarding that that a graphical form is broadly an imaging result that visually presents the information about the latency between electrodes at the particular locations on the subject.)
For Claim 40:
A computer-program product tangibly embodied in a non- transitory machine-readable storage medium ([0073] “control logic 830 may be in the form of instructions stored on a digital data storage medium accessible by the processor 810”), including instructions configured to cause one or more data processors to perform a set of actions ([0073] “…instructions cause the processor to perform various actions…”) including:
outputting the location-specific imaging result (Figure 7, “latency”; [0030] “Various techniques include presenting information in graphical form to thereby allow a clinician to monitor or assess nerve condition.”)( See examiner note above for more detail regarding that that a graphical form is broadly an imaging result that visually presents the information about the latency between electrodes at the particular locations on the subject.)
For the remainder of Claims 1, 23, 36, 39, and 40, Cholette discloses:
detecting a set of evoked compound action potentials ([0062] “CAP 510…an evoked CAP (ECAP); Fig 5; Fig 6, Fig 7, [0079] “obtaining a series of ECAPs”), wherein each of the set of evoked compound action potentials is defined to start at a corresponding stimulation time of a set of stimulation times (Fig 6, [0067] “square wave pulses at periodic intervals”, “eCAPs 614”; Fig 3; Fig 7);
generating an average evoked response using the set of evoked compound action potentials ([0094] “based on acquired nerve activity data such as a standard deviation of averaged samples)”;
extracting one or more features from the evoked response ([0079] “…one or more characteristics of an ECAP”), the one or more features including one or more signal characteristics ([0079] “…one or more characteristics of an ECAP”)
determining a latency of the evoked response relative to the corresponding stimulation time by using the one or more signal characteristics ([0079] “…one or more characteristics of an ECAP…”, Latency (e.g., time between site 0 and another site) may be used as a relative indication of nerve demyelination and/or other nerve condition.”)(Examiner notes that the latency is determined as the time for the signal between two particular locations or “sites”, which meets the broad recitation of location-specific.)
generating a location-specific imaging result based on the latency and one or more features ([0079] “Latency (e.g., time between site 0 and another site) may be used as a relative indication of nerve demyelination and/or other nerve condition.”; [0030] “Various techniques include presenting information in graphical form to thereby allow a clinician to monitor or assess nerve condition.”)(Examiner notes that the instant specification describes the “imaging” at [0060] with “locations of various recording electrodes (e.g., and of one or more stimulating electrodes) can be used to generate an image that illustrates where in a subject’s body the nervous system is predicted to be demyelinated (e.g., an extent of the demyelination).” Given this description, presenting this information of latency at locations labeled in graphical form would broadly be an imaging result of the location-specific information.), wherein the location-specific imaging result identifies:
a location of demyelination or remyelination in a subject ([0079] “Latency (e.g., time between site 0 and another site) may be used as a relative indication of nerve demyelination and/or other nerve condition.”)(Examiner notes that the latency is determined as the time for the signal between two particular locations or “sites”, which meets the broad recitation of a location.)and
Cholette does not specifically disclose from the average evoked response and latency of the average evoked response. Cholette broadly discloses calculating the average evoked response at [0094] “based on acquired nerve activity data such as a standard deviation of averaged samples)”;
Hughes teaches tip and tricks for measuring ECAP parameters, such as how to obtain “good ECAP recordings” [Page 1, Paragraph 1]. Specifically for Claims 1, 23, 36, 39, and 40, Hughes teaches extracting one or more features from the average evoked response ([Page 7, “Number of Averages” Section] “As with any evoked potential, increasing the number of averages will reduce the amount of noise in the recorded ECAP response…Options include 16, 32, 64, 128, and 256…typically find that 50-100 averages work best in most cases.”; [Page 8, “Amplitude Measurement: Picking Peaks” Section] “…measured ECAPs obtained…identify peaks…”; Figure 7)(Examiner notes that the averaging is part of the recording parameters, so subsequent data processing of the signals to find features is performed on the “average” signal that is noise-reduced in recording.) and
latency ([Page 10, Top] “…mark the peaks…stimulus level decreases…latency may increase slightly…”) of the average evoked response ([Page 7, “Number of Averages” Section]; [Page 8, “Amplitude Measurement: Picking Peaks” Section]; Figure 7)(See examiner note above about averaging.)
Hughes provides a motivation to combine at [Page 7, “Number of Averages” Section] with “As with any evoked potential, increasing the number of averages will reduce the amount of noise in the recorded ECAP response.“ A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that determining features from an averaged eCAP response would be useful to obtain more accurate data with less associated noise.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device that analyzes eCAP parameters to indicate nerve demyelination disclosed in Cholette with the averaging the recorded eCAP response with a number of averages (16, 32, 64, 128, 256) taught by Hughes, creating a single eCAP analysis device with reduced noise for the eCAP response measurement data.
Regarding Claims 5, 29, and 44, Cholette in view of Hughes discloses as described above, The method of claim 1, The method of claim 23, and The computer-program produce of claim 40, respectively. For the remainder of Claims 5, 29, and 44, Cholette discloses wherein the one or more features includes a time of a peak (Fig 3., [0051] “the different conduction velocities of an axon population…a shift in time of the amplitude peaks as the distance increases away from the energy delivery site.”) or trough in the average evoked response (Fig 3, [0051]; [0094] “…averaged samples”).
Cholette does not specifically disclose in the average evoked response. Cholette broadly discloses calculating the average evoked response at [0094] “based on acquired nerve activity data such as a standard deviation of averaged samples)”;
Hughes teaches wherein the one or more features includes a time of a peak or trough in the average evoked response ([Page 7, “Number of Averages” Section] “As with any evoked potential, increasing the number of averages will reduce the amount of noise in the recorded ECAP response…Options include 16, 32, 64, 128, and 256…typically find that 50-100 averages work best in most cases.”; [Page 8, “Amplitude Measurement: Picking Peaks” Section] “…measured ECAPs obtained…identify peaks…”; Figure 7) (Examiner notes that the averaging is part of the recording parameters, so subsequent data processing of the signals to find features is performed on the “average” signal that is noise-reduced in recording.)
The motivation for Claims 5, 29, and 44 to combine Cholette with Hughes is similar to that described in more detail in Claims 1, 23, 36, 39, and 40, above. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device that analyzes eCAP parameters to indicate nerve demyelination disclosed in Cholette with the averaging the recorded eCAP response with a number of averages (16, 32, 64, 128, 256) taught by Hughes, creating a single eCAP analysis device with reduced noise for the eCAP response measurement data.
Regarding Claims 6, 30, and 45, Cholette in view of Hughes discloses as described above, The method of claim 1, The method of claim 23, and The computer-program produce of claim 40, respectively. For the remainder of Claims 6, 30, and 45, Cholette discloses wherein the one or more features includes a magnitude or relative magnitude of a peak (Fig 5, [0054] “with progressive increases in stimulus intensity, the magnitude of each peak of the monophasic compound action potential eventually reaches a maximal value…”; [0062] “…parameters include…width of a peak at half amplitude…etc”) or trough in the average evoked response (Fig 3, [0051]; [0094] “…averaged samples”).
Cholette does not specifically disclose in the average evoked response. Cholette broadly discloses calculating the average evoked response at [0094] “based on acquired nerve activity data such as a standard deviation of averaged samples)”;
Hughes teaches wherein the one or more features includes a magnitude or relative magnitude of a peak in the average evoked response ([Page 7, “Number of Averages” Section] “As with any evoked potential, increasing the number of averages will reduce the amount of noise in the recorded ECAP response…Options include 16, 32, 64, 128, and 256…typically find that 50-100 averages work best in most cases.”; [Page 10, “3. Consider the overall noise floor” Section] “…peak-peak amplitude measured; Figure 6 and 7.)(Examiner notes that the averaging is part of the recording parameters, so subsequent data processing of the signals to find features is performed on the “average” signal that is noise-reduced in recording.)
The motivation for Claims 6, 30, and 45 to combine Cholette with Hughes is similar to that described in more detail in Claims 1, 23, 36, 39, and 40, above. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device that analyzes eCAP parameters to indicate nerve demyelination disclosed in Cholette with the averaging the recorded eCAP response with a number of averages (16, 32, 64, 128, 256) taught by Hughes, creating a single eCAP analysis device with reduced noise for the eCAP response measurement data.
Regarding Claims 9 and 32, Cholette in view of Hughes discloses as described above, The method of claim 1 and The method of claim 23, respectively. For the remainder of Claims 9 and 32, Cholette discloses wherein generating the result includes using a function ([0062] “The latency of the CAP (e.g., time between stimulus onset and the onset of P1) is typically about 100 μs to about 300 μsec.”; [0070] “latency may be determined along with conduction velocity for each of S-D1 and S-D2.”; Fig 7) that relates feature values with quantitative or qualitative ([0079] “relative indication…”) predicted degrees of inflammation or of myelination ([0079] “Latency (e.g., time between site 0 and another site) may be used as a relative indication of nerve demyelination and/or other nerve condition.”)
Regarding Claims 13 and 34, Cholette in view of Hughes discloses as described above, The method of claim 1 and The method of claim 23, respectively. For the remainder of Claims 13 and 34, Cholette discloses wherein the result further identifies a predicted degree of myelination or demyelination ([0079] “Latency (e.g., time between site 0 and another site) may be used as a relative indication of nerve demyelination and/or other nerve condition.”)
Regarding Claims 14 and 35, Cholette in view of Hughes discloses as described above, The method of claim 1 and The method of claim 23, respectively. For the remainder of Claims 14 and 35, Cholette discloses wherein the result further identifies a predicted degree to which a symptom or disease of the subject would be effectively treated by a remyelination therapy ([0095] “…determine if condition of the target nerve is worsening or improving…a disease may cause nerve condition to deteriorate while a therapy that treats the disease or its causes may improve nerve condition.”; [0023] “…some drugs can protect or promote regeneration of the nervous system…Cytoprotectants may prove useful for the treatment of…neurodegeneration and potentially other diseases and conditions.”)
Regarding Claim 26, Cholette in view of Hughes discloses as described above, The method of claim 23. For the remainder of Claim 26, Cholette discloses wherein the stimulation device ([0065] “electrodes implanted…”) is configured and positioned to deliver stimulation to a cochlear nerve of the subject ([0065] “uses electrodes implanted on the auditory nerve to deliver energy at various levels and to measure evoked responses for programming the cochlear implants of young children”).
Regarding Claim 37, Cholette in view of Hughes discloses as described above, The system of claim 36. For the remainder of Claim 37, Cholette discloses further comprising a stimulation device ([0035] “exemplary device 200”; Fig 2) configured to deliver stimulation pulses ([0035] “For delivery of activation energy, the device 200 includes one or more pulse generators 242, 244...one or more electrodes”; [0067] “delivering therapeutic stimulation energy to a nerve…square wave pulses at periodic intervals.”)
Regarding Claim 38, Cholette in view of Hughes discloses as described above, The system of claim 36. For the remainder of Claim 38, Cholette discloses further comprising a recording device configured to record evoked compound action potentials ([0042] “position two electrodes 294, 296 on a nerve to acquire nerve activity…”; [0067] “acquire one or more of these ECAPs”; Fig 6; Fig 7; Fig 10)(Examiner notes that based on the 12f interpretation, “a recording device configured to record” is deemed to claim “the one or more electrodes configured to record”.)
Claims 12 and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, as evidenced by Marrodan (“Spinal Cord Involvement in MS and Other Demyelinating Diseases”)
Regarding Claims 12 and 33, Cholette in view of Hughes discloses as described above, The method of claim 1 and The method of claim 23, respectively. For the remainder of Claims 12 and 33, Cholette discloses wherein the result further identifies a predicted degree of inflammation ([0079] “Latency (e.g., time between site 0 and another site) may be used as a relative indication of nerve demyelination and/or other nerve condition.”)(Examiner notes that as evidenced by Marrodan at [Page 2, “2. Multiple Sclerosis” Section] “MS is a chronic inflammatory disease of the CNS leading to demyelination, neurodegeneration, and gliosis.” Cholette discloses detecting “indication of nerve demyelination and/or other nerve condition,” and the broad degree of inflammation can be that there is a presence of inflammation. Based on Marrodan, inflammation is present when there is demyelination of the CNS due to MS.)
Claims 2 – 4, 10 - 11, and 41 - 43 are rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, further in view of Obradovic, et. al, (United States Patent Application Publication US 2016/0166164 A1), hereinafter Obradovic.
Regarding Claims 2 and 41, Cholette in view of Hughes discloses as described above, The method of claim 1 and The computer-program produce of claim 40, respectively. For the remainder of Claims 2 and 41, Cholette discloses each of the set of evoked compound action potentials ([0062] “CAP 510…an evoked CAP (ECAP); Fig 5; Fig 6, Fig 7, [0079] “obtaining a series of ECAPs”).
Cholette does not specifically disclose wherein each of the set of evoked compound action potentials includes an antidromic compound action potential.
Obradovic teaches an implantable device for monitoring for neural injury using stimulus electrodes and measuring eCAPs in the dromic and antidromic direction. Specifically for Claims 2 and 41, Obradovic teaches wherein each of the set of evoked compound action potentials includes an antidromic compound action potential ([0034] “ECAP propagation is in an antidromic direction from the stimulus electrodes to the sense electrodes.”).
Obradovic provides a motivation to combine at [0062] with “at a critical volume (0.6 ml) a trauma can clearly be detected in the observed ECAPs, as the ECAP amplitude dropped when propagating through the pressure site (524) in both the orthodromic and antidromic direction”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that obtaining measurements in the dromic (orthodromic) and antidromic directions would be useful for determining if an observed injury characteristic is influenced by propagation directionality.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the eCAP stimulation and measurement device for determining nerve integrity disclosed in Cholette with the measurement of eCAP propagation in both the dromic and antidromic directions taught by Obradovic, creating a single eCAP analysis device that can investigate directionality of eCAP propagation relative to injury mechanisms.
Regarding Claims 3 and 42, Cholette in view of Hughes discloses as described above, The method of claim 1 and The computer-program produce of claim 40, respectively. For the remainder of Claims 3 and 42, Cholette discloses each of the set of evoked compound action potentials ([0062] “CAP 510…an evoked CAP (ECAP); Fig 5; Fig 6, Fig 7, [0079] “obtaining a series of ECAPs”).
Cholette does not specifically disclose wherein each of the set of evoked compound action potentials includes a dromic compound action potential
Obradovic teaches wherein each of the set of evoked compound action potentials includes a dromic compound action potential ([0034] “…ECAP propagation is in an orthodromic direction from the stimulus electrodes to the sense electrodes.”)
The motivation for Claims 3 and 42 to combine Cholette with Obradovic is the same as that described in more detail in Claim 2 (and 41). In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the eCAP stimulation and measurement device for determining nerve integrity disclosed in Cholette with the measurement of eCAP propagation in both the dromic and antidromic directions taught by Obradovic, creating a single eCAP analysis device that can investigate directionality of eCAP propagation relative to injury mechanisms.
Regarding Claims 4 and 43, Cholette in view of Hughes discloses as described above, The method of claim 1 and The computer-program produce of claim 40, respectively. For the remainder of Claims 4 and 43, Cholette discloses stimulated at each of the set of stimulation times using an electrode ([0042] “…one or more electrodes for sensing nerve activity and/or stimulating a nerve”; Fig 6, [0067] “delivering…stimulation energy to a nerve…square wave pulses at periodic intervals”, “eCAPs 614”; Fig 3; Fig 7);.
Cholette does not specifically disclose wherein a spinal cord of the subject was stimulated at each of the set of stimulation times using an electrode positioned via percutaneous access to the spinal cord.
Obradavic teaches wherein a spinal cord of the subject was stimulated at each of the set of stimulation times ([0055] “delivery of appropriate stimulus to the nerve 180…spinal cord stimulator”; Fig 3, “pulse generator 124”; [0054] “current pulses…”) using an electrode positioned via percutaneous access to the spinal cord (Fig 1, [0052] “an implanted spinal cord stimulator 100…electronics module 110 implanted at a suitable location in the patient’s lower abdominal area or posterior superior gluteal region, and an electrode assembly 150 implanted…epidural space…”).
Cholette and Obradavic both disclose and teach implantable electrodes that are used to stimulate a nerve with pulses: Cholette with the implantable neurostimulation device for “delivering stimulation energy to a target nerve” in pulses at periodic intervals [Cholette: 0005], and Obradavic with “implanted spinal cord stimulator” and stimuli in the form of “current pulses” ([Obradavic 0054]). Obradavic provides a motivation to combine at [0056] with “Delivery of appropriate stimulus to the nerve 180…therapeutic purposes which in the case of spinal cord stimulator for chronic pain might be to create paraesthesia at a desired location.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that applying a stimulus to the spinal cord could be useful for easing chronic pain while obtaining measurements of eCAPs.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device disclosed in Cholette with Obradavic’s taught stimulus from electrodes specifically targeting the spinal cord, creating a single eCAP stimulus and analysis device that can be used to ease chronic pain via the spinal cord.
Regarding Claim 10, Cholette in view of Hughes discloses as described above, The method of claim 1. For the remainder of Claim 10, Cholette does not specifically disclose wherein the result is a category. Cholette does broadly disclose that a result of the eCAP feature analysis is a relative indication of nerve demyelination and/or other nerve condition, which could be broadly considered being a category of nerve demyelination.
Obradovic teaches wherein the result is a category ([0069] “…neural injury”; [0008] “If a change in the diagnostic parameter occurs over time, an indication is output that neural injury has occurred.”)(Examiner notes that the category is whether “neural injury” is present due to the condition of myelin sheaths of neurons. The category takes that data of the changing eCAP parameter and categorically makes a further conclusory output based on it. In this teaching, that the tissue is tissue with “neural injury”, as opposed to tissue without “neural injury”).
Obradovic provides a motivation to combine at [0027] with “compound action potential can be used to monitor for damage occurring to the neural pathway over time, and can in some embodiments be used to provide an essentially immediate diagnostic to rapidly detect the onset of the effects of neural injury.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that categorizing sensor data into a “neural injury” category would be useful for attributing a diagnostic condition to a patient, quickly communicating a potential need of treatment.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device that analyzes eCAP parameters to indicate nerve demyelination disclosed in Cholette with the output of “neural injury” based on eCAP parameter analysis taught by Obradovic, creating a single eCAP stimulus and analysis device that can be used to make a categorical diagnostic conclusion regarding nerve tissue injury from measured eCAP characteristics.
Regarding Claim 11, Cholette in view of Hughes discloses as described above, The method of claim 1. For the remainder of Claim 11, Cholette discloses further comprising:
stimulating the nerve of the subject using one or more electrodes at each of the set of stimulation times ([0042] “…one or more electrodes for sensing nerve activity and/or stimulating a nerve”; Fig 6, [0067] “delivering…stimulation energy to a nerve…square wave pulses at periodic intervals”, “eCAPs 614”; Fig 3; Fig 7);.; and
measuring the set of evoked compound action potentials ([0062] “CAP 510…an evoked CAP (ECAP); Fig 5; Fig 6, Fig 7, [0079] “obtaining a series of ECAPs”).
Cholette does not specifically disclose stimulating a spinal cord of the subject.
Obradavic teaches stimulating a spinal cord of the subject using one or more electrodes (Fig 1, [0052] “an implanted spinal cord stimulator 100…electronics module 110 implanted at a suitable location in the patient’s lower abdominal area or posterior superior gluteal region, and an electrode assembly 150 implanted…epidural space…”) at each of the set of stimulation times ([0055] “delivery of appropriate stimulus to the nerve 180…spinal cord stimulator”; Fig 3, “pulse generator 124”; [0054] “current pulses…”)
The motivation for Claim 11 to combine Cholette with Obradavic is the same as that described in more detail in Claim 4 (and 43). In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device disclosed in Cholette with Obradavic’s taught stimulus from electrodes specifically targeting the spinal cord, creating a single eCAP stimulus and analysis device that can be used to ease chronic pain via the spinal cord.
Claims 7 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, further in view of Laudanski et. al., (United States Patent Application Publication US 2015/0264492 A1), hereinafter Laudanski.
Regarding Claims 7 and 46, Cholette in view of Hughes discloses as described above, The method of claim 1 and The computer-program produce of claim 40, respectively. For the remainder of Claims 7 and 46, Cholette discloses wherein the one or more electrodes ([0042] “…one or more electrodes for sensing nerve activity and/or stimulating a nerve”) were positioned on the subject to collect the set of evoked compound action potentials ([0062] “CAP 510…an evoked CAP (ECAP); Fig 5; Fig 6, Fig 7, [0079] “obtaining a series of ECAPs”).
Cholette does not specifically disclose wherein the set of evoked compound action potentials include signals from a brain of the subject.
Laudanski teaches a set of recording electrodes for measuring eCAPs from a subject’s scalp for hearing assessment. Specifically for Claims 7 and 46, Laudanski teaches wherein the set of evoked compound action potentials include signals from a brain of the subject ([0024] “’evoked’ responses can…be captured…brain wave signals…by recording electrodes,”,”Such evoked responses can e.g. be in the form of…electrically evoked compound action potentials (eCAPs)”).
Laudanski provides a motivation to combine at [0085] with “measuring the response of the auditory system/brain to a signal that is designed to mimic an acoustic sound that moves from one side to the other relative to a listener's ears. This is achieved by the proposed method of designing stimulation signals and the accompanying measurement method…“ A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using electrodes positioned on the head of subject measuring eCAPs would be useful to obtain measurements to analyze auditory processing.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention combine the implantable neurostimulation and eCAP analysis device disclosed in Cholette with the scalp-attached electrodes to capture eCAPs from the brain taught by Laudanski, creating a single eCAP stimulus and analysis device with scalp-mounted sensors that can be used to analyze a subject’s auditory processing.
Claims 8 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, further in view of Ramekers et. al., “Changes in the Electrically Evoked Compound Action Potential over time After Implantation and Subsequent Deafening in Guinea Pigs”, hereinafter Ramekers.
Regarding Claims 8 and 31, Cholette in view of Hughes discloses as described above, The method of claim 1 and The method of claim 23, respectively. For the remainder of Claims 8 and 31, Cholette discloses quantitative or qualitative predicted degrees of inflammation or of myelination ([0079] “Latency (e.g., time between site 0 and another site) may be used as a relative indication of nerve demyelination and/or other nerve condition.”; [0062] “The latency of the CAP (e.g., time between stimulus onset and the onset of P1) is typically about 100 μs to about 300 μsec.”).
Cholette does not specifically disclose wherein generating the result includes using a look-up table that associates various feature values with quantitative or qualitative predicted degrees of inflammation or of myelination.
Ramekers teaches eCAP measurements relative to mammalian nerve damage, with measurements being taken pre- and post-deafening nerve damage for the subjects. Specifically for Claims 8 and 31, Ramekers teaches wherein generating the result includes using a look-up table (Table 1; rmANOVA results for absolute eCAP characteristics, related Latency to Pre-deafening and Post-deafening conditions)(Examiner notes that the researchers use a look-up table to communicate their results associated with eCAP characteristics and nerve damage.) that associates various feature values with quantitative or qualitative predicted degrees of inflammation or of myelination (Table 1; rmANOVA results for absolute eCAP characteristics, related eCAP characteristics to Pre-deafening and Post-deafening conditions of the nerve; “Our results suggest that gradual changes in peak width and latency reflect the rate of neural degeneration“).
Ramekers provides a motivation to combine at [Page 665, Right Column, Top] “Our results suggest that gradual changes in peak width and latency reflect the rate of neural degeneration…which may be valuable for clinical diagnostics.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that a collection of measured research results in table form, such as eCAP characteristic measurements (for example, latency times) associated with healthy nerves and nerve injury, would be useful for making diagnostic conclusions from numeric eCAP measurement results. While Ramekers is reporting results for eCAPs in guinea pigs, the procedure teaches obtaining data from a subject’s nerve without neuronal injury and data from a subject’s nerve with neuronal injury, and reporting that information in a table that can be used as a reference for the differences in quantitative eCAP data that could indicate neuronal degeneration (for example, the eCAP latency duration being significantly higher with neuronal damage). Cholette already reports “typical” eCAP latency results for not-damaged nerves, and it discloses that latency can be used as a relative indication of nerve demyelination, information of which could be organized in a table for reference like Ramekers’.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Cholette’s disclosed eCAP measurements and analysis device that determines relative indication of nerve demyelination using latency from eCAP with Ramekers’ teaching of a table-format of eCAP data results relative to neuronal injury, creating a single eCAP stimulus and analysis device that uses a table to help determine if measured eCAP characteristics indicate nerve demyelination.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, further in view of Coelho (“Immunomodulator FTY720 Has a Direct Cytoprotective Effect in Oligodendrocyte Progenitors”)
Regarding Claim 15, Cholette in view of Hughes discloses as described above, The method of claim 14. For the remainder of Claim 15, Cholette discloses wherein the remyelination therapy is a particular remyelination therapy [0023] “…some drugs can protect or promote regeneration of the nervous system…Cytoprotectants may prove useful for the treatment of…neurodegeneration and potentially other diseases and conditions.”)(Examiner notes that the therapy is broadly particular in that it is a cytoprotectant drug therapy, as opposed to another type of therapy that could be used.)
Cholette does not specifically disclose that uses a particular active ingredient.
Coelho teaches that the immunomodulator FTY720 has a direct cytoprotective effect in oligodendrocyte progenitors, as applied to treatment for demyelination in multiple sclerosis. Specifically for Claim 15, Keough teaches a remyelination therapy that uses a particular active ingredient ([Page 634, Right Column, Top] “FTY720 treatment for MS should include the use of remyelinating agents such as NT-3…”;Title: “Immunomodulator FTY720 Has a Direct Cytoprotective Effect in Oligodendrocyte Progenitors”; [Page 632, “FTY720 Protects OLG Progenitors from Cell Death Induced by Cytokines and Microglial Activation” Section]).
Cholette and Coelho both disclose and teach cytoprotectants for treatment of neurodegeneration, Cholette broadly at [Cholette: 0023] and Coelho specifically with the cytoprotectant FTY270 with NT-3 remyelination therapy. Coelho provides a motivation to combine at [Page 624, Right Column, Top] with “…FTY720 treatment for MS should include the use of remyelinating agents such as NT-3. This therapeutic approach would ensure both protection of existing OLG progenitor pools against immune mediated insults as well as stimulation of remyelination by enhancing the differentiation of these cells.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using this FTY720 treatment for MS with NT-3 would be useful as a cytoprotectant and to treat demyelination that is detected in a subject through examination.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the categorically-described cytoprotectant for treatment of demyelination disclosed in Cholette with the specific FTY270 with NT-3 cytoprotectant remyelination therapy taught by Coelho, creating a single eCAP stimulus and analysis device that can measure efficacy of treatment of demyelination using a FTY270 with NT-3 cytoprotectant remyelination therapy to help oversee a patient’s treatment progress.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, further in view of Berenpas et. al., “Long-term use of implanted peroneal functional electrical stimulation for stroke-affected gait: the effects on muscle and motor nerve”, hereinafter Berenpas.
Regarding Claim 24, Cholette in view of Hughes discloses as described above, The method of claim 23. For the remainder of Claim 24, Cholette discloses the stimulation device ([0105] “ implantable neurostimulation device”) is configured and positioned to deliver stimulation to the nerve ([0051] “…a CAP 322 may be initiated on a peripheral nerve by an electrical stimulus 321 applied to the nerve at some point at a distance from the recording site.”; Fig 3).
Cholette does not specifically disclose wherein the stimulation device is a Functional Electrical Stimulation device that is configured and positioned to deliver stimulation to a paretic peroneal nerve. Cholette is open to deliver stimulation to a paretic peroneal nerve as disclosed at [0051] with “As shown in FIG. 3, a CAP 322 may be initiated on a peripheral nerve by an electrical stimulus 321 applied to the nerve at some point at a distance from the recording site.”
Berenpas teaches a Functional Electrical Stimulation device that is used to stimulate the peroneal nerve for therapy of stroke-related foot drop symptoms. Specifically for Claim 24, Berenpas teaches wherein the stimulation device is a Functional Electrical Stimulation device ([Page 3, Left Column, 1st Paragraph and section heading] “ActiGait® implanted FES system: The ActiGait® system is an implantable 4-channel peroneal nerve stimulator”) that is configured and positioned to deliver stimulation to a paretic peroneal nerve ([Page 2, Left Column, 1st Full Paragraph] “With peroneal FES, paretic dorsiflexor muscles are electrically activated during the swing phase and early stance of the gait cycle, resulting in an ‘active’ foot elevation”).
Cholette and Berenpas both disclose and teach implanted electrode-based devices that stimulate nerves for therapeutic purposes: Cholette with implantable neurostimulation device for “delivering stimulation energy to a target nerve” for nerve stimulation therapy and Berenpas with implanted FES to stimulate the paretic peroneal nerve to treat muscular changes following supratentorial stroke. Berenpas provides a motivation to combine at [Page 9, Left Column, “Conclusion” Section] “we have shown that structural changes to muscles following supratentorial stroke are reversible with implanted peroneal FES”. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that implanting electrodes to stimulate specifically the peroneal nerve would be useful for treating stroke-related foot drop.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device disclosed in Cholette with Berenpas’ taught stimulus from electrodes specifically targeting the paretic peroneal nerve, creating a single eCAP stimulus and analysis device that can be used to treat foot drop for persons with stroke-affected gait by stimulating the peroneal nerve.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, further in view of Offutt, et. al., (United States Patent Application Publication US 2022/0331586 A1), hereinafter Offutt.
Regarding Claim 25, Cholette in view of Hughes discloses as described above, The method of claim 23. For the remainder of Claim 25, Cholette discloses wherein the stimulation device is configured and positioned to deliver stimulation ([0042] “…one or more electrodes for sensing nerve activity and/or stimulating a nerve”)
Cholette does not specifically disclose wherein the stimulation device is configured and positioned to deliver stimulation to a sacral nerve of the subject.
Offutt teaches a neurostimulation device for electric stimulation therapy using eCAPs for therapy for pain, bladder and/or bowel dysfunction, and other therapeutic benefits. Specifically for Claim 25, Offutt teaches wherein the stimulation device is configured and positioned to deliver stimulation to a sacral nerve of the subject. (Fig 1; [0041] “..stimulation-evoked signal…a compound action potential such as an ECAP…”, “signal sources may include nerves such as sacral nerves”; [0047] “a neurostimulation device configured to deliver sacral neuromodulation (SNM).”)
Cholette and Offutt both disclose and teach implanted electrode-based devices that stimulate nerves for therapeutic purposes: Cholette with implantable neurostimulation device for “delivering stimulation energy to a target nerve” for nerve stimulation therapy and Offutt with implanted electrical leads to stimulate the sacral nerve to activate muscles in the pelvic floor and foot for bladder-related therapy. Offutt provides a motivation to combine at [0029] with “Electrical stimulation therapy, e.g., sacral nerve stimulation, tibial nerve stimulation, and/or other types of invasive or noninvasive neuromodulation, may provide bladder and/or bowel dysfunction therapy, pain relief and/or other therapeutic benefits,” and “stimulation of sacral nerves through electrical leads implanted near sacral nerves via sacral neuromodulation may evoke a neural response in adjacent nerves, muscle contractions within the pelvic floor, and distal contractions in the foot.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that implanting electrodes to stimulate specifically the sacral nerve would be useful for treating bladder-related dysfunctions.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the implantable neurostimulation device disclosed in Cholette with Berenpas’ taught stimulus from electrodes specifically targeting the sacral nerve, creating a single eCAP stimulus and analysis device that can be used to treat bladder dysfunction by stimulating the sacral nerve.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Cholette in view of Hughes, further in view of Cassar et. al., (United States Patent Application Publication US 2022/0111213 A1), hereinafter Cassar.
Regarding Claim 27, Cholette in view of Hughes discloses as described above, The method of claim 23. For the remainder of Claim 27, Cholette discloses further comprising: adjusting parameters that the stimulation device delivers based on the result ([0084] “clinician may optionally adjust one or more operational parameters of a therapeutic and/or a diagnostic process based at least in part on such presented information.”; [0093] “a therapy may be adjusted…”)
Cholette does not specifically disclose automatically adjusting an intensity of the stimulations. Cholette does broadly disclose that the therapy stimulation parameters can be adjusted by the clinician based on the eCAP measurements. Further, as recited, a broad interpretation of automatically could be a human making the parameter adjustment based on the information without hesitation, or automatically.
Cassar teaches systems and methods to adjust stimulation parameters of neuromodulation therapy using evaluation of features of eCAPs. Specifically for Claim 27, Cassar teaches further comprising: automatically [0045] “the shape or characteristics of the EP can be used…as a part of feedback control during stimulation (e.g., ongoing closed-loop stimulation)…tuning through the use of an automated algorithm”; [0055] “algorithm can thus be designed to sweep through each possible stimulation amplitude and/or pulse width and find the setting(s) that induce the highest cEP magnitude that is beyond a desired latency.”) adjusting an intensity of stimulations that the stimulation device delivers based on the result [0038] “EPs are also referred to as evoked compound action potential (ECAP)…For the purposes of the present disclosure, the term “evoked potential” refers to any of these types of recordings.”; [0052] “the EP…quantitative biomarker to aid in stimulation parameter selection…selecting the stimulation…amplitude”; [0055] “EP may also be used to help determine the optimal stimulation amplitude and/or pulse width…”; [0057] “at least one stimulation parameter can be altered with respect to the reference EP recording…stimulation parameters that can be altered…stimulation amplitude”)
Cholette and Cassar both disclose and teach implanted neurostimulation devices that use features of measured eCAPs to dictate adjustments to stimulation parameters: Cholette with using analysis of eCAP data to provide information for clinicians to adjust stimulation parameters of the neurostimulation device, and Cassar with “characteristics of the EP” used as feedback control to adjust stimulation parameters. Cassar provides a motivation to combine at [0004] with “Therefore, the changes in the shape and characteristics of the EP provide a proxy for changes in symptoms produced by application of stimulation relief,” [0043] “ embodiments of the present disclosure include examples of the utility of using the shape and/or characteristics of the EP as a means to evaluate, select, and/or adjust one or more stimulation parameter settings” and [0004] “…proper “dose” of the therapy. Dose…is determined by the electrical stimulation settings or stimulation parameters that are delivered.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using the eCAP characteristics to inform the stimulation parameters, or “dose” of neuromodulation treatment, would be useful for attaining more effective therapeutic outcomes for patients.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Cholette’s disclosed suggestion of stimulation parameter adjustment by clinicians from the implantable neurostimulation device’s eCAP analysis with Cassar’s taught automated algorithmic feedback adjustment of stimulation intensity parameters based on eCAP characteristics, creating a single eCAP stimulus and analysis device that can use information from measured eCAPs for feedback control of stimulation parameter adjustment, increasing treatment efficacy for patients.
Regarding Claim 28, Cholette in view of Hughes discloses as described above, The method of claim 23. For the remainder of Claim 28, Cholette discloses further comprising: adjusting parameters that the stimulation device delivers based on the result ([0084] “clinician may optionally adjust one or more operational parameters of a therapeutic and/or a diagnostic process based at least in part on such presented information.”; [0093] “a therapy may be adjusted…”)
Cholette does not specifically disclose automatically adjusting a frequency of the stimulations. Cholette does broadly disclose that the therapy stimulation parameters can be adjusted by the clinician based on the eCAP measurements. Further, as recited, a broad interpretation of automatically could be a human making the parameter adjustment based on the information without hesitation, or automatically.
Cassar teaches further comprising: automatically [0045] “the shape or characteristics of the EP can be used…as a part of feedback control during stimulation (e.g., ongoing closed-loop stimulation)…tuning through the use of an automated algorithm”; adjusting a frequency of stimulations that the stimulation device delivers based on the result [0038] “EPs are also referred to as evoked compound action potential (ECAP)…For the purposes of the present disclosure, the term “evoked potential” refers to any of these types of recordings.”; [0052] “the EP…quantitative biomarker to aid in stimulation parameter selection…selecting the stimulation…frequency”; [0050] “Using the EP to Update the Stimulation Pulse Repetition Frequency… stimulation pulse repetition frequency can be switched…dependent on one or more features of the EP.”; [0057] “at least one stimulation parameter can be altered with respect to the reference EP recording…stimulation parameters that can be altered…stimulation pulse repetition frequency”)
The motivation for Claim 28 to combine Cholette with Cassar is the same as that described in more detail in Claim 27. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Cholette’s disclosed suggestion of stimulation parameter adjustment by clinicians from the implantable neurostimulation device’s eCAP analysis with Cassar’s taught automated algorithmic feedback adjustment of stimulation frequency parameters based on eCAP characteristics, creating a single eCAP stimulus and analysis device that can use information from measured eCAPs for feedback control of stimulation parameter adjustment, increasing treatment efficacy for patients.
Response to Arguments
Applicant's arguments filed 04 May 2026 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. 101 Rejections:
Applicant argues at [Page 10, “Step 2A, Prong One” Section] – [Page 11, Paragraph 3] that claim 1 is not directed to an abstract idea because it pertains to generating a location-specific imaging result which is inherently tied to a physical structure of the subject analogous to other forms of medical imaging that map biological conditions to specific anatomic locations. Examiner notes that the physical structure of a subject is not patentable subject matter, as discussed above under the 35 U.S.C. 101 rejections (See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Regarding the imaging result, as recited, the broad “generating a location-specific result based on the latency” and “outputting the location-specific imaging result” limitations could be a performed by a researcher drawing a rough diagram of a spinal column, circles for the approximate locations of the attached electrodes, and a numeric latency results with arrows between the latency value-associated electrodes. The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper.
Further, the generic recitation of generating an image to report data represents extra-solution activity because it is a mere nominal or tangential addition to the claim. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity, for instance the step of printing a menu that was generated through an abstract process in Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1241-42 (Fed. Cir. 2016) and the mere generic presentation of collected and analyzed data in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016). The argument is not persuasive.
Applicant argues at [Page 11, Paragraph 1] that the transformation from time-domain signal data to location-resolved imaging output cannot be performed as a mental process or data interpretation as it requires a specialized technical operation grounded in physiological measurement and spatial mapping. There is nothing particular recited in the claims of a specialized technical operation to generate the location-specific imaging output. As discussed above, the “generating a location-specific result based on the latency” and “outputting the location-specific imaging result” limitations could be a performed by a researcher drawing a rough diagram of a spinal column with labeled results on paper. The argument is not persuasive.
Applicant argues at [Page 11, “Step 2A, Prong Two” Section, Paragraph 1] that claim 1 generates a clinically actionable, spatially defined result that corresponds to physical structures in the body, so it is not directed to merely analyzing data or identifying relationships. As noted above, the physical structure of a subject is not patentable subject matter, as discussed above under the 35 U.S.C. 101 rejections (See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims recite a series of limitations that encompass an abstract idea of manipulating variables obtained from electronic components used in a usual way, and that variable manipulation can be accomplished with the aid of time, equations, and paper. The argument is not persuasive.
Applicant argues at [Page 11, “Step 2A, Prong Two” Section, Paragraph 1] the claimed method is a real-world application that transforms raw biological signals into a different state, an imaging result rooted in the physical properties of nerve conduction, and not “disembodied data analysis. As discussed above, the generic recitation of generating an image to report data represents extra-solution activity because it is a mere nominal or tangential addition to the claim. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity, for instance the step of printing a menu that was generated through an abstract process in Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1241-42 (Fed. Cir. 2016) and the mere generic presentation of collected and analyzed data in Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354 (Fed. Cir. 2016). The recited abstract ideas do not improve the function of any of the recited hardware elements of the electrodes, stimulation device, non-transitory computer readable storage medium, or processors. The argument is not persuasive.
Regarding the 35 U.S.C. 103 Rejections:
Applicant argues at [Page 12, Whole Page] that the cited art does not recite the amended features of “determining an occurrence of latency…using the one or more signal characteristics” and “generating a location specific imaging result based on the latency…identifies a location of demyelination or remyelination.” Based on the citations in the 35 U.S.C. 103 Rejection above, Cholette discloses these features. The argument is not persuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA J MONTGOMERY whose telephone number is (571)272-2305. The examiner can normally be reached Monday - Friday 7:30 - 5:00 ET.
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/MELISSA JO MONTGOMERY/ Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
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