DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 6, 2026 has been entered.
This Office action is responsive to an amendment filed December 9, 2025. Claims 1-9 & 11-20 are pending. Claim 10 has been canceled. Claims 1, 13 & 15 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 22, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-9 & 11-20 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regards to claim 1, at lines 13, 20 & 22, the limitations “the subset” renders the claim indefinite; for example, from the limitations “at least a subset” at line 11 of the claim, it is unclear whether or not the claim requires one or more than one subset. The Office suggests that Applicant amend the claim to read --the at least a subset--.
In regards to claim 15, at lines 10, 17 & 19, the limitations “the subset” renders the claim indefinite; for example, from the limitations “at least a subset” at lines 7-8 of the claim, it is unclear whether or not the claim requires one or more than one subset. The Office suggests that Applicant amend the claim to read --the at least a subset--.
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 1-9 & 11-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1 recite(s), at least in part the following step(s): “determining, based on the plurality of resultant electrical waveforms, whether at least a subset of the plurality of resultant electrical waveforms includes a patient physiological response,” “comparing the subset of resultant electrical waveforms of the plurality of resultant electrical waveforms to a model waveform selected from a database of a plurality of model waveforms, the plurality of model waveforms derived from predicted physiological responses and an ensemble average of noise candidates” and “determining, based on the comparison, a comparison feature, the comparison feature indicating whether the patient physiological response exists in the subset of resultant electrical waveforms.” These step(s), when given its/their broadest reasonable interpretation(s), describe(s) carrying out said step(s) mentally (i.e., a mental task in the human mind), and/or by a mathematical process but for the recitation of generic computer components. In other words, absent the recitation of “at least one processor,” “database” and “at least one memory storing instructions…executed by the at least one data processor,” nothing precludes the claimed step from practically being performed mentally (i.e. a mental task in the human mind), and/or by a mathematical process (as evidenced at least by claim 9). For example, absent the limitation(s) “at least one processor,” “from a database” and “at least one memory storing instructions…executed by the at least one data processor” in the step(s), the “determining…,” “comparing…” and “determining…” in the step(s) involves the user manually using pen and paper, mentally, visually and/or by a mathematical process, function, or equation “determining…,” “comparing…” and “determining....” In view of the foregoing, claim(s) 1 recite(s) an abstract idea.
For example, the following caselaw: Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016) contains the following analysis: “Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S. 437, 451 n.12 (2007). Accordingly, we have treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon. com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). In a similar vein, we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Diamond v. Diehr, 450 U.S. 175 (1981). And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular assertedly inventive technology for performing those functions. They are therefore directed to an abstract idea.” [Emphasis added].
The judicial exception(s) is/are not integrated into a practical application. Particularly, the claim(s) recite(s) the following additional element(s): “at least one processor,” “a database” and “at least one memory storing instructions…executed by the at least one data processor.” Neither the arrangement of the additional elements, nor the additional elements themselves, apply, rely on, or use the judicial exception recited supra in a manner that imposes a meaningful limit on the judicial exception. Rather, the additional element(s) is/are recited with a high level of generality (i.e., as a generic data collection means performing a generic data collection function such as stimulating, via a stimulating electrode configured to be coupled to a patient, one or more nerves of the patient and recording, via a recording electrode configured to be coupled to the patient, a plurality of resultant electrical waveforms, a generic data display means performing a generic display function such as displaying, via a display, an indication when the patient physiological response exists in the subset of resultant electrical waveforms, and/or a generic computer performing a generic computer function such as executing instructions stored in a memory) such that it amounts to no more than instructions to apply the exception using a generic computer component. Therefore, the additional element(s) does not integrate the exception(s) into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea and/or law of nature.
The claim(s) include(s) the additional step(s)/element(s) recited above. The additional step(s)/element(s) are not sufficient to amount to significantly more than the judicial exception(s) since such additional step(s)/element(s) are generically claimed to enable an insignificant extra-solution activity including the collection of data by performing the basic functions of: (i) receiving, processing, and/or calculating data, and/or (ii) automating mental tasks and/or a mathematical process. The courts have recognized these functions to be well-understood, routine, and conventional functions when claimed in a merely generic manner. Therefore, the Office takes Official notice that the instantly claimed additional steps/elements are well-understood, routine and convention (see for example, par 0007 of US 2004/0254494). Merely adding hardware that performs ‘“well understood, routine, conventional activities]’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). In other words, the additional step(s)/element(s) amount(s) to no more than mere instructions to apply the exception(s) using generic computer component(s). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Accordingly, Claim(s) 1 do(es) not amount to significantly more than the abstract idea itself.
In regards to claim(s) 2-3, 5-9, 11-12 & 14, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application and/or providing additional elements that are sufficient to amount to significantly more than the judicial exception for reasons provided supra.
In regards to claim(s) 4 & 13, the claimed invention(s) further recite(s) additional element(s) that do(es) not integrate the judicial exception into a practical application and is/are not sufficient to amount to significantly more than the judicial exception for the reasons provided supra.
Claim(s) 15 recite(s), at least in part the following step(s): “determining, based on the plurality of resultant electrical waveforms, whether at least a subset of the plurality of resultant electrical waveforms includes a patient physiological response,” “comparing the subset of resultant electrical waveforms of the plurality of resultant electrical waveforms to a model waveform from a database of a plurality of model waveforms, the plurality of model waveforms based at least in part on predicted phvsiological responses and an ensemble average of noise candidates”; and “determining, based on the comparison, a comparison feature, the comparison feature indicating whether the patient physiological response exists in the subset of resultant electrical waveforms.” These step(s), when given its/their broadest reasonable interpretation(s), describe(s) carrying out said step(s) mentally (i.e., a mental task in the human mind), and/or by a mathematical process but for the recitation of generic computer components. In other words, absent the recitation of a database, nothing precludes the claimed step from practically being performed mentally (i.e. a mental task in the human mind), and/or by a mathematical process. For example, absent the limitation(s) “a database” in the step(s), the “determining…,” “comparing…” and “determining…” in the step(s) involves the user manually using pen and paper, mentally, visually and/or by a mathematical process, function, or equation “determining…,” “comparing…” and “determining…” In view of the foregoing, claim(s) 15 recite(s) an abstract idea.
For example, the following caselaw: Elec. Power Grp., LLC v. Alstom S.A. (Fed. Cir. 2016) contains the following analysis: “Information as such is an intangible. See Microsoft Corp. v. AT & T Corp., 550 U.S. 437, 451 n.12 (2007). Accordingly, we have treated collecting information, including when limited to particular content (which does not change its character as information), as within the realm of abstract ideas. See, e.g., Internet Patents, 790 F.3d at 1349; OIP Techs., Inc. v. Amazon. com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015). In a similar vein, we have treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category. See, e.g., TLI Commc’ns, 823 F.3d at 613; Digitech, 758 F.3d at 1351; SmartGene, Inc. v. Advanced Biological Labs., SA, 555 F. App’x 950, 955 (Fed. Cir. 2014); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Canada (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012); CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372 (Fed. Cir. 2011); SiRF Tech., Inc. v. Int’l Trade Comm’n, 601 F.3d 1319, 1333 (Fed. Cir. 2010); see also Mayo, 132 S. Ct. at 1301; Parker v. Flook, 437 U.S. 584, 589–90 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Diamond v. Diehr, 450 U.S. 175 (1981). And we have recognized that merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis. See, e.g., Content Extraction, 776 F.3d at 1347; Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 715 (Fed. Cir. 2014). Here, the claims are clearly focused on the combination of those abstract-idea processes. The advance they purport to make is a process of gathering and analyzing information of a specified content, then displaying the results, and not any particular assertedly inventive technology for performing those functions. They are therefore directed to an abstract idea.” [Emphasis added].
The judicial exception(s) is/are not integrated into a practical application. Particularly, the claim(s) recite(s) the following additional element(s): “stimulating, via a stimulating electrode coupled to a patient, one or more nerves of the patient,” “recording, via a recording electro coupled to the patient, a plurality of resultant electrical waveforms,” “a database” and “displaying, via a display, an indication that the patient physiological response exists in the subset of resultant electrical waveforms.” Neither the arrangement of the additional elements, nor the additional elements themselves, apply, rely on, or use the judicial exception recited supra in a manner that imposes a meaningful limit on the judicial exception. Rather, the additional element(s) is/are recited with a high level of generality (i.e., as a generic data collection means (e.g., electrodes) performing a generic data collection function such as stimulating one or more nerves of the patient and recording a plurality of resultant electrical waveforms, a generic data display means performing a generic display function such as displaying an indication that the patient physiological response exists in the subset of resultant electrical waveforms, and/or a generic computer component (e.g., database) performing a generic computer function such as storing model waveforms) such that it amounts to no more than instructions to apply the exception using a generic computer component. Therefore, the additional element(s) does not integrate the exception(s) into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea and/or law of nature.
The claim(s) include(s) the additional step(s)/element(s) recited above. The additional step(s)/element(s) are not sufficient to amount to significantly more than the judicial exception(s) since such additional step(s)/element(s) are generically claimed to enable an insignificant extra-solution activity including the collection of data by performing the basic functions of: (i) receiving, processing, and/or calculating data, and/or (ii) automating mental tasks and/or a mathematical process. The courts have recognized these functions to be well-understood, routine, and conventional functions when claimed in a merely generic manner. Therefore, the Office takes Official notice that the instantly claimed additional steps/elements are well-understood, routine and convention (see for example, par 0007 of US 2004/0254494). Merely adding hardware that performs ‘“well understood, routine, conventional activities]’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). In other words, the additional step(s)/element(s) amount(s) to no more than mere instructions to apply the exception(s) using generic computer component(s). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Accordingly, Claim(s) 15 do(es) not amount to significantly more than the abstract idea itself.
In regards to claim(s) 16-17 & 19-20, the claimed invention further describes the judicial exception in detail without however integrating said judicial exception into a practical application and/or providing additional elements that are sufficient to amount to significantly more than the judicial exception for reasons provided supra.
In regards to claim(s) 18, the claimed invention(s) further recite(s) additional element(s) that do(es) not integrate the judicial exception into a practical application and is/are not sufficient to amount to significantly more than the judicial exception for the reasons provided supra.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-7, 9, 12-17 & 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kent et al. (US 2018/0140843) (“Kent” hereinafter).
In regards to claim 1, Kent discloses a stimulation system (e.g., NS system 100 shown in fig. 1C) for detecting and identifying a patient physiological response (e.g., candidate response function or resultant response function) (see at least par 0038-0040), the stimulation system (e.g., NS system 100 shown in fig. 1C) comprising:
at least one processor (e.g., one or more processors from controller 151 shown in fig. 1C and par 0062 and CPU 1402 from external device 1400, shown in fig. 9, which may be the same as the external device 160 of NS system 100, see par 0136-0137); and
at least one memory (e.g., memory 158 from NS system 100 shown in fig. 1C and par 0062 and ROM 1404, RAM 1406 and hard drive 1408 of external device 1400, shown in fig. 9, which may be the same as the external device 160 of NS system 100, see par 0136) storing instructions which, when executed by the at least one data processor (e.g., one or more processors from controller 151 shown in fig. 1C and par 0062 and CPU 1402 from external device 1400, shown in fig. 9, which may be the same as the external device 160 of NS system 100, see par 0136-0137), result in operations comprising:
stimulating, via a stimulating electrode 121a-d (see at least fig. 1C and par 0061, 0064, 0078 & 0082) configured to be coupled to a patient, one or more nerves of the patient;
recording, via a recording electrode 121a-d (e.g., stimulating electrodes also act as sensing electrodes, see at least fig. 1C and par 0061, 0064, 0078 & 0082) configured to be coupled to the patient, a plurality of resultant electrical waveforms (e.g., collecting an ensemble of evoked potential waveforms, see at least par 0084, 0087 & 0093-0094);
determining, based on the plurality of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094), whether at least a subset of the plurality of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094) includes a patient physiological response (e.g., candidate or resultant response function) (see at least fig. 3B and par 0095), the determining comprising:
comparing the subset of resultant electrical waveforms of the plurality of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094) to a model waveform (e.g., candidate or potential response function that exhibits desirable characteristics, at least par 0133-0134) selected from a database of a plurality of model waveforms (e.g., collection of candidate response functions, see par 0009-0012, 0093 & 0095, and/or template(s) for potential response function(s), see at least par 0100), the plurality of model waveforms (e.g., collection of candidate response functions, see par 0009-0012, 0093 & 0095 and/or template(s) for potential response function(s), see at least par 0100) derived from predicted physiological responses (i.e., based on similarities and/or differences between the input stimulation waveform and evoked neural responses using cross-correlation or deconvolution, see par 0009, 0012, 0039, 0088-0089, 0093 & 0111) and an ensemble average of noise candidates (see at least par 0085-0086, 0088, 0090 & 0094); and
determining, based on the comparison, a comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135), the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) indicating whether the patient physiological response (e.g., candidate or resultant response function) exists in the subset of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094); and
displaying, via a display 1422 (see fig. 9 and par 0136 & 0138), an indication (see par 0104) when the patient physiological response (e.g., candidate response function or resultant response function) exists in the subset of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094).
In regards to claim 2, Kent discloses the system of claim 1, wherein the model waveform (e.g., candidate or potential response function that exhibits desirable characteristics, at least par 0133-0134) comprises a predicted physiological response (i.e., based on similarities and/or differences between the input stimulation waveform and evoked neural responses using cross-correlation or deconvolution, see par 0009, 0012, 0039, 0088-0089, 0093 & 0111) and an ensemble average of a plurality of artifact signals (e.g., after repeated stimulation, the one or more processors calculate an ensemble average of the EP waveforms associated with a current stimulation waveform, which provide substantial noise or artifact signals cancellation due to averaging, see par 0085, 0088, 0090 & 0094).
In regards to claim 3, Kent discloses the system of claim 2, wherein the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) further indicates whether an artifact signal exists in the subset of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094), the artifact signal generated by noise (e.g., after repeated stimulation, the one or more processors calculate an ensemble average of the EP waveforms associated with a current stimulation waveform, which provide substantial noise or artifact signals cancellation due to averaging, see par 0085, 0088, 0090 & 0094).
In regards to claim 6, Kent discloses the system of claim 1, wherein the determination of whether the plurality of resultant electrical waveforms includes the patient physiological response (e.g., candidate response function or resultant response function) further comprises:
determining that the patient physiological response (e.g., candidate response function or resultant response function) exists when the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) of the subset of electrical waveforms is within a threshold range of a threshold value of the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135).
In regards to claim 7, Kent discloses the system of claim 6, wherein the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and/or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) comprises a correlation (i.e., similarity) between the subset of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094) and the model waveform (e.g., candidate or potential response function that exhibits desirable characteristics, at least par 0133-0134).
In regards to claim 9, Kent discloses the system of claim 1, wherein the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and/or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) represents a comparison of a morphology (e.g., shape) of the subset of resultant electrical waveforms to a morphology (e.g., shape) of the model waveform (e.g., candidate or potential response function that exhibits desirable characteristics, at least par 0133-0134).
In regards to claim 12, Kent discloses the system of claim 1, wherein the subset of the plurality of resultant electrical waveforms (e.g., an ensemble of evoked potential (EP) waveforms, see at least par 0084, 0087 & 0093-0094) are time-locked (see at least par 0089).
In regards to claim 13, Kent discloses the system of claim 1, wherein the stimulating comprises transmitting a plurality of electrical stimuli (see at least fig. 1C and par 0061, 0064, 0078 & 0082); and
wherein the stimulating electrode 121a-d (see at least fig. 1C and par 0061, 0064, 0078 & 0082) is in communication with an evoked potential detection device 159 (see fig. 1C and par 0061) configured to monitor the one or more peripheral nerves of the patient (e.g., stimulating electrodes also act as sensing electrodes, see at least fig. 1C and par 0061, 0064, 0078 & 0082).
In regards to claim 14, Kent discloses the system of claim 13, wherein the plurality of resultant electrical waveforms is received by the evoked potential detection device 159 (see fig. 1C and par 0061), the resultant electrical waveforms generated by the patient in response to the electrical stimuli (e.g., stimulating electrodes also act as sensing electrodes, see at least fig. 1C and par 0061, 0064, 0078 & 0082).
In regards to claim 15, Kent discloses a method for detecting and identifying a patient physiological response (e.g., candidate response function or resultant response function) (see at least par 0038-0040), the method comprising:
stimulating, via a stimulating electrode 121a-d (see at least fig. 1C and par 0061, 0064, 0078 & 0082) coupled to a patient, one or more nerves of the patient;
recording, via a recording electrode 121a-d (e.g., stimulating electrodes also act as sensing electrodes, see at least fig. 1C and par 0061, 0064, 0078 & 0082) to the patient, a plurality of resultant electrical waveforms (e.g., collecting an ensemble of evoked potential waveforms, see at least par 0084);
determining, based on the plurality of resultant electrical waveforms (e.g., collecting an ensemble of evoked potential waveforms, see at least par 0084), whether at least a subset of the plurality of resultant electrical waveforms (e.g., collecting an ensemble of evoked potential waveforms, see at least par 0084) includes a patient physiological response (e.g., candidate response function or resultant response function) (see at least fig. 3B and par 0095), the determining comprising:
comparing the subset of resultant electrical waveforms of the plurality of resultant electrical waveforms to a model waveform (e.g., candidate or potential response function that exhibits desirable characteristics, at least par 0133-0134) from a database of a plurality of model waveforms (e.g., collection of candidate response functions, see par 0009-0012, 0093 & 0095 and/or template(s) for potential response function(s), see at least par 0100), the plurality of model waveforms (e.g., collection of candidate response functions, see par 0009-0012, 0093 & 0095 and/or template(s) for potential response function(s), see at least par 0100) based at least in part on predicted phvsiological responses (i.e., based on similarities and/or differences between the input stimulation waveform and evoked neural responses using cross-correlation or deconvolution, see par 0009, 0012, 0039, 0088-0089, 0093 & 0111) and an ensemble average of noise candidates (see at least par 0085-0086, 0088, 0090 & 0094); and
determining, based on the comparison, a comparison feature ((e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135), the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) indicating whether the patient physiological response (e.g., candidate response function or resultant response function) exists in the subset of resultant electrical waveforms (e.g., collecting an ensemble of evoked potential waveforms, see at least par 0084); and
displaying, via a display 1422 (see fig. 9 and par 0136 & 0138), an indication (see par 0104) that the patient physiological response (e.g., candidate response function or resultant response function) exists in the subset of resultant electrical waveforms (e.g., collecting an ensemble of evoked potential waveforms, see at least par 0084).
In regards to claim 16, Kent discloses the method of claim 15, wherein the model waveform (e.g., candidate or potential response function that exhibits desirable characteristics, at least par 0133-0134) comprises a predicted physiological response (i.e., based on similarities and/or differences between the input stimulation waveform and evoked neural responses using cross-correlation or deconvolution, see par 0009, 0012, 0039, 0088-0089, 0093 & 0111) and an ensemble average of a plurality of artifact signals (e.g., after repeated stimulation, the one or more processors calculate an ensemble average of the EP waveforms associated with a current stimulation waveform, which provide substantial noise or artifact signals cancellation due to averaging, see par 0085, 0088, 0090 & 0094).
In regards to claim 17, Kent discloses the method of claim 16, wherein the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) further indicates whether an artifact signal exists in the subset of resultant electrical waveforms (e.g., after repeated stimulation, the one or more processors calculate an ensemble average of the EP waveforms associated with a current stimulation waveform, which provide substantial noise or artifact signals cancellation due to averaging, see par 0085, 0088, 0090 & 0094).
In regards to claim 20, Kent discloses the method of claim 15, wherein the determination of whether the plurality of resultant electrical waveforms includes the patient physiological response (e.g., candidate response function or resultant response function) further comprises: determining that the patient physiological response (e.g., candidate response function or resultant response function) exists when the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) of the subset of electrical waveforms is within a threshold range of a threshold value of the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and /or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 4 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent et al. (US 2018/0140843) (“Kent” hereinafter) in view of Ternes et al. (US 2013/0138170) (“Ternes” hereinafter).
In regards to claim 4, Kent discloses the system of claim 3, that fails to explicitly teach a system wherein the operations further comprise: displaying, via the display, an indication that the artifact signal exists in the subset of resultant electrical waveforms. However, Ternes teaches that it is known to provide a system wherein the operations further comprise: displaying, via the display, an indication that the artifact signal exists in the subset of resultant electrical waveforms (see at least par 0034-0035 & 0042-0043). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Kent wherein the operations further comprise: displaying, via the display, an indication that the artifact signal exists in the subset of resultant electrical waveforms as taught by Ternes since such a modification would amount to applying a known technique (i.e., as taught by Ternes) to a known device (i.e., as taught by Kent) ready for improvement to achieve a predictable result such as alerting a clinician of the presence of signal artifact such that sensing parameters may be adjusted (see at least par 0036 of Ternes)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 18, Kent discloses the method of claim 17, that fails to explicitly teach a method further comprising: displaying, via the display, an indication that the artifact signal exists in the subset of resultant electrical waveforms. However, Ternes teaches that it is known to provide a method further comprising: displaying, via the display, an indication that the artifact signal exists in the subset of resultant electrical waveforms (see at least par 0034-0035 & 0042-0043). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Kent further comprising: displaying, via the display, an indication that the artifact signal exists in the subset of resultant electrical waveforms as taught by Ternes since such a modification would amount to applying a known technique (i.e., as taught by Ternes) to a known device (i.e., as taught by Kent) ready for improvement to achieve a predictable result such as alerting a clinician of the presence of signal artifact such that sensing parameters may be adjusted (see at least par 0036 of Ternes)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 5, 11 & 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent et al. (US 2018/0140843) (“Kent” hereinafter) in view of Bergelson (US 4,493,327) (“Bergelson” hereinafter).
In regards to claim 5, Kent discloses the system of claim 1, that fail to explicitly teach labeling, based on the comparison feature, the subset of the plurality of resultant electrical waveforms with a positive label or a negative label, the positive label indicating that the patient physiological response exists, and the negative label indicating that the patient physiological response does not exist. However, Bergelson teaches that it is known to provide a system comprising labeling, based on the comparison feature, the subset of the plurality of resultant electrical waveforms with a positive (green) label or a negative (red) label, the positive (green) label indicating that the patient physiological response exists, and the negative (red) label indicating that the patient physiological response does not exist (see at least abstract, figs. 1 & 5B and col. 11, lines 50-68 & col. 12, lines 1-10). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Kent comprising labeling, based on the comparison feature, the subset of the plurality of resultant electrical waveforms with a positive label or a negative label, the positive label indicating that the patient physiological response exists, and the negative label indicating that the patient physiological response does not exist as taught by Bergelson since such a modification would amount to applying a known technique (i.e., as taught by Bergelson) to a known device (i.e., as taught by Kent) ready for improvement to achieve a predictable result such as determining the presence of a significant evoked potential in a manner which allows quantification of the likelihood that the results would be accurate for the particular patient being tested (see col. 2, lines 31-35 of Bergelson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 11, Kent discloses the system of claim 5, wherein the labeling comprises comparing the comparison feature (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and/or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135) to a plurality of previously generated comparison features (e.g., i) initial and final response magnitude, ii) a shape of the response function, iii) rise time and/or falling time for all or a portion of a response function, iv) a duration of a local peak in the response function, v) a time interval over which the response function changes from maximum to minimum values or vice versa, vi) a response function that exceeds a threshold, see at least par 0095, 0101 & 0133-0135).
In regards to claim 19, Kent discloses the method of claim 15, that fails to explicitly teach a method comprising labeling, based on the comparison feature, the subset of the plurality of resultant electrical waveforms with a positive label or a negative label, the positive label indicating that the patient physiological response exists, and the negative label indicating that the patient physiological response does not exist. However, Bergelson teaches that it is known to provide a method comprising labeling, based on the comparison feature, the subset of the plurality of resultant electrical waveforms with a positive (green) label or a negative (red) label, the positive (green) label indicating that the patient physiological response exists, and the negative (red) label indicating that the patient physiological response does not exist (see at least abstract, figs. 1 & 5B and col. 11, lines 50-68 & col. 12, lines 1-10). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Kent comprising labeling, based on the comparison feature, the subset of the plurality of resultant electrical waveforms with a positive label or a negative label, the positive label indicating that the patient physiological response exists, and the negative label indicating that the patient physiological response does not exist as taught by Bergelson since such a modification would amount to applying a known technique (i.e., as taught by Bergelson) to a known device (i.e., as taught by Kent) ready for improvement to achieve a predictable result such as determining the presence of a significant evoked potential in a manner which allows quantification of the likelihood that the results would be accurate for the particular patient being tested (see col. 2, lines 31-35 of Bergelson)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kent et al. (US 2018/0140843) (“Kent” hereinafter) in view of Snell et al. (US 2014/0052012) (“Snell” hereinafter).
Kent discloses the system of claim 1, that fails to explicitly teach a system further comprising: determining when a polarity of each electrical waveform of the subset of resultant electrical waveforms is the same.
However, Snell teaches that it is known to provide a system further comprising: determining when a polarity of each electrical waveform of the subset of resultant electrical waveforms is the same (see at least fig. 6 and par 0047).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the system of Kent further comprising: determining that the patient physiological response exists, as taught by Kent, when a polarity of each electrical waveform of the subset of resultant electrical waveforms is the same as taught by Snell since such a modification would amount to applying a known technique (i.e., as taught by Snell) to a known device (i.e., as taught by Kent) ready for improvement to achieve a predictable result such as taking the polarity into account so as to properly align the waveforms for ensemble averaging (see at least par 0047 of Snell)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9 & 11-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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