DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 calls for “assessing hypertonicity severity based on the pelvic muscle hypertonicity index” “based on comparison of the resting RMS ratio to diagnostic thresholds”; there is no disclosure of this in the specification as filed. The specification addresses severity only to assert that this severity can be assessed (paragraphs [0021], [0022], [0024] as filed), but at no point is there any disclosure of any algorithm or procedure of how to achieve this assessment of “severity”; the amendment to the claim indicating this assessment involves comparison of a ratio to “diagnostic thresholds” is also not disclosed. At best the disclosure indicates that RMS ratios can be linked to patients having a particular condition (internal cystitis/bladder pain syndrome) versus a control group (paragraph [00140]), but this is not an indication of severity nor is there disclosure of these ratios to any threshold for evaluation of severity. As such, the disclosure does not reasonably convey possession of assessing hypertonicity severity at the time the invention was filed. The same issue is found in claim 5.
Further, claim 1 also still calls for “determining a BoNT dosage for each determined injection site”. There is no disclosure of how such a dosage is determined. At best the disclosure states that “the BoNT dosage may be determined by the severity assessment.” (paragraph [00145] as filed) and implies a desire to “minimize the required dose” (paragraph [00124]) but does not at any point actually describe the process of this determination. There is certainly no disclosure whatsoever of a dosage that is both based on the hypertonicity index and also determined “proportionally to the severity”. As such that the disclosure does not reasonably convey possession of determining a BoNT dosage based on a hypertonicity index and severity at the time the invention was filed. The same issue is found in claim 5.
Claim 3 now calls for diagnosing hypertonicity “by comparing the pelvic muscle hypertonicity index to at least one predetermined threshold or statistical reference value derived from HD-sEMG resting RMS ratio measurements, wherein a pelvic muscle hypertonicity index exceeding the threshold is indicative of pelvic floor hypertonicity”. The disclosure uses the word “threshold” twice, neither in any relation to diagnosing hypertonicity.
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The disclosure does not describe any “statistical reference” value or use the term “reference” in any way other than “by reference” or “with reference to”, particularly not in relation to diagnosing hypertonicity. As such, the disclosure does not reasonably convey possession of diagnosing hypertonicity by comparing a hypertonicity index to a threshold or statistical reference value at the time the invention was filed. The same issue is found in claim 7.
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 1-8 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 calls for “calculating a pelvic muscle hypertonicity index based on the first HD-sEMG signal and the second HD-sEMG signal” and then later defines, as part of assessing hypertonicity severity for some reason, that “the pelvic muscle hypertonicity index comprises a resting RMS ratio calculated by normalizing resting EMG RMS values to the peak MVC amplitude”. The abbreviation “RMS” is recited without providing the terms it abbreviates. There is no antecedent basis for “the peak MVC amplitude” in this clause, nor is it remotely clear what MVC might stand for in this claim. Further, the first clause indicates that both sEMG signals are used to calculate the index but then the second calls for only using “resting EMG RMS values” – are these resting EMG RMS values part of the first sEMG signal, which is captured during rest? Or do the EMG values differ from the sEMG values? If the same it should be clearly identified as such. If a separate EMG is required to acquire EMG RMS values it is not clear when or how such a signal might be obtained. Clarification is required.
Claim 1 further recites “determining a BoNT dosage for each determined injection site an individualized BoNT dosage” – are two dosages determined for each site? The clause continues by calling for the hypertonicity index to be “applied to the corresponding muscle region associated with that injection site” – it is entirely unclear how an index is applied to a muscle region. Is the index associated with a particular region? Further, if the index is used to assess a severity, why is the index “applied” to a region when the BoNT dosage “is determined proportionally to the severity indicated by the pelvic muscle hypertonicity index”? Clarification is required.
The same issues are all also found in claim 5.
Claim 3 defines “diagnosing the pelvic floor hypertonicity” based on comparing the pelvic muscle hypertonicity index to “at least one predetermined threshold or statistical reference value”, where an index “exceeding the threshold” is indicative of hypertonicity – this is indefinite in that it does not provide criteria when the statistical reference is used instead of the threshold. Further, it is not clear when or how these HD-sEMG resting RMS ratio measurements are obtained, whether from the current subject or a database, or what sort of “statistical reference value” might be derived from these unknown measurements. Clarification is required. The same issues are found in claim 7.
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 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a process, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a method comprising capturing electromyography signals using a probe during rest and contraction, calculating an index based on the signals comprising a ratio calculated by normalizing resting EMG values to an amplitude, performing decomposition of the signals into motor unit action potentials using a decomposition algorithm, assessing severity of hypertonicity based on the index by comparing the ratio to thresholds, mapping neuromuscular junctions based on the motor unit action potentials, determining an injection site based on the mapped junctions, and determining a dosage for each site based on the index and proportional to the determined severity.
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely indicate generating additional information (claims 2 and 3) and transmission of captured data (claim 4)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and processing data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on decomposition of a signal and calculating ratio and index, a form of performing calculations;
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of signal data to generate an evaluation result of “severity” and dosages – a judgment or opinion.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are that claim 1 is ostensibly “computer implemented” though does not positively recite using a computer for apparently performing the activities, and a probe for capturing signals. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no treatment or prophylaxis for a disease or medical condition provided as part of the claimed invention), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements relating to being “computer implemented”, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Paragraph [0005] as filed indicates “The computer includes a processor and a memory. The memory stores computer instructions configured to be executed by the processor.” – i.e., a generic or general-purpose computer.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The additional element of a “probe” is recited at a high level of generality and only for the purpose of insignificant extrasolution data gathering, where a “probe” used for capturing EMG signals is well-understood, routine, and conventional in the art, such that it also does not add anything significantly more to the abstract idea itself - See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Claims 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a system, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 5 recites a system comprising an amplifier, a probe with electrode grid configured for high-density surface electromyography, a processor, and a memory comprising instructions to capture electromyography signals using the probe during rest and contraction, calculate an index based on the signals comprising a ratio calculated by normalizing resting EMG values to an amplitude, perform decomposition of the signals into motor unit action potentials using a decomposition algorithm, assess severity of hypertonicity based on the index by comparing the ratio to thresholds, map neuromuscular junctions based on the motor unit action potentials, determine an injection site based on the mapped junctions, and determine a dosage for each site based on the index and proportional to the determined severity.
The dependent claims appear to be encompassed by the abstract idea of the independent claims since they merely indicate generating additional information (claims 6 and 7) and transmission of captured data (claim 8)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of obtaining and processing data to report biometric information; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). This idea is within the following grouping(s) of subject matter:
Mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) – as based on decomposition of a signal and calculating ratio and index, a form of performing calculations;
Mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) as based on the observation and evaluation of signal data to generate an evaluation result of “severity” and dosages – a judgment or opinion.
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are an amplifier, a probe including an electrode grid, a processor, and a memory. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, effect a particular treatment or prophylaxis for a disease or medical condition (there is no treatment or prophylaxis for a disease or medical condition provided as part of the claimed invention), implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the processor and memory, as indicated above, are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Paragraph [0005] as filed indicates “The computer includes a processor and a memory. The memory stores computer instructions configured to be executed by the processor.” – i.e., a generic or general-purpose computer.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The additional element of a “probe” with “surface electrode grid” is recited at a high level of generality and only for the purpose of insignificant extrasolution data gathering, where a “probe” used for capturing EMG signals is well-understood, routine, and conventional in the art, such that it also does not add anything significantly more to the abstract idea itself - See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional.
The additional element of the amplifier is not recited as being used and does not appear to have any function, such that beyond its mere existence as an electrical component it does not add anything significantly more to the abstract idea itself as it has no relation to the abstract idea.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself or the computer components performing the abstract idea; therefore the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Response to Arguments
Applicant's arguments filed 26 September 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112a, Applicant merely asserts that the amendments have resolved all issues; this is entirely untrue, as set forth above. The Examiner notes that Applicant’s remarks do not provide any suggestion of where the newly added limitations might find support in the disclosure.
Regarding the rejections under 112b, Applicant again merely asserts that the amendments to the claims have resolved all issues. Again, this is untrue, as set forth above.
Regarding the rejections under 101, Applicant initially argues that the claims do not include any abstract idea, addressing both the steps of the identified abstract idea and additional elements, asserting that EMG acquisition is not a mental process (despite being clearly identified as data gathering additional to the abstract idea), and that the remainder cannot be considered a mathematical concept, method of organizing human activity, or mental process, because “the claims are expressly tied to specialized” probes, amplifiers, hardware, and a “specific” algorithm. The Examiner notes that being “expressly tied” to objects is not part of the analysis of whether the claims recite an abstract idea. As noted above, the claims include both mental processes which are embodied on a generic computing device and also mathematical concepts.
Applicant continues by asserting that the invention as presented improves the functioning of “the technology” and the claims thus provide a practical application of the recited abstract idea, by “guiding and optimizing neuromuscular injection therapy using objective HD-sEMG data”. The Examiner notes that injection therapy is not performed as part of the invention as claimed, such that beyond being based on the abstract idea itself rather than the additional elements which must be used to integrate an abstract idea into a practical application, this argument is moot as the supposed improvement is not part of the invention as claimed.
Applicant next argue that the invention is applied in “meaningful ways” because the abstract idea itself (in Applicant’s own words, “the data analysis”, p. 12 line 1 of the remarks) is used “to guide the location and dosage of therapeutic BoNT injections”. Again, the practical application must be provided by additional elements, not the abstract idea itself. Further, injections are not delivered as part of the invention as claimed, such that this “meaningful” “application” of the abstract idea is not reflected in the invention as claimed rendering this argument moot.
Applicant continues by asserting that the “specific combination of specialized components” and “a concrete medical treatment application” “reflects a novel integration of sensing technology, computational decomposition, and treatment guidance” such that the “the claims amount to significantly more than any alleged abstract idea”. The Examiner notes that step 2B of analysis is directed to whether then additional elements amount to more than the abstract idea, not the claims as a whole. Further, as clearly discussed in MPEP 2106.05(I), “ the search for an inventive concept should not be confused with a novelty or non-obviousness determination”. As Applicant’s only argument is that the “claims” amount to significantly more than the abstract ide itself due to “a novel integration” of computations and analysis, this argument is moot in that novelty is unrelated to this analysis of the claims.
The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, as all claims are rejected under 112 and 101 above they are not presently allowable and the question of prior art will be revisited upon resolution of these other issues.
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.
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/KAREN E TOTH/ Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791