DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 March 2026 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 refers to “the second-HD-sEMG signal”; this appears to be a typographical error.
Appropriate correction is required.
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”; 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”. 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.
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. 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 or, for example, any sort of algorithm or relationship between “severity” and dosage/frequency/rate of delivery/etc.. As such that the disclosure does not reasonably convey possession of determining a BoNT dosage based on a hypertonicity severity at the time the invention was filed. The same issue is found in claim 5.
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 use of “a peak RMS value obtained during a maximum voluntary contraction (MVC) amplitude of the pelvic muscle from the second-HD-sEMG signal”; as a root mean square requires more than one data point, it is unclear how this is determined from a timepoint corresponding to a maximum amplitude. If the MVC amplitude refers to a period of time which encompasses the actual maximum amplitude but is some longer duration, it is unclear what this duration should be if not the entirety of the second signal which itself is captured during a period of elevated contraction amplitude. Clarification is required.
Claim 5 calls for the processor to “determine a BoNT dosage for each determined injection site based on the hypertonicity severity assessment”; there is insufficient antecedent basis for this limitation in the claim as no part of the claim calls for performing a hypertonicity severity assessment. The system is defined as being “for” this purpose, but at no point is there any limitation directed to actually performing a severity assessment. It is unclear whether the entirety of the instructions performed by the processor are considered this “assessment”, or if the “assessment” is only one of the instructions, or if the “assessment” is a metric obtained from some other source.
Further, claim 5 calls for the system to “administer the BoNT to a pelvic muscle region”; there is insufficient antecedent basis for recitation of “the BoNT”. The claim provides for a BoNT dosage(s) but not “the BoNT”. Clarification is required.
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 root mean squares of the signals, mapping neuromuscular junctions based on the motor unit action potentials, determining an injection site based on the mapped junctions, determining a dosage for each site based on the determined severity, and administering the dosage.
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 particular 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. See the Office’s 101 guidance example 43 which addresses the requirements for particularly in effecting a particular treatment or prophylaxis.
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, where administering the dosage fails to meaningfully limit the claim because it does not require any particular application of a recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. 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, perform decomposition of the signals into motor unit action potentials using a decomposition algorithm, map neuromuscular junctions based on the motor unit action potentials, determine an injection site based on the mapped junctions, determine a dosage for each site based on a determined severity, and administer the determine dosage.
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 an 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 particular 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. See the Office’s 101 guidance example 43 which addresses the requirements for particularly in effecting a particular treatment or prophylaxis.
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, where administering the dosage fails to meaningfully limit the claim because it does not require any particular application of a recited calculation and is at best the equivalent of merely adding the words “apply it” to the judicial exception. 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 March 2026 have been fully considered but they are not persuasive.
Regarding the rejections under 112, Applicant generally asserts that the amendments to the claims have resolved all issues. This is not the case, as noted above.
Regarding the rejections under 101, Applicant argues that the newly presented limitation of administering the determined BoNT dosage makes the invention as claimed not recite an abstract idea as per prong one of step 2A. Adding this step does not remove the presence of the identified abstract idea, such that this assertion is moot.
Applicant further asserts that this step integrates the abstract idea into a practical application; as noted above, the step of administering the determined dosage is recited at an insufficient level of specificity to constitute a practical application of the identified abstract idea. Particularly as there is no disclosure of how a dosage is determined beyond being “based on” some unidentified assessment of “severity”, this general concept of providing some dosage is not a particular treatment or prophylaxis; Although this limitation indicates that a treatment is to be administered, it does not provide any concrete information as to how the patient is to be treated, or what exactly the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. Like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 78 (2012), claim 1 here tells the relevant audience (doctors) about the mathematical concepts and at most adds a suggestion that the doctors take those laws into account when treating their patients. Claim 5 does not even define any relationship between the determination of a dosage and any other aspect of the claim. Merely administering some dosage in some manner in some location thus fails to meaningfully limit the claim because it does not require any particular application of the recited “determination”, and is at best the equivalent of merely adding the words “apply it” to the judicial exception.
Applicant also asserts that the invention as claimed “improves technology” by [performing the entire claimed invention]; as any integration into a practical application must be provided by additional elements, not the abstract idea itself, Applicant’s entire argument is moot as it relies on the entirety of the claimed invention including the abstract idea. Similarly, the assertion that the judicial exception is applied in meaningful ways also relies upon aspects of the abstract idea itself as providing the meaningful application, thus rendering this argument also moot.
Applicant continues by asserting that the invention as claimed is analogous to Vanda’s relationship between a dosage and administration of a drug relying on a discovered relationship to a specific method of treatment; as noted above, there is no disclosure of a specific relationship between dosage and administration or any particular method of treatment, such that the claims are not analogous.
Regarding step 2B, Applicant refers to “a concrete medical treatment application” as providing something more than well-understood, routine, and conventional. Again, as there is no particular disclosed relationship between “severity” and determination of a dosage, there is no “concrete medical treatment” that could be considered well-understood, routine, and conventional beyond the general concept of use of BoNT to treat pelvic muscle pain, which itself is well-understood, routine, and conventional.
The claims remain rejected.
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791
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