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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/21/2025 has been entered.
Remarks
This action is in response to the Remarks filed 07/21/2025.
Claims 1-4, 6-14, and 16-20 are pending.
Response to Arguments
Applicant's arguments, see pages 7-11, regarding the rejection of claims 1-4, 6-14, and 16-20 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Rejection of claims 1-4, 6-14, and 16-20 under 35 U.S.C. 101
Independent claims 1 and 12 have been amended to recite “analyzing EMG sensor data in real-time in response to stimulation delivered by the at least one stimulation electrode”, “determining, based on variations in amplitude and latency across the plurality of EMG sensors, at least one NMJ site characterized by signal polarity reversal or a channel exhibiting the lowest amplitude among the plurality of EMG sensors”, “processing EMG signals from multiple stimulations of at least one nerve”, and recommending a NMJ site based on the “real-time signal response profiles and mapped NMJ locations of the person from the EMG sensor array to the computer”.
Applicant argues that the amended claims are not directed to a mental process and that even if they were, the claims integrate the alleged judicial exception into a practical application. Further, Applicant points to SiRF Tech, Example 40 of the USPTO 101 examples, Ex parte Sanders, and DDR Holdings, LLC.
The argument that the claims are not directed to an abstract idea (see Remarks, pages 7-9) is not found to be persuasive. On pages 8-9, Applicant argues that the claim recites features that cannot practically be performed in the human mind, such as identifying neuromuscular junctions (NMJs) based on ECG sensor data by determining a direction of action propagation, determining the orientation and size of a facial muscle group, identifying an active facial muscle, and identifying a corresponding NMJ. Further, Applicant argues that it would not be practical for the human mind to analyze EMG sensor data in real-time in response to electrical nerve stimulation, determine NMJ site locations based on variations in amplitude and latency including polarity reversal or lowest-amplitude channels across an EMG array, or process EMG signals resulting from multiple stimulations, because these operations require continuous acquisition and analysis of physiological data across multiple channels and timepoints, as well as coordinated signal processing. Applicant argues that these steps operate within a real-time signal processing pipeline, and that it is not possible for a person to acquire and interpret EMG signals in real time detect propagation paths across multiple sensors, determine the spatial orientation and size of a facial muscle group from signal vectors, or localize NMJ sites based on channel-specific timing and waveform morphology using human cognition alone.
However, this is not found to be persuasive. As recited, it would be possible to perform the recited features in the human mind using generic computer components. For example, a user could obtain ECG sensor data and identify NMJs by determining a direction of action propagation and an orientation and size of an active facial muscle group. A user would further be able to analyze EMG sensor data in real time response to electrical nerve stimulation, determine NMJ locations based on variations in amplitude and latency or lowest-amplitude channels across an EMG array, and process EMG signals resulting from multiple stimulations using a generic computer and processing equipment. See MPEP 2106.04(a)(2)(III)(B), explaining that claims encompassing a human performing the steps with a physical aid is still an abstract idea. Further, the computer and processor claimed and described in the instant application are generic and well known (e.g. instant specification, par. [0049]).
As recited, the limitations of the claims are directed towards data collection and analysis. Under its broadest reasonable interpretation, these are steps that cover performance of the limitation in the mind or using pen and paper or generic computer components. The steps of identifying a plurality of neuromuscular junctions based on the EMG sensor data by determining direction of action propagation and an orientation and size of the facial muscle, identifying an active facial muscle group, identifying an NMJ corresponding to the active facial muscle, analyzing EMG sensor data, determining a NMJ site, processing EMG signals, and mapping the neuromuscular junctions are data analysis steps. The step of providing the recommendation is a data output step.
References to SiRF Tech are not applicable here due to distinct fact patterns. The claim in SiRf Tech required calculations of pseudoranges that estimated the distance from the GPS receiver to a plurality of satellites, which cannot practically be performed by the human mind. Here, the data analysis and calculations as claimed can be performed by the human mind, as explained above. Further, the comparison of the instant claims to Example 40 of the USPTO 101 examples is not found to be persuasive, since the claims of this case do not match the fact pattern of the examples cited. In Example 40 claim 1, the claim was integrated into a practical application because the method limits the collection of additional data when a threshold is reached. In the instant claims, as explained above, the data is simply collected, analyzed, and output. As best understood, the crux of the invention lies in the data analysis performed to identify the neuromuscular junctions, which is considered to be the abstract idea of data processing using generic computer components.
The argument (see Remarks, paragraph spanning pages 9-10) that the claim integrates the alleged exception into the practical application of improving the precision of botulinum neurotoxin injection is not found to be persuasive. As explained above, the crux of the invention lies in the data analysis performed to identify the neuromuscular junctions, which is the abstract idea of data processing using generic computer components.
The comparison of the instant case to Ex parte Sanders (see Remarks, page 10) is not found to be persuasive. In Sanders, the claimed features were structurally and computationally tied to a specific technological improvement in irrigation systems. Here, the instant claims are simply performing data gathering and analysis steps. The only required output is simply a recommendation, and does not appear to be structurally and computationally tied to a specific technological improvement as in Sanders.
The comparison of the instant claims to the holding in DDR Holdings, LLC (see Remarks, paragraph spanning pages 10-11) is not found to be persuasive. As explained above, the crux of the invention of the instant claims lies in the data analysis performed to identify the neuromuscular junctions, which is directed to an abstract idea.
Therefore, there is no further description, in the claims or the specification, of any particular technology for performing the steps recited in the claim other than generic computer components used in their ordinary capacity as tools to apply the abstract idea. Nor does the claimed invention use a particular, or special, machine. In other words, the claims “are not tied to any particular novel machine or apparatus” capable of rescuing them from the realm of an abstract idea.
Therefore, the claims do not recite any additional elements that: (1) improve the functioning of a computer or other technology, (2) are applied with any particular machine, (3) effect a transformation of a particular article to a different state, and (4) are applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment or field of use. Please See MPEP § 2106.05(a)(c), (e)-(h).
Therefore, the rejection of the claims under 35 U.S.C. 101 is maintained, as explained in the office action below.
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, 6-14, and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a system and method for mapping neuromuscular junctions for botulinum neurotoxin injections. To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.04. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed towards a system, and claim 12 is directed towards a method, and meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claim 1 is directed towards a system and claim 12 is directed towards a method mapping neuromuscular junctions for botulinum neurotoxin injections, comprising identifying a plurality of neuromuscular junctions based on the EMG sensor data by determining direction of action propagation and an orientation and size of the facial muscle, identifying an active facial muscle group, identifying an NMJ corresponding to the active facial muscle, analyzing EMG sensor data in real time, determining at least one NMJ site, processing EMG signals, mapping the neuromuscular junctions, and providing a recommendation of a neuromuscular junction site for the injection. The limitation of a system and method for mapping neuromuscular junctions for botulinum neurotoxin injections, as drafted in claims 1-4, 6-14, and 16-20, is a process that, under its broadest reasonable interpretation, covers performance of these limitations in the mind or using pen and paper or generic computer components, but for the recitation of generic sensing and processing components.
For example, a user could gather EMG data, identify a plurality of neuromuscular junctions based on the gathered EMG sensor data, determine direction of action propagation and an orientation and size of the facial muscle, identify an active facial muscle group, identify an NMJ corresponding to the active facial muscle, analyze EMG sensor data in real time, determine at least one NMJ site, process EMG signals, map the neuromuscular junctions, and provide a recommendation of a neuromuscular junction site for the injection. The steps of identifying a plurality of neuromuscular junctions based on the EMG sensor data by determining direction of action propagation and an orientation and size of the facial muscle, identifying an active facial muscle group, identifying an NMJ corresponding to the active facial muscle, analyzing EMG sensor data, determining a NMJ site, processing EMG signals, and mapping the neuromuscular junctions are considered to be a data analysis step. The step of providing the recommendation is considered to be a data output step.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
The additional elements of stimulation electrodes, a controller, an EMG sensor array, an EMG amplifier, and a computer with a processor and memory are recited at a high level of generality (i.e., as generic sensing and computing elements performing the steps of gathering, analyzing, and outputting data). These additional elements generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). Specifically, the additional elements of stimulation electrodes, a controller, an EMG sensor array, an EMG amplifier, and a computer with a processor and memory are generically recited computing elements that perform the steps of gathering, analyzing, and outputting data. Further, the computer and processor claimed and described in the instant application are generic and well known (e.g. instant specification, par. [0049]).
Accordingly, these additional elements do no integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. See MPEP 2106.04(a)(2)(III)(C).
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
The additional elements when considered individually and in combination is not enough to qualify as significantly more than the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the additional elements of stimulation electrodes, a controller, an EMG sensor array, an EMG amplifier, and a computer with a processor and memory amounts to no more than generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. Furthermore, the additional elements do not amount to more than generically linking the use of a judicial exception to a particular technological environment or field of use (see MPEP 2106.05(h)). Therefore, the claims are not patent eligible.
Claims 2-4, 6-11, 13, 14, and 16-20 depend on claims 1 and 12 and recite the same abstract idea as claims 1 and 12 from which they depend. Further, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process). For example, the additional limitations recited in claims 2, 3, 4, 10, 11, 13, 14, and 20 (i.e. providing details about the type of sensor and equipment used) are simply further describing the sensors used. The additional elements of claims 9 and 19 (i.e. describing additional collected data) are considered to be further data gathering steps. The additional elements of claims 6-8 and 16-18 (i.e. providing additional details about the output) are considered to be further data output steps. The additional elements individually do not amount to significantly more than the judicial exception explained above (the abstract idea). Looking at the limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves any technology or includes a particular solution to a computer-based problem or a particular way to achieve a computer-based outcome. Rather, the collective functions of the claimed invention merely provide a conventional computer implementation, i.e. the computer (processor) is simply a tool to perform the claimed invention.
While there are no prior art rejections for claims 1-4, 6-14, and 16-20, they are not indicated as allowable due to the rejection of the claims under 35 U.S.C. 101, as explained above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
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