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 .
Remarks
This action is in response to the remarks filed 01/07/2026.
Claims 1-4, 6-14, and 16-20 are pending.
Response to Arguments
Applicant's arguments, see pages 8-9, 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 “amplifying and digitizing the EMG sensor data using the EMG amplifier and an analog to digital converter to produce digitized multi-channel EMG for online signal processing” and “identifying, from the plurality of EMG sensors, an electrode pair exhibiting signal polarity reversal and confirming signal propagation in opposite directions away from the electrode pair along the orientation of the at least one facial muscle group, thereby localizing the NMJ to a spatial position of the electrode pair”. Applicant argues (see pages 8-9) that these amended claims recite features that cannot practically be performed in the human mind and do not fall within the mental process grouping and further that the claims significantly more than an abstract idea.
The argument that the claims are not directed to an abstract idea is not found to be persuasive. Applicant argues that the claim recites features that cannot practically be performed in the human mind, such as performing digitization of analog signals and resolving phase reversal and propagation directionality across high-speed electrical traces captured simultaneously across a multi-channel EMG array. Applicant argues that these steps require specific hardware configurations that are not generic computing elements but a specialized system.
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, amplify and digitize EMG sensor data, determine NMJ locations based on variations in amplitude and latency or lowest-amplitude channels across an EMG array, identify an electrode pair exhibiting signal polarity reversal, 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 computing elements (e.g. instant specification, par. [0049]).
As recited, the limitations of the claims are directed towards data collection and analysis. 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 § 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 1-4, 6-14, and 16-20 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.
Independent claims 1 and 12 recite the limitation “identifying, from the plurality of EMG sensors, an electrode pair exhibiting signal polarity reversal and confirming signal propagation in opposite directions away from the electrode pair along the orientation of the at least one facial muscle group, thereby localizing the NMJ to a spatial position of the electrode pair”. This limitation is not supported by the instant specification. The specification at par. [0027] discloses utilizing a channel with phase reversal to identify surface NMJ locations, which is not the same as the claimed identification of “an electrode pair exhibiting signal polarity reversal and confirming signal propagation in opposite directions away from the electrode pair along the orientation of the at least one facial muscle group, thereby localizing the NMJ to a spatial position of the electrode pair”.
Claims 2-4, 6-11, 13, 14, and 16-20 are rejected based on their dependency on claims 1 and 12.
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, amplifying and digitizing the EMG data, determining at least one NMJ site, identifying an electrode pair exhibiting signal polarity reversal, 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, amplify and digitize the EMG data, determine at least one NMJ site, identify an electrode pair exhibiting signal polarity reversal, 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, amplifying and digitizing the EMG data, determining at least one NMJ site, identifying an electrode pair exhibiting signal polarity reversal, 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, an analog to digital converter, 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, an analog to digital converter, 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, an analog to digital converter, 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 rejections of the claims under 35 U.S.C. 112(a) and 35 U.S.C. 101, as explained above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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