DETAILED ACTION
This action is pursuant to the claims filed on October 22, 2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding Step 1, claims 1-20 are all within at least one of the four statutory categories.
Claim 1 and its dependent claims disclose a system.
Claim 11 and its dependent claims disclose a method.
Regarding Step 2A, Prong One, the independent claims 1 and 11 recite the following limitations directed to an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
Mental Processes: Mental Processes can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
For example, claims 1 and 11 recite the following abstract ideas:
“generate data values based upon the first output and the second output” (This limitation is a form of evaluation or judgement, since an individual can mentally generate a specific numerical value corresponding to the first and second outputs)
“extract features from the data values including at least a feature based on relative amplitudes between the first output and the second output” (This limitation is a form of evaluation or judgement, since an individual can mentally extract the broadly claimed feature, such as low amplitude of the EMG signal, of the wearer); and
“analyze the extracted feature to assess the neurological condition of the user” (This limitation is also a form of evaluation or judgement, since an individual can mentally identify whether the extracted feature falls outside or within a normal range defined by a normal user).
Regarding Step 2A, Prong Two, the claim recites additional elements that, when considered either alone or in an ordered combination, would integrate the abstract idea into a practical application thereof.
Claim 1 recites the following additional elements that do not integrate the abstract idea into a practical application thereof:
The detectors are directed to a field of use since it is recited with a high level of generality in that the particulars of the detectors are not substantively claimed and amounts to generally linking the use of the judicial exception to a medical environment.
Regarding Step 2B: the additional elements do not amount to significantly more than the abstract idea. When considered in combination, the additional element (i.e., detectors) to collect data to be processed for assessment is well-understood, routine, conventional activity ([0016]).
Although the dependent claims 2-10 and 112-20 are further limiting, they do not recite significantly more than the abstract ideas. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
The following are abstract idea:
“assessing the neurological condition comprises monitoring progression of a neurological disorder over time” (claims 2 and 12, form of evaluation or judgement);
“the neurological disorder is Amyotrophic Lateral Sclerosis (ALS)” (claims 3 and 13, form of evaluation or judgement); and
“select different grouping of the detectors from which to acquire and process signal as channels” (claims 7 and 17, form of evaluation or judgement).
The following are additional elements:
“apply a machine learning process to the extracted feature to assess the neurological condition of the user” (claim 6 and 16). This limitation is directed to insignificant extrasolution activity since this amounts to necessary data gathering and outputting.
“wearable device” (claims 4 and 14), alignment features (claims 5 and 15), “an inertial measurement” (claims 8 and 18), “preamplifier” (claims 9 and 19) and “filter” (claims 10 and 20). When considered in combination, the additional elements are directed to field of use as these elements are recited with a high level of generality (not a particular machine) and amounts to generally linking the use of the judicial exception to a medical environment. In addition, the additional elements do not amount to significantly more than the judicial exception both individually and in combination because these are well-understood, routine and conventional features in a medical art for acquiring electrical signals and pre-processing electrical signals for diagnosis.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-14, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Linderman (U.S. PGPub. No. 2010/0106044) and further in view of Wagner et al. (hereinafter ‘Wagner’, U.S. PGPub. No. 2016/0313801).
In regards to independent claims 1 and 11 and claim 4, 7, 14, and 17, Linderman discloses a system and a method for assessing a neurological condition of a user ([0026]: EMG analysis obtained from fine motor task can detect cognitive impairment) comprising:
detecting, using detectors (Fig. 3 illustrates an example of a user interface garment comprising a plurality of electrodes 321, 322, 323, 324, 325, 326) positioned at, and configured to detect electrical potentials at, a surface of a skin of a wrist of a hand of the user ([0106]-[0108]: the actual locations of the electrodes… on the wrist on front and back sides of the hand these locations… in accordance with optimal EMG sensing);
Circuitry configured to:
reduce amplitudes indicative of frequency components that are characteristic of ambient noise from the first output and the second output ([0056]: EMG signals acquired from the electrodes and are processed for noise reduction; note that any noise reduction inherently requires reducing amplitude of frequencies associated with noise);
generate data values based upon the first output and the second output ([0056]: after processing noise reduction, the EMG signals are prepared in a digital representation for pattern recognition and classification);
extract features from the data values including at least a feature based on relative amplitudes between the first output and the second output ([0056]: algorithm is employed to identify repetitive activities, such as patterns of EMG digital representation);
analyze the extracted feature to assess the neurological condition of the user ([0056]: the patterns of the signals are analyzed to determine whether the patterns are associated with a pattern of a disease).
However, Linderman is silent as to whether the first output and the second output are based upon first pair of detectors and second pair of detectors, respectively, and wherein the detectors are arranged in a pattern along an inner surface of a wearable device configured to be worn on the wrist of the user and selecting different groupings of the detectors from which to acquire and process signals as channels.
Wagner teaches a wearable device configured to be worn on a wrist of a user, comprising a plurality of detectors arranged in a pattern along an inner surface of the wearable device for acquiring EMG signals (bio-potential sensors 12 disposed along a flexible PCB user interface 10 in Figs. 1A, 1B and 2; [0077]: the flexible PCB user interface 10 is in direct contact with the skin of the user 5 as shown in Fig. 2). Specifically, Wagner teaches that the plurality of detectors is selected into different groups to form a channel ([0074]: each sensor 12 comprises two electrodes 16 in which measures the voltage difference between the two electrodes of the sensor 12; one of the sensor 12 reads on the first pair of the detectors and another sensor 12 reads on the second pair of the detectors). Given that Linderman does not explicitly disclose that the EMG signals are acquired in a bipolar configuration , but does not show a reference electrode or the design of a wearable device configured to be positioned on the wrist, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the detectors of Linderman and incorporate in a wearable device of Wagner configured for a person’s wrist and the circuitry for selecting pairs or groups of detectors to acquire and process output signals in a bipolar manner to determine gesture or position of the hand ([0066],[0068], [0071]).
In regard to claims 2 and 12, Linderman further discloses wherein assessing the neurological condition comprises monitoring progression of a neurological disorder over time (the examiner notes that there is no specific timeline recited in the claim and monitoring the patterns of EMG signals inherently requires monitoring over time and determining the progression of the neurological disorder, [0056]).
In regard to claims 3 and 13, Linderman further discloses the neurological disorder is Amyotrophic Lateral Sclerosis (ALS) (the examiner notes that no further specific parameters/features are claimed to determine the neurological disorder, ALS, and the examiner is in the position that abnormal EMG pattern may false positively or positively be diagnosed as ALS).
In regard to claim 6 and 16, Linderman further discloses applying a machine learning process to extract features to assess the neurological condition of the user ([0092]-[0098]: Bavesian Classifier or [0099]-[0102]: artificial neural network is used to find patterns in data to determine neurological disorder).
In regard to claim 8 and 18, in view of the combination as set forth in claim 1, Wagner further discloses an inertial measurement unit configured to provide motion data ([0074]), and use the motion data to determine a more accurate assessment of gesture recognition ([0070]-[0071], [0077]). Given that Linderman uses EMG data to assess a handwriting gesture ([0077]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further incorporate an inertial measurement unit to measure the motion data as taught by Wagner to further accurately assess gesture recognition for diagnostic proposes ([0081]).
In regard to claim 9 and 19, Linderman further discloses wherein the circuitry comprises a pre-amplifier ([0104]: an amplifier to increase the signal to noise ratio), has a bandwidth configured to emphasize bandwidths associated with nerve activation signal levels of a person having a neurological disorder ([0104]: the examiner notes that since the claim does not specifically disclose a particular bandwidth and Linderman’s amplifier is configured to increase the signal to noise ratio which includes a person having a neurological disorder, the amplifier of Linderman is capable of emphasizing a bandwidth associated with the nerve activation signal levels of a person having a neurological disorder).
In regard to claims 10 and 20, Linderman further discloses wherein the circuitry comprises a filter configured to attenuate signals below and/or above a range associated with nerve activation signal levels of a person having a neurological disorder ([0135] To obtain predictions, EMG signals will be full-wave rectified and band-pass filtered in the range of 0.2-20 Hz; the examiner notes that the claim does not recite the range of frequency of a person having a neurological disorder, therefore, the filter of Linderman is capable of attenuating signals below or above the nerve activation signal associated a person having a neurological disorder).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Linderman and Wagner as applied to claim 5/4/1 and 13/12/11, respectively, and further in view of Su et al. (hereinafter ‘Su’, U.S. PGPub. No. 2014/0275875).
In regards to claims 5 and 15, Linderman/Wagner combination discloses the invention substantially as claimed in claim 5/4/1 and 13/12/11, respectively.
Linderman/Wagner combination is silent as to alignment features configured to position the detectors in contact with predetermined locations on the wrist.
Su teaches the concept of providing alignment features such as one or more indicia comprising a label on an electrode array to identify an anatomical feature of the patient and at least one arrow point toward the anatomical feature of the patient when the electrode array is applied to the patient (claims 9 and 14). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the wearable device of Linderman/Wagner combination and incorporate alignment features as taught by Su along the wearable device to identify an anatomical feature of the patient during application of the wearable device to the patient as doing so involves routine skill in the art and a predictable result would ensue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 6/18/20206
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