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 .
Status of Claims
2. Claims 1-20 are pending and currently under consideration for patentability under 37 CFR 1.104.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case, the abstract recites “In an aspect, a wearable device for targeted peripheral stimulation is presented” which includes language that can be implied. The Examiner suggests deleting “In an aspect” and “is presented.”
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claims 19-20 are objected to because of the following informalities:
Claim 19, line 3 recites “sever” which appears to be a typographical error. The Examiner suggests --severe--.
Claim 20, lines 1-2 recite “in part patient data” which appears to have omitted the word --by--. The Examiner suggests --in part by patient data--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 3, 5, 8, and 11-20 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 3, line 1 recites “the level of responsiveness” which lacks antecedent basis.
Claim 5, line 1 recites “the responsiveness” which lacks antecedent basis.
Claim 8, line 4 recites “the one or more stimulators” which lacks antecedent basis. Only a single stimulator has been previously recited.
Claim 11, the penultimate line recites “the stage” which lacks antecedent basis.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-5, 15-16, and 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 4 fails to further limit the subject matter of the claim upon which it depends (claim 2) because it merely recites an intended result comparing different populations using the apparatus. This does not further limit any structure of the claim 2 apparatus.
Claim 5 fails to further limit the subject matter of the claim upon which it depends (claim 1) because it merely recites that demographic data of the user will influence (at least in part) the “responsiveness” (lacking antecedent basis). This is a general statement that patients will have different responses to treatment at least partially based on demographic data. This does not further limit any structure of the claim 1 apparatus.
Claim 15 fails to further limit the subject matter of the claim upon which it depends (claim 13) because it merely recites that users with early stage onset disease state would have a correlation of high responsiveness (effectiveness). This does not actually require users with early stage onset to perform the method, nor does this require the method to calculate or determine the correlation. This does not further limit any steps of the claim 13 method.
Claim 16 fails to further limit the subject matter of the claim upon which it depends (claim 13) because it merely recites that users with mild or late stage onset disease state would have a correlation of low responsiveness (effectiveness). This does not actually require users with mild/late stage onset to perform the method, nor does this require the method to calculate or determine the correlation. This does not further limit any steps of the claim 13 method.
Claim 19 fails to further limit the subject matter of the claim upon which it depends (claim 11) because it merely recites an intended result comparing different populations. This does not actually require either population to perform the method of claim 11, and does not further limit any step of the claim 11 method.
Claim 20 fails to further limit the subject matter of the claim upon which it depends (claim 11) because it merely recites that “patient” data of the user will influence (at least in part) the “responsiveness.” This is a general statement that patients will have different responses to treatment at least partially based on patient data. This does not actually require the method to detect or use patient data for any purpose, and does not further limit any step of the claim 11 method.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 7 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 7, lines 1-4 recites “the stimulation output is applied to a proprioceptive nerve or proprioceptive tissue …” which is encompassing a human organism. The Examiner suggests --the stimulation output is configured to be applied to a proprioceptive nerve or proprioceptive tissue…”
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-12, and 18-20, as best understood, are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ong et al. (12,295,724).
Regarding claim 1, Ong discloses a wearable device (i.e., the tremor mitigating glove in Fig. 5) for targeted peripheral stimulation, comprising:
a processor (tremor analysis system 110, Fig. 1; The tremor analysis system may be part of the wearable tremor mitigation device, and includes a processing circuitry and a memory, see col. 9, lines 53-67);
a memory communicatively connected to the processor, the memory containing instructions (“tremor management system comprises a processing circuitry and a memory for storing instructions executable by the processing circuitry” see col. 9, lines 58-60) configuring the processor to:
determine a disease state (i.e., severity) of one or more movement disorder symptoms (tremors) of a user (tremor analysis system 110 includes a severity module 111, Fig. 1; “configured to determine the severity of a tremor based on the motion signal 234… For example, for a strong tremor, or a high severity tremor, the motion signal will have higher frequency and/or amplitude than a mild tremor (or a low severity tremor)” see col. 5, lines 55-64);
generate a stimulation output based on the one or more movement disorder symptoms (“the tremor analysis system 110 is configured to analyze the motion signal 234 in order to identify a tremor and control or manage a tremor mitigating device for dampening the tremor of the patient based on the identified tremor in real time … once a tremor has been detected, a control signal is sent to the tremor mitigating device to counteract the tremor” see col. 9, lines 31-41) and the disease state of the movement disorder symptoms (“the severity module controls the tremor mitigation device based on the motion signal, physiological data, a factor and user lifestyle information” see col. 7, lines 44-46); and
command a stimulator (“tremor mitigating device may be any device that is suitable for reducing tremor of a patient, for example, the device can be a gyroscope providing mechanical dampening, a device providing vibrostimulation and/or a device providing electrical stimulation” see col. 5, lines 34-38) in communication with the processor (the processor provides a control signal to the tremor mitigating device) to apply the stimulation output (i.e., mechanical dampening, vibration and/or electrical stimulation) to a peripheral nervous system of the user (the wearable tremor reduction device is worn on the hand as a glove, see Figure 5) to reduce the one or more movement disorder symptoms (the device is intended to mitigate tremors).
Regarding claim 2, Ong discloses further comprising a sensor (i.e., accelerometer or gyroscope, see col. 9, lines 3-14) in communication with the processor (the accelerometer or gyroscope communicates with the processor of the tremor analysis system 110 as seen by motion signal 234, Fig. 1), the sensor configured to output sensor data (motion data 234, see col. 9, lines 3-14) indicative of the one or more movement symptoms disorders of the user (the motion data 234 is used to determine the one or more movement symptoms, i.e., tremors), wherein the processor is further configured to: calculate a level of responsiveness of the user (“device effectiveness module 113 may use motion signal data 234 to derive a tremor suppression index … indicative of the effectiveness of the tremor mitigating device for mitigating a tremor” see col. 8, lines 30-39) based on the sensor data generated while the stimulation output is applied (“the tremor analysis system is continuously, or intermittently, analyzing an incoming motion signal to detect a tremor” see col. 9, lines 35-45; “tremors and trends may be analyzed in real-time for real-time mitigation” see col. 24, lines 1-4. Continuously analyzing incoming motion for real-time mitigation will include motion that is generated while stimulation is applied); and communicate the responsiveness to an external computing device (see col. 16, lines 8-16, col. 28, lines 19-37 and Figure 7, illustrating the tremor analysis system 720 including the device effectiveness engine 713 communicating with external computing devices 720 such as wearer computing device 721, caretaker computing device 722, and clinician computing device 723) via a wireless communication unit of the wearable device (“via a wired or wireless network connection” see col. 38, lines 18-26).
Regarding claim 3, Ong discloses wherein the level of responsiveness of the user is calculated as one of low responsiveness, average responsiveness, or high responsiveness (Ong’s device effectiveness module 113 derives a tremor suppression index, with “values near 1 indicate perfect suppression”, i.e., high responsiveness, “values near 0 indicate no change in tremor power”, i.e., low responsiveness, and thus values at approximately 0.5 would be representative of average responsiveness. See col. 8, lines 30-43).
Regarding claim 4, Ong satisfies the limitations of claim 4 because claim 4 does not further limit any structures of the claim 2 apparatus.
Regarding claim 5, Ong satisfies the limitations of claim 5 because claim 5 does not further limit any structures of the claim 1 apparatus.
Regarding claim 6, Ong discloses wherein the one or more movement disorder symptoms are one of tremor, stiffness, rigidity, freezing, paralysis, paresis, dyskinesia, or a combination thereof (Ong discloses the one or more movement disorder symptoms are a tremor, see the claim 1 rejection statement above).
Regarding claim 8, Ong discloses wherein the processor is further configured to: adjust the stimulation output based on the disease state (severity) of the movement disorder symptoms (tremor; “the severity module controls the tremor mitigation device based on the motion signal, physiological data, a factor and user lifestyle information” see col. 7, lines 44-46); and command the one or more stimulators to apply the adjusted stimulation output (severity engine, among other engines, is used to develop tremor feedback for mitigating tremors, see col. 27, lines 6-12; “tremor severity tracking and adjustment engine may be employed to, based on tremor severity patterns, provide tremor management hardware 11 modulations to predict and mitigate tremor onsets” see col. 44, lines 23-26) to the peripheral nervous system (via wearable glove) of the user.
Regarding claim 9, Ong discloses wherein the processor is further configured to generate the stimulation output through a stimulation selection algorithm (the processor determining when and how much stimulation to apply is considered a stimulation selection algorithm), wherein the stimulation selection algorithm generates the stimulation output at least in part on patient data communicated to the processor (patient data such as “inputs from physiological sensors, such as a heart rate monitor, pulse oximetry, electrodermal activity, blood pressure, body temperature, or others…” see col. 7, lines 15-28, and “severity module controls the tremor mitigation device based on the motion signal, physiological data, a factor and user lifestyle information” see col. 7, lines 44-47; see also col. 12, lines 9-30).
Regarding claim 10, Ong discloses wherein the disease state comprises one of a severity level of the one or more movement disorder symptoms, stage of onset of the one or more movement symptoms, stage of movement disorder of the one or more movement disorder symptoms, or combination thereof (the disease state comprises a severity level of the tremors, see the claim 1 rejection above).
Regarding claim 11, Ong discloses a method of target peripheral stimulation (using the tremor mitigating glove of Fig. 5), comprising:
placing a wearable device on a user (the glove is placed on the hand, see Fig. 5);
detecting one or more movement disorder symptoms (tremors are detected via motion signal 234, Fig. 1; “the tremor analysis system 110 is configured to analyze the motion signal 234 in order to identify a tremor and control or manage a tremor mitigating device for dampening the tremor of the patient” see col. 9, lines 31-41) of the user through a sensor of the wearable device (i.e., accelerometer or gyroscope, see col. 9, lines 3-14. The gyroscope is worn in the glove, see 20, Fig. 6);
calculating a disease state (i.e., severity) of the one or more movement disorder symptoms (tremors) based on the detection (tremor analysis system 110 includes a severity module 111, Fig. 1; “configured to determine the severity of a tremor based on the motion signal 234… For example, for a strong tremor, or a high severity tremor, the motion signal will have higher frequency and/or amplitude than a mild tremor (or a low severity tremor)” see col. 5, lines 55-64);
stimulating a peripheral nervous system of the user (the wearable tremor reduction device is worn on the hand as a glove, see Figure 5) through a stimulator of the wearable device (“tremor mitigating device may be any device that is suitable for reducing tremor of a patient, for example, the device can be a gyroscope providing mechanical dampening, a device providing vibrostimulation and/or a device providing electrical stimulation” see col. 5, lines 34-38) in response to the one or more movement disorder symptoms (tremors, detected via motion signal 234, Fig. 1);
detecting a responsiveness of the user (“device effectiveness module 113 may use motion signal data 234 to derive a tremor suppression index … indicative of the effectiveness of the tremor mitigating device for mitigating a tremor” see col. 8, lines 30-39) through the sensor of the wearable device (the effectiveness module 113 uses motion signal data 234, which is detected by the sensor, i.e., accelerometer or gyroscope); and
stimulating the peripheral nervous system of the user (via the tremor mitigating glove of Fig. 5) based on the detected responsiveness (“average level of tremor suppression per individual can then be estimated under different stimulation (e.g. mechanical, vibrostimulation or electrical stimulation) conditions to optimize the effectiveness of the device” see col. 8, lines 39-43. Ong discloses using a neural network with the device effectiveness engine, among other engines, to “develop the tremor feedback for mitigating tremors and/or diagnosing tremors and tremor patterns” see col. 26, line 44 through col. 27, line 24) and the stage of the disease state (i.e., the severity, “the severity module controls the tremor mitigation device based on the motion signal, physiological data, a factor and user lifestyle information” see col. 7, lines 44-46; the severity engine, among other engines, is used “to develop the tremor feedback for mitigating tremors,” see col. 27, lines 6-12; “tremor severity tracking and adjustment engine may be employed to, based on tremor severity patterns, provide tremor management hardware 11 modulations to predict and mitigate tremor onsets” see col. 44, lines 23-26) of the one or more movement disorder symptoms (tremors).
Regarding claim 12, Ong discloses wherein the disease state comprises one of a severity level of the one or more movement disorder symptoms, stage of onset of the one or more movement symptoms, stage of movement disorder of the one or more movement disorder symptoms, or combination thereof (the disease state comprises a severity level of the tremors, see the claim 11 rejection above).
Regarding claim 18, Ong discloses wherein stimulating the body part further comprises providing one or more of vibratory, electrical, or ultrasonic output or a combination thereof to the peripheral nervous system through the stimulator of the wearable device (“tremor mitigating device may be any device that is suitable for reducing tremor of a patient, for example, the device can be a gyroscope providing mechanical dampening, a device providing vibrostimulation and/or a device providing electrical stimulation” see col. 5, lines 34-38).
Regarding claim 19, Ong satisfies the limitations of claim 19 because claim 19 does not further limit any steps of the claim 11 method.
Regarding claim 20, Ong satisfies the limitations of claim 20 because claim 20 does not further limit any steps of the claim 11 method.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 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.
Claim(s) 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ong et al. (12,295,724) in view of Moaddeb (2021/0330547).
Regarding claim 7, Ong discloses the stimulation being output on the hand (via the glove of Fig. 5) and states that the stimulation device “may be any device that is suitable for reducing tremor of a patient” (see col. 5, lines 34-38), but does not specifically state wherein the stimulation output is applied to a proprioceptive nerve or proprioceptive tissue of one of flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, or a combination thereof of the peripheral nervous system of the user.
Moaddeb teaches a related wearable tremor reduction system (wearable tremor control system 100, Fig. 8) that applies vibratory stimulation output (via vibration elements 136, 138, Fig. 8) to a proprioceptive nerve or proprioceptive tissue of one of flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, or a combination thereof of the peripheral nervous system of the user (these tissues are generally in the forearm and wrist area, which is where the vibration is applied as seen in Fig. 5). This vibratory location vibrates the median nerve in the arm, which helps alter limb shaking as part of a physiological feedback loop (see lines 38-49 of [0040]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device of Ong to include at least a portion that surrounds the wrist to apply vibration to a proprioceptive nerve or proprioceptive tissue of one of flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, or a combination thereof of the peripheral nervous system of the user as taught by Moaddeb because this location is shown to be suitable for treating limb tremor or shaking.
Regarding claim 17, Ong states that the stimulation device “may be any device that is suitable for reducing tremor of a patient” (see col. 5, lines 34-38), but does not specifically state wherein a peripheral nerve or tissue in a wrist or arm of the user is stimulated.
Moaddeb teaches a related wearable tremor reduction system (wearable tremor control system 100, Fig. 8) that applies vibratory stimulation output (via vibration elements 136, 138, Fig. 8) to a peripheral nerve or tissue in a wrist or arm of the user (the device is worn in the wrist or arm area, which is where the vibration is applied as seen in Fig. 5). This vibratory location vibrates the median nerve in the arm, which helps alter limb shaking as part of a physiological feedback loop (see lines 38-49 of [0040]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device of Ong to include at least a portion that surrounds the wrist to apply vibration to a peripheral nerve or tissue in a wrist or arm of the user as taught by Moaddeb because this location is shown to be suitable for treating limb tremor or shaking.
Claim(s) 13-16 are rejected under 35 U.S.C. 103 as being obvious over Ong et al. (12,295,724).
Regarding claim 13, Ong discloses determining a correlation between user lifestyle information and the disease state (i.e., severity) (see col. 7, lines 34-38) of the one or more movement disorder symptoms (tremors), and states “the tremor severity engine 711 may correlate tremor severity shifts to other user information 703 and/or sensor data 702 …” (see col. 33, line 34, through col. 34, line 7), and “the device effectiveness engine 713 may employ an effectiveness machine learning model to correlate the motion signal 234 to improved metrics” (see col. 39, lines 57-60), but does not specifically state calculating a correlation between the responsiveness (i.e., effectiveness) of the user and the disease state (i.e., severity). Throughout Ong’s disclosure, there is discussion of using machine learning and trained neural networks to determine correlations and optimization to improve efficacy.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the Ong method to calculate a correlation between the responsiveness of the user and the disease state, since it has been held that where the general conditions of a claim are disclosed by the prior art (Ong discloses using machine learning to correlate various metrics and data to determine tremor severity), discovering the optimum or workable ranges (i.e., calculating a correlation between responsiveness and disease state) involves only routine skill in the art. MPEP 2144.05.
Regarding claim 14, the modified Ong device discloses further comprising adjusting, based on the correlation, one or more parameters of a stimulation output of the wearable device (“part of the Machine Learning environment, software of the tremor analysis system 710 may continuously run a feedback loop in the background and generates control system solutions that leaves the tremor sufferer, healthcare provider, or both, with an endpoint decision whether to apply the ‘new’ device operation parameter change. …feedback includes instruction feedback, such as, e.g., where device effectiveness may be improved with modulations and/or adjustments to strength and direction alignment(s) of a gyroscopic movement produced by the tremor management hardware 11 actuation” See col. 27, lines 25-31; col. 28, lines 53-65. In the modified device, the correlation would similarly be a basis for adjusting a stimulation parameter to improve effectiveness).
Regarding claim 15, Ong satisfies the limitations of claim 15 because claim 15 does not further limit any steps of the claim 13 method.
Regarding claim 16, Ong satisfies the limitations of claim 16 because claim 16 does not further limit any steps of the claim 13 method.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jung (2022/0296894) discloses a related wearable device for providing stimulation to reduce tremors. Maloney et al. (2018/0000685) discloses a related wearable device for providing stimulation to reduce tremors. Rosenbluth et al. (2019/0001129) discloses a related wearable device for providing stimulation to reduce tremors. Ross et al. (2021/0402172) discloses a related wearable device for providing stimulation to reduce tremors. Pracar et al. (2015/0073310) discloses a related device for tracking Parkinson’s disease and monitoring the intensity of tremor episodes. Wong et al. (9,802,041) discloses a related wearable device for providing stimulation to reduce tremors. Gesotti (7,369,896) discloses a related wearable device for providing stimulation to reduce tremors.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER E MILLER whose telephone number is (571)270-1473. The examiner can normally be reached Mon-Fri 9:00-5:30 (Eastern).
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/CHRISTOPHER E MILLER/ Examiner, Art Unit 3785
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