DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Objections
3. Claim 1 is objected to because of the following informalities: line 7 recites “an output unit configure dot output an optimal EM wave stimulation condition”. It is assumed, based on the specification, that this is a typo, and is meant to recite “an output unit configured to output an optimal EM wave stimulation condition”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
4. 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.
The factual inquiries 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.
5. Claims 1-3 and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Samant U.S. 2024/0278013 (herein referred to as “Samant”) and in view of John U.S. 12,623,068 (herein referred to as “John”).
6. Regarding Claim 1, Samant teaches an electromagnetic (EM) wave stimulation optimization system (Figs. 1 and 2; para 0081 describes the electromagnetic waves) comprising:
a. an input unit (Fig. 1, ref num 110) configured to receive information on a target person and information on an EM wave (para 0040, “sensing device 110 may include a pressure sensor, a temperature sensor, a moisture meter, an impedance sensor, an ultrasound sensor, a blood-flow sensor, a pulse oximeter (SP02 sensor), and more. As described in detail herein, one or more sensing devices 110 may be operable to detect a physiological measurement of a patient, including but not limited to, tissue oxygenation, surface temperature, surface moisture, electrical impedance, pressure, blood flow, and more”; para 0042, “controller 120 may automatically determine instructions for the speed, frequency, and/or intensity of desired stimulation through electrodes 105 at least partially based on sensor data detected by sensing device 110”);
b. a simulation unit (Fig. 1, ref num 120) configured to apply the received information on the target person and the received information on the EM wave to a previously stored human phantom to perform a simulation (Fig. 2, ref num 204, 206; para 0042); and
c. an output unit configured to output an optimal EM wave stimulation condition (Fig. 1, ref num 105; Fig. 2, ref num 208).
Samant fails to teach a simulation unit is configured to predict a human body response to EM wave stimulation, the output unit configured to output the optimal EM wave stimulation condition from the human body response of the EM wave stimulation for the information on the at least one EM wave.
John teaches a system of analogous art (Fig. 2, ref num 10a), wherein the system comprises a simulation unit configured to predict a human body response to stimulation, such that an output unit outputs an optimal stimulation condition based on the human body response of the stimulation for the information of the at least one stimulation (Col. 62, lines 62-67 – Col. 63, line 1), “The system 10a can use predictive analytics, AI, ranking algorithms, and machine learning to guide therapy according to operations defined in the rules/algorithms module 50p and to analyze and adjust treatment according to data of one or more subjects. These types of analysis can be used to predict treatment outcome, propose user actions, or adjust treatment parameters based upon user data”; Col. 63, lines 13-21, “The system may use artificial intelligence, machine learning, or other rule-based algorithm to guide therapy according to operations defined in the rules/algorithms module 50p and to correlate the success of various stimulation parameter settings to outcomes across a population of users. Based upon sensed data, measurements made by a user, or answers provided to survey times, the system may then recommend certain stimulation montages, or other system characteristics, that are more likely to work best for individual users”; also see Fig. 8a). This establishes improves stimulation protocol characteristics when treating the target person (Col. 2, lines 59-62). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samant to predict a human body response to the stimulation and output an optimal condition based on this information, as this improves the stimulation protocol when treating the target person.
7. Regarding Claim 2, Samant teaches the input unit sets a stimulation area and a purpose of the EM wave based on the received information on the target person (para 0012, “determine a presence of injured tissue at the target site in response to the at least one sensing device detecting a reflected signal”; Fig. 8, ref num 604, 606).
8. Regarding Claim 3, Samant teaches the information on the target person includes a stimulation area, and a specific position of the stimulation area of the target person (para 0012-0013), and the information on the EM wave includes a frequency, an amplitude, stimulation time, a stimulation pulse, and a stimulation pulse pattern of the EM wave para 0042, “Controller 120 may receive instructions as to the speed, frequency, and/or intensity of desired stimulation at electrodes 105 from the application or interface”; para 0085, “controller 120 may be configured to determine one or more properties of the reflected signal at step 606 (e.g., an amplitude) to calculate a position”; para 0055, “the duration of electrical stimulation may correlate to the measured variance between the predetermined threshold and the measured physiological characteristic”);
Samant fails to teach the information includes an age, a height, a weight, gender, a medical history, and a symptom.
John teaches a system of analogous art (Fig. 2a, ref num 10a), wherein the system comprises information on a target person including age, height, weight, gender, medical history, and a symptom (Col. 17, lines 30-33, “surveying the user about treatment goals, user information (e.g., age, gender, race, nationality, language, education level, coping strategies), a user's symptoms, user preferences, medical history, etc.”; Col. 86, lines 14-18, “User friendliness and training outcome can be improved by selecting or adjusting an anatomical image based upon user demographics, gender, height, race, ethnicity, weight, body type, or other characteristics of a user that has been input by a user”). This aids with calculating treatment progress reports (Col. 82, lines 56-64, “such as by step 110 which adjusts symptoms that are surveyed, tracked and used to calculate treatment progress scores (by the progress module 47). These are adjusted based upon, for example: a) patient baseline characteristics of the patient profile (e.g., medical history, disease state/severity, symptom bother assessment, etc.), and/or b) user input about which treatment outcomes are most important, and c) the level of desired interaction with the system that has been indicated by a user”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samant to have the target person information include age, height, weight, gender, medical history, and symptoms in order to track the progress of the treatment accurately.
9. Regarding Claim 6, Samant teaches an electromagnetic (EM) wave stimulation optimization method performed by an electromagnetic wave stimulation optimization system (Figs. 1 and 2; para 0081 describes the electromagnetic waves), the method comprising:
a. receiving information on a target person and information on an EM wave (para 0040, “sensing device 110 may include a pressure sensor, a temperature sensor, a moisture meter, an impedance sensor, an ultrasound sensor, a blood-flow sensor, a pulse oximeter (SP02 sensor), and more. As described in detail herein, one or more sensing devices 110 may be operable to detect a physiological measurement of a patient, including but not limited to, tissue oxygenation, surface temperature, surface moisture, electrical impedance, pressure, blood flow, and more”; para 0042, “controller 120 may automatically determine instructions for the speed, frequency, and/or intensity of desired stimulation through electrodes 105 at least partially based on sensor data detected by sensing device 110”);
b. applying the received information on the target person and the received information on the EM wave to a previously stored human phantom to perform a simulation (Fig. 2, ref num 204, 206; para 0042); and
c. outputting an optimal EM wave stimulation condition (Fig. 1, ref num 105; Fig. 2, ref num 208).
Samant fails to teach predicting a human body response to EM wave stimulation, outputting the optimal EM wave stimulation condition from the human body response of the EM wave stimulation for the information on the at least one EM wave.
John teaches a method of analogous art (Fig. 2, ref num 10a), wherein the method comprises predicting a human body response to stimulation, such that an output unit outputs an optimal stimulation condition based on the human body response of the stimulation for the information of the at least one stimulation (Col. 62, lines 62-67 – Col. 63, line 1), “The system 10a can use predictive analytics, AI, ranking algorithms, and machine learning to guide therapy according to operations defined in the rules/algorithms module 50p and to analyze and adjust treatment according to data of one or more subjects. These types of analysis can be used to predict treatment outcome, propose user actions, or adjust treatment parameters based upon user data”; Col. 63, lines 13-21, “The system may use artificial intelligence, machine learning, or other rule-based algorithm to guide therapy according to operations defined in the rules/algorithms module 50p and to correlate the success of various stimulation parameter settings to outcomes across a population of users. Based upon sensed data, measurements made by a user, or answers provided to survey times, the system may then recommend certain stimulation montages, or other system characteristics, that are more likely to work best for individual users”; also see Fig. 8a). This establishes improves stimulation protocol characteristics when treating the target person (Col. 2, lines 59-62). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samant to predict a human body response to the stimulation and output an optimal condition based on this information, as this improves the stimulation protocol when treating the target person.
10. Regarding Claim 7, Samant teaches in the receiving, a stimulation area and a purpose of the EM wave are set based on the received information on the target person (para 0012, “determine a presence of injured tissue at the target site in response to the at least one sensing device detecting a reflected signal”; Fig. 8, ref num 604, 606).
11. Regarding Claim 8, Samant teaches the information on the target person includes a stimulation area, and a specific position of the stimulation area of the target person (para 0012-0013), and the information on the EM wave includes a frequency, an amplitude, stimulation time, a stimulation pulse, and a stimulation pulse pattern of the EM wave para 0042, “Controller 120 may receive instructions as to the speed, frequency, and/or intensity of desired stimulation at electrodes 105 from the application or interface”; para 0085, “controller 120 may be configured to determine one or more properties of the reflected signal at step 606 (e.g., an amplitude) to calculate a position”; para 0055, “the duration of electrical stimulation may correlate to the measured variance between the predetermined threshold and the measured physiological characteristic”);
Samant fails to teach the information includes an age, a height, a weight, gender, a medical history, and a symptom.
John teaches a system of analogous art (Fig. 2a, ref num 10a), wherein the system comprises information on a target person including age, height, weight, gender, medical history, and a symptom (Col. 17, lines 30-33, “surveying the user about treatment goals, user information (e.g., age, gender, race, nationality, language, education level, coping strategies), a user's symptoms, user preferences, medical history, etc.”; Col. 86, lines 14-18, “User friendliness and training outcome can be improved by selecting or adjusting an anatomical image based upon user demographics, gender, height, race, ethnicity, weight, body type, or other characteristics of a user that has been input by a user”). This aids with calculating treatment progress reports (Col. 82, lines 56-64, “such as by step 110 which adjusts symptoms that are surveyed, tracked and used to calculate treatment progress scores (by the progress module 47). These are adjusted based upon, for example: a) patient baseline characteristics of the patient profile (e.g., medical history, disease state/severity, symptom bother assessment, etc.), and/or b) user input about which treatment outcomes are most important, and c) the level of desired interaction with the system that has been indicated by a user”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samant to have the target person information include age, height, weight, gender, medical history, and symptoms in order to track the progress of the treatment accurately.
12. Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Samant and John, and further in view of Bonmassar U.S. 2014/0249612 (herein referred to as “Bonmassar”).
13. Regarding Claim 4, Samant fails to teach the simulation unit applies the received information on the target person and the received information on the EM wave to a pre-stored human body phantom to perform a human body response simulation based on a Finite-difference time-domain (FDTD) and predicts a change in local body temperature of the stimulation area and a change in local blood flow of the stimulation area.
Bonmassar teaches a system of analogous art (Fig. 2) wherein the system comprises a simulation unit that applies received information on a target person and received information on an EM wave to a pre-stored human body phantom to perform a human body response simulation based on a FDTD (para 0062) and predicts a change in local body temperature of the stimulation area and a change in local blood flow of the stimulation area (para 0136). This optimizes the stimulation from the output unit (para 0062-0063). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samant to perform a human body response simulation based on a FDTD and predict changes in body temperature and blood flow of the stimulation area, as this optimizes the stimulation from the output unit.
14. Regarding Claim 9, Samant fails to teach in the predicting, the received information on the target person and the received information on the EM wave to a pre-stored human body phantom to perform a human body response simulation based on a Finite-difference time-domain (FDTD) and predicts a change in local body temperature of the stimulation area and a change in local blood flow of the stimulation area.
Bonmassar teaches a method of analogous art (Fig. 2) wherein the system comprises a simulation unit that applies received information on a target person and received information on an EM wave to a pre-stored human body phantom to perform a human body response simulation based on a FDTD (para 0062) and predicts a change in local body temperature of the stimulation area and a change in local blood flow of the stimulation area (para 0136). This optimizes the stimulation from the output unit (para 0062-0063). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Samant to perform a human body response simulation based on a FDTD and predict changes in body temperature and blood flow of the stimulation area, as this optimizes the stimulation from the output unit.
Allowable Subject Matter
15. Claims 5 and 10 contain allowable subject matter. The following is an examiner’s statement of reasons for allowable subject matter: the prior art of record fails to specifically teach the output unit matches an optimal body temperature change to an optimal blood flow change according to a height, a weight, and a stimulation area of the target person and use of the EM wave, stores a matching result in advance, and derives information on an EM wave causing a body temperature change and a blood flow change that are respectively most similar to the change in body temperature and the change in blood flow as information on an optimal EM wave. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
16. Claims 5 and 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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