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 .
Claim Objections
Claims 1, 5-6, 9-10, 13, 17, 26-27, and 29 are objected to because of the following informalities:
Claim 1, line 1 should be amended to recite, “A multi-modal sensor system[[,]] comprising[[,]]…”
Claim 1, line 4 should be amended to recite “at least one surface [[E]]electromyograph…”
Claim 5, line 1 should be amended to recite, “The [[A]] multi-modal system of claim 1”
Claim 6, line 3 should be amended to recite, “…surface [[E]]electromyography…”
Claim 6, line 4 should be amended to recite, “mechanical, and audio signals.”
Claim 9, line 2 should be amended to recite, “[[if]] is further configured to:”
Claim 9, line 3 should be amended to recite, “initiate a user interface to facilitate…”
Claim 9, line 5 should be amended to recite, “update[[ing]] instructions…”
Claim 10, line 2 should be amended to recite, “…further configured to provide[[ing]]…”
Claim 13, lines 3-4 should be amended to recite “at least one surface [[E]]electromyograph…”
Claim 17, line 3 should be amended to recite, “…device to [[the]] a neck or throat…”
Claim 26, line2 should be amended to recite, “…[[operate]] operating at least one…”
Claim 27, line 5 should be amended to recite, “…comparing with [[said]] a…”
Claim 29, line 3 should be amended to recite “at least one surface [[E]]electromyograph…”
Claim 29, line 7 should be amended to recite, “..throat[[;]].”
Appropriate correction is respectfully requested.
Claim Rejections - 35 USC § 112
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 1-6, 8-10, 13, 17-21, and 26-30 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 1 recites the limitation "the throat" in line 5. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the same deficiencies.
Claim 17 recites the limitation "the neck" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "said at least one mechanical sensor" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "said wearable device" in line 2. There is insufficient antecedent basis for this limitation in the claim. Dependent claims inherit the same deficiencies.
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 1-6, 8-10, 13, 17-21, and 26-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process of analyzing a swallowing process) without significantly more.
Step 1
The claimed invention in claims 1-6, 8-10, 13, 17-21, and 26-30 are directed to statutory subject matter as the claims recite a method/system for analyzing a swallowing process.
Step 2A, Prong One
Regarding claims 1-6, 8-10, 13, 17-21, and 26-30, the recited steps are directed to mental processes of performing concepts in a human mind or by a human using a pen and paper (See MPEP 2106.05(a)(2) subsection (III)).
Regarding claims 1 and 26, the limitations of “synchronize the signals…”, “analyze said first diagnostic data set”, and “assess, based on the analysis, the swallowing process of the subject to yield an assessment output” are a process, as drafted, that can be performed by a human mind (including an observation, evaluation, and judgment) under the broadest reasonable interpretation but for the recitation of generic computing components.
Step 2A, Prong Two
For claims 1-6, 8-10, 13, 17-21, and 26-30, the judicial exception is not integrated into a practical application. For claims 1 and 26, the additional limitation of “at least one processor” and “at least one memory” are recited at a high level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into a practical application.
Further, the limitations of “at least one electromyograph sensor…”, “at least one bio-impedance sensor…”, and “receive the signals as a first data set” amount to nothing more than the pre-solution activity of data gathering. The additional limitation of “present said assessment output” amounts to nothing more than the post activity solution of providing results (MPEP 2106.05(g)).
Step 2B
The claims do not include additional elements that are sufficient enough to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations of “at least one electromyograph sensor…”, “at least one bio-impedance sensor…”, “receive the signals as a first data set”, and “present said assessment output” are directed to nothing more than extra-solution activities which fail to integrate the abstract idea into a practical application. In addition, “at least one electromyograph sensor…”, and “at least one bio-impedance sensor…” are recited at a high level of generality and considered to be well known, routine, and conventional in the art For examples of an electromyograph sensor see Pitts et al (us 2015/0209583) [0066] and Lindenthaler et al (US 2021/0138231) [0067]. For examples of a bio-impedance sensor see Lindenthaler et al (US 2021/0138231) [0067] and Seidl et al (US 2012/0089045) [0071].
Dependent claims 5-6, 8-10, 20-21, and 27-28 are further directed towards the abstract idea. The above mentioned claims do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
Dependent claims 2-4, 13, 17-19, and 29-30 are further directed towards the insignificant extra-solution activity of data gathering. Further, the use of “at least one mechanical sensor”, “at least one microphone”, and “a wireless communication unit” for data transmitting/gathering is considered to be well-known, routine, and conventional in the art. For examples see:
a microphone
Pitts et al (us 2015/0209583) [0080]
Jedwab et al (US 2013/0310661) [0130]
a mechanical sensor
Jedwab et al (US 2013/0310661) [0130]
Seidl et al (US 2012/0089045) [0018] For examples of
a wireless communication unit
Pitts et al (us 2015/0209583) [0064]
Jedwab et al (US 2013/0310661) [0132].
Therefore, the above mentioned claims do not introduce any additional elements which amount to significantly more under the Step 2A prong 2 and Step 2B analyses.
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, 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) 1-4, 6, 8-10, 13, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Pitts et al (US 2015/0209583) hereinafter Pitts in view of Seidl et al (US 2012/0089045) hereinafter Seidl and further in view of Jedwab et al (US 2020/0170562) hereinafter Jedwab.
Regarding claim 1, Pitts discloses a multi-modal sensor system [0063], comprising,
a wearable device configured to receive signals relating to a swallowing process of a subject ([0061] systems of the disclosure are light weight and or small in size, so that they may be wearable), the wearable device comprising:
at least one surface Electromyograph sensor configured to receive signals relating to electrical potential in muscles of the throat ([0066] sensors 306, advantageously including EMG);
at least one sensor configured to receive signals relating to
the bio-impedance of the tissues and structures within the throat ([0081] one or more electrodes 200; Fig. 21: electrodes 200);
at least one memory ([0070] flash memory 806); and
at least one processor ([0070] microprocessor 802) configured to:
operate at least one sensor of said wearable device ([0057] Monitoring is advantageously carried out by a computer processor coupled to sensors 306 (FIG. 18) configured to detect electrical or other signals generated by the patient);
synchronize the signals to at least one predetermined event to generate a synchronization feature ([0087] audio information can be analyzed, alone or together with other information about the body, to determine that a cough or swallow is beginning, or should take place imminently);
receive the signals as a first diagnostic data set ([0066] cables 304 or wireless signals connect subunits 306 (sensors) to processor 802);
analyze said first diagnostic data set ([0057] computer processor analyzes the signals);and
assess, based on the analysis, the swallowing process of the subject to yield an assessment output ([0088] audio information can be analyzed together with EMG information gathered from electrodes 200, or other electrodes, to increase a probability that a cough or swallow is intended or needed);
Pitts fails to expressly disclose at least one bio-impedance sensor configured to receive signals relating to the bio-impedance of the tissues and structures within the throat; and at least one processor is configured to: present said assessment output.
However, Seidl discloses at least one bio-impedance sensor configured to receive signals relating to the bio-impedance of the tissues and structures within the throat ([0071] detecting change in bioimpedance using voltage measuring electrodes). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with at least one bio-impedance sensor configured to receive signals relating to the bio-impedance of the tissues and structures within the throat as taught by Seidl. Such a modification would provide the predictable results of detecting a closure of the airway during the swallowing process (Seidl, [0039-0041]).
Jedwab discloses at least one processor is configured to: present said assessment output ([0079] processor 106 can be configured to use the user interface 104 to identify the swallowing safety classification and the swallowing efficiency classification for the first swallowing event simultaneously relative to each other). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with at least one processor is configured to: present said assessment output as taught by Jedwab. Such a modification would provide the predictable results of classifying the swallowing events with a swallowing safety classification and a swallowing efficiency classification (Jedwab, Abstract).
Regarding claim 2, the modified Pitts discloses the system of claim 1 as discussed above, but fails to disclose wherein said at least one bio-impedance sensor is configured to receive signals relating to electric current flow in tissue of the throat in response to application of variable electric potential and said at least one processor is further configured to designate the signals received from said at least one bio-impedance sensor as bio-impedance signals.
However, Seidl discloses wherein said at least one bio-impedance sensor is configured to receive signals relating to electric current flow in tissue of the throat in response to application of variable electric potential ([0037] a change in bioimpedance being detected [0040] by two voltage measuring elements) and
said at least one processor is further configured to designate the signals received from said at least one bio-impedance sensor as bio-impedance signals ([0123] a measurement system wherein the magnitude of the bioimpedance is determined via amplitude modulation, preferably using an envelope detector).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with said at least one bio-impedance sensor is configured to receive signals relating to electric current flow in tissue of the throat in response to application of variable electric potential and said at least one processor is further configured to designate the signals received from said at least one bio-impedance sensor as bio-impedance signals as taught by Seidl. Such a modification would provide the predictable results of detecting a closure of the airway during the swallowing process (Seidl, [0039-0041]).
Regarding claim 3, the modified Pitts discloses the system of claim 1 as discussed above, but fails to disclose wherein said at least one bio-impedance sensor is configured to receive signals related to biopotential in response to current flow in tissue of the throat and said at least one processor is further configured to designate the signals received from said at least one bio-impedance sensor as bio-impedance signals.
However, Seidl discloses wherein said at least one bio-impedance sensor is configured to receive signals related to biopotential in response to current flow in tissue of the throat ([0071] detecting change in bioimpedance using voltage measuring electrodes) and
said at least one processor is further configured to designate the signals received from said at least one bio-impedance sensor as bio-impedance signals ([0123] a measurement system wherein the magnitude of the bioimpedance is determined via amplitude modulation, preferably using an envelope detector).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with said at least one bio-impedance sensor is configured to receive signals related to biopotential in response to current flow in tissue of the throat and said at least one processor is further configured to designate the signals received from said at least one bio-impedance sensor as bio-impedance signals as taught by Seidl. Such a modification would provide the predictable results of detecting a closure of the airway during the swallowing process (Seidl, [0039-0041]).
Regarding claim 4, Pitts discloses at least one microphone(microphone 250A) configured to collect audio signals relating to the throat of the subject [0080], but fails to disclose wherein said wearable device further comprises: at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject.
However, Jedwab discloses wherein said wearable device further comprises: at least one mechanical sensor (sensor 102) configured to receive signals relating to motion activity of the throat of the subject ([0061] sensor 102 of the device 100 can be an accelerometer). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject as taught by Jedwab. Such a modification would provide the predictable results of using accelerometry data to classify the swallowing events with a swallowing safety classification and a swallowing efficiency classification (Jedwab, Abstract).
Regarding claim 6, Pitts discloses wherein said assessment output includes a relation between the signals selected from the list which consists of: surface Electromyography, bio-impedance, mechanical and audio signals ([0088] audio information can be analyzed together with EMG information gathered from electrodes 200, or other electrodes, to increase a probability that a cough or swallow is intended or needed).
Regarding claim 8, Pitts discloses the multi-modal sensor system of claim 1,wherein said at least one processor is further configured to:
wait a predetermined time period ([0023] FIG. 8 is a graph of electrical activity of the mylohyoid muscle in with and without electrical stimulation; Examiner notes the control swallow data was gathered at a different time than the post-stimulation swallow data);
receive collected signals for a second diagnostic data set ([0055] The graph indicates electrical activity of the mylohyoid muscle (located under the chin) as a marker, or indication of the incidence and force of a swallow);
assess, by analyzing said second diagnostic data set and comparing with said first
diagnostic data set, whether the swallowing process changed ([0055] the electrical stimulation as described herein, significantly increases the force of a swallow); and,
generate a second assessment output indicating progress of the swallowing process ([0055] surface electrical stimulation increased the excitability of swallow from an injection of water in the mouth during post-stimulation swallowing).
Regarding claim 9, Pitts discloses the system of claim 8 as discussed above, but fails to disclose wherein said processor is further configured to: initiate a user interface facilitate instructing the subject with a predetermined treatment; and, updating instructions for the subject according to progress of the subject and said second assessment output.
However, Jedwab discloses wherein said processor is further configured to: initiate a user interface facilitate instructing the subject with a predetermined treatment ([0079] processor 106 is configured to use the user interface 104 to provide one or more second user outputs comprising at least one of audio or graphics that instruct administration of a plurality of doses of beverage); and,
updating instructions for the subject according to progress of the subject and said second assessment output ([0079] the processor 106 can be configured to use the user interface 104 to instruct administration of a first dose of beverage, then identify the swallowing safety classification and the swallowing efficiency classification for a first swallowing event corresponding to the first dose of beverage, then instruct administration of a second dose of beverage, and then identify the swallowing safety classification and the swallowing efficiency classification for a second swallowing event corresponding to the second dose of beverage).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with wherein said processor is further configured to: initiate a user interface facilitate instructing the subject with a predetermined treatment; and, updating instructions for the subject according to progress of the subject and said second assessment output as taught by Jedwab. Such a modification would provide the predictable results of identifying the swallowing safety classification and the swallowing efficiency classification for a second swallowing event corresponding to the second dose of beverage (Jedwab, [0079]).
Regarding claim 10, the modified Pitts discloses the system of claim 1 as discussed above, but fails to disclose wherein said processor is further configured to providing updated instructions according to said assessment output and input of a user. However, Jedwab discloses wherein said processor is further configured to providing updated instructions according to said assessment output and input of a user ([0077] user interface 104 can comprise an input element 105 (e.g., a keyboard or touchpad) that is configured to accept user input identifying at least one parameter selected from the group consisting of a type of sensor that provides the first accelerometry data and a type of beverage consumed during the first plurality of swallowing events; [0079] instruct administration of a second dose of beverage, and then identify the swallowing safety classification and the swallowing efficiency classification for a second swallowing event corresponding to the second dose of beverage).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with providing updated instructions according to said assessment output and input of a user as taught by Jedwab. Such a modification would provide the predictable results of identifying the swallowing safety classification and the swallowing efficiency classification for a second swallowing event corresponding to the second dose of beverage (Jedwab, [0079]).
Regarding claim 13, Pitts discloses a wireless communication unit configured to facilitate communication between said at least one processor and said at least one surface Electromyograph, at least one bio-impedance sensor, and at least one mechanical sensor and at least one audio sensor ([0064] communication subsystem elements such as a wireless transmitter 810, a wireless receiver 812, and associated components such as one or more antenna elements 814 and 816).
Regarding claim 18, the modified Pitts discloses the system of claim 1 as discussed above, but fails to disclose wherein said at least one bio-impedance sensor comprises a plurality of bio-impedance sensors positioned to surround the throat at least 300 degrees. However, Seidl discloses wherein said at least one bio-impedance sensor comprises a plurality of bio-impedance sensors positioned to surround the throat at least 300 degrees ([0144] a BI measurement wherein the change in BI magnitude was measured using the 4-electrode method; FIG. 1 exemplifies the electrode positions/points of measurement). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with said at least one bio-impedance sensor comprises a plurality of bio-impedance sensors positioned to surround the throat at least 300 degrees as taught by Seidl. Such a modification would provide the predictable results of detecting a closure of the airway during the swallowing process (Seidl, [0039-0041]).
Pitts discloses the claimed invention but does not disclose expressly the plurality of bio-impedance sensors positioned to surround the throat at least 300 degrees. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Pitts with the plurality of bio-impedance sensors positioned to surround the throat at least 300 degrees, because Applicant has not disclosed that plurality of bio-impedance sensors positioned to surround the throat at least 300 degrees provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant' s invention to perform equally well with [the element that is similar to the electrode placement as taught by Pitts, because it provides the recording of electrical activity of the throat during the swallowing process and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Pitts.Therefore, it would have been an obvious matter of design choice to modify Pitts to obtain the invention as specified in the claim(s).
Regarding claim 19, the modified Pitts discloses wherein said at least one surface Electromyograph is positioned adjacent to a Larynx of the subject (Abstract: electrodes are positioned upon skin of the neck of the patient), but fails to disclose said at least one mechanical sensor is positioned adjacent to a Larynx of the subject.
However, Jedwab discloses wherein said at least one mechanical sensor is positioned adjacent to a Larynx of the subject ([0057] sensor may be positioned externally on the neck of a human, preferably anterior to the cricoid cartilage of the neck; [0061] sensor 102 of the device 100 can be an accelerometer). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with wherein said at least one mechanical sensor is positioned adjacent to a Larynx of the subject as taught by Jedwab. Such a modification would provide the predictable results of using accelerometry data to classify the swallowing events with a swallowing safety classification and a swallowing efficiency classification (Jedwab, Abstract).
Regarding claim 20, Pitts discloses wherein analysis of the signal comprises measuring predetermined parameters of the signal ([0055] The graph indicates electrical activity (voltage) of the mylohyoid muscle (located under the chin) as a marker, or indication of the incidence and force of a swallow; [0081] record EMG readings from the body, which can be analyzed by the controller to determine a therapeutic or appropriate time to trigger a cough or swallow (Examiner notes this would require at least a voltage and timing measurement)).
Regarding claim 21, Pitts discloses wherein said analysis further comprises determining a correlation between at least two signals of the signals collected ([0088] audio information can be analyzed together with EMG information gathered from electrodes 200).
Claim(s) 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Pitts (US 2015/0209583) in view of Jedwab (US 2020/0170562).
Regarding claim 26, Pitts discloses a method comprising using at least one hardware processor ([0070] microprocessor 802) for:
operate at least one sensor of said wearable device ([0057] Monitoring is advantageously carried out by a computer processor coupled to sensors 306);
synchronizing the signals to at least one predetermined event to generate a synchronization feature ([0087] audio information can be analyzed, alone or together with other information about the body, to determine that a cough or swallow is beginning, or should take place imminently);
receiving the signals as a first diagnostic data set ([0066] cables 304 or wireless signals connect subunits 306 (sensors) to processor 802);
analyzing said first diagnostic data set ([0057] computer processor analyzes the signals); and
assessing, based on the analysis, the swallowing process of the subject to yield an assessment output ([0088] audio information can be analyzed together with EMG information gathered from electrodes 200, or other electrodes, to increase a probability that a cough or swallow is intended or needed).
Pitts fails to disclose using at least one hardware processor for: presenting said assessment output. However, Jedwab discloses disclose using at least one hardware processor for: presenting an assessment output ([0077] provide one or more first outputs comprising at least one of audio or graphics that identify the swallowing safety classification and the swallowing efficiency classification for each of the first plurality of swallowing events). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with using at least one hardware processor for: presenting an assessment output as taught by Jedwab. Such a modification would provide the predictable results of identifying the swallowing safety classification and the swallowing efficiency classification for a second swallowing event corresponding to the second dose of beverage (Jedwab, [0079]).
Regarding claim 27, Pitts discloses further comprising using the at least one processor for:
waiting a predetermined time period ([0023] FIG. 8 is a graph of electrical activity of the mylohyoid muscle in with and without electrical stimulation; Examiner notes the control swallow data was gathered at a different time than the post-stimulation swallow data);
receiving collected signals for a second diagnostic data set ([0055] The graph indicates electrical activity of the mylohyoid muscle (located under the chin) as a marker, or indication of the incidence and force of a swallow);
assessing, by analyzing said second diagnostic data set and comparing with said a
first diagnostic data set, whether the swallowing process changed ([0055] the electrical stimulation as described herein, significantly increases the force of a swallow); and,
generating a second assessment output indicating progress of the subject ([0055] surface electrical stimulation increased the excitability of swallow from an injection of water in the mouth during post-stimulation swallowing).
Regarding claim 28, Pitts discloses the method of claim 27, but fails to disclose further comprising using the at least one processor for: initiating a user interface to facilitate instructing the subject with a predetermined treatment; and, updating instructions for the subject according to progress of the subject and said second assessment output.
However, Jedwab discloses initiating a user interface to facilitate instructing the subject with a predetermined treatment ([0079] processor 106 is configured to use the user interface 104 to provide one or more second user outputs comprising at least one of audio or graphics that instruct administration of a plurality of doses of beverage); and,
updating instructions for the subject according to progress of the subject and said second assessment output ([0079] the processor 106 can be configured to use the user interface 104 to instruct administration of a first dose of beverage, then identify the swallowing safety classification and the swallowing efficiency classification for a first swallowing event corresponding to the first dose of beverage, then instruct administration of a second dose of beverage, and then identify the swallowing safety classification and the swallowing efficiency classification for a second swallowing event corresponding to the second dose of beverage).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with using the at least one processor for: initiating a user interface to facilitate instructing the subject with a predetermined treatment; and, updating instructions for the subject according to progress of the subject and said second assessment output as taught by Jedwab. Such a modification would provide the predictable results of identifying the swallowing safety classification and the swallowing efficiency classification for a second swallowing event corresponding to the second dose of beverage (Jedwab, [0079]).
Claim(s) 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Pitts (US 2015/0209583) in view of Jedwab (US 2020/0170562) and further in view of Seidl (US 2012/0089045).
Regarding claim 29, Pitts discloses wherein said signals are collected by a wearable device [0061] comprising: at least one surface Electromyograph configured to receive signals relating to electrical potential in tissue of the throat ([0066] sensors 306, advantageously including EMG); and at least one sensor configured to receive signals relating to electric current flow in response to application of variable electric potential in tissue of the throat ([0081] one or more electrodes 200; Fig. 21 shows 2 electrodes 200).
Pitts fails to expressly disclose at least one bio-impedance sensor configured to receive signals relating to electric current flow in response to application of variable electric potential in tissue of the throat. However, Seidl discloses at least one bio-impedance sensor configured to receive signals relating to electric current flow in response to application of variable electric potential in tissue of the throat ([0037] a change in bioimpedance being detected [0040] by two voltage measuring elements). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with at least one bio-impedance sensor configured to receive signals relating to electric current flow in response to application of variable electric potential in tissue of the throat as taught by Seidl. Such a modification would provide the predictable results of detecting a closure of the airway during the swallowing process (Seidl, [0039-0041]).
Regarding claim 30, Pitts discloses wherein said wearable device further comprises: at least one microphone configured to collect audio signals relating to the throat of the subject ([0080] body microphone 250A), but fails to disclose at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject. However, Jedwab discloses at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject ([0061] sensor 102 of the device 100 can be an accelerometer).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with at least one microphone configured to collect audio signals relating to the throat of the subject as taught by Jedwab. Such a modification would provide the predictable results of using accelerometry data to classify the swallowing events with a swallowing safety classification and a swallowing efficiency classification (Jedwab, Abstract).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Pitts (US 2015/0209583) in view of Seidl (US 2012/0089045) and Jedwab (US 2020/0170562) and further view of Tansley et al (US 2022/0061690) hereinafter Tansley.
Regarding claim 5, the modified Pitts discloses the system of claim 1 as discussed above, but fails to disclose wherein said at least one processor is further configured to analyze said bio-impedance signals to generate a time dependent tomographic map of the bio-impedance of a cross section of the throat. However, Tansley discloses wherein said at least one processor is further configured to analyze said bio-impedance signals to generate a time dependent tomographic map of the bio-impedance of a cross section of the throat ([0135] impedance tomography techniques for bladder, lung or throat mapping). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with wherein said at least one processor is further configured to analyze said bio-impedance signals to generate a time dependent tomographic map of the bio-impedance of a cross section of the throat as taught by Tansley. Such a modification would provide the predictable results of detecting a closure of the airway during the swallowing process as evidenced by Seidl (Seidl, [0039-0041]).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pitts (US 2015/0209583) in view of Seidl (US 2012/0089045) and Jedwab (US 2020/0170562) and further view of Lee et al (US 2022/0061690) hereinafter Lee.
Regarding claim 17, the modified Pitts discloses the system of claim 1 as discussed above, but fails to disclose wherein said wearable device further comprises a double-sided disposable adhesive surface to facilitate fastening said wearable device to the neck or throat of the subject. However, Lee discloses wherein said wearable device further comprises a double-sided disposable adhesive surface to facilitate fastening said wearable device to the neck or throat of the subject ([0070] a dual-axis accelerometer is positioned on the candidate’s neck (e.g. by way of a strap, elasticized band and/or double-sided adhesive tape)). ). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Pitts with a double-sided disposable adhesive surface to facilitate fastening said wearable device to the neck or throat of the subject as taught by Lee. Such a modification would provide the predictable results of ensuring the device stays placed on the neck or throat while collecting physiological data.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792