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 .
Response to Arguments
Prior Art Rejections
Applicant’s arguments with respect to claim(s) 1 and 26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Rejections under 35 U.S.C. 101
Applicant's arguments filed on 04/29/2026 have been fully considered but they are not persuasive.
Step 2A, Prong One
Applicant argues that the claims a as a whole are not directed to a mental process. Applicant specifically argues that the independent claims recite a “wearable multi-modal sensor system” including specific physical components and further recite real time synchronization of multiple physiological signals to a predetermined physiological event and generation of time-dependent bio-impedance tomographic representations of the throat which relies on electrical stimulation, voltage measurement, and spatial reconstruction of impedance distributions which cannot be practically performed by the human mind with pen and paper. Examiner respectfully disagrees and notes that using an electromyograph sensor and a bio-impedance sensor to sense physiological data amounts to mere data gathering which is a pre-solution activity. Examiner further notes that as currently written, the claims do not require the delivery of electrical stimulation.
Examiner maintains that using a generally recited processor and memory to synchronize signals to a predetermined event, receive the synchronized signals, analyze the received signals, and generate an assessment based on the analysis of the received signals amounts to mere instructions to implement the abstract idea on a computer. Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675 (MPEP 2106.04(a)(2)(III)).
Step 2A, Prong Two
Applicant further argues that the claims are integrated into a practical application since they recite signal analysis techniques in a specific technological context which improves existing medical technology by enabling real-time, non-radiative evaluation of swallowing function. Examiner respectfully disagrees and notes that the steps of synchronizing signals, receiving the synchronized signals as a data set, analyzing the data set, assessing a swallowing status (based on gathered data), and presenting the assessment amounts to gathering and analyzing information using conventional techniques and displaying the result which is not sufficient to show improvement to a technology (MPEP 2106.05(a)(II)).
Applicant further argues that the data acquisition recited in the claims is not conventional or incidental and is integral to the claimed technological solution. Applicant further argues that the claims require injecting electrical current into throat tissue, measuring voltage responses via multiple electrodes positioned around the neck, reconstructing time-dependent tomographic impedance maps, and correlating those maps with synchronized electromyographic and audio signals. Examiner respectfully disagrees and notes that as currently written, the claims do not require the injection of electrical current into throat tissue. Instead the claims require at least one bio-impedance sensor configured to receive signals relating to electric current flow in response to application of variable electric potential. Therefore, the injection of electrical current into the throat tissue is not positively recited in the claims. Examiner maintains that measuring signals using an electromyograph sensor and a bio-impedance sensor amount to mere data gathering. Reconstructing impedance maps using gathered data and correlating those maps with other gathered data using a generic processor amounts to nothing more than mere instructions to implement an abstract idea on a generic computer.
Step 2B
Applicant further argues that the claims represent a particularized medical sensing architecture that transforms raw electrical measurements into clinically meaningful physiological representations. Examiner respectfully disagrees and maintains that a generic computer component is responsible for the transformations of electrical measurements into physiological representations, not the sensing architecture. Moreover, using an electromyograph sensor sense physiological data and using a bio-impedance sensor to sense physiological data is also 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].
Examiner maintains that as currently written, the claims as a whole amount to nothing more than gathering and analyzing information using conventional techniques and displaying the result which is not sufficient to show improvement to a technology (MPEP 2106.05(a)(II)).
Claim Objections
Claims 1, 9, 19, 26, and 29 are objected to because of the following informalities:
Claim 1, line 12 should be amended to recite, “operate the at least one surface electromyograph sensor”.
Claim 9, line 3 should be amended to recite, “initiate a user interface configured to facilitate…”.
Claim 19, line 2 should be amended to recite, “…surface [[E]]electromyograph sensor…”.
Claim 26, line 5 should be amended to recite, “operating the at least one surface electromyograph sensor…”.
Claim 26, lines 6-7 should be amended to recite, “…a subject wearing the wearable device[[s];”.
Claim 26, line 9 should be amended to recite, “relating to the bio-impedance of the tissue[[s]] and structures…”.
Claim 29, line 3 should be amended to recite, “at least one surface electromyograph sensor configured…”.
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.
Regarding claim 1, the limitation of “receive synchronized signals as a first diagnostic data set” renders the claim unclear. Specifically, it is unclear if the processor is responsible for synchronizing the signals or if the processor is only receiving the synchronized signals from another structure. In order to further advance prosecution, Examiner is interpreting the claim as requiring a processor configured to synchronize the signals to a predetermined event. Examiner suggests amending the claim to recite “[[receive synchronized signals as a first diagnostic data set; analyze the first diagnostic data set;]]” in order to help overcome the pending 112 rejection. Dependent claims inherit the same deficiencies.
Claim 1 recites the limitation " the time-dependent bio-impedance tomographic representation" in line 20. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests further amending the claim to recite “assess, based on the synchronized signals [[time-dependent bio-impedance tomographic representation and the synchronized surface electromyograph signals]], a physiological swallowing status…” in order to help overcome the pending 112 rejection. Dependent claims inherit the same deficiencies.
Regarding claim 2, the limitation of “wherein the receiving is based on the time-dependent bio-impedance tomographic representation, the synchronized surface electromyograph signals and a physiological swallowing status of the subject to yield the assessment output” renders the claim unclear. Specifically, it is unclear if the bio-impedance sensor receives signals to determine a tomographic representation and synchronize signals for a swallowing assessment or if the bio-impedance sensor only receives signals according to a time-dependent tomographic representation, the synchronized electromyograph signals and a swallowing status. Since the bio-impedance signals are required for the assessment, Examiner is interpreting the claim as the bio-impedance sensor receiving signals for determining a time-dependent bio-impedance tomographic representation, synchronizing the bio-impedance signals with electromyograph signals, and determining a swallowing status.
Claim 6 recites the limitation "the list" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the at least one mechanical sensor" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 20, the limitation of “wherein analysis of the signal comprises measuring predetermined parameters of the signal” renders the claim unclear. Specifically, it is unclear which signal is being analyzed since claim 1 recites receiving both surface electromyograph signals and bio-impedance signals. In order to further advances prosecution, Examiner is interpreting the claim as reciting “wherein analysis of the signals comprises measuring predetermined parameters of the signals”.
Regarding claim 26, the limitation of “receive the synchronized signals as a first diagnostic data set” renders the claim unclear since the claim previously recited “receiving the bio-impedance signals as a first diagnostic data set”. It is unclear which data set is being analyzed when the claim later recited “analyze the first diagnostic data set”. Examiner suggests amending the claim to recite , “[[receiving the bio-impedance signals as a first diagnostic data set; receive synchronized signals as a first diagnostic data set; analyze the first diagnostic data set;]] assessing, based on the synchronized signals [[time dependent bio-impedance tomographic representation and the synchronized surface electromyograph signals]], a physiological swallowing status…” in order to increase clarity and help overcome the pending 112 rejection. Dependent claims inherit the same deficiencies.
Claim 26 recites the limitation " the time-dependent bio-impedance tomographic representation" in line 15. 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 assessing a swallowing status) 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 assessing a swallowing status.
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 signals…”, “analyze the first diagnostic set…”, “assess…a physiological swallowing status…”, and “present the 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 computer 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 limitations of “at least one memory”, “at least one processor”, and “a display” 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 “a wearable device configured to receive signals”, “at least one surface electromyograph sensor configured to receive signals…”, “at least one bio-impedance sensor configured to receive signals…” and “operate at least one surface electromyograph sensor and the at least one bio-impedance sensor concurrently…” amount to nothing more than the pre-solution activity of data gathering. The additional limitations of “present the assessment output” and “a display for displaying the assessment output” amount to the post activity solution of merely providing results.
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 “a wearable device configured to receive signals”, “at least one surface electromyograph sensor configured to receive signals…”, “at least one bio-impedance sensor configured to receive signals…”, “operate at least one surface electromyograph sensor and the at least one bio-impedance sensor concurrently…”, “present the assessment output”, and “a display for displaying the assessment output” amount to nothing more than insignificant extra-solution activities (MPEP 2106.05(g)) which do not amount to an inventive concept.
In addition, “a wearable device configured to receive signals”, “at least one surface electromyograph sensor configured to receive signals”, and “at least one bio-impedance sensor configured to receive signals” are recited at a high level of generality and considered to be well known, routine, and conventional in the art. Please see examples below:
wearable device
Vleugels et al (US 2017/0220772) [0031]
Sazonov et al (US 2018/0242908) [0049]
surface electromyograph sensor
Ternes et al (US 2012/0330373) [0071]
Dunki-Jacobs et al (US 2014/0275748) [0065]
bio-impedance sensor
Seidl et al (US 2012/0089045) [0125]
Ternes et al (US 2012/0330373) [0071]
Dependent claims 5-6, 8-10, 20-21, and 27-28 are further directed to 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 to insignificant extra-solution activities (MPEP 2106.05(g)). 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. Regarding claim 4, the use of “at least one mechanical sensor” and “at least one microphone” to gather data is considered to be well-known, routine, and conventional in the art. Regarding claim 13, the use of “a wireless communication unit” to facilitate data transmission between sensors and processors is considered to be well-known, routine, and conventional in the art. Please see examples below:
microphone
Pitts et al (US 2015/0209583) [0080]
Jedwab et al (US 2013/0310661) [0130]
mechanical sensor
Jedwab et al (US 2013/0310661) [0130]
Seidl et al (US 2012/0089045) [0018]
wireless communication unit
Pitts et al (US 2015/0209583) [0064]
Jedwab et al (US 2013/0310661) [0132]
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) 1-3, 5-6, 10, 13, 17-21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Kawada (JP2021062133) in view of Jedwab et al (US 2020/0170562) hereinafter Jedwab.
Regarding claim 1, Kawada discloses a multi-modal sensor system, comprising:
a wearable device ([0018] Device 1; Fig. 1) configured to receive signals relating to a swallowing process of a subject, the wearable device comprising:
at least one surface electromyograph sensor (electrode) configured to receive signals relating to electrical potential in muscles of a throat of the subject ([0019] electrode unit 11 measures movement of myoelectricity);
at least one bio-impedance sensor (electrode) configured to receive signals relating to the bio-impedance of the tissues and structures within the throat ([0019] electrode unit 11 measures the impedance when a subject swallows);
at least one memory ([0018] storage unit 15); and
at least one processor (control unit 16) operatively coupled to the wearable device and the at least one memory ([0018] device 1 contains control unit 16 and storage unit 15; [0029] storage unit 15 stores programs executed by control unit 16), the at least one processor configured to:
operate at least one surface electromyograph sensor and the at least one bio-impedance sensor concurrently ([0032] control unit 16 comprehensively controls each unit of device 1);
synchronize signals received from the at least one surface electromyograph sensor and the at least one bio-impedance sensor to at least one predetermined event to generate a synchronization feature ([0049] measured myoelectric waveform and impedance waveform during swallowing; Fig. 4);
receive synchronized signals as a first diagnostic data set ([0031] information and the like indicating the movement of the upper esophagus from the pharynx acquired by the measuring unit 12 are stored in the storage unit 15); and
a display (external device P) for displaying the assessment output [0046].
While Kawada discloses medical staff determining a swallowing state of a subject based on synchronized myoelectric and impedance waveforms [0050], Kawada fails to disclose a processor being configured to: analyze the first diagnostic dataset; assess, based on the time-dependent bio-impedance tomographic representation and the synchronized surface electromyograph signals, a physiological swallowing status of the subject to yield an assessment output and, present the assessment output.
However, Jedwab discloses a processor (processor 106) configured to: analyze a first diagnostic dataset ([0075] comparing of the swallowing data against the preset classification criteria);
assess, based on the analyzed first diagnostic dataset, a physiological swallowing status of the subject to yield an assessment output ([0075] processor 106 can classify each of the first plurality of swallowing events with a swallowing safety classification and a swallowing efficiency classification) and,
present the 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; [0081] at least one icon displayed on the user interface 104 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 Kawada with a processor being configured to: analyze the first diagnostic dataset; assess, based on the analyzed first diagnostic dataset, a physiological swallowing status of the subject to yield an assessment output and, present the assessment output as taught by Jedwab. Such a modification would provide the predictable results of determining a patient’s swallowing safety and efficiency (Jedwab, Abstract).
Regarding claim 2, Kawada discloses wherein the 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 ([0019] electrode unit measures impedance) 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 ([0046] the lower row is a waveform showing impedance),
wherein the receiving is based on the time-dependent bio-impedance tomographic representation, the synchronized surface electromyograph signals and a physiological swallowing status of the subject to yield the assessment output ([0051] medical staff can grasp the swallowing state of the subject by observing these waveforms).
Regarding claim 3, Kawada discloses wherein the at least one bio-impedance sensor is configured to receive signals related to biopotential in response to current flow in tissue of the throat ([0019] electrode unit measures impedance) and the at least one processor is further configured to designate the signals received from the at least one bio-impedance sensor as a bio-impedance signals ([0046] the lower row is a waveform showing impedance).
Regarding claim 5, Kawada discloses wherein the at least one processor is further configured to analyze the bio-impedance signals to generate a time dependent tomographic map of the bio-impedance of a cross section of the throat ([0046] the lower row is a waveform showing impedance; Fig. 4).
Regarding claim 6, Kawada discloses wherein the assessment output includes a relation between the signals selected from the list which consists of: surface electromyograph, bio-impedance, mechanical and audio signals ([0050] from the waveform showing the movement of myoelectricity and the waveform of impedance, it can be understood that they are related to each other and that the change shown by the waveform is caused by the subject swallowing).
Regarding claim 10, the modified Kawada discloses the system of claim 1 as discussed above, but fails to disclose wherein the processor is further configured to provide updated instructions according to the assessment output and input of a user. However, Jedwab discloses wherein the processor is further configured to provide updated instructions according to the 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] 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).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kawada 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, the modified Kawada discloses the system of claim 1 as discussed above, but fails to disclose a wireless communication unit configured to facilitate communication between the at least one processor and the at least one surface Electromyograph, at least one bio- impedance sensor, and at least one mechanical sensor and at least one audio sensor. However, Jedwab discloses a processor being operatively coupled to a sensor using one or more wireless data transfer protocols [0059]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kawada with a wireless communication unit configured to facilitate communication between the at least one processor and the sensors as taught by Jedwab. Such a modification would provide the predictable results of a wireless device that does not restrict patient movement.
Regarding claim 17, Kawada discloses wherein the wearable device further comprises a double-sided disposable adhesive surface (tape) to facilitate fastening the wearable device to a neck or the throat of the subject [0022].
Regarding claim 18, Kawada discloses the at least one bio-impedance sensor comprises a plurality of bio-impedance sensors ([0019] when measuring impedance, a plurality of electrode portions 11 are used on the body surface near the larynx of the subject; Fig. 2), but fails to expressly disclose the sensors are positioned to surround the throat at least 300 degrees. However, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system/method as taught by Kawada with the sensors being positioned to surround the throat at least 300 degrees, because Applicant has not disclosed that the sensors being 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 electrode unit as taught by Kawada, because it provides a measurement of impedance indicative of movement of the upper esophageal sphincter and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Kawada. Therefore, it would have been an obvious matter of design choice to modify Kawada to obtain the invention as specified in the claim(s).
Regarding claim 19, Kawada discloses wherein the at least one electromyograph is positioned adjacent to a larynx of a subject ([0019] electrode portion 11 is attached to the body surface near the larynx of the subject), but fails to disclose the at least one mechanical sensor is positioned adjacent to a larynx of a subject. However, Jedwab discloses at least one mechanical sensor is positioned adjacent to a larynx of a subject ([0058] device 100 can comprise a sensor 102 (e.g., a dual axis accelerometer) to be attached in a throat area).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kawada with at least one mechanical sensor is positioned adjacent to a larynx of a subject as taught by Jedwab. Such a modification would provide the predictable results of using sensed data to detect swallowing impairments (Jedwab, [0059]).
Regarding claim 20, Kawada discloses wherein analysis of the signal comprises measuring predetermined parameters of the signal (Fig. 4 shows a measured voltage and resistant amplitude; [0046] upper stage is an electromyographic waveform (unit: “μV”, for example). On the other hand, the lower row is a waveform showing impedance (unit is, for example, "Ω"); [0047-0048] depression of waveforms).
Regarding claim 21, Kawada discloses wherein the analysis further comprises determining a correlation between at least two signals of the signals collected ([0050] from the waveform showing the movement of myoelectricity and the waveform of impedance, it can be understood that they are related to each other and that the change shown by the waveform is caused by the subject swallowing).
Regarding claim 26, Kawada discloses a method comprising using at least one hardware processor (control unit 16) operatively coupled to a wearable device ([0018] device 1 contains control unit 16), the wearable device comprising at least one surface electromyograph sensor (electrode) and at least one bio-impedance sensor ([0018] device 1 includes electrode unit 11), the method comprising:
operating at least one surface electromyograph sensor to receive an electromyographic signal from a tissue in a throat of a subject wearing the wearable devices ([0019] electrode unit measures movement of myoelectricity);
operating the at least one bio-impedance sensor to receive bio-impedance signals relating to the bio-impedance of the tissues and structures within the throat ([0019] electrode unit measures impedance when a subject swallows);
synchronizing the electromyographic signal and the bio-impedance signals to at least one predetermined event to generate a synchronization feature ([0049] measured myoelectric waveform and impedance waveform during swallowing;] Fig. 4);
receiving the bio-impedance signals as a first diagnostic data set ([0031] a plurality of storage units 15 and store, for example, impedance information, information indicating the movement of myoelectricity, and the like separately);
receive synchronized signals as a first diagnostic data set ([0031] information and the like indicating the movement of the upper esophagus from the pharynx acquired by the measuring unit 12 are stored in the storage unit 15);
analyze the first diagnostic data set ([0047-0048] analyzing EMG and impedance waveform morphology during swallowing);
assess, based on the time-dependent bio-impedance tomographic representation and the synchronized surface electromyograph signals, a physiological swallowing status of the subject to yield an assessment output ([0051] the medical staff can grasp the swallowing state of the subject by observing these waveforms).
Kawada fails to disclose presenting the assessment output. However, Jedwab discloses presenting the 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; [0081] at least one icon displayed on the user interface 104 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 method as taught by Kawada with presenting the assessment output as taught by Jedwab. Such a modification would provide the predictable results of determining a patient’s swallowing safety and efficiency (Jedwab, Abstract).
Claim(s) 4, 8-9, and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Kawada (JP2021062133) in view of Jedwab (US 2020/0170562) and further in view of Pitts et al (US 2015/0209583) hereinafter Pitts.
Regarding claim 4, the modified Kawada discloses the system of claim 1 as discussed above, but fails to disclose wherein the wearable device further comprises: at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject; and, at least one microphone configured to collect audio signals relating to the throat of the subject.
Jedwab discloses a wearable device (Fig. 2) comprising 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) and Pitts discloses a wearable device (Fig. 19) comprising at least one microphone (microphone 250A) configured to collect audio signals relating to the throat of the subject [0080]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kawada with at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject as taught by Jedwab and, at least one microphone configured to collect audio signals relating to the throat of the subject as taught by Pitts. Such a modification would provide the predictable results of using audio information obtained from a microphone to determine that a cough or swallow is beginning, or should take place imminently (Pitts, [0087]) and using accelerometry data to classify swallowing events with a swallowing safety classification and a swallowing efficiency classification (Jedwab, Abstract).
Regarding claim 8, the modified Kawada discloses the system of claim 1 as discussed above, but fails to disclose wherein the at least one processor is further configured to: wait a predetermined time period; receive collected signals for a second diagnostic data set; assess, by analyzing the second diagnostic data set and comparing with the first diagnostic data set, whether the swallowing process changed; and, generate a second assessment output indicating progress of the swallowing process.
However, Pitts discloses wherein the at least one processor ([0070] microprocessor 802) 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 the second diagnostic data set and comparing with the 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).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the system as taught by Kawada with wherein at least one processor is further configured to: wait a predetermined time period; receive collected signals for a second diagnostic data set; assess, by analyzing the second diagnostic data set and comparing with the first diagnostic data set, whether the swallowing process changed; and, generate a second assessment output indicating progress of the swallowing process as taught by Pitts. Such a modification would provide the predictable results of determining if a swallowing process has improved or worsened in order to deliver a treatment to promote efficacious cough or swallow thereby protecting the airway from the introduction of unwanted material (Pitts, [0054]).
Regarding claim 9, the modified Kawada discloses the system of claim 8 as discussed above, but fails to disclose wherein the processor is further configured to: initiate a user interface facilitate instructing the subject with a predetermined treatment; and, update instructions for the subject according to progress of the subject and the second assessment output.
However, Jedwab discloses wherein the 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,
update instructions for the subject according to progress of the subject and the 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 further modify the system as taught by Kawada with the processor being further configured to: initiate a user interface facilitate instructing the subject with a predetermined treatment; and, update instructions for the subject according to progress of the subject and the 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 27, the modified Kawada discloses the method of claim 26 as discussed above, but fails to disclose using the at least one processor for: waiting a predetermined time period; receiving collected signals fora second diagnostic data set; assessing, by analyzing the second diagnostic data set and comparing with said a first diagnostic data set, whether the swallowing process changed; and, generating a second assessment output indicating progress of the subject.
However, Pitts discloses 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 the 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).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method as taught by Kawada with waiting a predetermined time period; receiving collected signals fora second diagnostic data set; assessing, by analyzing the second diagnostic data set and comparing with said a first diagnostic data set, whether the swallowing process changed; and, generating a second assessment output indicating progress of the subject as taught by Pitts. Such a modification would provide the predictable results of determining if a swallowing process has improved or worsened in order to deliver a treatment to promote efficacious cough or swallow thereby protecting the airway from the introduction of unwanted material (Pitts, [0054]).
Regarding claim 28, the modified Kawada discloses the method of claim 27 as discussed above, but fails to disclose 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 the 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 the 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 further modify the method as taught by Kawada with 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 the 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 29, Kawada discloses wherein the signals are collected by a wearable device comprising: at least one surface electromyograph (electrode) configured to receive signals relating to electrical potential in tissue of the throat ([0019] electrode unit 11 measures movement of myoelectricity); and,
at least one bio-impedance sensor (electrode) configured to receive signals relating to electric current flow in response to application of variable electric potential in tissue of the throat ([0019] electrode unit 11 measures impedance).
Regarding claim 30, the modified Kawada discloses the system of claim 29 as discussed above, but fails to disclose wherein the wearable device further comprises: at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject; and, at least one microphone configured to collect audio signals relating to the throat of the subject.
However, Jedwab discloses a wearable device (Fig. 2) comprising 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) and Pitts discloses a wearable device (Fig. 19) comprising at least one microphone (microphone 250A) configured to collect audio signals relating to the throat of the subject [0080]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to further modify the method as taught by Kawada with at least one mechanical sensor configured to receive signals relating to motion activity of the throat of the subject as taught by Jedwab and, at least one microphone configured to collect audio signals relating to the throat of the subject as taught by Pitts. Such a modification would provide the predictable results of using audio information obtained from a microphone to determine that a cough or swallow is beginning, or should take place imminently (Pitts, [0087]) and using accelerometry data to classify swallowing events with a swallowing safety classification and a swallowing efficiency classification (Jedwab, Abstract).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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