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 Amendments and Arguments/Remarks
The applicant’s amendments and arguments/remarks filed on 6/3/2026 have been fully considered and are persuasive to overcome the previously held 35 USC 102(a)(2) rejection over Chen et al (WO/2024/163742 A2) and 35 USC 103 rejection over Chen in view of Bernstein et al (US 2017/0172459 A1). Specifically, the applicant amended independent claim 1 to recite that the control unit calculates a position of the laryngeal prominence based on temporal changes in the displacement amount of the sensors and a positional relationship between the first and second displacement sensors; and outputting a result indicating the calculated position of the laryngeal prominence. Said amendments were sufficient to overcome the previously held rejections. However, upon updated search and consideration, the claims are now rejected as stated below and the applicant’s arguments are moot in view of the new grounds of rejection provided herein.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 5, 6, 8-11, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Shimuta et al (US 2020/0037947 A1).
Regarding claims 1, 2, 5, 6, 8-11, 14 and 15; Shimuta discloses a laryngeal elevation measurement device (figures 14-15) comprising:
a first displacement sensor (uppermost strain sensor, element 51a11) configured to be attached to a neck of a test subject (paragraphs [0117]-[0164]; figures 14-17)
a second displacement sensor (any other strain sensor, element 52a12-52a15) configured to be attached to a site that is part of the neck of the test subject and that is located at a predetermined distance from the first displacement sensor (wherein strain sensor elements 52a11-52a15 are arranged in parallel at regular intervals in the vertical direction over a set distance, thus predetermined; paragraphs [0117]-[0164], specifically [0148]; figures 14-17); and
a control unit (body, elements 20 and 42, and computer, element 30; paragraphs [0076], [0090]-[0095], [0117]-[0164], specifically [0076], [0090]-[0095] and [0148]; figures 14-17) configured to:
acquire a displacement amount of the first displacement sensor and a displacement amount of the second displacement sensor (wherein measured strain of strain sensor elements 52a11-52a15 represent displacement of the sensors via movement of the laryngeal prominence; paragraphs [0117]-[0164]; figures 14-17),
calculate a position of a laryngeal prominence of the test subject based on temporal changes in the displacement amount of each of the first and second displacement sensors and a positional relationship between the first and second displacement sensors based on the predetermined distance (wherein sensor elements 52a11-52a15 sense and calculate movement and positional changes of the laryngeal prominence; paragraphs [0117]-[0164]; figures 14-17), and
output a result indicating the calculated position of the laryngeal prominence (provides graphical data representative of positional changes in visual form as depicted in figure 17; paragraphs [0117]-[0164]; figures 14-17).
Further regarding claims 2, 5 and 6; Shimuta discloses the control unit is further configured to output the result concerning a first period including a point in time when the displacement amount of the first displacement sensor reaches or exceeds a first threshold value (wherein the control unit determines swallowing events when signals exceed predetermined threshold values during time periods by processing and monitoring the features the displacement signals measured by the strain sensors, including the time domain features (i.e. amplitude of specific sensors at different times and rate of change); paragraphs [0068]-[0164], specifically [0068]-[0073],[0079]-[0094],[0123]; figures 4, 5 and 13-17).
Further regarding claim 5; Shimuta discloses the control unit is further configured to: output the result concerning the first period when the displacement amount of the second displacement sensor at a specific time point is greater than or equal to a second threshold value that is smaller than the first threshold value, and not output the result when the displacement amount of the second displacement sensor at the specific time point is smaller than the second threshold value, wherein the specific time point is the point in time when the displacement amount of the first displacement sensor reaches or exceeds the first threshold value (wherein the control unit determines swallowing events using predetermined threshold values based on the signals from at least the first and second displacement sensors meeting threshold values indicative of a swallow, wherein the first sensor threshold indicates the laryngeal prominence (thyroid cartilage) reaches its peak while the second sensor indicates that the laryngeal prominence increases (during initial movement) but isn’t at the peak to indicate upward movement of the beginning of a swallowing, and doesn’t indicate swallowing when these conditions aren’t met; paragraphs [0068]-[0164], specifically [0068]-[0109],[0123]; figures 4, 5 and 13-17).
Further regarding claim 6; Shimuta discloses the control unit is further configured to: start calculating the position of the laryngeal prominence when the displacement amount of the first displacement sensor and the displacement amount of the second displacement sensor are each greater than or equal to a fourth threshold value that is smaller than the first threshold value, and not start calculating the position of the laryngeal prominence when the displacement amount of at least one of the first displacement sensor and the second displacement sensor is smaller than the fourth threshold value (wherein the control unit determines swallowing events using the predetermined values of the peaks representing swallowing movement, and thus only indicate when both peaks meets a threshold value indicative of movement of the laryngeal prominence and does not indicate swallowing when they value does not meet the threshold [see example where neck is moved but prominence does not, although displacement is experienced by sensors, the displacement does not exceed the required threshold and timing values to indicate a swallowing event, and thus meet the BRI of the 4th threshold; paragraphs [0068]-[0164], specifically [0068]-[0109], and [0123]; figures 4, 5 and 13-17).
Further regarding claims 8-11; Shimuta discloses the control unit is further configured to output the result in a form of a two-dimensional image that is based on a Cartesian coordinate system that is defined by a horizontal axis representing time and a vertical axis representing an up-down position or a front-rear position and that contains chromatic changes expressing one of the up-down position and the front-rear position that is not represented by the vertical axis (wherein the examiner notes that output figures 4 and 17 meet the BRI of the claim as the figures uses different lines/colors to represent all of the height of the cartilage, the strain of the each of the sensors, and the time).
Further regarding claim 9; Shimuta discloses the up-down position is the position of the laryngeal prominence in a direction of an arrangement of cervical vertebrae of the test subject, and the front-rear position is a position of a top of the laryngeal prominence in a front-rear direction of the test subject (as noted in figures cited in rejection of claim 8 above, the signal magnitude of respective top, middle and bottom sensors represents the up-down position of a laryngeal prominence [e.g. when top sensor has high magnitude and middle/bottom sensor have lower, no or negative magnitude, the laryngeal prominence is at upper position], and the front-rear position is represented by the magnitude of the signals of the top/middle/bottom sensors [e.g. when a respective signal has positive magnitude it represents when the laryngeal prominence is moved forward as it is flexing the strain sensor]).
Further regarding claim 10; Shimuta discloses the control unit is further configured to express, numerically in conformance with the form of the two-dimensional image, at least one of: a number of swallowing movements of the test subject in a period during which the control unit calculates the position of the laryngeal prominence, a swallowing duration that is time taken for the test subject to make a single swallowing movement, and a maximum shift distance of the laryngeal prominence in the single swallowing movement (as noted in the figures cited in rejection of claim 8 above, wherein the data represented in the figures depicts swallowing duration and the maximum shift distance of the laryngeal prominence using the numerical values of the axes).
Further regarding claim 11; Shimuta discloses the control unit is further configured to display the two-dimensional image in which a time period over which the test subject is making swallowing movements is made distinguishable from a time period over which the test subject is not making the swallowing movements (as noted in the figures cited in rejection of claim 8 above, system records and displays data for before and after swallowing movement, wherein the swallowing movement is distinguishable from the non-swallowing based on the baseline signal not having magnitude).
Further regarding claim 14; Shimuta discloses the first and second displacement sensors (elements 52a11-52a15) are strip-shaped that are separate from each other and extend in a direction parallel to each other (paragraphs [0068]-[0164], specifically [0141]-[0156]; figures 3, 14 and 15).
Further regarding claim 15; Shimuta discloses the control unit comprises one or more processors configured to execute program instructions on memory for acquiring the respective displacement amounts, estimating the respective positional changes of the laryngeal prominence of the test subject, and outputting the result (wherein the swallowing analyzer and signal processing unit receive, process, output and analyze the respective displacement amount and estimate the changes of the laryngeal prominence and output the result; paragraphs [0068]-[0164], specifically [0076]-[0077] and [0120]; figures 1, 5).
Further regarding claim 21; Shimuta discloses the control unit is further configured to calculate the position of the laryngeal prominence in a direction of arrangement of a cervical vertebrae of the test subject based on an up-down position of the laryngeal prominence and in an anterior-posterior position of an apex of the laryngeal prominence (wherein the signal processing and swallow analyzer determine the position of the laryngeal prominence via the displacement sensors, elements 3a and 3b or 52a11-52a15, which are used to determine both the up-down position and the anterior-posterior position of the thyroid cartilage (i.e. laryngeal prominence) by the location of the peak of the displacement signals recorded by each of the sensors; paragraphs [0033]-[0164], specifically [0077]-[0109] and [0125]-[0129]),
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shimuta as applied to claims 1 and 2 above, and further in view of Bernstein et al (US 2017/0172459 A1).
Regarding claim 7; Shimuta is described in the rejection of claims 1 and 2 above; however Shimuta does not explicitly disclose the control unit is further configured to generate an alert that the laryngeal elevation measurement device is unable to estimate the positional changes of the laryngeal prominence of the test subject when the displacement amount of at least one of the first displacement sensor and the second displacement sensor is smaller than a fourth threshold value that is smaller than the first threshold value.
Shimuta does disclose that the strain sensors are attached to the skin via adhesive and is concerned with the problem of the sensors peeling from the skin which reduces accuracy by making them as lightweight and flexible as possible (paragraphs [0043],[0090],[0107],[0118],[0131]).
Bernstein teaches a system for monitoring a patient wherein the system includes alarms which may be triggered to indicate a particular situation, such as sensor failure which is provided to the user device (paragraph [0170]).
As Shimuta teaches that the system is ineffective when the sensor peels from the skin and corrective action must to be taken to ensure proper sensitivity, and Bernstein teaches having a sensor system provide an alert/alarm when a sensor fails; it would have been obvious to one of ordinary skill in the art at the time of filing to modify Shimuta’s control unit to generate an alert when the sensor is failing (i.e. insufficient contact) as taught by Bernstein in order to indicate to the user that they need to take correcting action (i.e. re-attaching the sensor). Furthermore, it would have been obvious to one of ordinary skill in the art at the time of filing obvious to one of ordinary skill in the art at the time of the invention to set the alarm condition as a fourth threshold value which that represents when Shimuta’s strain sensors (elements 3a and 3b or 52a11-52a15) are not sufficiently attached to the skin to generate a signal with a magnitude greater than said threshold value representing the desired sensitivity. As such, the Shimuta/Bernstein combination control unit would be configured to generate an alert that the laryngeal elevation measurement device is unable to estimate the positional changes of the laryngeal prominence of the test subject when the displacement amount of at least one of the first displacement sensor and the second displacement sensor (magnitude output from sensor element 110) is smaller than a fourth threshold value (threshold value would require signal to exceed in order show that the sensors are attached to the skin) that is smaller than the first threshold value.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2020/0170562 A1 to Jedwab et al; discloses a method and device for determining signal quality for a swallowing impairment classification model.
US 2019/0125243 A1 to Oku et al; discloses a swallowing training apparatus.
US 2020/0022639 A1 to Shimuta et al; discloses a swallowing sensor.
US 2023/0404433 A1 to Ouchi et al; discloses a neck movement measuring device.
US 2013/0310661 A1 to Jedwab et al; discloses an apparatus and method for diagnosing swallowing dysfunction.
US 5,143,087 to Yarkony; discloses analysis and treatment of swallowing dysfunction using a piezoelectric transducer placed on the neck.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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