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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of group I, species A, claims 1, 2, 5-11 and 14-15, in the reply filed on 2/5/2026 is acknowledged.
Claims 3, 4, 12, 13 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II and/or species B, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/5/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/23/2024 and 7/21/2025 were received and placed in the record on file. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“Control unit configured to…” in claims 1, 2, 5-11 and 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“Control unit configured to…” corresponding structure is described in the specification in paragraph [0028], and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, 6, 8-11, 14 and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chen et al (WO 2024/163742 A2).
Regarding claims 1, 2, 5, 6, 8-11, 14 and 15; Chen discloses a laryngeal elevation measurement device comprising:
a first displacement sensor (middle strain sensor, element 110) configured to be attached to a neck of a test subject (held on neck via garment or band elements 130 and 140, respectively; page 13, line 17 – page 19, line 19; figures 1A-1B, 2A-2B, 3, 5A-5B, 6)
a second displacement sensor (upper strain sensor, element 110) 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 element 110 are a woven into the fabric of the garment/band elements 130/140 at a distance that doesn’t change and is thus predetermined; page 13, line 17 – page 19, line 19, page 26, line 30 – page 27, line 17; figures 1A-1B, 2A-2B, 3, 5A-5B, 6); and
a control unit (MCU and computers; figure 5A-5B; page 30, line 29 – page 31, line 11) 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 110 represent a displacement of the sensor via movement of the laryngeal prominence; page 13, line 17 – page 19, line 19, page 26, line 30 – page 27, line 17; figures 1A-1B, 2A-2B, 3, 5A-5B, 6),
estimate positional changes of a laryngeal prominence of the test subject based on changes over time in the displacement amount of each of the first and second displacement sensors and the predetermined distance (wherein sensor elements 110 sense and determine positional changes of the laryngeal prominence; page 90, line 23 – page 95, line 11), and
output a result based on the estimated positional changes (provides graphical data representative of positional changes to a serial monitor and on serial plotter; page 90, line 23 – page 95, line 11; figures 9, 11A-L, 19-25).
Further regarding claims 2, 5 and 6; Chen 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 using a trained machine learning classifier which utilizes various features from the signals measured by the sensors, and the examiner notes that the time domain features (i.e. amplitude of specific sensors at different times) used as one of the inputs into the machine learning classifier during training of the classifier inherently creates predetermined thresholds for displacement that must be met in order to be classified as a swallow; page 90, line 23 – page 108, line 20, specifically page 99, line 10 – page 106, line 8).
Further regarding claim 5; Chen 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 a trained machine learning classifier which utilizes various features from the signals measured by the sensors, and the examiner notes that the time domain features (i.e. amplitude of specific sensors at different times) used as one of the inputs into the machine learning classifier during training of the classifier inherently creates predetermined maximum and minimum thresholds for displacement of the first and second sensors that must be met in order to be classified as a swallow to output as a swallowing event; page 90, line 23 – page 108, line 20, specifically page 99, line 10 – page 106, line 8).
Further regarding claim 6; Chen discloses the control unit is further configured to: start estimating the positional changes 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 estimating the positional changes 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 a trained machine learning classifier which utilizes various features from the signals measured by the sensors, and the examiner notes that the time domain features (i.e. amplitude of specific sensors at different times) used as one of the inputs into the machine learning classifier during training of the classifier inherently creates predetermined maximum and minimum thresholds for displacement of the first and second sensors that must be met in order to be classified as a swallow to output as a swallowing event; page 90, line 23 – page 108, line 20, specifically page 99, line 10 – page 106, line 8).
Further regarding claims 8-11; Chen 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 plots 11A – 11L, 19, 33A-33F, 34A-34C, 36A,C,E,H, 38A,C,E,G from control system meet claim limitations as horizonal axis is time, vertical represents a front-rear position (as measured strain represents position of the sensor being forced forward/backward) and the different colors/shades of each line represent the top, middle and bottom sensors which represents the up-down position).
Further regarding claim 9; Chen discloses the up-down position is a 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; Chen 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 estimates 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).
Further regarding claim 11; Chen 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; Chen discloses the first and second displacement sensors (elements 110) are strip-shaped that are separate from each other and extend in a direction parallel to each other (page 14, lines 14-17; figures 1A-1B, 2A-2B, 3, 5A-5B, 6).
Further regarding claim 15; Chen 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 (figures 5A and 6; wherein the system utilizes an MCU and computer/cell phone to execute instructions to perform testing).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chen as applied to claims 1 and 2 above, and further in view of Bernstein et al (US 2017/0172459 A1).
Regarding claim 7; Chen is described in the rejection of claims 1 and 2 above; however Chen 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.
Chen does disclose that the strain sensors may show signs of wear due to reduced elasticity after repeated usage and that sensitivity can be affected and the garment may need to be adjusted to provide the desired sensitivity (page 34, lines 10-15).
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 Chen teaches that the system is ineffective when the sensor shows wear 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 Chen’s control unit to generate an alert when the sensor is failing (i.e. insufficient sensitivity) as taught by Bernstein in order to indicate to the user that they need to take correcting action (i.e. tightening drawstring or replacing shirt/collar). 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 Chen’s strain sensors (elements 110) are not fitted sufficiently and/or failing from wear to generate a signal with a magnitude greater than said threshold value representing the desired sensitivity. As such, the Chen/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 (sensitivity threshold which would require signal to exceed in order be desired sensitivity and signal magnitudes below indicates sensor failure/wear) 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 2019/0209073 A1 to Yoshioka et al; discloses swallowing diagnosis apparatus and storage medium.
US 2024/0298330 A1 to Balberg et al; discloses a wearable device for real time measurement of swallowing.
US 2018/0242900 A1 to Kuwa et al; discloses a swallowing movement monitoring sensor.
US 2019/0038208 A1 to Mohammadi et al; discloses a signal trimming and false positive reduction of post-segmentation swallowing accelerometry data.
US 2024/0000322 A1 to Xu et al; discloses advanced mechano-acoustic sensing and applications of same.
JP 2018-50755 A to Araki et al; discloses throat passing movement measuring apparatus, system and method.
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