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 Amendment
The rejection under 35 U.S.C. 112(a) & 35 U.S.C. 112(b) has been withdrawn in light of the amendment & arguments of 20 August 2025.
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 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.
Claims 1-4 & 8-18 are rejected under 35 U.S.C. 103 as being unpatentable over Girard (“AUTOMATED DETECTION OF OBSTRUCTIVE SLEEP APNEA USING ULTRASOUND IMAGING,” (May 2003), Master Of Science In Biomedical Engineering Thesis, University Of Virginia).
With regards to Claim 1, a method for monitoring airflow in a subject's tongue using an ultrasound system (tracking tongue motion; see Girard pg. 28, ¶ 1; to detect apneic events; see Girard pg. 55, ¶ 1), the steps of the method comprising:
(a) selecting a region-of-interest in a subject that includes an anatomical region corresponding to the subject's tongue (placing the transducer used to acquire midsagittal images of the tongue in motion in which a kernel having a search area {i.e. ROI} spaced around the center position of the tongue; see Girard pg. 31, ¶ 2-3; it should be appreciated that tracking the surface of the tongue, in which the said surface is the image feature {i.e. also ROI} that is tracked in a sequence of images; see Girard pg. 29, ¶ 2 & pg. 31, ¶ 2);
(b) acquiring B-mode signals from the region-of-interest using an ultrasound system and providing the B-mode signals to a computer system (the tongue surface is tracked in grey scale images {i.e. B-mode} using the MSAD algorithm; see Girard FIGS. 4a-4b);
(c) computing B-mode motion signal data from the B-mode signals using the computer system, wherein the B-mode motion signal data indicate motion occurring in the region-of-interest while the B-mode signals were acquired (Table 4.1 of Girard illustrates the motion of the tongue surface in the Z & X directions, i.e. motion signal based on displacement); and
(d) estimating from the B-mode motion signal data, respiratory parameter data that characterize airflow in the subject's tongue (magnitude and direction of tongue motion can then be quantifiably compared to the characteristic motion {i.e. baseline} of the tongue observed during an apneic event {i.e. respiratory parameter data}; see Girard pg. 55, ¶ 1; detecting apneic events; see Girard pg. 55, ¶ 1).
While Girard teaches of the ROI as the tongue and not explicitly an airway, one of ordinary skill in the art would understand that the tongue within the oral cavity and part of the respiratory system1. Thus, one of ordinary skill in the art would understand that tongue is part of the subject’s airway.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Girard to provide at least the tongue as part of the subject’s airway. Doing so would amount to simple substitution of one known element for another to obtain predictable results, i.e. the tongue as part of the respiratory system and, thus, part of the airway.
With regards to Claim 21, modified Girard teaches of wherein the B-mode motion signal data indicate displacements occurring in the region-of-interest while the B-mode signals were acquired (Table 4.1 of Girard illustrates the motion of the tongue surface in the Z & X directions, i.e. motion signal based on displacement).
With regards to Claim 31, while modified Girard teaches of displacement between frames and ultrasound frame rate2 is well-known in the art, it appears that Girard may be silent to wherein the B-mode motion signal data indicate velocities occurring in the region-of-interest while the B-mode signals were acquired. However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Girard to provide at least the motion in the Z and X-directions as velocities based on frame rate and displacement. Doing so would amount to simple substitution of one known element for another {i.e. displacement for velocity} to obtain predictable results, apneic event detection based on tongue motion.
With regards to Claim 41, modified Girard teaches of wherein the B-mode motion signal data are computed from the B-mode signals using a non-rigid affine registration (image-based registration to track magnitude and direction of motion; see Girard pg. 29, ¶ 1).
With regards to Claim 81, modified Girard teaches of wherein the respiratory parameter data comprise quantitative estimates of at least one of respiratory rate, tidal volume, minute ventilation, flow velocity, Reynolds number, and respiratory effort (detecting apneic events {i.e. event of zero flow velocity}; see Girard pg. 55, ¶ 1 & Glossary pg. xii in which apnea is defined as when breathing (airflow) stops for 10 seconds or more).
With regards to Claim 91, modified Girard teaches of wherein the respiratory parameter data indicate whether the B-mode signals were acquired during one of an inspiratory phase or expiratory phase of breath (during expiration, the airway of apneic subjects narrows significantly and heads towards a closed position, i.e. apneic events occur during expiration and thus the detected apneic event indicates expiration; see Girard pg. 8, ¶ 1).
With regards to Claim 101, modified Girard teaches of wherein the respiratory parameter data indicate a breathing state of the subject (detecting apneic events {i.e. breathing state}; see Girard pg. 55, ¶ 1).
With regards to Claim 1110, modified Girard teaches of wherein the breathing state of the subject includes at least one of apnea, central apnea, obstructive apnea, and hypopnea (detecting apneic events {i.e. breathing state}; see Girard pg. 55, ¶ 1).
With regards to Claim 121, modified Girard teaches of wherein estimating the respiratory parameter data includes comparing the B-mode motion signal data to baseline signal data, generating output as the respiratory parameter data (magnitude and direction of tongue motion can then be quantifiably compared to the characteristic motion {i.e. baseline} of the tongue observed during an apneic event {i.e. respiratory parameter data}; see Girard pg. 55, ¶ 1; detecting apneic events; see Girard pg. 55, ¶ 1).
With regards to Claim 1312, modified Girard teaches of wherein comparing the B-mode motion signal data to the baseline signal data comprises comparing a parameter of the B-mode motion signal data with a similar parameter of the baseline signal data (magnitude and direction of tongue motion can then be quantifiably compared to the characteristic motion {i.e. baseline of a similar parameter} of the tongue observed during an apneic event {i.e. respiratory parameter data}; see Girard pg. 55, ¶ 1; detecting apneic events; see Girard pg. 55, ¶ 1).
With regards to Claim 1413, while modified Girard teaches of quantifiably comparing magnitude and direction of tongue motion to the characteristic motion having a distinct pattern of motion during an apneic event (see Girard pg. 29, ¶ 1), it appears that Girard may be silent to further comprising generating an output to a user with the computer system when the parameter of the B-mode motion signal data differs from the similar parameter of the baseline signal data by a selected threshold amount. However, Girard teaches of an edge detection of active contours algorithm that utilizes a lateral dimension of the airway threshold to determine an open airway versus an obstructed airway based (see Girard pg. 26, ¶ 2-3 cont. pg. 27, ¶ 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Girard to provide at least a similar threshold for determining an apneic event when quantifiably comparing measured tongue motion to characteristic tongue motion. Doing so would amount to combining prior art elements according to known methods to yield predictable results, i.e. thresholding to detect apneic events (see Girard pg. 26, ¶ 2-3 cont. pg. 27, ¶ 1).
With regards to Claim 1514, while modified Girard teaches all of the limitations of intervening claim 14 as shown above, it appears that Girard may be silent to wherein the selected threshold amount is a percent decrease of the parameter relative to the similar parameter. However, Girard teaches thresholding based on the lateral dimension of the air way when open (maximum) and when obstructed (minimum), wherein the relative obstruction is merely a simple ratio of the measured lateral dimension to the maximum when open. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Girard to provide at least a percentage based threshold. Doing so would amount to combining prior art elements according to known methods to yield predictable results, i.e. converting relative distances into a ratio and applying the threshold accordingly.
With regards to Claim 1613, wherein the parameter is an amplitude of the B-mode motion signal data and the similar parameter is an amplitude of the baseline signal data (the surface of the tongue is based on the a B-mode image as shown in FIGS. 4a-4b, i.e. B-mode refers to brightness mode which is based on echoes amplitude to determine corresponding grey-levels).
With regards to Claim 1712, modified Girard teaches of wherein the baseline signal data is baseline B-mode signal data acquired from the subject before acquiring the B-mode ultrasound signals in step (b) (magnitude and direction of tongue motion can then be quantifiably compared to the characteristic motion {i.e. baseline} of the tongue observed during an apneic events, the MSAD algorithm was successful in detecting posterior motion of the tongue base that is comparable to the motion of the tongue observed in ultrasound video of apneic events {i.e. baseline from previous B-mode ultrasound signals are compared to the detected motion}; see Girard pg. 29, ¶ 1; detecting apneic events; see Girard pg. 55, ¶ 1).
With regards to Claim 181, modified Girard teaches of wherein the anatomical region comprises at least one of a connective tissue or a cartilaginous tissue in the subject's airway (the tongue surface detected by Girard amounts to connective tissue in the subjects airway).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Girard in view of Colbaugh et al. (US PGPUB 20130289401; hereinafter "Colbaugh").
With regards to Claim 211, while modified Girard teaches of comparing tracked magnitude and direction of the tongue surface to characteristic motion of the tongue (see Girard pg. 29, ¶ 1), it appears that Girard may be silent to further comprising acquiring Doppler ultrasound signals from the region-of-interest with the ultrasound system and computing the respiratory parameter data using both the B-mode motion signal data and the Doppler ultrasound signals. However, Colbaugh teaches of an ultrasound apparatus to detect obstructive sleep apnea (OSA) (see Colbaugh ¶ [0075]). In particular, Colbaugh teaches of acquiring Doppler ultrasound signals from the region-of-interest with the ultrasound system and computing the respiratory parameter data using both the B-mode motion signal data and the Doppler ultrasound signals (the velocity of the tongue's surface or internal features would have an oscillation characteristic of the subject tremor motion described herein... with Doppler-based motion measurements being used to detect the characteristic motion (e.g., 30-40 Hz motion) of the genioglossus and/or other airway patency muscles in order to diagnose OSA; see Colbaugh ¶ [0078]).
Girard and Colbaugh are both considered to be analogous to the claimed invention because they are in the same field of ultrasound based diagnosis of apnea. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Girard to incorporate the above teachings of Colbaugh to provide at least acquiring Doppler ultrasound signals from the region-of-interest with the ultrasound system and computing the respiratory parameter data using both the B-mode motion signal data and the Doppler ultrasound signals. Doing so would aid in detecting the characteristic motion of the genioglossus and/or other airway patency muscles in order to diagnose OSA (see Colbaugh ¶ [0078]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Girard in view of Colbaugh, as applied to Claim 21, and in further view of Bilen-Rosas et al. (US PGPUB 20190223810; hereinafter "Rosas").
With regards to Claim 2018, while modified Girard teaches of detecting the characteristic motion (e.g., 30-40 Hz motion) of the genioglossus and/or other airway patency muscles in order to diagnose OSA (see Colbaugh ¶ [0078]), it appears that modified Girard may be silent to wherein the anatomical region comprises a tracheal wall. However, Rosas teaches of acquiring velocity data via Doppler Ultrasound of the tracheal wall {i.e. other airway patency muscles because the tracheal wall comprises muscle fibers} (see Rosas ¶ [0030]).
Modified Girard and Rosas are both considered to be analogous to the claimed invention as admitted by the Applicant in the IDS of 14 August 2024. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Girard to incorporate the above teachings of Rosas to provide at least an anatomical region of the tracheal wall. Doing so would aid in monitoring for airway obstruction or respiratory compromise and/or failure (see Rosas ¶ [0030]).
Claims 5-7 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Girard in view of Zhao et al. (“PREDICTING TONGUE MOTION IN UNLABELED ULTRASOUND VIDEOS USING CONVOLUTIONAL LSTM NEURAL NETWORKS,” (17 April 2019), ICASSP 2019 - 2019 IEEE International Conference on Acoustics, Speech and Signal Processing (ICASSP); hereinafter "Zhao").
With regards to Claim 51, modified Girard teaches of wherein computing the respiratory parameter data comprises:
accessing a motion algorithm to generate respiratory parameter data from B-mode motion signal data (using the MSAD algorithm to track tongue surface; see Girard pg. 29, ¶ 1-2 ); and
inputting the B-mode motion signal data to the motion algorithm, generating output as the respiratory parameter data (images of the ventral surface of the tongue are subjected to the MSAD algorithm; see Girard pg. 31, ¶ 2-3).
While modified Girard teaches of predictive models for predicting OSA (see Girard pg. 12, ¶ 3), it appears that modified Girard may be silent to the struck-through limitations above. However, Zhao teaches of predicting tongue motion with ultrasound using convolutional LSTM neural network (see Zhao Abstract; pg. 5927, ¶ 5-6 for generating the training dataset based on ultrasound images; and FIGS. 4, 6 for B-mode images).
Modified Girard and Zhao are both considered to be analogous to the claimed invention because they are in the same field of ultrasound imaging of tongue motion. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Girard to incorporate the above teachings of Zhao to provide at least the struck-through limitations above. Doing so would aid in predicting future tongue movements based on a short period of past tongue movements (see Zhao Abstract).
It should be appreciated that the same logic pattern and rationale are applied to Claims 6-7 as applied to Claim 5.
With regards to Claim 221, modified Girard teaches of wherein computing the B-mode motion signal data comprises:
accessing an algorithm to generate motion signal data from B-mode signals (images of the ventral surface of the tongue are subjected to the MSAD algorithm; see Girard pg. 31, ¶ 2-3); and
inputting the B-mode signals to the (images of the ventral surface of the tongue are subjected to the MSAD algorithm to generate the motion signals of Table 4.1 {i.e. motion signal}; see Girard pg. 31, ¶ 2-3).
While Girard teaches of predictive models for predicting OSA (see Girard pg. 12, ¶ 3), it appears that Girard may be silent to the struck-through limitations above. However, Zhao teaches of predicting tongue motion with ultrasound using convolutional LSTM neural network (see Zhao Abstract; pg. 5927, ¶ 5-6 for generating the training dataset based on ultrasound images; and FIGS. 4, 6 for B-mode images).
Modified Girard and Zhao are both considered to be analogous to the claimed invention because they are in the same field of ultrasound imaging of tongue motion. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Girard to incorporate the above teachings of Zhao to provide at least the struck-through limitations above. Doing so would aid in predicting future tongue movements based on a short period of past tongue movements (see Zhao Abstract).
Allowable Subject Matter
Claim 19 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: there is no teaching in either Rosas that would motivate one of ordinary skill in the art to combine Rosas cricothyroid or Girard. For example, Rosas explicitly teaches of using Doppler ultrasound to “airflow changes, air pressure changes, sound pressure changes, or combinations thereof,” while Girard teaches of detecting tongue surface motion while imaging the pharynx. But, Girard does not teach or suggest of imaging regions other than the pharynx or motion of other anatomical features (see Girard pg. 27, ¶ 2 and also pg. 21, ¶ 3). Similarly, Colbaugh teaches of using Doppler to determine characteristic motion of the muscles which is clearly distinct from a ligament especially the cricothyroid ligament situated in the larynx and not the pharynx (see Colbaugh ¶ [0078]). Zhao also teaches of only imaging the tongue and does not suggest monitoring other anatomies.
Weng et al. (“IMPLEMENTATION OF AWEARABLE ULTRASOUND DEVICE FOR THE OVERNIGHT MONITORING OF TONGUE BASE DEFORMATION DURING OBSTRUCTIVE SLEEP APNEA EVENTS,” (August 2017), Ultrasound in Medicine & Biology, Volume 43, Issue 8, August 2017, Pages 1639-1650) teaches of measuring tongue base thickness to monitor apnea events (see Weng Abstract). While Weng uses B-mode imaging to find a ROI (see Weng pg. 1643, ¶ 3), Weng relies on A-mode signals to quantify the tongue base thickness. Moreover, Weng’s signal processing method in FIG. 4b relies on specific measurements of the tongue and would not be adaptable for the cricothyroid. Al-Abed et al. (“Detection of Airway Occlusion in Simulated Obstructive Sleep Apnea/Hypopnea using Ultrasound: an In Vitro Study,” (11 November 2010), 2010 Annual International Conference of the IEEE Engineering in Medicine and Biology) also teaches of using A-mode ultrasound to characterize an occluded airway based on the energy of the reflected signals using a phantom simulation of the upper airway and not the larynx or cricothyroid ligament (see Al-Abed et al. pg. 286, ¶ 4-6). Kwan (“Breathing movements of the human tongue and genioglossus measured with ultrasound imaging,” (August 2018), PhD Doctorate Thesis, University of New South Wales, Sydney) teaches of also ultrasound imaging of the tongue {} and not the larynx or cricothyroid ligament (see Kwan pg. 55, FIG. 2.1).
Response to Arguments
Applicant’s arguments filed 20 August 2025, with respect to the rejection(s) under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Girard under 35 U.S.C. 103.
More specifically, Applicant contends that Girard does not anticipate subject’s airway. In support, Applicant argues that the tongue is not part of the subject’s airway. Applicant purports that that the airway is “(e.g., tracheal wall, cricothyroid ligament)”; however, the list of examples is a list of possible definitions of “airway” and does not amount to a special definition that invokes a lexicographic definition that acts as an “intentional disclaimer, or disavowal, of claim scope” per MPEP § 2111.01(IV). Accordingly, a plain and ordinary definition of airway would include all anatomical structures that come into direct contact with air, such as the oral cavity which includes the tongue. According to the Canadian Lung Association, as cited above & reproduced below, the respiratory system includes the oral cavity in which the tongue is clearly labelled. One of ordinary skill in the art would understand the tongue as part of the human airway is it comes into direct contact with air during oral breathing. It follows that Girard’s quantifiable tongue motion can characterize airflow in the subject’s airway because the tongue is measured directly and is within the subject’s airway. Accordingly, Applicant’s argument is not persuasive.
With regards to the 35 U.S.C. 103 rejection of Rosas in view of Girard, said rejection was made in error because it was determined that Rosas in view of Girard would not obviate Claim 19. However, the rejection was properly not deleted. Since, Claims 1-18 & 20-22 were rejected on the merits, the finality of the present Action is still proper.
With regards to dependent claims, Applicant relies on the virtue of their dependency upon abovementioned independent claim to argue novelty. Accordingly, said argument is not persuasive for at least the same reasons as Claim 1 as detailed above.
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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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith M. Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
1 https://web.archive.org/web/20161023060039/https://www.lung.ca/lung-health/lung-info/respiratory-system
2 https://www.youtube.com/watch?v=x8suZz5FeuM: Ultrasound Frame rate.