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The nonstatutory double patenting rejection has been withdrawn in light of the amendment to the claims filed on 29 September 2025.
Terminal Disclaimer
The terminal disclaimer filed on 29 September 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11819321B2 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26-28 & 30-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted). This can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015), see MPEP § 2161(I).
With regards to Claim 26, the claim recites “wherein the quantitative measure of airflow in the trachea comprises a volume of airflow in each breath taken by the subject”; however, the instant specification fails to explain the steps/procedure for performing the “quantitative measure of… the volume of airflow in each breath,” i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. More specifically, ¶ [0043] of the instant specification merely discloses “the number of breaths in a given time period can be quantified, while also monitoring the volume (e.g., a deep breath with good airflow versus a shallow breath with low airflow) of airflow in each breath.” The instant specification fails to disclose how the Doppler signal is processed to quantify respiratory volume. One of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended the function to be performed.
Since the instant specification fails to provide a finite sequence of steps for performing the “wherein the quantitative measure of airflow in the trachea comprises a volume of airflow in each breath taken by the subject,” the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Claims 28 recite similar limitations and are rejected under the same rationale as claim 26. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
With regards to Claim 30, the claim recites “wherein the changes in tissue Doppler velocities are identified by correlating the Doppler ultrasound signals with baseline signal data”; however, the instant specification fails to explain the steps/procedure for performing the correlation, i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. More specifically, ¶ [0030-0031 & 0037] merely mention an algorithmic correlation without providing and explicit or inherent details regarding said correlation, let alone any correlation related to the baseline. Therefore, the instant specification fails to disclose how the correlation such that one of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended the function to be performed.
Since the instant specification fails to provide a finite sequence of steps for performing the “wherein the changes in tissue Doppler velocities are identified by correlating the Doppler ultrasound signals with baseline signal data,” the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Allowable Subject Matter
Claim 22-25, 29-31, 38-41 allowed.
Claims 26-28 & 30-37 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a), set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
None of the cited or search prior art teaches of “generating a quantitative measure of airflow in the trachea of the subject by processing the Doppler ultrasound signals acquired from the trachea wall using a computer system.”
For example, Granges et al. (“Study of fetal tracheal fluid velocities using Doppler ultrasound,”(19 October 2009), European Journal of Obstetrics & Gynecology and Reproductive Biology 148 (2010) 141–143; hereinafter "Granges") teaches of measuring amniotic flow in the trachea using Doppler ultrasound, but fails to teach of quantifying airflow.
Brooks et al. (“Relationship between lung volume and tracheal area as assessed by acoustic reflection”, (March 1988), J Appl Physiol (1985), 1988 Mar;64(3):1050-4; hereinafter "Brooks”) relies and a microphone to detect acoustic reflections and not ultrasound.
Bae et al. (“Usefulness of ultrasound for selecting a correctly sized uncuffed tracheal tube for paediatric patients,” (Nov. 2011), Anaesthesia, 2011 Nov;66(11):994-8; hereinafter "Bae") teaches of using measuring the area of the air column using B-mode ultrasound imaging and not Doppler. Thus, the combination of Brooks and Bae would still not render the instant claims as obvious.
Previously cited Wolf, Miller, Halperin, Vivier (see parent US16/334,267 or US16/272,689 for corresponding citations & IDS of 17 November 2023) are silent to quantifying a measure of airflow from Doppler signals of the tracheal wall.
Response to Arguments
Applicant's arguments filed 29 September 2025 have been fully considered but they are not persuasive.
In particular, Applicant contends that Claims 26-28 meet the written description requirement. In support, Applicant argues that “an ultrasound technician with ordinary skill would understand how to quantify the volume of a fluid media from Doppler ultrasound signals. By way of example, measuring the volume of blood flow is a known process in the Doppler ultrasound arts. In this way, the person of ordinary skill would recognize how to translate those processes to instead estimate the volume of airflow from the Doppler ultrasound signals acquired when performing the method recited in claim 26.” The Office disagrees. One of ordinary skill in the art ultrasound would understand that ultrasonic flowmetry relies on tracking the Doppler shift of reflecting particles in the fluid medium1. Since there are no particles in the airway, not surrounding the airway such as tissue, which having sufficient reflective properties to enable Doppler flowmetry, one of ordinary skill in the art would not be able to “translate those processes to instead estimate the volume of airflow from the Doppler ultrasound signals acquired when performing the method recited in claim 26.” For at least this reason, the argument is not persuasive.
Furthermore, Applicant argues that “[A]pplicant's specification provides guidance to the skilled person. For example, Applicant's specification describes how a deep breath with good airflow will have more volumetric airflow than a shallow breath with low airflow” and said guidance is present in ¶ [0043]. The Office disagrees. ¶ [0043] of the instant specification discloses that “[B]y quantifying the subject's respiratory rate while also monitoring changes in the subject's airflow, the quality of each breath taken by the subject can be evaluated…. the number of breaths in a given time period can be quantified, while also monitoring the volume (e.g., a deep breath with good airflow versus a shallow breath with low airflow) of airflow in each breath.” The Office has failed to recognize or identify the “guidance” Applicant is referring to. For at least this reason, the argument is not persuasive. Moreover, it appears that Applicant maybe suggesting that the quantitative measure of airflow in the trachea is estimated based on the respiratory rate. However, the instant specification clearly discloses that they are separate processes that together qualitatively evaluates the quality of the patient’s breath. There is not disclosure or suggestion as to how the airflow in the trachea quantitatively measured. Regardless, MPEP § 2161(I) clearly establishes that the “steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed” and “[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.” Applicant has failed to provide any steps/procedures that that would inform one of ordinary skill in the art how the inventor intended the function to be performed. For at least this reason, Applicant’s arguments are not persuasive.
Finally, Applicant argues that “[A] person having ordinary skill in the art would understand that measuring the respiratory rate (as disclosed elsewhere in the application) would provide the information needed to estimate the volume of airflow (e.g., minute ventilation) based on whether the observed breaths were deep (longer, larger tidal volume) or shallow (shorter, smaller tidal volume). FIGS. 2A-2C provide example guidance of how Doppler signals changes for different volumes of airway obstruction (which correspond to different volumes of airflow within the airway).” The Office disagrees. Once again, Applicant relies on an undefined “guidance” standard which is not established under 35 U.S.C. 112(a). Furthermore, Applicant routinely establishes that the volume of airflow is “estimated,” yet Claim 1 clearly recites “generated a quantitative measure.” For at least this reason, Applicant’s argument is not persuasive.
Regardless, Applicant relies on relative terminology such as “minute,” “longer,” “larger,” “shorter,” and “smaller” to describe how breaths can be observed. However, these are qualitative and not quantitative measurements. One of ordinary skill in the art would recognize that the volume of airflow cannot be quantitatively measured based on qualitative measurements. For at least this reason, Applicant’s argument is not persuasive.
Furthermore, while FIGS. 2A-2C illustrate “examples of Doppler ultrasound signals showing changes in peak amplitude and peak width in measurements from a tracheal wall, where these changes are associated with changes in airflow,” they do not disclose how one of ordinary skill in the art can quantitively measure flow. More specifically, flow is measured by measuring the velocity of fluid over a known area. While the instant specification mentions “velocity associated with the underlying airflow,” the instant specification fails to identify which reflective particles in the airflow are inspected to generate a corresponding Doppler shift and how to indicate said velocity (see ¶ [0036 & 0040]). Accordingly, the figures do not “provide example guidance of how Doppler signals changes for different volumes of airway obstruction (which correspond to different volumes of airflow within the airway),” and, for at least these reasons, Applicant’s argument is not persuasive.
Applicant also contends that Claims 30-37 meet the written description requirement. In support, Applicant argues that “[A] person having ordinary skill in the ultrasound imaging arts would understand how to calculate the correlation between two signals, such as the acquired Doppler ultrasound signals and baseline signal data. Paragraph [0030] describes that "[a] suitable correlation or other algorithm can be used to identify critical changes in the subject's airflow, relative to the baseline data, in real-time." As one non-limiting example, a person having ordinary skill in the art would immediately recognize that cross-correlation can be used to measure the correlation between two series as a function of the displacement of one relative to the other. This cross-correlation is just one example of a "suitable correlation algorithm" that would be know to those skilled in the ultrasound imaging arts for computing the correlation between two signals (e.g., series of data).” The Office disagrees. The instant specification only discloses a “correlation” and not a “cross-correlation.” A cross-correlation is a species of the genus correlation and, thus, is not supported by the instant specification as filed. For at least this reason, Applicant’s argument is not persuasive.
Furthermore, ¶ [0030-0031 & 0037] only mentions a correlation with baseline data and does not disclose how said correlation is achieved and fails to provide any steps or procedures to achieve said correlation as intended. For example, the type of correlation is not mentioned. Applicant argues it could be cross-correlation, but there is no way to ensure that the inventor intended the correlation to be a cross-correlation versus a different correlation function {e.g. convolution, cross-correlation, Pearson, etc.} or multiple correlation algorithms. This is because the instant specification fails to disclose the how the correlation is achieved, as intended, or, at a minimum the type of correlation to the baseline data. For at least this reason, Applicant’s argument is not persuasive
As indicated by Applicant, the instant specification also discloses “Doppler ultrasound signals can be correlated with the baseline signal data, and portions of the Doppler ultrasound signals that correlate with the baseline signal data can be compared.” However, to one of ordinary skill in the art the correlation is the comparison. Therefore, it is unclear what it means that the “Doppler ultrasound signals that correlate with the baseline signal data can be compared.” Is the correlation the comparison, or is there a further comparison step after the correlation. Moreover, the instant specification fails to identify what level of correlation is required to establish that the correlation amounts to a quantitative measure of airflow in the trachea. For at least this reasons, Applicant’s argument is not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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 ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 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 at (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://en.wikipedia.org/w/index.php?title=Ultrasonic_flow_meter&oldid=724140386