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 .
Election/Restrictions
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 1, 2025.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-8 are directed to a method for identifying airway collapse using a computational algorithm, which is an abstract idea. Claims 1-8 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] – “detecting, by the acoustic sensor, echoes resulting from the series of acoustic pulses”;
[B1] – “generating, based on the detected echoes, a time series of passageway sizes of the airway”; and
[C1] – “based on the time series of passageway sizes, detecting an airway collapse has occurred”; and
These elements [A1]-[C1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] – “based on detecting the airway collapse has occurred, activating an airway collapse alarm”
The element [A2] of claim 1 does not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere output or display of data at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitation “emitting, from an acoustic sensor, a series of acoustic pulses into a tracheal tube positioned in an airway of a patient” does not qualify as significantly more because this limitation is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well-known elements or simply displaying the results of the algorithm that uses conventional, routine, and well-known elements. In particular, the acoustic sensor is nothing more than a generic sensor in the art. Such temperature sensors are conventional as evidenced by:
U.S. Patent Application Publication No. 20060198533 (Wang) discloses that acoustic sensors are typical for use in measuring sounds in the tracheal areas to detect obstruction of the airway [0116, 0046].
Claims 2-8 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 2 – “a monitor communicatively coupled to the acoustic sensor”;
Claim 6 – “displaying one or more of the dynamic characteristics on at least one of a monitor communicatively coupled to the acoustic sensor or a ventilator communicatively coupled to the acoustic sensor”;
Claim 7 – “adjusting ventilation delivered to the patient based on one or more of the dynamic characteristics”; and
Claim 8 – “storing the time series of passageway sizes in a buffer; and based on detection of the airway collapse, storing the time series of passageway sizes in permanent memory”.
Each of these claim limitations does not integrate the exception into a practical application. In particular, the elements of claims 2 and 6-7 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering or output/display at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Additionally, the limitations of claim 8 are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 9-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 9 recites “a tracheal tube positioned in an airway of a patient” in lines 7-8, which encompasses a portion of the human body as part of the claimed system. In order to overcome this rejection, Examiner suggests amending the claim to recite “a tracheal tube configured to be positioned in an airway of a patient”. Claims 10-13 are rejected based on their dependence on claim 9.
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.
(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.
Claims 1-7 and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200376218 A1 (Mansfield et al.).
Regarding claim 1, Mansfield teaches a method for identifying airway collapse, the method comprising:
emitting, from an acoustic sensor, a series of acoustic pulses into a tracheal tube positioned in an airway of a patient ([0016] “An acoustic reflectometry system consists of an adapter connected to the proximal end of an ETT and to a monitor … detecting the returning acoustic reflections, or echoes, with the microphones,”);
detecting, by the acoustic sensor, echoes resulting from the series of acoustic pulses ([0040] “The acoustic reflectometry system tracks the time delay of this airway echo, estimating relative changes in the distance between the ETT tip and the airway echo region.”);
generating, based on the detected echoes, a time series of passageway sizes of the airway ([0039] “This echo, referred to as the ETT tip echo, is analyzed by the acoustic reflectometry system to estimate the passageway size (or effective diameter) around the ETT.”);
based on the time series of passageway sizes, detecting an airway collapse has occurred ([0093] “Possible collapsed lung (indicated by a significant change in the airway sonic reflection morphology, which is a composite of the reflection coming from both the left and right lungs—change one lung volume and the composite signal will change significantly)”); and
based on detecting the airway collapse has occurred, activating an airway collapse alarm ([0091] “Low volume alarm”).
Regarding claim 2, Mansfield teaches the method of claim 1, wherein the time series of passageway sizes are displayed on a monitor communicatively coupled to the acoustic sensor ([0016] “monitor”; Fig. 5; [0041] “the acoustic reflectometry system includes a device 122. that is a handheld, portable device with a display 124 that provides information about the endotracheal tube position, obstruction, and movement.”).
Regarding claim 3, Mansfield teaches the method of claim 1, further comprising generating dynamic characteristics of the airway collapse based on the time series of passageway sizes ([0038-0039] “The acoustic reflectometry system estimates the obstruction size from the echo amplitude and the obstruction location from the echo delay time.”; “This echo, referred to as the ETT tip echo, is analyzed by the acoustic reflectometry system to estimate the passageway size (or effective diameter) around the ETT.”).
Regarding claim 4, Mansfield teaches the method of claim 3, wherein the dynamic characteristics include at least one of a peak-to-baseline value, a baseline shift, or a baseline trend ([0029] “FIG. 3 is a diagrammatical view of the sound waves and respective echo signals (i.e., acoustic reflections) after encountering changes in cross sectional area in a tube”; [0039] “This echo, referred to as the ETT tip echo, is analyzed by the acoustic reflectometry system to estimate the passageway size (or effective diameter) around the ETT. A negative deflection echo indicates that the ETT is located in a passageway that has a larger cross sectional area than the ETT. This would be the. case for an EFT that is in the trachea. If this echo were to change to a positive deflection, it would indicate that the ETT is located in a passageway that has a smaller cross sectional area than the ETT. This may correspond to an ETT that is in the esophagus or bronchus or that it is clogged at the tip, for example, from mucus.”).
Regarding claim 5, Mansfield teaches the method of claim 4, further comprising generating an airway-compliance indicator based on at least the peak-to-baseline value ([0070] “The amount of pressure necessary to deliver the tidal volume is determined by the resistance and compliance of the patient and ventilator circuit, and may vary from breath to breath.”; [0105]).
Regarding claim 6, Mansfield teaches the method of claim 4, further comprising displaying one or more of the dynamic characteristics on at least one of a monitor communicatively coupled to the acoustic sensor or a ventilator communicatively coupled to the acoustic sensor ([0034] “The acoustic reflectometry system adapter 110 couples between the ETT 102 and the ventilator hose 112 as shown in FIG. 1.”; [0041] “the acoustic reflectometry system includes a device 122. that is a handheld, portable device with a display 124 that provides information about the endotracheal tube position, obstruction, and movement”).
Regarding claim 7, Mansfield teaches the method of claim 3 further comprising adjusting ventilation delivered to the patient based on one or more of the dynamic characteristics ([0067]; [0078-0079]; [0081] “the user may set the desired trachea pressure (above, at, or below a desired baseline pressure), and the ventilator controller, which is provided access to the P.sub.TRACHEA data from the acoustic reflectometry system, may automatically adjust the pressure support level setting on the ventilator to obtain the desired trachea pressure.”; [0117]).
Regarding claim 9, Mansfield teaches a system for detecting airway collapse, the system comprising:
an acoustic sensor comprising an acoustic receiver and an acoustic generator ([0016] “Embedded inside the adapter is a sound generator such as a miniature speaker, for example, and at least one receiver such as a microphone array, for example”);
a monitor communicatively coupled to the acoustic sensor ([0016] “An acoustic reflectometry system consists of an adapter connected to the proximal end of an ETT and to a monitor.”);
a processor ([0025] “The system also includes a reflectometry device having at least one processor”); and
memory storing instructions that, when executed by the processor ([0025] “a memory that is accessible to the processor for analyzing timings and amplitudes of the returning acoustic reflections”), cause the system to perform a set of operations comprising:
emitting, from the acoustic generator, a series of acoustic pulses into a tracheal tube positioned in an airway of a patient ([0016] “An acoustic reflectometry system consists of an adapter connected to the proximal end of an ETT and to a monitor … detecting the returning acoustic reflections, or echoes, with the microphones,”);
detecting, by the acoustic receiver, echoes resulting from the series of acoustic pulses reflecting from a tip of the tracheal tube ([0040] “The acoustic reflectometry system tracks the time delay of this airway echo, estimating relative changes in the distance between the ETT tip and the airway echo region.”);
generating, based on the detected echoes, a time series of passageway sizes of the airway ([0039] “This echo, referred to as the ETT tip echo, is analyzed by the acoustic reflectometry system to estimate the passageway size (or effective diameter) around the ETT.”);
based on at least one of the time series of passageway sizes or the detected echoes, detecting an airway collapse has occurred ([0093] “Possible collapsed lung (indicated by a significant change in the airway sonic reflection morphology, which is a composite of the reflection coming from both the left and right lungs—change one lung volume and the composite signal will change significantly)”); and
displaying the time series of passageway size on the monitor ([0016] “monitor”; Fig. 5; [0041] “the acoustic reflectometry system includes a device 122. that is a handheld, portable device with a display 124 that provides information about the endotracheal tube position, obstruction, and movement.”).
Regarding claim 10, Mansfield teaches the system of claim 9, wherein the system further comprises a ventilator, and the monitor is integrated into the ventilator or is a stand-alone monitor separate from the ventilator ([0034] “The acoustic reflectometry system adapter 110 couples between the ETT 102 and the ventilator hose 112 as shown in FIG. 1.”; [0041] “the acoustic reflectometry system includes a device 122. that is a handheld, portable device with a display 124 that provides information about the endotracheal tube position, obstruction, and movement”).
Regarding claim 11, Mansfield teaches the system of claim 10, wherein the operations further comprise generating dynamic characteristics of the airway collapse based on the time series of passageway sizes, wherein the dynamic characteristics include at least one of a peak-to-baseline value, a baseline shift, or a baseline trend ([0029] “FIG. 3 is a diagrammatical view of the sound waves and respective echo signals (i.e., acoustic reflections) after encountering changes in cross sectional area in a tube”; [0039] “This echo, referred to as the ETT tip echo, is analyzed by the acoustic reflectometry system to estimate the passageway size (or effective diameter) around the ETT. A negative deflection echo indicates that the ETT is located in a passageway that has a larger cross sectional area than the ETT. This would be the. case for an EFT that is in the trachea. If this echo were to change to a positive deflection, it would indicate that the ETT is located in a passageway that has a smaller cross sectional area than the ETT. This may correspond to an ETT that is in the esophagus or bronchus or that it is clogged at the tip, for example, from mucus.”).
Regarding claim 12, Mansfield teaches the system of claim 11, wherein the operations further comprise, based on at least one of the dynamic characteristics, adjusting, by the ventilator, a pressure of delivered breathing gases to the patient ([0067]; [0078-0079]; [0081] “the user may set the desired trachea pressure (above, at, or below a desired baseline pressure), and the ventilator controller, which is provided access to the P.sub.TRACHEA data from the acoustic reflectometry system, may automatically adjust the pressure support level setting on the ventilator to obtain the desired trachea pressure.”; [0117]).
Regarding claim 13, Mansfield teaches the system of claim 9, wherein the operations further comprise, based on detecting the airway collapse has occurred, activating an airway-collapse alarm on the monitor ([0091] “Low volume alarm”; [0041] “the acoustic reflectometry system includes a device 122. that is a handheld, portable device with a display 124 that provides information about the endotracheal tube position, obstruction, and movement.”).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200376218 A1 (Mansfield et al.) in view of US 20190175852 A1 (Freeman et al.).
Regarding claim 8, Mansfield teaches the method of claim 1, further comprising: detection of the airway collapse ([0093] “Possible collapsed lung (indicated by a significant change in the airway sonic reflection morphology, which is a composite of the reflection coming from both the left and right lungs—change one lung volume and the composite signal will change significantly)”).
Mansfield does not explicitly teach storing the time series of passageway sizes in a buffer; and storing the time series of passageway sizes in permanent memory.
However,
Freeman teaches storing the time series of passageway sizes in a buffer; and storing the time series of passageway sizes in permanent memory ([0037] “Volatile memory 225 may comprise a cache area for the temporary storage of data. Non-volatile memory 230 may further comprise an electrically erasable programmable read only memory (EEPROM), flash memory, and/or the like. In an embodiment, ventilation monitoring device 145 may use memory to store information and/or data including computer program code to implement one or more features of ventilation monitoring device 145”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have modified the method disclosed in Mansfield to include storing the time series of passageway sizes in a buffer and permanent memory. One would have been motivated to make this modification because the temporary volatile memory and non-volatile memory may be used together with a tracheal tube and saving particular results to memory based on ventilation testing, as suggested by Freeman [0036, 0063].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-16 of U.S. Patent No. 11/696,993 in view of US 20210321939 A1 (Kent et al.).
Regarding claim 9, ‘993 teaches a system for detecting airway collapse, the system comprising:
an acoustic sensor comprising an acoustic receiver and an acoustic generator (Claims 14 – “a sound generator to emit sound waves into an endotracheal tube (“ETT”); at least one sound receiver to detect returning acoustic reflections”);
a monitor communicatively coupled to the acoustic sensor (Claim 14 – “display information that there is a possible mainstem bronchial intubation, a possible collapsed lung, a possible bronchial plug, or any combination thereof.”);
a processor (Claim 14 – “a reflectometry device having a controller”); and
emitting, from the acoustic generator, a series of acoustic pulses into a tracheal tube positioned in an airway of a patient (Claim 14 – “a sound generator to emit sound waves into an endotracheal tube (“ETT”)”);
detecting, by the acoustic receiver, echoes resulting from the series of acoustic pulses reflecting from a tip of the tracheal tube (Claim 14 – “at least one sound receiver to detect returning acoustic reflections; a reflectometry device having a controller for analyzing timings and amplitudes of the returning acoustic reflections to determine reflectometry data including a size of a passageway around an ETT tip, location and size of ETT obstructions relative movement of the ETT tip within a trachea, or any combination thereof;”);
generating, based on the detected echoes, a time series of passageway sizes of the airway (Claim 14 – “at least one sound receiver to detect returning acoustic reflections; a reflectometry device having a controller for analyzing timings and amplitudes of the returning acoustic reflections to determine reflectometry data including a size of a passageway around an ETT tip, location and size of ETT obstructions relative movement of the ETT tip within a trachea, or any combination thereof;”);
based on at least one of the time series of passageway sizes or the detected echoes, detecting an airway collapse has occurred (Claim 14 – “a reflectometry device having a controller for analyzing timings and amplitudes of the returning acoustic reflections to determine reflectometry data including a size of a passageway around an ETT tip, location and size of ETT obstructions relative movement of the ETT tip within a trachea, or any combination thereof; and a ventilation device having a pressure sensor and a flow sensor in an airway circuit and being configured to: analyze data from the pressure sensor and the flow sensor; based on analyzing the data from the pressure sensor and the flow sensor, issue an alarm when a predetermined low volume flow is detected; in response to the alarm, determine, based on the reflectometry data, a possible cause of the low volume flow; and display information that there is a possible mainstem bronchial intubation, a possible collapsed lung, a possible bronchial plug, or any combination thereof.”); and
displaying the time series of passageway size on the monitor (Claim 14 – “display information that there is a possible mainstem bronchial intubation, a possible collapsed lung, a possible bronchial plug, or any combination thereof.”).
The claims of ‘993 do not explicitly teach memory storing instructions that, when executed by the processor, cause the system to perform a set of operations.
However,
Kent teaches memory storing instructions that, when executed by the processor, cause the system to perform a set of operations ([0085] “Each software module may include instructions that, when executed by the processor 410, may cause appliance 400 to perform the corresponding function. Thus, the non-transitory computer-readable storage medium of memory 412 may include instructions for performing all or a portion of the operations described below with respect to FIG. 6”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by the claims of ‘993 to include a memory storing instructions. One would have been motivated to make this modification because the memory is capable of storing information corresponding to the patient’s respiratory functions and initiating treatment, as suggested by Kent ([0085]; [0257]).
Regarding claim 10, ‘993 teaches the system of claim 9, wherein the system further comprises a ventilator, and the monitor is integrated into the ventilator or is a stand-alone monitor separate from the ventilator (Claim 14 “A system for use of acoustic reflectometry in ventilation devices, the system comprising … a ventilation device having a pressure sensor and a flow sensor in an airway circuit … and display information that there is a possible mainstem bronchial intubation, a possible collapsed lung, a possible bronchial plug, or any combination thereof”).
Regarding claim 11, ‘993 teaches the system of claim 10, wherein the operations further comprise generating dynamic characteristics of the airway collapse based on the time series of passageway sizes, wherein the dynamic characteristics include at least one of a peak-to-baseline value, a baseline shift, or a baseline trend (Claim 14 “A system for use of acoustic reflectometry in ventilation devices, the system comprising: a sound generator to emit sound waves into an endotracheal tube (“ETT”); at least one sound receiver to detect returning acoustic reflections; a reflectometry device having a controller for analyzing timings and amplitudes of the returning acoustic reflections to determine reflectometry data including a size of a passageway around an ETT tip, location and size of ETT obstructions relative movement of the ETT tip \vi thin a trachea, or any combination thereof”; and Claim 16 “displaying a change in a size of the passageway detected distal of the ETT tip over time”).
Regarding claim 12, ‘993 teaches the system of claim 11.
The claims of ‘993 do not explicitly teach wherein the operations further comprise, based on at least one of the dynamic characteristics, adjusting, by the ventilator, a pressure of delivered breathing gases to the patient.
However,
Kent teaches wherein the operations further comprise, based on at least one of the dynamic characteristics, adjusting, by the ventilator, a pressure of delivered breathing gases to the patient ([0004]; [0255] “If the device 800 determines that a patient has lost central respiratory drive, the monitoring station may issue a special alert/alarm. This will notify the medical staff to begin ventilation, as stimulating the airway may not help in this instance.”; [0260] “The device 800 may also employ sensing capabilities so therapy is only delivered when necessary”; The ventilator is adjusted to provide pressurized air when the patient is experiencing respiratory issues, such as airway collapse.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method taught by the claims of ‘993 to include adjusting the delivered ventilation. One would have been motivated to make this modification because the capability to determine respiratory issues, such as airway obstructions and collapse, to initiate the proper ventilation treatment eliminates the need for guesswork that could cause harm regarding the patient’s respiration in acute care settings, as suggested by Kent ([0004], [0109-110], [0253-0255]).
Regarding claim 13, ‘993 teaches the system of claim 9, wherein the operations further comprise, based on detecting the airway collapse has occurred, activating an airway-collapse alarm on the monitor (Claim 14 - “a ventilation device having a pressure sensor and a flow sensor in an airway circuit and being configured to: analyze data from the pressure sensor and the flow sensor; based on analyzing the data from the pressure sensor and the flow sensor, issue an alarm when a predetermined low volume flow is detected; in response to the alarm, determine, based on the reflectometry data, a possible cause of the low volume flow; and display information that there is a possible mainstem bronchial intubation, a possible collapsed lung, a possible bronchial plug, or any combination thereof.”).
Conclusion
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/EVELYN GRACE PARK/Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791