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 .
This Office Action is in response to the amendments dated September 25, 2025.
Claims 1-23, 58, and 75-76 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 58, 75 and 76 are rejected under 35 U.S.C. 112(b), since they are each independent claims that claim both an apparatus (intubation system) and a method (Claim 58 – automatic calibration method for calibrating a position of the introducer; Claim 75 - introducer position calibration method; Claim 76 – automatic calibration method for calibrating a position of the ETT introducer). This is indefinite under 35 U.S.C. 112(b), since it is unclear whether infringement occurs when one makes/sells/uses the apparatus or performs the method. See MPEP 2173.05(p)(II).
Claim 58 is further rejected under 35 U.S.C. 112(b) for claiming “An intubation system adapted with endotracheal tube introducer calibration” in the preamble, which is unclear. For purposes of examination, Examiner interprets this phrase as “An intubation system comprising an endotracheal tube introducer”.
Claim 58 is further rejected under 35 U.S.C. 112(b) since the term “an ETT introducer robotically connected with one or more actuators” is unclear. For purposes of examination, this term is interpreted as the ETT introducer and the one or more actuators as being either part of a robotic system, and/or in communication with one another via a separate robotic system.
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. More specifically, Claim 23 claims a method of “calibrating a position of a distal tip of an ETT introducer relative to at least one component of the ETT” without describing/claiming how such calibration is performed (Visually? Using sensors? Other?). Examiner also notes that illustrations of this “calibration” shown in FIGs. 35A-36B are actually observing/determining/identifying where the ETT introducer is physically located relative to the ETT, rather than the calibration of equipment, etc. For purposes of examination, “calibrating a position of a distal tip of an ETT introducer relative to at least one component of the ETT” is interpreted as determination/observation of a physical position of an ETT introducer relative to an ETT.
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 and 76 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they claim a mental process. See MPEP 2106.04(a)(2)(III).
That is, Claim 1 uses a video signal (image) to determine the position of an endotracheal tube (ETT) introducer. Although Claim 1 claims “calibration of a position of…the introducer”, this phrase is interpreted as a mental process of observing an image in order to identify objects in the image and their relative locations. No other steps are performed that amount to “significantly more” under MPEP 2106.05, since changing a position of components based on a video/photo image is an insignificant extra-solution activity (see MPEP 2106.05(I)(A)).
Claim 76 determines/calibrates a position of the ETT introducer relative to the ETT based on the size of an ETT, which is a mental process. Again, no other steps are performed that amount to “significantly more” under MPEP 2106.05.
Claims 2-6 and 16-20 are rejected under 35 U.S.C. 101 based on their dependence on Claim 1.
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.
Claims 1, 6-12, 17, 19, 21-23, 58, and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Nearman et al. (US PGPUB 2016/0206189 – “Nearman”) in view of Perez-Lizano (US PGPUB 2020/0367722 – “Perez-Lizano”).
Regarding Claim 1, Nearman discloses:
A method of calibrating a position of an endotracheal tube introducer (Nearman FIG. 1, laryngoscope blade 106; Nearman paragraph [0103], “For example, a three-dimensional position of the articulating blade 106 and/or the endotracheal tube 108 can be confirmed or calibrated based on captured image data combined with chemical sensor data and/or pressure sensor data and a known configuration or shape of the airway management apparatus 102)”), comprising:
automatic calibration of a position of the distal tip of the introducer relative to the ETT (Nearman FIG. 1, endotracheal tube 108) using the received video signal (Nearman FIG. 21, analysis component 2102 of control circuit 110; Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108”).
Nearman does not explicitly disclose a handheld intubation system that includes an endotracheal tube (ETT) introducer and a video camera in a distal tip of the introducer, the ETT introducer within and extending at least partially through an ETT, receiving a video signal from the video camera.
Perez-Lizano teaches a handheld intubation system that includes an endotracheal tube (ETT) introducer (Perez-Lizano FIG. 41, distal end of stylet/endoscope 6010) and a video camera in a distal tip of the introducer (Perez-Lizano FIG. 43, camera and illumination source 9095; Perez-Lizano paragraph [0198], “At the distal end of the stylet is the optional camera and illumination source (9095)”), the ETT introducer within and extending at least partially through an ETT (Perez-Lizano FIG. 41, showing endoscope 6010 within and extending at least partially through distal end 6000 of an endotracheal tube; Perez-Lizano paragraph [0193], “FIG. 41, shows a side view (lateral view) of an ET's distal end (6000) of the invention. Within the ET is a stylet or endoscope (6010)”; see also Perez-Lizano FIG. 4, image acquisition element 25 at distal end of endoscope/stylet), receiving a video signal from the video camera (Perez-Lizano paragraph [0118], “the term “image acquisition element” is used to refer to a means to acquire an optical image and convert said optical image into an electronic signal”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Perez-Lizano’s ETT/endoscope device in the method disclosed by Nearman. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that allows a user to visualize the placement of an ETT with the stylet/endoscope (see Perez-Lizano paragraph [0140]).
Regarding Claim 6, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman further discloses wherein the automatic calibration is performed with a computer executable method stored in a memory (Nearman FIG. 21, processor 2110 and memory 2108), the computer executable method configured to compare information indicative of the video signal with information indicative of a reference image (Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108…throughout the intubation procedure based on combined information including but not limited to: the sensor data described above”).
Regarding Claim 7, Nearman in view of Perez-Lizano teach the features of Claim 6, as described above.
Nearman further discloses wherein the computer executable method is further configured to, in response to the comparing step, automatically initiate movement of the distal tip of the introducer in at least one of an X, Y, or Z direction (Nearman paragraph [0091], “a motor physically and/or electrically coupled to one or more parts of the articulating blade 106 and the control circuit can be configured to control movement of the articulating blade forward, backward, left, and right“).
Regarding Claim 8, Nearman in view of Perez-Lizano teach the features of Claim 7, as described above.
Nearman further discloses wherein automatically initiating movement comprises automatically changing the curvature of the distal tip in at least one of the X or Y direction (Nearman paragraph [0049], “the controls included with the handle 104 can mechanically alter the size, shape, curvature, orientation, etc. of the articulating blade 106.“).
Regarding Claim 9, Nearman in view of Perez-Lizano teach the features of Claim 8, as described above.
Perez-Lizano further teaches wherein automatically changing the curvature of the distal tip comprises making an introducer distal end co-axial with a distal end of the ETT (Perez-Lizano FIG. 1 showing endoscope 6010 coaxial with the ET’s distal end 6000).
Regarding Claim 10, Nearman in view of Perez-Lizano teach the features of Claim 7, as described above.
Nearman further discloses wherein automatically initiating movement comprises automatically moving the distal tip axially in the Z direction (Nearman paragraph [0064], “control circuit 110 can further automatically control advancement of the endotracheal tube 108”).
Regarding Claim 11, Nearman in view of Perez-Lizano teach the features of Claim 10, as described above.
Nearman further discloses wherein automatically moving the distal tip axially in the Z direction comprises at least one of axially aligning the distal end of the introducer with a distal end of the ETT, or positioning the distal end of the introducer within the ETT and within 20 mm of the distal end of the ETT (Nearman FIG. 18, showing a distal ends of distal end of endotracheal tube 108 within an axial center of articulating blade 106; Nearman paragraph [0064], “control circuit 110 can further automatically control advancement of the endotracheal tube 108”).
Regarding Claim 12, Nearman in view of Perez-Lizano teach the features of Claim 7, as described above.
Nearman further discloses wherein the computer executable method is further configured to, in response to the comparing step, automatically initiate movement of the distal tip and position a distal end of the introducer distal to a side aperture of the ETT and proximal to a distal end of the ETT (Nearman FIG. 18, showing a distal ends of distal end of endotracheal tube 108 within an axial center of articulating blade 106; Nearman paragraph [0064], “control circuit 110 can further automatically control advancement of the endotracheal tube 108”).
Regarding Claim 17, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman further discloses wherein automatic calibration occurs after positioning the introducer into a mouth of a subject (Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108 (and/or a portions thereof) relative to anatomical features of the patient's oral anatomy throughout the intubation procedure based on combined information including but not limited to: the sensor data described above…data correlating image patterns with features and/or points of the features, etc.)…The analysis component 2102 can also determine a current position of the endotracheal tube 108 relative to anatomical features of the patient's oral anatomy throughout the intubation procedure based on and a known distance between the tip of the endotracheal tube 108 and the distal end 118 of the articulating blade 106 (e.g., determined based on a fiducial marker provided on the endotracheal tube 108 included in captured image data, determined based on a rate of movement of the endotracheal tube through the channel, etc.”).
Regarding Claim 19, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman further discloses wherein automatic calibration occurs after initiating an intubation procedure (Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108 (and/or a portions thereof) relative to anatomical features of the patient's oral anatomy throughout the intubation procedure based on combined information including but not limited to: the sensor data described above…data correlating image patterns with features and/or points of the features, etc.)…The analysis component 2102 can also determine a current position of the endotracheal tube 108 relative to anatomical features of the patient's oral anatomy throughout the intubation procedure based on and a known distance between the tip of the endotracheal tube 108 and the distal end 118 of the articulating blade 106 (e.g., determined based on a fiducial marker provided on the endotracheal tube 108 included in captured image data, determined based on a rate of movement of the endotracheal tube through the channel, etc.”).
Regarding Claim 21, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman further discloses wherein automatic calibration includes automatic robotic control of the position of the distal tip of the introducer in one or more directions with one or more actuators (Nearman paragraph [0048], “The electrical components provided within the housing of the handle 104 can vary depending on the particular features and functionality of the airway management apparatus 102. In various embodiments, the electrical components include one or more motors (not shown) configured to manipulate the shape and configuration of the articulating blade 106, such as servo-motor, a linear motor, or another suitable motor.”) disposed in a handheld housing of the handheld intubation system (Nearman paragraph [0068], “This sensory data can further facilitate automatic robotic maneuvering of the articulating blade 106 and/or the endotracheal tube 108 into the correct positions to mitigate human error associated with performance of the intubation procedure.”).
Regarding Claim 22, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman further discloses wherein the automatic calibration comprises automatically causing robotic movement of the introducer in at least one of an x, y, or z direction (Nearman paragraph [0068], “This sensory data can further facilitate automatic robotic maneuvering of the articulating blade 106 and/or the endotracheal tube 108 into the correct positions to mitigate human error associated with performance of the intubation procedure.”).
Regarding Claim 23, Nearman discloses:
A method of calibrating a position of an endotracheal tube introducer (Nearman FIG. 1, laryngoscope blade 106; Nearman paragraph [0103], “For example, a three-dimensional position of the articulating blade 106 and/or the endotracheal tube 108 can be confirmed or calibrated based on captured image data combined with chemical sensor data and/or pressure sensor data and a known configuration or shape of the airway management apparatus 102)”), comprising:
with a handheld intubation system (Nearman FIG. 1, airway management system 102 including laryngoscope blade 106), calibrating a position of a distal tip of an endotracheal tube (ETT) introducer relative to at least one component of the handheld intubation system (Nearman FIG. 21, analysis component 2102 of control circuit 110; Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108”).
Nearman does not explicitly disclose the ETT introducer within and extending at least partially through an ETT.
Perez-Lizano teaches the ETT introducer within and extending at least partially through an ETT (Perez-Lizano FIG. 41, showing endoscope 6010 within and extending at least partially through distal end 6000 of an endotracheal tube; Perez-Lizano paragraph [0193], “FIG. 41, shows a side view (lateral view) of an ET's distal end (6000) of the invention. Within the ET is a stylet or endoscope (6010)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Perez-Lizano’s ETT/endoscope device in the method disclosed by Nearman. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that allows a user to visualize the placement of an ETT with the stylet/endoscope (see Perez-Lizano paragraph [0140]).
Regarding Claim 58, Nearman discloses an intubation system (Nearman FIG. 1, airway management system 102) adapted with endotracheal tube introducer calibration (Nearman FIG. 1, laryngoscope blade 106; Nearman FIG. 21, analysis component 2102 of control circuit 110; Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108”), comprising:
a handheld body (Nearman FIG. 1, handle 104) sized and configured to be handheld by a user;
an endotracheal tube (ETT) introducer (Nearman FIG. 1, laryngoscope blade 106) in robotic communication with one or more actuators (Nearman FIG. 20, motors 2006; Nearman paragraph [0068], “sensory data can further facilitate automatic robotic maneuvering of the articulating blade 106 and/or the endotracheal tube 108 into the correct positions to mitigate human error associated with performance of the intubation procedure”), the introducer including a video camera in a distal tip of the introducer (Nearman FIG. 1, sensors 112; Nearman paragraph [0054], “one or more sensors 112 are configured to capture various types of data and provide the captured data to the control circuit 110 for processing, storage, and/or sending to an external device (and/or an external device (not shown)). The one or more sensors can include but are not limited to: image sensors (e.g., a camera configured to capture still images and/or video data)”); and
an automatic calibration method for calibrating a position of the introducer, the calibration method stored in a memory (Nearman FIG. 21, memory 2108), executable by a processor (Nearman FIG. 21, processor 2110), and adapted to:
receive as input information that is indicative of a video signal from the video camera (Nearman FIG. 26, remote airway management device 2602; Nearman paragraph [0125], “the airway management apparatus 102 can provide image data (e.g., still images and/or video) to the remote airway management device 2602 captured via one or more cameras located on the articulating blade 106 and/or the endotracheal tube 108”).
Nearman does not explicitly disclose:
the ETT introducer within and extending at least partially through an ETT,
based on the information that is indicative of the video signal, determine a position of the endotracheal tube introducer relative to the ETT, and adjust an axial position of the ETT introducer within and relative to the ETT such that the ETT introducer is in a desired position relative to the ETT.
Perez-Lizano teaches:
Perez-Lizano teaches a handheld intubation system that includes an endotracheal tube (ETT) introducer (Perez-Lizano FIG. 41, distal end of stylet/endoscope 6010) and a video camera in a distal tip of the introducer (Perez-Lizano FIG. 43, camera and illumination source 9095; Perez-Lizano paragraph [0198], “At the distal end of the stylet is the optional camera and illumination source (9095)”), the ETT introducer within and extending at least partially through an ETT (Perez-Lizano FIG. 41, showing endoscope 6010 within and extending at least partially through distal end 6000 of an endotracheal tube; Perez-Lizano paragraph [0193], “FIG. 41, shows a side view (lateral view) of an ET's distal end (6000) of the invention. Within the ET is a stylet or endoscope (6010)”; see also Perez-Lizano FIG. 4, image acquisition element 25 at distal end of endoscope/stylet) receiving a video signal from the video camera (Perez-Lizano paragraph [0118], “the term “image acquisition element” is used to refer to a means to acquire an optical image and convert said optical image into an electronic signal”),
based on the information that is indicative of the video signal, determine a position of the endotracheal tube introducer relative to the ETT, and adjust an axial position of the ETT introducer within and relative to the ETT such that the ETT introducer is in a desired position relative to the ETT (Perez-Lizano paragraph [0169], “The kit can be used to perform an intubation process, including steps of a) inserting the stylet into the ET, b) inserting the stylet and ET into the airway of a patient, c) visualizing the airway of the patient using the image acquisition element disposed on the stylet tip, d) guiding the ET and stylet through the vocal cords of the patient into the trachea of the patient, and e) removing the stylet from the ET.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Perez-Lizano’s ETT/endoscope device in the system disclosed by Nearman. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that allows a user to visualize the placement of an ETT with the stylet/endoscope (see Perez-Lizano paragraph [0140]).
Regarding Claim 75, Nearman discloses:
An intubation system with endotracheal tube introducer position calibration, comprising:
a handheld portion (Nearman FIG. 1, airway management system 102 including laryngoscope blade 106) sized and configured to be handheld by a user;
a video camera (Nearman FIG. 1, sensors 112; Nearman paragraph [0054], “one or more sensors 112 are configured to capture various types of data and provide the captured data to the control circuit 110 for processing, storage, and/or sending to an external device (and/or an external device (not shown));
an endotracheal tube (ETT) introducer (Nearman FIG. 1, laryngoscope blade 106; Nearman paragraph [0103], “For example, a three-dimensional position of the articulating blade 106 and/or the endotracheal tube 108 can be confirmed or calibrated based on captured image data combined with chemical sensor data and/or pressure sensor data and a known configuration or shape of the airway management apparatus 102)”) in robotic communication with one or more actuators an endotracheal tube introducer (Nearman FIG. 1, laryngoscope blade 106) in robotic communication with one or more actuators (Nearman FIG. 20, motors 2006; Nearman paragraph [0068], “sensory data can further facilitate automatic robotic maneuvering of the articulating blade 106 and/or the endotracheal tube 108 into the correct positions to mitigate human error associated with performance of the intubation procedure”); and
an introducer position calibration method, stored in a memory (Nearman FIG. 21, memory 2108) and executable by a processor (Nearman FIG. 21, processor 2110), the calibration method adapted to:
receive as input information that is indicative of a video signal from the video camera receive as input information that is indicative of a video signal from the video camera (Nearman FIG. 26, remote airway management device 2602; Nearman paragraph [0125], “the airway management apparatus 102 can provide image data (e.g., still images and/or video) to the remote airway management device 2602 captured via one or more cameras located on the articulating blade 106 and/or the endotracheal tube 108”), compare the information indicative of the video signal from the video camera with information indicative of a reference image (Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108…throughout the intubation procedure based on combined information including but not limited to: the sensor data described above”), and in response, either
automatically initiate movement of the distal tip of the ETT introducer, in at least one of an x, y, or z direction (Nearman paragraph [0091], “a motor physically and/or electrically coupled to one or more parts of the articulating blade 106 and the control circuit can be configured to control movement of the articulating blade forward, backward, left, and right“), or
initiate a communication to a user with instructions related to moving the distal tip of the ETT introducer in at least one of an x, y, or z direction.
Nearman does not explicitly disclose the ETT introducer within and extending at least partially through an ETT.
Perez-Lizano teaches the ETT introducer within and extending at least partially through an ETT (Perez-Lizano FIG. 41, showing endoscope 6010 within and extending at least partially through distal end 6000 of an endotracheal tube; Perez-Lizano paragraph [0193], “FIG. 41, shows a side view (lateral view) of an ET's distal end (6000) of the invention. Within the ET is a stylet or endoscope (6010)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Perez-Lizano’s ETT/endoscope device in the method disclosed by Nearman. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that allows a user to visualize the placement of an ETT with the stylet/endoscope (see Perez-Lizano paragraph [0140]).
Claims 2-5, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nearman et al. (US PGPUB 2016/0206189 – “Nearman”) in view of Perez-Lizano (US PGPUB 2020/0367722 – “Perez-Lizano”) and Demers et al. (US PGPUB 2014/0055582 – “Demers”).
Regarding Claim 2, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman further discloses system calibration (Nearman paragraph [0103], “a three-dimensional position of the articulating blade 106 and/or the endotracheal tube 108 can be confirmed or calibrated based on captured image data combined with chemical sensor data and/or pressure sensor data and a known configuration or shape of the airway management apparatus 102”).
However, Nearman does not explicitly disclose wherein the system further includes a calibration initiator, the method further requiring user activation of the calibration initiator to cause the automatic calibration.
Demers teaches wherein the system further includes a calibration initiator, the method further requiring user activation of the calibration initiator to cause the automatic calibration (Demers FIG. 28, imaging assembly 414; Demers paragraph [0115], “The imaging assembly can include a hardware or software control to initiate the calibration process. The calibration process can be automatically or manually initiated. For instance the imaging assembly can include a button that is pressed by a person to initiate the calibration process once the working assembly is connected. As another example, the imaging assembly can automatically initiate the calibration process when a working assembly is connected.”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Demers’ calibration system with the method disclosed by Nearman in view of Perez-Lizano. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method in which components are positioned such that optimal image capture occurs (see Demers paragraph [0114]).
Regarding Claim 3, Nearman in view of Perez-Lizano teach the features of Claim 2, as described above.
Demers further teaches wherein the calibration initiator includes at least one of an icon on a display or an actuator on a handheld body (Demers FIG. 28, imaging assembly 414; Demers paragraph [0115], “the imaging assembly can include a button that is pressed by a person to initiate the calibration process”).
Regarding Claim 4, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman in view of Perez-Lizano do not explicitly teach sliding the ETT at least partially over the introducer, and wherein the automatic calibration occurs in response to the presence of the ETT.
Demers teaches sliding the ETT at least partially over the introducer, and wherein the automatic calibration occurs in response to the presence of the ETT (Demers FIG. 22, imaging assembly 302 connected to working assembly 304; Demers paragraph [0115], “the imaging assembly can automatically initiate the calibration process when a working assembly is connected”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Demers’ calibration system with the method disclosed by Nearman in view of Perez-Lizano. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method in which components are positioned such that optimal image capture occurs (see Demers paragraph [0114]).
Regarding Claim 5, Nearman in view of Perez-Lizano and Demers teach the features of Claim 4, as described above.
Demers further teaches coupling the ETT to a handheld body, and wherein coupling the ETT to the handheld body causes the automatic calibration (Demers paragraph [0115], “the imaging assembly can automatically initiate the calibration process when a working assembly is connected”).
Regarding Claim 16, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman in view of Perez-Lizano do not explicitly teach wherein automatic calibration occurs prior to positioning the introducer into a mouth of a subject.
Demers teaches wherein automatic calibration occurs prior to positioning the introducer into a mouth of a subject (Demers FIG. 28, packaging arrangement 418 with working assembly 412; Demers paragraph [0106], “The packaging arrangement can be used to perform a calibration of the endoscope. The packaging arrangement can be configured to include a predetermined picture, for example predetermined picture 422 shown in FIG. 28 and in further enlarged view of FIG. 29. Picture 422 can be located in a field of view of the working assembly objective lens when the packaging arrangement is positioned on the working assembly probe. The predetermined picture can include one or more patterns, shapes, colors and/or seamless backgrounds. Picture 422, by way of non-limiting example, includes a blue shape 424, a red shape 426 and a white seamless background area 428. The predetermined picture can also include texture, for example in predetermined picture 422, the blue and red shapes 424 and 426 can be engraved into the surface of the material of the packaging arrangement. The texture can be a variation in a surface such as, for example, by including different depths or elevation changes.”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Demers’ method of using ex vivo calibrating a working assembly/introducer with the method taught by Nearman in view of Perez-Lizano. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that pre-calibrates a working assembly/introducer, such that it is ready for immediate use.
Regarding Claim 18, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman in view of Perez-Lizano do not explicitly teach wherein automatic calibration occurs prior to initiating an intubation procedure.
Demers teaches wherein automatic calibration occurs prior to initiating an intubation procedure (Demers FIG. 28, packaging arrangement 418 with working assembly 412; Demers paragraph [0106], “The packaging arrangement can be used to perform a calibration of the endoscope. The packaging arrangement can be configured to include a predetermined picture, for example predetermined picture 422 shown in FIG. 28 and in further enlarged view of FIG. 29. Picture 422 can be located in a field of view of the working assembly objective lens when the packaging arrangement is positioned on the working assembly probe. The predetermined picture can include one or more patterns, shapes, colors and/or seamless backgrounds. Picture 422, by way of non-limiting example, includes a blue shape 424, a red shape 426 and a white seamless background area 428. The predetermined picture can also include texture, for example in predetermined picture 422, the blue and red shapes 424 and 426 can be engraved into the surface of the material of the packaging arrangement. The texture can be a variation in a surface such as, for example, by including different depths or elevation changes.”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Demers’ method of using ex vivo calibrating a working assembly/introducer with the method taught by Nearman in view of Perez-Lizano. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that pre-calibrates a working assembly/introducer, such that it is ready for immediate use.
Regarding Claim 20, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
Nearman in view of Perez-Lizano do not explicitly teach wherein automatic calibration occurs subsequent to an intubation procedure.
Demers teaches wherein automatic calibration occurs subsequent to an intubation procedure (Demers FIG. 28, packaging arrangement 418 with working assembly 412; Demers paragraph [0106], “The packaging arrangement can be used to perform a calibration of the endoscope. The packaging arrangement can be configured to include a predetermined picture, for example predetermined picture 422 shown in FIG. 28 and in further enlarged view of FIG. 29. Picture 422 can be located in a field of view of the working assembly objective lens when the packaging arrangement is positioned on the working assembly probe. The predetermined picture can include one or more patterns, shapes, colors and/or seamless backgrounds. Picture 422, by way of non-limiting example, includes a blue shape 424, a red shape 426 and a white seamless background area 428. The predetermined picture can also include texture, for example in predetermined picture 422, the blue and red shapes 424 and 426 can be engraved into the surface of the material of the packaging arrangement. The texture can be a variation in a surface such as, for example, by including different depths or elevation changes.”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Demers’ method of using ex vivo calibrating a working assembly/introducer with the method taught by Nearman in view of Perez-Lizano. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that confirms a calibration of a working assembly/introducer previously used on a patient.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Nearman et al. (US PGPUB 2016/0206189 – “Nearman”) in view of Perez-Lizano (US PGPUB 2020/0367722 – “Perez-Lizano”), Matthes (US PGPUB 2009/0143645 – “Matthes”), and Pacey et al. (US PGPUB 2010/0261967 – “Pacey”).
Regarding Claim 13, Nearman in view of Perez-Lizano teach the features of Claim 7, as described above.
Nearman in view of Perez-Lizano do not explicitly teach wherein the computer executable method is further configured to, in response to the comparing step, automatically initiate movement of the distal tip away from a side aperture of the ETT and towards a distal end of the ETT.
Matthes teaches wherein the computer executable method is further configured to, in response to the comparing step, automatically initiate movement of the distal tip away from the ETT and towards a distal end of the ETT (Matthes FIG. 7, showing endotracheal tube 105 within steerable endoscope 10 introduced in Matthes FIG. 1; see also Matthes FIG. 7, vertical and horizontal steering controls 103). Thus, the distal tip of the endoscope/introducer can be steered in any of two axes, including away from the ETT.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine use of Matthes’ steerable introducer with the method by Nearman in view of Perez-Lizano. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method for controlling insertion direction of an endotracheal tube.
Nearman in view of Perez-Lizano and Matthes do not explicitly teach that the ETT has a side aperture.
Pacey teaches an ETT that has a side aperture (Pacey FIG. 23, side aperture 518 (i.e., “Murphy’s Eye”) on endotracheal tube (ET) 512.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Pacey’s ET side aperture with the method taught by Nearman in view of Perez-Lizano and Matthes. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method than enables the use of an ET/ETT that has venting capability, such that a patient’s airway is not completely obstructed.
Regarding Claim 14, Nearman in view of Perez-Lizano teach the features of Claim 7, as described above.
Nearman in view of Perez-Lizano do not explicitly teach wherein the computer executable method is further configured to, in response to the comparing step, automatically initiate movement of the distal tip away from a side aperture of the ETT.
Matthes teaches wherein the computer executable method is further configured to, in response to the comparing step, automatically initiate movement of the distal tip away from the ETT (Matthes FIG. 7, showing endotracheal tube 105 within steerable endoscope 10 introduced in Matthes FIG. 1; see also Matthes FIG. 7, vertical and horizontal steering controls 103). Thus, the distal tip of the endoscope/introducer can be steered in any of two axes, including away from the ET/ETT.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine use of Matthes’ steerable introducer with the method disclosed by Nearman in view of Perez-Lizano. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method for controlling insertion direction of an endotracheal tube.
Nearman in view of Perez-Lizano and Matthes do not explicitly teach that the ETT has a side aperture.
Pacey teaches an ETT that has a side aperture (Pacey FIG. 23, side aperture 518 (i.e., “Murphy’s Eye”) on endotracheal tube (ET) 512.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Pacey’s ET side aperture with the method taught by Nearman in view of Perez-Lizano and Matthes. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method than enables the use of an ET that has venting capability, such that a patient’s airway is not completely obstructed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Nearman et al. (US PGPUB 2016/0206189 – “Nearman”) in view of Perez-Lizano (US PGPUB 2020/0367722 – “Perez-Lizano”) and Dalle et al. (US PGPUB 2004/0220454 – “Dalle”).
Regarding Claim 15, Nearman in view of Perez-Lizano teach the features of Claim 1, as described above.
More specifically, Nearman in view of Perez-Lizano teach automatic calibration of a handheld intubation system, as described above in the rejection of Claim 1.
However, Nearman in view of Perez-Lizano do not explicitly teach packaging the handheld intubation system at a time subsequent to the automatic calibration.
Dalle teaches packaging the handheld intubation system at a time subsequent to the automatic calibration (Dalle FIG. 1, laryngoscope L packaged in an outer bag S, after it has been manufactured for use).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to package Nearman’s calibrated introducer, in the method taught by Nearman in view of Perez-Lizano, using Dalle’s sterile bag S. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an introducer/laryngoscope that is sterile, in order to avoid cross-contamination from separate usage.
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Nearman et al. (US PGPUB 2016/0206189 – “Nearman”) in view of Hendriks et al. (US PGPUB 2023/0009274 – “Hendriks”), Perez-Lizano (US PGPUB 2020/0367722 – “Perez-Lizano”), and Takahashi et al. (US PGPUB 2016/0353980 – “Takahashi”).
Regarding Claim 76, Nearman discloses:
An intubation system (Nearman FIG. 1, airway management system 102) adapted with endotracheal tube introducer calibration (Nearman FIG. 1, laryngoscope blade 106; Nearman FIG. 21, analysis component 2102 of control circuit 110; Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108”), comprising:
a handheld body (Nearman FIG. 1, handle 104) sized and configured to be handheld by a user;
an endotracheal tube (ETT) introducer (Nearman FIG. 1, laryngoscope blade 106) in robotic communication with one or more actuators (Nearman FIG. 20, motors 2006; Nearman paragraph [0068], “sensory data can further facilitate automatic robotic maneuvering of the articulating blade 106 and/or the endotracheal tube 108 into the correct positions to mitigate human error associated with performance of the intubation procedure”), the ETT introducer including a video camera in a distal tip of the introducer (Nearman FIG. 1, sensors 112; Nearman paragraph [0054], “one or more sensors 112 are configured to capture various types of data and provide the captured data to the control circuit 110 for processing, storage, and/or sending to an external device (and/or an external device (not shown)). The one or more sensors can include but are not limited to: image sensors (e.g., a camera configured to capture still images and/or video data)”); and
an automatic calibration method for calibrating a position of the ETT introducer, the calibration method stored in a memory (Nearman FIG. 21, memory 2108), executable by a processor (Nearman FIG. 21, processor 2110), the processor adapted to:
calibrate a position of the distal tip of the introducer relative to the ETT (Nearman FIG. 1, endotracheal tube 108) using the received video signal (Nearman FIG. 21, analysis component 2102 of control circuit 110; Nearman paragraph [0103], “Accordingly, the analysis component 2102 can accurately determine a current position and orientation of the articulating blade 106 and/or the endotracheal tube 108”).
Nearman does not explicitly disclose the processor adapted to:
cause to be displayed on a screen a user interface that allows a user to select an endotracheal tube size from a plurality of different endotracheal tube sizes.
Hendriks teaches wherein the processor is adapted to:
cause to be displayed on a screen a user interface that allows a user to select an endotracheal tube size from a plurality of different endotracheal tube sizes (Hendriks paragraph [0049], “the recommended ETT size 50 for the patient P is displayed, via the GUI 28, on the display device 24 of the electronic processing device 18”; Hendriks paragraph [0044], the recommended ETT size 50 is selected by selecting a candidate ETT model of a candidate ETT size from a catalog 48 of ETT models 42 of different ETT sizes”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Hendriks’ ETT recommendation with the system disclosed by Nearman. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an intubation system that uses an ETT that is properly sized for a particular patient.
Nearman in view of Hendriks do not explicitly teach the ETT introducer within and extending at least partially through an ETT.
Perez-Lizano teaches the ETT introducer within and extending at least partially through an ETT (Perez-Lizano FIG. 41, showing endoscope 6010 within and extending at least partially through distal end 6000 of an endotracheal tube; Perez-Lizano paragraph [0193], “FIG. 41, shows a side view (lateral view) of an ET's distal end (6000) of the invention. Within the ET is a stylet or endoscope (6010)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize Perez-Lizano’s ETT/endoscope device in the system taught by Nearman in view of Hendriks. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that allows a user to visualize the placement of an ETT with the stylet/endoscope (see Perez-Lizano paragraph [0140]).
Nearman in view of Hendriks and Perez-Lizano do not explicitly teach calibrating a position of the distal tip of the introducer relative to the ETT based at least partially on a size of the ETT.
Takahashi teaches calibrating a position of the distal tip of the introducer (Takahashi FIG. 3, distal insertion portion 12 of endoscope 10 shown in Takahashi FIG. 1) relative to the ETT based at least partially on a size (i.e., length) of the ETT (Takahashi FIG. 3, oversheath 50 that surrounds the distal portion 12). That is, the calibration numbers printed on insertion portion 12 show the position of the distal tip of the endoscope 10 relative to the oversheath 50 when the insertion portion 12 is moved from a first position (A) to a second position (B).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Takahashi’s calibration/length indicators with the system taught by Nearman in view of Hendriks and Perez-Lizano. A person having ordinary skill in the art would be motivated to observe Takahashi’s indicators using Nearman’s camera sensor, and then using those observations to calibrate the position of the ETT introducer relative to the ETT using Nearman’s processor, in order to calibrate/observe in real-time and in situ the position of