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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 10, 2026 has been entered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 6-9, 11-12, 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 to determine an axial position of the introducer relative to the ETT (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”) wherein the automatic calibration further comprises automatic robotic movement of the introducer in at least an axial direction with the handheld intubation system (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“).
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 robotic 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 robotic 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.“; Examiner notes that Nearman paragraph [0091] discloses that such movement is robotic.).
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 11, Nearman in view of Perez-Lizano teach the features of Claim 10, as described above.
Nearman further discloses wherein automatic robotic movement of the introducer in at least an axial 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 robotic 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 the automatic robotic movement of the introducer occurs 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 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 an endotracheal tube based on a received video signal from a 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)). 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)”) at a distal end of the introducer to determine an axial position of the introducer relative to the ETT (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”);
wherein the calibrating further comprises robotically moving the introducer in at least an axial direction with one or more actuators disposed in a handheld housing of the handheld intubation system (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“)
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 of the system (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
one or more processors (Nearman FIG. 21, processor 2110) and a memory (Nearman FIG. 21, memory 2108) storing calibration instructions that when executed by the one or more processors, causes the system to perform:
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 an axial 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 an axial 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
one or more processors (Nearman FIG. 21, processor 2110) and a memory (Nearman FIG. 21, memory 2108) storing instructions that when executed by the one or more processors, causes the system to perform:
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 robotic 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 robotic 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.
Nearman discloses that such movement can be robotic (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 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 robotic 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 discloses that such movement can be robotic (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“).
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
one or more processors (Nearman FIG. 21, processor 2110) and a memory (Nearman FIG. 21, memory 2108) storing instructions that when executed by the one or more processors, causes the system to perform
automatically and robotically 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:
display 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:
display 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 the user selected 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 the user selected 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 the introducer (endoscope) based on the length of the overtube (ETT).
Response to Arguments
Applicant’s arguments, see pages 9-10, filed April 10, 2026, with respect to the rejection of Claims 23, 58, 75, and 76 under 35 U.S.C. 112(b) have been fully considered and are persuasive in view of the present amendments. The rejection of Claims 23, 58, 75, and 76 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see page 10, filed April 10, 2026, with respect to the rejection of Claims 1 and 76 under 35 U.S.C. 101 have been fully considered and are persuasive in view of the present amendments. The rejection of Claims 1 and 76 under 35 U.S.C. 101 has been withdrawn.
Applicant's arguments filed April 10, 2026 regarding the rejection of Claim 1 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant first asserts that Nearman et al. (US PGPUB 2016/0206189 – “Nearman”) in view of Perez-Lizano (US PGPUB 2020/0367722 – “Perez-Lizano”) fails to teach or suggest an endotracheal tube (ETT) within and extending at least partially through an ETT. Examiner respectfully disagrees. As described in the rejection of Claim 1 above, 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] teaches “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)”. Applicant does not dispute that the endoscope 6010 is within the endotracheal tube, but does not teach or suggest that the endoscope 6010 can extend beyond the distal end of the endotracheal tube. However, the lower figure in Perez-Lizano FIG. 41 shows the distal end 7000 of the ETT with the endoscope 6010 clearly visible through an opening in the end of the ETT. As such, contrary to Applicant’s assertion on page 11, Perez-Lizano does not prevent the endoscope from protruding from the distal end of the ET during intubation.
Applicant appears to be relying on Perez-Lizano paragraph [0050], which states “the stylet can be attached to an ET via attachment to an ET connector. This is not essential, but is advantageous, as it helps to prevent relative longitudinal movement of the stylet with respect to the ET during intubation, and can additionally help to prevent the stylet from protruding from the distal end of the ET during intubation”. Thus, Perez-Lizano explicitly teaches that the stylet/endoscope can exit the ET, but this egress can optionally be prevented with a connector.
Applicant further asserts that Nearman in view of Perez-Lizano fails to teach or suggest “wherein the automatic calibration further comprises automatic robotic movement of the introducer in at least an axial direction”. Examiner respectfully disagrees. As described above in the rejection of Claim 1, Nearman paragraph [0091] teaches “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“. Examiner properly interprets this passage, including control movement of the articulating blade (i.e., introducer) forward and backward.
As such, the rejection of independent Claim 1, and therefore dependent Claims 6-9, 11-12, 17, 19, and 21 under 35 U.S.C. 103 is maintained.
On page 11, Applicant asserts the same argument described above to be applied to the rejection under 35 U.S.C. 103 of independent Claims 23, 58, and 75. Examiner responds by reference to the arguments made by Examiner regarding the rejection of independent Claim 1 under 35 U.S.C. 103.
On pages 12-13, Applicant asserts that additional cited art presented in the rejection of dependent Claims 2-5, 13-16, 18, and 20 do not overcome the rejection of Claim 1 under 35 U.S.C. 103. As described above, the rejection of Claim 1 is proper, and thus these assertions regarding the rejection of dependent Claims 2-5, 13-16, 18, and 20 are moot.
On page 13, Applicant asserts that the rejection of Claim 76 under 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”) is improper. Examiner respectfully disagrees.
Applicant reasserts the arguments made against the rejection of Claim 1 against the rejection of Claim 76. Examiner has responded to these arguments by presenting Perez-Lizano FIG. 41 and paragraph [0193] as teaching “an endotracheal tube (ETT) within and extending at least partially through an ETT”.
Applicant further asserts that a combination of the cited prior art fails to teach or suggest that the system is configured to “automatically and robotically calibrate a position of the distal tip of the introducer relative to the ETT based at least partially on the user selected size of the ETT”; or an “introducer in robotic communication with one or more actuators”.
As described in the rejection of Claim 76 presented above, FIG. 3 of Takahashi teaches calibrating a position of the distal tip of the introducer relative to the ETT based at least partially on the user selected size (i.e., length) of the ETT. Applicant provides no reasoning why application of Takahashi is improper.
As described in the rejection of Claim 76 presented above, Nearman FIG. 1, FIG. 20, and paragraphs [0054] and [0054] disclose an “introducer in robotic communication with one or more actuators”. Applicant provides no reasoning why application of Nearman is improper.
Therefore, the rejection of Claim 1-9, 11-21, 23, 58, and 75-76 under 35 U.S.C. 103 is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
4/28/26
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