DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed December 26th, 2025 has been entered. Claim 2 has been amended. Claims 1-8, 10-18 are now pending in the application. The previous claim objection of claim 30, as well as, the previous 35 U.S.C. 112(b) rejections of claims 22, 23, and 28 are withdrawn in light of Applicant's amendment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 22-36 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: "oropharyngeal device that is configured to" in claim 32 and “securing device that is configured to” in claim 36. The "oropharyngeal device” will be interpreted as any device that can be inserted into a mouth of a patient, and the “securing device” will be interpreted as any device that engages or locks to a patient’s head, as per the specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Examiner’s Comments
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”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
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.
Claim(s) 22-27, 29-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chauhan et al. (US 12090273 B1, hereinafter Chauhan) in view of Yeung et al. (US 20180296281 A1, hereinafter Yeung).
Regarding Claim 22, Chauhan discloses
A guidance system (automated system 100) comprising:
an illumination source (guide light 206, 406) configured to illuminate an interior of the patient;
a robot system (automated intubation system 200, 400) including an imaging device (imaging sensor 205, 405); and
a stylet (invasive medical device 103) configured to be inserted into an orifice of a patient (Col. 7, Ln. 12-13 discloses invasive medical device is inserted inside a cavity of a patient),
the stylet having a proximal end (main body 201,401) and a distal end (flexible body 202, 402), and
wherein the guidance system is configured to advance a medical tube (tube 301, FIG. 3) along the stylet (depicted in FIG. 3),
such that the medical tube enters the orifice of the patient (Col. 10, Ln. 3-6 discloses tube is an endotracheal tube or an endobronchial tube designed for oral and/or nasal openings).
However, Chauhan does not disclose the stylet including an optical bundle having an optical fiber optically coupled to the imaging device; the optical fiber being configured to direct light from within the interior of the patient and to the imaging device.
Yeung teaches an analogous guidance system (200, FIG. 2, par. 102 discloses robotic colonoscope system) having an illumination source (par. 130 discloses light sources may be provided to illuminate a scene for better viewing), a robot system (steering control system 210, FIG. 2) including an imaging device (par. 123 discloses image sensors), and a stylet (colonoscope 110, FIG. 1A) configured to be inserted into an orifice of a patient (par. 94 discloses colonoscope is for examination of the colon). The stylet (110) having a proximal end (main body 205, FIG. 2) and a distal end (distal end 207, FIG. 2), as well as, including an optical assembly having one or more optical fibers that are optically coupled to the imaging device, and which collect light that is reflected, scattered, or emitted from a field-of-view proximal to the distal end of the colonoscope and transmit it to the imaging device [0123].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the stylet of Chauhan with the fiber optic assembly of Yeung in order to illuminate an area and field-of-view ahead of the distal end of the intubation device, process the light into image data, and visualize what is in front of the device as the user operates it [Yeung - 0123, 0130].
Regarding Claim 23, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 22, Chauhan further discloses wherein the stylet includes a plurality of filaments (cords 503) coupled to or integrated within a body of the stylet (Col. 9, Ln. 50-55 disclose cords pass through flexible part),
wherein the robot system includes a plurality of actuators (actuation unit 104, 208, 408), wherein each filament is coupled to an extender (Col. 9, Ln. 1-10 disclose rack and pinion mechanism) of a respective actuator, and
wherein extension and retraction of the extender of an actuator loads the respective filament to adjust the orientation of the stylet relative to the robot system (Col. 9, Ln. 1-10 disclose rack and pinion mechanism is connected to actuation unit for rotational movement/ displacement).
Regarding Claim 24, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 23, Chauhan further discloses wherein the robot system includes a motor that is configured to rotate the stylet to advance a distal end of the stylet further into the patient (Col. 8, Ln. 56-65 discloses motors used for advancing tubes in the patient cavity).
Regarding Claim 25, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 23, Chauhan further discloses wherein the stylet includes a CO2 sensor (Col. 14, Ln. 1-10 disclose CO2 monitor),
wherein the robot system includes a controller (user interface 105 + circuitry 106) in communication with the CO2 sensor, and
wherein the controller is configured to:
receive, using the CO2 sensor, a CO2 amount value; and determine that a distal end of the stylet is at a target location within the patient, based on the CO2 amount value (Col. 14, Ln. 1-20 disclose CO2 sensors provide confirmation of correct CO2 levels which indicate that the distal end of the ube is placed correctly/ is located in the desired position inside the patient).
Regarding Claim 26, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 25, Chauhan further discloses wherein the controller is in communication with the illumination source and the imaging device (Col. 7, Ln. 30-40 discloses processing circuitry is in communication with imaging sensor and all components of the system), and
wherein the controller is further configured to:
cause the illumination source to emit light to illuminate the interior of the patient (Col. 8, Ln. 52-55 disclose light guide is automatically turned on when system is turned on; Col. 7, Ln. 19-23 discloses communication circuitry provides communication between different components of the system);
receive, using the imaging device, an image of the interior of the patient (Col. 7 Ln. 30-40 disclose processing circuitry receives data from imaging sensor pertaining to the inside the cavity of the patient);
identify an anatomical region of interest within the image;
determine a desired orientation based on the identification of the anatomical region of interest within the image (Col. 7, Ln. 35-40 disclose processing circuitry recognizes structures around and inside the cavity of the patient and, based on that, determines an intended path for insertion, i.e. a desired orientation; Col. Col. 11, Ln. 60-65 disclose structures are anatomical structures);
cause the plurality of actuators to adjust the stylet to be oriented at the desired orientation; and advance the stylet further into the interior of the patient (Col. 7, Ln. 53-67 disclose processor communicates control signals to the actuator based on the intended path which causes the actuation unit to adjust the invasive medical device as it is inserted into the patient).
Regarding Claim 27, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 26, Chauhan further discloses
wherein the controller is further configured to:
receive, using the imaging device, another image of the interior of the patient (Col. 7, Ln. 30-40 discloses processing circuitry is in communication with imaging sensor and all components of the system);
identify a tracheal bifurcation within the another image (Col. 12 discloses the anatomical structure identified using the imaging sensor can be a tracheal bifurcation); and
determine that the distal end of the stylet is at the target location within the patient, based on the CO2 amount value exceeding a threshold value, and the identification of the tracheal bifurcation within the another image (Col. 13, Ln. 60-65 disclose confirmation methods for the position of the distal end of the tube involving capturing the corrent CO2 levels, i.e. a threshold amount; Col. 11, Ln. 60-65 disclose intended path, i.e. target location determined based on anatomical structure).
Regarding Claim 29, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 23, Chauhan further discloses
wherein the stylet includes a channel (outlet channel 207, 407),
wherein the robot system includes a vacuum source that is configured to be in fluid communication with the channel (Col. 10, Ln. 52-57 discloses outlet channel provided for additional devices to be inserted such as suction and irrigation), and
wherein the vacuum source draws fluid out from the interior of the patient and through and out the channel (Those skilled in the art will know the common definition of a suction device is a vacuum to remove bodily fluids).
Regarding Claim 30, Chauhan, as previously modified by Yeung, discloses all of the elements of the current invention disclosed in claim 22, Yeung further teaches
wherein the stylet (110, FIG. 1A) includes:
a light pipe optically coupled to the illumination source (par. 130 discloses optical fibers are optically coupled to light source; par. 123 discloses optical fiber can be light pipe),
the light pipe directing light emitted from the illumination source into the interior of the patient (par. 130 discloses optical fiber (i.e. light pipe) used to illuminate field of view); and
a lens optically coupled to a distal end of the optical fiber, the lens being configured to focus light from within the patient into the distal end of the optical fiber (par. 128 discloses zoom lens which provides optical zoom and allows for adjustment of focal length, i.e. focusing).
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the illumination source of Chauhan with the light pipe and lens of Yeung in order to provide the illumination source with a device that can allow for better illumination of the field-of-view of the intubation device and allow for more efficient transmission of information while exploring the patient’s body [Yeung - 0123, 0130], and in order to allow for optical zoom and adjusting/ focusing of the field-of-view [Yeung - 0128].
Regarding Claim 31, Chauhan, as previously modified by Yeung, discloses all of the elements of the current invention disclosed in claim 22, and Chauhan further discloses
wherein the stylet includes: a channel (housing unit 204, 404, FIGS. 2-4, Col. 10, Ln. 49-53 disclose housing unit contains image sensor, guide light, and outlet channel, all in one, i.e. acting as a conduit/ channel for the bending portion/ flexible part that organizes everything together);
the illumination source being part of the robot system (depicted in FIG. 2, 4); and
a CO2 sensor (Col. 14, Ln. 1-10 disclose CO2 monitor), and
wherein the CO2 sensor is positioned within the channel (Col. 14, Ln. 1-10 disclose CO2 sensor can be placed directly on or within device, i.e. stylet, and preferably near image sensor, i.e. in housing unit, potentially in outlet channel).
However, Chauhan does not disclose a light pipe optically coupled to the
illumination source, the light pipe positioned within the channel.
Yeung teaches a light pipe optically coupled to the illumination source (par. 130 discloses optical fibers are optically coupled to light source; par. 123 discloses optical fiber can be light pipe).
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the illumination source of Chauhan with the light pipe of Yeung in order to provide the illumination source with a device that can allow for better illumination of the field-of-view of the intubation device and allow for more efficient transmission of information while exploring the patient’s body [Yeung - 0123, 0130].
Additionally, the light pipe of Yeung would be capable of being positioned within the channel of Chauhan, since the modification of Chauhan’s illumination source (206, 406) would result in a light pipe being optically coupled to it, as is the case in Yeung, i.e. the light pipe would be positioned in the channel (204, 404).
Regarding Claim 32, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 23, Chauhan further discloses further comprising an oropharyngeal device that is configured to be inserted into the mouth of the patient (automated intubation device inserted through mouth of patient depicted in FIG. 8).
Regarding Claim 33, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 32, Chauhan further discloses wherein the oropharyngeal device includes a handle (main body 808) and a mouthpiece (detachable blade 801) coupled to the handle (depicted in FIG. 8),
the handle having a cross-sectional height that is greater than a cross-sectional height of the mouthpiece (depicted in FIG. 8),
the mouthpiece having a curved section that curves away from a longitudinal axis of the oropharyngeal device (depicted in FIG. 8),
wherein the mouthpiece is configured to be positioned inside the mouth of the patient when the oropharyngeal device is placed into the orifice of the patient (depicted in FIG. 8), and
wherein the handle is configured to be positioned outside of the mouth of the patient when the oropharyngeal device is placed into the orifice of the patient (depicted in FIG. 8).
Regarding Claim 34, Chauhan, as previously modified by Yeung, discloses all of the
elements of the current invention disclosed in claim 33, Chauhan further discloses wherein the mouthpiece of the oropharyngeal device is configured to contact a tongue of the patient (detachable blade is clearly making contact with tongue of patient as depicted in FIG. 8), and
wherein a distal end of the mouthpiece is configured to be positioned within the throat of the patient (Col. 13, Ln. 25-28 disclose detachable blade is inserted inside airway of patient, i.e. within the throat, as depicted in FIG. 8).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chauhan et al. (US 12090273 B1, hereinafter Chauhan) in view of Yeung et al. (US 20180296281 A1, hereinafter Yeung) as applied to claim 23 above, and further in view of Hamilton et al. (US 20030083547 A1, hereinafter Hamilton).
Regarding Claim 28, Chauhan, as previously modified by Yeung, discloses all of the elements of the current invention disclosed in claim 23, Chauhan further discloses wherein the stylet includes a channel (outlet channel 207, 407).
However, Chauhan, as previously modified by Yeung, does not disclose wherein the robot system includes a gas source that is configured to be in fluid communication with the channel, and wherein gas from the gas source is configured to be directed through and out the channel into the interior of the patient.
Hamilton discloses an analogous robot system (endoscope assembly 50) having a stylet (elongated insertion tube 54) with a working end (58) that is adapted to be inserted into the body of a patient [0030]. Moreover, flow tubes (68, i.e. channel) allow for the flow of gasses into the stylet (54) from a pressure source (i.e. gas source) [0030 & 0061].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the guidance system of Chauhan, as previously modified by Yeung, with the gas source of Hamilton as the robot system of Chauhan is provided with an outlet channel (207, 407) that can accept additional devices to be inserted such as suction and irrigation [Chauhan - Col. 10, Ln. 52-57] and in order to distend the outlet channel after the suction of fluids from it [Hamilton - 0006].
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chauhan et al. (US 12090273 B1, hereinafter Chauhan) in view of Yeung et al. (US 20180296281 A1, hereinafter Yeung) as applied to claim 33 above, and further in view of Christopher (US 20010032646 A1).
Regarding Claim 35, Chauhan, as previously modified by Yeung, discloses all of the elements of the current invention disclosed in claim 33, however, Chauhan, as previously modified by Yeung, does not disclose wherein the oropharyngeal device includes: a conduit extending through the handle and through the mouthpiece; a port connector configured to interface with an oxygen gas source, the port connector being in fluid communication with the conduit, and wherein oxygen gas from the oxygen gas source is configured to flow into the port connector, through and out the conduit into the throat of the patient.
Christopher teaches an analogous oropharyngeal device (laryngeal mask airway 10) which includes a channel formed inside a guide (12, i.e. handle) [0071], extending through it and through a laryngeal mask (i.e. mouthpiece). Moreover, the device (10) encompasses a ventilation port which delivers oxygen to a patient via the guide, by means of a ventilator or resuscitation bag [0077].
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the oropharyngeal device of Chauhan, as previously modified by Yeung, with the ventilation port of Christopher in order to supply oxygen into the patient's lungs without interfering with the insertion of an endotracheal tube through the oropharyngeal device [Christopher - Abstract].
Claim(s) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chauhan et al. (US 12090273 B1, hereinafter Chauhan) in view of Yeung et al. (US 20180296281 A1, hereinafter Yeung) as applied to claim 33 above, and further in view of McCracken (US 20180214651 A1).
Regarding Claim 36, Chauhan, as previously modified by Yeung, discloses all of the elements of the current invention disclosed in claim 33, Chauhan further discloses
further comprising an endotracheal tube (tube 804),
a distal end of the endotracheal tube being configured to be inserted into the mouth and throat of the patient (Col. 13, Ln. 27-30 discloses tube is inserted into airway of patient, i.e. through mouth and throat, as depicted in FIG. 8), and
wherein the endotracheal tube is configured to be removably coupled to the oropharyngeal device (Col. 14, Ln. 13-19 disclose tube is releasable, i.e. detachable).
However, Chauhan, as previously modified by Yeung, does not disclose a securing device that is configured to be coupled to the head of the patient.
McCracken teaches an analogous oropharyngeal device (bronchoscopy scope guide 30) having a mask (10, i.e. mouthguard), a semi-rigid grommet (34, i.e. handle), and a semi-rigid scope guide tube (32, i.e. endotracheal tube) that runs through both (depicted in FIG. 6) [0033]. Moreover, the device (30) includes a securing device (patient interface 10) that is coupled to a patient’s head (depicted in FIG. 6).
It would have been obvious to one of ordinary skill in the art at the effective filing date of
the invention to provide the oropharyngeal device of Chauhan, as previously modified by Yeung, with the securing device of McCracken in order to prevent undesirable bending or looping of the bending portion of the imaging device or the endotracheal tube during insertion into the mouth of the patient [McCracken - 0036].
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABDUL HADI ABBASI whose telephone number is (571)272-4076. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at (571) 272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABDUL HADI ABBASI/Examiner, Art Unit 3795
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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