DETAILED ACTION
This office action is in response to the amendment filed 2/2/2026. As directed by the amendment, claims 1, 13, and 16 have been amended, no claims have been cancelled or newly added. Thus, claims 1-18 are presenting pending in this application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/2/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
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 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.
Claims 1-2, 4-5, 12, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (2003/0172935) in view of Liegner (4,495,945).
Regarding claim 1, Miller in figs 1-5 discloses a pharyngeal tube (airway device) comprising: an elongated hollow tube (12, 14) (airway device includes a hollow stem (12) and chamber (14) including a proximal end and a distal end for establishing a patent airway for a patient (para [0027]); and one or more lateral openings (13) (one or more openings) provided at or near the distal end of the hollow tube (12, 14) (para [0027]), wherein the one or more lateral openings (13) are formed in a lateral wall of the hollow tube (12, 14) (see figs 1-2), and wherein a distal tip (20) (toe part) of the hollow tube (12, 14) is sealed so that air cannot escape the hollow tube (12, 14) from its distal tip (20) (toe end (20) is shown in fig 1 to not have a hole, and is configured to prevent gas from entering the stomach, and therefore is considered to be sealed to that air cannot escape from the toe end (20)) (para [0020]), and wherein the pharyngeal tube is configured to establish the patent airway without inflating a balloon or other sealing element (device obviates the need for an inflatable cuff by supplying devices in a variety of sizes so that the appropriate size to be chosen may specifically match the size of each prospective patient's pharyngeal cavity (para [0017]).
Miller does not disclose a mouthpiece provided at the proximal end of the hollow tube, wherein the mouthpiece is capable of providing an airtight seal at the mouth of the patient.
However, Liegner teaches a mouthpiece (10) configured to be used for endotracheal intubation, wherein the mouthpiece (10) includes a bore (72) to receive an endotracheal or oropharyngeal tube (col 3, ln 59-65), wherein the mouthpiece (10) is capable of providing an airtight seal at the mouth of the patient (mouthpiece includes ridge and flange components that sealingly engage the labium oris so that the oral cavity is restricted to communication to the exterior through the bore and optional bore of the mouthpiece) (col 2, ln 49-53).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Miller by providing a mouthpiece at the proximal end of the hollow tube, wherein the mouthpiece is capable of providing an airtight seal at the mouth of the patient as taught by Liegner in order to provide a bite block which is usefully employed in conjunction with endoscopy, bronchoscopy, endotracheal intubation and like medical-surgical procedures to permit stabilization of the tube and to prevent the patient for biting down on the tube (col 1, ln 31-39).
Regarding claim 2, the modified Miller’s reference discloses the mouthpiece (10 of Liegner) comprises an inner flange (22 of Liegner) (outer marginal zone shown in fig 2 of Liegner to be a flange) configured to be positioned between teeth and lips of the patient (groove (30 of Liegner) receives the teeth of a patient and therefore outer marginal zone (22 of Liegner) is configured to be positioned between teeth and lips of a patient) (Liegner, col 3, ln 23-39), and an outer flange (60 of Liegner) (upper flange) configured to be positioned on an outside of the lips of the patient (flange (60 of Liegner) extends external to the mouth) (Liegner, col 4, ln 4-15).
Regarding claim 4, the modified Miller’s reference discloses the inner flange (22 of Liegner), the outer flange (60 of Liegner), or the mouthpiece (10 of Liegner) are formed from a biocompatible material that is flexible or semi- flexible (ethylene-vinyl acetate) (Liegner, col 4, ln 60-64).
Regarding claim 5, Miller discloses the hollow tube (12, 14) comprises multiple lateral openings (13) (openings can comprise two vertical slits (13)) (para [0027]).
Regarding claim 12, the modified Miller’s reference discloses the mouthpiece (10 of Liegner) further comprises an additional port (70 of Liegner) (additional bore) capable of allowing an endoscope to be inserted (Liegner, col 3, ln 59-64).
Regarding claim 14, the modified Miller’s reference discloses the port (70 of Liegner) is configured to allow performing endoscopy with the patient without tracheal intubation (port (70 of Liegner) is configured to pass an endoscope and therefore is capable of allowing a user to perform endoscopy with the patient without tracheal intubation) (Liegner, col 3, ln 59-64).
Regarding claim 16, the modified Miller’s reference disclose the plurality of lateral openings (13) are provided at the distal end of the hollow tube (12, 14) (as shown in fig 2, lateral openings (13) are provided at the distal end of the chamber (14) of the hollow tube).
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller and Liegner as applied to claim 2 above, and further in view of Galleher, Jr.
Regarding claim 3, modified Miller discloses a mouthpiece with an inner flange and an outer flange.
Modified Miller does not disclose the inner flange and the outer flange are oblong-shaped.
However, Galleher teaches a respiratory device including a respiratory tube (12) (oral airway) and a mouthpiece including an inner flange (13) (inner plate) configured to be positioned between teeth and lips of the patient (outer convex surface (15) of the inner plate (13) has sealing engagement with the inner surfaces of the patient's upper and lower lips) and an outer flange (14) (outer plate) configured to be positioned on an outside of the lips of the patient (the inner concave surface (16) of the outer flange (14) has sealing contact with the outer surfaces of the patient's lips) (col 2, ln 25-34), wherein the inner flange (13) and outer flange (14) are oblong-shaped (as shown in figs 2-3, inner (13) and outer flanges (14) are shown to have an oblong shape) (Galleher, fig 1, col 2, ln 38-40).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Miller by providing the mouthpiece with an inner and outer flange that is oblong shaped as taught by Galleher, in order to provide mouthpiece that would provide a comfortable and effective sealing means to the device (col 1, ln 38-40).
Claims 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller and Liegner as applied to claim 1 above, and further in view of Mazal.
Regarding claim 6, modified Miller discloses a hollow tube.
Modified Miller does not disclose the hollow tube further comprises an inner septum that divides the tube into first and second lumens that are connected at the distal end of the tube.
However, Mazal in figs 1-2 teaches a respiratory device comprising a hollow tube (12) (main body portion of main tube (10)) (col 2, ln 19-28), wherein the hollow tube (12) includes an inner septum (30) (second tube) that divides the tube (12) into first and second lumens (as shown in fig 1, inspiratory gases enter a first lumen formed within the inner septum (30) (col 3, ln 29-32) and expiratory gasses exit a second lumen formed between the tube (12) and the inner septum (30) (col 3, ln 32-36) that are connected at the distal end of the tube (inner septum (30) terminates at open end (36) within the hollow tube (12) and therefore the first and second lumens are connected at the distal end of the hollow tube (12) (col 3, ln 14-16) .
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Miller by providing the hollow tube with an inner septum that divides the tube into first and second lumens as taught by Mazal in order to reduce the amount of dead space in the device to be less than the physiological dead space of the patient to be treated (col 1, ln 45-51)
Regarding claim 7, the modified Miller’s reference discloses the first lumen (lumen within inner septum (30 of Mazal) is for inspiratory gas flow, and is the second lumen (lumen between tube (12 of Mazal) and inner septum (30 of Mazal) is for expiratory gas flow (Mazal, col 3, ln 29-36).
Claims 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller and Liegner as applied to claim 1 above, and further in view of Cuevas et al.
Regarding claim 8, modified Miller discloses a hollow tube.
Modified Miller does not disclose the hollow tube further comprises an inner channel that that extends along the inner surface of the tube.
However, Cuevas teaches a tracheal catheter including a hollow tube (12) (tube), wherein the hollow tube (12) includes an inner channel (30) (flexible lumen) that extends along an inner surface of the tube (12) and terminating in a port (13) (para [0021]), wherein the inner channel (30) is configured to receive a suction catheter (32) (para [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the hollow tube of modified Miller by providing an inner channel that that extends along the inner surface of the tube as taught by Cuevas in order to allow the hollow tube to receive a suction catheter to suction any secretions that accumulate in a subglottic space of a patient (Cuevas, para [0011]).
Regarding claim 9, the modified Miller’s reference discloses the inner channel (30 of Cuevas) is configured to be a suction catheter (32 of Cuevas) (Cuevas, para [0030]).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller and Liegner as applied to claim 1 above, and further in view of Mooney.
Regarding claim 10, modified Miller discloses a pharyngeal tube.
Modified Miller does not disclose the pharyngeal tube has an attached gastric tube.
However, Mooney in figs 1-4 teaches a respiratory device including a breathing tube (12) (para [0029]), wherein the breathing tube (12) includes an attached gastric tube (23) (third tube is a feeding tube having a lumen for gastric access) (para [0029]), wherein the gastric tube (23) runs parallel to the breathing tube (12) (gastric tube (23) extends along the length of breathing tube (12) (para [0030]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Miller by providing an attached gastric tube as taught by Mooney in order to allowing the device to administer nutritional matter to the gut without interrupting airflow (Mooney, abstract).
Claim 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller and Liegner as applied to claim 1 above, and further in view of Brown et al.
Regarding claim 11, modified Miller discloses a hollow tube.
Modified Miller does not disclose a pressure relief valve configured to vent air from the hollow tube when pressure within the hollow tube exceeds a predetermined pressure threshold.
However, Brown in figs 1-2 teaches a respiratory device including a hollow tube (106) (catheter) (para [0024]), wherein the hollow tube (106) is coupled to a pressure relief valve (205) (relief valve) configured to vent air from the hollow tube (106) when pressure within the hollow tube (106) exceeds a predetermined pressure threshold (para [0024]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Miller by providing a pressure relief valve configured to vent air from the hollow tube when pressure within the hollow tube exceeds a predetermined pressure threshold as taught by Brown in order allow passage of air to be vented to prevent the flow of air to the patient above a maximum pressure (Brown, para [0026]).
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller and Liegner as applied to claim 12 above, and further in view of Rapacki et al.
Regarding claim 13, modified Miller discloses a port.
Modified Miller does not disclose the port is fitted with a suitable one-way valve, a check valve, multiple flexible flap or membrane valve, or a duckbill valve.
However, Rapacki in figs 1-5 teaches a respiratory device including a port (110) (sealing ports) for insertion of a bronchoscope (135) or a catheter (137) (para [0030]), wherein the port is fitted with a valve seal member (140) (para [0032]) comprising a multiple flexible membrane valve (valve seal members (140) can have openings such as slits (145) for receiving elongated instruments such as a bronchoscope (135)) (para [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Miller by providing the port with a suitable multiple flexible flap or membrane valve as taught by Rapacki in order to allow the port to provide a seal when a bronchoscope is inserted into the port (Rapacki, para [0006]) and to seal automatically when the bronchoscope is removed (Rapacki, para [0007]).
Claims 1-2, 4, 12, 14-15, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (2010/0224186) in view of Kruger (4,454,887) and Liegner (4,495,945).
Regarding claim 1, Uesegi discloses a pharyngeal tube (100) (endotracheal intubation assist instrument) comprising: an elongated hollow tube (10) (guide tube) including a proximal end and a distal end for establishing a patent airway for a patient; and one or more lateral openings (20) (side hole) provided at or near the distal end of the hollow tube (10) (para [0064]), wherein the one or more lateral openings (20) are formed in a lateral wall of the hollow tube (10) (para [0066]), and wherein the pharyngeal tube (10) is configured to establish the patent airway without inflating a balloon or other sealing element with the trachea or pharynx (guide tube (10) is configured so that side hole (20) is aligned to face a glottis of a patient (para [0075]), and as the tube (100) does not include a balloon or other sealing element, is configured to establish the patent airway without inflating a balloon or other sealing element with the trachea or pharynx).
Uesegi does not disclose a distal tip of the hollow tube is sealed so that air cannot escape the hollow tube from its distal tip.
However, Kruger in figs 1-4 teaches a device for introducing a medical instrument into a respiratory tract of a patient including an elongated hollow tube (1) including one or more lateral openings (4) (oval opening) (col 2, ln 59-67), wherein a distal tip of the hollow tube (1) includes an extension (2) which is sealed so that air cannot escape the hollow tube from its distal tip (2) (extension (2) is a hose that is closed at the end and is made of a soft highly pliable material) (col 2, ln 49-55).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Uesegi so that the distal tip of the hollow elongated tube comprises a hose that is closed at the end and is made of a soft highly pliable material to facilitate the insertion of the distal end into the esophagus to align the lateral opening with the larynx cavity of the patient (Kruger, col 3, ln 1-7).
The now-modified Uesegi’s device does not disclose a mouthpiece provided at the proximal end of the hollow tube, wherein the mouthpiece is capable of providing an airtight seal at the mouth of the patient.
However, Liegner teaches a mouthpiece (10) configured to be used for endotracheal intubation, wherein the mouthpiece (10) includes a bore (72) to receive an endotracheal or oropharyngeal tube (col 3, ln 59-65), wherein the mouthpiece (10) is capable of providing an airtight seal at the mouth of the patient (mouthpiece includes ridge and flange components that sealingly engage the labium oris so that the oral cavity is restricted to communication to the exterior through the bore and optional bore of the mouthpiece) (col 2, ln 49-53).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Uesegi by providing a mouthpiece at the proximal end of the hollow tube, wherein the mouthpiece is capable of providing an airtight seal at the mouth of the patient as taught by Liegner in order to provide a bite block which is usefully employed in conjunction with endoscopy, bronchoscopy, endotracheal intubation and like medical-surgical procedures to permit stabilization of the tube and to prevent the patient for biting down on the tube (col 1, ln 31-39).
Regarding claim 2, the modified Uesegi’s reference discloses the mouthpiece (10 of Liegner) comprises an inner flange (22 of Liegner) (outer marginal zone shown in fig 2 of Liegner to be a flange) configured to be positioned between teeth and lips of the patient (groove (30 of Liegner) receives the teeth of a patient and therefore outer marginal zone (22 of Liegner) is configured to be positioned between teeth and lips of a patient) (Liegner, col 3, ln 23-39), and an outer flange (60 of Liegner) (upper flange) configured to be positioned on an outside of the lips of the patient (flange (60 of Liegner) extends external to the mouth) (Liegner, col 4, ln 4-15).
Regarding claim 4, the modified Uesegi’s reference discloses the inner flange (22 of Liegner), the outer flange (60 of Liegner), or the mouthpiece (10 of Liegner) are formed from a biocompatible material that is flexible or semi- flexible (ethylene-vinyl acetate) (Liegner, col 4, ln 60-64).
Regarding claim 12, the modified Uesegi’s reference discloses the mouthpiece (10 of Liegner) further comprises an additional port (70 of Liegner) (additional bore) capable of allowing an endoscope to be inserted (Liegner, col 3, ln 59-64).
Regarding claim 14, the modified Uesegi’s reference discloses the port (70 of Liegner) is configured to allow performing endoscopy with the patient without tracheal intubation (port (70 of Liegner) is configured to pass an endoscope and therefore is capable of allowing a user to perform endoscopy with the patient without tracheal intubation) (Liegner, col 3, ln 59-64).
Regarding claim 15, Uesegi discloses the one or more lateral openings (20) comprises a large lateral opening, and wherein a bronchoscope (200) can be passed through the hollow tube (10) and out through the large lateral opening into the trachea (para [0068]).
Regarding claim 17, Uesegi discloses the pharyngeal tube (100) comprises a plurality of perforations (13) (cutting line) extending lengthwise along a wall of the hollow tube (100) (para [0068]).
Regarding claim 18, Uesegi discloses the perforations (13) are configured to separate the hollow tube (100) by tearing off (cutting line (13) is installed from the terminal end opening to the side hole (20) to cut easier when cutting and removing the guide tube (100)) (para [0068]).
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi, Kruger, and Liegner as applied to claim 2 above, and further in view of Galleher, Jr.
Regarding claim 3, modified Uesegi discloses a mouthpiece with an inner flange and an outer flange.
Modified Uesegi does not disclose the inner flange and the outer flange are oblong-shaped.
However, Galleher teaches a respiratory device including a respiratory tube (12) (oral airway) and a mouthpiece including an inner flange (13) (inner plate) configured to be positioned between teeth and lips of the patient (outer convex surface (15) of the inner plate (13) has sealing engagement with the inner surfaces of the patient's upper and lower lips) and an outer flange (14) (outer plate) configured to be positioned on an outside of the lips of the patient (the inner concave surface (16) of the outer flange (14) has sealing contact with the outer surfaces of the patient's lips) (col 2, ln 25-34), wherein the inner flange (13) and outer flange (14) are oblong-shaped (as shown in figs 2-3, inner (13) and outer flanges (14) are shown to have an oblong shape) (Galleher, fig 1, col 2, ln 38-40).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of Chang by providing the mouthpiece with an inner and outer flange that is oblong shaped as taught by Galleher, in order to provide mouthpiece that would provide a comfortable and effective sealing means to the device (col 1, ln 38-40).
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi, Kruger, and Liegner as applied to claim 12 above, and further in view of Rapacki et al.
Regarding claim 13, modified Uesegi discloses a port.
Modified Uesegi does not disclose the port is fitted with a suitable one-way valve, a check valve, multiple flexible flap or membrane valve, or a duckbill valve.
However, Rapacki in figs 1-5 teaches a respiratory device including a port (110) (sealing ports) for insertion of a bronchoscope (135) or a catheter (137) (para [0030]), wherein the port is fitted with a valve seal member (140) (para [0032]) comprising a multiple flexible membrane valve (valve seal members (140) can have openings such as slits (145) for receiving elongated instruments such as a bronchoscope (135)) (para [0036]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the device of modified Uesegi by providing the port with a suitable multiple flexible flap or membrane valve as taught by Rapacki in order to allow the port to provide a seal when a bronchoscope is inserted into the port (Rapacki, para [0006]) and to seal automatically when the bronchoscope is removed (Rapacki, para [0007]).
Response to Arguments
Applicant’s arguments, see page 4, third full paragraph-page 10, sixth full paragraph of applicant’s remarks, filed 2/2/2026, with respect to the rejection of claims 1-18 under U.S.C. § 103 in view of Chang have been fully considered and are persuasive. The rejection of claims 1-18 with respect to the Chang reference has been withdrawn.
Applicant's arguments filed 2/2/2026 have been fully considered but they are not persuasive.
Applicant argues on page 11, first full paragraph-page 12 that Miller’s LMA airway is incapable of forming an airtight seal at the mouth of the patient, and Liegner discloses the use of a porous bit block which is not designed to provide an airtight seal at the mouth of the patient because the bite block includes bores (70, 72, 74). However, Liegner teaches when the bite block (10) is so inserted into the vestibulum oris of a patient, the ridge (56) and flanges (60, 64) cooperate to sealingly engage the labium oris so that the oral cavity of the patient is restricted in communication to the exterior, through the bores (70, 72 and 74) (col 4, ln 7-12). The specification on page 7, lines 8-13 recites, “This mouthpiece 18 includes both an inner flange 20 configured to be positioned between the patient's lips and teeth or gums, and an outer flange 22 configured to be 10 positioned against the outside of the patient's lips. With such a configuration, the mouthpiece 18 or inner/outer flanges 20, 22 can form an airtight seal at the patient's mouth, thereby preventing leakage of the pressurized air that is delivered using the pharyngeal tube 12.” Although applicant’s mouthpiece includes an opening through which air is delivered to the pharyngeal tube, the mouthpiece is considered to form an airtight seal at the patient’s mouth because it prevents leakage of pressurized air that is delivered through the pharyngeal tube. Therefore, although Liegner discloses a mouthpiece having a bore through which a tracheal tube can be inserted, the mouthpiece is considered to form an airtight seal at the patient’s mouth because, similar to applicant’s invention, the mouthpiece includes flanges that to sealingly engage the labium oris and thereby preventing leakage of the pressurized air. Therefore, the rejection is maintained.
Applicant argues on page 12, third full paragraph-fourth full paragraphs of applicant’s remarks, that any modification of the stems of Miller with mouthpieces at its proximal end would have made Miller unfit for its intended purpose for a flexible free stem that can be flexed into a curve that deviates up to 90 degrees from said longitudinal axis. However, Miller in figs 3-4 disclose that the degree of flexibility is accomplished at the junction (19) where the stem (12) meets the chamber, where the cross-section of the stem (12) is reduced at (28) (para [0044]). Therefore, providing a proximal stem of Miller with a mouthpiece would not have made Miller unfit for its intended purpose, because Miller’s flexion point is discloses as being at the distal end of the stem where it meets the chamber, and would therefore still be capable of flexing if a mouthpiece were provided at the proximal end, and Miller teaches the benefit of providing a mouthpiece to permit stabilization of the tube and to prevent the patient for biting down on the tube (Liegner, col 1, ln 31-39). Therefore, the rejection is maintained.
Applicant argues on page 12, fifth full paragraph-page 16, fifth full paragraph of applicant’s remarks, that the secondary references do not teach a mouthpiece that is capable of providing an airtight seal at the mouth of the patient. However, as discussed above, because the combination of Miller and Liegner discloses the limitations of claim 1, the rejection is maintained.
Applicant argues on page 17, first full paragraph-page 18, sixth full paragraph of applicant’s remarks, that neither Uesugi, Kruger, Liegner, nor the secondary references teach a mouthpiece that is capable of providing an airtight seal at the mouth of the patient. However, as discussed above, because Liegner discloses an airtight seal at the mouth of a patient, the combination of Uesugi, Kruger, and Liegner discloses the limitations of claim 1. Therefore, the rejection is maintained.
Conclusion
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/DOUGLAS Y SUL/Examiner, Art Unit 3785