DETAILED ACTION
This office action is in response to the amendment filed 6/18/2026. As directed by the amendment, claims 1 and 3-4 have been amended, claim 2 has been cancelled, and no claims have been newly added. Thus, claims 1 and 3-18 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 .
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, 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 comprises an inner flange configured to be positioned between teeth and lips of the patient, and an outer flange configured to be positioned on an outside of the lips of the patient, and 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); wherein the mouthpiece (10) comprises an inner flange (22) (outer marginal zone shown in fig 2 to be a flange) configured to be positioned between teeth and lips of the patient (groove (30) receives the teeth of a patient and therefore outer marginal zone (22) is configured to be positioned between teeth and lips of a patient) (col 3, ln 23-39), and an outer flange (60) (upper flange) configured to be positioned on an outside of the lips of the patient (flange (60) extends external to the mouth) (col 4, ln 4-15).
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 comprises an inner flange configured to be positioned between teeth and lips of the patient, and an outer flange configured to be positioned on an outside of the lips of the patient, and 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 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]).
Allowable Subject Matter
Claims 5-11 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement for reasons for allowance: The closest prior art of the record, Uesugi (2010/0224186), Kruger (4,454,887) and Liegner (4,495,945) discloses the limitations of claim 1. However, neither Uesugi, Kruger, Liegner, nor the other prior art of record, disclose the limitations of claims 5-11, as Uesugi teaches the use of one large lateral opening to allow a bronchoscope to pass through, and providing multiple lateral openings as recited in claim 5 would frustrate the purpose of Uesugi to provide an opening large enough for a bronchoscope to pass through; Uesugi teaches that the pharyngeal tube is for introduction of a bronchoscope and therefore would be inappropriate to modify Uesugi’s bronchoscope introducing pharyngeal tube with features of a ventilation tube as recited in claims 6-11; and Kruger teaches the tube including an extension (2) at the distal end, and therefore the opening of the modified Uesugi’s device cannot be disposed at the distal end as recited in claim 16.
Response to Arguments
Applicant’s arguments, see page 5, second full paragraph-page 8, third full paragraph of applicant’s remarks, filed 6/18/2026, with respect to the rejection of claims 1-2, 4-5, 12, 14, and 16 under U.S.C. § 103 in view of Miller and Liegner have been fully considered and are persuasive. The rejection of claims 1-2, 4-5, 12, 14, and 16 with respect to the Miller reference has been withdrawn.
Applicant's arguments filed 6/18/2026 have been fully considered but they are not persuasive.
Applicant argues on page 14, fourth full paragraph-page 15, first full paragraph of applicant’s remarks, that Uesugi, Kruger, and Liegner fail to disclose a mouthpiece that includes an inner flange configure to be positioned between teeth and lips of the patient, and an outer flange configured to positioned on an outside of the lips of the patient. However, as shown in figs 1-2 of Liegner, the mouthpiece includes a groove (50) on an upper surface (18) between the inner (20) and outer marginal zones (22), said groove (50) being adapted by size and configuration to receive therein the upper teeth (col 3, ln 23-28). Therefore, the outer marginal zone (22) would be disposed at a position in the outside of the teeth. Liegner also discloses an upper space (62) configured to receive the labium superiori oris (upper lip) of a human in sealing engagement with a flange (60) (col 3, ln 45-53). Therefore, because the teeth are disposed in the groove (50) and the labium superiori oris is disposed in the upper space (62), the raised section comprising the outer marginal zone would read on the limitation of an inner flange (because, as shown in figs 2-3, it is shown to be a section raised with respect to the groove and the upper space) that is disposed between the teeth (which are disposed in the groove (50)) and lips (which are disposed in the upper space (62)) of the patient. Furthermore, the flange (60) would read on an outer flange which is positioned on an outside of the lips of the patient, as it is outside the upper space (62) in which the labium superiori oris is disposed). Therefore, the rejection is maintained.
Applicant argues on page 14, second full paragraph-third full paragraph of applicant’s remarks, that modified Uesugi does not disclose a pharyngeal tube configured to establish a patient airway without a balloon or any additional pharyngeal sealing element at or near the distal end of the hollow tube but only by sealing at the patient’s mouth, as modifying the device of Uesugi to only provide sealing at patient’s mouth would have made the reference unsuitable for its intended purpose of providing devices that facilitate intra-tracheal sealing. However, Uesugi’s tube itself does not seal the trachea, but is an endotracheal intubation assist instrument for inserting a bronchofiberscope from the oral or nasal cavity to the trachea easily and then inserting the endotracheal tube into the trachea easily. It is the endotracheal tube that is subsequently inserted into the trachea, and not Uesugi’s endotracheal assist instrument, that provides for sealing at or near a distal end of the patient. Liegner’s bite block 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), and because Uesugi’s device is configured to be used in conjunction with bronchoscopy and endotracheal intubation (assisting the insertion of a bronchofiberscope to perform endotracheal intubation) (Uesugi, abstract), modifying the device of Uesugi (which is used to perform endotracheal intubation by using a bronchoscope) by providing Leigner’s bite block (which is useful for stabilizing a tube for perform bronchoscopy and endotracheal intubation) would not render Uesugi unfit for its intended purpose of assisting in performing endotracheal intubation. Therefore, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/DOUGLAS Y SUL/Examiner, Art Unit 3785
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