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 .
Status of Claims
This Office Action is in response to the remarks and amendments filed on January 20th, 2026. Claims 18-20 have been canceled as such claim 12-17 and 21-34 are pending consideration in this Office Action.
Response to Amendment
The objections to the claims are withdrawn in light of the amendments.
Claim Objections
Claims 30 and 33 are objected to because of the following informalities:
Claim 30, “each airway tube” should read “each of the pair of airway tubes”
Claim 33, “the airway tubes” should read “the pair of airway tubes”
Appropriate correction is required.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 12, 13, 16, 21, 22, 30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646) and Parker (US 5038766).
Regarding claim 12. Uesugi discloses
A method of performing a procedure on a patient (Figs. 4-15; endotracheal intubation method; Paragraph 0010, Lines 1-11), the method comprising:
inserting an intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) through the mouth of the patient (Figs. 4-15; oral cavity; Paragraph 0065, Lines 1-6),
the intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) including:
an intubation tube (Figs. 1 and 2; guide tube 10; Paragraph 0064, Lines 10-12) having a distal opening (Figs. 1 and 2; opening 12; Paragraph 0067, Lines 1-3) and a proximal opening (Figs. 1 and 2; opening 11; Lines 1-3);
inserting an introducer rod (Figs. 2 and 6; bronchofiberscope 200; Paragraph 0079, Lines 1-5) into the intubation tube (Figs. 2 and 6; guide tube 10; Paragraph 0079, Lines 1-5);
advancing the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) through the intubation tube (Figs. 6-9; guide tube 10; Lines 1-3; guide tube makes up the tube part of the intubation instrument) until a distal end of the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) passes through the patient's vocal cords (bronchofiberscope has to pass the patient’s vocal cords in order to reach the trachea) into the patient's trachea (Figs. 6-9; trachea; Paragraph 0086, Lines 1-3);
withdrawing the intubation instrument (Figs. 10 and 11; endotracheal intubation assist instrument 100; Paragraph 0087, Lines 1-3 and Paragraph 0088, Lines 1-4) from the patient's mouth (Figs. 10 and 11; oral cavity) while maintaining the introducer rod (Figs. 10 and 11; bronchofiberscope 200; Paragraph 0088, Lines 1-4) in place relative to patient's trachea (Figs. 10 and 11; trachea; Paragraph 0088, Lines 1-4).
Uesugi does not disclose an esophageal tube that is curved and includes a lumen extending between a proximal esophageal tube opening and a distal esophageal tube opening, the intubation tube extending along at least a portion of the esophageal tube and having a distal intubation tube opening and a proximal intubation tube opening, an endoscopic camera tube extending adjacent the intubation tube, a balloon extending around a circumference of the esophageal tube without occluding the distal esophageal tube opening, wherein the balloon is configured to expand radially outward from the circumference of the esophageal tube when inflated and is positioned distal of the distal opening of the intubation tube; and (v) a pair of airway tubes positioned adjacent the intubation tube and running along opposite sides of the intubation tube, the pair of airway tubes including a first airway tube and a second airway tube; visualizing the vocal cords of the patient with an endoscopic camera; suctioning contents of the patient through the first airway tube; while suctioning the contents through the first airway tube, providing positive airflow in the distal direction through the second airway tube; inflating the balloon to occlude the esophageal opening of the patient without occluding the distal esophageal tube opening to thereby facilitate suctioning of stomach contents via the esophageal tube; deflating the balloon;
Molnar discloses a supraglottic airway device with
an esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus (cuff 22 is in upper esophagus which is surrounds bottom of tube 620); Col. 36, Lines 11-20) that is curved (Fig. 39; tube 620 is curved) and includes a lumen (Figs. 38-39; tube 620 creates a lumen between the two openings) extending between a proximal esophageal tube opening (Fig. 39; top opening of tube 620) and a distal esophageal tube opening (Fig. 39; bottom opening of tube 620, opening closest to cuff 22),
the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9) extending (Fig. 39; tube 618 extends along the front of tube 620) along at least a portion of the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus; Col. 36, Lines 11-20) and having a distal intubation tube opening (Fig. 39; bottom opening of tube 618) and a proximal intubation tube opening (Fig. 39; top opening of tube 618),
an endoscopic camera tube (Fig. 39; camera tube 12; Col. 35, Lines 31-37) extending adjacent (Fig. 39; camera holder tube 12 has holder 606 which holds and is adjacent to the endotracheal tube 618) the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9), and
a balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) extending around a circumference of the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus, extends around the circumference of tube 620; Col. 36, Lines 11-20) without occluding the distal esophageal tube opening (Fig. 39; cuff 622 is above the bottom opening; therefore, the cuff is not occluding the opening of tube 620), wherein the balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) is configured to expand radially outward (Fig. 39; cuff 622 is an inflatable cuff, it is necessary that when it inflates it expands radially outward) from the circumference of the esophageal tube when inflated (Fig. 39; cuff 622; Col. 36, Lines 14-20; cuff 622 is inflated in the upper esophagus) and is positioned distal (Fig. 39; cuff 622 is distal to tube 618) of the distal opening of the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9);
visualizing the vocal cords of the patient (Fig. 39; “direct visualization proximally to the vocal cords”; Col. 36, Lines 20-23) with an endoscopic camera (Fig. 39; camera 18; Col. 36, Lines 20-23);
inflating the balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) to occlude the esophageal opening of the patient (Fig. 39; cuff inflates in the upper esophagus; Col. 36, Lines 14-20; therefore, it is capable of occluding the esophageal opening) without occluding the distal esophageal tube opening (Fig. 39; cuff 622 is above the bottom opening; therefore, the cuff is not occluding the opening of tube 620) to thereby facilitate suctioning of stomach contents via the esophageal tube (Fig. 39; “the tube 620 can be designed such that it is used for suction”; Col. 36, Lines 30-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal intubation assist instrument of Uesugi with the supraglottic airway device Molnar to have a camera tube, camera, additional tube for the esophagus and cuff 622 to further prevent the bougie from going into the esophagus by continually visualizing the vocal cords and supraglottic structures and blocking the esophagus with the cuff (Molnar: Col. 4, Lines 54-64; Col. 36, Lines 12-25). Further, it would have been obvious to have the endotracheal intubation assist instrument of Uesugi be adjacent to the camera and proximal to the balloon as taught by the bougie and tube of Molnar in order to visualize where the bougie is going.
Molnar does not disclose the intubation instrument deflating the balloon and v) a pair of airway tubes positioned adjacent the intubation tube and running along opposite sides of the intubation tube, the pair of airway tubes including a first airway tube and a second airway tube; and suctioning contents of the patient through the first airway tube; while suctioning the contents through the first airway tube, providing positive airflow in the distal direction through the second airway tube.
Christopher discloses a laryngeal mask airway
deflating (Figs. 14 and 19; Paragraph 0097, Lines 1-4 and Lines 8-11) the balloon (Figs. 14 and 19; laryngeal mask 30; Paragraph 0097, Lines 1-4 and Lines 8-11);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuff of the modified endotracheal intubation assist instrument of Uesugi to be able to deflate as taught by the laryngeal mask of Christopher to allow for easier removal and to reduce risk of trauma to the airway.
Parker discloses a medical device for orotracheal intubation where
v) a pair of airway tubes (figs. 9 and 12; orotracheal tube 10 may include pilot tube 18a; col. 8, lines 23-24; and suction catheter/tube 302; col. 12, lines 1-4) positioned adjacent the intubation tube and running along opposite sides of the intubation tube (see fig. 9, pilot tube 18a extends along the length of orotracheal tube 18 on front side of tube towards airway path extension; see figs. 9 and 12, suction tube 302 is to be used medical device 10, 110 and is positioned in tunnel 302 (opposite side of tube 18) which is positioned adjacent to where airway tubes are inserted into airway path extension 144; col. 12, lines 1-10), the pair of airway tubes including a first airway tube (figs. 9 and 12; suction catheter/tube 302; col. 12, lines 1-4) and a second airway tube (figs. 9 and 12; pilot tube 18a; col. 8, lines 23-24); and suctioning contents of the patient through the first airway tube (fig. 12; “The presence of substantial blood, vomitus, or other debris in the throat currently requires that a suction catheter be introduced into the throat to evacuate these larynx-obscuring substances”; col. 2, lines 66-68 and col. 3, line 1); while suctioning the contents through the first airway tube (figs. 9 and 12; suction tube 302 is capable of being used with orotracheal tube 18/pilot tube 18a; col. 2, lines 66-68 and col. 3, lines 1-8; col. 12, lines 1-10), providing positive airflow (see fig. 9, pilot tube 18a has a “proximal end 146 which may be connected to a respirator (not shown), and the patient's lungs (not shown) ventilated thereby”; col. 8, lines 23-24 and col. 11, lines 17-19) in the distal direction through the second airway tube (see figs. 9 and 12; pilot tube 18a provides air and “during esophageal intubation, airway path extension 144 provided by channel 22 maintains breathability of the patient”; col. 12, lines 1-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal intubation assist instrument of the modified of method of Uesugi with the pilot tube, suction tube, and channels as disclosed in Parker to provide ventilation to the patient’s lungs while evacuating blood, vomitus, or other debris in the throat that obscures the view impairing the attempt to intubate (Parker: col. 2, lines 55-68 and col. 3, lines 1-8; col. 11, lines 17-19).
Regarding claim 13, the modified method of Uesugi further discloses
The method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon) of claim 12,
wherein advancing the introducer rod (Uesugi: Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) through the intubation tube (Uesugi: Figs. 6-9; guide tube 10; Lines 1-3; guide tube makes up the tube part of the intubation instrument) until a distal end of the introducer rod (Uesugi: Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) passes through the patient's vocal cords (Uesugi: bronchofiberscope has to pass the patient’s vocal cords in order to reach the trachea) into the patient's trachea (Uesugi: Figs. 6-9; trachea; Paragraph 0086, Lines 1-3) includes: contacting the balloon (Molnar: Fig. 39; cuff 22; Col. 36, Lines 14-20) in an inflated condition (Molnar: Fig. 39; cuff is inflated; Col. 36, Lines 14-20) with the distal end of the introducer rod (Molnar: Fig. 39; bougie 608 is proximal to cuff 622).
While Molnar is silent to whether the bougie contacts the cuff in an inflated position, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that since the bougie can be slid up and down alongside the tube (Molnar: Col. 35, Lines 0-46), when slid further down it would touch the cuff.
Regarding claim 16, the modified device of Uesugi further discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon) of claim 12, further comprising:
inserting an endoscopic camera (Molnar: Fig. 39; camera 18; Col. 35, Lines 18-24) distally (Molnar: Fig. 39; Col. 35, Lines 18-24; camera is inserted at the proximal end of the camera tube; therefore, is inserted distally) into the endoscopic camera tube (Molnar: Fig. 39; camera tube 12; Col. 35, Lines 18-24) and
visualizing (Col. 35, Lines 18-24 and Col. 36, Lines 20-23), with the endoscopic camera (Molnar: Fig. 39; camera 18; Col. 35, Lines 18-24 and Col. 36, Lines 20-23), the distal end of the introducer rod (Molnar: Fig. 39; distal end bougie 608; Col. 35, Lines 18-24 and Col. 36, Lines 20-25; bougie 608 placed in vocal cords is distal to the camera 18 which visualized the vocal cords) as the introducer rod (Molnar: Fig. 39; bougie 608; Col. 35, Lines 18-24 and Col. 36, Lines 20-25) passes through the patient's vocal cords (Molnar: “bougie can be placed through the vocal cords”; Col. 36, Lines 20-25).
Regarding claim 21, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method) of claim 12,
wherein the camera tube (Molnar: Fig. 39; camera tube 12; Col. 35, Lines 31-37) extends along an exterior of the intubation tube (Molnar: Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9) and is coupled (Molnar: Fig. 39; camera holder tube 12 has holder 606 which holds and is adjacent to the endotracheal tube 618; Col. 35, Lines 31-39) with the exterior of the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9) to thereby facilitate viewing of the distal end of the introducer rod (Molnar: Fig. 39; distal end bougie 608; Col. 35, Lines 18-24 and Col. 36, Lines 20-25; bougie 608 placed in vocal cords is distal to the camera 18 which visualized the vocal cords).
Regarding claim 22, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon) of claim 12, further comprising suctioning contents from the stomach of the patient through the esophageal tube (Fig. 39; “the tube 620 can be designed such that it is used for suction”; Col. 36, Lines 30-31; therefore, tube 620 which is positioned in the esophagus would be capable of suctioning stomach contents) subsequent to inflating the balloon.
While Molnar is silent to suctioning stomach contents subsequent to inflating the balloon, “the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process (MPEP 2112.02 section I). The tube 620 (that can perform suctioning) with cuff 622 is the same as esophageal tube 110 with balloon 116) as such it would be obvious that the tube would be able to perform the claimed process of suctioning stomach contents subsequent to inflating the cuff/balloon.
Regarding claim 30, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Parker: airway tubes) of claim 12,
wherein each airway tube (Parker: see fig. 9, pilot tube 18a extends along the length of orotracheal tube 18; see figs. 9 and 12, suction tube 302 is to be used medical device 10, 110 and is positioned in tunnel 302 which is positioned adjacent to where airway tubes are inserted into airway path extension 144; col. 12, lines 1-10) is adjacent both the intubation tube and the esophageal tube (Molnar: see fig. 39; endotracheal tube 618 is positioned adjacent to esophageal tube 620; it would have been readily understood that the pilot/suction tube would be capable of being adjacent to both the intubation tube and esophageal tube by simply moving a part of the tube).
Regarding claim 32, the modified method of Uesugi discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Parker: airway tubes) of claim 12,
wherein the second airway tube is positioned to provide the positive airflow (Parker: see fig. 9 below; pilot tube 18a which extend along length of orotracheal tube 18 is connected to a respirator at proximal end 146 to ventilate the lungs; col. 8, lines 23-24 and col. 11, lines 17-19)
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at a distal camera tube opening of the camera tube (Molnar: see fig. 39; distal end 17 of camera tube 14 is adjacent to distal end of endotracheal tube 618; both pilot tube and camera tube are adjacent to the tracheal tube) to thereby promote an unobstructed line of sight for the endoscopic camera (this is intended use and therefore not given any patentable weight; regardless, the combination of Parker and Molnar which discloses the positioning of the airway tube and camera tube relative to the intubation tube would render it capable of promoting an unobstructed line of sight for the camera by providing an airflow with a high enough pressure).
Claims 31, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646), Parker (US 5038766), and Molnar 2014 (US 20140309494)
Regarding claim 31, the modified method of Uesugi discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Parker: airway tubes) of claim 12,
The modified method of Uesugi does not explicitly disclose wherein the first airway tube is positioned to provide suction at a distal camera tube opening of the camera tube to thereby promote an unobstructed line of sight for the endoscopic camera.
However, Molnar 2014 discloses an analogous medical device to be inserted into the throat
wherein the first airway tube is positioned to provide suction at a distal camera tube opening of the camera tube (fig. 40; “the suction tube 726 and the camera lumen 58 are side-by-side. The distal ends of the suction tube 726 and the camera lumen 58 preferably terminate at the same point.”; [0157]) to thereby promote an unobstructed line of sight for the endoscopic camera (this is intended use and therefore not given any patentable weight; regardless the suction tube is “to provide suction to a cavity of the patient 22, such as the lungs, the chest cavity, etc. to drain fluids”, [0155]-[0157]; therefore, being capable of providing unobstructed line of sight).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the suction tube of the modified method of Uesugi to be positioned such that the camera tube and suction tube are side-by-side and has distal ends that terminate at the same point as disclosed in Molnar 2014 in order to drain fluids from the cavity around the camera (Molnar 2014: [0155]-[0157]) Additionally, since such a modification would simply involve merely moving the suction tube to be adjacent with the camera tube without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Regarding claim 33, the modified method of Uesugi discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Parker: airway tubes) of claim 12,
wherein the airway tubes are positioned to provide positive airflow (Parker: see fig. 9 below; pilot tube 18a which extend along length of orotracheal tube 18 is connected to a respirator at proximal end 146 to ventilate the lungs; col. 8, lines 23-24 and col. 11, lines 17-19)
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at a distal camera tube opening of the camera tube (Molnar: see fig. 39; distal end 17 of camera tube 14 is adjacent to distal end of endotracheal tube 618; both pilot tube and camera tube are adjacent to the tracheal tube) to thereby promote an unobstructed line of sight for the endoscopic camera (this is intended use and therefore not given any patentable weight; regardless, the combination of Parker and Molnar which discloses the positioning of the airway tube and camera tube relative to the intubation tube would render it capable of promoting an unobstructed line of sight for the camera by providing an airflow with a high enough pressure).
The modified method of Uesugi does not explicitly disclose wherein the first airway tube is positioned to provide suction at a distal camera tube opening of the camera tube to thereby promote an unobstructed line of sight for the endoscopic camera.
However, Molnar 2014 discloses an analogous medical device to be inserted into the throat
wherein the airway tubes are positioned to provide suction at a distal camera tube opening (fig. 40; “the suction tube 726 and the camera lumen 58 are side-by-side. The distal ends of the suction tube 726 and the camera lumen 58 preferably terminate at the same point.”; [0157]) of the camera tube to thereby promote an unobstructed line of sight for the endoscopic camera (this is intended use and therefore not given any patentable weight; regardless the suction tube is “to provide suction to a cavity of the patient 22, such as the lungs, the chest cavity, etc. to drain fluids”, [0155]-[0157]; therefore, being capable of providing unobstructed line of sight).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the suction tube of the modified method of Uesugi to be positioned such that the camera tube and suction tube are side-by-side and has distal ends that terminate at the same point as disclosed in Molnar 2014 in order to drain fluids from the cavity around the camera (Molnar 2014: [0155]-[0157]) Additionally, since such a modification would simply involve merely moving the suction tube to be adjacent with the camera tube without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Regarding claim 34, the modified device of Uesugi discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Parker: airway tubes) of claim 12,
wherein distal openings of the second airway tube (Parker: see fig. 9 above; pilot tube 18a which extend along length of orotracheal tube 18 is connected to a respirator at proximal end 146 to ventilate the lungs; col. 8, lines 23-24 and col. 11, lines 17-19), the camera tube (Molnar: see fig. 39; distal end 17 of camera tube 14 is adjacent to distal end of endotracheal tube 618; both pilot tube and camera tube are adjacent to the tracheal tube), and the intubation tube are positioned adjacent one another (Parker and Molnar: both pilot tube and camera tube are adjacent to the tracheal/intubation tube) to thereby promote an unobstructed line of sight of the introducer rod (Uesugi: Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3, bronchofiberscope is inserted intro trachea) for the endoscopic camera (this is intended use and therefore not given any patentable weight; regardless, the combination of Parker and Molnar which discloses the positioning of the airway tube and camera tube relative to the intubation tube would render it capable of promoting an unobstructed line of sight of the bronchofiberscope for the camera by providing an airflow with a high enough pressure).
The modified method of Uesugi does not explicitly disclose wherein the distal opening of the first airway tube is positioned to adjacent to thereby promote an unobstructed line of sight of for the camera
However, Molnar 2014 discloses an analogous medical device to be inserted into the throat
the first airway tube is positioned to adjacent (fig. 40; “the suction tube 726 and the camera lumen 58 are side-by-side. The distal ends of the suction tube 726 and the camera lumen 58 preferably terminate at the same point.”; [0157]) to thereby promote an unobstructed line of sight for the endoscopic camera (this is intended use and therefore not given any patentable weight; regardless the suction tube is “to provide suction to a cavity of the patient 22, such as the lungs, the chest cavity, etc. to drain fluids”, [0155]-[0157]; therefore, being capable of providing unobstructed line of sight).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the suction tube of the modified method of Uesugi to be positioned such that the camera tube and suction tube are side-by-side and has distal ends that terminate at the same point as disclosed in Molnar 2014 in order to drain fluids from the cavity around the camera (Molnar 2014: [0155]-[0157]) Additionally, since such a modification would simply involve merely moving the suction tube to be adjacent with the camera tube without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646), Parker (US 5038766), and Alonso (WO 202000032)
Regarding claim 14, Uesugi further discloses
the method (Uesugi: endotracheal intubation method) of claim 12, further comprising:
advancing an endotracheal tube (Figs. 11-13; endotracheal tube 300; Paragraph 0090, Lines 1-4 and Paragraph 0091, Lines 1-5) along the introducer rod (Figs. 11-13; bronchofiberscope 200; Paragraph 0090, Lines 1-4 and Paragraph 0091, Lines 1-5), subsequent to withdrawing (Figs 10-13; Paragraph 0087, Lines 1-3 and Paragraph 0089, Lines 1-4; Paragraph 0090, Lines 1-4) the intubation instrument (Figs. 10 and 11; endotracheal intubation assist instrument 100; Paragraph 0087, Lines 1-3 and Paragraph 0088, Lines 1-4) from the patient's mouth (Figs. 10 and 11; oral cavity), until a distal end of the endotracheal tube passes (Figs. 11-13; endotracheal tube 300; Paragraph 0090, Lines 1-4 and Paragraph 0091, Lines 1-5) into the patient's trachea (Figs. 11-13; trachea; Paragraph 0090, Lines 1-4);
removing (Paragraph 0092, Lines 1-7) the introducer rod (Figs. 14-15; bronchofiberscope 200; Paragraph 0092, Lines 1-7) from the patient (Figs. 14-15; Paragraph 0092, Lines 1-2), which includes retracting the introducer rod (Figs. 14-15; Paragraph 0092, Lines 1-) proximally (Figs. 14-15) through the endotracheal tube (Figs. 14-15; endotracheal tube 300; Paragraph 0090, Lines 1-4 and Paragraph 0091, Lines 1-5);
Uesugi does not disclose inflating an endotracheal balloon coupled to the endotracheal tube
Alonso discloses an intubation device
inflating (Paragraph 0159, Lines 1-3) an endotracheal balloon (Fig. 3B; balloon 213; Paragraph 0159, Lines 1-3) coupled to the endotracheal tube (Fig. 3B; endotracheal tube 210; Paragraph 0159, Lines 1-3);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal tube of Uesugi with the endotracheal tube of Alonso to have a balloon in order to seal the tracheal passage around the endotracheal tube (Paragraph 0159, Lines 1-3).
It directly follows that the resultant modified method of Uesugi combined with the balloon surrounding the endotracheal tube of Alonso would meet the claimed structural limitations since:
the modified method of Uesugi and Alonso combined discloses
wherein the endotracheal balloon (Alonso: Fig. 3B; balloon 213; Paragraph 0159, Lines 1-3) and the endotracheal tube (Uesugi: Figs. 11-13; endotracheal tube 300; Paragraph 0090, Lines 1-4 and Paragraph 0091, Lines 1-5) are included in an endotracheal system (Alonso: Fig. 3B; balloon 213; Paragraph 0159, Lines 1-3; Uesugi: Figs. 11-13; endotracheal tube 300; Paragraph 0090, Lines 1-4 and Paragraph 0091, Lines 1-5) that is separate from the intubation instrument (Uesugi: endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7; endotracheal intubation assist instrument is removed before endotracheal tube is inserted; therefore, two separate systems).
Regarding claim 15, the modified device of Uesugi further discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon) of claim 14,
wherein the balloon is the only balloon of the intubation instrument (The endotracheal intubation assist instrument of Uesugi is the primary ref which was modified with one of the cuffs of Molnar; as such, only comprises a single balloon) such that the intubation instrument (Uesugi: Figs. 4-6; endotracheal intubation assist instrument 100; Paragraph 0078, Lines 1-6) includes only a single balloon (Molnar: Fig. 39; cuff 622; Col 36, Lines 14-20).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646)
Regarding claim 17, Uesugi discloses
A method of performing a procedure on a patient (Figs. 4-15; endotracheal intubation method; Paragraph 0010, Lines 1-11), the method comprising:
inserting an intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) through the mouth of the patient (Figs. 4-15; oral cavity; Paragraph 0065, Lines 1-6),
the intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) including:
an intubation tube (Figs. 1 and 2; guide tube 10; Paragraph 0064, Lines 10-12) having a distal opening (Figs. 1 and 2; opening 12; Paragraph 0067, Lines 1-3) and a proximal opening (Figs. 1 and 2; opening 11; Lines 1-3)
inserting an introducer rod (Figs. 2 and 6; bronchofiberscope 200; Paragraph 0079, Lines 1-5) into the intubation tube (Figs. 2 and 6; guide tube 10; Paragraph 0079, Lines 1-5);
advancing the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) through the intubation tube (Figs. 6-9; guide tube 10; Lines 1-3; guide tube makes up the tube part of the intubation instrument) until a distal end of the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) passes through the patient's vocal cords (bronchofiberscope has to pass the patient’s vocal cords in order to reach the trachea) into the patient's trachea (Figs. 6-9; trachea; Paragraph 0086, Lines 1-3);
deflating the balloon; and
withdrawing the intubation instrument (Figs. 10 and 11; endotracheal intubation assist instrument 100; Paragraph 0087, Lines 1-3 and Paragraph 0088, Lines 1-4) from the patient's mouth (Figs. 10 and 11; oral cavity) while maintaining the introducer rod (Figs. 10 and 11; bronchofiberscope 200; Paragraph 0088, Lines 1-4) in place relative to patient's trachea (Figs. 10 and 11; trachea; Paragraph 0088, Lines 1-4).
Uesugi does not disclose an esophageal tube that is curved, the intubation tube extending along at least a portion of the esophageal tube and having a distal opening and a proximal opening, an endoscopic camera tube extending adjacent the intubation tube, a single balloon, the single balloon extending around a circumference of the esophageal tube and positioned distal of the distal opening of the intubation tube; wherein the single balloon is the only balloon of the intubation instrument; visualizing the vocal cords of the patient with an endoscopic camera; inflating the balloon to occlude the esophageal opening of the patient suctioning contents from the stomach of the patient through the esophageal tube subsequent to inflating the balloon; and deflating the balloon.
Molnar discloses a supraglottic airway device with
an esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus (cuff 22 is in upper esophagus which is surrounds bottom of tube 620); Col. 36, Lines 11-20) that is curved (Fig. 39; tube 620 is curved)
the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9) extending (Fig. 39; tube 618 extends along the front of tube 620) along at least a portion of the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus; Col. 36, Lines 11-20) and having a distal opening (Fig. 39; bottom opening of tube 618) and a proximal tube opening (Fig. 39; top opening of tube 618),
an endoscopic camera tube (Fig. 39; camera tube 12; Col. 35, Lines 31-37) extending adjacent (Fig. 39; camera holder tube 12 has holder 606 which holds and is adjacent to the endotracheal tube 618) the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9), and
a balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) extending around a circumference of the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus, extends around the circumference of tube 620; Col. 36, Lines 11-20) and is positioned distal (Fig. 39; cuff 622 is distal to tube 618) of the distal opening of the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9);
visualizing the vocal cords of the patient (Fig. 39; “direct visualization proximally to the vocal cords”; Col. 36, Lines 20-23) with an endoscopic camera (Fig. 39; camera 18; Col. 36, Lines 20-23);
inflating the balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) to occlude the esophageal opening of the patient (Fig. 39; cuff inflates in the upper esophagus; Col. 36, Lines 14-20; therefore, it is capable of occluding the esophageal opening);
suctioning contents from the stomach of the patient through the esophageal tube (Fig. 39; “the tube 620 can be designed such that it is used for suction”; Col. 36, Lines 30-31; therefore, tube 620 which is positioned in the esophagus would be capable of suctioning stomach contents) subsequent to inflating the balloon.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal intubation assist instrument of Uesugi with the supraglottic airway device Molnar to have a camera tube, camera, additional tube for the esophagus and cuff 622 to further prevent the bougie from going into the esophagus by continually visualizing the vocal cords and supraglottic structures and blocking the esophagus with the cuff (Molnar: Col. 4, Lines 54-64; Col. 36, Lines 12-25). Further, it would have been obvious to have the endotracheal intubation assist instrument of Uesugi be adjacent to the camera and proximal to the cuff as taught by the bougie and tube of Molnar in order to visualize where the bougie is going. Additionally, while Molnar is silent to suctioning stomach contents subsequent to inflating the balloon, “the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process (MPEP 2112.02 section I). The tube 620 (that can perform suctioning) with cuff 622 is the same as esophageal tube 110 with balloon 116) as such it would be obvious that the tube would be able to perform the claimed process of suctioning stomach contents subsequent to inflating the cuff/balloon.
It directly follows that the resultant endotracheal intubation method of Uesugi combined with the supraglottic device of Molnar as modified above would meet the claimed structural limitations since:
The modified method discloses
a single balloon, the single balloon (Molnar: Fig. 39; cuff 622; Col 36, Lines 14-20); wherein the single balloon is the only balloon of the intubation instrument (The endotracheal intubation assist instrument of Uesugi is the primary ref which was modified with one of the cuffs of Molnar; as such, only comprises a single balloon)
Molnar does not disclose the intubation instrument deflating the balloon.
Christopher discloses a laryngeal mask airway
deflating (Figs. 14 and 19; Paragraph 0097, Lines 1-4 and Lines 8-11) the balloon (Figs. 14 and 19; laryngeal mask 30; Paragraph 0097, Lines 1-4 and Lines 8-11);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuff of the modified endotracheal intubation assist instrument of Uesugi to be able to deflate as taught by the laryngeal mask of Christopher to allow for easier removal and to reduce risk of trauma to the airway.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646) and Heinen (US 5372131).
Regarding claim 23, Uesugi discloses
A method of performing a procedure on a patient (Figs. 4-15; endotracheal intubation method; Paragraph 0010, Lines 1-11), the method comprising:
inserting an intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) through the mouth of the patient (Figs. 4-15; oral cavity; Paragraph 0065, Lines 1-6),
the intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) including:
inserting an introducer rod (Figs. 2 and 6; bronchofiberscope 200; Paragraph 0079, Lines 1-5) into an intubation tube (Figs. 2 and 6; guide tube 10; Paragraph 0079, Lines 1-5);
advancing the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) through the intubation tube (Figs. 6-9; guide tube 10; Lines 1-3; guide tube makes up the tube part of the intubation instrument) until a distal end of the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) passes through the patient's vocal cords (bronchofiberscope has to pass the patient’s vocal cords in order to reach the trachea) into the patient's trachea (Figs. 6-9; trachea; Paragraph 0086, Lines 1-3); and
withdrawing the intubation instrument (Figs. 10 and 11; endotracheal intubation assist instrument 100; Paragraph 0087, Lines 1-3 and Paragraph 0088, Lines 1-4) from the patient's mouth (Figs. 10 and 11; oral cavity) while maintaining the introducer rod (Figs. 10 and 11; bronchofiberscope 200; Paragraph 0088, Lines 1-4) in place relative to patient's trachea (Figs. 10 and 11; trachea; Paragraph 0088, Lines 1-4).
Uesugi does not disclose an esophageal tube that is curved; an intubation tube positioned exterior to the esophageal tube; a balloon circumferentially surrounding a distal portion of the esophageal tube, the balloon configured to expand radially outward from the esophageal tube when inflated; and a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube, the cover extending along an axial length of the esophageal tube; a camera tube positioned exterior to the esophageal tube and the intubation tube; and visualizing vocal cords of the patient with an endoscopic camera inserted through the camera tube; inflating the balloon to occlude the esophageal opening of the patient without occluding the distal opening of the esophageal tube to thereby facilitate suctioning of stomach contents via the esophageal tube; and deflating the balloon; and a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube, the cover extending along an axial length of the esophageal tube
Molnar discloses a supraglottic airway device with
an esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus (cuff 22 is in upper esophagus which is surrounds bottom of tube 620); Col. 36, Lines 11-20) that is curved (Fig. 39; tube 620 is curved);
the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9) positioned exterior (Fig. 39; tube 618 extends outside of and along the front of tube 620) to the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus; Col. 36, Lines 11-20);
a balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) circumferentially surrounding a distal portion of the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus; cuff extends around the circumference of a distal part of tube 620; Col. 36, Lines 11-20),
the balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) configured to expand radially outward (Fig. 39; cuff 622 is an inflatable cuff, it is necessary that when it inflates it expands radially outward) from the esophageal tube when inflated (Fig. 39; cuff 622; Col. 36, Lines 14-20; cuff 622 is inflated in the upper esophagus);
a camera tube (Fig. 39; camera tube 12; Col. 35, Lines 31-37) positioned exterior to the esophageal tube (Fig. 39; second tube 620; Col. 36, Lines 11-20) and the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9; camera tube is exterior to the tubes 618, 620 as seen in Fig. 39); and
visualizing the vocal cords of the patient (Fig. 39; “direct visualization proximally to the vocal cords”; Col. 36, Lines 20-23) with an endoscopic camera (Fig. 39; camera 18; Col. 36, Lines 20-23) inserted through the camera tube (Fig. 39; camera tube 12; Col. 35, Lines 31-37);
inflating the balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) to occlude the esophageal opening of the patient (Fig. 39; cuff inflates in the upper esophagus; Col. 36, Lines 14-20; therefore, it is capable of occluding the esophageal opening) without occluding the distal opening of the esophageal tube (Fig. 39; cuff 622 is above the bottom opening; therefore, the cuff is not occluding the opening of tube 620) to thereby facilitate suctioning of stomach contents via the esophageal tube (Fig. 39; “the tube 620 can be designed such that it is used for suction”; Col. 36, Lines 30-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal intubation assist instrument of Uesugi with the supraglottic airway device Molnar to have a camera tube, camera, additional tube for the esophagus and cuff 622 to further prevent the bougie from going into the esophagus by continually visualizing the vocal cords and supraglottic structures and blocking the esophagus with the cuff (Molnar: Col. 4, Lines 54-64; Col. 36, Lines 12-25). Further, it would have been obvious to have the endotracheal intubation assist instrument of Uesugi be adjacent to the camera and proximal to the balloon as taught by the bougie and tube of Molnar in order to visualize where the bougie is going.
Molnar does not disclose the intubation instrument deflating the balloon and a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube, the cover extending along an axial length of the esophageal tube.
Christopher discloses a laryngeal mask airway
deflating (Figs. 14 and 19; Paragraph 0097, Lines 1-4 and Lines 8-11) the balloon (Figs. 14 and 19; laryngeal mask 30; Paragraph 0097, Lines 1-4 and Lines 8-11);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuff of the modified endotracheal intubation assist instrument of Uesugi to be able to deflate as taught by the laryngeal mask of Christopher to allow for easier removal and to reduce risk of trauma to the airway.
Heinen discloses an intratracheal tube
a cover that contacts and surrounds the tubes, the cover extending along an axial length of the tubes (figs. 2-3; “sheath 26 can be utilized to substantially encapsulate all or part of lumens 12, 18 and 20”; col. 3, lines 27-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guide tube, camera tube, and esophageal tube of the modified method of Uesugi with the sheath of Heinen to create a rounded surface area for the purpose of minimizing the irritation of the glottis and trachea (Heinen: col. 3, lines 27-29, claim 5).
It directly follows that the resultant tubing of the modified method of Uesugi combined with the sheath of Heinen would meet the claimed structural limitations since:
the esophageal tube (Molnar: Fig. 39; second tube 620 is placed in upper esophagus (cuff 22 is in upper esophagus which is surrounds bottom of tube 620); Col. 36, Lines 11-20), the intubation tube (Uesugi: Figs. 2 and 6; guide tube 10; Paragraph 0079, Lines 1-5), and the camera tube (Molnar: Fig. 39; camera tube 12; Col. 35, Lines 31-37:), the cover extending along an axial length of the esophageal tube (Heinen: figs. 2-3; “sheath 26 can be utilized to substantially encapsulate all or part of lumens 12, 18 and 20”; col. 3, lines 27-29).
Claims 23 and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646) and Shikani (US 5762638).
Regarding claim 23, Uesugi discloses
A method of performing a procedure on a patient (Figs. 4-15; endotracheal intubation method; Paragraph 0010, Lines 1-11), the method comprising:
inserting an intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) through the mouth of the patient (Figs. 4-15; oral cavity; Paragraph 0065, Lines 1-6),
the intubation instrument (Figs. 1 and 2; endotracheal intubation assist instrument 100; Paragraph 0064, Lines 1-7) including:
inserting an introducer rod (Figs. 2 and 6; bronchofiberscope 200; Paragraph 0079, Lines 1-5) into the intubation tube (Figs. 2 and 6; guide tube 10; Paragraph 0079, Lines 1-5);
advancing the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) through the intubation tube (Figs. 6-9; guide tube 10; Lines 1-3; guide tube makes up the tube part of the intubation instrument) until a distal end of the introducer rod (Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3) passes through the patient's vocal cords (bronchofiberscope has to pass the patient’s vocal cords in order to reach the trachea) into the patient's trachea (Figs. 6-9; trachea; Paragraph 0086, Lines 1-3); and
withdrawing the intubation instrument (Figs. 10 and 11; endotracheal intubation assist instrument 100; Paragraph 0087, Lines 1-3 and Paragraph 0088, Lines 1-4) from the patient's mouth (Figs. 10 and 11; oral cavity) while maintaining the introducer rod (Figs. 10 and 11; bronchofiberscope 200; Paragraph 0088, Lines 1-4) in place relative to patient's trachea (Figs. 10 and 11; trachea; Paragraph 0088, Lines 1-4).
Uesugi does not disclose an esophageal tube that is curved; an intubation tube positioned exterior to the esophageal tube; a balloon circumferentially surrounding a distal portion of the esophageal tube, the balloon configured to expand radially outward from the esophageal tube when inflated; and a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube, the cover extending along an axial length of the esophageal tube; a camera tube positioned exterior to the esophageal tube and the intubation tube; and visualizing vocal cords of the patient with an endoscopic camera inserted through the camera tube; inflating the balloon to occlude the esophageal opening of the patient without occluding the distal opening of the esophageal tube to thereby facilitate suctioning of stomach contents via the esophageal tube; and deflating the balloon; and a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube, the cover extending along an axial length of the esophageal tube
Molnar discloses a supraglottic airway device with
an esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus (cuff 22 is in upper esophagus which is surrounds bottom of tube 620); Col. 36, Lines 11-20) that is curved (Fig. 39; tube 620 is curved);
an intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9) positioned exterior (Fig. 39; tube 618 extends outside of and along the front of tube 620) to the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus; Col. 36, Lines 11-20);
a balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) circumferentially surrounding a distal portion of the esophageal tube (Fig. 39; second tube 620 is placed in upper esophagus; cuff extends around the circumference of a distal part of tube 620; Col. 36, Lines 11-20),
the balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) configured to expand radially outward (Fig. 39; cuff 622 is an inflatable cuff, it is necessary that when it inflates it expands radially outward) from the esophageal tube when inflated (Fig. 39; cuff 622; Col. 36, Lines 14-20; cuff 622 is inflated in the upper esophagus);
a camera tube (Fig. 39; camera tube 12; Col. 35, Lines 31-37) positioned exterior to the esophageal tube (Fig. 39; second tube 620; Col. 36, Lines 11-20) and the intubation tube (Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9; camera tube is exterior to the tubes 618, 620 as seen in Fig. 39); and
visualizing the vocal cords of the patient (Fig. 39; “direct visualization proximally to the vocal cords”; Col. 36, Lines 20-23) with an endoscopic camera (Fig. 39; camera 18; Col. 36, Lines 20-23) inserted through the camera tube (Fig. 39; camera tube 12; Col. 35, Lines 31-37);
inflating the balloon (Fig. 39; cuff 622; Col. 36, Lines 14-20) to occlude the esophageal opening of the patient (Fig. 39; cuff inflates in the upper esophagus; Col. 36, Lines 14-20; therefore, it is capable of occluding the esophageal opening) without occluding the distal opening of the esophageal tube (Fig. 39; cuff 622 is above the bottom opening; therefore, the cuff is not occluding the opening of tube 620) to thereby facilitate suctioning of stomach contents via the esophageal tube (Fig. 39; “the tube 620 can be designed such that it is used for suction”; Col. 36, Lines 30-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal intubation assist instrument of Uesugi with the supraglottic airway device Molnar to have a camera tube, camera, additional tube for the esophagus and cuff 622 to further prevent the bougie from going into the esophagus by continually visualizing the vocal cords and supraglottic structures and blocking the esophagus with the cuff (Molnar: Col. 4, Lines 54-64; Col. 36, Lines 12-25). Further, it would have been obvious to have the endotracheal intubation assist instrument of Uesugi be adjacent to the camera and proximal to the balloon as taught by the bougie and tube of Molnar in order to visualize where the bougie is going.
Molnar does not disclose the intubation instrument deflating the balloon and a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube, the cover extending along an axial length of the esophageal tube.
Christopher discloses a laryngeal mask airway
deflating (Figs. 14 and 19; Paragraph 0097, Lines 1-4 and Lines 8-11) the balloon (Figs. 14 and 19; laryngeal mask 30; Paragraph 0097, Lines 1-4 and Lines 8-11);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cuff of the modified endotracheal intubation assist instrument of Uesugi to be able to deflate as taught by the laryngeal mask of Christopher to allow for easier removal and to reduce risk of trauma to the airway.
Shikani discloses an endotracheal tube system with
a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube (figs. 8-9d; tracheostomy device and other similar device that are inserted into a body orifice (endotracheal tube, gastric tube, airway tube, etc.) are covered with anti-inflammatory and/or anti-infective coating; col. 12, lines 33-43), the cover extending along an axial length of the esophageal tube (see fig. 8; coating 11 extends length of tube; coating is applied by dipping the tube into the coating solution; col. 8, lines 18-22 and col. 11, lines 44-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each of the guide tube, camera tube, and esophageal tube of the modified method of Uesugi with the coatings as disclosed in Shikani to reduce, control, and prevent inflammation, infection, and granulation that occur with prolonged intubation (Shikani: col. 4, lines 38-42).
Regarding claim 25, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method) of claim 23,
wherein the balloon (Molnar: Fig. 39; cuff 622; Col. 36, Lines 14-20) does not extend distally beyond a distal end of the esophageal tube (Molnar: Fig. 39; second tube 620 is placed in upper esophagus; Col. 36, Lines 11-20; cuff is proximal to the distal opening of the esophageal tube; therefore, does not extend distally beyond a distal end of the esophageal tube).
Regarding claim 26, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method) of claim 23,
wherein the balloon (Molnar: Fig. 39; cuff 622; Col. 36, Lines 14-20), when inflated (Molnar: Fig. 39; cuff 622 is inflated; Col. 36, Lines 14-20), prevents the distal end of the introducer rod (Uesugi: Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3; Molnar: Fig. 39; bougie 608 is proximal to cuff 622) from passing into the esophagus (Molnar: Fig. 39; inflated cuff 622 in esophagus acts as an esophageal blocker/blocks the esophagus; Col. 4, Lines 59-64 and Col. 36, Lines 14-20) during the advancing of the introducer rod (Uesugi: Figs. 6-9; bronchofiberscope 200; Paragraph 0086, Lines 1-3).
Regarding claim 27, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method) of claim 23, further comprising:
while the balloon is inflated (Molnar: Fig. 39; cuff 622; Col. 36, Lines 14-20), suctioning stomach contents from a stomach of the patient via the esophageal tube (Fig. 39; “the tube 620 can be designed such that it is used for suction”).
While Molnar is silent to suctioning while the balloon is inflated, “the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process (MPEP 2112.02 section I). The tube 620 (that can perform suctioning) with cuff 622 is the same as esophageal tube 110 with balloon 116) as such it would be obvious that the tube would be able to perform the claimed process of suctioning stomach contents while the cuff/balloon is inflated.
Regarding claim 28, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method) of claim 23,
wherein the camera tube (Molnar: Fig. 39; camera tube 12; Col. 35, Lines 31-37) extends along an exterior of the intubation tube (Molnar: Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9; camera tube is exterior to the tube 618 as seen in Fig. 39) and is coupled (Molnar: Fig. 39; camera holder tube 12 has holder 606 which holds and is adjacent to the endotracheal tube 618) with the exterior of the intubation tube (Molnar: Figs. 38-39; endotracheal tube 618; Col. 36, Lines 4-9) to thereby facilitate viewing of the distal end of the introducer rod (Molnar: Fig. 39; distal end bougie 608; Col. 35, Lines 18-24 and Col. 36, Lines 20-25; bougie 608 placed in vocal cords is distal to the camera 18 which visualized the vocal cords) via the camera (Molnar: Fig. 39; camera 18; Col. 35, Lines 18-24 and Col. 36, Lines 20-23).
Regarding claim 29, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Shikani: anti-inflammatory and anti-infective coating) of claim 23,
wherein the cover is provided as a coating (Shikani: figs. 8-9d; tracheostomy device and other similar device that are inserted into a body orifice (endotracheal tube, gastric tube, airway tube, etc.) are covered with anti-inflammatory and/or anti-microbial coating; col. 12, lines 33-43).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646), Shikani (US 5762638), Schwartz (US 20200171256), and the second embodiment of Molnar (US 11147442)
Regarding claim 24, the modified method of Uesugi discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Shikani: anti-inflammatory and anti-infective coating) of claim 23,
Uesugi does not disclose wherein the intubation instrument further comprises a pair of airway tubes extending alongside the intubation tube; and wherein the method further comprises introducing oxygen via a first of the airway tubes and suctioning air via a second of the airway tubes.
Schwartz discloses an intubation system with an insertion device
a pair of airway tubes (Fig. 1; tubes 103, 105; Paragraph 0055, Lines 4-17)
wherein the method further comprises introducing oxygen (Fig. 1; gas source 112; Paragraph 0055, Lines 9-17) via a first of the airway tubes (Fig. 1; outer tube 105; Paragraph 0055, Lines 9-17) and suctioning air (Fig. 1; suction source 114; Paragraph 005, Lines 4-9) via a second of the airway tubes (Fig. 1; inner suction tube 103; Paragraph 0055, Lines 4-9; fluid or gas can be vacated).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the endotracheal intubation assist tube of Uesugi with the intubation system of Schwartz to have an inner suction tube for evacuating fluids accumulated in the patient’s body while simultaneously supplying gas to the patient through the outer tube (Schwartz: Paragraph 0055, Lines 4-17 and 20-23).
Schwartz does not disclose wherein the intubation instrument further comprises the pair of airway tubes extending alongside the intubation tube.
Molnar discloses a second embodiment with a ventilator adaptable cap (Col. 13, Lines 54-67 and Col.14, Lines 1-24) that can be used with a supraglottic device
wherein the intubation instrument further comprises the pair of airway tubes (additional tubes (can be a suction tube); Col. 14, Lines 10-19) extending alongside (Col. 14, Lines 10-19; additional tubes placed through sleeve 76 which has bougie tube 80 and camera tube 12) the intubation tube (Fig. 5C; bougie tube 80; Col. 13, Lines 54-67 and Col.14, Lines 1-24).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner suction tube and outer tube of the modified method of Uesugi to be positioned like the bougie tube and additional tubes as taught by the second embodiment of Molnar as it is a recognized alternative in the art. Additionally, since such a modification would simply involve merely moving the airway tubes to be adjacent to the intubation tube without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Response to Arguments
Applicant’s arguments, see pages 3-4 of the remarks, filed 01/20/2026, with respect to the rejection(s) of claim(s) claim 12 and dependent claims 13-16, 21, 22, and 30-34 under 103 have been fully considered and are persuasive. As the prior art of final rejection filed on 09/25/2025 does not disclose “a pair of airway tubes running along opposite sides of the intubation tube” Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Parker (US 5038766).
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive.
On page 4-5 of the remarks, Applicant argues that independent claim 17 and dependent claim 15, do not disclose the feature of the intubation instrument only having “a single balloon” that is “the only balloon of the intubation instrument” as Molnar is equipped with a cuff 622 and can slide distally through cuff lumen 616 with cuff 602. However, the examiner disagrees as the cuff 602 that is being referred to is not being relied upon. The endotracheal intubation assist instrument of Uesugi is modified with the supraglottic airway device Molnar to have a camera tube, camera, additional tube for the esophagus and cuff 622 to further prevent the bougie from going into the esophagus by continually visualizing the vocal cords and supraglottic structures and blocking the esophagus with the cuff (Molnar: Col. 4, Lines 54-64; Col. 36, Lines 12-25). As such, the modified endotracheal intubation assist instrument/guide tube of Uesugi only includes a single ballon, being the cuff 622. Therefore, this argument is deemed unpersuasive.
On page 5 of the remarks, Applicant argues that Molnar in view of the new amendment of claim 23, “a cover that contacts and surrounds the esophageal tube, the intubation tube, and the camera tube, the cover extending along an axial length of the esophageal tube”, would be incapable of being modified to perform this limitation as Molnar states that each of the tubes can move independently from each other. Therefore, providing a cover that would inhibit the relative motion of the tubes, preventing the tubes to move as designed to facilitate. However, the examiner disagrees as a cover that contacts and surrounds the tube does not inherently mean that the cover is restricting movement of the tubes. For example, a cover that is looser/doesn’t tightly hold the tubes would still contact and surround the tube without restricting the tubes from moving independently from each other. Additionally, a cover that contacts and surrounds the tubes, can also be interpreted as each tube individually being covered; therefore, contacting and surrounding the tubes. A new ground(s) of rejections for claim 23 has been made in view of Heinen (US 5372131) and Shikani (US 5762638).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dryden (US 4256099) – A resuscitation system using one tube to provide suctioning and a second tube to provide ventilation
Agdanowski (US 4488548) – A tracheal system using a catheter with one lumen to provide jet ventilation and another lumen to provide suctioning
Marten (US 20090062927) – A protective coating for inner and outer surface of tracheal tubes to control mucus and granulation accumulation both internally and externally. In addition, such coating serves to ease in the insertion and removal of suction tubes.
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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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785