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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/28/2026 has been entered.
Status of Claims
This Office Action is in response to the remarks and amendments filed on July 28th, 2026]. Claims 1-11 and 18-20 have been canceled and claim 35 has been added as such claims 12-17 and 21-35 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The objections to the claims are withdrawn in light of the amendments.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 12-16, 21, 22, and 30-34 are objected to because of the following informalities:
Claim 12, line 19, “such that the such that the” should read “such that the”
Claims 13-16, 21, 22, and 30-34 are objected due to being dependent off of claim 12.
Appropriate correction is required.
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, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Uesugi (US 20100224186) in view of Molnar (US 20160262603) and further in view of and Dryden (US 4256099).
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);
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).
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.
Dryden discloses an intubation system with
an esophageal tube that is curved (fig. 1; tube 11 which is flexible and resilient, preferably with a slight curve simulating the general curvature of the oral cavity and passageway to the esophagus; col. 2, lines 16-19)
a single balloon, the single balloon extending around a circumference of the esophageal tube (figs. 1-2, and 7; an external cuff 31 is provided around tube 11 which is provided in the esophagus; col. 2, lines 49-55), wherein the single balloon is the only balloon of the intubation instrument (see figs. 1-3; esophageal tube 11 is only provided with cuff 31; col. 2, lines 49-55);
inflating the single balloon to occlude the esophageal opening of the patient (fig. 1; when the tube 11 has properly entered the esophagus, the balloon 31 is inflated by pushing inward the plunger of the syringe 36, thus sealing tube 11 to the esophagus wall; col. 3, lines 36-39);
suctioning contents from the stomach of the patient through the esophageal tube (figs. 1-3; the lumen of the tube 11 in the esophagus can be used for evacuation from or introduction of material to the stomach; col. 3, lines 25-35) subsequent to inflating the balloon
deflating the single balloon (fig. 2 and 7; plunger 37 therein and which is operable to inflate or deflate the cuff. FIG. 1 shows the cuff inflated using inflation tube 34, whereas FIG. 2 shows it substantially deflated; col. 2, lines 49-55).
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 esophageal tube, external cuff, inflation tube, plunger, and syringe of Dryden to seal the tube to the esophagus wall, prevent interference with respiration/loss of air, and be able to evacuate/introduce material from/to the stomach (Dryden: col. 1, lines 10-37, col. col. 3, lines 33-39). Additionally, while Dryden 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 11 (that can perform suctioning) with cuff 31 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.
The modified method of Uesugi does not disclose
Molnar discloses a visualization device for an analogous intubation system comprising
the intubation tube extending (figs. 41a-41c; bougie 670 can be inserted in the tool tube 652 through the proximal opening 653; [0212]) along at least a portion of the esophageal tube (see fig. 41b; the visualization device 650 is attached to a tube using rings 654; [0212]-[0213]) and having a distal opening and a proximal tube opening (figs. 41a-41c; a tool tube 652 with a lumen with proximal and distal openings, 653 and 655; [0212]),
an endoscopic camera tube (fig. 1a and 41a-41c; visualization device 650 comprises the visualization device 10 of FIG. 1A which comprises the camera tube 12 and the camera 18 placed inside of the camera tube 12; [0212]-[0213]) extending adjacent the intubation tube (see figs. 41a-41c; the tool tube 652 can be sealed, welded or otherwise attached to the camera tube 12; [0212]-[0213]; the tool tube and camera tube extend adjacent to one another), and
the balloon and is positioned distal of the distal opening of the intubation tube (see fig. 41b; the distal opening of tool tube 652 is positioned proximal to the cuff of the tube);
visualizing the vocal cords of the patient (visualization device can be used to allow continuous visualization of supraglottic structures, airway, internal organ anatomy, and vocal cords during normal and abnormal ventilation; [0088]) with an endoscopic camera (figs. 41a-41c; camera 18; [0023] and [0212]-[0213]);
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 esophageal tube of the endotracheal intubation assist instrument of the modified Uesugi with the visualization device of Molnar to further prevent the bougie from going into the esophagus by continually visualizing the vocal cords and supraglottic structures (Molnar: [0023] and [0088]). 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.
Claim 23-28 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 Meah (US 20230058772).
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.
Meah discloses an endoscope device for visual inspection of an internal organ of a subject with
a cover that contacts and surrounds the tubes (figs. 1a-1d; a disposable sheath 100 that surrounds endoscope 110 and ports 112 for medical instruments (such as cannulas); [0031]-[0032]), the cover extending along an axial length of the tubes (see figs. 1a-1d; sheath 100 includes elongated conduit 102 which extends along the endoscope from distal end 110a to proximal end 110b; [0031]); wherein the cover comprises a unitary body (see figs. 1a-1d; sheath 100 includes elongated conduit 102 and shield body member 104; [0032]) that surrounds and conforms (figs. 1a-1d; the opening formed by the sheath 100 when operated in the closed position 122 encases and conforms to the endoscope 110; [0035]-[0037]).
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 disposable sheath of Meah such that the guide tube and camera tube are inserted through the ports with the sheath conforming and encasing the guide tube, camera tube, and esophageal tube to protect the tubes from tissue fluids, thus preventing the spread of infection, contamination, and bleeding caused by direct contact with the tissues of internal organs and be able to dispose and use the tubes from one patient to another (Meah: [0002]-[0004] and [0053])
It directly follows that the resultant tubing of the modified method of Uesugi combined with the disposable sheath of Meah would meet the claimed structural limitations since:
wherein the cover comprises a unitary body (Meah: figs. 1a-1d; the opening formed by the sheath 100 when operated in the closed position 122 encases and conforms to the endoscope 110; [0035]-[0037]) that surrounds (Meah: figs. 1a-1d; the opening formed by the sheath 100 when operated in the closed position 122 encases and conforms to the endoscope 110; [0035]-[0037]) the esophageal tube, the intubation tube, and the camera tube collectively (Uesugi: Figs. 6-9; guide tube 10; Lines 1-3; Molnar: Fig. 39; camera tube 12; Col. 35, Lines 31-37 and Fig. 39; second tube 620; Col. 36, Lines 11-20; Meah: sheath collectively encases the endoscope and medical instruments through the ports 112) and wherein the unitary body conforms (Meah: figs. 1a-1d; the opening formed by the sheath 100 when operated in the closed position 122 encases and conforms to the endoscope 110; [0035]-[0037]) to the esophageal tube, the intubation tube, and the camera tube collectively and individually (Uesugi: Figs. 6-9; guide tube 10; Lines 1-3; Molnar: Fig. 39; camera tube 12; Col. 35, Lines 31-37 and Fig. 39; second tube 620; Col. 36, Lines 11-20; Meah: sheath 100 conforms around the endoscope and to the medical instruments through the ports 112).
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).
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), Meah (US 20230058772), 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; Meah: conforming disposable sheath) 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).
Claim 29 and 35 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), Meah (US 20230058772), and Zocca (US 20170188799).
Regarding claim 29, the modified method of Uesugi discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Meah: conforming disposable sheath) of claim 23,
The modified method of Uesugi does not explicitly disclose wherein the cover is provided as a coating.
Zocca discloses a disposable catheter for tracheal suction and ventilation where
wherein the cover is provided as a coating (fig. 1-6; the tubular group 2 can comprise a removable sheath or outer coating 11; [0044]).
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 disposable sheath of the modified method of Uesugi to be provided as a removable outer coating as disclosed in Zocca to yield the predictable result of be able to carry out mean insertions and removals while keeping the tubular body protected and thus keeping it not contaminated by external agents during the insertion into or removal from the patient (Zocca: [0044]-[0045]).
Regarding claim 35, the modified method of Uesugi further discloses
the method (Uesugi: endotracheal intubation method; Molnar: supraglottic tubal body, camera, camera tube, balloon; Meah: conforming disposable sheath) of claim 29,
wherein the esophageal tube, the intubation tube, and the camera tube are physically coupled (Uesugi: Figs. 6-9; guide tube 10; Lines 1-3; Molnar: Fig. 39; camera tube 12; Col. 35, Lines 31-37 and Fig. 39; second tube 620 (esophageal tube); Col. 36, Lines 11-20; as modified the esophageal tube is encased with the guide tube and camera tube coupled through the ports as disclosed in Meah) to one another through the coating (Meah: figs. 1a-1d; the opening formed by the sheath 100 when operated in the closed position 122 encases and conforms to the endoscope 110; [0035]-[0037]; Zocca: fig. 1-6; the tubular group 2 can comprise a removable sheath or outer coating 11; [0044]).
Response to Arguments
Applicant’s arguments, see pages 3-7 of the remarks, filed 07/28/2026, with respect to the amended subject matter of claim 12 and subsequently its dependents have been fully considered and are persuasive. The 103 rejection of claim 12 has been withdrawn.
Applicant's arguments filed 07/28/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments with respect to claim 23 and dependent claims 24-29 and 35 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 12-16, 21, 22, and 30-34 are allowable except for the formal requirement described above (see claim objections).
The following is an examiner’s statement of reasons for allowance:
Regarding the subject matter of independent claim 12 the closest identified prior art of record are as follows:
Regarding claim 12, the closest prior art record is Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646) and Lenhardt (US 20190099572).
In particular 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).
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.
Uesugi does not disclose (ii) an 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, (iii) an endoscopic camera tube extending adjacent the intubation tube, (iv) 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, wherein distal openings of the first airway tube and the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube such that the such that the suctioning through the first airway tube and the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera; 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; 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) 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.
The modified method of Uesugi does not disclose (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; 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, wherein distal openings of the first airway tube and the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube such that the such that the suctioning through the first airway tube and the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera; and 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).
The modified method of Uesugi does not disclose (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; 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, and wherein distal openings of the first airway tube and the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube such that the such that the suctioning through the first airway tube and the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera.
Lenhardt discloses an airway device to assist insertion of a bronchoscope, an endotracheal tube, or other medical devices [0025] includes
(v) a pair of airway tubes (figs. 1-8; tube ports 103 and 104 can be disposed on the outer side of the tube wall of the main body and used for multiple purposes, including suction and oxygen delivery, respectively, as well as other purposes; [0027]) running along opposite sides of the intubation tube (see figs. 2 and 6-8; tube ports 103 and 104 run along opposite sides of airway device 100),
the pair of airway tubes including a first airway tube and a second airway tube (figs. 1-8; tube ports 103 and 104 can be disposed on the outer side of the tube wall of the main body and used for multiple purposes, including suction and oxygen delivery, respectively, as well as other purposes; [0027], see figs. 5-8 additional suction and oxygen ports);
suctioning contents of the patient through the first airway tube (see figs. 2 and 6-8; suction tube port 103 to enable removal of upper airway secretions; [0008] and [0027]);
while suctioning the contents through the first airway tube, providing positive airflow in the distal direction through the second airway tube (see figs. 2 and 6-8; oxygen tube port 104 to optimize delivery of oxygen to lungs; [0008] and [0027]), and
wherein distal openings of the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube (see figs 5-8; distal end of oxygen tube is positioned adjacent to camera tube 109; [0037]) such that the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera (see figs. 5-8; the oxygen tube port provide delivery of oxygen [0008] and [0027], the positioning of the oxygen tube being adjacent to the camera tube 109 would be capable of providing an unobstructed field of view for the endoscopic camera).
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 assist intubation assist instrument of modified Uesugi with the suction tube port and oxygen tube port as disclosed in Lenhardt such that removal of upper airway secretions and optimize delivery of oxygen to lungs may be provided (Lenhardt: [0008] and [0027]).
However, Uesugi, Molnar, Christopher, and Lenhardt fail to teach, disclose, or render obvious
“(the pair of airway tubes positioned adjacent the intubation tube, wherein distal openings of the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube such that the such that the suctioning through the first airway tube and the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera)” in addition to other limitations.
Claims 13-16, 21, 22, and 30-34 are also allowable (except for the formal requirement) due to being dependent off of claim 12.
Regarding claim 12, the closest prior art record is Uesugi (US 20100224186) in view of Molnar (US 11147442) and further in view of Christopher (US 20010032646) and Meah (US 20230058772).
In particular 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).
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.
Uesugi does not disclose (ii) an 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, (iii) an endoscopic camera tube extending adjacent the intubation tube, (iv) 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, wherein distal openings of the first airway tube and the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube such that the such that the suctioning through the first airway tube and the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera; 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; 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) 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.
The modified method of Uesugi does not disclose (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; 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, wherein distal openings of the first airway tube and the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube such that the such that the suctioning through the first airway tube and the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera; and 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).
The modified method of Uesugi does not disclose (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; 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, and wherein distal openings of the first airway tube and the second airway tube are positioned adjacent a distal opening of the endoscopic camera tube such that the such that the suctioning through the first airway tube and the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera.
Meah discloses a disposable sheath for an endoscope
(v) a pair of airway channel ports (figs. 1a-1d; hollow ports 108 include first hollow ports 112a and 112b running along the length of the conduit 102; [0032] and [0039]) positioned adjacent the port and running along opposite sides of the port (figs. 1a-1d; hollow ports 112a are positioned adjacent to hollow port 112b for medical instruments and run along opposite sides of hollow port 112b; [0032]),
the pair of airway tubes including a first airway port and a second airway port (figs. 1a-1d; hollow ports 112a is configured to allow passage for fluids; [0032]);
suctioning contents of the patient through the first airway tube (see figs. 1a-1d; hollow port 112b can alternatively be a vacuum channel for allowing the vacuum therethrough for enhancing visualization of the internal organ while maneuvering the endoscope device 110; [0032] and [0053]);
while suctioning the contents through the first airway tube, providing positive airflow in the distal direction through the second airway tube (see figs. 1a-1d; hollow ports 112a is configured to allow passage for fluids out a distal end 110a; [0032]), and
wherein distal openings of the first airway port and second airway port are positioned adjacent a distal opening of the endoscopic camera tube (see figs. 1a-1d; first hollow ports 112a and second hollow port 112b are positioned adjacent to the distal end of the endoscope 110; [0032]) such that the providing of positive airflow through the second airway tube provide an unobstructed field of view for the endoscopic camera (such that the hollow ports 112a, 112b may provide fluid (air) and vacuum into the internal organ during the endoscopy for enhancing visualization of the internal organ using the endoscope 110; [0032 and [0053]).
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 assist intubation assist instrument of modified Uesugi with the sheath and ports as disclosed in Meah to provide fluid (air) and vacuum into the internal organ during the endoscopy for enhancing visualization of the internal organ (Meah: [0032] and [0053]).
However, while Meah does disclose multiple ports [0032], it does not disclose the ports being tubes and more specifically the second hollow port which is used for a medical instrument is alternatively used for suctioning. Therefore, if the second hollow port is exchanged for a suction port, the pair of airway ports are no longer positioned adjacent to the medical instrument port, but are position instead on opposite sides of the suctioning port.
As such, Uesugi, Molnar, Christopher, and Lenhardt fail to teach, disclose, or render obvious
“a pair of airway tubes positioned adjacent the intubation tube and running along opposite sides of the intubation tube” in addition to other limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Parker (US 5038766) –discloses an esophageal guiding and aiming device using a suction catheter and a ventilating through a pilot tube
Don Michael (US 533980) – discloses an esophageal intubation device with an embodiment only using a single balloon to occlude the esophagus with an opening that can allow for suctioning
Sniadach (US 20030062039) – discloses an intubation method of occluding the esophagus using an esophageal obturator/tube with a single balloon 14 around the tube, inserting an intubation instrument, inserting an endotracheal tube, and removing both the esophageal tube and intubation instrument
Trusty (US 20090054728) – discloses a guide system for accommodating and supporting endoscopic tools with working channels to apply suction, pressurized air, etc. which are positioned adjacent to a camera; however, it does not disclose a pair of airway tubes positioned adjacent to an intubation tube and running along opposite sides of the intubation tube
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/S.R.R./Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785
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