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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to National Stage App. PCT/US2022/078304 filed October 18, 2022; to Non-Provisional App. No. 17/511,155 filed October 26, 2021; and to Non-Provisional App. No. 16/045,396, now Pat. No. 11,224,337, filed July 25, 2018 as a CIP.
Status of Claims
Claims 1-21, filed December 9, 2022, are presently pending in this application.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. See Fig. 4. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 5, 10, 11, and 16 are objected to because of the following informalities:
Claims 5 and 16 are missing a period at the end.
Claim 10 recites “procedure.”, ln 19 should read --procedure;--;
Claims 10 and 11 recite “anaesthesia” should read –anesthesia-- .
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.
Claim(s) 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Matus (U.S. Pub. No. 2020/0029800) in view of Slavei et a. (WO 2011/033331 A2; hereinafter: “Slavei”).
Regarding Claim 1, Matus an oropharyngeal glove "OPG" configured for use with a bronchoscope that is passed through the OPG into a patient's trachea during a bronchoscopy procedure (Fig. 4, 5; ¶ 0025), the OPG comprising: a main tube (30; Fig. 5) having a proximal end (33; Fig. 5), a distal end (at 48; Fig. 5) and a hollow inner lumen that extends from the proximal end to the distal end (¶ 0029; Figs. 5; Examiner notes: Matus discloses a first opening 32 formed in proximal end 33 and opening 48 formed in a distal end of the oropharyngeal glove, 30), the inner lumen being sized to allow a bronchoscope tube (31; Fig. 5) to be passed therethrough (¶ 0029), the proximal end and the distal end having first (32; Fig. 5) and second openings (48; Fig. 5), respectively, through which the bronchoscope tube can pass (¶ 0029; Figs. 5 & 7; Examiner notes: Matus discloses tubular portion, 31, of a rigid bronchoscope inserted through a first opening 32 formed in a proximal end 33 thereof through the second opening 48, formed in the distal end thereof into the patient's trachea as shown in Fig. 7 block 54); a flexible body (37, 39; ¶¶ 0026-0027; Examiner notes: Matus discloses membranes 37, 39 which conform to the inner surfaces of the mouth and throat, thus being flexible) secured about the main tube, the flexible body (37, 39; ¶¶ 0026-0027; Fig. 5) comprising at least a first insufflatable bladder (38; Fig. 5; ¶¶ 0026-0027) configured to be insufflated to a state in which outer surfaces of said at least a first bladder form a seal with a patient's mouth and throat when the OPG is in an installed state in a patient's mouth and throat (Fig. 5; ¶¶ 0026-0029; Examiner notes: Matus discloses membrane portions 37 and 39 forms an airtight or nearly airtight seal of the patient's mouth and throat).
Matus does not specifically disclose the OPG comprising a tubular extension having a proximal end, a distal end, and a hollow inner bore that extends from the proximal end of the tubular extension to the distal end of the tubular extension, the distal end of the tubular extension interfacing with the proximal end of the main tube, the hollow inner bore having an inner diameter that is sufficiently large to allow the tube of the bronchoscope to pass through the hollow inner bore and into the first opening of the main tube during a bronchoscopy procedure.
Slavei teaches a tubular extension having a proximal end, a distal end (1; Fig. 3; Examiner notes: Slavei discloses the central working tube, 1 has proximal and distal ends, as shown in Fig. 3.), and a hollow inner bore that extends from the proximal end of the tubular extension to the distal end of the tubular extension (page 6 lines 29-32, page 7 line 28 to page 8 line 13; Fig. 3; Examiner notes: Slavei discloses the central working tube, 1 has a diameter wide enough to enable easy insertion of the devices used during the bronchoscopy.), the distal end of the tubular extension interfacing with the proximal end of a main tube (9; Fig. 3; page 7 line 28-page 8 line 13; Examiner notes: Slavei discloses the distal end of working tube, 1 interfaces with the proximal end of ventilation tube, 9.), the hollow inner bore having an inner diameter that is sufficiently large to allow the tube of the bronchoscope (18; Fig. 3) to pass through the hollow inner bore and into the first opening of the main tube during a bronchoscopy procedure (page 7 line 28-page 8 line 13, Fig. 3; Examiner notes: Slavei discloses the bronchoscope 18 is inserted into working tube, 1 and advanced through the ventilation tube 1.) for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (page 8, lines 24-29).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify OPG of Matus to include the a tubular extension having a proximal end, a distal end, and a hollow inner bore that extends from the proximal end of the tubular extension to the distal end of the tubular extension, the distal end of the tubular extension interfacing with the proximal end of the main tube, the hollow inner bore having an inner diameter that is sufficiently large to allow the tube of the bronchoscope to pass through the hollow inner bore and into the first opening of the main tube during a bronchoscopy procedure as taught in Slavei, for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (See Slavei: page 8, lines 24-29).
Regarding Claim 2, the modified device of Matus discloses the OPG, shown above.
The modified device of Matus does not specifically to disclose wherein the tubular extension is configured to couple with a ventilator machine via one or more tubes of a breathing circuit and to act as an airway device to deliver air produced by the ventilator machine to the patient after completion of the bronchoscopy procedure.
However, Slavei discloses wherein the tubular extension is configured to couple with a ventilator machine via one or more tubes of a breathing circuit and to act as an airway device to deliver air produced by the ventilator machine to the patient after completion of the bronchoscopy procedure (central tube, 1 is coupled to a ventilator tube, 9, the laryngeal mask 8, which is connected to the ventilator, stays in place until after the process and the patient is fully awake, page 8, lines 14-16) for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (page 8, lines 24-29).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the modified device of Matus to have the tubular extension be configured to couple with a ventilator machine via one or more tubes of a breathing circuit and to act as an airway device to deliver air produced by the ventilator machine to the patient after completion of the bronchoscopy procedure, as taught by Slavei, for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (See Slavei: page 8, lines 24-29).
Regarding Claim 3, the modified device of Matus discloses the OPG wherein said at least a first insuffiatable bladder (See Matus: 38, 39; Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses the pocket 38, disposed in wall of second membrane portion 39.) is configured such that when the OPG is in the installed state in the patients mouth and throat the and said at least first insuffiatable bladder is in a partially or wholly insuffiated state, a seal is created (Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses widening the first and second membrane portions 37 and 39, respectively, in this manner causes the first and second membrane portions 37 and 39, respectively, to conform the inner surfaces of the mouth and throat, respectively, to create an airtight, or nearly airtight, seal between these surfaces and the outer surfaces of the first and second membrane portions 37 and 39 respectively.).
The embodiment of Matus of Fig. 5 does not disclose that the seal acts to seal off an upper aperture of an esophagus of the patient to prevent aspiration of gastric contents from the esophagus into a trachea of the patient.
However, in an alternate embodiment of Matus (hereinafter: Matus’2) the OPG of Figs. 1-4 discloses a seal that acts to seal off an upper aperture of an esophagus of the patient to prevent aspiration of gastric contents from the esophagus into a trachea of the patient (Fig. 1; ¶ 0020; Examiner notes: Matus discloses the second membrane portion, 22 blocks the entryway of the esophagus of the patient and the outer surfaces of the first and second membrane portions 21 and 22 to create an airtight or nearly airtight seal.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second membrane portion of the membrane of the modified device of Matus to include a seal that acts to seal off an upper aperture of an esophagus of the patient to prevent aspiration of gastric contents from the esophagus into a trachea of the patient as taught in the embodiment of Figs. 1-4 of Matus for the advantage of preventing and reducing leakage and prevent aspiration of gastric contents into the trachea.
Regarding Claim 4, the modified device of Matus discloses the OPG wherein said at least a first insuffiatable bladder (38, 39; Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses pocket 38, disposed in wall of second membrane portion 39.) is configured such that when the OPG is in the installed state in the patient's mouth and throat and said at least a first insuffiatable bladder is in a partially or wholly insuffiated state (Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses as a result of the pocket portion 38, being filled with air, the second membrane portion, 39 is insuffiated and expanded, said seal acts to prevent or reduce air leakage from the trachea out of the mouth of the patient.
Regarding Claim 5, the modified device of Matus discloses the OPG wherein the flexible body is configured to protect the patient's mouth and throat from being damaged by the bronchoscope tube during a bronchoscopy procedure (Fig. 5; ¶ 0030; Examiner notes: Matus discloses oropharyngeal glove 30, protects the mouth, teeth and throat of the patient from being damaged by the bronchoscope.).
Regarding Claim 6, the modified device of Matus discloses the OPG further comprising a teeth guards (45, 46; Fig. 5) mechanically coupled to or joined (7; Fig. 1, 3; Abstract; Pg. 6, ln 29-32; Pg. 7, ln 11-15) to an exterior surface of the tubular extension (exterior of tube 1), the teeth guards being configured to protect upper and lower teeth respectively, of the patient, the teeth guards being in contact with front surfaces of upper and lower teeth of the patient when the OPG is in the installed state (Fig. 5, 7; ¶ 0029; Examiner notes: Matus discloses upper and lower teeth guards 45 and 46, respectively, in contact with the upper and lower teeth, to protect the mouth, teeth and throat.).
Regarding Claim 7, the modified device of Matus discloses the OPG of claim 2, shown above.
The modified device of Matus does not specifically to disclose wherein the proximal end of the tubula1 extension has an outer surface with an outer diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the outer surface of the proximal end of the tubular extension and an inner surface of the connecting tube.
Slavei teaches the tubular extension (central tube, 1, Pg. 7 lines 11-15, Fig. 1) that has an outer surface with an outer diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the outer surface of the proximal end of the tubular extension and an inner surface of the connecting tube (sockets 2 and 3 are arranged outside of central tube 1, that interconnects with connecting pipes 4 and 5, page 7 lines 11-15, where during the process there is no aspiration, i.e. a seal would exist, page 9, lines 9-12, Fig.1 ) for the purpose of more easily achieving and controlling ventilation (page 8, lines 24-29)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to the modified device of Matus to include the tubular extension have an outer surface with an outer diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the outer surface of the proximal end of the tubular extension and an inner surface of the connecting tube as taught in Slavei, for the purpose of more easily achieving and controlling ventilation (See Slavei: page 8, lines 24-29).
Regarding Claim 8, the modified device of Matus discloses the OPG wherein the proximal end of the tubular extension (See Slavei: central tube, 1, page 7 lines16-20, Fig. 2) has an inner surface with an inner diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the inner surface of the proximal end of the tubular extension and an outer surface of the connecting tube (See Slavei: Fig. 2; Pg. 9, ln 9-12; Examiner notes: Slavei discloses sockets 2 and 3 are arranged inside of central tube 1, that interconnects with connecting pipes 4 and 5, page 7 lines 16-20, where during the process there is no aspiration, i.e. a seal would exist.).
Regarding Claim 9, the modified device of Matus discloses the OPG wherein said at least a first insufflatable bladder comprises at least first and second insufflatable bladders (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses pocket 38 is the first bladder, and pocket 42 is the second bladder), and wherein the bladders can be insufflated to different levels independently of one another via first and second insufflation tubes (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses first tube 35 and second tube, 41 supplies air to the first, 38 and second pockets, 42, respectively, thus they are insufflated to different levels independently of one another.), the first and second insufflation tubes having proximal ends that are exterior to the OPG for access by a user and distal ends that are disposed within the first and second insufflation bladders, respectively (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses insufflation tubes, 35 and 41 having proximal ends that are exterior to the OPG, 30, for access by a user and distal ends that are disposed within the first and second insufflation bladders.).
Regarding Claim 10, Matus discloses a method for performing a rigid or flexible bronchoscopy procedure and for performing anesthesia recovery after the bronchoscopy procedure, the method comprising: installing an oropharyngeal glove "OPG" in a patient's mouth and throat (Fig. 5; ¶¶ 0025, 0029), the OPG comprising (oropharyngeal glove, 30 installed in a patients mouth and throat and a tubular portion of bronchoscope 31, passing through the openings, Fig.5; paragraphs [0025] and [00291): a main tube (30; Fig. 5) having a proximal end (33; Fig. 5), a distal end (at 48; Fig. 5) and a hollow inner lumen that extends from the proximal end to the distal end (¶ 0029; Figs. 5; Examiner notes: Matus discloses a first opening 32 formed in proximal end 33 and opening 48 formed in a distal end of the oropharyngeal glove, 30), the inner lumen being sized to allow a bronchoscope tube (31; Fig. 5) to be passed therethrough (¶ 0029), the proximal end and the distal end having first (32; Fig. 5) and second openings (48; Fig. 5), respectively, through which the bronchoscope tube can pass (¶ 0029; Figs. 5 & 7; Examiner notes: Matus discloses tubular portion, 31, of a rigid bronchoscope inserted through a first opening 32 formed in a proximal end 33 thereof through the second opening 48, formed in the distal end thereof into the patient's trachea as shown in Fig. 7 block 54); a flexible body (37, 39; ¶¶ 0026-0027; Examiner notes: Matus discloses membranes 37, 39 which conform to the inner surfaces of the mouth and throat, thus being flexible) secured about the main tube, the flexible body (37, 39; ¶¶ 0026-0027; Fig. 5) comprising at least a first insufflatable bladder (38; Fig. 5; ¶¶ 0026-0027) configured to be insufflated to a state in which outer surfaces of said at least a first bladder form a seal with a patient's mouth and throat when the OPG is in an installed state in a patient's mouth and throat (Fig. 5; ¶¶ 0026-0029; Examiner notes: Matus discloses membrane portions 37 and 39 forms an airtight or nearly airtight seal of the patient's mouth and throat).
Matus does not disclose a tubular extension having a proximal end, a distal end, and
a hollow inner bore that extends from the proximal end of the tubular extension to the distal end of the tubular extension, the distal end of the tubular extension interfacing with the proximal end of the main tube, the hollow inner bore having an inner diameter that is sufficiently large to allow the tube of the bronchoscope to pass through the hollow inner bore and into the first opening of the main tube during a bronchoscopy procedure and inserting a tube of a bronchoscope through the hollow inner bore, through the first and second openings and into a trachea of the patient; and manipulating the tube of the bronchoscope to perform a bronchoscopy procedure.
Slavei teaches a tubular extension having a proximal end, a distal end (1; Fig. 3; Examiner notes: Slavei discloses the central working tube, 1 has proximal and distal ends, as shown in Fig. 3.), and a hollow inner bore that extends from the proximal end of the tubular extension to the distal end of the tubular extension (page 6 lines 29-32, page 7 line 28 to page 8 line 13; Fig. 3; Examiner notes: Slavei discloses the central working tube, 1 has a diameter wide enough to enable easy insertion of the devices used during the bronchoscopy.), the distal end of the tubular extension interfacing with the proximal end of a main tube (9; Fig. 3; page 7 line 28-page 8 line 13; Examiner notes: Slavei discloses the distal end of working tube, 1 interfaces with the proximal end of ventilation tube, 9.), the hollow inner bore having an inner diameter that is sufficiently large to allow the tube of the bronchoscope (18; Fig. 3) to pass through the hollow inner bore and into the first opening of the main tube during a bronchoscopy procedure (page 7 line 28-page 8 line 13, Fig. 3; Examiner notes: Slavei discloses the bronchoscope 18 is inserted into working tube, 1 and advanced through the ventilation tube 1.) and inserting a tube of a bronchoscope through (18; Fig. 3; page 8 lines 1-6, Fig. 3) the hollow inner bore, through the first and second openings and into a trachea of the patient; and manipulating the tube of the bronchoscope to perform a bronchoscopy procedure (Fig. 3; page 8 lines 1-13; Examiner notes Slavei discloses bronchoscope, 18 is inserted into the central working tube, 1 and the bronchoscope is advanced through ventilation tube of laryngeal mask, 8 and into the trachea.) for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (page 8, lines 24-29).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Matus to include the tubular extension having a proximal end, a distal end, and a hollow inner bore that extends from the proximal end of the tubular extension to the distal end of the tubular extension, the distal end of the tubular extension interfacing with the proximal end of the main tube, the hollow inner bore having an inner diameter that is sufficiently large to allow the tube of the bronchoscope to pass through the hollow inner bore and into the first opening of the main tube during a bronchoscopy procedure and inserting a tube of a bronchoscope through the hollow inner bore, through the first and second openings and into a trachea of the patient; and manipulating the tube of the bronchoscope to perform a bronchoscopy procedure as taught by Slavei for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (See Slavei: page 8, lines 24-29).
Regarding Claim 11, the modified method of Matus discloses the OPG method further comprising after manipulating the tube of the bronchoscope to perform the bronchoscopy procedure: removing the tube of the bronchoscope from the OPG (¶ 0014; Examiner notes: Matus discloses installation and removal of the bronchoscope).
The modified method of Matus does not specifically disclose the OPG method comprising a ventilator machine coupled via one or more tubes of a breathing circuit to the proximal end of the tubular extension, using the tubular extension as an airway device to deliver air produced by the ventilator machine to the patient to perform anesthesia recovery.
Slavei discloses a ventilator machine (ventilator system, 15, page 7, lines31-34; Fig. 3) coupled via one or more tubes of a breathing circuit to the proximal end of the tubular extension (ventilator pipe, 16, page 15, lines 31-34, Fig. 3), using the tubular extension as an airway device to deliver air produced by the ventilator machine to the patient to perform anesthesia recovery (page 8, lines 14-16; Examiner notes: Slavei discloses the mask remains in position until patient is fully awake.) for the purpose of more easily achieving and controlling ventilation (page 8, lines 24-29).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Matus to include the ventilator machine coupled via one or more tubes of a breathing circuit to the proximal end of the tubular extension, using the tubular extension as an airway device to deliver air produced by the ventilator machine to the patient to perform anesthesia recovery as taught by Slavei for the purpose of more easily achieving and controlling ventilation (See Slavei: page 8, lines 24-29).
Regarding Claim 12, the modified method of Matus discloses the OPG method further comprising after installing the OPG, insufflating said at least a first insufflatable bladder to adjust the seal (See Matus: ¶ 0026; Fig. 5, 7; Examiner notes Matus discloses after glove 30 has been installed, pocket, 38 disclosed in wall of the second membrane portion, 39, is insufflated.).
Regarding Claim 13, the modified method of Matus discloses the OPG method of claim 10, shown above.
The modified device of Matus does not specifically to disclose wherein the tubular extension is configured to couple with a ventilator machine via one or more tubes of a breathing circuit and to act as an airway device to deliver air produced by the ventilator machine to the patient after completion of the bronchoscopy procedure.
However, Slavei discloses wherein the tubular extension is configured to couple with a ventilator machine via one or more tubes of a breathing circuit and to act as an airway device to deliver air produced by the ventilator machine to the patient after completion of the bronchoscopy procedure (central tube, 1 is coupled to a ventilator tube, 9, the laryngeal mask 8, which is connected to the ventilator, stays in place until after the process and the patient is fully awake, page 8, lines 14-16) for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (page 8, lines 24-29).
Therefore, it would have been obvious to one of ordinary skill in the art to modify the modified method of Matus to have the tubular extension be configured to couple with a ventilator machine via one or more tubes of a breathing circuit and to act as an airway device to deliver air produced by the ventilator machine to the patient after completion of the bronchoscopy procedure, as taught by Slavei, for the purpose of more easily achieving and controlling ventilation, additionally, the pulmonary/bronchoscopy is more comfortable to the pulmonologist (See Slavei: page 8, lines 24-29).
Regarding Claim 14, the modified method of Matus discloses the OPG method wherein said at least a first insuffiatable bladder (See Matus: 38, 39; Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses the pocket 38, disposed in wall of second membrane portion 39.) is configured such that when the OPG is in the installed state in the patients mouth and throat the and said at least first insuffiatable bladder is in a partially or wholly insuffiated state, a seal is created (Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses widening the first and second membrane portions 37 and 39, respectively, in this manner causes the first and second membrane portions 37 and 39, respectively, to conform the inner surfaces of the mouth and throat, respectively, to create an airtight, or nearly airtight, seal between these surfaces and the outer surfaces of the first and second membrane portions 37 and 39 respectively.).
The embodiment of Matus of Fig. 5 does not disclose that the seal acts to seal off an upper aperture of an esophagus of the patient to prevent aspiration of gastric contents from the esophagus into a trachea of the patient.
However, in an alternate embodiment of Matus (hereinafter: Matus’2) the OPG of Figs. 1-4 discloses a seal that acts to seal off an upper aperture of an esophagus of the patient to prevent aspiration of gastric contents from the esophagus into a trachea of the patient (Fig. 1; ¶ 0020; Examiner notes: Matus discloses the second membrane portion, 22 blocks the entryway of the esophagus of the patient and the outer surfaces of the first and second membrane portions 21 and 22 to create an airtight or nearly airtight seal.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second membrane portion of the membrane of the modified method of Matus to include a seal that acts to seal off an upper aperture of an esophagus of the patient to prevent aspiration of gastric contents from the esophagus into a trachea of the patient as taught in the embodiment of Figs. 1-4 of Matus for the advantage of preventing and reducing leakage and prevent aspiration of gastric contents into the trachea.
Regarding Claim 15, the modified method of Matus discloses the OPG method further discloses wherein said at least a first insuffiatable bladder (38, 39; Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses pocket 38, disposed in wall of second membrane portion 39.) is configured such that when the OPG is in the installed state in the patient's mouth and throat and said at least a first insuffiatable bladder is in a partially or wholly insuffiated state (Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses as a result of the pocket portion 38, being filled with air, the second membrane portion, 39 is insuffiated and expanded, said seal acts to prevent or reduce air leakage from the trachea out of the mouth of the patient.
Regarding Claim 16, the modified method of Matus discloses the OPG method wherein the flexible body is configured to protect the patient's mouth and throat from being damaged by the bronchoscope tube during a bronchoscopy procedure (Fig. 5; ¶ 0030; Examiner notes: Matus discloses oropharyngeal glove 30, protects the mouth, teeth and throat of the patient from being damaged by the bronchoscope.).
Regarding Claim 17, the modified method of Matus discloses the OPG method further comprising a teeth guards (45, 46; Fig. 5) mechanically coupled to or joined (7; Fig. 1, 3; Abstract; Pg. 6, ln 29-32; Pg. 7, ln 11-15) to an exterior surface of the tubular extension (exterior of tube 1), the teeth guards being configured to protect upper and lower teeth respectively, of the patient, the teeth guards being in contact with front surfaces of upper and lower teeth of the patient when the OPG is in the installed state (Fig. 5, 7; ¶ 0029; Examiner notes: Matus discloses upper and lower teeth guards 45 and 46, respectively, in contact with the upper and lower teeth, to protect the mouth, teeth and throat.).
Regarding Claim 18, the modified method of Matus discloses the OPG method of claim 11, shown above.
The modified device of Matus does not specifically to disclose wherein the proximal end of the tubula1 extension has an outer surface with an outer diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the outer surface of the proximal end of the tubular extension and an inner surface of the connecting tube.
Slavei teaches the tubular extension (central tube, 1, Pg. 7 lines 11-15, Fig. 1) that has an outer surface with an outer diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the outer surface of the proximal end of the tubular extension and an inner surface of the connecting tube (sockets 2 and 3 are arranged outside of central tube 1, that interconnects with connecting pipes 4 and 5, page 7 lines 11-15, where during the process there is no aspiration, i.e. a seal would exist, page 9, lines 9-12, Fig.1 ) for the purpose of more easily achieving and controlling ventilation (page 8, lines 24-29)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to the modified device of Matus to include the tubular extension have an outer surface with an outer diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the outer surface of the proximal end of the tubular extension and an inner surface of the connecting tube as taught in Slavei, for the purpose of more easily achieving and controlling ventilation (See Slavei: page 8, lines 24-29).
Regarding Claim 19, the modified method of Matus discloses the OPG method of claim wherein the proximal end of the tubular extension (See Slavei: central tube, 1, page 7 lines16-20, Fig. 2) has an inner surface with an inner diameter that is selected to interconnect with a connecting tube of said one or more tubes of the breathing circuit such that an airtight or substantially airtight seal exists between the inner surface of the proximal end of the tubular extension and an outer surface of the connecting tube (See Slavei: Fig. 2; Pg. 9, ln 9-12; Examiner notes: Slavei discloses sockets 2 and 3 are arranged inside of central tube 1, that interconnects with connecting pipes 4 and 5, page 7 lines 16-20, where during the process there is no aspiration, i.e. a seal would exist.).
Regarding Claim 20, the modified method of Matus discloses the OPG method wherein said at least a first insufflatable bladder comprises at least first and second insufflatable bladders (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses pocket 38 is the first bladder, and pocket 42 is the second bladder), and wherein the bladders can be insufflated to different levels independently of one another via first and second insufflation tubes (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses first tube 35 and second tube, 41 supplies air to the first, 38 and second pockets, 42, respectively, thus they are insufflated to different levels independently of one another.), the first and second insufflation tubes having proximal ends that are exterior to the OPG for access by a user and distal ends that are disposed within the first and second insufflation bladders, respectively (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes: Matus discloses insufflation tubes, 35 and 41 having proximal ends that are exterior to the OPG, 30, for access by a user and distal ends that are disposed within the first and second insufflation bladders.).
Regarding Claim 21, the modified method of Matus discloses the OPG method further discloses wherein said at least a first insufflatable bladder comprises at least first and second insufflatable bladders (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes Matus discloses pocket 38 is the first bladder, and pocket 42 is the second bladder.), and wherein the bladders can be insufflated to different levels independently of one another via first and second insufflation tubes (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes Matus discloses first tube 35 and second tube, 41 supplies air to the first, 38 and second pockets, 42, respectively, thus they are insufflated to different levels independently of one another.), the first and second insufflation tubes having proximal ends that are exterior to the OPG for access by a user and distal ends that are disposed within the first and second insufflation bladders, respectively (See Matus: Fig. 5; ¶¶ 0026-0027; Examiner notes Matus discloses insufflation tubes, 35 and 41 having proximal ends that are exterior to the OPG, 30, for access by a user and distal ends that are disposed within the first and second insufflation bladders.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLIOT S RUDDIE whose telephone number is (571)272-7634. The examiner can normally be reached M-F usually 9-7 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ELLIOT S RUDDIE/Primary Patent Examiner, Art Unit 3785