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 .
Information Disclosure Statement
The information disclosure statement filed on 7/21/2025 and 10/15/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is in response to the amendment filed on 7/21/2025. As directed by the amendment, claims 1, 7, 10, 15, 24 and 27 have been amended and claim 37 have been cancelled. As such, claims 1-10, 15, 20-25, 27, 32-34 and 36 are pending in the instant application.
Applicant has amended claims 7, 10, 24 and 27 to address a minor informality; the objection to the claim has been withdrawn.
Applicant has amended claim 25 address a 112(b); the 112(b) rejection to the claim has been withdrawn.
Response to Arguments
Applicant's arguments, see pages 8-10 of Remarks, filed 7/21/2025 have been fully considered but they are not persuasive. Applicant recites “…Bullard actually goes on to describe an alternative so-called "laryngoscope" construction that is differentiated from these types of traditional bladed laryngoscopes. However, a person skilled in the art would understand that Bullard's "laryngoscope" does not actually include a "blade portion being a laryngoscope blade" as required in the amended claims 1 and 7.” However, as applicant has stated, Bullard teaches a laryngoscope 10 including a blade section 14 as seen in Fig. 2. Bullard further teaches any type of laryngoscope can be used including laryngoscopes with anatomically curved blades (see Col. 4, lines 33-39). Applicant further argues “…there does not appear to be any clear disclosure or teaching of inserting Bullard's "laryngoscope" through an intubation guide as required in the claimed invention…” The modification of Christopher in view of Bullard now replaces the fiber optic of Christopher with only the fiberoptic laryngoscope taught by Bullard.
Applicant's arguments, see pages 11-12 of Remarks, filed 7/21/2025 have been fully considered but they are not persuasive. Applicant recites “Persons skilled in the art would appreciate that this additional functionality (which is discussed further in paragraph [0083]) is facilitated by the insertion of the laryngoscope blade into the guide, where the laryngoscope can be manipulated by the user for holding/depressing the tongue via the guide in use.” However, the current claim amendment only states holding a tongue of the subject and/or depressing the tongue using the intubation guide without any mentions of the laryngoscope blade within part d) iii). As such, Christopher teaches curved guide 25 to go over, hold and depress the tongue to allow an open passageway as seen in Fig. 6 and Col. 5, lines 32-38.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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(s) 1-2, 5-7, 9-10, 15, 21, 27, 32-33 and 36 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Christopher (US 5694929 A) in view of Bullard (US 5643221 A).
Regarding claim 1, Christopher teaches a method for use in an endotracheal intubation procedure (“This invention provides a method and apparatus for guiding insertion of an endotracheal tube into a patient's trachea during resuscitation by using a face mask and a curved guide.” See Col. 3, lines 37-39), the method including:
a) inserting an intubation guide (curved guide 25, see Fig. 6) into a mouth of a subject (“The guide 25 extends posteriorly through the face mask 20 and has a curved distal portion that is inserted into the patient's mouth…” see Col. 5, lines 27-30 and Fig. 6), the intubation guide including an elongate body (curved guide 25 has an elongated body as seen in Fig. 6) defining a passageway (curved guide 25 has a passageway in which a fiber optic probe 30 and endotracheal tube 40 is inserted into as seen in Fig. 6 and Col. 6, lines 10-14) extending between a proximal opening (proximal opening, see Christopher’s Annotated Fig. 6) and a distal opening (distal opening, see Christopher’s Annotated Fig. 6), the passageway being configured for receiving an intubation device (fiber optic probe 30, see Fig. 6) (see Fig. 6 and Col. 6, lines 10-14), and the proximal opening being positioned proximate to the mouth of the subject (the proximate opening of the curved guide 25 is positioned proximate to the mouth of the subject as shown in Fig. 6. Additionally, Figure 11 shows an alternative embodiment in which curved guide 25 is positioned closer to the mouth as it is interior to the mask as seen in Col. 7, lines 13-15) and the distal opening being positioned proximate to a pharynx of the subject (the distal opening of curved guide 25 is in the pharynx of a user as seen in Fig. 6 and Col. 5, lines 32-35);
b) covering the mouth of the subject with a ventilation mask (face mask 20, see Fig. 6; “The face mask 20 is adapted to fit over the patient's mouth and nose for resuscitation of the patient 10 as shown in FIG. 5.” See Col. 5, lines 5-7) including:
i) a ventilation port connected to a ventilator (ventilation port, see Christopher’s Annotated Fig. 6; mask 20 comprises a ventilation port that can be attached to a resuscitation bag 22 or other conventional oxygen supply as seen in Col.5, lines 63 to Col. 6, lines 2); and
ii) an intubation port (face mask port 23, see Fig. 6) for receiving the intubation device (the fiber optic probe 30 is inserted into the face mask port 23 as seen in Fig. 6), the intubation port being aligned with the mouth of the subject (the face mask port 23 is aligned with the mouth of the subject as seen in Fig. 6);
c) ventilating the subject using the ventilation mask (mask 20 comprises a ventilation port that can be attached to a resuscitation bag 22 or other conventional oxygen supply to be ventilated as seen in Col.5, lines 63 to Col. 6, lines 2); and
d) while ventilation of the subject continues (“Resuscitation, oxygenation, or artificial ventilation continue without interruption while the fiber optic probe and endotracheal tube are inserted through a flexible port at the proximal end of the guide and then advanced along the guide into the patient's airway.” See Col. 3, lines 45-49):
i) inserting the intubation device into the passageway of the intubation guide through the intubation port (fiber optic probe 30 is inserted into curved guide 25 through face mask port 30 as seen in Fig. 6 and Col. 4, lines 38-42)
ii) positioning a distal tip of the intubation device proximate to the larynx of the subject (the distal tip of the fiber optic probe 30 is proximate to the larynx of the subject (although the fiber optic probe 30 is inserted past the larynx, it is still proximate to the larynx of the subject) as seen in Fig. 6 and Col. 6, lines 10-14);
iii) at least one of: i) holding a tongue of the subject; and ii) depressing the tongue using the intubation guide (curved guide 25 goes over, holds and depresses the tongue to allow an open passageway as seen in Fig. 6 and Col. 5, lines 30-38); and
iv) advancing an endotracheal tube along the intubation device through the intubation port and the intubation guide into a trachea of the subject (“The fiber optic probe 30 and endotracheal tube 40 are then inserted through the guide port 27 and along the guide 25 to a position within the trachea 16 past the larynx 18 while resuscitation continues…” see Col. 6, lines 10-14 and Fig. 6) but does not teach a blade portion of the intubation device, the blade portion being a laryngoscope blade.
Christopher’s Annotated Fig. 6
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However, Bullard teaches a laryngoscope 10 with a blade section 14 and fiber optic components (illumination bundle 25, image bundle 27, working channel 29 and illumination bundle channel 28) used to view the target area as seen in Figs. 2 and 2A and Col. 3, lines 62 to Col. 4, line 1). Furthermore, Bullard teaches laryngoscope 10 placing an intubation tube 12 into the glottal opening of a patient, using a placement device 20 at the end of blade section 14 as seen in Fig. 2 and Col. 3, lines 47-58). Not to mention Bullard teaches any type of laryngoscope can be used including laryngoscopes with anatomically curved blades (see Col. 4, lines 33-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Christopher to replace the fiber optic with a fiberoptic laryngoscope as taught by Bullard to have a fast and precise access to the larynx and trachea region of a patient as the position of the tube can be checked and placed using a control lever (see Col. 6, lines 10-22 and 39-46).
Regarding claim 2, Christopher in view of Bullard teaches a method of claim 1, and further teaches wherein the method includes, after advancing the endotracheal tube into the trachea of the subject, and while leaving the endotracheal tube in place in the trachea of the subject (the endotracheal tube 40 is inserted and placed within the trachea 16 as shown in Fig. 6 and Col. 6, lines 10-14 of Christopher):
a) withdrawing the blade portion of the intubation device from the intubation guide and the intubation port (“After placement of the tube, or at least the leading portion of the tube, the operator can then remove the laryngoscope from the patient.” See Col. 6, lines 40-43 of Bullard);
b) removing the ventilation mask from the subject (“The face mask 20 and guide 25 can then be removed while leaving the endotracheal tube 40 in place within the trachea 16, as shown in FIG. 9.” See Col. 6, lines 46-48 and Fig. 9 of Christopher); and
c) removing the intubation guide from the mouth of the subject (“The face mask 20 and guide 25 can then be removed while leaving the endotracheal tube 40 in place within the trachea 16, as shown in FIG. 9.” See Col. 6, lines 46-48 and Fig. 9 of Christopher). Regarding claim 5, Christopher in view of Bullard teaches a method of claim 1, and further teaches wherein the ventilation mask includes a seal covering the intubation port (“…the face mask port 23 consists of a flexible, elastic membrane having a stretchable opening 24 with dimensions large enough to allow a curved guide 25 to pass through the face mask port 23. For example, this elastic membrane can be made of rubber with slot or hole forming an opening 24, as shown in FIG. 4.” See Col. 5, lines 24-27 of Christopher), the seal normally being in a closed position for sealing the intubation port (the flexible, elastic membrane with stretchable opening 24 will be in a closed position until an intubation device passes through as seen in Fig. 4) and being moveable to an open position when the blade portion of the intubation device is inserted through the intubation port (Christopher in view of Bullard teaches the flexible, elastic membrane with a stretchable opening 24 moved to an open position (see Fig. 7 of Christopher) when the laryngoscope 10 taught by Bullard passes through to be inserted into a patient’s mouth), the method including inserting the blade portion through the seal of the intubation port (Christopher in view of Bullard teaches blade 14 of laryngoscope 10 (taught by Bullard) passing through the flexible, elastic membrane with stretchable opening 24 as it inserted into a patient’s mouth).
Regarding claim 6, Christopher in view of Bullard teaches a method of claim 1, and Christopher further teaches wherein ventilating the subject using the ventilation mask includes oxygenating the subject using the ventilation mask (mask 20 comprises a ventilation port that is attached to a resuscitation bag 22 or other conventional oxygen supply as seen in Col.5, lines 63 to Col. 6, lines 2 in which the user will be oxygenated as seen in Col. 3, lines 45-49).
Regarding claim 7, Christopher teaches an apparatus for use in an endotracheal intubation procedure (“This invention provides a method and apparatus for guiding insertion of an endotracheal tube into a patient's trachea during resuscitation by using a face mask and a curved guide.” See Col. 3, lines 37-39), the apparatus including:
a) an intubation guide (curved guide 25, see Fig. 6) including an elongate body (curved guide 25 has an elongated body as seen in Fig. 6) defining a passageway (curved guide 25 has a passageway in which a fiber optic probe 30 and endotracheal tube 40 is inserted into as seen in Fig. 6 and Col. 6, lines 10-14) extending between a proximal opening (proximal opening, see Christopher’s Annotated Fig. 6) and a distal opening (distal opening, see Christopher’s Annotated Fig. 6), the passageway being configured for receiving an intubation device (fiber optic probe 30, see Fig. 6) (see Fig. 6 and Col. 6, lines 10-14), and the intubation guide being configured for insertion into a mouth of the subject so that the proximal opening is positioned proximate to the mouth of the subject (the proximate opening of the curved guide 25 is positioned proximate to the mouth of the subject as shown in Fig. 6. Additionally, Figure 11 shows an alternative embodiment in which curved guide 25 is positioned closer to the mouth as it is anterior to the mask as seen in Col. 7, lines 13-15) and the distal opening is positioned proximate to a pharynx of the subject (the distal opening of curved guide 25 is in the pharynx of a user as seen in Fig. 6 and Col. 5, lines 32-35), and the intubation guide being configured to, in use, at least one of: i) hold a tongue of the subject; and ii)depress the tongue (curved guide 25 goes over, holds and depresses the tongue to allow an open passageway as seen in Fig. 6 and Col. 5, lines 30-38); and
b) a ventilation mask for covering the mouth of the subject (face mask 20, see Fig. 6; “The face mask 20 is adapted to fit over the patient's mouth and nose for resuscitation of the patient 10 as shown in FIG. 5.” See Col. 5, lines 5-7), the ventilation mask including:
i) a ventilation port for connection to a ventilator (ventilation port, see Christopher’s Annotated Fig. 6; mask 20 comprises a ventilation port that can be attached to a resuscitation bag 22 or other conventional oxygen supply as seen in Col.5, lines 63 to Col. 6, lines 2); and
ii) an intubation port (face mask port 23, see Fig. 6) for receiving the intubation device (the fiber optic probe 30 is inserted into the face mask port 23 as seen in Fig. 6), the intubation port being configured to align with the mouth of the subject (the face mask port 23 is aligned with the mouth of the subject as seen in Fig. 6) to thereby allow the intubation device to be inserted into the passageway of the intubation guide through the intubation port (the fiber optic probe 30 is inserted into the curved guide 25 through face mask port 23 as seen in Fig. 6).
but does not teach a blade portion of the intubation device, the blade portion being a laryngoscope blade.
However, Bullard teaches a laryngoscope 10 with a blade section 14 and fiber optic components (illumination bundle 25, image bundle 27, working channel 29 and illumination bundle channel 28) used to view the target area as seen in Figs. 2 and 2A and Col. 3, lines 62 to Col. 4, line 1). Furthermore, Bullard teaches laryngoscope 10 placing an intubation tube 12 into the glottal opening of a patient, using a placement device 20 at the end of blade section 14 as seen in Fig. 2 and Col. 3, lines 47-58). Not to mention Bullard teaches any type of laryngoscope can be used including laryngoscopes with anatomically curved blades (see Col. 4, lines 33-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method taught by Christopher to replace the fiber optic with a fiberoptic laryngoscope as taught by Bullard to have a fast and precise access to the larynx and trachea region of a patient as the position of the tube can be checked and placed using a control lever (see Col. 6, lines 10-22 and 39-46).
Regarding claim 9, Christopher in view of Bullard teaches an apparatus of claim 7, and further teaches wherein the ventilation mask includes a seal covering the intubation port (“…the face mask port 23 consists of a flexible, elastic membrane having a stretchable opening 24 with dimensions large enough to allow a curved guide 25 to pass through the face mask port 23. For example, this elastic membrane can be made of rubber with slot or hole forming an opening 24, as shown in FIG. 4.” See Col. 5, lines 24-27 of Christopher), the seal normally being in a closed position for sealing the intubation port (the flexible, elastic membrane with stretchable opening 24 will be in a closed position until an intubation device passes through as seen in Fig. 4) and being moveable to an open position when the blade portion of the intubation device is inserted through the intubation port (Christopher in view of Bullard teaches the flexible, elastic membrane with stretchable opening 24 moved to an open position (see Fig. 7 of Christopher) when the blade 14 of laryngoscope 10 taught by Bullard passes through to be inserted into a patient’s mouth).
Regarding claim 10, Christopher in view of Bullard teaches an apparatus of claim 9, and further teaches wherein the seal includes at least one resilient membrane configured to deform in response to the blade portion being urged against the seal (the flexible, elastic membrane (taught by Christopher) is capable of deforming as seen in Figs. 4 and 7 in response to the blade 14 of the laryngoscope 10 (taught by Bullard)), to thereby define an opening for receiving the blade portion (flexible, elastic membrane has a stretchable opening 24 (taught by Christopher) which will receive the blade 14 of the laryngoscope 10 (taught by Bullard)), and wherein at least one of:
a) the seal includes a resilient membrane that is supported around a perimeter of the intubation port (the flexible, elastic membrane is supported around a perimeter of face mask port 23 as seen in Fig. 4), the resilient membrane including an aperture that is substantially closed in the closed position and that stretches to define the opening in the open position (Christopher teaches the flexible, elastic membrane to include a stretchable opening 24 that is substantially closed in closed position as seen in Fig. 4 and stretches to define the opening in the open position as seen in Fig. 7);
b) the seal includes two or more resilient membranes that are supported around the perimeter of the intubation port, the respective aperture of each resilient membrane differing from the apertures of other resilient membranes in at least one of: shape, location, and orientation; and
c) the seal includes two or more resilient membranes that are each supported around a respective part of a perimeter of the intubation port and that each include a respective unsupported edge, the unsupported edges at least partially overlapping in the closed position and separating to define the opening in the open position.
Regarding claim 15, Christopher in view of Bullard teaches an apparatus of claim 7, and Christopher further teaches wherein the ventilation mask is for covering the mouth and a nose of the subject (“The face mask 20 is adapted to fit over the patient's mouth and nose for resuscitation of the patient 10 as shown in FIG. 5.” See Col. 5, lines 5-7) (see 112(b) rejection above), and wherein at least one of:
a) the ventilation port is located proximate to the nose covering portion of the ventilation mask;
b) the ventilation port is configured to direct a flow of ventilation gas towards nostrils of the subject (the mask covers both the patients mouth and nose as seen in Col. 5, lines 5-7 and Fig. 5, therefore when the patient is being ventilated (see Col. 3, lines 45-49), air will be directed from the ventilation port to the user’s nostrils);
c) the ventilation mask includes an internal partition for defining separate volumes proximate to the mouth and the nose of the subject; and
d) the ventilation port is offset laterally relative to a central plane of the ventilation mask that is aligned with a sagittal plane of the subject when the ventilation mask covers the mouth of the subject.
Regarding claim 21, Christopher in view of Bullard teaches an apparatus of claim 7, and Christopher further teaches wherein the intubation guide is separate from the ventilation mask and moveable relative to the ventilation mask in use (the curved guide 25 is readily inserted through the face mask port 23 as seen in Col. 5, lines 19-20, and therefore curved guide 25 is separate from the mask 20 and is movable relative to the mask in use).
Regarding claim 27, Christopher in view of Bullard teaches an apparatus of any one of claim 7, 9-10, 15 and 21, and Christopher further teaches wherein at least one of:
a) the intubation port of the ventilation mask and the passageway of the intubation guide have similar cross sections (face mask port 23 of mask 20 has similar cross sections to the passageway of curved guide 25 as seen in Figs. 3 and 4 as they are both circular);
b) a shape of the intubation port is selected based on a cross section shape of the blade portion of the intubation device;
c) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device;
d) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device;
e) a shape of the passageway is selected based on a cross section shape of the blade portion of the intubation device;
f) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device; and
g) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device.
Regarding claim 32, Christopher in view of Bullard teaches an apparatus of claim 7, and Christopher further teaches wherein at least one of the intubation guide and the ventilation mask is formed from a flexible material (mask 20 is made from an elastic material such as rubber or flexible plastic as seen in Col. 5, lines 7-11).
Regarding claim 33, Christopher in view of Bullard teaches an apparatus of claim 32, and further teaches wherein at least one of the intubation guide and the intubation port is configured to expand when receiving the blade portion (face mask port 23 consists of a flexible, elastic membrane having a stretchable opening 24 that is configured to expand (See Col. 5, lines 24-27 of Christopher) when receiving the blade 24 of laryngoscope 10 taught by Bullard).
Regarding claim 36, Christopher in view of Bullard teaches an apparatus of claim 7, and Christopher further teaches wherein the intubation guide is configured to, in use, at least one of:
a) hold a tongue of the subject; and
b) depress the tongue (curved guide 25 goes over, holds and depresses the tongue to allow an open passageway as seen in Fig. 6 and Col. 5, lines 30-38).
Claim(s) 3, 24-25 and 27 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Christopher (US 5694929 A) in view of Bullard (US 5643221 A), as applied to claims 1-2 above, and further in view of Berman (US 4069820 A).
Regarding claim 3, Christopher in view of Bullard teaches a method of claim 2, but does not further teach wherein at least one of:
a) the intubation guide is configured to be broken along the passageway, the method including breaking the intubation guide to allow the intubation guide to be removed while the endotracheal tube remains in place; and
b) the ventilation mask is configured to be broken about the intubation port, the method including breaking the ventilation mask to allow the ventilation mask to be removed while the endotracheal tube remains in place.
However, Berman teaches wherein at least one of:
a) the intubation guide (intubating airway 10a, see Figs. 9-14) is configured to be broken along the passageway, the method including breaking the intubation guide to allow the intubation guide to be removed while the endotracheal tube remains in place (intubating airway 10a comprises a tubular mid-section 16a with longitudinal opening 24a and opposite hinge side 22a which can be broken along the longitudinal opening 24a, as seen in Figs. 11 and 13 and Col. 3, lines 30-43, to help keep the endotracheal tube in place as the intubating airway 10a is removed (see Col. 1, lines 52-54)); and
b) the ventilation mask is configured to be broken about the intubation port, the method including breaking the ventilation mask to allow the ventilation mask to be removed while the endotracheal tube remains in place.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the intubation guide of the method taught by Christopher in view of Bullard to include a longitudinal opening and opposite hinge side as taught by Berman for an easier removal of the intubation guide while keeping the endotracheal tube in place.
Regarding claim 24, Christopher in view of Bullard teaches an apparatus of claim 7, but does not teach wherein the intubation guide is configured to be broken along the passageway.
However, Berman teaches wherein the intubation guide (intubating airway 10a, see Figs. 9-14) is configured to be broken along the passageway (intubating airway 10a comprises a tubular mid-section 16a with longitudinal opening 24a and opposite hinge side 22a which can be broken along the longitudinal opening 24a as seen in Figs. 11 and 13 and Col. 3, lines 30-43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the intubation guide taught by Christopher in view of Bullard to include a longitudinal opening and opposite hinge side as taught by Berman for an easier removal of the intubation guide while keeping the endotracheal tube in place.
Regarding claim 25, modified Christopher teaches an apparatus of claim 24, and Berman further teaches wherein the body of the intubation guide includes two break lines extending longitudinally along opposing sides of the passageway, to thereby allow the intubation guide to be broken along the break lines (Applicant discusses the use of two break lines to not be essential and the intubation guide to include a different arrangement to allow it to be broken to facilitate its removal, such as a single break line and a hinge line (see [0106]). Berman teaches a single break line of longitudinal opening 24a and a hinge line of hinge 22a as seen in Figs. 11 and 13, which allows the breaking of the intubating airway 10a at the longitudinal opening 24a).
Regarding claim 27, modified Christopher teaches an apparatus of any one of claims 7-10, 15 and 20-25 and Christopher further teaches wherein at least one of:
a) the intubation port of the ventilation mask and the passageway of the intubation guide have similar cross sections (face mask port 23 of mask 20 has similar cross sections to the passageway of curved guide 25 as seen in Figs. 3 and 4 as they are both circular);
b) a shape of the intubation port is selected based on a cross section shape of the blade portion of the intubation device;
c) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device;
d) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device;
e) a shape of the passageway is selected based on a cross section shape of the blade portion of the intubation device;
f) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device; and
g) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device.
Claim(s) 4, 8 and 27 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Christopher (US 5694929 A) in view of Bullard (US 5643221 A), as applied to claim 1/7 above and further in view of Jeshuran (US 5197463 A).
Regarding claim 4, Christopher in view of Bullard teaches a method of claim 1, but does not teach wherein the ventilation mask includes a closure for covering the intubation port, the method including removing the closure prior to inserting the blade portion through the intubation port.
However, Jeshuran teaches wherein the ventilation mask (anesthesia mask 28, see Fig. 7) includes a closure (plug 146, see Fig. 7) for covering the intubation port (opening 80, see Fig. 7) (opening 80 is sealed by plug 146 in seal core 54 as seen in Fig. 7 and Col. 7, lines 36-41) the method including removing the closure prior to inserting an intubation device through the intubation port (plug 146 is removed being inserting fiberoptic scope tube 40 as seen in Col. 7, lines 54-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilation mask of the method taught by Christopher in view of Bullard to include a plug as taught by Jeshuran to fully seal the mask and keep the pressure within the mask before an intubation device is inserted (see Col. 7, lines 36-41).
Regarding claim 8, Christopher in view of Bullard teaches an apparatus of claim 7, but does not teach wherein the ventilation mask includes a closure for covering the intubation port when the blade portion is not inserted through the intubation port.
However, Jeshuran teaches wherein the ventilation mask (anesthesia mask 28, see Fig. 7) includes a closure (plug 146, see Fig. 7) for covering the intubation port (opening 80, see Fig. 7) (opening 80 is sealed by plug 146 in seal core 54 as seen in Fig. 7 and Col. 7, lines 36-41) the method including removing the closure prior to inserting an intubation device through the intubation port (plug 146 is removed being inserting fiberoptic scope tube 40 as seen in Col. 7, lines 54-57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Christopher in view of Bullard to include a plug in the ventilation mask as taught by Jeshuran to fully seal the mask and keep the pressure within the mask before an intubation device is inserted (see Col. 7, lines 36-41).
Regarding claim 27, modified Christopher teaches an apparatus of claim 8, and Christopher further teaches wherein at least one of:
a) the intubation port of the ventilation mask and the passageway of the intubation guide have similar cross sections (face mask port 23 of mask 20 has similar cross sections to the passageway of curved guide 25 as seen in Figs. 3 and 4 as they are both circular);
b) a shape of the intubation port is selected based on a cross section shape of the blade portion of the intubation device;
c) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device;
d) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device;
e) a shape of the passageway is selected based on a cross section shape of the blade portion of the intubation device;
f) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device; and
g) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device.
Claim(s) 20 and 27 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Christopher (US 5694929 A) in view of Bullard (US 5643221 A), as applied to claim 7 above, and further in view of Stegman (US 20140332000 A1).
Regarding claim 20, Christopher in view of Bullard teaches an apparatus of claim 7, but does not further teach wherein the ventilation mask is configured to be broken about the intubation port.
However, Stegman teaches wherein the ventilation mask (respiratory mask 10 and connector 100, see Figs 1-2) is configured to be broken about the intubation port (port 140, see Figs. 1-2) (first end portion 110 of connector 100 is to be opened along joint 160 for removing endotracheal tube 50 from port 140 as seen in Figs. 1-2 and [0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Christopher in view of Bullard to have the ventilation mask be broken about the intubation port as taught by Stegman for easy removal of the tube (see [0022]), as well as, easier insertion of the tube.
Regarding claim 27, modified Christopher teaches an apparatus of claim 20 and Christopher further teaches wherein at least one of:
a) the intubation port of the ventilation mask and the passageway of the intubation guide have similar cross sections (face mask port 23 of mask 20 has similar cross sections to the passageway of curved guide 25 as seen in Figs. 3 and 4 as they are both circular);
b) a shape of the intubation port is selected based on a cross section shape of the blade portion of the intubation device;
c) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device;
d) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device;
e) a shape of the passageway is selected based on a cross section shape of the blade portion of the intubation device;
f) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device; and
g) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device.
Claim(s) 22-23 and 27 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Christopher (US 5694929 A) in view of Bullard (US 5643221 A), as applied to claim 7 above, and further in view of Avitsian (US 20140144432 A1).
Regarding claim 22, Christopher in view of Bullard teaches an apparatus of claim 7, but does not teach wherein the intubation guide includes a flange surrounding the proximal opening.
However, Avitsian teaches wherein the intubation guide (oral suction device 10, see Fig. 1) includes a flange (flange 70, see Fig. 1) surrounding the proximal opening (opening 60, see Figs. 1-2) (flange 70 surrounds the proximal opening 60 (opening proximal to a user’s mouth) as seen in Figs. 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Christopher in view of Bullard to include a flange surrounding the proximal opening on the intubation guide as taught by Avitsian to discourage inserting the intubation guide past a patient’s lips (see [0041]).
Regarding claim 23, modified Christopher teaches an apparatus of claim 22, and Avitsian further teaches wherein the flange is configured to prevent over-insertion of the intubation guide by abutting the subject's mouth to thereby ensure that the proximal opening remains positioned outside the mouth (“The flange 70 of the end piece 16 is engaged with the patient's lips 90 and is sized to discourage insertion of the flange 70 past the patient's lips 90.” See [0041] and Fig. 2).
Regarding claim 27, modified Christopher teaches an apparatus of any one of claim 22-23 and Christopher further teaches wherein at least one of:
a) the intubation port of the ventilation mask and the passageway of the intubation guide have similar cross sections (face mask port 23 of mask 20 has similar cross sections to the passageway of curved guide 25 as seen in Figs. 3 and 4 as they are both circular);
b) a shape of the intubation port is selected based on a cross section shape of the blade portion of the intubation device;
c) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device;
d) a size of the intubation port is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device;
e) a shape of the passageway is selected based on a cross section shape of the blade portion of the intubation device;
f) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device; and
g) a size of the passageway is selected based on a cross section size of the blade portion of the intubation device, and is smaller than the cross section size of the blade portion of the intubation device.
Claim(s) 34 is/are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Christopher (US 5694929 A) in view of Bullard (US 5643221 A), as applied to claim 7 above, and further in view of Azagury (US 20140000622 A1).
Regarding claim 34, Christopher in view of Bullard teaches an apparatus of claim 7, and Christopher further teaches wherein the intubation guide is curved (the curved guide 25 is curved as seen in Fig. 5) but does not teach wherein a curvature of the intubation guide is selected based on a curvature of the blade portion of the intubation device.
However, Azagury teaches a shaft 34 (taken as intubation guide as seen in Fig. 1) which is flexible and can take on a specific curvature and/or can conform to the patient’s anatomy when a pushing force is applied to the handle 32 as seen in [0071] and Figs. 2A-2C.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus taught by Christopher in view of Bullard to have a flexible intubation guide as taught by Azagury to allow the intubation guide to curve into the patient’s anatomy (see [0071]) and/or be flexible to conform to a curvature of an incubation device for patient comfort.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785