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 Application No. PCT/US2022/025668 filed April 21, 2022 and to Provisional Application No. 63/185/053 filed May 06, 2021.
Status of Claims
This present office action is responsive to the Application filed on October 31, 2023. As directed, claims 1-26 are presently pending in this application.
Claim Objections
Claims 1-26 are objected to because of the following informalities:
Claim 1 recites, “a bag of gas in fluid configured for inhalation in fluid communication” in ln 3 which Examiner suggest amending to read --a bag of gas configured for inhalation in fluid communication--
Claims 2-22 and 24-26 recite, “device of Claim” in ln 1 which Examiner suggest amending to read --device of claim-- to lowercase --claim--
Claim 9 recites, “hyperpolarized noble gas” in ln 2 which Examiner suggest amending to read --a hyperpolarized noble gas--
Claim 12 recites, “(2)” in ln 8 which Examiner suggest amending to read --(ii)-- for consistency with “(i)” in ln 7.
Claims 13-15 are objected by dependency to claim 12
Claims 19-20 recite, “part of” the “first flow” or the “second flow” which Examiner suggest amending to read --a part of--
Claim 21 recites, “the first enclosed flow path” in ln 4 which Examiner suggest amending to read --the first flow path-- for consistency and possible avoid antecedent basis issue.
Claim 23 recites, “of the patient” in ln 7 which Examiner suggest amending to read --of a patient-- as it has not been recited previously.
Claim 23 recites, “a face over” in ln 8 which Examiner suggest amending to read --the face over--
Claim 23 recites, “of a patient” in ln 9 which Examiner suggest amending to read --of the patient--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 17 and 23-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites, “wherein the hyperpolarized noble gas” in ln 1-2 which renders claim indefinite. Claim 10 is dependent to claim 7, but the limitations of claim 7 and preceding claims of claim 7 do not introduce the “hyperbolized noble gas”. Thus, it is unclear whether said claim 10 is intended to be dependent to claim 9 or newly introduced in claim 10 as presented as dependent to claim 7 in order to avoid antecedent basis.
For the examination purposes, it is interpreted as claim 10 is dependent to claim 9.
Claim 17 recites, “air inlets of the inhalation delivery in the second position” in ln 3 and “an inhalation gas inlet of the inhalation device when the piston is in the first position” in ln 4-5 which renders claim indefinite. It is unclear whether the “air inlets” is a structure from the “first flow path” or newly introduced inlets as a new source of fluid and the “gas inlet” is a structure from the “bag of gas” or the “second enclosed flow path” or newly introduced gas inlet as a new source of fluid.
For the examination purposes, it is interpreted as to --the first flow path-- and --the second enclosed flow path-- respectively.
Regarding claim 23, the phrase "such as" in ln 3 renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the examination purposes, Examiner interprets as to --providing an inhalation delivery output member-- without the phrase “such as” and the limitation following the phrase.
Claims 24-26 are rejected by virtue of dependency to claim 23.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 8, 12-14 and 17-21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by White et al. (US 20230330376 A1).
Regarding claim 1, White et al. discloses, an inhalation gas delivery device (an assembly of Figs 19-21, and 23-24 for using different type of gas delivery such as via a resuscitation bag or a transport ventilator), comprising:
an inhalation delivery output member (an endotracheal tube connected to a connection port 550 as shown in Fig 23 while connected to 150 via an opening of a housing 102 of Fig 2-3);
a bag of gas (a resuscitation bag 514, Fig 23) in fluid configured for inhalation in fluid communication with the inhalation delivery output member (¶0053, 0107, manual ventilation which implies that the fluid communication with the endotracheal tube/connection port); and
an actuator assembly (a respiratory valve apparatus 100, Figs 1-2) comprising an actuator member (a piston assembly 108, Fig 2) coupled to the inhalation delivery output member, wherein the actuator member has a first position (a position where a spring 162 is in a non-compressed state shown in Fig 2) which allows room air to flow along a first flow path (a ventilator connection port 140 which is a ventilator connection port 540 of Fig 24) to the inhalation gas output member (the ventilator connection as shown in Fig 20; Examiner notes that the embodiments of Figs 19-21 are analogous to the Fig 23 as well as similar to Figs 2-3 as the position of the piston 560 would be position as shown in Fig 2 as described in ¶0096 and the first position is assisted by the pressure of a ventilator as described in ¶0083 in view of Fig 20; ¶0101, implies the air flow from the transport ventilator delivered to a patient. Examiner notes that the transport ventilator is capable of transferring room air so thus the delivery device of White et al. is capable of allowing room air to flow along a first flow path), and
wherein the actuator member has a second position (a position where the spring 162 is in a compressed state shown in Fig 3) which allows gas from the bag to flow along a second enclosed flow path to the inhalation gas output member (the bag is connected as shown in Fig 23; ¶0053,0068,0075-77,0107 implies that the airflow from the bag via the manual ventilation while a pathway P1 is blocked) thereby blocking air from entering the second enclosed flow path (the pathway P1 is blocked so thus blocking air from entering the second enclosed flow path as shown in Fig 3).
Regarding claim 2, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, a conduit (a resuscitation bag connector 515, Fig 23) in fluid communication with the actuator assembly (the bag connected to the valve assembly as shown in Fig 23) and a pressurized gas source (the bag 514 when compressed would provide a pressurized gas source, Fig 23) whereby a user pneumatically actuates the actuator member (when a user pneumatically connects the connector of the bag into the valve assembly by pushing against the spring through the opening, the actuator member moves to the second position as shown in Fig 3 in view of Fig 23), via the conduit, to move from the first position to the second position.
Regarding claim 8, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, an air vent closure member (a housing of the piston 160 forming an opening 168, Fig 3) that is coupled to the actuator member, wherein the air vent closure member slides linearly in concert with the actuator member as the actuator member moves from the first position to the second position (as the piston assembly moves from the non-compressed position to the compressed position as shown in Figs 2-3, the closure members slides along closing the passage of P1).
Regarding claim 12, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, wherein the actuator assembly comprises a housing (a housing 102, Figs 2-3) with an internal chamber (an internal chamber of the 102 as shown in Fig 2; See annotation below, Fig 2),
wherein the housing comprises an outer wall (see annotation below, Fig 2) with at least one fluid port (see annotation below, Fig 2), wherein the actuator member is a piston (a piston 160, Figs 2-3) in the internal chamber of the housing,
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wherein the piston comprises a first segment having a first outer diameter (P1 which an opening of the piston as shown in Fig 2; see annotation below, Fig 2) and a second segment having a second outer diameter in the internal chamber of the housing (P2 which is another opening of the piston as shown in Fig 3; see annotation below, Fig 3),
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wherein the piston comprises an open channel extending therethrough (either P1 or P2 for fluid communication as shown in Figs 2-3),
wherein the piston is configured to cooperate with the housing to (i) allow room air to flow through the piston to the inhalation gas output member when the piston is in the first position (P1 as shown in Fig 2 which allows air from the travel ventilator as discussed in claim 1 above) and (ii) block room air while also allowing gas from the bag to flow to the inhalation gas output member when the piston is in the second position (P2 as shown in Fig 2 which allows air from the travel ventilator as discussed in claim 1 above).
Regarding claim 13, White et al. discloses the device of claim 12 as discussed above.
White et al. further disclose, wherein the second segment comprises first and second seals (a second seal 184, a third seal 186 which are axially spaced apart and extending circumferentially as shown in Fig 3) axially spaced apart and extending circumferentially thereabout, wherein the first segment comprises at least one seal (a first seal 182 similarly arrange to the other seals as shown in Fig 2) extending circumferentially thereabout.
Regarding claim 14, White et al. discloses the device of claim 12 as discussed above.
White et al. further disclose, a conduit (a bag connector 515 which is connected to the bag and to the housing as shown in Fig 23) attached to the bag and to the housing, wherein the at least one fluid port comprises an actuator input port (a resuscitation bag connection port 512, Fig 23 which is 170 of Fig 3 showing the piston assembly in the compressed state when the bag is inserted as described in ¶0070-72) in fluid communication with the piston.
Regarding claim 17, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, wherein the actuator assembly comprises a piston (a piston 160, Figs 2-3) as the actuator member inside an internal chamber of a piston housing (an internal chamber of a housing 102 as shown in Fig 2, Fig 2), wherein the piston seals the first flow path of the inhalation delivery device in the second position (P2 of Fig 3 which allows air to flow into the second path when the piston is in compressed state) and the piston seals the second enclosed flow path of the inhalation delivery device when the piston is in the first position (P1 of Fig 2 which allows air to flow into the first path when the piston is in un-compressed state).
Regarding claim 18, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, a pressurized fluid source comprising a compressible bulb (514, Fig 23; ¶0057, “a resuscitation bag can include a bag valve mask, manual resuscitator, a transport ventilator, and/or an Ambu bag, including various embodiments known in the art for using with assisting with respiration”; Examiner notes that the Ambu bag, a bag valve, or manual resuscitator is a compressible) coupled to a length of conduit (a bag connector 515 “length” as to any length) and to the actuator assembly.
Regarding claim 19, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, wherein the inhalation delivery output member comprises a single branch (Examiner notes that the housing of the valve apparatus 100 is similar to T-connector, so thus it can be interpreted as a single branch or having plural of branches as one branch diverging to two branches or two branches converging into one branch as BRI. So, the P1 of Fig 2 can be interpreted as a part of the first flow path while P2 of Fig 3 interpreted as a part of the second flow path) that serially defines part of the first flow path and part of the second flow path.
Regarding claim 20, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, wherein the inhalation delivery output member comprises a first branch that defines part of the first flow path and a separate second branch that defines part of the second flow path Examiner notes that the housing of the valve apparatus 100 is similar to T-connector, so thus it can be interpreted as a single branch or having plural of branches as one branch diverging to two branches or two branches converging into one branch as BRI. So, the P1 of Fig 2 can be interpreted as a first branch while P2 of Fig 3 interpreted as a second branch).
Regarding claim 21, White et al. discloses the device of claim 1 as discussed above.
White et al. further disclose, wherein the actuator member comprises a piston (a piston 160, Figs 2-3) with a plurality of longitudinally spaced apart seals (seals 182, 184, 186, Figs 2-3) that extend circumferentially about the piston, and
wherein the actuator assembly is configured to allow air to flow into of the first flow path (P1 of Fig 2 which allows air to flow into the first path when the piston is in un-compressed state) when the piston is in the first position and is configured to allow only gas from the bag to flow into the second enclosed flow path (P2 of Fig 3 which allows air to flow into the second path when the piston is in compressed state) when the piston is in the second position.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brookman (US 20060048777 A1; cited in IDS filed on 10/31/2023).
Regarding claim 1, Brookman discloses, an inhalation gas delivery device (an assembly of Fig 1A), comprising:
an inhalation delivery output member (a facemask 20, Fig 1A);
a bag of gas (a compressed air tank 28, Fig 1A; Examiner interprets the “bag” as to a portable container for carrying as BRI) in fluid configured for inhalation in fluid communication with the inhalation delivery output member (¶0038, implies that a breathable air or oxygen from the tank is in fluid communication with the facemask); and
an actuator assembly (a pressure regulator 54, Fig 1A) comprising an actuator member (a control valve actuator 64 coupled to the facemask 20 as shown in Fig 1A) coupled to the inhalation delivery output member, wherein the actuator member has a first position (¶0041, “ A control valve actuator 64 can be operably connected to a control valve in the manifold 36 for controlling which air supply, either the PAPR 16 or the SCBA 18”; a position where air supply from a PAPR 16) which allows room air to flow along a first flow path (a conduit 22a, Fig 1A) to the inhalation gas output member, and
wherein the actuator member has a second position (¶0041, a position where air supply from SCBA; ¶0047, “The valve actuator 64 permits the user to manually switch the air source from the PAPR 16 to the SCBA 18”) which allows gas from the bag to flow along a second enclosed flow path (a conduit 22b, Fig 1A) to the inhalation gas output member thereby blocking air from entering the second enclosed flow path (¶0041, 47, implies that the switching between two sources would blocks air from entering from the controlled flow path).
Regarding claim 4, Brookman discloses the device of claim 1 as discussed above.
Brookman wherein the inhalation gas delivery device is configured to vent expiration breaths of inhaled air and inhaled gas to atmosphere (¶0019, “Where a face mask is used, it is suitably equipped with a one-way valve that enables exhausted, exhaled air to be vented”; ¶0046, “ When the user exhales, the inlet valve 51 of the face mask 20 closes and the exhaled air exits through an outlet port 47”; Fig 3).
Claims 1, 3, 9-10 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Albert et al. (US Pat 6467479 B1; cited in IDS filed on 10/31/2023).
Regarding claim 1, Albert et al. discloses an inhalation gas delivery device (a ventilator system 100 of Fig 1), comprising:
an inhalation delivery output member (a tracheal tube 108, Fig 1);
a bag of gas (a tedlar gas bag/special gas 122 in a sealed enclosure 120) in fluid configured for inhalation in fluid communication with the inhalation delivery output member (the gas bag is in fluid communication with tracheal tube as shown in Fig 1; Col 3, ln 15-17, “special gas 122 is allowed to flow into the patient via tracheal tube 108”); and
an actuator assembly (pneumatic valve assemblies, A - 114 and B - 110, Fig 1; Col 2, ln 29-43, “a system of valves for controlling the injection of special gas 122, and computer 124 for controlling the operation of ventilator 102 and the system of valves”) comprising an actuator member (110 which is connected to 108 as shown in Fig 1) coupled to the inhalation delivery output member, wherein the actuator member has a first position (Col 3, ln 7-17, “When pneumatic valve 110 is open, ventilator 102 is connected to tracheal tube 108 and ventilator 102 functions as does a normal ventilator”; a first position is when the valve is open) which allows room air to flow along a first flow path (an airways 104, Fig 1) to the inhalation gas output member (Col, 2, ln 28 - Col 3, ln 17, implies that the ventilator provides flow to the tracheal tube), and
wherein the actuator member has a second position (Col 3, ln 7-17, “When valve 110 is closed, special gas 122 is allowed to flow into the patient via tracheal tube 108”; a second position is when the valve is closed) which allows gas from the bag to flow along a second enclosed flow path (a flow path 112 to 110 as shown in Fig 1) to the inhalation gas output member thereby blocking air from entering the second enclosed flow path Col, 2, ln 28 - Col 3, ln 41, implies that the special gas flow to the tracheal tube while blocking air from entering as the valves are closed).
Regarding claim 3, Albert et al. discloses the device of claim 1 as discussed above.
Albert et al. further discloses, wherein the inhalation gas delivery device is non-ferromagnetic and configured for use in an MRI scanner room (Col 2, ln 25-28, “the components of ventilator system 100 were chosen so that ventilator system 100 could be used inside the bore of a MR or other magnetic device”; Examiner interprets the “non-ferromagnetic” as to components that are MRI compatible as BRI. As the magnet within an MRI is known to be strong, and given that the device is used specifically in the bore of the MR machine, it’s reasonable to conclude that the components aren’t magnetic for user’s safety and to avoid machine malfunction).
Regarding claim 9, Albert et al. discloses the device of claim 1 as discussed above.
Albert et al. further discloses, wherein the gas in the bag comprises hyperpolarized noble gas (Col 1, ln 18-25, “Hyperpolarized noble gasses such as Xenon 129 and Helium 3 work particularly well for this purpose”; Col 3, ln 17-20, “Special gas 122 is kept inside a Tedlar gas bag, which is a flexible bag that can compress as the special gas is expelled from the bag”; claim 3, wherein said special gas is Xenon), and wherein the inhalation gas delivery device is non- ferromagnetic (Col 2, ln 25-28, “the components of ventilator system 100 were chosen so that ventilator system 100 could be used inside the bore of a MR or other magnetic device”; Examiner interprets the “non-ferromagnetic” as to components that are MRI compatible as BRI. As the magnet within an MRI is known to be strong, and given that the device is used specifically in the bore of the MR machine, it’s reasonable to conclude that the components aren’t magnetic for user’s safety and to avoid machine malfunction).
Regarding claim 10, Albert et al. discloses the device of claim 1 as discussed above.
Albert et al. further discloses, wherein the hyperpolarized noble gas is 129Xe (Col 1, ln 18-25; claim 3).
Regarding claim 16, Albert et al. discloses the device of claim 1 as discussed above.
Albert et al. further discloses, wherein the actuator assembly comprises a housing (an exterior of the pneumatic valve 110 that houses the actuating member as shown in Fig 1), wherein the housing comprises an outer wall with first and second fluid ports (ports that communicate between the ventilator and the tedlar gas as shown in Fig 1), the first fluid port in fluid communication with the bag via a length of conduit (a path from tedlar gas bag to the valve 110 as shown in Fig 1) and the second fluid port in fluid communication with a pressurized fluid source (Col 3, ln 7-17, implies the second fluid port is in fluid communication from a pressurized air from the ventilator) configured to actuate the actuator member to move to the second position (Col 3, ln 7-17; Examiner interprets as to --the housing configured to actuate the actuator-- directly or indirectly as the actuator member is held by the housing and moved by the pressure to open or close).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-7, 11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 20230330376 A1) as applied to claim 1 above and in further view of Ogawa (US 20120027628 A1)
Regarding claim 5, White et al. discloses the device of claim 1 as discussed above.
While White et al. disclose the actuator member comprises a piston (108, Figs 2-3) and a stroke movement of the actuator member between the first and second position as shown in Figures 2-3, White et al. is silent on a travel distance of the piston in a range of 3 mm and 30 mm between the first and second positions.
However, Ogawa which is analogous art to the claimed invention related to the ventilation for medical usage (¶0001), teaches a stroke movement of a piston and a travel distance about 1 mm to 10 mm (¶0094, “an identical stroke length of about 1 mm to 10 mm”). In the case where the claimed range is overlapped by a range found in the prior art, a prima facie case of obviousness exists (see MPEP 2144.05 I).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of White et al. to include a stroke distance in a range of 1 mm and 10 mm between the first and second positions for the piston as taught by Ogawa as the stroke distance/length is known in the medical ventilation.
Looking at other consideration, Examiner notes that White et al. discloses diameters of a male connection and a female connection of the ports are 15 mm and 22 mm (¶0092). Since the piston of White et al. moves linearly about roughly the diameter of the port, one of the ordinary skills in the art would have recognize the stroke distance of the piston would have been range of 3 mm and 30 mm in view of Figures 2-3.
Regarding claim 6, White et al. in view of Ogawa discloses the device of claim 5 as discussed above.
Modified White et al. discloses, wherein the stroke distance is in a range of about 1 mm and about 10 mm (Ogawa: ¶0094; see MPEP 2144.05 I as discussed above, and note that the claimed range of 5-10 mm lies inside the prior art disclosed range of 1-10 mm).
Regarding claim 7, modified White et al. discloses the device of claim 5 as discussed above.
White et al. further discloses, wherein the actuator assembly comprises a housing (a housing 102, Fig 2) that encloses at least part of the piston (160 is enclosed within the housing), wherein the housing comprises at least one air inlet (an opening 170 for connecting the airbag and an opening near 140 for connecting the ventilator as shown in Fig 2), and wherein the actuator assembly closes the at least one air inlet when the actuator member is in the second position (when the piston is in compressed state as shown in Fig 3, one of the air inlets are closed).
Regarding claim 11, modified White et al. discloses the device of claim 1 as discussed above.
While White et al. discloses, wherein the bag and the actuator assembly are connected to the inhalation output member as shown in Fig 23, White et al. is silent on wherein the bag and the actuator assembly reside a distance in a range of about 0.1 inches (2.54 mm)-12 inches (30.4 cm) from the inhalation delivery output member.
However, White et al. teaches wherein the bag and the actuator assembly reside a distance in from the inhalation delivery output member in Figure 23 as annotated below, and thus it is a results effective variable. One of the ordinary skills in the art would have try different distance between the patient and the valve assembly with the air bag in order to have optimal configuration based on a placement of the patient within a room.
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of White et al. to include wherein the bag and the actuator assembly reside a distance in a range of about 0.1 inches (2.54 mm)-12 inches (30.4 cm) from the inhalation delivery output member as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (see MPEP 2144.05).
Regarding claim 23, a method of providing inhalable gas for a medical procedure (abstract, “methods related to embodiments of a respiratory valve apparatus…a first flow pathway that allows fluid flow between the first and third ports when in the first position and a second flow pathway that allows fluid flow between the second and third ports when in a second position”), comprising:
providing a bag of inhalable gas (a resuscitation bag 514, Fig 23);
providing an inhalation delivery output member such as a mouthpiece (an endotracheal tube connected to a connection port 550 as shown in Fig 23 while connected to 150 via an opening of a housing 102 of Fig 2-3);
connecting an actuator assembly (a respiratory valve apparatus 100, Figs 1-2) to the bag and to the inhalation delivery output member (as shown in Fig 23),
placing the inhalation delivery output member on in a mouth of a patient (Fig 23; ¶0062, “The endotracheal tube may be at least partially disposed within a patient”; Examiner notes that the endotracheal tube is known to be inserted via a mouth of a patient);
directing the patient to inhale practice room air breaths with the inhalation delivery output member in the mouth (abstract; ¶0003-0008, implies that the respiratory valve is to direct the patient to inhale room air breaths via the endotracheal tube in the mouth between the airbag or the transport ventilator) while an actuator member of the actuator assembly is in a first position (a position where a spring 162 is in a non-compressed state shown in Fig 2) providing open air inlets (the ventilator connection as shown in Fig 20; ¶0101, implies the air flow from the transport ventilator delivered to a patient. Examiner notes that the transport ventilator is capable of transferring room air so thus the delivery device of White et al. is capable of allowing room air to flow along a first flow path); and
then actuating the actuating assembly to move the actuator member to a second position (a position where the spring 162 is in a compressed state shown in Fig 3) to close the air inlets and open gas intake inlets to provide a flow path that directs gas from the bag of inhalable gas to flow to the inhalation delivery output member for inhalation by the patient (the bag is connected as shown in Fig 23; ¶0053,0068,0075-77,0107 implies that the airflow from the bag via the manual ventilation while a pathway P1 is blocked; the pathway P1 is blocked so thus blocking air from entering the second enclosed flow path as shown in Fig 3).
While White et al. discloses, wherein the bag and the actuator assembly are connected to the inhalation output member as shown in Fig 23, White et al. is silent on wherein the bag and the actuator assembly reside a distance in a range of about 0.1 inches (2.54 mm)-12 inches (30.4 cm) from the inhalation delivery output member.
However, White et al. teaches wherein the bag and the actuator assembly reside a distance in from the inhalation delivery output member in Figure 23 as annotated below, and thus it is a results effective variable. One of the ordinary skills in the art would have try different distance between the patient and the valve assembly with the air bag in order to have optimal configuration based on a placement of the patient within a room.
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of White et al. to include wherein the bag and the actuator assembly reside a distance in a range of about 0.1 inches (2.54 mm)-12 inches (30.4 cm) from the inhalation delivery output member as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." (see MPEP 2144.05).
Claims 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 20230330376 A1) as applied to claims 1 and 23 above, and in further view of Kim et al. (machine translation of CN 212282454).
Regarding claim 22, White et al. discloses the device of claim 1 as discussed above.
While White et al. discloses the resuscitation bag connected to the valve assembly as shown in Fig 23 (¶0099), White et al. does not specifically discloses, a bag holder configured to hold at least part of the bag a distance above a table or bed of a scanner when the inhalation delivery output member is inserted into a patient to thereby reduce or remove any torque arm generated onto the inhalation delivery output member to reduce any retention force needed to be applied by the patient to retain the inhalation delivery output member in a mouth of the patient.
However, Kim et al. which is analogous art to the claimed invention for supplying gas to a patient using an oxygen storage bag by the medical care personnel squeezing the bag and identifies a problem when the personnel is required to hold a mask and to squeeze the bag (PG 1-2, section, “Technical field” and “Background Technology”), teaches a bag holder (a bracket assembly of Fig 2 holding the air bag as shown in Fig 1) configured to hold at least part of the bag a distance above a table or bed of a scanner (PG 5, ln 13 - PG 6, ln 34, implies that that the brackets are capable of being adjusted to suitable different heights in purpose of supporting to the height of the pressing medical staff and the mounting frame can be fixed on the medical bed. Examiner notes that the bracket is capable of allowing the bag to be held at distance above the medical bed as needed) when the inhalation delivery output member is inserted into a patient to thereby reduce or remove any torque arm generated onto the inhalation delivery output member to reduce any retention force needed to be applied by the patient to retain the inhalation delivery output member in a mouth of the patient (PG 1-2, section, “Background Technology”; PG 4, ln 23-38; PG 5, ln 13 - PG 6, ln 34; Examiner interprets as to a function language after the phrase “when”. Examiner notes that the bracket assembly is capable of reducing/removing any torque arm generated onto the output member as the bracket assembly holds the bag in place so that the medical personnel does not need to support the face mask while squeezing the airbag).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of White et al. to include a bag holder configured to hold at least part of the bag a distance above a table or bed of a scanner when the inhalation delivery output member is inserted into a patient to thereby reduce or remove any torque arm generated onto the inhalation delivery output member to reduce any retention force needed to be applied by the patient to retain the inhalation delivery output member in a mouth of the patient as taught by Kim et al. in purpose of convenience for the medical staff using the bag (PG 2, ln 13 - PG 3, ln 11).
Regarding claim 25, modified White et al. discloses the method of claim 23 as discussed above.
While White et al. discloses the resuscitation bag connected to the valve assembly as shown in Fig 23 (¶0099), White et al. does not specifically discloses, placing the bag of inhalable gas into a bag holder.
However, Kim et al. which is analogous art to the claimed invention for supplying gas to a patient using an oxygen storage bag by the medical care personnel squeezing the bag and identifies a problem when the personnel is required to hold a mask and to squeeze the bag (PG 1-2, section, “Technical field” and “Background Technology”), teaches placing the bag of inhalable gas into a bag holder (a bracket assembly of Fig 2 holding the air bag as shown in Fig 1; PG 5, ln 13 - PG 6, ln 34, implies that that the brackets are capable of being adjusted to suitable different heights in purpose of supporting to the height of the pressing medical staff and the mounting frame can be fixed on the medical bed. Examiner notes that the bracket is capable of allowing the bag to be held at distance above the medical bed as needed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of White et al. to include placing the bag of inhalable gas into a bag holder as taught by Kim et al. in purpose of convenience for the medical staff using the bag (PG 2, ln 13 - PG 3, ln 11).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over White et al. (US 20230330376 A1) in view of Kim et al. (machine translation of CN 212282454) as applied to claim 25 above and in further view of Albert et al. (US Pat 6467479 B1; cited in IDS filed on 10/31/2023).
Regarding claim 26, modified White et al. in view of Kim et al. discloses the method of claim 25 as discussed above
Modified White et al. is silent on a material of the bag holder.
However, Albert et al. which is analogous art to the claimed invention for having a similar configuration to the White et al. such as a respiratory valve which switches between a ventilator and an airbag to a patient with tracheal tube (abstract; Fig 1) teaches a method of use of MRI environment (abstract) and wherein the ventilation system is non-ferromagnetic and configured for use in an MRI scanner room (Col 2, ln 25-28, “the components of ventilator system 100 were chosen so that ventilator system 100 could be used inside the bore of a MR or other magnetic device”; Examiner interprets the “non-ferromagnetic” as to components that are MRI compatible as BRI. As the magnet within an MRI is known to be strong, and given that the device is used specifically in the bore of the MR machine, it’s reasonable to conclude that the components aren’t magnetic for user’s safety and to avoid machine malfunction).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of White et al. to include wherein the bag holder is non-ferromagnetic as taught by Albert et al. in purpose of MRI compatible assembly.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 24 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reasons for Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding the subject matters of claims 15 and 24, the closest identified prior art document of record is White et al. (US 20230330376 A1), and Albert et al. (US Pat 6467479 B1; cited in IDS filed on 10/31/2023).
Regarding claim 15, White et al. discloses the main components of the claims 1 and 12 and the actuating of the valve of White et al. is achieved by the pressing the output of the airbag portion to the valve assembly, but the prior art does not specifically suggest or teach a length of conduit coupled to the housing and in fluid communication with a pressurized fluid source, wherein the length of conduit cooperates with the housing to direct pressurized fluid from the fluid source toward a working surface of the piston whereby pressurized fluid input into the housing from the conduit actuates the piston to move to the second position.
Regarding claim 24, Albert et al. discloses, the hyperpolarized gas which can be Xenon (Col 1, ln 18-25, “Hyperpolarized noble gasses such as Xenon 129 and Helium 3 work particularly well for this purpose”; Col 3, ln 17-20, “Special gas 122 is kept inside a Tedlar gas bag, which is a flexible bag that can compress as the special gas is expelled from the bag”; claim 3, wherein said special gas is Xenon) and suggest having a conduit that has a length of 1-10 feet as the prior art is silent on the specific dimension while presenting conduits between the two sources of gas to the valve assembly as shown in Fig 1, but the prior art does not specifically teach or disclose, wherein the actuator assembly and the bag reside within 0.1-12 inches (2.54 mm-30.48 cm) from a face of the patient.
No other prior art is found which alternately would obviously satisfy the overall requirements of the instant claim. It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
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/J.J./Examiner, Art Unit 3785
/PAIGE KATHLEEN BUGG/Primary Examiner, Art Unit 3785
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