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 .
Response to Amendment
Examiner acknowledges the reply filed on 12/17/2025 in which claims 17-33 have been amended and claims 18-19 have been canceled. Currently, claims 17 and 20-33 are pending for examination in this application.
Response to Arguments
Applicant has resolved the claim objections and rejections under 35 USC 112(b). However, additional objections have been added.
Applicant has resolved the objections to the specifications.
Applicant's arguments, see Remarks pg. 7-9, filed 12/17/2025 have been fully considered but they are not persuasive. Applicant argues that Phillips lacks any structural protrusions extending inwardly to contact or pressurize the membrane. However, as noted in the previous office action, figure 1 of Phillips clearly depicts the end of flexible tube 42 protrudes into the flexible enclosure 39 which is marked at aperture 44, the end of flexible tube 42 is also seen directly contacting the bladder 18 in this figure. Thus, the end of flexible tube 42 is the claimed protrusion. The end of flexible tube 42 pressurizes the bladder 18 as air is blown into the mouthpiece end 45 and out of the aperture 44 and the end the flexible tube 42. Phillips only teaches one flexible tube 42. The Kim reference is relied upon solely for teaching a plurality of the air inlets 124 and elastic partitions 122 that function to pressurize the air bag 10, and modifying Phillips to have multiple of the mechanism that pressurizes the air bag which is the flexible tube 42 which functions to pressurize the blabber 18. Kim teaches the benefits of having a plurality of the mechanisms for pressurizing the air bag is to be able to more finely adjust the capacity of the air bag 10 [0048] and thus the air delivered to the patient.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 32 and 33 are objected to because of the following informalities:
Claim 32 line 3, “the pressure chamber” should be “the tubular membrane” as the tubular membrane is the structure that is collapsed into a tricuspid shape, as supported by Applicant’s specification pg. 5 line 24-34. Examiner is interpreting the claim as “collapsing the tubular membrane into a tricuspid shape”.
Claim 33 is identical to claim 20 and they both depend on claim 17, as such claim 33 should be canceled.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 17, 20, 23-25, 30, and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US 5427091 A) and Kim (KR 101819065 B1).
Regarding claim 17, Phillips discloses a respirator (bag valve mask resuscitator; figure 1-3), comprising:
an air bag that is pressurized to provide air to a user (squeezable bladder 18; col. 3 line 58-61; figure 1-2),
wherein the air bag is a tubular membrane (bladder 18; figure 1-2) housed within a pressure chamber (flexible enclosure 36; col. 4 line 14-27);
wherein the pressure chamber comprises a fluid inlet and outlet (inlet/outlet at aperture 44; figure 1-3; see col. 4 line 24-34), the fluid pressurizing the tubular membrane to provide air to a user (A flexible tube 42 connects to an aperture 44 in the flexible enclosure 36 and has a mouthpiece 45 at the exterior end for an operator to blow into the tube 42 and hence pressurize the flexible enclosure 36; col. 4 line 24-27. FIG. 2 illustrates the situation when an operator has blown through the tube 42, pressurized the flexible enclosure 36 and built up sufficient pressure in the enclosure 36 to deflate or compress the bladder 18. Thus, oxygen in the bladder 18 flows through the face mask 10 into the lungs of a patient; col. 4 line 36-41), and
wherein the pressure chamber comprises a protrusion extending inwardly and configured to pressurize the tubular membrane (see figure 1, end of flexible tube 42 extending inwardly and protruding into flexible enclosure 36 forms a protrusion at aperture 44. Examiner notes the end of flexible tube 42 pressurizes the bladder 18 as air is blown into the mouthpiece end 45 and out of the aperture 44 and the end the flexible tube 42). Phillips teaches a protrusion and a fluid inlet and outlet but does not teach a multiple fluid inlets and outlets and multiple protrusions.
However, Kim teaches a variable capacity air mask bag unit (AMBU) 1; figure 1-4) comprising a plurality of fluid inlets (air inlet 124; figure 1-3) pressurizing the tubular membrane to provide air to a user ([0045] The elastic partition (122) that partitions the capacity control unit (120) is made of rubber or silicon and can be expanded within a set range by injecting air from the outside into the capacity control unit (120). Therefore, the capacity (air injection amount) of the air receiving unit (100) can be increased or decreased according to the patient's age, gender, and physical condition through the number of inflatable capacity control units (120) or the contraction/inflation combination of two or more capacity control units (120). [0046] Each capacity control unit (120) may be provided with at least one air inlet (124). Accordingly, the user can change the capacity of the air receiving portion (100) by directly blowing air into the air inlet (124) to expand each capacity control portion (120)). Additionally, Kim teaches [0049] Of course, if the capacity adjustment parts (120) are formed in a larger number in a continuous manner in the circumferential direction, the capacity of the air pocket (10) can be adjusted more finely.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Phillips to implement multiple means of pressurizing the tubular membrane by increasing the number of air inlet tubes as seen in Phillips in order to more finely adjust the capacity of the air bag and thus the air delivered to the patient according to the patient's age, gender, and physical condition, as taught by Kim (see [0045-0046] and [0049]).
As modified, Phillips would include fluid inlets and outlets in the form of inlet/outlet at aperture 44 of each of the flexible tubes. As modified Phillips would include protrusions in the form of the end of flexible tube 42 at each of the flexible tubes extending inwardly and protruding into flexible enclosure 36.
Regarding claim 20, modified Phillips teaches the respirator according to claim 17, wherein the fluid inlets and outlets (inlet/outlet at aperture 44; figure 1-3) are arranged in the plurality of protrusions located inside the pressure chamber (Examiner notes: end of flexible tube 42 extending inwardly and protruding into flexible enclosure 36 forms a protrusion at aperture 44, see figure 1-3. As modified above there are a plurality of fluid inlets and outlets formed by each flexible tube 42 and a plurality of protrusions formed by the end of each of the flexible tube 42 where the aperture 44 is arranged).
Regarding claim 23, modified Phillips teaches the respirator according to claim 17, wherein the pressure chamber comprises one or more exhaust valves (purge valve 46; figure 1-3) for the exhaust of air from the pressure chamber (The air from the enclosure 36 is vented to the atmosphere at the purge valve 46; col. 4 line 32-34).
Regarding claim 24, modified Phillips teaches the respirator according to claim 17, wherein the pressure chamber comprises a support flange (flange at straps 38,40; figure 1-3).
Regarding claim 25, modified Phillips teaches the respirator according to claim 17, wherein the pressure chamber comprises flanges (flanges at straps 38,40; figure 1-3) arranged to secure the tubular membrane to the pressure chamber (A flexible enclosure 36, shown separately in FIG. 3, which is in the form of a sheet plastic tubular sleeve, fits over the bladder 18 and has a first strap 38 which reduces one end of the enclosure 36 and clamps it to the outlet collar 20. This provides a substantially sealed connection between the flexible enclosure 36 and the outlet collar 20. A second strap 40 reduces the other end of the flexible enclosure 36 and clamps it to the inlet collar 22 and seals it therearound. Thus, the bladder 18 is contained within a substantially sealed flexible enclosure; col. 4 line 14-24; figure 1-2).
Regarding claim 30, modified Phillips teaches the respirator according to claim 17, further comprising a portable power source (collapsible oxygen reservoir 26; figure 1-2. Examiner is interpreting power source to be some sort of oxygen or air source in light of Applicant’s Specifications, pg. 2 line 20-23).
Regarding claim 32, modified Phillips teaches the respirator according to claim 17, wherein the plurality protrusions of the pressure chamber physically press by dimensional interference against the tubular membrane (Examiner notes: see figure 1, end of flexible tube 42 extending inwardly and protruding into flexible enclosure 36 forms a protrusion at aperture 44 that presses against the bladder 18. As modified above there are a plurality of fluid inlets and outlets and thus a plurality of protrusions formed by end of flexible tube 42), but is silent as to collapsing the pressure chamber into a tricuspid shape (Examiner is interpreting as “collapsing the tubular membrane into a tricuspid shape” as per the Claim Objections above) in an orderly and sequential manner (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)).
However, Kim teaches [0049] Of course, if the capacity adjustment parts (120) are formed in a larger number in a continuous manner in the circumferential direction, the capacity of the air pocket (10) can be adjusted more finely.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Phillips multiple means of pressurizing the tubular membrane by increasing the number of air inlet tubes to three as seen in Phillips, 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The motivation for doing so would be to more finely adjust the capacity of the air bag according to the patient's age, gender, and physical condition and thus the air delivered to the patient, as taught by Kim (see [0045] and [0049]). As modified Phillips would include three protrusions in the form of end of flexible tube 42 extending inwardly and protruding into flexible enclosure 36 forms a protrusion at aperture 44 that presses against the bladder 18 at each of the flexible tubes capable of collapsing the bladder into a tricuspid in an orderly and sequential manner by the action of air being blown into each flexible tube (see Phillips col. 4 line 36-41).
Regarding claim 33, modified Phillips discloses the respirator according to claim 17, wherein the fluid inlets and outlets (inlet/outlet at aperture 44; figure 1-3) are arranged in the plurality of protrusions located inside the pressure chamber (Examiner notes: end of flexible tube 42 extending inwardly and protruding into flexible enclosure 36 forms a protrusion at aperture 44, see figure 1-3. As modified above there are a plurality of fluid inlets and outlets formed by each flexible tube 42 and a plurality of protrusions formed by the end of each of the flexible tube 42 where the aperture 44 is arranged).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US 5427091 A) and Kim (KR 101819065 B1) as applied to claim 17 above, and further in view of Cook (GB 2139099 A).
Regarding claim 21, modified Phillips teaches the respirator according to claim 17, but is silent as to wherein the pressure chamber comprises a flat membrane as a seal and diaphragm.
Phillips teaches an inlet collar 22 is provided at the other end of the bladder 18. This inlet collar 22 is substantially rigid and has included therein a flap valve (not shown) that permits air and oxygen to pass into the bladder 18, but prevents gas passing out through the inlet collar 22 when the bladder 18 is compressed or squeezed; col. 3 line 60-65; figure 1-2.
Additionally, Cook teaches a resuscitator (figure 1-3) comprising a flat membrane as a seal and diaphragm (a second diaphgragm valve 40 and a diaphragm body 42. Diaphragm 40 and body 42 define a one-way valve, such valves being well known in the art. In the present invention, fluid is permitted to flow into bag 12 through openings 45 only in the direction of arrows 100. Diaphragm 40 is preferably mounted on protrusion 44 centrally located on body 42 as it is also conventional in the art. In the operation of assembly 10, as squeeze bag 12 is depressed, internal pressure causes the diaphragm 40 to press against diaphragm body 42 and thus closes off openings 100 and the second end 16 of the bag 12; pg. 2 line 54-72).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Phillips to implement a flat diaphragm valve at the inlet collar as a seal, in order to permit fluid flow into the bag in one direction and prevent flow in the opposite direction, as taught by Cook pg. 2 line 54-72.
Claim(s) 22 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US 5427091 A) and Kim (KR 101819065 B1) as applied to claim 17 above, and further in view of Bisera et al. (US 4409977 A).
Regarding claim 22, modified Phillips teaches the respirator according to claim 17, but is silent as to wherein the tubular membrane comprises an upstream non-return valve and a downstream non-return valve.
However, Bisera teaches an air bag comprising a tubular membrane housed within a pressure chamber (a compressible container 20 such as a flexible bag, which lies within a housing 22 forming a pump chamber 24; col. 2 line 42-44; figure 1-2), wherein the tubular membrane comprises an upstream non-return valve (check valve 30; figure 1-2. The bag 20 has entrance and exit ends 26, 28 with openings therein that are connected to check valves 30, 32. Each of the check valves 30, 32 can be of the simple type shown in FIG. 3 which utilizes a ball 34 held against a valve seat by a spring 36 to permit air flow in only a downward direction for the orientation of FIG. 1; col. 2 line 44-50. a compressible container such as a flexible bag, having check valves at its entrance and exit openings and lying within a pump chamber; col. 4 line 61-64) and a downstream non-return valve (check valve 32; figure 1-3. The bag 20 has entrance and exit ends 26, 28 with openings therein that are connected to check valves 30, 32. Each of the check valves 30, 32 can be of the simple type shown in FIG. 3 which utilizes a ball 34 held against a valve seat by a spring 36 to permit air flow in only a downward direction for the orientation of FIG. 1; col. 2 line 44-50. a compressible container such as a flexible bag, having check valves at its entrance and exit openings and lying within a pump chamber; col. 4 line 61-64).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the tubular membrane of Phillips to implement an upstream and downstream non-return valve in order to control flow of air into and out of the air bag, as taught by Bisera col. 4 line 61-64.
Regarding claim 26, modified Phillips teaches the respirator according to claim 17, but is silent as to also further comprising a control panel.
However, Bisera teaches an air bag comprising a tubular membrane housed within a pressure chamber (a compressible container 20 such as a flexible bag, which lies within a housing 22 forming a pump chamber 24; col. 2 line 42-44; figure 1-2) comprising a control panel (pressure pulse source 46 detailed in figure 2 comprising elements 54, 56, 50, 58, and 60; col. 2 line 64-col. 3 line 32).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Phillips to implement a control panel comprising the elements disclosed in Bisera in order to automatically air delivery and control the rate at which air pulses are delivered to the patient (see Bisera, col. 2 line 64-col. 3 line 32)
Regarding claim 27, modified Phillips teaches the respirator according to claim 26, Bisera teaches wherein the control panel comprises a solenoid valve configured to regulate air intake into the space between the tubular membrane and the pressure chamber (FIG. 2 illustrates details of the pressure pulse source 46. The apparatus is powered primarily from pressured air, such as at a pressure of 50 psi which is commonly available in a hospital environment. This high pressure is delivered through a tube 49 and through a pressure regulator and valve 50 which is cycled to open and close to deliver pressure pulses of about 30 psig to the pump chamber inlet 42. The compressed air delivered through the tube 48 is also delivered through a venturi device 54, so that a vacuum can be obtained from the throat of the venturi for delivery to the pump inlet 42 when a high pressure pulse is not being delivered thereto. The pneumatic regulator-valve 50 is opened and closed by a solenoid 56 which is operated by a low frequency voltage controlled oscillator 58; col. 3 line 8-22).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US 5427091 A), Kim (KR 101819065 B1), and Bisera et al. (US 4409977 A) as applied to claim 27 above, and further in view of Oddo et al. (US 20200386333 A1).
Regarding claim 28, modified Phillips teaches the respirator according to claim 27, but is silent as to wherein the solenoid valve is connected to a programmable logic controller.
Bisera teaches the pneumatic regulator-valve 50 is opened and closed by a solenoid 56 which is operated by a low frequency voltage controlled oscillator 58.
However, Oddo teaches a solenoid valve connected to a programmable logic controller ([0024] This controller 504 can be in the form of an FPGA, MCU, single board computer, ASIC, PLC on a chip, and/or other processing or computer hardware that can control the ON/OFF or OPEN/CLOSE cycles of the valve 502 (e.g., solenoid valve); figure 1-A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the modified Phillips device to include a PLC on a chip, as taught by Oddo, as it would have been obvious substitution of one known element for another, using the PLC on a chip connected to the solenoid valve taught by Oddo in place of the oscillator of modified Phillips, and would provide predictable results, controlling the opening/closing cycles of the solenoid valve (see Oddo [0024]).
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over B Phillips (US 5427091 A), Kim (KR 101819065 B1), and Bisera et al. (US 4409977 A) as applied to claim 26 above, and further in view of Bergman (US 20110041852 A1).
Regarding claim 29, modified Phillips teaches the respirator according to claim 26, but is silent as to wherein the control panel comprises a pressure sensor.
However, Bergman teaches an AMBU-Bag Automation System (100; figure 1-9) including a control panel (housing 112; figure 1-5 and 7-9) comprising a pressure sensor ([0090] Controller 122 may receive input and/or provide controlling output to squeezer 6, both in terms of cyclical frequency as well as squeezing volume, or both, or neither, as previously described. Optionally, one or more sensors may be placed on the compression squeezers and/or the outside service of the AMBU-bag. For example, such sensors may detect pressure and/or displacement. A pressure sensor may be used to correlate to the amount of back pressure in the patient's lungs. By providing such optional sensors and feedback (not illustrated in the drawings), the controller/microprocessor 122 may receive data input therefrom. Optionally, such data input may be used to fully or partially automate and/or self-adjust the amount of squeezing pressure and/or volume, such as to accommodate the various physiologies of various patients; figure 9).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the control panel of modified Phillips to implement a pressure sensor and a controller in order to provide real-time feedback control and automation of air being delivered to the patient to accommodate the various physiologies of various patients, as taught by Bergman [0090].
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillips (US 5427091 A) and Kim (KR 101819065 B1) as applied to claim 30 above, and further in view of Kim et al. (US 20130180527 A1), hereinafter Kim_D.
Regarding claim 31, modified Phillips teaches the respirator according to claim 30, but is silent as to wherein the portable power source is a compressed gas, medical air, or oxygen cylinder.
However, Kim_D teaches a bag valve mask (figure 1) comprising an oxygen cylinder ([0047] The BVM of the present invention may further include an oxygen or air cylinder disposed at the air bag 20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Boesherz device to include an oxygen cylinder, as taught by Kim_D, as it would have been obvious substitution of one known element for another, using the oxygen cylinder taught by Kim_D in place of the collapsible oxygen reservoir of Phillips, and would provide predictable results, directing oxygen to a patient when the air bag is pressurized (see Kim_D [0047]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mautin I Ashimiu whose telephone number is (571)272-0760. The examiner can normally be reached Monday - Friday, 7:30 a.m. - 4:30 p.m. ET.
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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785