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
The amendment filed 1/22/2026 has been entered. Claim 15 been amended. Claims 1-20 remain pending.
Drawings
The drawings were received on 1/22/2026. These drawings are unacceptable. Figures 7-9 are not entered because they contain new matter. To obtain entry upon resubmission, any new matter, particularly in regards to the arm, the weight member, and the spring-operated member, must be removed.
Specification
The amendment filed 1/22/2026 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
The original disclosure does not have support for a controller member (131) in addition to an arm (137), a weight member (139A 139B), or a spring-operated member (138). The original disclosure states that the controller member may be an arm, a weight member, or a spring-operated member.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 16 recites the limitation “the controller member is a regulator to regulate size of the inflation bag by providing resistance to the pressured air going to the inflation bag from the air vessel”. Applicant’s specification states that the regulator regulates the air flow inside the inflation bag (par. 0030). Applicant’s specification does not provide any description on how the regulator is operated to vary the tidal volume. The Applicant’s specification fails to teach how to make and use the claimed invention without undue experimentation and therefore, fails to comply with the enablement requirement.
Claim 17 recites the limitation “the controller member is an arm to regulate size of the inflation bag by providing resistance to the pressured air going to the inflation bag from the air vessel”. Applicant’s specification states that the controller member may be an arm to regulate size of the inflation bag by providing resistance to the pressured air going to the inflation bag (par. 0030). Applicant’s specification does not provide any description on how the arm is operated to vary the tidal volume. The Applicant’s specification fails to teach how to make and use the claimed invention without undue experimentation and therefore, fails to comply with the enablement requirement.
Claim 18 recites the limitation “the controller member is a weight member to regulate size of the inflation bag by providing resistance to the pressured air going into the inflation bag from the air vessel”. Applicant’s specification states that the controller member may be a weight member to regulate size of the inflation bag by providing resistance to the pressured air going to the inflation bag (par. 0030). Applicant’s specification does not provide any description on how the weight member is operated to vary the tidal volume. The Applicant’s specification fails to teach how to make and use the claimed invention without undue experimentation and therefore, fails to comply with the enablement requirement.
Claim 19 recites the limitation “the controller member is a spring-operated member to regulate size of the inflation bag by providing resistance to the pressured air going into the inflation bag from the air vessel”. Applicant’s specification states that the controller member may be a spring-operated member to regulate size of the inflation bag by providing resistance to the pressured air going to the inflation bag (par. 0030). Applicant’s specification does not provide any description on how the spring-operated member is operated to vary the tidal volume. The Applicant’s specification fails to teach how to make and use the claimed invention without undue experimentation and therefore, fails to comply with the enablement requirement.
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.
Claims 1, 3-11, 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bergman (US 20120145151 A1).
Regarding claim 1, Bergman discloses a ventilator comprising: at-least one air vessel (Fig. 1C-1E, attachment 130); at-least one inflation bag (Fig. 1C, flexible squeeze bag 200); at-least one connecting member to connect the at-least one air vessel and the at- least one inflation bag (Fig. 1C, intake tube 104 connects vessel 130 to inflation bag 200); and at-least one controller member configured to operate the at-least one inflation bag (Fig. 1C, member 204 squeezes the inflation bag 200; par. 0119) thereby changing size of the inflation bag to vary a tidal volume and an inspiration- expiration ratio of the ventilator (volume and rate of squeezing is adjustable; par. 0102-0103), wherein the changing of the size of the inflation bag to vary the tidal volume and the inspiration-expiration ratio of the ventilator uses no electrical power (powered actuator can be operated by mechanical, hydraulic, or pneumatic power; par. 0078).
Regarding claim 3, Bergman discloses the ventilator of claim 1 (shown above), wherein the at-least one controller member is configured to change size of the inflation bag by performing contraction and expansion of the inflation bag (member 204 squeezes and releases the inflation bag 200; par. 0119).
Regarding claim 4, Bergman discloses the ventilator of claim 1 (shown above), wherein the at-least one controller member is at-least one pushing member for performing to and fro motion with a bag holder (Fig. 1C, 6G, member 204 slides along guides 230 and 232 within the housing 112 to squeeze and release the inflation bag 200; par. 0119).
Regarding claim 5, Bergman discloses the ventilator of claim 1 (shown above), wherein the inflation bag is a bag-valve-mask and the bag-valve-mask is configured to be squeezed and expanded (inflation bag 200 is described as a flexible squeeze bag of an AMBU-bag, par. 0091).
Regarding claim 6, Bergman discloses the ventilator of claim 1 (shown above), wherein the at-least one controller member contracts the inflation bag which is configured to push fresh air into a patient's lungs, and when the at-least one controller member comes backwards, the at-least one controller member expands the inflation bag which is configured to draw air out of the patient's lungs (controller member 204 squeezes and releases the inflation bag to assist in respiration of a patient, par. 0038, 0119).
Regarding claim 7, Bergman discloses a ventilator comprising: at-least one air vessel (Fig. 1C-1E, attachment 130); at-least one inflation bag (Fig. 1C, flexible squeeze bag 200); at-least one connecting member to connect the at-least one air vessel and the at- least one inflation bag (Fig. 1C, intake tube 104 connects vessel 130 to inflation bag 200); a bag holder configured to hold the at-least one inflation bag (Fig. 1C, housing 112 holds bag 200); and at-least one controller member mounted on the bag holder (Fig. 1C, members 204 and 206), wherein the at-least one controller member is configured to slide within the bag holder to change the shape of the at-least one inflation bag (Fig. 6G, members 204 and 206 slide along guides 230 and 232 to squeeze the inflation bag 200; par. 0119) to vary a tidal volume and an inspiration-expiration ratio of the ventilator (volume and rate of squeezing is adjustable; par. 0102-0103), wherein the changing of the shape of the at least one inflation bag to vary the tidal volume and the inspiration-expiration ration of the ventilator uses no electrical power (powered actuator can be operated by mechanical, hydraulic, or pneumatic power; par. 0078).
Regarding claim 8, Bergman discloses the ventilator of claim 7 (shown above), wherein the at-least one controller member is operatively configured with the at-least one inflation bag and configured to move in to and fro motion, wherein when the at-least one controller member moved towards the at-least one inflation bag, the at-least one controller member presses the at-least one inflation bag (Fig. 6G, members 204 and 206 move along guides 230 and 232 to squeeze and release the bag 200; par. 0119).
Regarding claim 9, Bergman discloses the ventilator of claim 7 (shown above), wherein the at-least one controller member comprises a left controller member and a right controller member [rubber feet 103 can be located on other sides of the housing (par. 0092) making device 100 operable in alternative orientations such that member 204 is a left controller member and member 206 is a right controller member], wherein the left controller member and the right controller member operatively configured with the at-least one inflation bag and are operatively configured to move in to and fro motion (Fig. 6G, members 204 and 206 move along guides 230 and 232 to squeeze and release the bag 200; par. 0119).
Regarding claim 10, Bergman discloses the ventilator of claim 9 (shown above), wherein the left controller member and the right controller member when moved towards the at-least one inflation bag, presses the at-least one inflation bag, and wherein when the left controller member and the right controller member comes backward, the left controller member and the right controller member un-presses the at-least one inflation bag (Fig. 6G, members 204 and 206 move along guides 230 and 232 to squeeze and release the bag 200; par. 0119).
Regarding claim 11, Bergman discloses the ventilator of claim 9 (shown above), wherein the left controller member and the right controller member is an expandable cushion member, such that the expansion of the expandable cushion member facilitates compressing of the at-least one inflation bag (squeezing and releasing force may be pneumatic inflation bags, par. 0119).
Regarding claim 13, Bergman discloses the ventilator of claim 7 (shown above), wherein the at-least one controller member is another inflation bag to regulate size of the at-least one inflation bag by sliding within the bag holder, wherein the another inflation bag used as a movable arm (Fig. 6G, the controller members 204 and 206 moving along guides 230 and 232 for squeezing the inflation bag 200 can be pneumatic inflation bags, par. 0119).
Regarding claim 14, Bergman discloses the ventilator of claim 7 (shown above), wherein the at-least one controller member is an at-least one moveable arm member to regulate size of the at-least one inflation bag by sliding within the bag holder (Fig. 6G, members 204 and 206 squeeze the bag 200 by sliding along guides 230 and 230; par. 0119), wherein the at-least one moveable arm member is regulating size of the at-least one inflation bag by doing contraction and expansion (Fig. 6G, members 204 and 206 squeeze and release the bag 200; par. 0119).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bergman in view of Piracha et al. (US 20190336713 A1), hereafter Piracha.
Regarding claim 2, Bergman discloses the ventilator of claim 1 (shown above).
Bergman does not disclose wherein the at-least one air vessel is a compressor for providing pressured air to the inflation bag.
Piracha teaches a ventilation apparatus wherein the air vessel can be a compressor (par. 0038 ln 1-8) for providing pressured air to the inflation bag (par. 0038 ln 8-13). Piracha teaches the air vessel could also be a gas cylinder, similar to the air vessel of Bergman (See Bergman Fig 1C-E, attachment 130).
For this reason and absent any showing of unexpected benefit, it would have been obvious to modify the air vessel of Bergman to be a compressor as taught by Piracha as this would have yielded the predictable result of providing pressured air to the inflation bag.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the embodiment of Bergman applied to claim 9 above, hereafter the first embodiment, in view of an alternative embodiment of Bergman.
Regarding claim 12, the first embodiment of Bergman discloses the ventilator of claim 9 (shown above), wherein the at-least one controller member and the right controller member change the shape of a cross-section of the at-least one inflation bag thereby facilitating compressing of the inflation bag (Fig. 6G, the inflation bag 200 is squeezed by the controller members 204 and 206; par. 0119).
The first embodiment of Bergman does not disclose the shape of a cross-section of the inflation bag changes from circular to elliptical.
An alternative embodiment of Bergman teaches a spherical inflation bag (Fig. 11B, bag 200). The squeezing of the spherical inflation bag by the controller members would change the cross-section shape from a circular shape to a more elliptical shape. It would have been obvious to modify the first embodiment of Bergman to have a spherical inflation bag, as taught by the alternative embodiment, as a spherical inflation bag would have been able to serve the same function of providing ventilation to a patient and yielded predictable results to one of ordinary skill in the art.
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bromster (US 7073502 B2) in view of Christenson et al. (US 20210299378 A1), hereafter Christenson.
Regarding claim 15, Bromster discloses a ventilator (ventilation system 10; Fig. 1) comprising: an air vessel (compressed air tank 38; Fig. 1); an inflation bag (manual bag 20; Fig. 1); a connecting member to connect the air vessel and the inflation bag (conduits 36, 48, 52, 70, and 150 connect air tank 38 to bag 20; Fig. 1); and a controller member (manual bag filling valve 96; Fig. 1, 3a/b) mounted on the connecting member (manual bag filling valve 96 is located between conduits 70 and 150; Fig. 1), and the controller member is operably configured to provide resistance to the pressured air going into the inflation bag from the air vessel (manual bag filling valve 96 controls the flow of gas into the bag; col. 4 ln 17-22) thereby varying a tidal volume of the ventilator (controlling the flow of gas into the bag would vary the tidal volume), wherein the providing of resistance to the pressured air going into the inflation bag from the air vessel to vary the tidal volume of the ventilator uses no electrical power (the manual bag filling valve 96 operates by forces generated by pressure and a bias spring, therefore using no electrical power; col. 6 ln 16-col. 7 ln 7).
Bromster does not disclose a bag holder configured to hold the inflation bag.
Christenson teaches a bag holder (case; Fig. 2) configured to hold an inflation bag (resuscitation bag; Fig. 2) for the purpose of increasing durability in harsh environments (par. 0017).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bromster to comprise a bag holder as taught by Christenson for the purpose of increasing durability in harsh environments (Christenson par. 0017).
Regarding claim 16, the modified Bromster discloses the ventilator of claim 15 (shown above), wherein the controller member is a regulator to regulate size of the inflation bag (manual bag filling valve 96 controls flow of gas into the bag when it is not fully inflated; Bromster col. 4 ln 15-24) by providing resistance to the pressured air going to the inflation bag from the air vessel (manual bag filling valve 96 provides resistance to gas flow to conduit 150; Bromster col. 6 ln 16-col. 7 ln 7).
Regarding claim 17, the modified Bromster discloses the ventilator of claim 15 (shown above), wherein the controller member is an arm (adjustment member 174 is an arm; Bromster Fig. 3a/b) to regulate size of the inflation bag by providing resistance to the pressured air going to the inflation bag from the air vessel (manual bag filling valve 96 provides resistance to gas flow and can be adjusted by adjustment member 174; Bromster col. 6 ln 7-col. 7 ln 7).
Regarding claim 18, the modified Bromster discloses the ventilator of claim 15 (shown above), wherein the controller member is a weight member (adjustment member 174 is a weight member; Bromster Fig. 3a/b) to regulate size of the inflation bag by providing resistance to the pressured air going into the inflation bag from the air vessel (manual bag filling valve 96 provides resistance to gas flow and can be adjusted by adjustment member 174; Bromster col. 6 ln 7-col. 7 ln 7).
Regarding claim 19, the modified Bromster discloses the ventilator of claim 15 (shown above), wherein the controller member is a spring-operated member (bias spring 172; Bromster Fig. 3a/b) to regulate size of the inflation bag by providing resistance to the pressured air going into the inflation bag from the air vessel (manual bag filling valve 96 provides resistance to gas flow and bias spring 172 can be adjusted by adjustment member 174; Bromster col. 6 ln 7-col. 7 ln 7).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bergman, in view of Hines (US 20140000613 A1).
Regarding claim 20, Bergman discloses the ventilator of claim 1 (shown above). Bergman discloses a powered actuator (par. 0005) to facilitate to and fro movement of the movement of the at-least one moveable member (powered actuator powers the mechanical squeezing member 204 to squeeze and release; par. 0005, 0119) resulting into the pushing of the at-least one inflation bag against one of the another inflation bag and a wall of a bag holder (the member 204 pushes inflation bag 200 against member 206 which may be an inflation bag, par. 0119).
Bergman does not disclose wherein an at-least one moveable member is operably connected to a foot operated member, such that the movement of the foot operated member facilitate to and fro movement of the at-least one moveable member.
Hines teaches an apparatus for actuating a ventilation bag (abstract ln 1-2) wherein the at-least one moveable member is operably connected to a foot operated member, such that the movement of the foot operated member facilitate to and fro movement of the movement of the at-least one moveable member (Fig. 3, foot pedal moves the paddles 312 to exert pressure on the bag 302; par. 0029-0031). One of ordinary skill in the art would have reasonably recognized that this alternative apparatus for actuating the at-least one moveable member would have been capable of providing the function of ventilating a patient.
For this reason and absent any showing of unexpected benefit, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the ventilator of Bergman to have the at-least one moveable member operably connected to a foot operated member as taught by Hines because Hines teaches this is a known apparatus for actuating a moveable member to provide ventilation. This apparatus would provide the benefit of a simple and low-cost actuator for providing ventilation.
Response to Arguments
Applicant's arguments filed 1/22/2026 have been fully considered but they are not persuasive.
Regarding claims 1 and 7, Applicant argues that Bergman does not disclose “the ventilator uses no electrical power”. However, the claim language only requires the changing of the size of the inflation bag to vary the tidal volume and inspiration-expiration ratio of the ventilator to use no electrical power. The claim language does not require the entire ventilator to use no electrical power. The cyclical squeezing of the inflation bag in Bergman is carried out by a power actuator. Bergman contemplates that the power actuator can be hydraulic or pneumatic (par. 0078). Bergman does not require the power actuator to be electrical. Applicant mentions the sensors of Bergman being electrically powered. However, these sensors are optional (par. 0109). Therefore, Bergman meets the claimed limitation.
Regarding claims 15-19, Applicant argues that the Bromster-Christenson combination would be untenable because the Bromster bag needs to be autoclavable. However, Bromster does not disclose that the manual bag must be autoclavable. Bromster states that in prior art rebreathing systems, the bag must be autoclavable. However, Bromster’s improvements to the ventilation system eliminate the need for autoclaving the manual bag since gases from the patient are prevented from flowing back into the manual bag (col. 1 ln 20-37).
Further, Applicant argues that the manual bag of Bromster does not require increased durability because it is being used in a sensitive environment. However, the manual bag of Bromster in a sensitive environment would still benefit from a bag holder to prevent accidental damage.
Conclusion
THIS ACTION IS MADE FINAL. 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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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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