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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 in the reply filed on 8/4/2026 is acknowledged. Accordingly, claims 1-15 are pending in the current application and claims 16-20 are withdrawn.
Claim Objections
Claim 16-20 are objected to because of the following informalities:
As claims 16-20 were nonelected, the status identifier before each claim should read “(Withdrawn)”.
Appropriate correction is required.
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.
Claim(s) 1, 4-8, 11 and 13-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hess (WO 2020/214490 A1).
Regarding claim 1, Hess teaches a gas valve for a ventilation apparatus (gas valve 11 for ventilation, Abstract, and Figure 1) comprising a first valve body having a main gas path chamber for guiding a ventilation gas to a patient, comprising at least a first chamber section (first gas chamber 13, Figure 3 and page 17), a second chamber section (gas chamber 17, Figure 3 and page 17) and a third chamber section (gas chamber 15, Figure 3 and page 17), an inlet duct configured to supply the ventilation gas to the first chamber section (see inlet duct 14, Figure 3 and Page 17, lines 15-17), an outlet duct configured to release the ventilation gas from the third chamber section (outlet duct 22, Figure 3 and Page 17 lines 15-17) wherein said first chamber section and said third chamber section comprise a first cross-section area (see first chamber 13 and second chamber 15 comprising a first cross-sectional area 22, Figures 3-4) and said second chamber section comprises a second cross-section area (see second chamber 17 comprising a second cross-sectional area 19, 20, Figure 3) wherein said second cross-section area is smaller than said first cross-section area (see cross sectional area 19, 20 being smaller than that of 22, claims 3-4, page 17 lines 18-29, and Figure 3), and wherein said second chamber section comprises a leakage channel configured to allow a leakage gas flow out of the gas valve during exhalation (exhalation gas opens at least the first passage opening/channel 19, allowing exhaled gases to flow out of the valve 11, Figures 1-6 and Page 21 lines 20-25).
Regarding claim 4, Hess further discloses wherein said leakage channel is arranged at a minimum cross section area at said second chamber section (see channel 19 arranged at a cross sectional area at second gas chamber 17, Figure 3).
Regarding claim 5, Hess further discloses wherein further comprising a measuring device configured to measure said leakage gas flow of said leakage channel during exhalation is provided (pressure measurement apparatus 105 for measuring gas pressure of gas valve 11, carbon dioxide in the second gas chamber and thus through the opening 19 during exhalation may be measured, Page 23, first paragraph).
Regarding claim 6, Hess further discloses wherein said leakage channel comprises at least one opening for connecting configured to connect with said measuring device for measuring said leakage gas flow (see Figures 6-8 showing opening 19 comprising an opening configure to connect with pressure measuring device 105).
Regarding claim 7, Hess further discloses wherein said leakage channel comprises at least a filter medium for filtering configured to filter said leakage gas flow (leakage channel comprises a filter medium 50 configured to filter the gas exiting valve 11, Figure 7 and Page 22, second paragraph).
Regarding claim 8, Hess further discloses wherein the second cross- section area of the second chamber section is adjustable, while preferably and said second chamber section comprises an adjustable chamber wall (an adjustment mechanism 60 for adjusting the effective cross-section of said second passage opening 22; said adjustment mechanism 60 comprises a cap 61 with cap openings 67, which can be assembled to the main body 12 of said gas valve 11; cap 61 is twistable around the central longitudinal axes of said main body 12 of said gas valve 11 and comprises a control opening 63 for adjusting the effective cross-section area of said second passage opening 22; therefore the ratio of said cross-section areas are adjustable, Figure 7 and Page 22, second paragraph).
Regarding claim 11, Hess further discloses a second valve body comprising a bypass gas channel configured to receive an inhalation the ventilation gas, wherein said second valve body is connected to said first valve body by said leakage channel (inhalation gas supplied to the first gas chamber 13 through the inlet duct 14, Figures 1-6 and Page 22).
Regarding claim 13, Hess further discloses wherein the second chamber section comprises at least a second controllable leakage channel (a further adjustable leakage channel 76 may be included, Page 22, fourth paragraph).
Regarding claim 14, Hess further discloses a circuit for a ventilation system comprising a ventilation limb and at least a leakage gas valve according to claim 1, and the gas valve is preferably assembled at a distal end of the ventilation limb (see Figure 8 showing a circuit 70 for a ventilation system 100 comprising a ventilation limb 71 and the gas valve 11, gas valve 11 assembled at distal end 72 of ventilation limb 71, Page 22, third paragraph).
Regarding claim 15, Hess further discloses a circuit for a ventilation system comprising a ventilation limb and at least a leakage gas valve according to claim 12 and preferably the leakage gas valve is assembled at a proximal end of the ventilation limb (see Figure 8 showing a circuit 70 for a ventilation system 100 comprising a ventilation limb 71 and the gas valve 11, gas valve 11 assembled at distal end 72 of ventilation limb 71, Page 22, third paragraph; a further leakage 76 may be placed at the proximal end 73 of ventilation limb, Page 22, fourth paragraph).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hess (WO 2020/214490 A1) in view of Nashed (CA 2788657 A1).
Regarding claim 2, Hess teaches the gas valve according to claim 1, however is silent wherein said leakage channel comprises a controllable valve for controlling configured to control said leakage gas flow, wherein said controllable valve is preferably a gate-type valve.
However, Nashed teaches a respiratory valve (Abstract and Figures 1-4) comprising a leakage channel comprising a controllable valve, wherein the controllable valve is a gate-type valve (leakage channel 60 having a rotatable gate valve controlled by handle 61, rotation of handle 61 varies the size of an opening to therefore adjust the flow of the exhaled waste gas, Figure 4 and Page 22).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hess’s gas valve apparatus by having the leakage channel controlled by a gate-type valve, as taught by Nashed, as using a gate-type valve is a well-known means of varying the size of a channel, and therefore provides further control over the flow of the exhaled gases exiting the valve.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hess (WO 2020/214490 A1) in view of Rapoport (US 2010/0269827 A1).
Regarding claim 3, Hess teaches the gas valve according to claim 1, however is silent wherein said leakage channel is a tubular channel and preferably contains at least a venturi valve.
However, Rapoport teaches a respiratory gas valve (valve 208, Figure 2 and Paragraph 0016) wherein said leakage channel is a tubular channel containing a venturi valve (exhaled leakage gas flows out of venturi opening 211, Paragraph 0017 and Figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hess’s gas valve apparatus by having the leakage channel include a venturi valve, as taught by Rapoport, as using a venturi valve provides precise, pressure-independent flow control throughout the valve.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hess (WO 2020/214490 A1) in view of Bonassa (US 5303699 A).
Regarding claim 12, Hess teaches the gas valve according to claim 11, however is silent wherein said second valve body comprises a venturi nozzle.
However, Bonassa teaches a respiratory gas valve (valve 6, Figure 2 and Col. 5 lines 1-5) wherein said valve body comprises a venturi nozzle (nozzle 30 is a venturi nozzle, Figure 2 and Col. 5 lines 5-10).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Hess’s gas valve apparatus such that the second valve body included a venturi nozzle, as taught by Bonassa, as using a venturi nozzle helps in the exhalation of gases, eliminating the occurrence of residual pressure even at high flow rates (Col. 5 lines 8-11 of Bonassa).
Allowable Subject Matter
Claims 9-10 are 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. Claims 9-10 are directed towards the second chamber section comprising a cage structure with at least one adjustable balloon, wherein said adjustable balloon comprising a controllable opening configured to connect with a fluid pump. Although Hess teaches a gas valve comprising adjustable chamber sections, Hess is silent on such an adjustable balloon structure integrated within the second chamber. A radical structural modification of Hess’s valve would be required in order to arrive at the structure that is recited by claims 9-10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Edwards et al. (US 2022/0118209 A1) and Bayron et al. (US 6,886,561 B2).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH B LEDERER whose telephone number is 571-272-7274. The examiner can normally be reached on Monday - Friday, 7:30 AM - 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached on (571)-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH B LEDERER/Examiner, Art Unit 3785
/MARGARET M LUARCA/Primary Examiner, Art Unit 3785
