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
This office action is in response to the amendments filed on 09/24/2025. As directed by the amendment: claims 1, 7-9, 14, and 17-19 have been amended, no claims have been added, and claims 3-6 and 15-16 have been canceled. Thus, claims 1-2, 7-14, and 17-22 are pending in the application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation is:
“program code means” in claim 13 line 2
The structure that performs the claim function is stated as “a computer program with program code instructions that can be executed by a computer, on the one hand, and a storage medium with such a computer program, i.e., a computer program product with program code means, as well as finally also a control device or a ventilator, in the memory of which such a computer program is loaded or can be loaded as means for carrying out the process and its embodiments” (specification paragraph [0026] lines 8-12)
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth 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.
Claims 1-2 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Fig. 4 of Kimm et al. (US 2013/0167843 ; hereinafter referred to solely as “Kimm”) in view of Fig. 5 of Kimm, Hirata et al. (US 2010/0196177; hereinafter referred to solely as “Hirata”), and Adahan (US 5,484,270).
Regarding claim 1, Kimm discloses a ventilator (see Kimm ventilator 100) comprising at least one exhalation and/or inhalation valve (see Kimm [0022] lines 3-5 “exhalation module 108 coupled with the expiratory limb 134 and an inhalation module 104 coupled with the inspiratory limb 132”) comprising: a valve drive (see Kimm piezoelectric blower 218 and piezoelectric inlet port 220 form valve drive); and a closing body (see Kimm diaphragm 212), wherein the valve drive is configured to influence a position of the closing body (see Kimm [0039] lines 1-2 “In general, the pilot pressure P.sub.pilot in the pilot pressure chamber 210 exerts a force (F.sub.pilot) on the diaphragm 212”); the valve drive is configured to act on a valve chamber (see Kimm [0005] lines 3-5 and 8-9 “an internal pneumatic valve chamber, the internal pneumatic valve chamber divided by a diaphragm into a plurality of chambers… a pilot pressure chamber coupled to a piezoelectric outlet port for receiving gases”); a volume within the valve chamber determines the position of the closing body (see Kimm [0040] lines 8-13 “If the inlet force (F.sub.inlet) created by the inlet pressure (P.sub.inlet) acting against the seat area of the diaphragm is less than the pilot force (F.sub.pilot) exerted by the pilot pressure acting against the diaphragm area, the pneumatic valve 200 will be closed with the diaphragm 212 pushed against the valve seat 206”); and the valve drive comprises a plurality of piezo pumps (see Kimm Fig. 4 piezoelectric blowers 418, 424), including at least one piezo pump with a direction of action towards the valve chamber (see Kimm Fig. 4 piezoelectric blower 418) and another piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424), wherein the piezo pumps work against one another (see Kimm Fig. 4 piezoelectric blowers 418, 424 direction of action arrows).
Additionally, Kimm discloses the valve drive of a valve functioning as the exhalation valve or as the inhalation valve (see Kimm ventilator 100 and [0022] above) comprises the another piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424) and the at least one piezo pump with a direction of action towards the valve chamber (see Kimm Fig. 4 piezoelectric blower 418), the at least one piezo pump with the direction of action towards the valve chamber being configured to produce a flow rate of a fluid delivered to the valve chamber, the another piezo pump with the direction of action away from the valve chamber being configured to reduce the flow rate of a flow of the fluid delivered to the valve chamber produced by the at least one piezo pump with the direction of action towards the valve chamber (see Kimm [0056] “a pilot pressure (P.sub.pilot) is generated in the pilot pressure chamber 406 that is a function of the net volume of gas entering the pilot pressure chamber 410 through first piezoelectric outlet port 418 and exiting the pilot pressure chamber 410 through second piezoelectric blower 424”… pilot pressure in chamber 410 increased by increasing generation by piezo 418, or decreased by decreasing generation by piezo 424… “Accordingly, the pilot pressure (P.sub.pilot) in the pilot pressure chamber 410 may be more quickly adjusted (increased or decreased) based on controlling both the first piezoelectric blower 418 and the second piezoelectric blower 424”).
Furthermore, figure 4 of Kimm discloses the piezo pumps as claimed, but is silent as to the explicit first and second housing. Figure 4 of Kimm shows the piezoelectric blowers 418 and 424 drawn almost identically to the piezo pumps of present application Figures 2a and 2b. In regards to piezoelectric blower 418, Kimm discloses a pump opening (see Kimm a first piezoelectric inlet port 420) and a second passage opening (see Kimm first piezoelectric outlet port 422) and the figures show a similar structure as the claimed first passage opening, where fluid flow enters the side passages between the two arrows of flow. It appears that Kimm piezoelectric blowers have the same structure as the claimed piezo pumps and fluid flows in the same way, therefore, it is implied that the piezoelectric blowers of Kimm have the same housing structure and function as the claimed piezo pumps.
Even if modified Kimm does not disclose the first and second housing as claimed, however, Hirata teaches the piezo pumps comprising a first housing (see Hirata Annotated II Fig. 2A below) and a second housing (see Hirata Annotated I Fig. 2A below), the first housing comprising a pump opening (see Hirata Figs. 2A, 2B open hole 31), the first housing and the second housing defining a first passage opening (see Hirata Figs. 2A, 2B inlets 32, 42, 52, 62), the second housing comprising a second passage opening (see Hirata Figs. 2A, 2B open hole 11), the first passage opening, the second passage opening and the pump opening being in fluid communication with each other (see Hirata Fig. 2B shows fluid flow through piezoelectric pump 100). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Kimm’s pumps with a first and second housing as taught by Hirata so as to ensure consistent fluid flow through correct openings within the piezo pump.
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Furthermore, modified Kimm discloses everything claimed including a ventilator in accordance with claim 1, and discloses a valve comprising a valve drive at the at least one piezo pump with the direction of action towards the valve chamber such that no escape of the volume from the valve chamber against the direction of action is made possible. Kimm has the valve operating with the properties of the claimed nonreturn valve but is silent as an explicit nonreturn valve structure that is arranged in the valve drive. Kimm discloses “gas enters first piezoelectric blower 418 through a first piezoelectric inlet port 420. Pressurized gas exits the first piezoelectric blower 418 through a first piezoelectric outlet port 422 that leads into the pilot pressure chamber 410”(see Kimm [0054] lines 9-13). It appears that the gas has no other direction of action disclosed and is only moved into the piezoelectric blower through the valve drive, therefore, it is implied that the valve is a one-way valve, moving the fluid in only one direction.
Even if Kimm does not disclose a nonreturn valve as claimed, however, Adahan teaches “an inlet conduit connecting said pump housing inlet to both said chambers and having one-way valves which permit fluid flow only in the direction from said pump housing inlet into the respective chamber” (see Adahan Claim 4 lines 3-6). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve drive of Kimm, with the teachings of a nonreturn valve from Adahan, because the volume of the chamber with a piezo pump direction of action towards from the valve chamber would not be inconsistent with its intended value so long as the nonreturn valve was present within the valve drive to ensure fluid flow in only one direction.
Modified Kimm discloses everything claimed including a ventilator in accordance with claim 1, and discloses a valve comprising a valve drive at the another one piezo pump with the direction of action away from the valve chamber such that no escape of the volume from the valve chamber against the direction of action is made possible. Kimm has the valve operating with the properties of the claimed nonreturn valve but is silent as an explicit nonreturn valve structure that is arranged in the valve drive. Kimm discloses “gas enters the second piezoelectric blower 424 from pilot pressure chamber 410 through a second piezoelectric inlet port 426. Pressurized gas exits the second piezoelectric blower 424 through a second piezoelectric outlet port 428 that releases gas from the pilot pressure chamber 410” (see Kimm [0055] lines 5-10). It appears that the gas has no other direction of action disclosed and is only moved out of the piezoelectric blower through the valve drive, therefore, it is implied that the valve is a one-way valve, moving the fluid in only one direction.
Even if Kimm does not disclose a nonreturn valve as claimed, however, Adahan teaches “an outlet conduit connecting said pump housing outlet to both said chambers and having one-way valves which permit fluid flow only in the direction from the respective chamber to said pump housing outlet” (see Adahan Claim 4 lines 7-10). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve drive of Kimm, with the teachings of a nonreturn valve from Adahan, because the volume of the chamber with a piezo pump direction of action away from the valve chamber would not be inconsistent with its intended value so long as the nonreturn valve was present within the valve drive to ensure fluid flow in only one direction.
Regarding claim 2, modified Fig. 4 of Kimm discloses all of the claimed structures, see rejection to claim 1 above (Kimm modified Fig. 4 now in series arrangement).
Regarding claim 21, modified Kimm discloses wherein at least one piezo pump and the another piezo pump are arranged in a longitudinal direction with respect to a longitudinal axis of the valve (see Kimm Fig. 4 piezoelectric blower 418 is arranged in the longitudinal direction of air flow towards the chamber within the valve; piezoelectric blower 424 is arranged in the longitudinal direction of air flow away from the chamber within the valve).
Regarding claim 22, modified Kimm discloses wherein the nonreturn valve arranged in the valve drive at the at least one piezo pump is located axially opposite the nonreturn valve arranged in the valve drive at the another piezo pump with respect to a longitudinal axis of the valve (see rejection to claim 1 above: The piezoelectric blowers 418, 424 of Kimm appear to be nonreturn valves themselves, and thus the inward and outward flow longitudinal axes have opposing nonreturn valves. Or, Adahan teaches a nonreturn valve permitting flow only into/out of the respective pump housing, thus providing the same placement as described in the previous sentence).
Claims 7, 9-11, 13-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Fig. 4 of Kimm et al. (US 2013/0167843 ; hereinafter referred to solely as “Kimm”) in view of Fig. 5 of Kimm and Hirata et al. (US 2010/0196177; hereinafter referred to solely as “Hirata”).
Regarding claim 7, Kimm discloses a process for operating a ventilator (see Kimm Claim 10 Line 1 “A method for delivering ventilation to a patient”), the process comprising the steps of: providing the ventilator with a valve (see Kimm title) comprising a valve drive (see Kimm piezoelectric blower 218 and piezoelectric inlet port 220 form valve drive) and a closing body (see Kimm diaphragm 212), wherein the valve drive is configured to influence a position of the closing body (see Kimm [0039] lines 1-2 “In general, the pilot pressure P.sub.pilot in the pilot pressure chamber 210 exerts a force (F.sub.pilot) on the diaphragm 212”), the valve drive is configured to act on a valve chamber (see Kimm [0005] lines 3-5 and 8-9 “an internal pneumatic valve chamber, the internal pneumatic valve chamber divided by a diaphragm into a plurality of chambers… a pilot pressure chamber coupled to a piezoelectric outlet port for receiving gases”), a volume within the valve chamber determines the position of the closing body (see Kimm [0040] lines 8-13 “If the inlet force (F.sub.inlet) created by the inlet pressure (P.sub.inlet) acting against the seat area of the diaphragm is less than the pilot force (F.sub.pilot) exerted by the pilot pressure acting against the diaphragm area, the pneumatic valve 200 will be closed with the diaphragm 212 pushed against the valve seat 206”) and the valve comprises one piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424).
Modified Kimm further discloses the valve drive, with the valve functioning as exhalation valve or as inhalation valve (see Kimm [0022] lines 3-5 “exhalation module 108 coupled with the expiratory limb 134 and an inhalation module 104 coupled with the inspiratory limb 132”) comprises the one piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424), but is silent as to a plurality of piezo pumps with a direction of action towards the valve chamber. However, Kimm teaches a plurality of piezo pumps with a direction of action towards the valve chamber (see Kimm first and second piezoelectric blowers 518, 522). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the singular piezo pump with a direction of action towards the valve chamber of Kimm Figure 4 with the plurality of piezo pumps with a direction of action towards the valve chamber as taught by Kimm Figure 5 so as to ensure the valve can be actuated to a higher pressurized feed flow path (see Kimm [0065] Lines 9-12 “a plurality of piezoelectric blowers may be coupled to a pneumatic valve in series and in parallel to increase both the pilot pressure attainable and the response time for piloting the pneumatic valve”).
Modified Kimm further discloses the valve drive of a valve functioning as the exhalation valve or as the inhalation valve comprises one piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424), but is silent as to a plurality of piezo pumps with a direction of action towards the valve chamber. However, figure 5 of Kimm teaches a plurality of piezo pumps with a direction of action towards the valve chamber (see Kimm first and second piezoelectric blowers 518, 522). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the singular piezo pump with a direction of action towards the valve chamber of in figure 4 of Kimm with the plurality of piezo pumps with a direction of action towards the valve chamber as taught by figure 5 of Kimm so as to ensure the valve can be actuated to a higher pressurized feed flow path (see Kimm [0065] Lines 9-12 “a plurality of piezoelectric blowers may be coupled to a pneumatic valve in series and in parallel to increase both the pilot pressure attainable and the response time for piloting the pneumatic valve”).
The modified Kimm discloses the plurality of piezo pumps with the direction of action towards the valve chamber being configured to produce a combined flow rate of a flow of a fluid delivered to the valve chamber (see above Kimm [0056]), but is silent as to the one piezo pump with the direction of action away from the valve chamber being configured to reduce the combined flow rate of the flow of the fluid delivered to the valve chamber produced by the plurality of piezo pumps with the direction of action towards the valve chamber.
However, modified Figure 4 of Kimm has a piezoelectric blower (424) located in parallel with the plurality of piezo pumps with the direction of action towards the valve chamber for adjustment of the combined flow rate (see Kimm Fig. 4; [0056] Lines 16-20 “the pilot pressure (P.sub.pilot) in the pilot pressure chamber 410 may be more quickly adjusted (increased or decreased) based on controlling both the first piezoelectric blower 418 and the second piezoelectric blower 424”), but lacks a piezoelectric pump located in series with the plurality of piezo pumps with the direction of action towards the valve chamber. However, Kimm discloses the location of the piezo pumps to be non-critical, (see Kimm [0058] Lines 8-9 “the second piezoelectric blower 424 may be coupled to pneumatic valve 400 in any suitable location or orientation”; [0065] Lines 9-12 “any suitable number of piezoelectric blowers may be coupled in series and/or in parallel to a pneumatic valve in order to precisely and quickly regulate the pilot pressure”). Therefore, the feature of changing the parallel arrangement of Fig. 4 of Kimm’s piezoelectric blower (424) to be in series arrangement is considered an obvious design choice, since it appears that the modified Kimm’s adjustment pump would perform equally well when it is located in series with the plurality of piezo pumps with the direction of action towards the valve chamber.
As discussed in rejection to claim 1 above, it can be implied that Figure 4 of Kimm discloses the first and second housing of the piezo pumps, and even if Kimm does not disclose the first and second housing as claimed, modified Kimm in view of the teachings of Hirata discloses the claimed structures, see rejection to claim 1 above.
Regarding claim 9, modified Kimm discloses the process in accordance with claim 7 (see Claim 7 above), wherein when the valve functions as an exhalation valve (see Kimm [0022] lines 3-5 “exhalation module 108 coupled with the expiratory limb 134”) with the one piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424), the exhalation valve is actively opened via the one piezo pump with a direction of action away from the valve chamber (see Kimm [0055] lines 7-13 “Pressurized gas exits the second piezoelectric blower 424 through a second piezoelectric outlet port 428 that releases gas from the pilot pressure chamber 410, e.g., to the atmosphere, to the expiratory limb of the patient tubing, to the expiratory module of the pneumatic system, or to'another chamber suitable for releasing gases from the pneumatic valve 400”).
Regarding claim 10, modified Kimm discloses the process in accordance with claim 9 (see Claim 9 above), wherein the exhalation valve is actively opened at the beginning of an expiratory phase (see Kimm [0055] lines 7-13 “Pressurized gas exits the second piezoelectric blower 424 through a second piezoelectric outlet port 428 that releases gas from the pilot pressure chamber 410, e.g., to the atmosphere, to the expiratory limb of the patient tubing, to the expiratory module of the pneumatic system, or to'another chamber suitable for releasing gases from the pneumatic valve 400”).
Regarding claim 11, modified Kimm discloses the process in accordance with claim 10 (see Claim 10 above), wherein the exhalation valve is actively opened at the beginning of the expiratory phase for a predefined or predefinable duration (see Kimm [0041] lines 1-6 “Using the force balance, a change in pilot pressure (P.sub.pilot) can be used to control the inlet pressure (P.sub.inlet) level at which the pneumatic valve 200 will open and relieve/control pressure. If the pilot pressure (P.sub.pilot) is held constant, the pneumatic valve 200 will either close or open and relieve pressure based upon the dynamics of the inlet pressure (P.sub.inlet).”).
Regarding claim 13, modified Kimm discloses the process according to claim 7 (see Claim 7 above), wherein a computer program with program code means (see Kimm [0027] lines 1-2 “The memory 112 includes non-transitory, computer-readable storage media that stores software”) carries out at least some of the steps when the control program is run on a control device for the ventilator (see Kimm [0023] lines 3-8 “Controller 110 is operatively coupled with pneumatic system 102, signal measurement and acquisition systems, and an operator interface 120 that may enable an operator to interact with the ventilator 100 (e.g., change ventilatory settings, select operational modes, view monitored parameters, etc.)”).
Regarding claim 14, Kimm discloses a ventilator (see Kimm ventilator 100) comprising: a valve comprising (see Kimm title): a closing body (see Kimm diaphragm 212) and a valve chamber partially defined by the closing body (see Kimm pilot pressure chamber 210), a volume within the valve chamber determining a position of the closing body (see Kimm [0040] lines 8-13 “If the inlet force (F.sub.inlet) created by the inlet pressure (P.sub.inlet) acting against the seat area of the diaphragm is less than the pilot force (F.sub.pilot) exerted by the pilot pressure acting against the diaphragm area, the pneumatic valve 200 will be closed with the diaphragm 212 pushed against the valve seat 206”); and a valve drive configured to influence a position of the closing body by acting on the valve chamber (see Kimm [0039] lines 1-2 “In general, the pilot pressure P.sub.pilot in the pilot pressure chamber 210 exerts a force (F.sub.pilot) on the diaphragm 212”); [0005] lines 3-5 and 8-9 “an internal pneumatic valve chamber, the internal pneumatic valve chamber divided by a diaphragm into a plurality of chambers… a pilot pressure chamber coupled to a piezoelectric outlet port for receiving gases), the valve drive comprising a plurality of piezo pumps (see Kimm Fig. 4 piezoelectric blowers 418, 424), including at least one piezo pump with a direction of action towards the valve chamber (see Kimm Fig. 4 piezoelectric blower 418) and at least one piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424).
Additionally, Kimm discloses the valve drive of a valve functioning as the exhalation valve or as the inhalation valve (see Kimm ventilator 100 and [0022] above) comprises the one piezo pump with a direction of action away from the valve chamber (see Kimm Fig. 4 piezoelectric blower 424) and the at least one piezo pump with a direction of action towards the valve chamber (see Kimm Fig. 4 piezoelectric blower 418), the at least one piezo pump with the direction of action towards the valve chamber being configured to produce a combined flow rate of a flow of a fluid delivered to the valve chamber, the one piezo pump with the direction of action away from the valve chamber being configured to reduce the combined flow rate of the flow of the fluid delivered to the valve chamber produced by the at least one piezo pump with the direction of action towards the valve chamber (see Kimm [0056] “a pilot pressure (P.sub.pilot) is generated in the pilot pressure chamber 406 that is a function of the net volume of gas entering the pilot pressure chamber 410 through first piezoelectric outlet port 418 and exiting the pilot pressure chamber 410 through second piezoelectric blower 424”… pilot pressure in chamber 410 increased by increasing generation by piezo 418, or decreased by decreasing generation by piezo 424… “Accordingly, the pilot pressure (P.sub.pilot) in the pilot pressure chamber 410 may be more quickly adjusted (increased or decreased) based on controlling both the first piezoelectric blower 418 and the second piezoelectric blower 424”).
As discussed in rejections to claims 1 and 7 above, it can be implied that Kimm discloses the first and second housing of the piezo pumps, and even if Kimm does not disclose the first and second housing as claimed, Kimm in view of the teachings of Hirata discloses the claimed structures, see rejection to claim 1 above.
Furthermore, modified Kimm discloses a control unit configured to control the at least one piezo pump with a direction of action away from the valve chamber to actively open the valve (see Kimm [0023] lines 3-8 “Controller 110 is operatively coupled with pneumatic system 102, signal measurement and acquisition systems, and an operator interface 120 that may enable an operator to interact with the ventilator 100 (e.g., change ventilatory settings, select operational modes, view monitored parameters, etc.)” ).
Regarding claim 19, modified Kimm discloses the ventilator in accordance with claim 14 (see Claim 14 above), wherein the valve functions as an exhalation valve (see Kimm [0022] lines 3-5 “exhalation module 108 coupled with the expiratory limb 134”) with the exhalation valve actively opened by means of the one piezo pump with a direction of action away from the valve chamber (see Kimm [0055] lines 7-13 “Pressurized gas exits the second piezoelectric blower 424 through a second piezoelectric outlet port 428 that releases gas from the pilot pressure chamber 410, e.g., to the atmosphere, to the expiratory limb of the patient tubing, to the expiratory module of the pneumatic system, or to'another chamber suitable for releasing gases from the pneumatic valve 400”).
Regarding claim 20, modified Kimm discloses the ventilator in accordance with claim 14 (see Claim 14 above), wherein the exhalation valve is actively opened at the beginning of an expiratory phase (see Kimm [0055] lines 7-13 “Pressurized gas exits the second piezoelectric blower 424 through a second piezoelectric outlet port 428 that releases gas from the pilot pressure chamber 410, e.g., to the atmosphere, to the expiratory limb of the patient tubing, to the expiratory module of the pneumatic system, or to'another chamber suitable for releasing gases from the pneumatic valve 400”).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Fig. 4 of Kimm in view of Fig. 5 of Kimm and Hirata as applied to claim 14 above, and further in view of Adahan.
Regarding claim 17, modified Kimm has all the claimed structures, see rejection to claim 1 above.
Claims 8, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Fig. 4 of Kimm in view of Fig. 5 of Kimm and Hirata as applied to claims 7 and 14 above, and further in view of Bleys (US 2004/0200477; hereinafter referred to solely as “Bleys”).
Regarding claim 8, modified Kimm discloses the process in accordance with claim 7 (see Claim 7 above) but is silent as to further comprising the steps of: providing a pressure sensor; and detecting a measured pressure value with the pressure sensor assigned in space to a valve of the ventilator; and regulating a position of the closing body of the valve by means of the measured pressure value as an actual value and by means of a predefined or predefinable pressure value as a desired value. However, Bleys discloses steps of: providing a pressure sensor (see Bleys pressure sensor 20); and detecting a measured pressure value with the pressure sensor assigned in space to a valve of the ventilator (see Bleys [0016] “the respiratory assistance ventilator additionally comprises a flowrate sensor and a pressure sensor for measuring the flowrate and the pressure of the gas in the internal circuit said sensors cooperating with the control means in such a way as to permit automatic control and regulation of the proportional valve in terms of flowrate and/or pressure;”); and regulating a position of the closing body of the valve by means of the measured pressure value as an actual value and by means of a predefined or predefinable pressure value as a desired value (see Bleys [0033] “By virtue of the proportional valve 13 connected to the inlet of the venturi injector 16 and to the flowrate and pressure sensors 19, 20, it is possible to control the opening and closing of said valve 13 as a function of the flowrate and pressure set-points regulated by the doctor on the man/machine interface 4 and in response to the measurements of flowrate and pressure effected by the sensors 19, 20 which cooperate with the control means 14.”). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the process of Kimm with the pressure sensor, detection, and regulation system as taught by Bleys for more precise control of the closing body relates to real-time pressure measurements of the invention.
Regarding claim 12, modified Kimm has all the claimed structures, see rejections to claims 8 and 11 above.
Regarding claim 18, modified Kimm discloses the ventilator in accordance with claim 14, but is silent as to further comprising a pressure sensor, wherein: the pressure sensor (see Bleys pressure sensor 20) detects a pressure value of the volume (see Bleys [0016] “the respiratory assistance ventilator additionally comprises a flowrate sensor and a pressure sensor for measuring the flowrate and the pressure of the gas in the internal circuit said sensors cooperating with the control means in such a way as to permit automatic control and regulation of the proportional valve in terms of flowrate and/or pressure”); and the control unit (see Kimm controller 110) is configured to control the one piezo pump with a direction of action away from the valve chamber (see Kimm Fig 4 piezoelectric blower 424) by regulating a position of the closing body of the valve by means of the measured pressure value as an actual value and by means of a predefined or predefinable pressure value as a desired value (see Bleys [0033] “By virtue of the proportional valve 13 connected to the inlet of the venturi injector 16 and to the flowrate and pressure sensors 19, 20, it is possible to control the opening and closing of said valve 13 as a function of the flowrate and pressure set-points regulated by the doctor on the man/machine interface 4 and in response to the measurements of flowrate and pressure effected by the sensors 19, 20 which cooperate with the control means 14.”). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the controller and subsequent operation of the valve drive with the piezo pump of Kimm with the pressure sensor detection and regulation of Bleys because the use of the pressure sensor would allow for more precise control, and more specifically “permit automatic control and regulation of the proportional valve in terms of flowrate and/or pressure” (see Bleys [0016] lines 6-7).
Response to Arguments
Applicant's arguments filed 09/24/2025 have been fully considered but they are not persuasive.
Applicant argues, on pages 10-11 of the remarks, that “Kimm et al., Hirata et al. and Adahan as a whole do not teach and do not suggest at least one piezo pump with a direction of action towards a valve chamber that is configured to produce a flow rate of a flow of fluid that is delivered to the valve chamber, and another piezo pump with a direction of action away from the valve chamber that is configured to reduce the flow rate of the flow of the fluid delivered to the valve chamber produced by the at least one piezo pump with the direction of action towards the valve chamber as claimed”. More specifically, Applicant argues “The second piezoelectric blower 424 of Kimm et al. does not have anything to do with the supply of a flow of fluid to the pilot pressure chamber 410 such that the second piezoelectric blower 424 does not reduce a flow rate of the gas delivered to the pilot pressure chamber 410 via the first piezoelectric blower 418. Kimm et al. merely discloses that the pressure in the pilot pressure chamber 410 is controlled via the first piezoelectric blower 418 and the second piezoelectric blower 424”. Examiner disagrees, seeing as the pressure in the chamber 410 is controlled by the fluid flow moving in and out of the chamber via blowers 418, 424. Increasing/decreasing the flow rate according to the directionality of the blower 418, 424 is what is increasing/decreasing the pressure. Kimm is cited in the claim 1 rejection as controlling the “net volume of gas” entering and exiting the chamber via the blowers (Kimm [0056]). It is unclear to the Examiner how this is not the same manipulation of the flow of fluid as is claimed, but encourages the Applicant to specify through an interview or future amendment for clarity if the interpretation is incorrect. Therefore, the rejection still stands.
Applicant argues, on pages 11-13 of the remarks, the same combination of references as argued above. Therefore, the rejections still stand.
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 GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785 /RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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