DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on March 11, 2026 were received and fully considered. Claims 1-4, 6-9, 14, 15, and 21-23 were amended. Claim 5 was cancelled (now incorporated into independent claims 1, 9, and 23). The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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.
Claims 1-4, 6-9, 10, and 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over Hakala (US Patent No. 5873361) in view of Hansmann et al. (WO 2019/072605 A1) (hereinafter “Hansmann”).
Hakala and Hansmann were applied in the previous office action.
Note: Regarding Hansmann, Examiner provides citations from English equivalent Patent, US 11964108 B2.
With respect to claims 1, 9, and 23, Hakala teaches a process, device, and non-transitory computer-readable media storage device comprising a non-transitory computer-readable media program product for determining a carbon dioxide concentration in measured gas (col. 2, lines 56-59 “The analyzing can comprise the measuring or identifying, or both, of one or several gas component concentrations. Carbon dioxide…”), the process comprising the steps of: branching off the measured gas from a main line of a medical device through a branch line to a sensor unit during an inhalation phase of a person who is connected to the medical device as inhalation gas and during an exhalation phase of the person as exhalation gas (Fig. 1 shows respiratory 1 with 2 branches: inspiration tube 13 and expiration tube 14; sensor 4 and gas analyzer 3 measures and analyzes the patient’s inspired and/or expired gas; see also col. 2, lines 53-59); delivering the measured gas from the main line through the branch line to the sensor unit by means of a fluid delivery unit (col. 2, lines 53-56 “The sample is preferably aspirated through the sampling line by the pump 2 of the monitor 11 to the gas analyzing unit 3, in which the patient's inspired and/or expired gas is analyzed.”); adaptively setting the fluid delivery unit based on an airway pressure in the main line for generating a uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit during the inhalation phase and the exhalation phase (col. 3, lines 1+ “The gas sampling pump 2 is controlled through the signal way 9 from the control unit 5, which receives information about the pressure variation…The control unit can simultaneously send a signal through the connection 10 to the valve 6, through which there is a connection to the ambient air, to open the valve to prevent the underpressure possibly formed in the tubes from injuring the patient”; see also col. 3, lines 40-53); and determining the concentration of carbon dioxide in the measured gas by means of the sensor unit (col. 2, lines 56-59; col. 3, lines 53-55).
However, Hakala does not teach the limitations further recited in claim 5.
Hansmann teaches wherein the fluid delivery unit has a piezo pump for delivering the measured gas from the main line through the branch line to the sensor unit (see Figs. 5a-5d; col. 10, lines 46+ “piezo pump… has a flow in two directions”) and an operating voltage of the piezo pump is adaptively set for generating a uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit (col. 11, lines 15+ “piezo element 118 is acted on with alternating electrical voltages in a manner known basically per se by means of an alternating voltage generator 124. These voltages bring about a voltage-induced deformation of the piezo element 118 and this deformation leads to a controlled vibration of the pump diaphragm element 120”), taking into consideration the airway pressure as well as with data of a look-up table (col. 14, lines 58+ “operation of the valve… as a function of the back pressure…Depending on the value of the back pressure, the valve drive (piezo pump) 34 can pump only a certain volume into the control pressure chamber 130”; col. 17, lines 20+ “lookup table 50… data sets are associated with an individual body weight… ventilation of the patient and in this connection an actuation of the valve device 30… actuation is basically known per se, is carried out with the ventilation parameters 52 of the determined data set 54 automatically and under the control of the control unit 44”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Hakala to incorporate and control a piezo pump in the manner recited (taking into consideration airway pressure as well as data from a look-up table, e.g. body weight), as doing so would be a simple substitution (replacing Hakala’s pump 2 with a conventional piezo pump would only involve routine skill in the art), thereby allowing for operation a ventilation system by staff not trained medically or with minimally training, at least to the extent that an initial ventilation of the patient can be carried out, as evidence by Hasmann (col. 1, lines 67+).
With respect to claims 2 and 10, Hakala teaches wherein the airway pressure in the main line is measured by an airway pressure sensor and the fluid delivery unit is adaptively set for generating a uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit, with use of the measured airway pressure in the main line (col. 2, line 60- col. 3, line 14; col. 3, lines 40-52).
With respect to claim 3, Hakala teaches determining the carbon dioxide concentration in the measured gas during a pressure-controlled ventilation of the person by means of the medical device, wherein the fluid delivery unit is adaptively set for generating the uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit, with the use of the airway pressure in the main line, which airway pressure is set by a pressure-controlled ventilation of the person (col. 2, line 60- col. 3, line 14; col. 3, lines 40-52).
With respect to claims 4 and 15, Hakala teaches determining the carbon dioxide concentration in the measured gas during a volume-controlled ventilation of the person by means of the medical device, wherein the fluid delivery unit is adaptively set for generating the uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit, with use of the airway pressure in the main line, which airway pressure results from a volume-controlled ventilation of the person (col. 2, line 60- col. 3, line 14; col. 3, lines 40-52).
With respect to claim 6, Hakala teaches wherein the fluid delivery unit is adaptively set for generating the uniform volume flow and/or gas pressure in the measured gas in the branch line to the sensor unit, only based on the airway pressure during an inhalation phase of ventilation in the main line or only based on the airway pressure during an exhalation phase of the ventilation in the main line (Fig. 1; col. 2, line 60- col. 3, line 14; col. 3, lines 40-52).
With respect to claim 7, Hakala teaches wherein the fluid delivery unit is operated with consistent output during an exhalation phase of ventilation for generating the uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit and is adaptively set during an inhalation phase of the ventilation based on the airway pressure during the inhalation phase of the ventilation (Fig. 1; col. 2, line 60- col. 3, line 14; col. 3, lines 40-52)..
With respect to claim 8, Hakala teaches wherein the fluid delivery unit is adaptively set for generating the uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit during an exhalation phase of ventilation based on the airway pressure during the exhalation phase of the ventilation and is deactivated during an inhalation phase of the ventilation (Fig. 1; col. 2, line 60- col. 3, line 14; col. 3, lines 40-52).
With respect to claim 14, Hakala teaches determining a carbon dioxide concentration in measured gas from the medical device during a pressure-controlled ventilation of a person by means of the medical device, wherein the setting unit is configured for the adaptive setting of the fluid delivery unit with the use of the airway pressure in the main line, which airway pressure is set by means of a pressure-controlled ventilation of the person with the medical device (col. 2, line 60- col. 3, line 14; col. 3, lines 40-52).
With respect to claim 16, Hakala teaches determination device in accordance with claim 9, in combination with the medical device for ventilating a person, having the main line for sending inhalation gas and for sending exhalation gas (Fig. 1).
With respect to claim 17, determination device in combination with the medical device in accordance with claim 16, wherein the main line has an inhalation gas line section for sending an inhalation gas and a total gas line section for sending the inhalation gas as well as an exhalation gas, wherein the branch line is configured for branching off the measured gas from the total gas line section (Fig. 1).
With respect to claim 18, Hakala wherein an exhalation valve in the total gas line section is configured for releasing the exhalation gas from the medical device into an area surrounding the medical device, wherein at least one heat and moisture exchanger filter is provided in the exhalation valve (col. 2, lines 60+).
With respect to claim 19, Hakala teaches wherein the branch line for branching off the measured gas from the main line is connected to the exhalation valve (col. 3, lines 8+).
With respect to claim 20, Hakala teaches wherein the medical device is configured as a ventilator (Fig. 1).
With respect to claim 21, Hakala teaches wherein the setting unit is configured and embodied for the adaptive setting of the fluid delivery unit based on the airway pressure in the main line for generating a uniform volume flow and/or gas pressure in the measured gas in the branch line to the sensor unit during the inhalation phase and/or during the exhalation phase (col. 2, line 60- col. 3, line 14; col. 3, lines 40-52).
With respect to claim 22, Hakala teaches wherein a non-transitory computer-readable media computer program product, comprising commands, which during execution of the computer program product by a computer cause this computer program product to carry out at least some of the process steps (col. 3, lines 55+).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hakala and Hansmann in view of Pierry (US Patent No. 7556039 B1).
Pierry was applied in the previous office action.
With respect to claims 11 and 12, Hakala and Hansmann teach a process and device for determining a carbon dioxide concentration in measured gas, as established above.
However, Hakala and Hansmann do not teach the limitations further recited in claims 11 and 12.
Regarding claim 11, Pierry teaches at least one heat and moisture exchanger filter is configured in and/or at the branch line (col. 2, lines 8-18).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Hakala and Hansmann to incorporate at least one heat and moisture exchanger filter is configured in and/or at the branch line as results in a drier sampling tube, as evidence by Pierry (col. 2, lines 8-18).
Regarding claim 12, Hakala, Hansmann, and Pierry do not explicitly teach wherein the at least one heat and moisture exchanger filter has a length in a range of 8 mm to 20 mm and a width in a range of 2 mm to 6 mm. However, further modification of Hakala and Pierry in the manner claimed would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Moreover, it is noted that the recited length and width ranges are without criticality in the specification.
Response to Arguments
Applicant’s arguments filed with respect to the claim objections and 35 USC 112B rejections raised in the previous office action were persuasive in view of amendment. Therefore, these objections and rejections are withdrawn.
Applicant's arguments filed with respect to the prior art rejections raised in the previous office action have been fully considered, but they are not persuasive. Applicant argues that the current amendment (amending independent claims 1, 9, and 23 to incorporate limitations from now cancelled claim 5) is nonobvious over the cited references, with specific regards to Hansmann. More specifically, applicant appears to argue that, while Hansmann teaches a piezo pump, the piezo pump does not operate “taking into consideration” airway pressure was well as data of a look-up table to set an operating voltage for generating a uniform volume flow and/or gas pressure, as eclaimed. Examiner respectfully disagrees. As set forth in the prior art section above, Hansmann’s piezo pump, actuation valves, etc. operate in the equivalent manner recited, i.e., by taking into consideration airway pressure and data from a look-up table (e.g. body weight) to set an operating voltage for generating a uniform volume flow and/or gas pressure. See US Patent 11961108 B2 (English equivalent to WO 2019/072605 A1): Figs. 5a-5d; col. 10, lines 46+; col. 11, lines 15+; col.14, lines 58+; col. 17, lines 20+. Examiner also argues that the claims provide no specificity with regards to “taking into consideration” such that this limitation provides any nonobvious distinction over the manner in which Hansmann’s piezo pump operates based on broadest reasonable interpretation. For at least these reasons, the obviousness rejections (Hakala in view of Hansmann) are maintained. Please see prior art rejections above for more detail.
Conclusion
No claim is allowed.
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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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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