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 .
Status of Claims
Claims 1-23 are pending and currently under consideration for patentability under 37 CFR 1.104
Foreign Priority
Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy (DE10 2020 117 607.4 filed on July 3, 2020) has been received.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 20, 2022 has been considered by the examiner.
Claim Objections
Claim 22 is objected to because of the following informalities:
“computer program product (2)” in line 3 should be changed to --computer program product--.
Appropriate correction is required.
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 limitations are:
“a medical device” and “means of the medical device” in claims 1, 3, 4, 9, 14-20, and 23;
“a sensor unit” in claims 1-10, 13, 15, 21, and 23;
“a fluid delivery unit” in claims 1-8, 9, 10, 13-15, 23; and
“the setting unit” and “the setting device” in claims 14 and 21
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
[0021] The fluid delivery unit, especially a pump vacuum of a fluid delivery unit configured as a pump, can now be set such that the sum of the airway pressure and the pump pressure or the pressure generated by the fluid delivery unit together is 30 mbar.
[0024] …Consequently, the sensor unit preferably comprises a heat conduction sensor for measuring the heat conductivity and/or the heat conduction of the measured gas, i.e., the heat conductivity of the branched-off part of the inhalation gas as well as of the branched-off part of the exhalation gas. The carbon dioxide concentration is subsequently determined on the basis of the measured heat conductivity. The fact that the carbon dioxide concentration is determined by means of the sensor unit may consequently be defined as the carbon dioxide concentration being determined on the basis of different measurements and calculations and the sensor unit being used in this case, or in order words, as the carbon dioxide concentration in the measured gas being determined on the basis of a heat conductivity of the measured gas, which heat conductivity was measured by the sensor unit…
[0025] … The process may be carried out as a process for determining the carbon dioxide concentration in measured gas from a main line or from the so-called mainstream of a medical device, especially of a ventilator…
[0026] The adaptive setting of the fluid delivery unit is especially carried out by means of a suitable setting unit, for example, in the form of a control device of the medical device. The measured gas may be defined as a gas sample to be measured at the sensor unit. The measured gas corresponds during the inhalation phase to a part of the inhalation gas and during the exhalation phase to a part of the exhalation gas. In other words, a part of the inhalation gas is branched off as measured gas during the inhalation phase and a part of the exhalation gas is likewise branched off as measured gas during the exhalation phase.
[0027] The delivery of the measured gas may be defined as a suctioning off of the measured gas from the main line into the branch line to the sensor unit. The fluid delivery unit is configured in this case especially as a pump and/or suction pump. The process steps described do not have to be carried out in the order indicated. Rather, the process steps may be carried out simultaneously at least partially. A uniform volume flow may be defined in the present case as a volume flow, the value of which changes over time from at least one inhalation phase and an exhalation phase subsequent thereto by less than 20%, especially by less than 10%.
[0040] The determination device according to the present invention thus offers the same advantages as they have been described in detail with reference to the process according to the present invention. The determination device may be configured as a device separate from the medical device or as a component of the medical device. The setting unit may comprise a control device of this kind of the medical device or may be configured as a component of such a control device.
[0052] The sensor unit may be embodied and/or configured according to a sensor for determining the carbon dioxide concentration in the measured gas, which is described in DE 10 2010 047 159 A1, the measured gas being fed to the sensor unit by means of the fluid delivery unit and especially by means of a suction pump. The branch line has an internal diameter that is smaller, especially several times smaller, than that of a main line of this class for a ventilator.
[0067] According to another aspect of the present invention, a medical device for ventilating a person is made available…The medical device may have a breathing mask and/or an exhalation valve, wherein the main line may be configured for sending inhalation gas to the breathing mask and for sending exhalation gas away from the breathing mask and/or to the exhalation valve. The branch line may be configured for branching off the measured gas from the main line through the breathing mask and/or through the exhalation valve. In case of a medical device according to the present invention, an exhalation valve may accordingly be arranged at the breathing mask, and the main line extends from an exhalation area of the breathing mask to the exhalation valve and from there, i.e., in and/or at the exhalation valve, the branch line is arranged at the main line for branching off the measured gas from the main line. The medical device may have, in addition, a fluid delivery unit, especially a pump, for example, a piezo pump, for delivering, pumping and/or suctioning off the measured gas or inhalation gas and exhalation gas from the main line into the branch line. The medical device and/or the determination device are each configured and embodied for carrying out the process described above.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112B
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8, 15, 18, 19, 21-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, and all dependent claims thereof, recites “the steps” in line 2, which lacks antecedent basis.
Claim 2 recites “the use” in lines 4-5, which lacks antecedent basis.
Claim 3 recites “the use” in line 5, which lacks antecedent basis.
Claim 4 recites “the use” in line 5, which lacks antecedent basis.
Claim 6 recites “the ventilation” in lines 5-6 (multiple instances), all of which lack antecedent basis.
Claim 7 recites “the ventilation” in lines 3, 5, and 6 (multiple instances), all of which lack antecedent basis.
Claim 8 recites “the ventilation” in lines 4-6 (multiple instances), all of which lack antecedent basis.
Claim 15 recites “the use” in line 5, which lacks antecedent basis.
Claim 18 recites “the area” in line 4, which lacks antecedent basis.
Claim 21 recites “the setting device” in line 3, which lacks antecedent basis.
Claim 22 recites “the execution” in line 3 and “the process steps” in line 4, both of which lack antecedent basis.
Claim 23 recites:
“the execution” in lines 4-5, which lacks antecedent basis.
“the computer program product” in line 5 and “this computer program product” in line 5, both of which are unclear. Do these refer to “a non-transitory computer-readable media computer program product” previously recited in lines 2-3?
“the process” in line 6, which lacks antecedent basis.
“the steps” in line 6, which lacks antecedent basis.
“the measured gas” in lines 7, 10, 12-13, and 15 (multiple instances), all of which lack antecedent basis.
Claim Rejections - 35 USC § 102(A)(1)
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 1-4, 6-9, 10, and 14-23 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Hakala (US Patent No. 5873361).
Hakala was cited in applicant’s IDS filed on December 20, 2022.
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).
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 the 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 a uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit, with the use of an 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 a uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit, with the use of an 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 a uniform volume flow and/or gas pressure in the measured gas in the branch line to the sensor unit, only based on an airway pressure during an inhalation phase of the ventilation in the main line or only based on an 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 the ventilation for generating a 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 a uniform volume flow and/or gas pressure of the measured gas in the branch line to the sensor unit during an exhalation phase of the 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 an 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 the 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 device 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 the execution of the computer program product (2) by a computer cause this computer program product to carry out at least some of the process steps (col. 3, lines 55+).
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 5 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hakala in view of Hansmann et al. (WO 2019/072605 A1) (hereinafter “Hansmann”).
Hansmann was cited in applicant’s IDS filed on December 20, 2022.
With respect to claims 5 and 13, Hakala teaches a process and device for determining a carbon dioxide concentration in measured gas, as established above.
However, Hakala does not teach the limitations further recited in claims 5 and 13.
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 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, taking into consideration the airway pressure as well as with data of a look-up table (Figs. 1-3; page 4, line 31 - page 5, line 20; page 16, lines 18-33).
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 a piezo pump in the manner recited as doing so would be a simple substitution, i.e. replacing Hakala’s pump 2 with a convention piezo pump would only involve routine skill in the art. Furthermore, it is widely known to utilize piezo pumps as part of a ventilation system, as evidence by Hansmann.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hakala in view of Pierry (US Patent No. 7556039 B1).
Pierry was cited in applicant’s IDS filed on December 20, 2022.
With respect to claims 11 and 12, Hakala teaches a process and device for determining a carbon dioxide concentration in measured gas, as established above.
However, Hakala does 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 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 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.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791