DETAILED ACTION
Primary Examiner acknowledges Claims 1-20 are pending in this application, as originally filed on March 5, 2024.
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 .
Claim Objections
Claims 2-11 and 13-19 are objected to because of the following informalities:
The preamble of Claims 2-11 should read “The process” to be consistent with patent convention. Appropriate correction is required.
The preamble of Claims 13-19 should read “The device” to be consistent with patent convention. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim limitation “means providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval and interrupting the first flushing volume flow during a second time interval” (Claim 12); and “means providing a second flushing volume flow in the gas measurement line in the direction of the patient and interrupting the second flushing volume flow” (Claim 17) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
From a review of the original specification as filed there does not appear to be any clear and unmistakable disclosure as to what structure provides the functionality resulting in the “means providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval and interrupting the first flushing volume flow during a second time interval” (Claim 12); and “means providing a second flushing volume flow in the gas measurement line in the direction of the patient and interrupting the second flushing volume flow” (Claim 17). Rather, the term “means” is only utilized in the original specification as filed in Para 0046 (“Continuous provision means that the basic volume flow is provided continuously during the process.”) and Para 0089 (“The control unit 50 can be configured, by means of suitable hardware and/or software, to control the device 30 and thus to carry out the process according to the invention.”). In each of these disclosures, there is not specific structure recited which performs the functionality by which the “flushing volume flow” is provided. Although the specification appears to hint at the concept of “valves or other actuators” within the lines of the flushing gas sources, there is no explicit disclosure to what means is being utilized. Consequently, Primary Examiner is unsure if Applicant’s means is referring to the operation of a valve whereby the functionality is performed manually, the operation of the valve whereby the functionality is performed as a result of a controller, the gas sources for each flushing volume, or some other feature.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 7 and 19 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.
Specifically, Claim 7, Line 8 recites the limitation “first time duration”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure if the term “first time duration” is meant to be coextensive with the former recitation of “first duration” (as seen in Claims 2, 3, and 6) or if this is a separate and distinct limitation. Appropriate correction and clarification is required.
Specifically, Claim 19, Line 8 recites the limitation “first time duration”; however, this limitation appears to lack antecedent basis in the claims. Primary Examiner is unsure if the term “first time duration” is meant to be coextensive with the former recitation of “first duration” (as seen in Claims 15, 16, and 18) or if this is a separate and distinct limitation. Appropriate correction and clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
(STEP 1): Four Categories of Statutory Subject Matter
The independent claim, Claim 1, and its dependents, Claims 2-11, recite a method/process that is one of the four statutory categories. The independent claim, Claim 12, and its dependents, Claims 13-19, recite a device/product that is one of the four statutory categories.
With respect to the subject matter of the independent claim, Claim 1, and further as incorporated into its dependents, Claims 2-11, Claim 1 recites:
A process of flushing a gas measurement line of a medical device, the process comprising the steps of:
providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval; and
interrupting the first flushing volume flow during a second time interval.
With respect to the subject matter of the independent claim, Claim 12, and further as incorporated into its dependents, Claims 13-19, Claim 12 recites:
A device configured to flush a gas measurement line of a medical device, the device comprising:
means providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval and interrupting the first flushing volume flow during a second time interval; and
a first flushing gas source connection or a first flushing gas source for the first flushing volume flow.
(STEP 2A): Whether a Claim is Directed to a Judicial Exception
(STEP 2A, Prong One): Whether a Claim Recites an Abstract Idea, Law of Nature, or Natural Phenomenon
With respect to the subject matter of the independent claim, Claim 1, and its dependents, Claims 2-11:
Regarding “providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval”, this limitation appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG.
Regarding “interrupting the first flushing volume flow during a second time interval”, this limitation appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG.
With respect to the subject matter of the independent claim, Claim 12, and its dependents, Claims 13-19:
Regarding “means providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval and interrupting the first flushing volume flow during a second time interval”, this limitation appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG.
Regarding “a first flushing gas source connection or a first flushing gas source for the first flushing volume flow”, this limitation appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG.
Thus, the subject matter of the independent claims, Claims 1 and 12, and their dependents, Claims 2-11 and 13-19, are directed to a judicial exception because they recite an abstract idea.
(STEP 2A, Prong Two): Whether a Claim Recites an Additional Elements that Integrate the Judicial Exception into a Practical Application
Although the subject matter of the independent claims, Claims 1 and 12, and their dependents, Claims 2-11 and 13-19, are directed to a judicial exception – abstract idea, this judicial exception is not integrated into a practical application.
With respect to Claim 1, it is noted the only additional elements appear to be “a medical device” and “a gas measurement line”; while, with respect to Claim 12, it is noted the only additional elements appear to be “a medical device”, “a gas measurement line”, and “a first flushing gas source connection” or “a first flushing gas source”. It is noted the concepts of “a medical device”, “a gas measurement line”, and “a first flushing gas source connection” or “a first flushing gas source” well-understood, routine, conventional features to convey the delivery of gas from a source to a sink. Thus, the recitation of these additional elements appear to amount to being conventional practice in the field of use.
For Example: Acker et al. (2007/0144518) discloses the features of a medical device (12, “Referring first to FIG. 1, a nasal cannula control system 10 is shown as used with a positive pressure ventilator 12.” Para 0020; “The ventilator 12 delivers a supply of ventilation gas to a patient breathing circuit 14 to provide mechanical ventilation of the patient. In the embodiment of the invention shown in FIG. 2, the patient breathing circuit 14 includes a non-invasive ventilation (NIV) breathing mask 16 that is used to deliver gases to the patient 18.” Para 0021), a gas measurement line (24, defined by the combination of 26 and 28, “Referring back to FIG. 1, the nasal cannula control system 10 includes a self-contained monitoring unit 25 that interfaces with the nasal cannula assembly 24 that includes two separate lumens. The nasal cannula assembly 24 includes a nasal lumen 26 that is in pneumatic communication with the patient's nostrils and a mask lumen 28 that is in pneumatic communication with the interior of the patient's breathing mask. Although the two lumens 26, 28 are described as extending to defined areas, namely the nostrils and breathing mask, the lumens 26, 28 could terminate at other locations depending upon the specific patient and the configuration of the patient breathing circuit 14. The nasal cannula control system 10 utilizes the combination of the nasal lumen 26 and the mask lumen 28 to monitor the pressure within the patient mask and nostrils of the patient, as well as to monitor an exhaled gas from the patient, such as the carbon dioxide concentration within the nasal canal of the patient.” Para 0023), and a first flushing gas source connection or first flushing gas source (defined by the admixture at 56 of gases from 36 and 38 as directed along 24 to each of 26 and 28, “Referring back to FIG. 1, the monitoring unit 25 of the nasal cannula control system 10 is coupled to an oxygen supply 36 and a fresh air supply 38.” Para 0027; “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029).
It is noted Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by the claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is like, Affinity Labs of Tex., LLC v. DirecTV, LLC (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
Thus, for these reasons, the aforementioned abstract idea of the independent claims and their dependents are not integrated into a practical application under 2019 PEG.
(STEP 2B): Whether a Claim Amounts to Significantly More
Although the subject matter of the independent claims, Claims 1 and 12, and their dependents, Claims 2-11 and 13-19, are directed to a judicial exception – abstract idea, this judicial exception does not amount to significantly more.
With respect to the subject matter of the independent claim, Claim 1, and its dependents, Claims 2-11:
Regarding “providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval”, Acker et al. (2007/0144518) discloses providing (via operation of one of valves 58/60 to open, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) a first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) for flushing the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28, “Referring back to FIG. 1, the nasal cannula control system 10 includes a self-contained monitoring unit 25 that interfaces with the nasal cannula assembly 24 that includes two separate lumens. The nasal cannula assembly 24 includes a nasal lumen 26 that is in pneumatic communication with the patient's nostrils and a mask lumen 28 that is in pneumatic communication with the interior of the patient's breathing mask. Although the two lumens 26, 28 are described as extending to defined areas, namely the nostrils and breathing mask, the lumens 26, 28 could terminate at other locations depending upon the specific patient and the configuration of the patient breathing circuit 14. The nasal cannula control system 10 utilizes the combination of the nasal lumen 26 and the mask lumen 28 to monitor the pressure within the patient mask and nostrils of the patient, as well as to monitor an exhaled gas from the patient, such as the carbon dioxide concentration within the nasal canal of the patient.” Para 0023) in a direction of a patient (18, “The ventilator 12 delivers a supply of ventilation gas to a patient breathing circuit 14 to provide mechanical ventilation of the patient. In the embodiment of the invention shown in FIG. 2, the patient breathing circuit 14 includes a non-invasive ventilation (NIV) breathing mask 16 that is used to deliver gases to the patient 18. As illustrated, the breathing mask 16 covers both the nose and mouth of the patient 18 and forms a seal 20 with the patient along the outer peripheral edges of the breathing mask 16.” Para 0021) during a first time interval (the amount of time one of the valves 58/60 is open) was a well-understood, routine, conventional limitation.
Regarding “interrupting the first flushing volume flow during a second time interval”, Acker et al. (2007/0144518) discloses interrupting the first flushing flow volume (via operation of one of valves 58/60 to close) the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) during a second time interval (the amount of time one of the valves 58/60 is closed) was a well-understood, routine, conventional limitation.
With respect to the subject matter of the independent claim, Claim 12, and its dependents, Claims 13-19:
Regarding “means providing a first flushing volume flow for flushing the gas measurement line in a direction of a patient during a first time interval and interrupting the first flushing volume flow during a second time interval”, Acker et al. (2007/0144518) discloses a means (one of valves 58/60, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) providing a first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) for flushing the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28, “Referring back to FIG. 1, the nasal cannula control system 10 includes a self-contained monitoring unit 25 that interfaces with the nasal cannula assembly 24 that includes two separate lumens. The nasal cannula assembly 24 includes a nasal lumen 26 that is in pneumatic communication with the patient's nostrils and a mask lumen 28 that is in pneumatic communication with the interior of the patient's breathing mask. Although the two lumens 26, 28 are described as extending to defined areas, namely the nostrils and breathing mask, the lumens 26, 28 could terminate at other locations depending upon the specific patient and the configuration of the patient breathing circuit 14. The nasal cannula control system 10 utilizes the combination of the nasal lumen 26 and the mask lumen 28 to monitor the pressure within the patient mask and nostrils of the patient, as well as to monitor an exhaled gas from the patient, such as the carbon dioxide concentration within the nasal canal of the patient.” Para 0023) in a direction of a patient (18, “The ventilator 12 delivers a supply of ventilation gas to a patient breathing circuit 14 to provide mechanical ventilation of the patient. In the embodiment of the invention shown in FIG. 2, the patient breathing circuit 14 includes a non-invasive ventilation (NIV) breathing mask 16 that is used to deliver gases to the patient 18. As illustrated, the breathing mask 16 covers both the nose and mouth of the patient 18 and forms a seal 20 with the patient along the outer peripheral edges of the breathing mask 16.” Para 0021) during a first time interval (the amount of time one of the valves 58/60 is open) and interrupting the first flushing flow volume (via operation of one of valves 58/60 to close) the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) during a second time interval (the amount of time one of the valves 58/60 is closed) was a well-understood, routine, conventional limitation.
Regarding “a first flushing gas source connection or a first flushing gas source for the first flushing volume flow”, Acker et al. (2007/0144518) discloses a first flushing gas source connection or a first flushing gas source (36 or 38, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) for the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) was a well-understood, routine, conventional limitation.
Thus, for these reasons, the aforementioned abstract idea of the independent claims and their dependents appears to amount to being conventional practice in the field of use.
Consideration of Additional Subject Matter of the Dependent Claims
With respect to Claim 2, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it is noted the “determining” limitation appears to be an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
With respect to Claim 3, the subject matter appears to be directed towards an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
With respect to Claim 4, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it should be noted Acker et al. (2007/0144518) discloses a second flushing volume (via operation of other of valves 58/60 to open) in the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28) in a direction of a patient (18).
With respect to Claim 5, the subject matter appears to be directed towards an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
With respect to Claim 6, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it is noted the “determining” limitation appears to be an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
With respect to Claim 7, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it is noted the “determining” limitation appears to be an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
With respect to Claim 8, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG.
With respect to Claim 9, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it should be noted Acker et al. (2007/0144518) discloses a second flushing volume (via operation of other of valves 58/60 to open) operating during second time interval (the amount of time other of the valves 58/60 is closed) and interrupting the second flushing flow volume (via operation of other of valves 58/60 to close) the second flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) during a first time interval (the amount of time one of the valves 58/60 is closed).
With respect to Claim 10, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG.
With respect to Claim 11, Acker et al. (2007/0144518) discloses a computer program (via 34, “The CO.sub.2 sampling system 30 is in communication with a control unit 34 of the nasal cannula control system 10. The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired.” Para 0025; “ If control unit 34 detects the a differential pressure change that signals an occluded lumen, the control unit 34 will signal the ventilator 12. The ventilator 12 can provide a message to the nasal cannula control system 10 along communication line 63 to begin the purging operation in synchronization with a specific portion of the patient breathing cycle.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033; “ The detection of the patient's spontaneous breath attempt is relayed from the control unit 34 to the ventilator 12.” Para 0041; “If the differential pressure sensor 64 detects this change in the differential pressure, the detected pressure change causes the control unit 34 to signal the ventilator 12 to begin the inspiration support phase.” Para 0042; “Upon detection of the change in the pressure differential, the control unit 34 signals the ventilator 12 to begin the expiration phase of the breathing cycle.” Para 0043; “This is when the control unit 34 will signal the positive pressure ventilator 12, via the communications link 63, that the patient is inhaling. The ventilator 12 will begin the delivery of positive pressure in an inspiration support phase. At 2.25 seconds, the differential pressure goes back above -1 cm H.sub.2O and the control unit 34, via the communications link, notifies the ventilator 12 that the patient has begun to exhale. The ventilator 60 will then start to provide pressure support for the expiratory cycle.” Para 0044; “The CO.sub.2 sampling system 30 includes a measuring device that determines the amount of carbon dioxide within the exhale gases of the patient and provides this signal to the control unit 34. Thus, the single nasal cannula assembly 24 can be utilized for not only monitoring the pressure differential between the patient's nostrils and the face mask, but also for monitoring the carbon dioxide exhaled by the patient.” Para 0047) which cooperates the device (10) with the medical device (12) to execute the process of flushing the gases.
With respect to Claim 13, Acker et al. (2007/0144518) discloses the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28) with the medical device (12).
With respect to Claim 14, Acker et al. (2007/0144518) discloses the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28) is configured as a pressure measurement line (via 64, “The nasal cannula control system 10 utilizes the differential pressure sensed by the pressure sensor 64 to determine whether the nasal lumen 26 or the mask lumen 28 has become blocked, such by mucous or other fluid.” Para 0030) and/or the medical device (12) is a ventilator.
With respect to Claim 15, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it is noted the “determining” limitation appears to be an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
With respect to Claim 16, Acker et al. (2007/0144518) discloses the control unit (34) determines the time periods of the time interval.
With respect to Claim 17, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it should be noted Acker et al. (2007/0144518) discloses a second flushing volume (via operation of other of valves 58/60 to open) operating during second time interval (the amount of time other of the valves 58/60 is closed) and interrupting the second flushing flow volume (via operation of other of valves 58/60 to close) the second flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) during a first time interval (the amount of time one of the valves 58/60 is closed).
With respect to Claim 18, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it is noted the “determining” limitation appears to be an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
With respect to Claim 19, the subject matter appears to be directed towards an action that manages a personal behavior as it is an instruction, which is grouped as certain methods of organizing human activity under 2019 PEG. Additionally, it is noted the “determining” limitation appears to be an observation, evaluation, judgement, or opinion, which is grouped under mental processes under 2019 PEG.
Thus, the additional subject matter added to the dependent claims, Claims 2-11 and 13-19, retain the status of not being integrated into a practical application, as the subject matter is not significantly more than the aforementioned abstract idea.
Conclusion of the 35 U.S.C. 101 Analysis
In light of the aforementioned reasoning, Claims 1-19 are deemed rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-7, 9, 10, 12-19 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Acker et al. (2007/0144518).
As to Claim 1, Acker discloses a process of flushing a gas measurement line (24) of a medical device (12), comprising the steps of: providing (via operation of one of valves 58/60 to open, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) a first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) for flushing the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28, “Referring back to FIG. 1, the nasal cannula control system 10 includes a self-contained monitoring unit 25 that interfaces with the nasal cannula assembly 24 that includes two separate lumens. The nasal cannula assembly 24 includes a nasal lumen 26 that is in pneumatic communication with the patient's nostrils and a mask lumen 28 that is in pneumatic communication with the interior of the patient's breathing mask. Although the two lumens 26, 28 are described as extending to defined areas, namely the nostrils and breathing mask, the lumens 26, 28 could terminate at other locations depending upon the specific patient and the configuration of the patient breathing circuit 14. The nasal cannula control system 10 utilizes the combination of the nasal lumen 26 and the mask lumen 28 to monitor the pressure within the patient mask and nostrils of the patient, as well as to monitor an exhaled gas from the patient, such as the carbon dioxide concentration within the nasal canal of the patient.” Para 0023) in a direction of a patient (18, “The ventilator 12 delivers a supply of ventilation gas to a patient breathing circuit 14 to provide mechanical ventilation of the patient. In the embodiment of the invention shown in FIG. 2, the patient breathing circuit 14 includes a non-invasive ventilation (NIV) breathing mask 16 that is used to deliver gases to the patient 18. As illustrated, the breathing mask 16 covers both the nose and mouth of the patient 18 and forms a seal 20 with the patient along the outer peripheral edges of the breathing mask 16.” Para 0021) during a first time interval (the amount of time one of the valves 58/60 is open); and interrupting the first flushing flow volume (via operation of one of valves 58/60 to close) the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) during a second time interval (the amount of time other of the valves 58/60 is closed).
As to Claim 2, Acker discloses receiving first information (via 64 as communicating with 34 along 66, “The nasal cannula control system 10 utilizes the differential pressure sensed by the pressure sensor 64 to determine whether the nasal lumen 26 or the mask lumen 28 has become blocked, such by mucous or other fluid.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033) corresponding to a flow rate (“The differential pressure sensor 64 will monitor the flow of oxygen through the cannula 24 as a laminar flow element, since the mask lumen 28 will not include any flow of gas.” Para 0045) of the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18); receiving second information (via energizing/deenergizing of 58/60) corresponding to a volume of the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28); and determining (via 34, “The CO.sub.2 sampling system 30 is in communication with a control unit 34 of the nasal cannula control system 10. The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired.” Para 0025; “ If control unit 34 detects the a differential pressure change that signals an occluded lumen, the control unit 34 will signal the ventilator 12. The ventilator 12 can provide a message to the nasal cannula control system 10 along communication line 63 to begin the purging operation in synchronization with a specific portion of the patient breathing cycle.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033; “ The detection of the patient's spontaneous breath attempt is relayed from the control unit 34 to the ventilator 12.” Para 0041; “If the differential pressure sensor 64 detects this change in the differential pressure, the detected pressure change causes the control unit 34 to signal the ventilator 12 to begin the inspiration support phase.” Para 0042; “Upon detection of the change in the pressure differential, the control unit 34 signals the ventilator 12 to begin the expiration phase of the breathing cycle.” Para 0043; “This is when the control unit 34 will signal the positive pressure ventilator 12, via the communications link 63, that the patient is inhaling. The ventilator 12 will begin the delivery of positive pressure in an inspiration support phase. At 2.25 seconds, the differential pressure goes back above -1 cm H.sub.2O and the control unit 34, via the communications link, notifies the ventilator 12 that the patient has begun to exhale. The ventilator 60 will then start to provide pressure support for the expiratory cycle.” Para 0044; “The CO.sub.2 sampling system 30 includes a measuring device that determines the amount of carbon dioxide within the exhale gases of the patient and provides this signal to the control unit 34. Thus, the single nasal cannula assembly 24 can be utilized for not only monitoring the pressure differential between the patient's nostrils and the face mask, but also for monitoring the carbon dioxide exhaled by the patient.” Para 0047) a first duration of the first time interval (the amount of time one of the valves 58/60 is open) as a function of the first information (via 64 as communicating with 34 along 66) and the second information (via energizing/deenergizing of 58/60).
As to Claim 3, Acker discloses determining a second time duration of the second time interval (the amount of time one of the valves 58/60 is closed) as a function of the first duration (the amount of time one of the valves 58/60 is open), so that the second duration (the amount of time one of the valves 58/60 is closed) is at least as long as the first duration (the amount of time one of the valves 58/60 is open).
Acker states “During normal ventilation by the ventilator 12, the pair of purge valves 58, 60 are closed and the differential pressure sensor 64 measures the pressure difference between the nasal lumen 26 and the mask lumen 28.” (Para 0033); thus, the second duration is at least as long, if not longer than the first duration as only “During the purging cycle, the pump within the CO.sub.2 sampling system 30 is initially turned off to discontinue drawing any measurement gas flow from the patient. Once the CO.sub.2 pump has been turned off, if the nasal lumen 26 is to be purged, the first purge valve 58 is opened. Once the purge valve 58 has been opened, the corresponding flow valve 50 or 54 is opened to supply either the pressurized oxygen or air to the nasal cannula 26. After a brief period of time, the purge valve 58 is closed and the purge valve 60 opened to purge the mask lumen 28. Once both the nasal lumen 26 and the mask lumen 28 have been purged, both of the purge valves 58, 60 are closed and the CO.sub.2 sampling system 30 begins operation the capnometer pump.” (Para 0031).
As to Claim 4, Acker discloses a second flushing volume (via operation of other of valves 58/60 to open) in the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28) in a direction of a patient (18).
As to Claim 5, Acker discloses an oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the first flushing volume flow (via operation of one of valves 58/60 to open) and the oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the second flushing volume flow (via operation of other of valves 58/60 to open) are different (“It is believed that drawing the measurement gas flow from the nostrils of the patient will lead to a more accurate CO.sub.2 measurement due to the more direct gas withdrawal from the patient. However, utilizing the mask lumen 28 would also allow for CO.sub.2 sampling and measurement.” Para 0026).
As to Claim 6, Acker discloses receiving third information (via 34 as connected to 63 and 12, “The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired. Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” Para 0025; also see: “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024) corresponding to an oxygen concentration of the ventilation volume flow (“During post-ventilation oxygen therapy, the clinician can set a constant oxygen flow rate and the system 10 will deliver the required oxygen to the patient.” Para 0045); receiving fourth information (via 34 of operation of one of valves 58/60 to open) corresponding to an oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the first flushing volume flow (via operation of one of valves 58/60 to open); and determining (via 34) the first duration depending on the third information (via 34 as connected to 63 and 12) and on the fourth information (via 34 of operation of one of valves 58/60 to open), so that the mixing of the ventilation volume flow (via 14), the first flushing volume (via operation of one of valves 58/60 to open) does not exceed or fall below a threshold value of the inspiratory oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026).
Regarding the concept of threshold, it is noted Acker discloses “Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” (Para 0025), the generation of an alarm is effectively a warning that a safety threshold has been exceeded or fallen.
As to Claim 7, Acker discloses receiving third information (via 34 as connected to 63 and 12, “The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired. Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” Para 0025; also see: “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024) corresponding to an oxygen concentration of the ventilation volume flow (“During post-ventilation oxygen therapy, the clinician can set a constant oxygen flow rate and the system 10 will deliver the required oxygen to the patient.” Para 0045); receiving fourth information (via 34 of operation of one of valves 58/60 to open) corresponding to an oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the first flushing volume flow (via operation of one of valves 58/60 to open); receiving fifth information (via 34 of operation of other of valves 58/60 to open) corresponding to an oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the second flushing volume flow (via operation of other of valves 58/60 to open); and determining (via 34) the first duration depending on the third information (via 34 as connected to 63 and 12), on the fourth information (via 34 of operation of one of valves 58/60 to open), and on the fifth information (via 34 of operation of other of valves 58/60 to open), so that the mixing of the ventilation volume flow (via 14), the first flushing volume (via operation of one of valves 58/60 to open), and the second flushing volume (via operation of other of valves 58/60 to open) does not exceed or fall below a threshold value of the inspiratory oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026).
Regarding the concept of threshold, it is noted Acker discloses “Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” (Para 0025), the generation of an alarm is effectively a warning that a safety threshold has been exceeded or fallen.
As to Claim 9, Acker discloses providing the second flushing volume (via operation of other of valves 58/60 to open) during second time interval (the amount of time one of the valves 58/60 is closed); and interrupting the second flushing flow volume (via operation of other of valves 58/60 to close) during the first time interval (the amount of time one of the valves 58/60 is closed).
As to Claim 10, Acker discloses providing a continuous basic volume flow (“Although the nasal cannula control system 10 shown and described in the Figures has been discussed as being particularly useful in monitoring a pressure differential between the patient's nasal passages and within a breathing mask to signal the beginning of the inspiratory and expiratory phases of the breathing cycle, the nasal cannula assembly may also be used separate from the operation of the mechanism ventilator 12, such as for post-ventilation oxygen therapy. During post-ventilation oxygen therapy, the clinician can set a constant oxygen flow rate and the system 10 will deliver the required oxygen to the patient.” Para 0045) in a breathing gas line (14 via 12, “The ventilator 12 delivers a supply of ventilation gas to a patient breathing circuit 14 to provide mechanical ventilation of the patient. In the embodiment of the invention shown in FIG. 2, the patient breathing circuit 14 includes a non-invasive ventilation (NIV) breathing mask 16 that is used to deliver gases to the patient 18.” Para 0021) of the medical device (12) during the performance of the process.
As to Claim 12, Acker discloses a device (10, “Referring first to FIG. 1, a nasal cannula control system 10 is shown as used with a positive pressure ventilator 12.” Para 0020) configured to flush a gas measurement line (24, defined by the combination of 26 and 28, “Referring back to FIG. 1, the nasal cannula control system 10 includes a self-contained monitoring unit 25 that interfaces with the nasal cannula assembly 24 that includes two separate lumens. The nasal cannula assembly 24 includes a nasal lumen 26 that is in pneumatic communication with the patient's nostrils and a mask lumen 28 that is in pneumatic communication with the interior of the patient's breathing mask. Although the two lumens 26, 28 are described as extending to defined areas, namely the nostrils and breathing mask, the lumens 26, 28 could terminate at other locations depending upon the specific patient and the configuration of the patient breathing circuit 14. The nasal cannula control system 10 utilizes the combination of the nasal lumen 26 and the mask lumen 28 to monitor the pressure within the patient mask and nostrils of the patient, as well as to monitor an exhaled gas from the patient, such as the carbon dioxide concentration within the nasal canal of the patient.” Para 0023) of a medical device (12, “Referring first to FIG. 1, a nasal cannula control system 10 is shown as used with a positive pressure ventilator 12.” Para 0020), the device (10) comprising: means (one of valves 58/60, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) providing a first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) for flushing the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28, “Referring back to FIG. 1, the nasal cannula control system 10 includes a self-contained monitoring unit 25 that interfaces with the nasal cannula assembly 24 that includes two separate lumens. The nasal cannula assembly 24 includes a nasal lumen 26 that is in pneumatic communication with the patient's nostrils and a mask lumen 28 that is in pneumatic communication with the interior of the patient's breathing mask. Although the two lumens 26, 28 are described as extending to defined areas, namely the nostrils and breathing mask, the lumens 26, 28 could terminate at other locations depending upon the specific patient and the configuration of the patient breathing circuit 14. The nasal cannula control system 10 utilizes the combination of the nasal lumen 26 and the mask lumen 28 to monitor the pressure within the patient mask and nostrils of the patient, as well as to monitor an exhaled gas from the patient, such as the carbon dioxide concentration within the nasal canal of the patient.” Para 0023) in a direction of a patient (18, “The ventilator 12 delivers a supply of ventilation gas to a patient breathing circuit 14 to provide mechanical ventilation of the patient. In the embodiment of the invention shown in FIG. 2, the patient breathing circuit 14 includes a non-invasive ventilation (NIV) breathing mask 16 that is used to deliver gases to the patient 18. As illustrated, the breathing mask 16 covers both the nose and mouth of the patient 18 and forms a seal 20 with the patient along the outer peripheral edges of the breathing mask 16.” Para 0021) during a first time interval (the amount of time one of the valves 58/60 is open) and interrupting the first flushing flow volume (via operation of one of valves 58/60 to close) the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) during a second time interval (the amount of time one of the valves 58/60 is closed); and a first flushing gas source connection or a first flushing gas source (36 or 38, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) for the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18).
As to Claim 13, Acker discloses a gas measurement line (24, defined by the combination of 26 and 28) and a medical device (12) in combination.
As to Claim 14, Ackers discloses the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28) is configured as a pressure measurement line (via 64, “The nasal cannula control system 10 utilizes the differential pressure sensed by the pressure sensor 64 to determine whether the nasal lumen 26 or the mask lumen 28 has become blocked, such by mucous or other fluid.” Para 0030) and/or the medical device (12) is a ventilator.
As to Claim 15, Acker discloses a control unit (34, “The CO.sub.2 sampling system 30 is in communication with a control unit 34 of the nasal cannula control system 10. The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired.” Para 0025; “ If control unit 34 detects the a differential pressure change that signals an occluded lumen, the control unit 34 will signal the ventilator 12. The ventilator 12 can provide a message to the nasal cannula control system 10 along communication line 63 to begin the purging operation in synchronization with a specific portion of the patient breathing cycle.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033; “ The detection of the patient's spontaneous breath attempt is relayed from the control unit 34 to the ventilator 12.” Para 0041; “If the differential pressure sensor 64 detects this change in the differential pressure, the detected pressure change causes the control unit 34 to signal the ventilator 12 to begin the inspiration support phase.” Para 0042; “Upon detection of the change in the pressure differential, the control unit 34 signals the ventilator 12 to begin the expiration phase of the breathing cycle.” Para 0043; “This is when the control unit 34 will signal the positive pressure ventilator 12, via the communications link 63, that the patient is inhaling. The ventilator 12 will begin the delivery of positive pressure in an inspiration support phase. At 2.25 seconds, the differential pressure goes back above -1 cm H.sub.2O and the control unit 34, via the communications link, notifies the ventilator 12 that the patient has begun to exhale. The ventilator 60 will then start to provide pressure support for the expiratory cycle.” Para 0044; “The CO.sub.2 sampling system 30 includes a measuring device that determines the amount of carbon dioxide within the exhale gases of the patient and provides this signal to the control unit 34. Thus, the single nasal cannula assembly 24 can be utilized for not only monitoring the pressure differential between the patient's nostrils and the face mask, but also for monitoring the carbon dioxide exhaled by the patient.” Para 0047) receiving first information (via 64 as communicating with 34 along 66, “The nasal cannula control system 10 utilizes the differential pressure sensed by the pressure sensor 64 to determine whether the nasal lumen 26 or the mask lumen 28 has become blocked, such by mucous or other fluid.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033) corresponding to a flow rate (“The differential pressure sensor 64 will monitor the flow of oxygen through the cannula 24 as a laminar flow element, since the mask lumen 28 will not include any flow of gas.” Para 0045) of the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18); receiving second information (via energizing/deenergizing of 58/60) corresponding to a volume of the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28); and determining (via 34, “The CO.sub.2 sampling system 30 is in communication with a control unit 34 of the nasal cannula control system 10. The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired.” Para 0025; “ If control unit 34 detects the a differential pressure change that signals an occluded lumen, the control unit 34 will signal the ventilator 12. The ventilator 12 can provide a message to the nasal cannula control system 10 along communication line 63 to begin the purging operation in synchronization with a specific portion of the patient breathing cycle.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033; “ The detection of the patient's spontaneous breath attempt is relayed from the control unit 34 to the ventilator 12.” Para 0041; “If the differential pressure sensor 64 detects this change in the differential pressure, the detected pressure change causes the control unit 34 to signal the ventilator 12 to begin the inspiration support phase.” Para 0042; “Upon detection of the change in the pressure differential, the control unit 34 signals the ventilator 12 to begin the expiration phase of the breathing cycle.” Para 0043; “This is when the control unit 34 will signal the positive pressure ventilator 12, via the communications link 63, that the patient is inhaling. The ventilator 12 will begin the delivery of positive pressure in an inspiration support phase. At 2.25 seconds, the differential pressure goes back above -1 cm H.sub.2O and the control unit 34, via the communications link, notifies the ventilator 12 that the patient has begun to exhale. The ventilator 60 will then start to provide pressure support for the expiratory cycle.” Para 0044; “The CO.sub.2 sampling system 30 includes a measuring device that determines the amount of carbon dioxide within the exhale gases of the patient and provides this signal to the control unit 34. Thus, the single nasal cannula assembly 24 can be utilized for not only monitoring the pressure differential between the patient's nostrils and the face mask, but also for monitoring the carbon dioxide exhaled by the patient.” Para 0047) a first duration of the first time interval (the amount of time one of the valves 58/60 is open) as a function of the first information (via 64 as communicating with 34 along 66) and the second information (via energizing/deenergizing of 58/60).
As to Claim 16, Acker discloses determining a second time duration of the second time interval (the amount of time one of the valves 58/60 is closed) as a function of the first duration (the amount of time one of the valves 58/60 is open), so that the second duration (the amount of time one of the valves 58/60 is closed) is at least as long as the first duration (the amount of time one of the valves 58/60 is open).
Acker states “During normal ventilation by the ventilator 12, the pair of purge valves 58, 60 are closed and the differential pressure sensor 64 measures the pressure difference between the nasal lumen 26 and the mask lumen 28.” (Para 0033); thus, the second duration is at least as long, if not longer than the first duration as only “During the purging cycle, the pump within the CO.sub.2 sampling system 30 is initially turned off to discontinue drawing any measurement gas flow from the patient. Once the CO.sub.2 pump has been turned off, if the nasal lumen 26 is to be purged, the first purge valve 58 is opened. Once the purge valve 58 has been opened, the corresponding flow valve 50 or 54 is opened to supply either the pressurized oxygen or air to the nasal cannula 26. After a brief period of time, the purge valve 58 is closed and the purge valve 60 opened to purge the mask lumen 28. Once both the nasal lumen 26 and the mask lumen 28 have been purged, both of the purge valves 58, 60 are closed and the CO.sub.2 sampling system 30 begins operation the capnometer pump.” (Para 0031).
As to Claim 17, Acker discloses means (other of valves 58/60, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) providing the second flushing volume (via operation of other of valves 58/60 to open) during second time interval (the amount of time one of the valves 58/60 is closed); and interrupting the second flushing flow volume (via operation of other of valves 58/60 to close) during the first time interval (the amount of time one of the valves 58/60 is closed).
As to Claim 18, Acker discloses receiving third information (via 34 as connected to 63 and 12, “The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired. Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” Para 0025; also see: “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024) corresponding to an oxygen concentration of the ventilation volume flow (“During post-ventilation oxygen therapy, the clinician can set a constant oxygen flow rate and the system 10 will deliver the required oxygen to the patient.” Para 0045); receiving fourth information (via 34 of operation of one of valves 58/60 to open) corresponding to an oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the first flushing volume flow (via operation of one of valves 58/60 to open); and determining (via 34) the first duration depending on the third information (via 34 as connected to 63 and 12) and on the fourth information (via 34 of operation of one of valves 58/60 to open), so that the mixing of the ventilation volume flow (via 14), the first flushing volume (via operation of one of valves 58/60 to open) does not exceed or fall below a threshold value of the inspiratory oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026).
Regarding the concept of threshold, it is noted Acker discloses “Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” (Para 0025), the generation of an alarm is effectively a warning that a safety threshold has been exceeded or fallen.
As to Claim 19, Acker discloses receiving third information (via 34 as connected to 63 and 12, “The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired. Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” Para 0025; also see: “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024) corresponding to an oxygen concentration of the ventilation volume flow (“During post-ventilation oxygen therapy, the clinician can set a constant oxygen flow rate and the system 10 will deliver the required oxygen to the patient.” Para 0045); receiving fourth information (via 34 of operation of one of valves 58/60 to open) corresponding to an oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the first flushing volume flow (via operation of one of valves 58/60 to open); receiving fifth information (via 34 of operation of other of valves 58/60 to open) corresponding to an oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026) of the second flushing volume flow (via operation of other of valves 58/60 to open); and determining (via 34) the first duration depending on the third information (via 34 as connected to 63 and 12), on the fourth information (via 34 of operation of one of valves 58/60 to open), and on the fifth information (via 34 of operation of other of valves 58/60 to open), so that the mixing of the ventilation volume flow (via 14), the first flushing volume (via operation of one of valves 58/60 to open), and the second flushing volume (via operation of other of valves 58/60 to open) does not exceed or fall below a threshold value of the inspiratory oxygen concentration (via 30, “As an example, the CO.sub.2 sampling system 30 could be replaced by a sampling system that detects exhaled gases such as nitric oxide, an inhaled anesthetic agent, oxygen, nitrous oxide or any other exhaled gas that may be of concern during the treatment of the patient.” Para 0024; also see: “Although the CO.sub.2 sampling system 30 is shown in the preferred embodiment of the invention as drawing the measurement gas flow from the nasal lumen 26, it should be understood that the sampling system could also draw the measurement gas flow from the mask lumen 28.” Para 0026).
Regarding the concept of threshold, it is noted Acker discloses “Upon receiving the carbon dioxide sampling measurement, the ventilator 12 can either adjust its operation or generate an alarm signal as desired.” (Para 0025), the generation of an alarm is effectively a warning that a safety threshold has been exceeded or fallen.
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.
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Acker et al. (2007/0144518) in view of Ahmad (2013/0206144).
As to Claim 11, Acker discloses a computer program (via 34, “The CO.sub.2 sampling system 30 is in communication with a control unit 34 of the nasal cannula control system 10. The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired.” Para 0025; “ If control unit 34 detects the a differential pressure change that signals an occluded lumen, the control unit 34 will signal the ventilator 12. The ventilator 12 can provide a message to the nasal cannula control system 10 along communication line 63 to begin the purging operation in synchronization with a specific portion of the patient breathing cycle.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033; “ The detection of the patient's spontaneous breath attempt is relayed from the control unit 34 to the ventilator 12.” Para 0041; “If the differential pressure sensor 64 detects this change in the differential pressure, the detected pressure change causes the control unit 34 to signal the ventilator 12 to begin the inspiration support phase.” Para 0042; “Upon detection of the change in the pressure differential, the control unit 34 signals the ventilator 12 to begin the expiration phase of the breathing cycle.” Para 0043; “This is when the control unit 34 will signal the positive pressure ventilator 12, via the communications link 63, that the patient is inhaling. The ventilator 12 will begin the delivery of positive pressure in an inspiration support phase. At 2.25 seconds, the differential pressure goes back above -1 cm H.sub.2O and the control unit 34, via the communications link, notifies the ventilator 12 that the patient has begun to exhale. The ventilator 60 will then start to provide pressure support for the expiratory cycle.” Para 0044; “The CO.sub.2 sampling system 30 includes a measuring device that determines the amount of carbon dioxide within the exhale gases of the patient and provides this signal to the control unit 34. Thus, the single nasal cannula assembly 24 can be utilized for not only monitoring the pressure differential between the patient's nostrils and the face mask, but also for monitoring the carbon dioxide exhaled by the patient.” Para 0047) which cooperates the device (10) with the medical device (12) to execute the process of flushing the gases of the gas measurement line (24, defined by the combination of 26 and 28) of the medical device (12).
Yet, Acker does not expressly disclose the configuration of the computer program product “with a computer readable storage medium comprising a tangible device that is non-transitory with instructions retained and stored on the computer readable storage medium for use by an instruction execution device”.
Ahmad teaches the use of a computer readable storage medium (“EEPROM, RAM, etc.” Para 0024) retaining and storing a program (“programming” Para 0024) to be executed by the instruction execution device (16) to operate the control of the ventilation device (14).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the computer program of Ackers to include the features of “computer readable storage medium”, as taught by Ahmad to permit the programming to operate the control of the ventilation device.
As to Claim 20, Acker discloses a computer program (via 34, “The CO.sub.2 sampling system 30 is in communication with a control unit 34 of the nasal cannula control system 10. The control unit 34 can communicate with the ventilator 12 over the communication line 63 to provide the carbon dioxide sampling measurement to the ventilator 12 as desired.” Para 0025; “ If control unit 34 detects the a differential pressure change that signals an occluded lumen, the control unit 34 will signal the ventilator 12. The ventilator 12 can provide a message to the nasal cannula control system 10 along communication line 63 to begin the purging operation in synchronization with a specific portion of the patient breathing cycle.” Para 0030; “The differential pressure sensor 64 is in communication with the control unit 34 through the communication line 66. In this manner, the control unit 34 can monitor for changes in the differential pressure, which is indicative of the various phases within the patient's breath cycle.” Para 0033; “ The detection of the patient's spontaneous breath attempt is relayed from the control unit 34 to the ventilator 12.” Para 0041; “If the differential pressure sensor 64 detects this change in the differential pressure, the detected pressure change causes the control unit 34 to signal the ventilator 12 to begin the inspiration support phase.” Para 0042; “Upon detection of the change in the pressure differential, the control unit 34 signals the ventilator 12 to begin the expiration phase of the breathing cycle.” Para 0043; “This is when the control unit 34 will signal the positive pressure ventilator 12, via the communications link 63, that the patient is inhaling. The ventilator 12 will begin the delivery of positive pressure in an inspiration support phase. At 2.25 seconds, the differential pressure goes back above -1 cm H.sub.2O and the control unit 34, via the communications link, notifies the ventilator 12 that the patient has begun to exhale. The ventilator 60 will then start to provide pressure support for the expiratory cycle.” Para 0044; “The CO.sub.2 sampling system 30 includes a measuring device that determines the amount of carbon dioxide within the exhale gases of the patient and provides this signal to the control unit 34. Thus, the single nasal cannula assembly 24 can be utilized for not only monitoring the pressure differential between the patient's nostrils and the face mask, but also for monitoring the carbon dioxide exhaled by the patient.” Para 0047) which cooperates the device (10) with the medical device (12) to execute the process of flushing the gases of the gas measurement line (24, defined by the combination of 26 and 28) of the medical device (12), wherein the computer program (via 34) is able to perform the steps of providing (via operation of one of valves 58/60 to open, “The oxygen supply 36 is received in a oxygen flow line 52, which also includes a flow valve 54 for regulating the flow of oxygen. The pair of flow valves 50, 54 are independently operable such that either or both of oxygen supply 36 and air supply 38 can be directed to the patient. The flow of oxygen and air are both supplied to a purging and sensing circuit 55 by conduit 56, which separates and supplies the flow of gas to a first purge valve 58 and a second purge valve 60. As illustrated, the first purge valve 58 is in communication with the nasal lumen 26 through gas line 33, while the second purge valve 60 is in communication with the mask lumen 28 through gas line 62.” Paras 0028 and 0029) a first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) for flushing the gas measurement line (24, defined by the combination of 26 and 28, whereby valve 58 is associated with line 26 and valve 60 is associated with line 28, “Referring back to FIG. 1, the nasal cannula control system 10 includes a self-contained monitoring unit 25 that interfaces with the nasal cannula assembly 24 that includes two separate lumens. The nasal cannula assembly 24 includes a nasal lumen 26 that is in pneumatic communication with the patient's nostrils and a mask lumen 28 that is in pneumatic communication with the interior of the patient's breathing mask. Although the two lumens 26, 28 are described as extending to defined areas, namely the nostrils and breathing mask, the lumens 26, 28 could terminate at other locations depending upon the specific patient and the configuration of the patient breathing circuit 14. The nasal cannula control system 10 utilizes the combination of the nasal lumen 26 and the mask lumen 28 to monitor the pressure within the patient mask and nostrils of the patient, as well as to monitor an exhaled gas from the patient, such as the carbon dioxide concentration within the nasal canal of the patient.” Para 0023) in a direction of a patient (18, “The ventilator 12 delivers a supply of ventilation gas to a patient breathing circuit 14 to provide mechanical ventilation of the patient. In the embodiment of the invention shown in FIG. 2, the patient breathing circuit 14 includes a non-invasive ventilation (NIV) breathing mask 16 that is used to deliver gases to the patient 18. As illustrated, the breathing mask 16 covers both the nose and mouth of the patient 18 and forms a seal 20 with the patient along the outer peripheral edges of the breathing mask 16.” Para 0021) during a first time interval (the amount of time one of the valves 58/60 is open); and interrupting the first flushing flow volume (via operation of one of valves 58/60 to close) the first flushing volume flow (defined by the passage of gas via 36 or 38 towards the patient 18) during a second time interval (the amount of time other of the valves 58/60 is closed).
Yet, Acker does not expressly disclose the configuration of the computer program product “with a computer readable storage medium comprising a tangible device that is non-transitory with instructions retained and stored on the computer readable storage medium for use by an instruction execution device”.
Ahmad teaches the use of a computer readable storage medium (“EEPROM, RAM, etc.” Para 0024) retaining and storing a program (“programming” Para 0024) to be executed by the instruction execution device (16) to operate the control of the ventilation device (14).
Therefore, it would have been obvious to one having ordinary skill in the art to modify the construction of the computer program of Ackers to include the features of “computer readable storage medium”, as taught by Ahmad to permit the programming to operate the control of the ventilation device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Oldfield et al. (2018/0104426) discloses an additional gas flushing system for a medical device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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