DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 12/18/2025 has been entered. Claims 1-7, 9-16, and 20-23 remain pending in the application. Claim 24 has been newly added. Applicant’s amendments to the claims have overcome the objections, 112(a) rejections, and 112(b) rejections previously set forth in the Final Rejection mailed 02/24/2025.
Information Disclosure Statement
The information disclosure statements (IDS) dated 11/04/2025 and 11/05/2025 have been received and considered.
Response to Arguments
The arguments presented in “Remarks” dated 12/18/2025 have been carefully considered.
The previously set forth 112(b) rejection has been rendered moot by the amendments to the claims and have been withdrawn.
The argument on page 13 that Tan and Berthon-Jones do not teach stopping ventilations via a ventilator, as per the amended claim language, the examiner agrees. However, please refer to the updated rejection below, since Löser does teach stopping compressions and ventilations via the ventilator.
The argument on page 14 that one of ordinary skill in the art would not have been motivated to combine Kawabe with the other cited references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation for combining the references are listed in the Non-Final Rejection mailed 07/23/2025, and are again listed in the updated rejection below based on the amended claim language further defining that the ventilation being stopped via the ventilator.
Regarding the argument on page 14 that the claimed gas flow parameter is unfiltered, please refer to the updated rejection below.
Regarding the argument on page 15 that claim 20 has been amended to specify that the airways are open and that Lynn and Berthon-Jones are used for detecting a heartbeat using closed airways, this has been considered but is not persuasive. Lynn and Berthon-Jones are used to demonstrate that it was known in the art that oscillations in respiratory flow due to a beating heart are in the claimed range. Kawabe is the primary reference which uses an open airway to detect a heartbeat signal in the ventilatory waveform (col. 2 lines 16-21). Lynn and Berthon-Jones are only used to teach the specifically claimed characteristics of the heartbeat waveform not explicitly disclosed by Kawabe.
Claim Objections
Claim 24 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The original specification does not describe how the data is “unfiltered”. Only [0016] states that “It is possible that at least one filter is provided for the data”. However, it is not detailed how the data may be utilized without a filter. See MPEP 2173.05(i). In this case, the statement in the specification that at least one filter may be provided for the data is not sufficient support for utilizing unfiltered data, since the specification does not further detail how data may be utilized without data filtering.
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 24 recites the limitation "… that the cardiac massage and the ventilator via the ventilator via the ventilator are to be restarted" in lines 22-23. There is insufficient antecedent basis for this limitation in the claim. It is not clear in the claim that control device configured to operate the cardiac massage has stopped cardiac massage; instead, the claim recites that there is an operating mode for the use of the ventilator in combination with a cardiac massage, and only that the ventilator is suspended. It is not clear that the cardiac massage is started or suspended. It is suggested to amend line 18 to recite “…by suspending the ventilator and the cardiac massage”.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
Claims 1, 20, and 23: “wherein the respiratory device is able to be operate by means of the control device”
Claim 15: “the ventilator according to claim 1, wherein by means of the monitoring device”
Claim 19: “wherein a detection mode, by means of the monitoring device, flow changes or pressure changes are able to be recorded…”
“The monitoring device” is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because monitoring devices are understood to be a structural component and are recognized in the art.
“The control device” is not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because control devices are understood in the art to be structural components.
Because these claim limitations are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 9-16, and 23-24 are rejected under 35 U.S.C. 103 as unpatentable over Kawabe et al. (US 10765377), hereafter Kawabe, in view of Lynn et al (US 2002/0117173), hereafter Lynn, Berthon-Jones et al. (5704345), hereafter Berthon-Jones, and Löser (US 2015/0328417), hereafter Löser.
Regarding Claim 1, Kawabe discloses a ventilator with at least one respiratory device for generating a respiratory gas flow for a ventilation (fig. 3, 42, col. 15 line 45) and with at least one monitoring device (fig. 3, gas flow sensor 36, col. 15 line 38) for monitoring at least one characteristic parameter of the respiratory gas flow (36 measures gas flow speed, col. 16 line 18),
characterized by at least one control device (fig. 3, 40, col. 15 line 20) which is configured to carry out at least one detection mode for a cardiac activity (heartbeat detecting signal device 30, fig. 3 col. 15 line 18) and to register for the cardiac activity a temporal profile of the at least one characteristic parameter of the respiratory gas flow (fig. 8, the respiration signal SR is a cyclic change in the flow rate FR, last line of col. 17 to line 3 of col. 18) and to examine the temporal profile of the at least one characteristic parameter for at least one profile structure feature (fig. 8, SH is the signal of the effect of the heart beating on the respiratory waveform, col. 18 lines 4-10) and to detect heartbeats at least in that the profile structure feature at least partially fulfils at least one stored condition for a predetermined profile structure feature caused by a known heartbeat (col. 18 lines 7-10, the heartbeats are detected based on frequency characteristics with a fundamentally higher frequency than the respiratory waveform; the stored condition is the frequency of heartbeats, since it is known that heartbeat frequency is higher than respiratory frequency), wherein the control device is configured for the detection of the heartbeats (heartbeat detecting signal device 30, fig. 3 col. 15 line 18), and carrying out the detection of heartbeat (col. 22 lines 4-9, “it is possible to confirm the presence or absence of a pulse of the heart 26 with higher reliability, perform quickly medical treatment at an emergency lifesaving site”).
Kawabe is silent on an operating mode for the use of the ventilator in combination with a cardiac massage and the control device being configured to emit at least one indication that the cardiac massage is to be suspended and that the ventilation via the ventilator is to be suspended, and whilst the cardiac massage and the ventilator are suspended, carrying out the detection of the heartbeats according to the condition by measuring whether the flow rate of the respiratory gas lies between 0.01 liters per second and 0.3 liters per second;
wherein if no heartbeats are detected according to the condition, then the control device is configured to emit at least another indication that the cardiac massage and ventilation are to be restarted, and if heartbeats are detected according to the condition, then emit at least one other indication that the cardiac massage suspension be continued, wherein the respiratory device is able to be operated by means of the control device in the operating mode for the use of the ventilator in combination with the cardiac massage and wherein the respiratory device in the operating mode provides at least one specific ventilation for a cardiopulmonary reanimation.
Löser teaches a ventilation system (fig. 1, emergency ventilator 1’ [0196] line 35) with a control device (fig. 1b, control elements 55 [0196] line 33) which is able to be operated by means of the control device in an operating mode for the use of the ventilator in combination with a cardiac massage ([0010] and [0172]) and wherein the respiratory device provides at least one specific ventilation for cardiopulmonary reanimation ([0066] last 5 lines, PC-AC is a pressure controlled form of ventilation; also [0172], the ventilator fills the lungs in coordination with cardiac massage). Löser’s device is also able to emit at least one indication that the cardiac massage is to be suspended and that the ventilation via the ventilator is to be suspended (fig. 7a, assist device for performing cardiac massage 1500 and ventilator 1 are paused by a control signal [0225]), and whilst the cardiac massage and the ventilator are suspended, carrying out the detection of the heartbeats ([0175] pressure sensors continue to operate during the pause in ventilation and cardiac compressions). The device also uses a display unit to monitor a parameter of a patient wherein if no heartbeats are detected according to the condition, then the control device is configured to emit at least another indication that the cardiac massage and ventilation are to be restarted, and if heartbeats are detected according to the condition, then emit at least one other indication that the cardiac massage suspension be continued ([0040] the example of exhaled CO₂ as a parameter is given to indicate whether the patient is breathing on their own and to stop CPR, or whether to continue CPR; [0041] also uses an SPO₂ sensor, which detects heartbeats).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the ventilation and cardiac massage device to operate in a specific ventilation for cardiopulmonary resuscitation, as taught by Löser, in order to synchronize the ventilation of the lungs with the chest compressions to assist the backflow of blood to the patient’s body during decompression of the chest cavity (Löser [0172]). It further would have been obvious to emit at least one indication to suspend both ventilation and cardiac massage, while continuing to sense patient respiratory parameters, as taught by Löser, in order to be able to deliver a defibrillation if needed (Löser [0175]). It also would have been obvious to one of ordinary skill in the art to include an indication to resume cardiac massage and ventilation if no heartbeats are detected, or to stop if heartbeats are detected, to preserve circulation in the patient and to stop when circulation has been restored.
The now-modified Kawabe is silent on as a condition, for a detection of the heartbeats, at least one upper threshold is provided for an amount of a flow rate of the respiratory gas, which lies between 0.01 liters per second and 0.3 liters per second (Kawabe discloses a flow rate of the heartbeat signal (fig. 11, shown in cc/min since the data is provided from a rat, col. 19 lines 15-18), but does not disclose using a respiratory flow rate as a condition to detect heartbeats) and carrying out the detecting of heartbeats by measuring whether the flow rate of the respiratory gas lies between 0.01 liters per second and 0.3 liters per second.
Lynn teaches a resuscitation system (abstract) which includes a ventilator (fig. 5, resuscitation bag system 100 with microprocessor 150 [0033]) used in combination with cardiac massage (abstract) and a control device (fig. 5, microprocessor [0033]) and provides a pressure or flow monitor to detect cardiogenic oscillations in the airway, which indicates the return of cardiac contraction ([0035] lines 51-60). The system then provides a real-time output indication to rescuers that cardiac contraction has returned ([0035] lines 58-60). Lynn further teaches that the magnitude of the cardiac oscillations can indicate the magnitude of the return of cardiac contractility ([0035] lines 62-64).
Lynn, however, is silent on the specific magnitude of the cardiogenic oscillation flow.
Berthon-Jones teaches that cardiogenic activity in the heart has an observed airflow of 0.02-0.1 l/sec with each beat of the heart. This range is known in the art to be consistent with respiratory airflow due to cardiogenic activity (col. 13 lines 25-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the heartbeat detection in Kawabe’s device, which uses a frequency characteristic to distinguish the effect of a beating heart on the respiratory flow, to also include a flow rate of respiratory gas to be indicative of cardiogenic airflow due to a heart beating, and to use the cardiogenic airflow as an indication that a heartbeat has returned during cardiac resuscitation as taught by Lynn in order to allow the rescue team to evaluate the effectiveness of the cardiac contractions (Lynn [0035] lines 1-3 of page 5), where the cardiogenic oscillations are an airflow in the range of 0.02-0.1 L/sec as taught by Berthon-Jones. Since Berthon-Jones teaches that this oscillatory flow magnitude is known to be cardiogenic, and Lynn teaches that decisions on the effectiveness of CPR can be made off of the presence of cardiac oscillations in the respiratory flow, this method of detecting heartbeats would add to the data set confirming that the flow is due to cardiac oscillations, of Kawabe’s method of filtering for the frequency of cardiogenic oscillations.
Regarding Claim 2, the modified Kawabe discloses a ventilator according to the preceding claim, further comprising another parameter as a measurement for a pressure of the respiratory gas (in the modified device, the method of determining whether heartbeats includes Lynn/Berthon-Jones and Kawabe; Lynn [0034] lines 51-53, cardiac contraction can be detected through pressure or flow monitoring).
Regarding claim 3, the modified Kawabe discloses a ventilator according to claim 1, wherein the at least one profile structure feature describes a temporal change of the at least one characteristic parameter (Kawabe fig. 8, gas flow rate is measured over time) and wherein the stored condition is at least one measurement with a similar temporal change of the at least one characteristic parameter caused by known heartbeats (fig. 8, the heartbeat waveform is extracted from the respiration signal, as modified to add Lynn and Berthon-Jones, can either be to be a magnitude in volume of cardiac oscillatory flow, Lynn [0035]; or, in Kawabe, the respiration signal is extracted based on the known frequency range of a beating heart, col. 18 lines 4-6).
Regarding Claim 4, the modified Kawabe discloses a ventilator according to claim 1, wherein the at least one profile structure feature describes a temporal flow change (Kawabe fig. 8, the respiration waveform SR is change in flow rate over time) and wherein the stored condition is at least that the temporal flow change has a defined similarity to a temporal flow change or pressure change caused by heartbeats (the condition for extracting the heartbeat waveform is the similarity to a frequency in known heartbeats, Kawabe col. 18 lines 6-10; as modified by Lynn and Berthon-Jones, the similarity is the known magnitude of cardiac oscillations).
Regarding Claim 5, the modified Kawabe discloses a ventilator according to claim 1, wherein the ventilator is configured to predetermine how frequently or regularly the at least one profile structure feature occurs in the temporal profile of the at least one characteristic parameter (Kawabe fig. 8 and col. 18 lines 4-10, it is known that heartbeat frequency is higher than respiration frequency, thus the heartbeat structures occurring in the flow would be more frequent than respiratory flow).
Regarding Claim 6, the modified Kawabe discloses a ventilator according to claim 1, wherein the at least one profile structure feature describes an occurrence of maxima or minima in the temporal profile of the at least one characteristic parameter (Kawabe fig. 8, two maxima and three minima are shown in waveform SR) and wherein at least one maximum threshold is provided for a value or amount of the at least one characteristic parameter at a maximum or minimum (col. 18 lines 37-41, a bandpass filter may be applied to the SR waveform to extract frequencies lower than heartbeat components; i.e. apply a maximum threshold to retain only lower frequency respiratory signal, SR0).
Regarding claim 7, the modified Kawabe discloses a ventilator according to claim 1, wherein the at least one profile structure feature describes a maximum or minimum flow rate (Kawabe fig. 8, two maxima and three minima are shown in respiratory signal SR; SR is output from gas-flow, col. 21 lines 56-57; there are also maxima and minima present in waveform SH; Lynn/Berthon-Jones method of detection uses oscillatory flow in the range of 0.02 L/sec to 0.1 L/sec), and wherein at least one upper threshold is provided for an amount of the flow rate or pressure (Kawabe col. 18 lines 37-41, a bandpass filter may be applied to the SR waveform to extract frequencies that are lower than heartbeat components; i.e. apply a maximum (and a minimum) threshold to retain only lower frequency respiratory signal, SR0; Berthon-Jones provides the upper flow rate for volumetric cardiac oscillation flow at 0.1 L/sec, col. 13 lines 34-36).
Regarding Claim 9, the modified Kawabe discloses a ventilator according to claim 1, wherein the ventilator is configured to at least recognize when the temporal profile of the at least one characteristic parameter changes between a positive value and a negative value (Kawabe discloses that the respiratory flow rate waveform SR in fig. 8 changes between a positive and a negative value; this sign change is part of the recognized respiratory signal).
Regarding Claim 10, the modified Kawabe discloses a ventilator according to claim 1, wherein the ventilator is configured to recognize temporal changes of the at least one characteristic parameter (fig. 10, the known frequency of a heartbeat is extracted based on frequency characteristics of the heartbeat waveform, col. 18 lines 4-7) and an occurrence of maxima or minima in the temporal profile of the at least one characteristic parameter with a defined frequency or regularity in the temporal profile of the at least one characteristic parameter (fig. 8, maxima and minima are present in waveform SH at a regular frequency; the definition of frequency is “the rate at which something occurs or is repeated over a particular period of time or in a given sample”, Oxford Languages dictionary).
Regarding Claim 11, the modified Kawabe discloses a ventilator according to claim 1, wherein the ventilator is configured to recognize temporal changes {fig. 10, waveform heart signal SH is in the time domain and changes over time) of the at least one characteristic parameter (fig. 10, the known frequency of a heartbeat is extracted based on frequency characteristics of the heartbeat waveform, col. 18 lines 4-7), but is silent on quantifying the frequency (particularly since the data acquired for figs. was acquired from a rat, col. 18 lines 27-28).
Berthon-Jones teaches processing the airflow signal to determine the heart rate in the range of 0.75 – 3 Hz (or 45-180 cycles/beats per minute). This range is the known range of an airflow signal indicative of heartbeat activity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kawabe’s condition for detecting heartbeats to be a frequency in the range of 45-180 beats/minute as taught by Berthon-Jones, since this was a known method for detecting cardiogenic airflow.
However, Berthon-Jones does not explicitly disclose the frequency of 30 to 200 per minute.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the frequency from 0.75-3 Hz to 30-200 per minute since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 12, the modified Kawabe discloses a ventilator according to claim 1, wherein the control device is configured to examine the temporal profile of the at least one characteristic parameter for at least one saved pattern caused by heartbeat (Kawabe col. 18 lines 29-34, waveform analysis controlling portion 72 of the controller 40, fig. 3, uses the frequency component of heartbeats, which must be saved to the controller, so that the controller can extract the heartbeat signal SH) and to detect heartbeats at least in that the pattern occurs at least approximately (col. 18 lines 19-22 and fig. 10).
Regarding Claim 13, the modified Kawabe discloses a ventilator according to claim 1, wherein the control device is configured to determine a frequency of the at least one profile structure feature in the temporal profile of the at least one characteristic parameter and to determine from the frequency a number of heartbeats or a cardiac frequency (Kawabe col. 18 lines 57-62).
Regarding Claim 14, the modified Kawabe discloses a ventilator according to claim 1, but is silent on wherein the control device is configured to carry out the detection of the heartbeats, taking into consideration whether the at least one profile structure feature with a minimum quality or minimum number has occurred in the registered temporal profile of the at least one characteristic parameter or whether the temporal profile of the at least one characteristic parameter of the respiratory gas flow was registered during a minimum duration or whether the temporal profile of the at least one characteristic parameter of the respiratory gas flow was registered with a defined minimum signal quality.
Berthon-Jones teaches taking into consideration whether the at least one profile structure feature with a minimum number has occurred in the registered temporal profile of the at least one characteristic parameter (the respiratory flow signal is filtered to remove frequency components below 0.1 Hz to remove leak from the determination of cardiogenic activity; col. 14 lines 6-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kawabe’s determination of heartbeats by taking into consideration whether the at least one profile structure (respiratory waveform) has a minimum feature (a frequency component above 0.1 Hz) as taught by Berthon-Jones in order to remove noise from the signal such as that from a leak in the ventilation system (col. 14 lines 6-10), which will yield a more accurate result.
Regarding Claim 15, the modified Kawabe discloses a ventilator according to claim 1, but is silent on wherein by means of the monitoring device a carbon dioxide content of the blood or of the respiratory gas or a blood pressure or an oxygen concentration of the blood are able to be recorded as at least one further parameter and wherein the control device is configured to register an additional temporal profile of the at least one further parameter and to take it at least partially into consideration for the detection of the heartbeats.
Berthon-Jones teaches additionally using a pulse oximeter to detect cardiogenic oscillations (i.e. heartbeats) in the respiratory flow (col. 14 lines 25-38). This leads to a more accurate estimation of the heart rate (col. 14 lines 39-41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kawabe’s monitoring device to further include monitoring an oxygen concentration of the blood (a pulse oximeter) to be recorded and registered as one further parameter taken into consideration for the detection of heartbeats as taught by Berthon-Jones, for the benefit of a more accurate estimation of heart rate from the respiratory flow by adding the additional parameter.
Regarding Claim 16, the modified Kawabe discloses a ventilator according to claim 1, but is silent on wherein the control device is further configured for the monitoring of a cardiac massage, to register a temporal profile of a pressure of the respiratory gas at least during the cardiac massage and to evaluate an effect of the cardiac massage as a function of the temporal profile having a defined temporal pressure change.
Löser teaches the use of a ventilator which uses a control device (control elements 55, [0196] line 33) to monitor cardiac massage [0196] lines 33-37), registers a temporal profile of pressure of the respiratory gas (fig. 5a, pressure variation P 610 over time t during ventilation [0201]) during cardiac massage ([0203] line 1) and evaluates the effect of the cardiac massage as a function of the temporal profile having a defined temporal pressure change ([0203] pressure change thresholds may be reached an not exceeded as additional criteria to trigger messages to start or stop CPR).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Kawabe’s ventilator of claim 1 with Löser’s control device for monitoring cardiac massage, registering a temporal profile of pressure of the respiratory gas during the cardiac massage, and evaluate an effect of the cardiac massage as a function of the temporal profile having a defined temporal pressure change in order to inform the user whether resuscitation is effective, i.e. can be stopped or continued ([0203]).
Regarding Claim 23, Kawabe discloses a method using a ventilator with at least one respiratory device (fig. 3, 42, col. 15 line 45) for generating a respiratory gas flow for a ventilation and with at least one monitoring device for monitoring (fig. 3, gas flow sensor 36, col. 15 line 38) at least one characteristic parameter of the respiratory gas flow (fig. 3, gas flow sensor 36, col. 15 line 38) for an operating mode for the use of the ventilator (col. 15 lines 40-48),
comprising the steps of: carrying out at least one detection mode for a cardiac activity (heartbeat detecting signal device 30, fig. 3 col. 15 line 18) using at least one control device (fig. 3, 40, col. 15 line 20) and registering for the cardiac activity a temporal profile of the at least one characteristic parameter of the respiratory gas flow (fig. 8, the respiration signal SR is a cyclic change in the flow rate FR, last line of col. 17 to line 3 of col. 18) and examining the temporal profile of the at least one characteristic parameter for at least one profile structure feature (fig. 8, SH is the signal of the effect of the heart beating on the respiratory waveform, col. 18 lines 4-10) and detecting heartbeats at least in that the profile structure feature at least partially fulfils at least one stored condition for a predetermined profile structure feature caused by a known heartbeat (col. 18 lines 7-10, the heartbeats are detected based on frequency characteristics with a fundamentally higher frequency than the respiratory waveform; the stored condition is the frequency of heartbeats, since it is known that heartbeat frequency is higher than respiratory frequency); detecting the heartbeats, according to a condition (heartbeat detecting signal device 30, fig. 3 col. 15 line 18); detecting the heartbeats with the control device, according to the stored condition (col. 22 lines 4-9, “it is possible to confirm the presence or absence of a pulse of the heart 26 with higher reliability, perform quickly medical treatment at an emergency lifesaving site”).
Kawabe is silent on the use of the ventilator in combination with a cardiac massage, detecting heartbeats according to at least one upper threshold is provided for an amount of the measured flow rate of the respiratory gas flow, which lies between 0.01 liters per second and 0.3 liters per second, the control device being configured to emit at least one indication that the cardiac massage is to be suspended and the ventilation via the ventilator is to be suspended, and whilst the cardiac massage and the ventilator are suspended, carrying out the detection of the heartbeats according to the condition by measuring whether the flow rate of the respiratory gas lies between 0.01 liters per second and 0.3 liters per second;
wherein if no heartbeats are detected according to the condition, then the control device is configured to emit at least another indication that the cardiac massage and ventilation are to be restarted, and if heartbeats are detected according to the stored condition, then emit at least one other indication that the cardiac massage suspension be continued; and operating the respiratory device by means of the control device in the operating mode for using the ventilator in combination with the cardiac massage and wherein the respiratory device in the operating mode provides at least one specific ventilation for a cardiopulmonary reanimation.
Löser teaches a method of ventilation and cardiac massage (fig. 7a, ventilator 1’ and assist device 1500 for performing cardiac massage [0225]) with a control device (fig. 1b, control elements 55 [0196] line 33) in which the use of the ventilator in combination with a cardiac massage ([0010] and [0172]) and wherein the respiratory device provides at least one specific ventilation for cardiopulmonary reanimation ([0066] last 5 lines, PC-AC is a pressure controlled form of ventilation; also [0172], the ventilator fills the lungs in coordination with cardiac massage). Löser’s device also emits at least one indication that the cardiac massage is to be suspended and that the ventilation via the ventilator is to be suspended (fig. 7a, assist device for performing cardiac massage 1500 and ventilator 1 are paused by a control signal [0225]), and whilst the cardiac massage and the ventilator are suspended, carrying out the detection of the heartbeats ([0175] pressure sensors continue to operate during the pause in ventilation and cardiac compressions). The device also uses a display unit to monitor a parameter of a patient wherein if no heartbeats are detected, then the control device is configured to emit at least another indication that the cardiac massage and ventilation are to be restarted, and if heartbeats are detected according to the condition, then emit at least one other indication that the cardiac massage suspension be continued ([0040] the example of exhaled CO₂ as a parameter is given to indicate whether the patient is breathing on their own and to stop CPR, or whether to continue CPR; [0041] also uses an SPO₂ sensor, which detects heartbeats).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the ventilation and cardiac massage method to operate in a specific ventilation for cardiopulmonary resuscitation, as taught by Löser, in order to synchronize the ventilation of the lungs with the chest compressions to assist the backflow of blood to the patient’s body during decompression of the chest cavity (Löser [0172]). It further would have been obvious to emit at least one indication to suspend both ventilation and cardiac massage, while continuing to sense the patient’s respiratory parameters, as taught by Löser, in order to be able to deliver a defibrillation if needed (Löser [0175]). It also would have been obvious to one of ordinary skill in the art to include an indication to resume cardiac massage and ventilation if no heartbeats are detected, or to stop if heartbeats are detected, to preserve circulation in the patient and to stop when circulation has been restored.
The now-modified Kawabe is silent on as a condition, for a detection of the heartbeats, at least one upper threshold is provided for an amount of a flow rate of the respiratory gas, which lies between 0.01 liters per second and 0.3 liters per second (Kawabe discloses a flow rate of the heartbeat signal (fig. 11, shown in cc/min since the data is provided from a rat, col. 19 lines 15-18), but does not disclose using a respiratory flow rate as a condition to detect heartbeats) and carrying out the detecting of heartbeats by measuring whether the flow rate of the respiratory gas lies between 0.01 liters per second and 0.3 liters per second.
Lynn teaches a resuscitation system (abstract) which includes a ventilator (fig. 5, resuscitation bag system 100 with microprocessor 150 [0033]) used in combination with cardiac massage (abstract) and a control device (fig. 5, microprocessor [0033]) and provides a pressure or flow monitor to detect cardiogenic oscillations in the airway, which indicates the return of cardiac contraction ([0035] lines 51-60). The system then provides a real-time output indication to rescuers that cardiac contraction has returned ([0035] lines 58-60). Lynn further teaches that the magnitude of the cardiac oscillations can indicate the magnitude of the return of cardiac contractility ([0035] lines 62-64).
Lynn, however, is silent on the specific magnitude of the cardiogenic oscillation flow.
Berthon-Jones teaches that cardiogenic activity in the heart has an observed airflow of 0.02-0.1 l/sec with each beat of the heart. This range is known in the art to be consistent with respiratory airflow due to cardiogenic activity (col. 13 lines 25-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the heartbeat detection in Kawabe’s method, which uses a frequency characteristic to distinguish the effect of a beating heart on the respiratory flow, to also include a flow rate of respiratory gas to be indicative of cardiogenic airflow due to a heart beating, and to use the cardiogenic airflow as an indication that a heartbeat has returned during cardiac resuscitation as taught by Lynn in order to allow the rescue team to evaluate the effectiveness of the cardiac contractions (Lynn [0035] lines 1-3 of page 5), where the cardiogenic oscillations are an airflow in the range of 0.02-0.1 L/sec as taught by Berthon-Jones. Since Berthon-Jones teaches that this oscillatory flow magnitude is known to be cardiogenic, and Lynn teaches that decisions on the effectiveness of CPR can be made off of the presence of cardiac oscillations in the respiratory flow, this method of detecting heartbeats would add to the data set confirming that the flow is due to cardiac oscillations, of Kawabe’s method of filtering for the frequency of cardiogenic oscillations.
Regarding Claim 24, Kawabe discloses a ventilator with at least one respiratory device for generating a respiratory gas flow for a ventilation (fig. 3, 42, col. 15 line 45) and with at least one monitoring device (fig. 3, gas flow sensor 36, col. 15 line 38) for monitoring at least one characteristic parameter of the respiratory gas flow (36 measures gas flow speed, col. 16 line 18),
characterized by at least one control device (fig. 3, 40, col. 15 line 20) which is configured to carry out at least one detection mode for a cardiac activity (heartbeat detecting signal device 30, fig. 3 col. 15 line 18) and to register for the cardiac activity a temporal profile of the at least one characteristic parameter of the respiratory gas flow (fig. 8, the respiration signal SR is a cyclic change in the flow rate FR, last line of col. 17 to line 3 of col. 18) and to examine the temporal profile of the at least one characteristic parameter for at least one profile structure feature (fig. 8, SH is the signal of the effect of the heart beating on the respiratory waveform, col. 18 lines 4-10) and to detect heartbeats at least in that the profile structure feature at least partially fulfils at least one stored condition for a predetermined profile structure feature caused by a known heartbeat (col. 18 lines 7-10, the heartbeats are detected based on frequency characteristics with a fundamentally higher frequency than the respiratory waveform; the stored condition is the frequency of heartbeats, since it is known that heartbeat frequency is higher than respiratory frequency); wherein the control device is configured for the detection of the heartbeats (heartbeat detecting signal device 30, fig. 3 col. 15 line 18),
Kawabe is silent on an operating mode for the use of a ventilator in combination with a cardiac massage; or wherein as the stored condition, for a detection of the heartbeats, at least one upper threshold is provided for an amount of a measured flow rate of the respiratory gas flow, which lies between 0.01 litres per second and 0.3 litres per second; detecting heartbeats according to the stored condition by suspending the ventilator and measuring whether the flow rate of the respiratory gas flow lies between 0.01 litres per second and 0.3 litres per second; wherein if no heartbeats are detected according to the stored condition, then the control device is configured to emit at least another indication that the cardiac massage and the ventilation via the ventilator are to be restarted, and if heartbeats are detected according to the stored condition, then emit at least one other indication that the cardiac massage suspension be continued; and wherein the respiratory device is able to be operated by means of the control device in the operating mode for the use of the ventilator in combination with the cardiac massage and wherein the respiratory device in the operating mode provides at least one specific ventilation for a cardiopulmonary reanimation.
Löser teaches a ventilation system (fig. 1, emergency ventilator 1’ [0196] line 35) with a control device (fig. 1b, control elements 55 [0196] line 33) which has an operating mode for the use of the ventilator in combination with a cardiac massage ([0010] and [0172]) and wherein the respiratory device provides at least one specific ventilation for cardiopulmonary reanimation ([0066] last 5 lines, PC-AC is a pressure controlled form of ventilation; also [0172], the ventilator fills the lungs in coordination with cardiac massage). Löser’s device is also able to suspend the ventilator and measure the flow of respiratory gas ([0175] pressure sensors continue to operate during the pause in ventilation and cardiac compressions; one of ordinary skill in the art would have been able to understand that pressure and flow are directly related in the respiratory art). The device also uses a display unit to monitor a parameter of a patient wherein if no heartbeats are detected according to the stored condition, then the control device is configured to emit at least another indication that the cardiac massage and the ventilation via the ventilator are to be restarted, and if heartbeats are detected according to the stored condition, then emit at least one other indication that the cardiac massage suspension be continued ([0040] the example of exhaled CO₂ as a parameter is given to indicate whether the patient is breathing on their own and to stop CPR, or whether to continue CPR; [0041] also uses an SPO₂ sensor, which detects heartbeats).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the ventilation and cardiac massage device to operate in a specific ventilation for cardiopulmonary resuscitation, as taught by Löser, in order to synchronize the ventilation of the lungs with the chest compressions to assist the backflow of blood to the patient’s body during decompression of the chest cavity (Löser [0172]). It further would have been obvious to supend ventilation, while continuing to sense patient airway pressure, as taught by Löser, in order to be able to deliver a defibrillation if needed (Löser [0175]). It also would have been obvious to one of ordinary skill in the art to include an indication to resume cardiac massage and ventilation if no heartbeats are detected, or to stop if heartbeats are detected, to preserve circulation in the patient and to stop when circulation has been restored.
The now modified device remains silent on as a condition, for a detection of the heartbeats, at least one upper threshold is provided for an amount of a flow rate of the respiratory gas, which lies between 0.01 liters per second and 0.3 liters per second (Kawabe discloses a flow rate of the heartbeat signal (fig. 11, shown in cc/min since the data is provided from a rat, col. 19 lines 15-18), but does not disclose using a respiratory flow rate as a condition to detect heartbeats) and carrying out the detecting of heartbeats by measuring whether the flow rate of the respiratory gas lies between 0.01 liters per second and 0.3 liters per second.
Lynn teaches a resuscitation system (abstract) which includes a ventilator (fig. 5, resuscitation bag system 100 with microprocessor 150 [0033]) used in combination with cardiac massage (abstract) and a control device (fig. 5, microprocessor [0033]) and provides a pressure or flow monitor to detect cardiogenic oscillations in the airway, which indicates the return of cardiac contraction ([0035] lines 51-60). The system then provides a real-time output indication to rescuers that cardiac contraction has returned ([0035] lines 58-60). Lynn further teaches that the magnitude of the cardiac oscillations can indicate the magnitude of the return of cardiac contractility ([0035] lines 62-64).
Lynn, however, is silent on the specific magnitude of the cardiogenic oscillation flow.
Berthon-Jones teaches that cardiogenic activity in the heart has an observed airflow of 0.02-0.1 l/sec with each beat of the heart. This range is known in the art to be consistent with respiratory airflow due to cardiogenic activity (col. 13 lines 25-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the heartbeat detection in Kawabe’s device, which uses a frequency characteristic to distinguish the effect of a beating heart on the respiratory flow, to also include a flow rate of respiratory gas to be indicative of cardiogenic airflow due to a heart beating, and to use the cardiogenic airflow as an indication that a heartbeat has returned during cardiac resuscitation as taught by Lynn in order to allow the rescue team to evaluate the effectiveness of the cardiac contractions (Lynn [0035] lines 1-3 of page 5), where the cardiogenic oscillations are an airflow in the range of 0.02-0.1 L/sec as taught by Berthon-Jones. Since Berthon-Jones teaches that this oscillatory flow magnitude is known to be cardiogenic, and Lynn teaches that decisions on the effectiveness of CPR can be made off of the presence of cardiac oscillations in the respiratory flow, this method of detecting heartbeats would add to the data set confirming that the flow is due to cardiac oscillations, of Kawabe’s method of filtering for the frequency of cardiogenic oscillations.
Claims 20-22 are rejected under 35 U.S.C. 103 as unpatentable over Kawabe, Löser, Lynn, Berthon-Jones, and further in view of Sackner (US 5178151), hereafter Sackner.
Claim 20, Kawabe discloses a monitoring system with at least one monitoring device for monitoring (fig. 3, gas flow sensor 36, col. 15 line 38) at least one unfiltered characteristic parameter of a respiratory gas flow (36 measures gas flow speed, col. 16 line 18; the measured data is not filtered prior to a waveform analysis, col. 18 lines 29-42), and with at least one control device (fig. 3, 40, col. 15 line 20), for the use of a ventilator (col. 1 line 65), characterized in that
the control device is configured to carry out at least one detection mode for a cardiac activity (heartbeat detecting signal device 30, fig. 3 col. 15 line 18) and to register for the cardiac activity a temporal profile of the at least one characteristic parameter of the respiratory gas flow (fig. 8, the respiration signal SR is a cyclic change in the flow rate FR, last line of col. 17 to line 3 of col. 18) and to examine the temporal profile of the at least one characteristic parameter for at least one profile structure feature (fig. 8, SH is the signal of the effect of the heart beating on the respiratory waveform, col. 18 lines 4-10) and to detect heartbeats at least in that the profile structure feature fulfils at least one stored condition for a predetermined profile structure which is caused by a known heartbeat (col. 18 lines 7-10, the heartbeats are detected based on frequency characteristics with a fundamentally higher frequency than the respiratory waveform; the stored condition is the frequency of heartbeats, since it is known that heartbeat frequency is higher than respiratory frequency; the stored condition is based on a predetermined condition of known heartbeats);
wherein the control device is configured for the detection of heartbeats (heartbeat detecting signal device 30, fig. 3 col. 15 line 18),
Kawabe is silent on the following:
The use of the ventilator in combination with a cardiac massage;
The characteristic parameter of the respiratory flow being unfiltered when registering and examining the cardiac activity (Kawabe uses a low pass or bandpass filter to extract the heartbeat signal SH, col. 18 lines 37-42);
wherein as the stored condition, for a detection of heartbeats, at least one upper threshold is provided for an amount of an unfiltered measured flow rate of the respiratory gas flow, which lies between 0.01 liters per second and 0.3 liters per second ;
and to emit at least one indication that the cardiac massage is to be suspended and that the ventilation of open airways via the ventilator is to be suspended, and whilst the cardiac massage and the ventilator are suspended, carrying out the detection of heartbeats according to the stored condition by measuring whether the unfiltered flow rate of the respiratory gas flow lies between 0.01 liters per second and 0.3 liters per second;
wherein if no heartbeats are detected according to the stored condition, then the control device is configured to emit at least another indication that the cardiac massage and the ventilation of open airways are to be restarted, and if heartbeats are detected according to the stored condition, then emit at least one other indication that the cardiac massage suspension be continued;
And wherein a respiratory device is able to be operated by means of the control device in at least one operating mode for the use of the ventilator in combination with the cardiac massage and wherein the respiratory device in the operating mode provides at least one specific ventilation of open airways for a cardiopulmonary reanimation.
Löser teaches a monitoring system as part of a ventilator ([0032]) operated in combination with a cardiac massage ([0010] and [0172]) wherein a respiratory device is able to be operated by means of a control device ([0170]) in at least one operating mode for the use of the ventilator in combination with the cardiac massage ([0172]) and wherein the respiratory device in the operating mode provides at least one specific ventilation of open airways for a cardiopulmonary reanimation ([0172] the ventilator fills the lungs in a coordinated manner with cardiac massage). Löser’s system is also able to emit at least one indication that the cardiac massage is to be suspended and that the ventilation of open airways via the ventilator is to be suspended (fig. 7a, assist device for performing cardiac massage 1500 and ventilator 1 are paused by a control signal [0225]), and whilst the cardiac massage and the ventilator are suspended, carrying out the detection of heartbeats ([0175] pressure sensors continue to operate during the pause in ventilation and cardiac compressions), wherein if no heartbeats are detected according to the stored condition, then the control device is configured to emit at least another indication that the cardiac massage and the ventilation of open airways are to be restarted, and if heartbeats are detected according to the stored condition, then emit at least one other indication that the cardiac massage suspension be continued ([0040] the example of exhaled CO₂ as a parameter is given to indicate whether the patient is breathing on their own and to stop CPR, or whether to continue CPR; [0041] the device also uses an SPO₂ sensor, which detects heartbeats).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the ventilation and cardiac massage device to operate in a specific ventilation for cardiopulmonary resuscitation, as taught by Löser, in order to synchronize the ventilation of the lungs with the chest compressions to assist the backflow of blood to the patient’s body during decompression of the chest cavity (Löser [0172]). It further would have been obvious to emit at least one indication to suspend both ventilation and cardiac massage, while continuing to sense patient respiratory parameters, as taught by Löser, in order to be able to deliver a defibrillation if needed (Löser [0175]). It also would have been obvious to one of ordinary skill in the art to include an indication to resume cardiac massage and ventilation if no heartbeats are detected, or to stop if heartbeats are detected, to preserve circulation in the patient and to stop when circulation has been restored.
The now-modified Kawabe is remains silent on as a condition, for a detection of the heartbeats, at least one upper threshold is provided for an amount of a flow rate of the respiratory gas, which lies between 0.01 liters per second and 0.3 liters per second (Kawabe discloses a flow rate of the heartbeat signal (fig. 11, shown in cc/min since the data is provided from a rat, col. 19 lines 15-18), but does not disclose using a respiratory flow rate as a condition to detect heartbeats) and carrying out the detecting of heartbeats by measuring whether the flow rate of the respiratory gas lies between 0.01 liters per second and 0.3 liters per second.
Lynn teaches a resuscitation system (abstract) which includes a ventilator (fig. 5, resuscitation bag system 100 with microprocessor 150 [0033]) used in combination with cardiac massage (abstract) and a control device (fig. 5, microprocessor [0033]) and provides a pressure or flow monitor to detect cardiogenic oscillations in the airway, which indicates the return of cardiac contraction ([0035] lines 51-60). The system then provides a real-time output indication to rescuers that cardiac contraction has returned ([0035] lines 58-60). Lynn further teaches that the magnitude of the cardiac oscillations can indicate the magnitude of the return of cardiac contractility ([0035] lines 62-64).
Lynn, however, is silent on the specific magnitude of the cardiogenic oscillation flow.
Berthon-Jones teaches that cardiogenic activity in the heart has an observed airflow of 0.02-0.1 l/sec with each beat of the heart. This range is known in the art to be consistent with respiratory airflow due to cardiogenic activity (col. 13 lines 25-36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the heartbeat detection in Kawabe’s device, which uses a frequency characteristic to distinguish the effect of a beating heart on the respiratory flow, to also include a flow rate of respiratory gas to be indicative of cardiogenic airflow due to a heart beating, and to use the cardiogenic airflow as an indication that a heartbeat has returned during cardiac resuscitation as taught by Lynn in order to allow the rescue team to evaluate the effectiveness of the cardiac contractions (Lynn [0035] lines 1-3 of page 5), where the cardiogenic oscillations are an airflow in the range of 0.02-0.1 L/sec as taught by Berthon-Jones. Since Berthon-Jones teaches that this oscillatory flow magnitude is known to be cardiogenic, and Lynn teaches that decisions on the effectiveness of CPR can be made off of the presence of cardiac oscillations in the respiratory flow, this method of detecting heartbeats would add to the data set confirming that the flow is due to cardiac oscillations, of Kawabe’s method of filtering for the frequency of cardiogenic oscillations.
As modified, the device remains silent on whether the characteristic parameter of the respiratory flow is unfiltered when registering and examining the cardiac activity.
Sackner teaches a system of monitoring cardiac flow in a subject (abstract) which uses an unfiltered respiratory measurement (col. 5 lines 21-31), which can include gas flow in the lungs (col. 8 lines 35-36; see also col. 9 line 62-col. 10 line 4, cardiogenic oscillations during breath holding are known to be caused by the beating heart as read by a pressure sensor). The cardiogenic oscillation is detected using a curve fit technique rather than filtering (col. 16 lines 29-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kawabe’s extraction of cardiogenic oscillations from the respiratory flow so that the characteristic parameter, i.e., the respiratory flow, is unfiltered by instead using a curve fitting technique to identify the cardiogenic oscillations as taught by Sackner as an alternative method known in the art that is equally effective at identifying a heartbeat.
Regarding Claim 21, the modified Kawabe discloses a ventilator according to claim 1, wherein whilst the cardiac massage is suspended carrying out the detection of the heartbeats according to the stored condition by measuring whether the flow rate of the respiratory gas lies between 0.02 liters per second and 0.15 liters per second (as modified by Berthon-Jones, cardiac oscillations are known to be in the range of 0.02 - 0.1 L/s, col. 13 lines 25-36; where the prior art discloses a range that lies within the claimed range, the prior art anticipates the claim (MPEP 2131.03)).
Regarding Claim 22, the modified Kawabe discloses a ventilator according to claim 20, wherein whilst the cardiac massage is suspended carrying out the detection of the heartbeats according to the stored condition by measuring whether the unfiltered flow rate of the respiratory gas lies between 0.02 liters per second and 0.15 liters per second (as modified by Berthon-Jones, cardiac oscillations are known to be in the range of 0.02 - 0.1 L/s, col. 13 lines 25-36; where the prior art discloses a range that lies within the claimed range, the prior art anticipates the claim (MPEP 2131.03)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Banville et al. (US 2012/0016279 A1) discloses pausing chest compressions to check for the return of spontaneous circulation ([0065]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARA K TOICH/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785