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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are: “A chest compression member” in claims 1, 8 and 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure as described in the paragraph [0011] of the specification appears to be “plunger 116”, therefore the “chest compression member” will be interpreted as a plunger or equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
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 1-3, 6-10, 13-15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Havardsholm (US 20070270724 A1) in view of Loser (US 20150328417 A1) and Nilsson (US 20140180180 A1).
Regarding claim 1, Havardsholm teaches a chest compression machine, comprising: a chest compression member (Fig. 1, compression member 3 as disclosed in Paragraph 0020); a user interface electrically coupled to the chest compression machine configured to receive user input (Fig. 2; paragraph 0029 discusses how the user controls element 13 can be provided separately. One skilled in the art would reasonably expect that when the user controls element is provided separately, this would consist of a user interface that is still coupled to the main controller 12); and a control module (Fig. 2, main controller 12) configured to: generate instructions to cause the chest compression member to administer chest compressions (Paragraph [0070] discloses pulse patterns, e.g. instructions, provided to the device and Paragraph [0029] discloses receiving feedback signals from the patient to further inform operation of the device), each of the chest compressions having a plurality of chest compression parameters (Paragraph [0010] discloses the motor controlling compression parameters. Annotated Figure 5B shows parameters such as the time 36 between compression 34 and decompression 35, compression depth, and both the speed and duration of compression and decompression).
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Annotated Figure 5B: Harvardsholm
Havardsholm is silent on receiving a first carbon dioxide (CO2) measurement from the user interface, alter a first chest compression parameter when the first CO2 measurement is below a first threshold, receive a second CO2 measurement after the first chest compression parameter has been altered, and administer active decompressions when the second CO2 measurement is below a second threshold.
However, Loser teaches a system for coordinating ventilations and chest compressions which receive a first carbon dioxide measurement from a user interface (Paragraph 0196 user interface 54; Paragraph 0033 discloses data including C02 content of exhaled air; Paragraph 0194 “Furthermore, a data interface 30 is provided on the ventilator 1. Additional sensor systems or accessories may be directly connected via this data interface 30 to the ventilator 1 with a unidirectional or bidirectional data exchange, or a unidirectional or bidirectional exchange of data 21 from the ventilator 1 with external devices may be performed”), alter a first chest compression parameter (Paragraph [0207] discloses sending first message 701 to a user that compressions are being performed insufficiently and then goes on to disclose a message 702 is sent to confirm compressions are being performed sufficiently. The first message prompted an alteration in chest compressions. Paragraph [0219] discloses parameters such as timing and applied pressure) when the first CO2 measurement is below a first threshold (Paragraph [0203] discloses in phase 1002, if C02 concentration 602 of the breathed gas is below a first threshold value 660 it is evaluated as an indicator that cardiac massage is not performed sufficiently. Paragraph [0219] discloses this case occurs when the timing between compressions and/or applied pressure are performed incorrectly and does not have sufficient pressure or the time intervals between the individual administrations of the pressure massage on the chest are too long which prompts alterations in chest compressions via message 701; this means an indication of increased pressure or frequency is required), receive a second CO2 measurement after the first chest compression parameter has been altered (Paragraph [0207] discloses and Fig. 4 shows process 600 is a continuously repeating sequence and will continue to collect patient data to determine if a threshold is reached).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to combine the chest compression device disclosed by Havardsholm (the operation of which is readily modifiable with patient feedback data as disclosed in Paragraph [0029]) with the ventilation and C02 monitoring system to incorporate feedback system of the CO2 monitoring to instruct changes to the compression parameter taught by Loser (a system which is taught to be able to interface with automatic compression devices in Paragraph [0225]) in order to increase the efficiency of both ventilation and cardiac massage (Loser; Paragraph [0135]) and incorporate an interface that can communicate with both a user and the device itself.
Modified Havardsholm does not disclose wherein the control module is further configured to administer active decompressions.
However, Nilsson teaches a CPR device wherein the control module (paragraph [0020]; controller that can control the movement of the piston) is further configured to administer active decompressions (Paragraph [0026] and [0036] discloses a reference position for which the depth of CPR compressions and the height of CPR decompressions can be measured; Paragraph [0022] discloses a suction cup for activated decompressions).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the compression member disclosed by Havardsholm as modified by Loser with the suction cup as taught by Nilsson in order to provide active decompression which improves circulation during CPR by improving the venous return flow of blood back to the heart for improved cardiac output (para. 0036).
Havardsholm as modified by Loser discloses administering active decompressions (Havardsholm; Paragraphs [0010] and [0011] discloses the motor controlling compression parameters which includes active decompression which is performed with each stroke anyways), but does not specify that the active decompression is performed when the second CO2 measurement is specifically below a second threshold. However, since Loser teaches a feedback system that regularly monitors CO2, one of ordinary skill in the art before the effective filing date of the would have found it obvious to have modified the control module to administer active decompression specifically after a CO2 measurement being below a second threshold (that is a second CO2 measurement that is regularly performed as modified by Loser) in order to assist in effective oxygenation of the blood of the patient.
Regarding claim 2, modified Havardsholm teaches the machine of claim 1.
Havardsholm further teaches wherein the control module is further configured to generate the instructions to cause the chest compression member to administer the chest compressions according to a treatment profile (Havardsholm; Paragraph [0054] discloses downloading a drive profile to control the motor).
Regarding claim 3, modified Havardsholm teaches the machine of claim 1.
Havardsholm further teaches wherein the control module is further configured to receive the first carbon dioxide (CO2) measurement from one or more patient physiological parameter sensing devices (paragraph 0029 " Main controller 12 can receive signals from different sensors and provide feedback signals to control the device. Main controller 12 is also able to receive signals not generated by the device itself, such as, for example, user controls, patient feedback data and output values of signals providing data logging"; One skilled in the art would reasonably expect that the controller receive the CO2 measurements disclosed in Loser as patient feedback data or output values when Havardsholm is modified by Loser as above).
Regarding claim 6, modified Havardsholm teaches the machine of claim 1.
Loser further teaches wherein the user input comprises a CO2 measurement from a medical device (paragraph 0194 “Furthermore, a data interface 30 is provided on the ventilator 1. Additional sensor systems or accessories may be directly connected via this data interface 30 to the ventilator 1 with a unidirectional or bidirectional data exchange, or a unidirectional or bidirectional exchange of data 21 from the ventilator 1 with external devices may be performed. This FIG. 1a shows as an external physiological sensor a “CO.sub.2 sidestream sensor” 31, which draws breathing air from the connection piece (Y-piece) 17 by means of a suction line 32 and analyzes it with respect to the carbon dioxide concentration, and is connected to the data interface 30”).
Regarding claim 7, modified Havardsholm teaches the machine of claim 1.
Loser further teaches wherein the user input comprises direct instructions from a user to alter at least one of the plurality of chest compression parameters (paragraph 0067 "The respiration rate (RR), the target pressure of ventilation (P), the maximum pressure amplitude during ventilation, the tidal volume (Vt) and the I:E ratio, which corresponds to the ratio of the duration of inspiration to the duration of expiration, are sent as parameters for controlling and regulating the ventilator which assists cardiopulmonary resuscitation to a control and regulation unit. On the one hand, these parameters can be set by the user as direct set values on a control unit, and the set values may also be derived from other parameters in another variant").
Regarding claim 8, Havardsholm teaches a chest compression machine, comprising: a chest compression member configured to administer one or both of chest compressions and chest decompressions (Fig. 1, compression member 3 for performing compressions as disclosed in Paragraph [0020]) according to a treatment profile (Paragraph [0070] discloses pulse patterns, e.g. instructions, provided to the device and Paragraph [0054] discloses downloading a profile to control the motor), each of the one or both of the chest compressions and the chest decompressions having one or more chest compression parameters (Paragraph [0010] discloses the motor controlling compression parameters. Annotated Figure 5B above shows parameters such as the time 36 between compression 34 and decompression 35, compression depth, and both the speed and duration of compression and decompression); a user interface electrically coupled to the chest compression machine configured to receive user input (Fig. 2; paragraph 0029 discusses how the user controls element 13 can be provided separately. One skilled in the art would reasonably expect that when the user controls element is provided separately, this would consist of a user interface that is still coupled to the main controller 12); and a control module (Fig. 2, main controller 12) configured to: generate instructions to cause the chest compression member to administer chest compressions according to the treatment profile (Paragraph [0070] discloses pulse patterns, e.g. instructions, provided to the device and Paragraph [0054] discloses downloading a profile to control the motor).
Havardsholm is silent on identifying a first threshold corresponding to a first chest compression parameter of the chest compressions or decompressions and a second threshold corresponding to a second chest compression parameter of the chest compressions or decompressions, receive a first physiological parameter measurement from the user interface, determine that the first physiological parameter measurement is below the first threshold, based on the determination that the first physiological parameter measurement is below the first threshold, alter the first chest compression parameter, receive a second physiological parameter from the patient after the first chest compression parameter has been altered, determine that the second physiological parameter is below the second threshold, and based on the determination that the second physiological parameter is below the second threshold, generate instructions to cause the chest compression member to administer chest decompressions at a specific height.
However, Loser teaches a system for coordinating ventilations and chest compressions (Paragraph [0016) comprising: identifying a first threshold (Paragraph [0203] discloses thresholds of C02 concentrations) corresponding to a first chest compression parameter of the chest compressions or decompressions (Paragraph [0219] discloses compression parameters such as timing or pressure being adjusted corresponding to CO2 measurement being below thresholds); and a second threshold corresponding to a second chest compression parameter of the chest compressions or decompressions (Paragraph [0203] discloses thresholds of C02 concentrations with a second threshold 660), receive a first physiological parameter measurement from the user interface (Paragraph [0169] discloses CO2 measuring module in the form of a combination capnometer/oximeter which is a part of the monitoring device that is also the user interface. Paragraph [0033] discloses data including C02 content of exhaled air, the first physiological parameter), determine that the first physiological parameter measurement is below the first threshold (Paragraph [0203] discloses in phase 1002, if C02 concentration 602 of the breathed gas is below a first threshold value 650 it is evaluated as an indicator that cardiac massage is not performed sufficiently), based on the determination that the first physiological parameter measurement is below the first threshold, alter the first chest compression parameter (Paragraph [0219] discloses this case occurs when the timing between compressions and/or applied pressure are performed incorrectly and does not have sufficient pressure or the time intervals between the individual administrations of the pressure massage on the chest are too long which prompts alterations in chest compressions via message 701), receive a second physiological parameter from the patient after the first chest compression parameter has been altered (Paragraph [0207] discloses and Fig. 4 shows process 600 is a continuously repeating sequence and will continue to collect patient data to determine if a threshold is reached. Thus the newly collected C02 measurement is the second patient physiological data), determine that the second physiological parameter is below the second threshold (Fig. 3, if the second patient physiological data is below first threshold 650, it is also necessarily below second threshold 660), and based on the determination that the second physiological parameter is below the second threshold, generate instructions to adjust chest decompressions (Paragraph [0219] discloses being below the first threshold occurs (and being below the first threshold means you are below the second threshold too) when the timing between compressions and/or applied pressure are performed incorrectly which prompts alterations in chest compressions via message 701).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to combine the chest compression device disclosed by Havardsholm (the operation of which is readily modifiable with patient feedback data as disclosed in Paragraph [0029]) with the ventilation and C02 monitoring system to incorporate feedback system of the CO2 monitoring to instruct changes to the compression parameter taught by Loser (a system which is taught to be able to interface with automatic compression devices in Paragraph [0225]) in order to increase the efficiency of both ventilation and cardiac massage (Loser; Paragraph [0135]).
Havardsholm as modified by Loser does not disclose wherein the control module is further configured to administer active decompressions.
However, Nilsson teaches a CPR device wherein the control module (paragraph [0020] a controller that can control the movement of the piston) is further configured to administer active decompressions (Paragraph [0026] and [0036] discloses a reference position for which the depth of CPR compressions and the height of CPR decompressions can be measured; Paragraph [0022] discloses a suction cup for activated decompressions).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the compression member disclosed by Havardsholm as modified by Loser with the suction cup as taught by Nilsson in order to provide active decompression which improves circulation during CPR by improving the venous return flow of blood back to the heart for improved cardiac output (para. 0036).
Havardsholm as modified by Loser discloses administering chest decompressions at a specific height (Paragraphs [0010] and [0011] disclose the motor controlling compression parameters which includes active decompression which is performed with each stroke anyways and controlling compression depth), but does not specify that the administering chest decompressions when the second physiological parameter is specifically below a second threshold. However, since Loser teaches a feedback system that regularly monitors CO2, one of ordinary skill in the art before the effective filing date of the would have found it obvious to have modified the control module to administer active decompression specifically after a CO2 measurement being below a second threshold (that is a second CO2 measurement that is regularly performed as modified by Loser) in order to assist in effective oxygenation of the blood of the patient.
Regarding claim 9, modified Havardsholm teaches the machine of claim 8.
Loser further teaches wherein in response to the physiological parameter measurement being above the threshold (using Fig. 5e as a visual reference – see C02 concentration 620 being above both first threshold 650 and second threshold 660), the control module being further configured to decrease at least one of the chest compression parameters (Paragraph [0207] refers to an example fourth phase 1004 wherein the C02 concentration is above the first threshold and the second threshold which indicates the patient is independently supplying their organs with sufficient oxygen and thus the cardiac massage is not necessary and can be de-escalated. This is best shown in Fig. 5e wherein threshold 660 is exceeded and thus cardiac massage 615 ceases at time T4).
Regarding claim 10, modified Havardsholm teaches the machine of claim 8.
Loser further teaches wherein, in response to the physiological parameter measurement being below the threshold (using Fig. 5d as a visual reference – see C02 concentration 620 being below both first threshold 650 and second threshold 660), the control module being further configured to increase at least one of the chest compression parameters (Paragraph [0207] refers to an example second phase 1002 wherein the C02 concentration is below the first threshold and the second threshold which indicates the massage is not being performed sufficiently and the patient needs to be supplied with sufficient oxygen).
Regarding claim 13, modified Havardsholm teaches the machine of claim 8.
Loser further teaches wherein the user input comprises a physiological parameter measurement from a medical device (paragraph 0194 “Furthermore, a data interface 30 is provided on the ventilator 1. Additional sensor systems or accessories may be directly connected via this data interface 30 to the ventilator 1 with a unidirectional or bidirectional data exchange, or a unidirectional or bidirectional exchange of data 21 from the ventilator 1 with external devices may be performed. This FIG. 1a shows as an external physiological sensor a “CO.sub.2 sidestream sensor” 31, which draws breathing air from the connection piece (Y-piece) 17 by means of a suction line 32 and analyzes it with respect to the carbon dioxide concentration, and is connected to the data interface 30”).
Regarding claim 14, modified Havardsholm teaches the machine of claim 8.
Loser further teaches wherein the user input comprises direct instructions from a user to alter at least one of the one or more chest compression parameters (paragraph 0067 "The respiration rate (RR), the target pressure of ventilation (P), the maximum pressure amplitude during ventilation, the tidal volume (Vt) and the I:E ratio, which corresponds to the ratio of the duration of inspiration to the duration of expiration, are sent as parameters for controlling and regulating the ventilator which assists cardiopulmonary resuscitation to a control and regulation unit. On the one hand, these parameters can be set by the user as direct set values on a control unit, and the set values may also be derived from other parameters in another variant").
Regarding claim 15, Havardsholm teaches a chest compression administration system (Abstract discloses controlling the device in a predetermined manner and Paragraph [0007] refers specifically to the art of automatic chest compression), comprising: a chest compression machine (Fig. 1, Paragraph [0020] discloses a device comprising a motor 1, transmission mechanism 2) having a chest compression member (Fig. 1, Paragraph [0020] the device further comprises compression element 3); a user interface electrically coupled to the chest compression machine configured to receive user input (Fig. 2; paragraph 0029 discusses how the user controls element 13 can be provided separately. One skilled in the art would reasonably expect that when the user controls element is provided separately, this would consist of a user interface that is still coupled to the main controller 12); one or more patient physiological parameter sensing devices electrically coupled to the chest compression machine (Paragraph [0020] discloses patient feedback signal 6 in Fig. 1 and Paragraph [0029] discloses using patient data as feedback); and a control module (Fig. 2, main controller 12) configured to: cause the chest compression member to administer one or both of chest compressions or chest decompressions (Paragraph [0070] discloses compression patterns), each of the chest compressions and the chest decompressions having chest compression or decompression parameters (Paragraph [0010] discloses the motor controlling compression parameters. Annotated Figure 5B above shows parameters such as the time 36 between compression 34 and decompression 35, compression depth, and both the speed and duration of compression and decompression).
Havardsholm is silent on receiving a first patient physiological parameter from one or both of the user interface and the one or more patient physiological parameter sensing devices, evaluate whether the first patient physiological parameter is below a first threshold, if the received first patient physiological parameter is below the first threshold, escalate a first compression parameter, if the received first patient physiological parameter is above the first threshold, de-escalate the first compression parameter, receive a second patient physiological parameter from the one or more patient physiological parameter sensing devices, and escalate a first chest decompression parameter to a specific height when the received second patient physiological parameter is below a second threshold.
However, Loser teaches the control module configured to receive a first patient physiological parameter from one or both of the user interface and the one or more patient physiological parameter sensing devices (Paragraph [0033] discloses a control unit receiving the first parameter, CO2 content; paragraph [0029] “Main controller 12 is also able to receive signals not generated by the device itself, such as, for example, user controls, patient feedback data and output values of signals providing data logging”), evaluate whether the first patient physiological parameter is below a first threshold (Paragraph [0203] discloses in phase 1002, if C02 concentration 602 of the breathed gas is below a first threshold value 650 it is evaluated as an indicator that cardiac massage is not performed sufficiently. Also refer to Fig. 5d wherein concentration 620 falls below threshold 650), if the received first patient physiological parameter is below the first threshold, escalate a first compression parameter (Paragraph [0219] discloses this case occurs when the timing between compressions and/or applied pressure are performed incorrectly and does not have sufficient pressure or the time intervals between the individual administrations of the pressure massage on the chest are too long which prompts alterations in chest compressions via message 701; this means an indication of increased pressure or frequency is required), if the received first patient physiological parameter is above the first threshold, de-escalate the first compression parameter (Using Fig. 5e as a visual reference – see C02 concentration 620 being above both first threshold 650 and second threshold 660. Paragraph [0207] refers to an example fourth phase 1004 wherein the C02 concentration is above the first threshold and the second threshold which indicates the patient is independently supplying their organs with sufficient oxygen and thus the cardiac massage is not necessary and can be de-escalated. This is best shown in Fig. 5e wherein threshold 660 is exceeded and thus cardiac massage 615 ceases at time T4), receive a second patient physiological parameter from the one or more patient physiological parameter sensing devices (Paragraph [0169] discloses the combination oximeter/capnometer also provides the second parameter, oxygen concentration), and escalate and escalate a second chest compression parameter when the received second patient physiological data exceeds a second threshold (Paragraph [0203] discloses describes the concentration ranges in Fig. 3 to be used in the process described in [0207]. It is followed by Paragraph [0204] which states oxygen may be used besides CO2 concentrations. This teaches using oxygen concentration thresholds in a similar way as previously described above for CO2 concentration thresholds wherein cardiac massage is altered. Paragraph [0113] and [0116] disclose the associate first and second thresholds).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to combine the chest compression device disclosed by Havardsholm (the operation of which is readily modifiable with patient feedback data as disclosed in Paragraph [0029]) with the ventilation and CO2/O2 monitoring system to incorporate feedback system to instruct changes to the compression parameter based on the CO2/O2 monitoring system taught by Loser (a system which is taught to be able to interface with automatic compression devices in Paragraph [0225]) in order to increase the efficiency of both ventilation and cardiac massage (Loser; Paragraph [0135]).
Havardsholm as modified by Loser discloses wherein the control module is configured to alter the one or more chest compression parameters the chest compressions (Havardsholm discloses in Paragraph [0010] a controller configured to alter parameters of the chest compressions).
Havardsholm as modified by Loser does not disclose wherein the control module is further configured to administer active decompressions.
However, Nilsson teaches a CPR device wherein the control module (paragraph [0020] controller that can control the movement of the piston) is further configured to administer active decompressions (Paragraph [0026] and [0036] discloses a reference position for which the depth of CPR compressions and the height of CPR decompressions can be measured; Paragraph [0022] discloses a suction cup for activated decompressions).
Therefore, it would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the compression member disclosed by Havardsholm as modified by Loser with the suction cup as taught by Nilsson in order to provide active decompression which improves circulation during CPR by improving the venous return flow of blood back to the heart for improved cardiac output (para. 0036).
Havardsholm as modified by Loser discloses administering active decompressions (Havardsholm; Paragraphs [0010] and [0011] disclose the motor controlling compression parameters which includes active decompression which is performed with each stroke anyways), but does not specify that the first chest decompression is escalated to a specific height when the second patient physiological parameter specifically below a second threshold. However, since Loser teaches a feedback system that regularly monitors CO2 and O2, one of ordinary skill in the art before the effective filing date of the would have found it obvious to have modified the control module to administer active decompressions at a specified height specifically after a second parameter being below a second threshold in order to assist in effective oxygenation of the blood of the patient.
Regarding claim 18, modified Havardsholm teaches the machine of claim 15.
Loser further teaches wherein the user input comprises a physiological parameter measurement from a medical device (paragraph 0194 “Furthermore, a data interface 30 is provided on the ventilator 1. Additional sensor systems or accessories may be directly connected via this data interface 30 to the ventilator 1 with a unidirectional or bidirectional data exchange, or a unidirectional or bidirectional exchange of data 21 from the ventilator 1 with external devices may be performed. This FIG. 1a shows as an external physiological sensor a “CO.sub.2 sidestream sensor” 31, which draws breathing air from the connection piece (Y-piece) 17 by means of a suction line 32 and analyzes it with respect to the carbon dioxide concentration, and is connected to the data interface 30”).
Regarding claim 19, modified Havardsholm teaches the machine of claim 8.
Loser further teaches wherein the user input comprises direct instructions from a user to alter at least one of the one or more chest compression parameters (paragraph 0067 "The respiration rate (RR), the target pressure of ventilation (P), the maximum pressure amplitude during ventilation, the tidal volume (Vt) and the I:E ratio, which corresponds to the ratio of the duration of inspiration to the duration of expiration, are sent as parameters for controlling and regulating the ventilator which assists cardiopulmonary resuscitation to a control and regulation unit. On the one hand, these parameters can be set by the user as direct set values on a control unit, and the set values may also be derived from other parameters in another variant").
Claims 4, 11, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Havardsholm (US 20070270724 A1) in view of Loser (US 20150328417 A1) and Nilsson (US 20140180180 A1) as applied above and in further view of Nilsson (US 20160136042 A1).
Regarding claim 4, modified Havardsholm teaches the machine of claim 1.
Modified Havardsholm is silent wherein the user interface is integrated with the chest compression machine.
However, Nilsson teaches wherein the user interface is integrated with the chest compression machine (paragraph 0065 " Interface 114 may be implemented on the CPR chest compression machine, or on another device").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Havardsholm so the user interface is integrated within the chest compression machine. Integrating the user interface allows for direct connection between the controller and compression circuity, which may improve machine efficiency and speed between a user input and the desired output and reduce device setup time.
Regarding claim 11, modified Havardsholm teaches the machine of claim 8.
Modified Havardsholm is silent wherein the user interface is integrated with the chest compression machine.
However, Nilsson teaches wherein the user interface is integrated with the chest compression machine (paragraph 0065 " Interface 114 may be implemented on the CPR chest compression machine, or on another device").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Havardsholm so the user interface is integrated within the chest compression machine. Integrating the user interface allows for direct connection between the controller and compression circuity, which may improve machine efficiency and speed between a user input and the desired output and reduce device setup time.
Regarding claim 16, modified Havardsholm teaches the machine of claim 15.
Modified Havardsholm is silent wherein the user interface is integrated with the chest compression machine.
However, Nilsson teaches wherein the user interface is integrated with the chest compression machine (paragraph 0065 " Interface 114 may be implemented on the CPR chest compression machine, or on another device").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Havardsholm so the user interface is integrated within the chest compression machine. Integrating the user interface allows for direct connection between the controller and compression circuity, which may improve machine efficiency and speed between a user input and the desired output and reduce device setup time.
Claims 5, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Havardsholm (US 20070270724 A1) in view of Loser (US 20150328417 A1) and Nilsson (US 20140180180 A1) as applied above and in further view of Quan (WO 2016201367 A1).
Regarding claim 5, modified Havardsholm teaches the machine of claim 1.
Modified Havardsholm is silent wherein the user interface is integrated with a medical device.
However, Quan teaches wherein the user interface is integrated with a medical device (paragraph 0031 "The monitoring device 106 enables user input via the user interface 110 and additional control buttons 112 and 114").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Havardsholm so the user interface is integrated with an external medical device. This allows for the interface to be displayed without the constraints of the compression machine and allows for more input options and patient monitoring via the external device (paragraph 0045 “In some cases, the patient data can include ECG signals, cardiac mechanical signals, results of data processing and, optionally, additional coregistered physiological data. The patient data can be made available for display on remote device 202 and/or directly at the patient monitoring device 208”).
Regarding claim 12, modified Havardsholm teaches the machine of claim 8.
Modified Havardsholm is silent wherein the user interface is integrated with a medical device.
However, Quan teaches wherein the user interface is integrated with a medical device (paragraph 0031 "The monitoring device 106 enables user input via the user interface 110 and additional control buttons 112 and 114").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Havardsholm so the user interface is integrated with an external medical device. This allows for the interface to be displayed without the constraints of the compression machine and allows for more input options and patient monitoring via the external device (paragraph 0045 “In some cases, the patient data can include ECG signals, cardiac mechanical signals, results of data processing and, optionally, additional coregistered physiological data. The patient data can be made available for display on remote device 202 and/or directly at the patient monitoring device 208”).
Regarding claim 17, modified Havardsholm teaches the machine of claim 15.
Modified Havardsholm is silent wherein the user interface is integrated with a medical device.
However, Quan teaches wherein the user interface is integrated with a medical device (paragraph 0031 "The monitoring device 106 enables user input via the user interface 110 and additional control buttons 112 and 114").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Havardsholm so the user interface is integrated with an external medical device. This allows for the interface to be displayed without the constraints of the compression machine and allows for more input options and patient monitoring via the external device (paragraph 0045 “In some cases, the patient data can include ECG signals, cardiac mechanical signals, results of data processing and, optionally, additional coregistered physiological data. The patient data can be made available for display on remote device 202 and/or directly at the patient monitoring device 208”).
Conclusion
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/AKHIL A JAYAN/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785