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
Receipt is acknowledged of applicant's amendment filed on 3/27/26. Claims 10, 16 and 18 are cancelled. Claims 21-23 are new. Claims 1-9, 11-15 and 17-23 are currently pending and an action on the merits is as follows.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9, 11-15 and 17-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites determining a second physiological parameter of the patient by analyzing the first physiological parameter; outputting the second physiological parameter on a display associated with a medical device; determining that the second physiological parameter is below a threshold level for a threshold period of time; and in response to determining that the second physiological parameter is below the threshold level for the threshold period of time, outputting the first physiological parameter on the display.
The limitation of determining a second physiological parameter and determining the second physiological parameter is below a threshold, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor” and a “display”, the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor and the display, “determining” in the context of this claim encompasses the user manually calculating a parameter and a observing if the data crosses a threshold. Similarly the displaying could be considered as organizing human activity as the user could change the display based on the calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of capnography sensor. This sensor involves mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor and display are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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.
Claim(s) 1-2, 4-8, 11-15 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. US 2018/0177463 in view of Colman et al. US 2013/0289364 and Meador et al. US 2018/0289338.
Regarding claim 1, 4 and 13, Addison discloses a capnography monitoring device, comprising:
a capnography sensor configured to detect a capnograph of a patient ([¶20] sensor 20 is a carbon dioxide sensor);
a respiration sensor configured to detect a respiration rate of the patient ([¶35] a plethysmographic sensor is also used to collect pulse signals and determine breathing rate);
a display ([¶21] multiparameter monitor 24 has a screen display);
a processor ([¶22,27] a processor is used to determine characteristics) electrically coupled to the capnography sensor, the respiration sensor, and the display, the processor being configured to:
determine an end-tidal carbon dioxide of the patient by analyzing the capnograph ([¶20] end tidal carbon dioxide is determined from the carbon dioxide sensor signals);
cause the display to visually output an indication of the end-tidal carbon dioxide ([¶20,21,34] the end tidal carbon can be displayed with or without the capnogram);
cause the display to visually output an indication of the respiration rate ([¶64] the respiration rate can also be displayed);
determine that the respiration rate is below a threshold level for a threshold period of time ([¶39] the threshold can be certain breath rates over a period of time), and
in response to determining that the respiration rate is below the threshold level for the threshold period of time, cause the display to visually output a waveform indicating the capnograph ([¶59,62,64-65] the respiration rate or end tidal carbon dioxide can be displayed and then removed depending on the breathing characteristics).
Addison does not specifically disclose the threshold level being in a range of zero to five breaths per minute, the threshold period of time being in a range of ten to thirty seconds. Colman teaches a similar capnogram device that has a threshold of no breaths over a period of time ([¶93,95] the breaths and time are used to determine apnea or periods of zero breaths). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Addison with the teachings of Colman as Addison discloses changing the display based on thresholds and Colman teaches particular thresholds that allow for different levels of information to be displayed (¶95).
Addison as modified does not disclose that the in response to determining the respiration rate is below a threshold level remove the indication of the end-tidal carbon dioxide from the display. Meador teaches a similar physiological measurement device that detects and displays end tidal carbon dioxide and can switch between the numerical value and the waveform ([¶206] when switching to the capnogram the old indication of the etCO2 is removed). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Addison with the display teachings of Meador in order to allow the clinician to observe breathing patterns ([¶207]).
Regarding claim 2, 8 and 14, Addison discloses the processor is further configured to cause the display to alter a feature in response to determining that the respiration is below the threshold level for the threshold period of time cause the display to alter a feature comprising: a color output by the display; a brightness output by the display; or a portion of a label output by the display ([¶64] the display can change colors and output various symbols to alert to health conditions).
Regarding claims 5 and 18, Addison discloses the second physiological parameter is determined using a first subset of data representing the first physiological parameter ([¶18,38-40] the parameters are determined based on a signal portions).
Regarding claim 6, Addison discloses the indication of the first physiological parameter indicates a second subset of the data representing the first physiological parameter, the second subset being different from the first subset ([¶59] the etCO2 is determined from the capnogram but the capnogram is a broader subset of the signal data).
Regarding claims 7, 12 and 15, Meador teaches the processor is configured to cause the display to visually output the indication of the second physiological parameter at a location on the display and to cause the display to visually output the indication of first physiological ([¶206] the same box on screen shows the etCO2 or the capnogram).
Regarding claims 11 and 17, Addison discloses the first physiological parameter comprises: an oxygenation of blood of the patient; a capnograph of the patient; or an electrocardiogram (ECG) of the patient ([¶20,35] carbon dioxide sensor and a capnogram).
Regarding claim 20, Addison discloses the second physiological parameter comprises a heart rate, a respiration rate, or an end-tidal carbon dioxide of the patient ([¶20,21,64-66] etCO2 is determined from the capnogram which is the first physiological signal collected).
Regarding claim 21, Meador teaches the indication of the second physiological parameter is an indication of a numeric value, and wherein the indication of the first physiological parameter comprises a waveform ([¶206] the etCO2 is a numeric value and capnogram is a waveform).
Regarding claim 22, Addison discloses the sensor being a first sensor ([¶5] carbon dioxide sensor), the medical device further comprising: a second sensor configured to detect the third physiological parameter of the patient ([¶5] PPG sensor).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. US 2018/0177463 in view of Colman et al. US 2013/0289364 and Meador et al. US 2018/0289338 further in view of Walker et al. US 20180303411.
Regarding claim 23, Colman does teaches that capnography is useful with CPR ([¶5]) but does not disclose a chest compression device configured to administer chest compressions to the patient, wherein the processor is further configured to: output, to the chest compression device, an instruction to alter a characteristic of the chest compressions based on the first physiological parameter. Walker teaches an automated compression device that alters its compressions based on capnogram data it receives ([¶48]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Addison with the compression device of Walker as capnography is widely used with CPR and Walker teaches tracking airway CO2 with compression is important for tracking hypoxia and tissue oxygenation ([¶48]).
Claim(s) 3 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Addison et al. US 2018/0177463 in view of Colman et al. US 2013/0289364 and Meador et al. US 2018/0289338 further in view of Al-Ali et al. US 2005/0203352.
Regarding claim 3 and 9, Addison discloses a speaker that can generate different alerts but does not disclose the speaker in response to causing the display to visually output the indication of the end-tidal carbon dioxide cause the speaker to output an audio signal with a first pitch and in response to causing the display to visually output the waveform indicating the capnograph cause the speaker to output the audio signal with a second pitch, the second pitch being different than the first pitch. Al-Ali teaches a similar physiological monitoring system using a capnometer that can change the tone or modulation of the alerts and sounds ([¶20]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Addison with the tone modulation of Al-Ali in order to signal priority ([¶20]).
Response to Arguments
Applicant's arguments filed 3/27/26 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 101 rejection, Examiner respectfully disagrees.
As per the argument the claims provide a patent-eligible improvement to a technical field, Examiner respectfully disagrees. Applicant argues that displaying the capnogram when the respiration rate is low allows the clinician to determine if breathing is actually low or the sensor is malfunction. Examiner does not dispute this. However, it is not clear how the claims provide a technological improvement as it related to display the capnogram and removing the display of the etCO2. The prior art teaches switching between the waveform and numeric readings or displaying them both which seem to provide the same advantage so it is not clear how either the automation of that change or displaying the waveform while not displaying the numeric value provides a technical advantage over the other displays.
As per the argument the claims include features applied by a particular machine, Examiner respectfully disagrees. Applicant argues that the device is composed of a capnography sensor, a respiration sensor, a display and a processor connected to the display and sensors. However, the sensors are generically recited and only perform pre-solutional data gathering for use with the abstract idea which is the determinations fall under the mental process grouping of judicial exceptions. Similarly, the processor performs the general computer function of processing input data and only performs the abstract determinations. The display is generically recited as well and only performs post-solutional display of the determinations performed by the processor.
As per the argument the claims include unconventional features, Examiner respectfully disagrees. Based on a threshold or trigger display one metric over another is taught in the art and is not unconventional it seems.
Applicant’s arguments, see pg. 12, with respect to the rejection(s) of claim(s) 1-20 under 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Meador.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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