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 6/30/25. Claim 22 is added. Claims 1, 2, 4, 6-10 and 12-22 are currently pending and an action on the merits is as follows.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear when the SpO2 variability is determined as claim 1 only recites that the measured microfluctuations reflect SpO2 variability. Applicant clarifies in the arguments that the SpO2 variability is the determine microfluctuations but this is not clear in the claim language.
Claim 22 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear whether the claim is just stating there is a maximum and a minimum or if the maximum and minimum are determined somehow. It seems the claim is just stating that the values or a graph of values shows a maximum and a minimum but there is inherently a maximum and a minimum in any set of measurement values.
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, 6-7 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. US 2015/0112605 in view of Remmers et al. US 2016/0022205 in view of Toth et al. US 2015/0351690.
Regarding claim 1, Watson discloses a method of measuring arterial oxygen saturation (SpO2) respiratory variability with a multi-wavelength pulse oximetry system, comprising:
Generating, with a multi-wavelength pulse oximetry system ([¶32] at least two wavelengths, Red and IR, are used in the measurement), a series of SpO2 indications based on light transmission changes at a first wavelength and a second wavelength through blood originating from a carotid artery of a patient over a first duration ([¶20,32] the PPG sensors can be placed on the neck or the forehead, both supplied by the carotid artery. [¶27,50] oxygen saturation, SpO2, is measured. [¶42,50] signals measured and processed over a time period)
electronically measuring, with the multi-wavelength pulse oximetry system, one or more respiration cycle microfluctuations in the series of SpO2 indications ([¶29,71-75] respiratory fluctuations and effects can be determined on the PPG signal), including identifying one or more instantaneous SpO2 values over a first threshold value in the series of SpO2 indications, identifying one or more instantaneous SpO2 values under a second threshold value in the series of SpO2 indications and calculating differential values based on the one or more instantaneous SpO2 values over the first threshold value and the one or more instantaneous SpO2 values under the second threshold value to determine the one or more respiration cycle microfluctuations, wherein each microfluctuation of the one or more respiration cycle microfluctuations is a differential value ([¶36,71-75] the threshold is the physiological threshold range with an upper and lower value. The oxygen saturation values are compared to determine a difference over time); and
displaying the one or more respiration cycle microfluctuations as an arterial blood oxygenation respiratory variability indicator ([¶82]).
Watson discloses continuous sampling of the PPG signal ([¶47] continuous PPG signal) and discloses calculating the oxygen saturation ([¶50] saturation can be determined on any suitable portions of the signal). Watson does not specifically disclose wherein each Sp02 indication comprises a respective instantaneous Sp02 value, wherein each instantaneous Sp02 value is measured over a second duration that is shorter than the first duration, wherein the second duration is less than or equal to a cardiac interbeat interval. Remmers teaches a similar patient monitoring device for respiration and cardiac parameters that teaches sampling the oxygen saturation at an interval of once a second ([¶108,109] sampled at 1Hz in a moving window that is 10 seconds) which is less than a cardiac cycle and shorter than the first duration of the window. Therefore it would have been obvious to one of ordinary skill in the art at the time of invention to combine the device of Watson with the sampling of Remmers in order to monitor respiratory and saturation events in real-time ([¶48]).
The device as modified by Remmers does not specifically disclose the second duration varies adaptively based on a heart rate of the patient and a respiration rate of the patient. Toth teaches a similar physiological monitoring system that measures oxygen saturation among other parameters that adapt its sampling based on heart rate ([¶273]). 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 Watson with the teachings of Toth in order to adjust the sampling rate and conserve power ([¶273]). Toth does not specifically disclose using the respiration rate as well but at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to change the duration or sampling based on the respiration rate as well because Applicant has not disclosed that the respiration rate specifically provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the modified device of Watson, and applicant' s invention, to perform equally well with either the adaptive sampling taught by Toth or the claimed adaptive duration because both would perform the same function of adjusting the saturation collection rate equally well considering heart rate and respiration are closely linked.
Therefore, it would have been prima facie obvious to modify Watson in view of Toth to obtain the invention as specified in claim 1 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Toth.
Regarding claim 2, Watson discloses generating the series of SpO2 indications comprises determining heart beat related relative light transmission changes at the first wavelength and the second wavelength ([¶20,27]).
Regarding claim 6, Watson discloses the first duration is greater than or equal to a respiration period ([¶47,48]).
Regarding claim 7, Watson disclose the duration is greater than or equal to two respiration periods ([¶47,48] the interval is several respiratory periods).
Regarding claim 22, Watson discloses the one or more instantaneous SpO2 values used to measure the one or more respiration cycle microfluctuations indicate maximums and minimums in the series of SpO2 indications ([¶20,27] the pleth signals has maximums and minimums and its indicative of oxygen saturation).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. and Remmers et al and Toth et al. further in view of Abreu US 2015/0216479.
Regarding claim 4, Watson disclose the one or more respiration cycle microfluctuations are displayed numerically, visually, or audibly ([¶27]) and wherein the multi-wavelength pulse oximetry system includes a plurality of light emitters at different wavelengths and a detector ([¶32] IR and Red LEDs with a detector). Watson does not specifically disclose that the emitters and detector are shaped to be attached on a nasal root of the patient. Abreu teaches a similar biological parameter monitoring device that uses oximetry sensor and detector in the nose pad of glasses which sit at the nasal root ([¶56][FIG. 22B]). 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 Watson with the teachings of Abreu in order to monitor oxygenation of the brain specifically ([¶56])
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. and Remmers et al. and Toth et al. further in view of Haryadi et al. US 6042550.
Regarding claim 8, Watson does not specifically disclose prior to displaying the one or more respiration cycle microfluctuations as the arterial blood oxygenation respiratory variability indicator, the one or more respiration cycle microfluctuations in the series of SpO2 indications are converted to PaO2 microfluctuations. Haryadi teaches a similar device and method for determine various parameters from oximetry readings that teaches converting SpO2 to PaO2 ([FIG.6][C12 L11-68]). Therefore it would have been obvious to one of ordinary skill in the art at the time of filing to combine the device of Watson with the conversion of Haryadi in order to determine other parameters like pulmonary shunt ([C12 L11-68]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Watson et al. and Remmers et al and Toth et al. further in view of Lisogurski et al. US 2015/0157269.
Regarding claim 21, Watson as modified does not specifically disclose indicating hypovolemia responsive to an SpO2 variability amplitude being greater than a threshold amount for a third duration, the SpO2 variability amplitude based on the series of SpO2 indications. Lisogurski teaches a PPG monitoring device that uses electrical capacitance or optical sensors ([¶8]) and can determine dehydration which is hypovolemia based on the variability of the saturation or pleth signal ([¶33] it is noted that since the threshold and the variability are not defined based on any calculations that the variability of the PPG which is based on saturation meets the claim language).
Response to Arguments
Applicant's arguments filed 6/30/25 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments that Remmers does not teach that the second duration is less than or equal to a cardiac beat interval, Examiner respectfully disagrees. Applicant argues that Remmers only teaches sampling the signal at 1 Hz or every second which is essentially one interbeat interval. However, Remmers teaches that the oxygen saturation specifically is sampled not just the PPG attenuation signal which would mean that there is a calculation for that determination. Remmers' signal is a raw PPG that is processed to get an oxygen saturation so sampling at 1 Hz must involve some determination which seems to be the same as Applicant’s device according to ¶86 of the specification.
Regarding Applicant’s arguments that Watson does not disclose determining the microfluctuations, Examiner respectfully disagrees. Watson discloses evaluating the oxygen saturation and uses an upper and lower threshold that in its case are the physiologically possible parameter ranges and determines a difference in the oxygen saturation values. Its purpose is to determine lost respiration but it is still identifying respiratory fluctuations in the signal. The specific determination of microfluctuations is determined based on the resolution of the instantaneous SpO2 it seems. Remmers is then relied on to teach determining an instantaneous SpO2 that is sampled at 1Hz so is less than the cardiac period for any person whose heart rate is under 60bpm. Remmers also determines changes in the SpO2, specifically looking for desaturation events. Toth is then relied on to teach varying the sampling rate of a physiological signal based on heart rate. Applicant argues that Watson as modified does not show an output like FIG 18 of the current specification. However, the claim language is not specific enough to limit the determination and display of the microfluctuations to a graph like FIG 18. It seems the distinction between the current device and the prior art cited is determining the difference in the current instantaneous SpO2 and the mean SpO2 over 10 seconds and plotting that trend to determine microfluctuations but this needs to be embodied in the claim language.
Conclusion
THIS ACTION IS MADE FINAL. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL A CATINA/ Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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