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 12/8/25. Claims 5, 7, 9-10 and 19 are cancelled. Claims 21-25 are new. Claims 1-4, 6, 8, 11-18 and 20-25 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 1-4, 6, 8, 11-18 and 20-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of processing the pulse rate signal to determine a plurality of pulse rates and a baseline pulse rate; determining for a predetermined time period at least one pulse rate of the plurality of pulse rates is a multiple of the baseline pulse rate; determining the at least one pulse rate is an erroneous pulse rate when the multiple of the baseline pulse rate is within a multiple threshold; processing the erroneous pulse rate to create a modified sensed pulse rate signal; and determining an HRV value based on the modified pulse rate signal over the predetermined time period.
The limitation of determining the pulse rate is erroneous, process the erroneous pulse rate to create a modified pulse rate and determining an HRV from the modified pulse rate, 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 “processor circuitry”; and outputting digital data (all of which include or involve generic computer components), 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 circuitry and output language, “determining” and “processing” in the context of this claim encompasses the user manually removing signal that don’t meet some threshold and calculating the HRV from the remaining signals. 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 element of processing circuitry and some implied output device. These 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. The sensor and pulse oximetry sensor are pre-solutional to the mental concept and do not add significantly more. 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 § 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.
Claims 1-4, 6, 8, 11-18 and 20-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear in “determining the at least one pulse rate is an erroneous pulse rate when the multiple of the baseline pulse rate is within a multiple threshold” where or when the multiple of the baseline is determined. The claim earlier determines if the pulse rate is a multiple of the baseline but does not recite actually determining the multiple.
Claim 3 and 17 and their dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear how a ratio is determined against a plurality of pulse rates. It could be a ratio of the valid pulse rate against each of the polarity of pulse but it is not clear if this is the case.
Claim 6 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear if the providing of a representation is the same or different than the outputting of the indication of the HRV in claim 1. It is also unclear when and where a second HRV is determined.
Claim 8 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear how a slope is determined from the baseline to a second pulse rate. It is unclear if the pulse rates are a time series.
Claims 11 and 22 and their dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear how a ratio is determined against a plurality of pulse rates.
Claim 13 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear what the current pulse rate is. It seems it may just be a currently selected pulse rate but this is not clear from the claim language or specification.
Claim 14 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear what the current pulse rate is. It seems it may just be a currently selected pulse rate but this is not clear from the claim language or specification.
Claim 21 and its dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. It is unclear when a second HRV is determined.
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) 1-4, 6, 8, 11-18 and 20-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frei et al. US 2011/0270347 in view of Cheng et al. US 2016/0198969.
Regarding claims 1 and 20, Frei discloses a device for determining heart rate variability (HRV) ([¶90]), the device comprising:
a sensor configured to generate a pulse rate signal based on detecting artery pulsatile flow of the patient ([¶175])
processor circuitry ([¶181])
a memory storing instructions that when executed by the processor circuitry cause the device to perform one or more operations comprising
receiving from the sensor the sensed pulse rate signal ([¶122] [¶181] the device memory logs the collected pulse data);
processing the pulse rate signal to determine a plurality of pulse rates and a baseline pulse rate ([¶139])
determining for a predetermined time period, at least one pulse rate is a multiple of the baseline pulse rate ([¶63,131,214] the pulse data is tested for validity including if it is an integer multiple of the previous rate or baseline);
determining the at least one pulse rate is an erroneous pulse rate when the multiple of the baseline pulse rate is within a multiple threshold ([¶214])
determining for the predetermined time period the at least one HRV value based on the modified pulse rate signal ([¶99,190] HRV is determined from the valid beats); and
outputting information of the at least one HRV value ([¶194-195] the device outputs the determinations to a handheld device or computer).
Frei does not disclose processing the erroneous pulse rate based on a multiplier to create a modified sensed pulse rate signal. Cheng teaches a similar heart rate detection device that corrects the invalid signal segments by using a multiple of the pulse rate ([¶113,115] a multiplier is used to correct for missing beats). 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 Frei with the correction of Cheng in order to get a better signal for further processing.
Regarding claims 2, 16 and 24, Cheng teaches a similar heart rate detection device that corrects the invalid signal segments by using a multiple of the pulse rate ([¶113,115] a multiplier is used to correct for missing beats).
Regarding claims 3 and 17, Frei discloses the one or more operations further comprising determining, for the predetermined time period, one or more valid pulse rates of the plurality of pulse rates, determining, for the predetermine time period, a ratio of the one or mor valid pulse rate samples, and determining the at least one HRV value based on the modified pulse rate signal when the ratio is greater than or equal to a predetermined minimum ratio ([¶71,77,190] the ratio of valid beats in the window is used to determine whether to process the data for HRV and seizure detection).
Regarding claims 4, 18 and 25, Frei discloses the plurality of sensed pulse rates is sampled at a fixed sampling rate ([¶204] an A?D converter is used so the signal is sampled at a fixed rate of the resolution of the A/D converter).
Regarding claim 6 and 21, Frei discloses the at least one HRV value is a first HRV value, the or more operations further comprising: in response to determining that the at least one pulse rate is erroneous, preventing a representation of a second HRV value; determining, at least one of, a current pulse rate of the plurality of pulse rates is within a predetermined range of the baseline pulse rate, or a predetermined timeout period as elapsed since determining the erroneous pulse rate; in response to determining at least one of the current sensed pulse rate being within the predetermined range of the baseline pulse rate, or the predetermined time period has elapsed since determining erroneous pulse rate, determining a third HRV value based on the modified pulse rate signal ([¶193,218] if a certain amount of time has passed since the last valid beat the constraints are relaxed to find the next valid beat to continue calculations).
Regarding claim 8, Frei discloses the processing circuitry is further configured to, based on determining that the pulse rate is within the predetermined multiple rate threshold, after a minimum elapsed time:
determine a slope from a last baseline rate value to a first pulse rate value within the predetermined multiple rate threshold;
determine that the slope is greater than or equal to a predetermined slope threshold; and
based on the slope being greater than or equal to the predetermined slope threshold, stop outputting HRV values and delete the slope from the sensed pulse rate signal ([¶65,126, 215] the device determines if the slope from the previous pulse to the current one is too large to be physiologically possible and discards the pulse as invalid).
Regarding claim 11 and 22, Frei discloses the processor circuitry is further configured to: determine a ratio of the one or more erroneous pulse rate samples to the plurality of pulse rates and based on the ratio being greater than or equal to a predetermined maximum ration, discontinuing determining the at least one HRV value for the predetermined time period ([¶65,126, 215] the device determines various parameters and threshold to determine if the pulse is valid and discards the pulse as invalid).
Regarding claim 12 and 23, Frei discloses wherein the predetermined time period is a first predetermined time period, the one or more operations further comprising resuming determining the at least one HRV value during a second predetermined time period ([¶76,193] the metrics for the time period and validity are reset).
Regarding claim 13, Frei discloses storing the at least one valid pulse rate of the one or more valid pulse rates and a time stamp associated with the at least one valid pulse rate;
determining, during the predetermined time period, a difference between the at least one valid pulse rate and a current pulse rate of the plurality of pulse rates is greater than a predetermined difference threshold ([¶126]); and
deleting remaining pulse rates of the plurality of pulse rates determined after a time associated with the time stamp until the predetermined time period expires ([¶126] the time difference is compared to determine if the pulse is valid. [¶193,218] after a certain time limit the valid pulse determination is reset and detection continues).
Regarding claim 14, Frei discloses the processor circuitry is further configured to:
determining incoming pulse rates have been held constant for a predetermined constant time threshold;
based on the determining the incoming pulse rates have been held constant for the predetermined constant time threshold, discarding incoming pulse rate values ([¶156] variance and dispersion limits for the beats are set and used to invalid signals);
determining that a current pulse rate of the plurality of pulse rates is different than the discarded incoming pulse rates; and
resume accepting incoming pulse rate of the plurality of pulse rates during the predetermined time period ([¶131,156] the device determines if the beat has been constant for too long and discards the beat as a missed beat).
Claim(s) 15-18 and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Frei et al. US 2011/0270347 in view of Cheng et al. US 2016/0198969 and Baker et al. US 2015/0201859.
Regarding claims 15, Frei discloses a device for determining heart rate variability (HRV) ([¶90]), the device comprising:
a sensor configured to generate a pulse rate signal based on detecting artery pulsatile flow of the patient ([¶175])
processor circuitry ([¶181])
a memory storing instructions that when executed by the processor circuitry cause the device to perform one or more operations comprising
receiving from the sensor the sensed pulse rate signal ([¶122] [¶181] the device memory logs the collected pulse data);
processing the pulse rate signal to determine a plurality of pulse rates and a baseline pulse rate ([¶139])
determining for a predetermined time period, at least one pulse rate is a multiple of the baseline pulse rate ([¶63,131,214] the pulse data is tested for validity including if it is an integer multiple of the previous rate or baseline);
determining the at least one pulse rate is an erroneous pulse rate when the multiple of the baseline pulse rate is within a multiple threshold ([¶214])
determining for the predetermined time period the at least one HRV value based on the modified pulse rate signal ([¶99,190] HRV is determined from the valid beats); and
outputting information of the at least one HRV value ([¶194-195] the device outputs the determinations to a handheld device or computer).
Frei does not disclose processing the erroneous pulse rate based on a multiplier to create a modified sensed pulse rate signal. Cheng teaches a similar heart rate detection device that corrects the invalid signal segments by using a multiple of the pulse rate ([¶113,115] a multiplier is used to correct for missing beats). 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 Frei with the correction of Cheng in order to get a better signal for further processing.
Frei does not specifically disclose the pulse sensor is a pulse oximetry sensor. Baker teaches a similar monitoring system that uses pulse oximetry as well ([¶12,16]). 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 Frei with the pulse oximeter of Baker in order to also monitor oxygen saturation which is useful for cardiac diagnosis.
Regarding claim 16, Cheng teaches a similar heart rate detection device that corrects the invalid signal segments by using a multiple of the pulse rate ([¶113,115] a multiplier is used to correct for missing beats).
Regarding claim 17, Frei discloses the one or more operations further comprising determining, for the predetermined time period, one or more valid pulse rates of the plurality of pulse rates, determining, for the predetermine time period, a ratio of the one or mor valid pulse rate samples, and determining the at least one HRV value based on the modified pulse rate signal when the ratio is greater than or equal to a predetermined minimum ratio ([¶71,77,190] the ratio of valid beats in the window is used to determine whether to process the data for HRV and seizure detection).
Regarding claim 18, Frei discloses the plurality of sensed pulse rates is sampled at a fixed sampling rate ([¶204] an A?D converter is used so the signal is sampled at a fixed rate of the resolution of the A/D converter).
Regarding claim 21, Frei discloses the at least one HRV value is a first HRV value, the or more operations further comprising: in response to determining that the at least one pulse rate is erroneous, preventing a representation of a second HRV value; determining, at least one of, a current pulse rate of the plurality of pulse rates is within a predetermined range of the baseline pulse rate, or a predetermined timeout period as elapsed since determining the erroneous pulse rate; in response to determining at least one of the current sensed pulse rate being within the predetermined range of the baseline pulse rate, or the predetermined time period has elapsed since determining erroneous pulse rate, determining a third HRV value based on the modified pulse rate signal ([¶193,218] if a certain amount of time has passed since the last valid beat the constraints are relaxed to find the next valid beat to continue calculations).
Regarding claim 22, Frei discloses the processor circuitry is further configured to: determine a ratio of the one or more erroneous pulse rate samples to the plurality of pulse rates and based on the ratio being greater than or equal to a predetermined maximum ration, discontinuing determining the at least one HRV value for the predetermined time period ([¶65,126, 215] the device determines various parameters and threshold to determine if the pulse is valid and discards the pulse as invalid).
Response to Arguments
Applicant's arguments filed 12/8/25 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that the claimed elements are not directed to mental concepts, Examiner respectfully disagrees. The additional component of the sensor is a generic component but it also is pre-solutional to the abstract mental concept, i.e. the determinations. The human mind cannot generate a pulse rate signal so the sensor does but the collecting of the pulse rate signal is pre-solutional data gathering. The determinations for the HRV can be performed in the mind.
Regarding Applicant’s arguments that the claims recite a particular solution to a problem, Examiner respectfully disagrees. The claims do not effect a particular treatment or practical application. The sensor and outputting step merely link the abstract idea to a particular technical environment. Aside from the actual determination steps the claim amounts to collect a signal, perform abstract determinations and thinking and output the determination. All of this is generally linked to PPG monitoring but it does not provide a practical application.
Regarding step 2B, the current claims seek to correct problems cause by the input pulse rate suddenly changing to a multiple of the pulse rate and to fix this the current device may modify the sample in order to have faster HRV determinations than deleting the erroneous measurement would. It is unclear how this is an improvement in the technical field when Frei discloses using weighting, similar modification, to provide faster determinations ([¶112,227]).
Regarding Applicant’s arguments against the 102 and 103 rejections, Examiner respectfully disagrees. Cheng teaches using the multiplier to correct or offset the pulse rate ([¶115] beats are added for missed beats determined based on the multiplier). Applicant argues that Cheng does not determine at least one pulse rate of the plurality of pulse rates is a multiple of the baseline pulse rate but Examiner disagrees. First, Cheng is not relied on to teach this aspect, Frei specifically teaches this limitation ([¶131,214]). To be clear though, Cheng also teaches this limitation where pulse rates are identified as multiples of the baseline ([¶113]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 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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