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 9/29/25. Claims 2, 5, 7, 11, 12, 17 and 19 are cancelled. Claims 21-26 are new. Claims 1, 3, 4, 6, 8, 9, 13-16, 18 and 20-26 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, 3, 4, 6, 8, 9, 10, 13-16, 18 and 20-26 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 determining a baseline pulse rate, identifying a suspected transient decelerations, qualifying the suspected transient deceleration, removing the qualified transient deceleration from the sensed pulse rate signal to form a modified pulse rate signal, determining a modified HRV from the modified pulse rate signal.
The limitations of determining a baseline pulse rate, identifying a suspected transient decelerations, qualifying the suspected transient deceleration, removing the qualified transient deceleration from the sensed pulse rate signal to form a modified pulse rate signal, determining a modified HRV from the modified pulse rate signal, as drafted, are processes that, under their broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “processing 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 and output language, “determining” “identifying” “qualifying” and “removing” in the context of this claim encompasses the user visually assessing a data stream or signal plot with minor 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 processor and a visual display which 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 claims are 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, 3, 4, 6, 8, 9, 10 and 21-24 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. Claim 1 recites “output, to a visual display, an alarm or notification” which is presumed to be an alternative between an alarm and notification with “a visual display” being a parenthetical phrase. However, It could also be that the determination is output to one of a visual display, an alarm or notification so clarification is required.
Claims 21 and 25 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 what symmetry is being checked. It could be the symmetry of the whole signal or a specific deceleration and return and it is unclear what specific feature or features is being checked for symmetry.
Claim 25 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 what model is being referred to. Could be any type of model whether its algorithmic or a machine learning model or some template or physical mode. It is presumed from the specification that model in claim 25 refers to a machine learning model.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 8-10, 13-15, 20-22 and 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moorman et al. US 2010/0234748.
Regarding claims 1, 13 and 20, Moorman discloses a device for detecting deterioration of a patient, the device comprising:
a memory configured to store a sensed pulse rate signal indicative of one or more sensed pulse rates over time ([¶29] cardiac heart rate signals are collected and analyzed); and
processing circuitry configured to:
determine, from the sensed pulse rate signal, a baseline pulse rate ([¶67,77] comparisons are made to a baseline);
identify a suspected transient deceleration, the suspected transient deceleration comprising a drop in the sensed pulse rate below the baseline pulse rate where the drop exceeds an amplitude threshold ([¶73,112,115] an amplitude threshold of 100ms is used) to within a range of a baseline pulse rate ([FIG. 3]);
qualify the suspected deceleration from the sensed pulse rate signal to form modified pulse rate signal ([¶59] different features are compared or matched to determine if the deceleration is normal variation or a qualified deceleration);
remove the qualified transient deceleration from the sensed pulse rate signal to form a modified pulse rate signal ([¶77]);
store the modified pulse rate signal in the memory ([¶97,101] the determinations are stored in memory);
determine a modified heart rate variability (HIRV) value from the modified pulse rate signal ([¶77] decelerations can be removed to have a better accuracy for the HRV);
output, to a visual display, an alarm or notification indicative of the qualified transient deceleration or modified HRV value ([¶96] a display interface shows the determinations).
Regarding claims 3 and 15, Moorman discloses the HRV value is a first HRV value and the determined HRV value is a first determined HRV value, wherein the processing circuitry is further configured to: determine a second HRV value based on the sensed pulse rate signal, wherein the second HRV value is at least partially based on the transient deceleration ([¶77] HRV can be determined without removing the decelerations); and output information indicative of the second determined HRV value ([¶96] a display interface shows the determinations).
Regarding claims 4 and 16, Moorman discloses the processing circuitry is further configured to: determine a count of one or more qualified transient decelerations ([¶76,77]); and output information indicative of the count ([¶96] a display interface shows the determinations).
Regarding claims 7 and 19, Moorman discloses the count is sortable according to a period and amplitude of a sensed pulse rate of each of the one or more transient decelerations ([¶76-77] the amplitude and duration are used in classifying the decelerations).
Regarding claim 8, Moorman discloses the processing circuitry is further configured to: determine that a sensed pulse rate of one or more sensed pulse rates associated with the transient deceleration falls below a predetermined key threshold; and based on the determination that the sensed pulse rate of the transient deceleration falls below the predetermined key threshold ([¶73,77] different thresholds are used for significant decelerations from normal accelerations and decelerations), output information indicative of the transient deceleration being a key transient deceleration ([¶96] a display interface shows the determinations).
Regarding claim 9, Moorman discloses the processing circuitry is further configured to: determine a deceleration skew associated with the transient deceleration ([¶21,74] asymmetry is determined which is the same as skewness); and output information indicative of the deceleration skew ([¶96] a display interface shows the determinations).
Regarding claim 10, Moorman discloses the processing circuitry is further configured to: determine one or more accelerations in the sensed pulse rate signal ([¶30,73] accelerations can be determined); determine at least one acceleration skew associated with at least one of the one or more accelerations ([¶21,74] asymmetry is determined which is the same as skewness); and output information indicative of the at least one acceleration skew ([¶96] a display interface shows the determinations).
Regarding claim 21, Moorman discloses the processor being configured to qualify the suspected transient deceleration as a qualified transient deceleration comprises being configured to check for symmetry in the suspected transient deceleration ([¶67,74] asymmetry is determined).
Regarding claim 22, Moorman discloses the processor being configured to qualify the suspected transient deceleration as a qualified transient deceleration comprises being configured to compare the suspected transient deceleration to a template ([¶4] template functions can be used).
Regarding claim 24, Moorman discloses the processor being configured to identify the suspected transient deceleration comprises being configured to identify that the return of the sensed pulse rate to within the range of the baseline pulse rate takes place within a time period ([¶63-72]).
Regarding claim 25, Moorman discloses wherein determining the transient deceleration comprises identifying a suspected transient deceleration and qualifying the suspected transient deceleration as a qualified transient deceleration based on a model, a template, or a symmetry check ([¶67,74] asymmetry is determined. [¶4] template functions can be used).
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) 6, 18 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moorman in view of Baker et al. US 2018/0078216.
Regarding claims 6 and 18, Moorman does not disclose the processing circuitry is further configured to: determine a blood oxygen saturation (SpO2) value coinciding with each of the one or more transient decelerations, wherein the count is sortable according to the SpO2 value, according to when the SpO2 value drops below a predetermined threshold, or according to an SpO2 value drop. Baker discloses a similar diagnostic device that analyzes cardiac signals for decelerations ([¶51]) and that determines SpO2 values ([¶57,103]) associated with the decelerations. 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 Moorman with the teachings of Baker in order to better determine or predict disease ([¶104]).
Regarding claim 26, Moorman discloses determining clinical risk but does not disclose initiating an alarm based on the determined transient deceleration. Baker discloses a similar heart rate monitoring system that display alarms ([¶76]). 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 Moorman with the teachings of Baker in order to better determine or predict disease ([¶104]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moorman in view of Hamilton et al. US 2004/0133115.
Regarding claim 23, Moorman does not specifically disclose the device comprising a neural network or machine learning model trained to qualify the suspected transient deceleration as the qualified transient deceleration. Hamilton teaches a similar heart rate monitoring system that uses machine learning ([¶178,239]). 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 Moorman with teachings of Hamilton in order to classify events not seen in the training population ([¶178]).
Response to Arguments
Applicant's arguments filed 9/29/25 have been fully considered but they are not persuasive.
Regarding Applicant’s arguments against the 101 rejection, Examiner respectfully disagrees. For step 2A, removing qualified transient decelerations from the signal can be performed by the human mind with the assistance of pen and paper. Similarly, under a broadest reasonable interpretation the abstract steps claimed could be as simple as the clinician removing data points that look like decelerations upon visual inspection and performing a HRV calculation without those data points. Regarding step 2A prong two, the claims do not recite a practical application as the recited additional components are generic computer components. Similarly, the claim as a whole does not integrate the judicial exception into a practical application as there is no clear improvement that would add significantly more to the abstract idea. Similarly, in the step 2B analysis there is no improvement to the specific technology or clinical diagnosis as the prior art teaches the limitations of the claims and it is not clear how the current device provides an improvement.
Regarding Applicant’s arguments against the 103 rejection, Examiner respectfully disagrees. Applicant argues that the current device can process and detect decelerations faster than the device of Moorman; however, this is not recited in the claim language. The claims do not have limitations directed to specific time periods or windows of processing so Moorman discloses the processing recited in the claims. Additionally, it appears Moorman can also process the decelerations in similar time frames to the current device as shown in ¶80.
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 W CHEN/Supervisory Patent Examiner, Art Unit 3791
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