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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 7/31/2026 is acknowledged. The traversal is on the ground(s) that a thorough search for the subject matter of any one Group I to Group III is sufficiently related and would not be a serious burden. This is found persuasive.
The previous restriction requirement is withdrawn and prosecution will proceed on all claims 1-20.
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 2 and 11-20 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.
Regarding claim 2, “the other one of the light” lacks antecedent basis.
Regarding claims 11 and 17, the claims are method claims that appear to depend from an apparatus claim thus crossing statutory classes. The claims appear to refer to the AHI score and the ODI score of device claim 1.
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 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to an abstract idea without significantly more.
With Respect to claims 11 and 17 the claims recite the following limitation(s):
It is noted that claims 11 and 17 refer only to the AHI score and the ODI score of device claim 1 and the structural features of device claim 1 do not appear to be included as part of the method of claims 11 and 17.
Claim 11: A determining method of the AHI score of claim 1, the determining method comprising:
labelling reasonable peak intervals to determine the peak interval plot;
determining a steady segment in the peak interval plot;
up-sampling peak interval data within the steady segment to generate up-sampled interval data; respectively calculating a difference between every adjacent data points of the up-sampled interval data to generate interval difference data;
calculating variances of the interval difference data to generate variance data;
determining a first threshold according to the variance data and the peak interval data; determining a second threshold according to the first threshold and a number of consecutive data points in the variance data smaller than the first threshold;
and taking a ratio of a counting number of the variance data larger than the second threshold and a total time of the peak interval plot as the AHI score.
Claim 17: A determining method of the ODI score of claim 1, the determining method comprising:
scanning the SpO2 plot to determine a reasonable SpO2 value;
determining a base SpO2 according to SpO2 values within a predetermined time behind the reasonable SpO2 value;
determining a low SpO2 threshold according to the base SpO2;
and taking a ratio of a counting value of consecutive data points behind the reasonable SpO2 value in the SpO2 plot lower than the low SpO2 threshold and a total time of the SpO2 plot as the ODI score.
Step 1- Claims 11 and 17 are directed to a method for determining an AHI score and a method for determining a ODI score for ultimately determining an obstructive sleep apnea level.
Step 2a Prong 1 – The claimed invention is directed to non-statutory subject matter. The above limitations, under their broadest reasonable interpretation, fall within the “Certain
Mathematical concepts and mental processes grouping of abstract ideas, enumerated in MPEP
2106.04(a)(2)(II), in that they recite a series of mathematical calculations and mental steps which
produce an AHI and ODI score to ultimate contribute to the determination of an obstructive sleep apnea level. When given their BRI, the limitations are considered an abstract idea of being certain mathematical concepts and mental processes.
With respect to claim 11, The method sets forth steps for labelling reasonable peak intervals,
determining a steady segment,
up-sampling peak interval data,
respectively calculating a difference between every adjacent data points,
calculating variances of the interval difference data,
determining a first threshold,
determining a second threshold,
and taking a ratio.
With respect to claim 17, The method sets forth steps scanning the SpO2 plot ,
determining a base SpO2,
determining a low SpO2 threshold,
taking a ratio of a counting value,
and a total time of the SpO2 plot.
Step 2a Prong 2 - The claims do not appear to add any additional elements and do not include any of the structure of the device claim 1. The claimed steps are performed on a generic processor. Further, the recitation adding a generic processor to the claim would serve to generally link the use of the abstract idea to a particular technological environment or field of use, i.e., a computerized environment. MPEP 2106.05(h).
As such, under Prong 2 of Step 2A, when considered both individually and as a whole, the limitations of claims 11 and 17 are not indicative of integration into a practical application (Prong 2, Step 2A: NO). MPEP 2106.04(d)
With respect to claim 11, There do not appear to be any additional elements provided and the abstract idea is not integrated into a practical application of utilizing any system components and actually performing the prostate Brachytherapy in accordance with the optimum treatment plan using the algorithm set forth.
With respect to claim 17, , There do not appear to be any additional elements provided and the abstract idea is not integrated into a practical application of utilizing any system components and actually performing the prostate Brachytherapy in accordance with the optimum treatment plan using the algorithm set forth.
As such, these method steps performed on a generic processor do not integrate the abstract idea into a practical application and therefore the claim is directed to the judicial exception.
Step 2B - The recitation of the additional elements is acknowledged, as identified above with respect to Prong 2 of Step 2A. These additional elements do not add significantly more to the abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
Even when considered as an ordered combination, the additional elements of claims 11 and 17 do not add anything that is not already present when they are considered individually. Therefore, under Step 2B, there are no meaningful limitations in claims 11 and 17 that transform the judicial exception into a patent eligible application such that the claim amounts to significantly more than the judicial exception itself (Step 2B: NO). MPEP 2106.05.
Accordingly, under the Subject Matter Eligibility test, claims 11 and 17 are ineligible.
Furthermore, the dependent claims, 12-16 and 18-20 do not add significantly more to the
abstract idea for the same reasons as addressed above with respect to Prong 2 of Step 2A.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou(TW M622782) hereinafter Zhou.
Zhou teaches a finger-worn physiological device and system, wherein the finger-worn physiological device includes a casing, an adjustable finger-worn structure, a control unit, at least one light-emitting source and at least one light detector. Through the adjustable finger-wearing structure, the finger-wearing physiological device is arranged on the user's finger, so as to obtain the blood physiological signal of the user during the user's sleep, and obtain the blood physiological signal according to the blood physiological signal. A light sensor refers to a sensor having both a light source, such as an LED, and a light detector, such as a photodiode, and as is well known, it uses PPG (photoplethysmography, According to the principle of photoplethysmography, light is emitted from the light source and enters human tissue, and the light detector will receive the light that penetrates the blood in the blood vessel or is reflected by the blood, and then passes through the light to obtain the light due to the volume change of the blood. The light sensor may also include at least two light sources, such as a plurality of LEDs, preferably green light/infrared light/red light, and at least one light detector to obtain the blood oxygen concentration (SPO2). In the field of sleep research, a symptom that has received considerable attention is sleep-disordered breathing, and the blood physiological information provided by light sensors can help to understand sleep-disordered breathing. One such sleep-disordered breathing is sleep apnea (Sleep Apnea), which generally has three types: Obstructive Sleep Apnea (OSA), Central Sleep Apnea (CSA), and mixed sleep Apnea (Mixed Sleep Apnea, MSA), hereinafter collectively referred to as breathing event (Breathing Event). Obstructive sleep apnea (OSA) is characterized by a decrease or cessation of respiratory airflow for a period of time due to complete or partial obstruction of the upper airway during sleep, usually accompanied by desaturation of blood oxygen concentration. The Apnea Hypoxia Index (AHI) is an indicator of the severity of sleep apnea that combines the number of apnea (apnea) and hypopnea (hypopnea) to give a simultaneous assessment of sleep (breathing) interruptions An overall sleep apnea severity score of the number of times and oxygen saturation levels (blood oxygen levels), where AHI is calculated by dividing the total number of apnea and hypopnea events by the number of hours of sleep, usually the AHI value is divided into, 5-15 times per hour is mild, 15-30 times per hour is moderate, and >30 times per hour is severe. In addition to AHI, studies have confirmed that another important indicator for assessing or detecting sleep apnea is the Oxygen Desaturation Index (ODI), which refers to the drop in blood oxygen levels from baseline to a certain degree per hour during sleep Generally speaking, ODI is expressed in two ways: the number of times the oxygen saturation drops by 3% (ODI3%) and the number of times the oxygen saturation drops by 4% (ODI4%). The difference between ODI and AHI is that AHI also includes Events that may cause sleep arousal (awaken) or arousal (arousal), but do not affect oxygen levels, and studies have confirmed that ODI has a certain correlation with AHI and sleep apnea, which can be effectively used for the diagnosis of OSA. ODI is calculated from the blood oxygen concentration, so ODI is also a kind of blood bio-information.
Regarding claim 1, Zhou teaches a device main body, comprising an inner surface configured to be attached to a surface of a skin of the user; at least one light source, arranged on the inner surface and configured to emit light of at least two wavelengths; a light sensor, arranged on the inner surface and configured to output at least two photoplethysmography (PPG) signals in response to light emission of the at least one light source; and a processor, configured to generate a peak interval plot according to one of the at least two PPG signals, generate an oxygen saturation (SpO2) plot according to two of the at least two PPG signals, determine an Apnea Hypopnea Index (AHI) score according to the peak interval plot, determine an Oxygen Desaturation Index (ODI) score according to the SpO2 plot, and determine the OSA level index according to the AHI score and the ODI score. Note fig. 2, 3 and 13 and the corresponding description. As shown in Figure 13, PPI refers to the peak-to-peak interval: it is defined as the time difference between two consecutive peaks in the PPG signal. First, the peak value (Peak.amp) of each cycle of the PPG signal is detected, and the time stamps of all Peak.amp points are stored in the array buffer. The PPI is calculated as the time difference between consecutive Peak.amp points and in order to detect sleep apnea/hypopnea events and their onsets, PPI, PWA, PA derived from PPG waveforms, and RIIV from optical sensors can also be used to correlate various respiratory events.
Regarding claim 2, Zhou teaches one of the light of the at least two wavelengths is red light, and
the other one of the light of the at least two wavelengths is infrared light. Note fig. 2, 3 and 13 and the corresponding description.
Regarding claim 3, Zhou teaches the wearable device further comprises a display or is wirelessly coupled to an electronic device having a display, and the display is configured to show the OSA level index or an OSA category associated with the OSA level index. The finger-worn physiological detection device according to the present application may also include a power module, such as a button cell, an alkaline battery, or a rechargeable lithium battery, or, alternatively, a charging module , for example, an inductive charging circuit, or, alternatively, a USB port or a pogo pin for charging; in addition, optionally, the finger-worn physiological detection device according to the present case may also include an information providing unit , preferably, an LCD or LED display element to display, for example, statistical information, analysis results, stored events, operating modes, progress, battery status, or more; and finger-worn physiological testing according to the present case
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 4-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou(TW M622782) hereinafter Zhou in view of Terrill(Respirology (2020) 25, 475–485)_ A review of approaches for analyzing obstructive sleep apnea related patterns in pulse oximetry data hereinafter Terrill.
Regarding claim 4, Zhou teaches the Apnea Hypoxia Index (AHI) is an indicator of the severity of sleep apnea that combines the number of apnea (apnea) and hypopnea (hypopnea) to give a simultaneous assessment of sleep (breathing) interruptions An overall sleep apnea severity score of the number of times and oxygen saturation levels (blood oxygen levels), where AHI is calculated by dividing the total number of apnea and hypopnea events by the number of hours of sleep, usually the AHI value is divided into, 5-15 times per hour is mild, 15-30 times per hour is moderate, and >30 times per hour is severe. In addition to AHI, studies have confirmed that another important indicator for assessing or detecting sleep apnea is the Oxygen Desaturation Index (ODI), which refers to the drop in blood oxygen levels from baseline to a certain degree per hour during sleep Generally speaking, ODI is expressed in two ways: the number of times the oxygen saturation drops by 3% (ODI3%) and the number of times the oxygen saturation drops by 4% (ODI4%). The difference between ODI and AHI is that AHI also includes Events that may cause sleep arousal (awaken) or arousal (arousal), but do not affect oxygen levels, and studies have confirmed that ODI has a certain correlation with AHI and sleep apnea, which can be effectively used for the diagnosis of OSA. ODI is calculated from the blood oxygen concentration, so ODI is also a kind of blood bio-information.
Zhou does not specifically teach the analytical steps as outlined in the claims. However it appears the limitations outlined in claims 4-20 seem to be describing the fundamental analysis of the SPO2 raw data to calculate the AHI and ODI parameters as is well known.
Terrill teaches the oxygen desaturation index (ODI) that calculates the number of desaturation events (also referred to as dips or transient hypoxaemic events) per hour which drop 3% (ODI3) or 4% (ODI4) below baseline levels; the proportion of total recording time with SpO2 ≤ 90% (T90); and other simple time series statistics. When used as part of a PSG, oximetry contributes to the scoring of hypopneas, and consequently, the apnea–hypopnea index (AHI) that summarizes the severity of sleep disordered breathing as the number of apneas and hypopneas per hour. As such, this study reviews the technical approaches for analyzing pulse oximetry data that may better capture important aspects of the physiological complexity, and therefore provide further physiological, clinical and epidemiological insight. Note the entire article and Figures 1-3 show the detailed raw SPO2 plots and corresponding peaks, thresholds, and variance as they relate to calculating AHI and ODI.
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It is noted that there are a limited number of choices available to a person of ordinary skill in the art for calculating AHI and ODI from the PPG related blood oxygen saturation waveforms as outlined in Zhou and Terrill.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device and method of Zhou the steps to calculate AHI and ODI as taught by Terrill as one of a finite number of methods for determining AHI and ODI, with a reasonable expectation of successfully calculating AHI and ODI as they relate to OSA events. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 4, Zhou teaches
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
ZHANG et al.( CN 112971766) teaches a sleep respiratory event detection method, according to chest and abdomen respiratory signal of the subject, initially judging sleep respiratory event, then using blood oxygen saturation data and three-axis acceleration data corresponding to the chest and abdomen respiratory signal to calibrate, so as to determine sleep respiratory event; the sleep breathing event is sleep apnea or low ventilation; wherein the sleep apnea is obstructive sleep apnea, central sleep apnea, or mixed sleep apnea.
NAKAMU(JP 2007292514) teaches a respiratory motion detection apparatus 1 according to the present embodiment is used for, for example, a test for sleep apnea syndrome, and mainly uses an apnea / hypopnea index (AHI [Apnea] as an index for determining sleep apnea syndrome. Hypopnea Index]) is used to determine sleep apnea syndrome. Here, AHI is a value representing the number of apneas or hypopneas that occur per hour of sleep, AHI = 5 to less than 15 is mild, AHI = 15 to less than 30 is moderate, and AHI = 30. The above is diagnosed as severe. blood oxygen saturation measuring instrument is used to calculate an apnea arterial oxygen saturation index (ODI [Oxygen Desaturation index]), which is an index for determining sleep apnea syndrome, similar to AHI. is there. This ODI is an index indicating how many times the blood oxygen concentration has decreased per hour of sleep, and if it is 5 or more, it is determined that it is sleep apnea syndrome. In general, the decrease in the blood oxygen concentration is counted by counting once until the blood oxygen concentration decreases by 3 to 4% and returns to a level equivalent to that immediately before the decrease.
SHOULDICE et al.( WO 2023031802) teaches [0028] The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea during a sleep session. The AHI is calculated by dividing the number of apnea and/or hypopnea events experienced by the user during the sleep session by the total number of hours of sleep in the sleep session. The event can be, for example, a pause in breathing that lasts for at least 10 seconds. An AHI that is less than 5 is considered normal. An AHI that is greater than or equal to 5, but less than 15 is considered indicative of mild sleep apnea. An AHI that is greater than or equal to 15, but less than 30 is considered indicative of moderate sleep apnea. An AHI that is greater than or equal to 30 is considered indicative of severe sleep apnea. In children, an AHI that is greater than 1 is considered abnormal. Sleep apnea can be considered “controlled” when the AHI is normal, or when the AHI is normal or mild. The AHI can also be used in combination with oxygen desaturation levels to indicate the severity of Obstructive Sleep Apnea.
Gozal et al.( US 20180353126) teaches assessing the performance of automated analysis of blood oxygen saturation (SpO2) recordings as a screening tool for OSAHS. As an initial step, statistical, spectral and nonlinear features are estimated to compose an initial feature set. Then, a fast correlation-based filter (FCBF) is next applied to search for the optimum subset. Finally, the discrimination power (OSAHS negative vs. OSAHS positive) of three pattern recognition algorithms is assessed: linear discriminant analysis (LDA), quadratic discriminant analysis (QDA) and logistic regression (LR). According to another aspect of the invention, oximetry is used to determine the OSAHS severity in children. For testing the severity of OSAHS, first spectral analysis is conducted to define and characterize a frequency band of interest in SpO2. Then the spectral data is combined with 3% oxygen desaturation index (ODI3) by means of a multi-layer perceptron (MLP) neural network, in order to classify children into one of the three OSAHS severity groups.
CHOU(WO 2020228725) teaches to provide a sleep physiology system, which adopts a decentralized hardware configuration architecture so that when performing sleep breathing disorder assessment and performing sleep posture training and/or sleep physiology feedback training, you can freely choose to meet your needs Physiological sensors to obtain appropriate sleep physiological information, and to freely select the type and location of warnings, which help to more accurately reflect the actual sleep physiological conditions and enhance the training effect.
EDOUARD et al.( EP 3906853) teaches a method to detect breathing disturbances of a user, carried out in a single/integral device comprising a plurality of LEDs (11,12,13) configured to emit light rays at least three wavelengths (λ1, λ2, λ3), at least a light sensing device (e.g. photodiode), a control unit and at least a motion sensor and a step of determining an Apnea/Hypopnea Index (AHI) computed from a calculation of a number of breathing disturbance event(s) (BDE) over a total/cumulated sleep duration. A synthetic report of the past night can therefore be issued for the user and/of for its caretaker. The synthetic report of the past night is considered a score of sleep quality and/or reveal light or severe apnea syndrome.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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