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 .
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 112(b)
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, 4, 10-17, and 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.
The term “long-run hypoxia burden score” positively recited in claims 2, 4, 10, 12, and 20 is a relative term which renders the claim(s) indefinite. The term “long-run” is not defined by the claim(s), the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim(s) is indeterminate with respect to magnitude, frequency, and/or duration of score that may be expressly, implicitly, inherently, and/or inferentially required and/or excluded to be considered “long-run”. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention given the infinite number of possibilities that may be considered “long-run”. Depending claims 11 and 13-17 inherit and do not remedy the indefiniteness.
The term “long-run hypoxia burden score” positively recited in claims 2, 4, 10, 12, and 20 is a relative term which renders the claim(s) indefinite. The term “burden” is not defined by the claim(s), the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim(s) is indeterminate with respect to magnitude, frequency, duration and/or degree of problem/issue that may be expressly, implicitly, inherently, and/or inferentially required and/or excluded to be considered “burden”. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention given the infinite number of possibilities that may be considered “burden”. Depending claims 11 and 13-17 inherit and do not remedy the indefiniteness.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea is a mental process of determining events and scores from sleep and respiratory data.
For independent claim 18, the claim(s) recite(s) a receiving and identifying sleep sessions from sleep data, determining from the data respiratory events, event-metrics, and hypoxia burden scores.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a medical professional capturing data, printing it out, and using the data to mentally extract, classify or learn from data features to determine events and metrics from sleep data.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Conversely, the determinations are merely processed on a generic computing system with processor and memory that do not integrate into a practical application and are considered additional elements.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary steps using a computing system for receiving and identifying sleep sessions from sleep data, determining from the data respiratory events, event-metrics, and hypoxia burden scores are well-known, routine and conventional computing functionalities amounting to insignificant data gathering and computation as pre-solution activity.
Depending claims 19-20 inherit and do not remedy the non-statutory deficiency noted above. Despite reciting a means for sensing pressure and/or further score generation, these additional limitations do not integrate into a practical application nor do they add additional elements amounting to significantly more because special purpose computing is not required and means for sensing pressure are well-known, routine and conventional, thus not amounting to significantly more as additional element(s). Thus, claims 19-20 are non-statutory as directed to an abstract idea as iterated above.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siyahjani et al. (US 2022/0395233 A1, hereinafter Siyahjani).
For claim 1, Siyahjani discloses a system (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]), comprising inter alia:
a bed (100) having a mattress (112) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
at least one pressure sensor (one of 902, 904, 906, or 908) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]) configured to:
sense pressure applied to the bed by a user on the bed (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]); and
transmit, to a computing system (1800) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]), a pressure stream from the sensing of the pressure applied to the bed (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
at least one force sensor (a different one of 902, 904, 906, or 908) ([0042, 0124]) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]) configured to:
sense force applied to the bed by the user (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]); and
transmit, to the computing system, a force stream from the sensing of the force applied to the bed (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
the computing system comprising at least one processor (1802) and memory (1804) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]), the computing system configured to:
receive the pressure stream (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
receive the force stream (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
identify one or more sleep sessions for the user sleeping on the bed using at least one of the group consisting of i) the pressure stream, and ii) the force stream (Figs 18-20) ([0166-0207]);
for each of the sleep sessions, determine occurrences of one or more respiratory-events (Figs 18-20) ([0166-0207]);
for each of the respiratory-events, determine a plurality of event-metrics using the pressure stream and the force stream (Figs 18-20) ([0166-0207]); and
for each of the sleep sessions, determine a single-session hypoxia-burden score using the plurality of event-metrics for respiratory-events of the sleep session (Figs 18-20) ([0166-0207]).
For claim 2, Siyahjani discloses the system of claim 1, wherein the computing system is further configured to generate a long-run hypoxia burden score for the user from a plurality of single-session hypoxia-burden scores from a plurality of the sleep sessions (Figs 18-20) ([0166-0207]).
For claim 3, Siyahjani discloses the system of claim 1, wherein:
the plurality of event-metrics for a respiratory-event comprises at least one of the group consisting of i) an area under a curve of inter-beat interval (IBI) over a time period after the respiratory-event, ii) a minimum (IBI) value during the time period, iii) an area under a curve of skin temperature over the time period, and iv) a minimum skin temperature value during the time period (Figs 18-20) ([0166-0207]); and
the single-session hypoxia-burden score is created from at least one of the group consisting of i) a sum of all area under the curve of inter-beat interval (IBI) over the time periods of the sleep session, divided by a length of the sleep session, ii) a mean value across all minimum IBI values of the sleep session, iii) a sum of all area under the curve of skin temperature over the time periods of the sleep session, divided by the length of the sleep session, and iv) a mean value across all minimum skin temperature values of the sleep session (Figs 18-20) ([0166-0207]).
For claim 4, Siyahjani discloses the system of claim 3, wherein: the computing system is further configured to generate a long-run hypoxia burden score for the user from a plurality of single-session hypoxia-burden scores (Figs 18-20) ([0166-0207]); and the long-run hypoxia burden score comprises at least one of the group consisting of i) a time-series of single-session hypoxia-burden scores, and ii) a trend equation of single-session hypoxia-burden scores (Figs 18-20) ([0166-0207]).
For claim 5, Siyahjani discloses the system of claim 1, wherein: the pressure sensor senses air pressure in a fluid bladder (114A,114B) of the bed the force sensor senses force transmitted through a rigid frame of the bed (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]).
For claim 6, Siyahjani discloses the system of claim 1, wherein: the respiratory-events are apnea-hypoxia events (Figs 18-20) ([0166-0207]); and the computer system is further configured to determine the occurrences of the one or more respiratory-events by submitting, to a machine-learning classifier (2010) (Figs 18-20) ([0166-0207]), input from the pressure stream and receive, as output, the determined occurrences of the one or more respiratory-events (Figs 18-20) ([0166-0207]).
For claim 7, Siyahjani discloses the system of claim 1, wherein: the plurality of event-metrics comprises a measure of skin temperature of the user (via another different one of 902, 904, 906, or 908) ([0042, 0124]) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]); and the computer system is further configured to determine the skin temperature of the user by determining a weighted average of various sensor readings of a temperature stream received from a temperature sensor (Figs 18-20) ([0166-0207]).
For claim 8, Siyahjani discloses the system of claim 1, wherein: the plurality of event-metrics comprises a measure of cardiac action of the user (2014); and the computer system is further configured to determine cardiac action of the user by filtering, at a first frequency, at least one of the group consisting of i) the pressure stream and ii) the force stream (Figs 18-20) ([0166-0207]).
For claim 9, Siyahjani discloses the system of claim 8, wherein: the plurality of event-metrics comprises a measure of respiratory action of the user (2014); and the computer system is further configured to determine cardiac action of the user by filtering, at a first frequency, at least one of the group consisting of i) the pressure stream and ii) the force stream (Figs 18-20) ([0166-0207]).
For claim 10, Siyahjani discloses a system (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]), comprising inter alia:
a bed (100) having a mattress (112) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
at least one pressure sensor (one of 902, 904, 906, or 908) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]) configured to:
sense pressure applied to the bed by a user on the bed (one of 902, 904, 906, or 908) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]); and
transmit, to a computing system (1800) (one of 902, 904, 906, or 908) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]), a pressure stream from the sensing of the pressure applied to the bed (one of 902, 904, 906, or 908) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
at least one force sensor (a different one of 902, 904, 906, or 908) ([0042, 0124]) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]) configured to:
sense force applied to the bed by the user (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]); and
transmit, to the computing system, a force stream from the sensing of the force applied to the bed (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
the computing system comprising at least one processor (1802) and memory (1804) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]), the computing system configured to:
receive the pressure stream (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
receive the force stream (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]);
identify one or more sleep stages within multiple sleep sessions for the user sleeping on the bed using at least one of the group consisting of i) the pressure stream, and ii) the force stream (Figs 18-20) ([0166-0207]);
for each of the sleep stages, determine occurrences of one or more respiratory-events (Figs 18-20) ([0166-0207]);
for each of the respiratory-events, determine a plurality of event-metrics using the pressure stream and the force stream (Figs 18-20) ([0166-0207]);
for each of the sleep stages, determine a single-stage hypoxia-burden score using the plurality of event-metrics for respiratory-events of the sleep session (Figs 18-20) ([0166-0207]); and
generate a long-run hypoxia burden score for the user from the single-stage hypoxia-burden scores (Figs 18-20) ([0166-0207]).
For claim 11, Siyahjani discloses the system of claim 10, wherein:
the plurality of event-metrics for a respiratory-event comprises at least one of the group consisting of i) an area under a curve of inter-beat interval (IBI) over a time period after the respiratory-event, ii) a minimum (IBI) value during the time period, iii) an area under a curve of skin temperature over the time period, and iv) a minimum skin temperature value during the time period (Figs 18-20) ([0166-0207]); and
the single-stage hypoxia-burden score is created from at least one of the group consisting of i) a sum of all area under the curve of inter-beat interval (IBI) over the time periods of the sleep session, divided by a length of the sleep session, ii) a mean value across all minimum IBI values of the sleep session, iii) a sum of all area under the curve of skin temperature over the time periods of the sleep session, divided by the length of the sleep session, and iv) a mean value across all minimum skin temperature values of the sleep session (Figs 18-20) ([0166-0207]).
For claim 12, Siyahjani discloses the system of claim 11, wherein: the long-run hypoxia burden score comprises at least one of the group consisting of i) a time-series of single-stage hypoxia-burden scores, and ii) a trend equation of single-stage hypoxia-burden scores (Figs 18-20) ([0166-0207]).
For claim 13, Siyahjani discloses the system of claim 10, wherein: the pressure sensor senses air pressure in a fluid bladder (114A,144B) of the bed the force sensor senses force transmitted through a rigid frame of the bed (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]).
For claim 14, Siyahjani discloses the system of claim 10, wherein: the respiratory-events are apnea-hypoxia events (Figs 18-20) ([0166-0207]); and the computer system is further configured to determine the occurrences of the one or more respiratory-events by submitting, to a machine-learning classifier (2010) (Figs 18-20) ([0166-0207]), input from the pressure stream and receive, as output, the determined occurrences of the one or more respiratory-events (Figs 18-20) ([0166-0207]).
For claim 15, Siyahjani discloses the system of claim 10, wherein: the plurality of event-metrics comprises a measure of skin temperature of the user (via another different one of 902, 904, 906, or 908) ([0042, 0124]) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]); and the computer system is further configured to determine the skin temperature of the user by determining a weighted average of various sensor readings of a temperature stream received from a temperature sensor (Figs 18-20) ([0166-0207]).
For claim 16, Siyahjani discloses the system of claim 10, wherein: the plurality of event-metrics comprises a measure of cardiac action (2014) of the user (Figs 18-20) ([0166-0207]); and the computer system is further configured to determine cardiac action of the user by filtering, at a first frequency, at least one of the group consisting of i) the pressure stream and ii) the force stream (Figs 18-20) ([0166-0207]).
For claim 17, Siyahjani discloses the system of claim 16, wherein: the plurality of event-metrics comprises a measure of respiratory action (2014) of the user (Figs 18-20) ([0166-0207]); and the computer system is further configured to determine cardiac action of the user by filtering, at a first frequency, at least one of the group consisting of i) the pressure stream and ii) the force stream (Figs 18-20) ([0166-0207]).
For claim 18, Siyahjani discloses a computing system (Figs 18-20) ([0166-0207]), comprising inter alia:
at least one processor (1802) and memory (1804), the computing system configured to:
receive sleep-data for a user’s physiological activities while sleeping (Figs 18-20) ([0166-0207]);
identify one or more sleep sessions for the user from the sleep-data; for each of the sleep sessions, determine occurrences of one or more respiratory-events (Figs 18-20) ([0166-0207]);
for each of the respiratory-events, determine a plurality of event-metrics using the sleep-data (Figs 18-20) ([0166-0207]); and
for each of the sleep sessions, determine a single-session hypoxia-burden score using the plurality of event-metrics for respiratory-events of the sleep session (Figs 18-20) ([0166-0207]).
For claim 19, Siyahjani discloses the computing system of claim 18, and further comprising means for sensing pressure (one of 902, 904, 906, or 908) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]) applied to a bed by a user on the bed and means for sensing force (a different one of 902, 904, 906, or 908) ([0042, 0124]) (Figs 1-3, 9 & 18-20) ([0027-0050, 0122-0124 & 0166-0207]) applied to the bed by the user.
For claim 20, Siyahjani discloses the computing system of claim 18, wherein the computing system is further configured to generate a long-run hypoxia burden score for the user from a plurality of single-session hypoxia-burden scores from a plurality of the sleep sessions (Figs 18-20) ([0166-0207]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for determining/computing respiratory events, cardiac events, and hypoxia from bed/mattress based pressure, temperature, and force measurements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II 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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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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