DETAILED ACTION
Applicant' s arguments, filed 01/07/2026 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 03/20/2023, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 21-37 are the current claims hereby under examination.
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 .
Claim Objections
Claims 21-23, 27, 29, 34, and 37 are objected to because of the following informalities:
Claim 21 line 1 it appears that “a control unit” should read “at least one control unit” to clearly indicate that there may be more than one control unit as indicated later in the claim.
Claim 22 line 3 it appears that “at least one threshold” should read “at least one predefined threshold”
Claim 23 line 3-5 it appears that each reference to “selected movement/cardiac/respiration signals” should read “the selected movement/cardiac/respiration signals”
Claim 27 lines 6-7 it appears that “a sleeping phase or waking phase” should read “the sleeping phase or the waking phase”
Claims 29 and 34 it appears that each recitation of “sleeping phase” and “waking phase” should read “the sleeping phase” and “the waking phase”
Claim 37 lines 6 and 8 it appears that “parameter parameter” should recite “parameter”
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A control unit of claim 21 line 1 and line 15
At least one monitoring unit of claim 21 line 7
One or more classification units of claim 21 line 10
One or more extraction units of claim 23 lines 1-2
Each of these limitations are being interpreted as comprising the corresponding structure or algorithm described in the specification and its equivalents. The interpretation of each element is as follows:
A control unit of claim 21 line 1 and line 15 is interpreted as the particular structure of algorithm for performing the recited functions. The control unit is recited as activating one of the classification units based on results of the monitoring unit. The control unit is described in purely functional language in paragraphs 0005, 0021, 0034, 0074, 0105-0106, 0116, 0144, and 0166 as some type of structure or algorithm which coordinates the other components of the system. The control unit does not appear defined as a particular structure or a particular algorithm by the specification.
Examiner’s Note: it would seem that the control unit is not described as having a particular structure associated with the unit, such as a processor, nor is it described as a particular series of method steps, and thus the limitation will continue to lack sufficient support under 35 USC 112(f) interpretation. However, the functionality of the control unit is capable of being performed by an off-the-shelf processor. As such, an amendment to the claim to recite “a controller for” and/or “at least one controller for” would provide the element with sufficient structure to avoid interpretation under 35 USC 112(f) and would still be considered to be supported by the specification.
At least one monitoring unit of claim 21 line 7 is interpreted as the particular algorithm for carrying out the claimed function and its equivalents. Paragraphs 0091, and 0096-0098 describe the monitoring unit as an algorithm for comparing the input signals to a threshold to determine presence and/or quality. However the specification does not appear to describe the particular steps taken to carry out the comparison. In particular, the specification does not appear to describe what type of threshold the input signals are being compared to. For example, the movement signal inputs acceleration measurements in three axial directions as described by paragraph 0063. The specification does not describe if the threshold comparison is a maximum amplitude threshold, minimum amplitude threshold, range threshold, or if the threshold is a particular acceleration curve shape and any acceleration signal not matching that shape does not pass the threshold. The particular features of the signal being compared to the threshold have not been described not has the threshold itself been described. The features provided in paragraphs 0124-0127 do not have an associated method of determining them, nor is the particular threshold to compare them to described. Paragraphs 0134-0135 provide further statements of functionality that the determined features can be used to determine signal quality but fail to describe the specific method for determining the signal quality. Similarly, the particular metric or measurement being compared to the threshold for the other two inputs is not explicitly disclosed.
One or more classification units of claim 21 line 10 is interpreted as the particular algorithm used to determine a sleep or awake state of the patient. Paragraphs 0101-0105 and 0151-0153 describe that the classification units may classify the raw values or determine statistical values from the extracted signals and compared the statistical values to a threshold to determine if an epoch should be classified as sleep/wake. However these paragraphs do not recite the particular steps taken to make the comparison nor do they describe which values must fall below the threshold and which above to make a particular determination. Paragraph 0152 recites “A sleeping phase 110 can be assigned to a time period 113 if the analyzed values (signals 2, 5, 8 and/or features 3, 6, 9) are above the limiting value 42. Conversely, a waking phase 111 can be assigned to a time period 113 if the analyzed values (signals 2, 5, 8 and/or features 3, 6, 9) are below the limiting value 42 and vice versa” which indicates that the sleeping or waking phase may be assigned regardless of if the signals or features fall above or below the threshold. The specification does not set forth specific requirements for the threshold comparisons to produce the recited phase determination. Rather the threshold comparison is described in purely function language that indicates that a large variety of signal features and the signals themselves can be compared to some threshold and a determination of a sleeping/waking phase is output based on if the value is above or below the threshold. No particular relationships have been provided to serve as exemplary threshold comparisons nor does the specification appear to describe how the threshold and resultant output is adapted based on the particular signal and/or feature being utilized. Thus it would seem that the particular algorithm used to carry out the sleep/wake phase determination is not fully disclosed.
One or more extraction units of claim 23 lines 1-2 is interpreted as the particular algorithm used to determine features from each of the input values. Paragraphs 0107-0117 and 0125-0127 describe the extraction unit extracts at least one of a plurality of features from the input signals. While paragraphs 0125-0127 list a plurality of features which may be extracted, the specification does not appear to recite how each of these features are extracted from the measurement signals. Thus the specification does not appear to disclose the particular algorithm of the extraction unit which produces the recited features.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 21-37 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 claim limitations “a control unit”, “at least one monitoring unit”, and “at least one classification unit” of claim 21 and “one or more extraction units” of claim 23 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. In particular the specification does not appear to describe the particular structure, algorithm, or steps taken by each of these units to accomplish their recited function as described in the above claim interpretation section, Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 21 recites “at least one classification unit, which is configured to determine at least a sleeping phase and/or a waking phase on the basis of a determination and assessment by the at least one monitoring unit of the presence and quality of the …” which reads as though the presence or quality of the various signals is “the basis” to determine the sleeping or waking phase. It is unclear how such a determination is carried out on the basis of only an indication of presence and an indication of a signal quality. It is unclear how an indication of presence and quality is being utilized to determine a sleeping or waking phase. For the purposes of this examination, any method of determining sleeping and waking phases will be considered analogous. It is noted that claim 37 is not rejected on the basis provided above because claim 37 indicates that the determination is carried out using the acquired signals on the basis of their presence and quality which clearly indicates that the acquired signals themselves are used for the determination rather than their respective indications of their presence and quality.
Claims 22-37 are rejected by virtue of their dependence on claim 21.
Claim 23 recites “selected movement, cardiac, and/or respiration signals from the at least one monitoring unit” but the monitoring unit has been described as determining a presence and a quality of each of the input signals. No recitation of performing a selection of the signals has been established for the monitoring unit. It is unclear what the “selected” signals are meant to refer to. For the purposes of this examination, the limitation will be interpreted as the monitoring unit selecting signals that are both present and have sufficient quality according to some metric.
Claim 27 recites “wherein the at least one classification unit is configured to receive movement, cardiac and/or respiration signals from the at least one monitoring unit and/or movement, cardiac and/or respiration features from the one or more extraction units, the at least one classification unit being configured to statistically evaluate the movement, cardiac and/or respiration signals and/or the movement, cardiac and/or respiration features on the basis of at least one statistical key figure to determine if a sleeping phase or waking phase is present.” but it is unclear what relationship is meant to be conveyed by the statistical evaluation being performed “on the basis of at least one statistical key figure”. It is unclear what a “statistical key figure” comprises and how it is utilized in the statistical evaluations. For the purposes of this examination, the “statistical key figure” is interpreted as the statistical metric being determined and the statistical evaluation is interpreted as the process of determining the metric .
Claim 34 recites “wherein the system is configured and designed to assign a sleeping phase and/or a waking phase” in lines 1-2 and lines 4-5 but it is unclear if this limitation is the same as, related to, different from, or has some other relationship to “at least one classification unit which is configured to determine a t least a sleeping phase and/or a waking phase” of claim 21. In particular, it is unclear if the system and classification unit are the same or if one is a component of the other. It is unclear if the assigning of a phase is different from the determination of a phase. It is finally unclear if the respective sleeping and waking phases are referring to the same phases. For the purposes of this examination the limiting will be interpreted as further limiting the classification unit to determining the phase on the basis of one or more of the signals and/or features.
Claim 34 recites “at least one time period” but it is unclear if the time period is the same as, related to, different from, or a subset of “at least one time span” of claim 21. For the purposes of this examination, the time period is interpreted to be the same limitation as the time span.
Claim 35 recites “an analysis of different movement, cardiac and/or respiration features is weighted differently, for which purpose at least one weighting value is stored and retrievable in the at least one classification unit” but it is unclear what “analysis” is being referred to and how it relates to the claimed system. For the purposes of this examination, the limitation will be interpreted as the classification units being capable of determining the phase based on the extracted features and that each of the features considered by a respective classification unit may be weighted differently for determining the phase.
Claim 36 recites “wherein the system is configured to determine …” but it is unclear what element of the system is carrying out the recited determination. For the purposes of this examination, the limitation will be interpreted as the classification unit carrying out the determination.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21, 24-27, 29, and 34-37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claim limitations “a control unit”, “at least one monitoring unit”, and “at least one classification unit” of claim 21 and “one or more extraction units” of claim 23 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. In particular the specification does not appear to describe the particular algorithm or steps taken by each of these units to accomplish their recited function as described in the above claim interpretation section. Therefore, there is insufficient written description support for each of these elements.
Claim 21 recites “at least one first sensor configured for acquiring at least one movement signal, at least one second sensor configured for acquiring at least one cardiac signal, at least one third sensor configured for acquiring at least one respiration signal” however the specification does not provide sufficient support for the claimed genus of sensors and their collected signals. In particular the specification provides only a single example sensor for each of the categories in paragraphs 0036-0038. The specification further describes the invention only with respect to each of the single disclosed sensor types such as in paragraphs 0064-0067 in reference to the PPG sensor, paragraphs 0068-0070 in reference to the flow sensor, and paragraphs 0062-0063 in reference to the actigraphy sensor. The single disclosed sensor for each of the claimed genus of sensor types is not considered to be sufficient as each of the claimed genus of sensor types encompasses a wide variety of different sensor types having different mounting, attachment, and/or insertion requirements and also includes a vast array of possible detected signals. This rejection is similarly applied to claim 37.
Claim 21 recites “determine a presence and assess a quality of the acquired at least one movement signal and/or the acquired at least one cardiac signal and/or the acquired at least one respiration signal” but the specification does not support any method of determining the presence and assessing a quality of a signal. In particular, paragraphs 0072, 0091-0098 describe that the quality of a signal is determined but do not provide the particular algorithm or method steps required to determine the signal quality. The specification provides several examples of events that may cause unacceptable quality in the signals in paragraphs 0092-0095 but does not describe how such events are detected or how the system processes the incoming data to detect these events or others that lead to unacceptable quality. Paragraphs 0096-0098 describe that the quality determination is a threshold comparison but do not describe what particular inputs are being compared to the threshold. The specification further recites that acceptable quality may be above or below the threshold but does not provide a description of when it is acceptable to be above and when it is acceptable to be below. The quality determination algorithm is a “black box” which receives a wide variety of possible signal types, makes an undefined comparison to a threshold, and outputs that a signal is of acceptable quality. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. This rejection is further applied to the similar recitations of claim 37.
Claim 21 recites “at least one classification unit which is configured to determine at least a sleeping phase and/or a waking phase on the basis of the determination and assessment by the at least one monitoring unit of the presence and quality of the at least one movement signal and/or the at least one cardiac signal and/or the at least one respiration signal” but the specification does not appear to support the sleep/wake phase determination being based upon the determination of quality/presence of a signal. In particular paragraphs 0101-0105 and 0151-0153 describe the classification units in purely functional language and recite that they may classify the raw values or determine statistical values from the extracted signals and compared the statistical values to a threshold to determine if an epoch should be classified as sleep/wake. Paragraphs 0154-0157 further recite that the recognition of a sleeping or waking phase may be performed by “a machine learning algorithm”. The specification does not describe the particular process required to transform the input signals into the output classifications nor does the specification describe the particular structure or training methods of the classification units or the machine learning algorithm. Applicant described the machine learning algorithm, as a “black box” in paragraphs 0158-0159. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. The written description requirement is not satisfied by merely outlining the goals or results one hopes to achieve with the invention. See MPEP 2163(II)(A)(3)(a). The specification does not appear to describe how the classification algorithm determines sleeping/waking phases based on the input signals, nor does it appear to describe how the sleeping/waking phases are determined “on the basis of the determination and assessment” of signals presence and quality. This rejection is further applied to the recitations drawn towards the classification unit determining a sleep or waking phase of claims 27, 29, 34 (as interpreted as presented in the 35 USC 112(b) rejections above), and 37.
Claim 24 recites “wherein the at least one determined movement feature is selected from activity count, zero crossing count, median, standard deviation, acceleration minima, acceleration maxima” but the specification does not appear to describe how an activity count is determined. The features “zero crossing count, median, standard deviation, acceleration minima, acceleration maxima” are each considered well known in the art and thus a corresponding method of their determination is not required. However the feature of “activity count” is not considered a well-known and well defined feature as what qualifies as an “activity” is not clearly defined. The specification does not particularly describe what data patterns or values constitute an “activity” and thus the specification does not appear to support the determination of an activity count despite such a feature being listed in paragraphs 0012 and 0126.
Claim 25 recites “wherein the at least one determined cardiac feature is selected from heart rate, heartbeat interval, heart rate variability, pulse rate, pulse wave, spectral power density, oxygen saturation (SpO2 or SaO2), plethysmograph, increase angle of pulse waves, decrease angle of pulse waves, ratios of increase to decrease angles of pulse waves, durations of pulse wave increases, durations of pulse wave decreases, ratios of increase to decrease durations, pulse wave maxima, pulse wave minima, PTT (pulse transit time), CWF (continuous wave fluctuation).” But the specification does not appear to describe how the features of SaO2, increase angle of pulse waves, decrease angle of pulse waves, ratios of increase to decrease angles of pulse waves, PTT (pulse transit time), or CWF (continuous wave fluctuation) are calculated or describe what types of sensors may be required to capture such features. In particular the specification references the use of a PPG sensor (paragraphs 0066-0067) which may provide a variety of cardiac features but typical PPG sensors do not provide features such as SaO2, increase angle of pulse waves, decrease angle of pulse waves, ratios of increase to decrease angles of pulse waves, PTT (pulse transit time), or CWF (continuous wave fluctuation) each of these features are not considered to be well known and well defined features of a PPG signal and the specification does not appear to explicitly recite how each are calculated from a single PPG signal seemingly arranged on a finger as described in paragraphs 0065-0067. Additionally, the features SAO2 is typically received from an invasive sensor placed in the user’s arteries. The specification does not describe the presence of such a sensor nor contemplate the use of invasive sensors to acquire physiological features.
Claim 26 recites “wherein the at least one determined respiration feature is selected from respiration frequency, peak flow, respiratory gas volume per breath, respiratory gas flow, contour of a respiratory gas flow curve, inspirational or expirational tidal volume, inspiration duration, expiration duration, ratio of inspiration to expiration duration, respiratory minute volume” but the specification does not appear to recite how to determine the features of “contour of the respiratory gas flow curve” which is not considered to be well known and well defined features obtained from a flow sensor. In particular the specification does not describe the generation of such a curve and does not recite what particular points or shapes are indicative of its “contour” for use as a feature on the classification algorithms
Claim 35 recites “an analysis of different movement, cardiac and/or respiration features is weighted differently, for which purpose at least one weighting value is stored and retrievable in the at least one classification unit” but the specification does not describe how the weights may be assigned or what the analysis that the weights are being applied to entails. This limitation is described in purely functional language in paragraphs 0033, 0039, 0153-0154, and 0158-0160. The analysis itself is described as a “black box” in paragraph 0159 to which the weights, which may be different for each received signal and extracted feature, are applied. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement.
Claim 36 recites “wherein the system is configured to determine a sleep quality based on a number of sleeping phases and/or the number of waking phases” but the specification does not describe the method steps taken or algorithm used to determine such a metrics. The particular steps taken to transform the input data into the output is not disclosed. Paragraphs 0086-0088 recite this limitation in purely functional language and do not describe how the output is determined. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement.
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 21-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 21-37 are directed to a method of processing sensor signals using a computational algorithm, which is an abstract idea. Claims 21-37 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 21 is as follows:
Step 1: Claim 21 is drawn to a machine.
Step 2A – Prong One: Claim 21 recites an abstract idea. In particular, claim 21 recites the following limitations:
[A1] determine a presence and assess a quality of the acquired at least one movement signal and/or the acquired at least one cardiac signal and/or the acquired at least one respiration signal
[B1] determine at least a sleeping phase and/or a waking phase on the basis of the determination and assessment of the presence and quality of the at least one movement signal and/or the at least one cardiac signal and/or the at least one respiration signal
These elements [A1]-[B1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] a control unit
[B2] at least one first sensor configured for acquiring at least one movement signal
[C2] at least one second sensor configured for acquiring at least one cardiac signal
[D2] at least one third sensor configured for acquiring at least one respiration signal
[E2] at least one monitoring unit
[F2] one or more classification units comprising three classification subunits
These elements [A2]-[F2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [B2]-[D2] are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements [A2] and [E2]-[F2] are merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Additionally, the element [F2] is nothing more than the computer implementation/automation of an abstract mental process of screening a patient, which is what a physician typically does with a patient in a diagnostic setting.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations “at least one first/second/third sensor configured for acquiring at least one movement/cardiac/respiration signal” are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements or simply displaying the results of the algorithm that uses conventional, routine, and well known elements. In particular, the data acquirer is nothing more than an actigraphy sensor or accelerometer, a PPG or pulse oximeter, and a flow sensor. Such sensors are conventional as evidenced by the lack of a particular description for any of the above sensors in Applicant’s specification and further evidenced by at least:
U.S. Patent Application Publication No. US 2019/0000375 A1 (Philips) discloses that body movements are conventionally recorded with an accelerometer implemented onto an actigraphy device (paragraph 0041 of Philips);
U.S. Patent Application Publication No. US 2017/0099711 A1 (Polley) discloses that conventional PPG sensors include the well-known pulse oximeter (paragraph 0005-0006 of Polley);
U.S. Patent No. US 5477861 A (Pullen) discloses that flow transducers are conventional (Col 1 lines 45-59 of Pullen); and
Further, the element [A2] does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Additionally, the elements [E2]-[F2] are merely the computer implementation/automation of an abstract mental process of performing the recited determinations. Furthermore, the recitation “the at least one control unit being configured to activate one of the three classification subunits in each case based on results of the at least one monitoring unit in dependence on the presence and the quality of the movement, cardiac and/or respiration signal” is nothing more than a computer adaptation of a human mind’s decision making capability and adaptability to make decisions based on available information.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 22-36 depend from claim 21, and recite the same abstract idea as claim 21. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 22: a memory
Claim 23: one or more extraction units ;
Each of these claim limitations does not integrate the exception into a practical application. In particular, the element of claim 22 is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). The element of claim 23 are merely the computer implementation/automation of an abstract mental process of performing the recited determinations.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claim 37 recites only limitations already addressed in the above rejection of claim 21 and is thus rejected on the same basis as claim 21.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 21, and 23-37 are rejected under 35 U.S.C. 103 as being unpatentable over Fox US Patent Application Publication Number US 2023/0099622 A1 hereinafter Fox in view of Ferreira US Patent Application Publication Number US 2019/0183414 A1 hereinafter Ferreira.
Regarding claim 21, Fox discloses a system having a control unit for determining at least one sleeping phase and/or at least one waking phase of a subject for at least one time span (Abstract), wherein the system comprises
- at least one first sensor configured for acquiring at least one movement signal (Fig. 1 reference 138; Paragraphs 0115, 0129 and 0132: actigraphy sensors and/or accelerometers for capturing body motion),
- at least one second sensor configured for acquiring at least one cardiac signal (Fig. 1 reference 154; Paragraphs 0074 and 0105 the PPG, blood flow, oximetry, and pulse sensor sensor),
- at least one third sensor configured for acquiring at least one respiration signal (Fig. 1 reference 134; Paragraphs 0089-0090: the respiratory flow rate sensor),
- at least one monitoring unit, which is configured to determine a presence and assess a quality of the acquired at least one movement signal and/or the acquired at least one cardiac signal and/or the acquired at least one respiration signal (Paragraphs 0023 and 0027: metrics are selected for consideration based on their quality; 0161-0162: the system determines the quality of data provided by each modality),
- at least one classification unit which is configured to determine at least a sleeping phase and/or a waking phase on the basis of the determination and assessment by the at least one monitoring unit of the presence and quality of the at least one movement signal and/or the at least one cardiac signal and/or the at least one respiration signal (Paragraphs 0157-0159: the classifier receives a plurality of parameters and/or raw values and classifies them into sleep state; Paragraphs 0023, 0027, and 0161-0162 describe how a quality metric may be used to select which parameters are input into the classifier and thus the determination of the sleeping stage is based on the quality assessment),
Fox is further considered to at least suggest the system wherein the at least one classification unit comprises three classification subunits, the at least one control unit being configured to activate one of the three classification subunits in each case based on results of the at least one monitoring unit in dependence on the presence and the quality of the movement, cardiac and/or respiration signal, wherein a first classification subunit is activated if all of movement, cardiac and respiration signals are present in satisfactory quality, wherein a second classification subunit is activated if only movement and cardiac signals are present in satisfactory quality, and wherein a third classification subunit is activated if only movement signals are present in satisfactory quality, the system being dynamic, with the control unit activating the three classification subunits once or multiple times during the at least one time span as a function of the presence and quality of the movement, cardiac and/or respiration signals.
These limitations are suggested in at least paragraphs 0023, 0027, and 0159-0163 where Fox describes how the classifier receives either raw data or feature data from a plurality of modalities. The classifier then determines a quality signal with respect to each modality and selects a subset of the modalities with the best quality signals for further processing. Conflicts between modalities may further be resolved on the basis of signal quality. Thus, paragraphs 0159-0163 describe how the classifier of Fox is adaptable to receive any single signal or any combination of the plurality of measurement modalities as illustrated in Figs. 4-7 and selects a subset of those modalities based on their signal quality. Thus it would seem that the classifier of Fox comprises a plurality of “subunits” which correspond to each possible combination of selected inputs and the particular subunit utilized for a given epoch depends on the selection of which input modality is to be utilized. The selection is based on signal quality in each individual epoch as described in paragraphs 0159-0163 For example, paragraph 0161 provides the example of receiving flow data and determining that the sleep status cannot be determined based on a satisfaction threshold. The system then combines the flow data with a second and/or third modality which may be cardiac activity and/or movement of the user. Thus the classifier must have various “subunits” to adapt to the different combinations of inputs in order to satisfy the threshold determination metric. Paragraphs 0159-0163 at least suggest the presence of a plurality of subunits within the classifier wherein each subunit corresponds to a given combination of input parameters. The subunits are “activated” on a basis of the selection of the input data based on their quality for each epoch. The classifier is thus considered to at least suggest the inclusion of subunits including a “first” subunit for processing respiration (flow), cardiac, and movement data, a “second” subunit for processing movement and cardiac data, and a “third” subunit for processing only movement data. As well as a subunit for each other possible combination of the input types. The system of Fox further at least suggests their activation one or more times during a time span since the classifier is applied to each epoch (Paragraph 0158) and the subsequent data selection (Paragraphs 0159-0162) appears to be performed for each epoch. The capability of Fox to process different combinations of input data for each epoch is considered sufficient to at least suggest the presence of various “subunits” within the classifier which are each associated with a given combination of the input data and thus are “activated” by the system one or more times during a time span in response to their associated combination of data being selected.
Ferreira teaches a determination system, a corresponding determination method and a computer program for determining a sleep stage of a subject (Abstract). Thus, Ferreira falls within the same field of endeavor as Applicant’s invention.
Ferreira teaches a classifier for determining sleep stages with different subunits for different data input types. The different subunits allows the classifier to be optimized for the particular data type being provided (Paragraphs 0043-0044 and 0049).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the classifier of Fox with a plurality of classification subunits which are each optimized for the particular data being input into the classifier as taught by Ferreira because Ferreira teaches that having multiple classification subunits which are each trained on their respective data types allows the classification subunits to be optimized for their particular use case (Ferreira: Paragraph 0049).
Regarding claim 23 Fox in view of Ferreira teaches the system of claim 21. Fox further teaches the system wherein the system further comprises one or more extraction units, which are configured to receive selected movement, cardiac and/or respiration signals from the at least one monitoring unit and to determine from selected movement signals at least one movement feature and/or from selected cardiac signals at least one cardiac feature and/or from selected respiration signals at least one respiration feature (Paragraphs 0126-0128 and 0159: the statistical features).
Regarding claim 24 Fox in view of Ferreira teaches the system of claim 23. Fox further teaches the system wherein the at least one determined movement feature is selected from activity count, zero crossing count, median, standard deviation, acceleration minima, acceleration maxima (Paragraphs 0115: the motion signals may come from accelerometers; Paragraph 0159-0160: peak values may be extracted as a feature, zero-crossing may be used.; Paragraph 0127: activity count).
Regarding claim 25 Fox in view of Ferreira teaches the system of claim 23. Fox further teaches the system wherein the at least one determined cardiac feature is selected from heart rate, heartbeat interval, heart rate variability, pulse wave, spectral power density, oxygen saturation (SpO2 or SaO2), plethysmograph, increase angle of pulse waves, decrease angle of pulse waves, ratios of increase to decrease of angles of pulse waves, durations of pulse wave increases, durations of pulse wave decreases, ratios of increase to decrease durations, pulse wave maxima, pulse wave minima, PTT (pulse transit time), CWF (continuous wave fluctuation) (Paragraphs 0079-0080: heart rate and heart rate variability, SpO2; Paragraph 0159: peak values, signal variance, and spectral components may be extracted from the heart rate/PPG signal; Paragraph 0105: the pulse, oximetry, blood flow, sphygmomanometer sensor(s)).
Regarding claim 26 Fox in view of Ferreira teaches the system of claim 23. Fox further teaches the system, wherein the at least one determined respiration feature is selected from respiration frequency, peak flow, respiratory gas volume per breath, respiratory gas flow, contour of a respiratory gas flow curve, inspirational or expirational tidal volume, inspiration duration, expiration duration, ratio of inspiration to expiration duration, respiratory minute volume (Paragraph 0159: peak values and signal variance may be calculated from the flow values; Paragraph 0165: respiration rate and tidal volume may be determined from the flow signal).
Regarding claim 27 Fox in view of Ferreira teaches the system of claim 23. Fox further teaches the system, wherein the at least one classification unit is configured to receive movement, cardiac and/or respiration signals from the at least one monitoring unit and/or movement, cardiac and/or respiration features from the one or more extraction units, the at least one classification unit being configured to statistically evaluate the movement, cardiac and/or respiration signals and/or the movement, cardiac and/or respiration features on the basis of at least one statistical key figure to determine if a sleeping phase or waking phase is present (Paragraph 0128: the input features may be combined to produce a discriminant value. The combination may be done in a linear fashion such as a linear weighted combination. Linear weighted combination is considered a statistical evaluation to generate a statistical key feature of the discriminant value; Paragraphs 0131 and 0137: movement signals may be analyzed to determine frequency, amplitude, and other patterns to determine sleep; Paragraphs 0145-0146: the cardiac input can be evaluated to determine heart rate variability; Paragraph 0158-0159: signal variance and peak values may be extracted as features which may be extracted prior to feeding the data to the classifier. The classifier uses the extracted features).
Regarding claim 28 Fox in view of Ferreira teaches the system of claim 27. Fox further teaches the system, wherein the statistical key figure is selected from minimum, maximum, mean value, median, standard deviation, variance, span, distribution, sum, difference (Paragraphs 0131 and 0137: movement signals may be analyzed to determine frequency, amplitude, and other patterns to determine sleep; Paragraph 0158-0159: signal variance and peak values may be extracted as features).
Regarding claim 29 Fox in view of Ferreira teaches the system of claim 23. Fox further suggests the system, wherein the first classification subunit is configured to receive movement features and cardiac features and respiration features and to determine sleeping phases and/or waking phases from the movement features and the cardiac features and the respiration features and/or wherein the second classification subunit is configured to receive movement features and cardiac features and to determine sleeping phases and/or waking phases from the movement features and the cardiac features, and/or wherein the third classification subunit is configured to receive movement features and to determine sleeping phases and/or waking phases from the movement features (Paragraphs 0023, 0027, and 0159-0163: the classifier may receive various combinations of the data types as described in the rejection of claim 21 above).
Ferreira teaches a classifier for determining sleep stages with different subunits for different data input types. The different subunits allows the classifier to be optimized for the particular data type being provided (Paragraphs 0043-0044 and 0049).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to configure the classifier of Fox with a plurality of classification subunits which are each optimized for the particular data being input into the classifier as taught by Ferreira because Ferreira teaches that having multiple classification subunits which are each trained on their respective data types allows the classification subunits to be optimized for their particular use case (Ferreira: Paragraph 0049).
Regarding claims 30-33 Fox in view of Ferreira teaches the system of claim 21. Fox further teaches the system wherein the at least one time span is predeterminable; wherein the at least one time span is at least 10 minutes; wherein the at least one time span corresponds to a duration of a night's sleep; or wherein the at least one time span is divided into one or more time periods which are at least 10 seconds long. (Paragraph 0081-0082: the “time span” of measurement is a sleep session, or duration of a night’s sleep; Paragraphs 0159: the duration of the measurement, or time span, is divided into epochs).
The particular duration of the recording time span and the epochs into which it is divided is considered a matter of routine optimization and experimentation. The particular time span and duration of epochs is an optimizable parameter to adjust the use of the system to a particular duration of use and to adjust the epoch duration to identify periods of sleep of waking based on the duration of the desired parameters. Various parameters of interest occur over different time periods so one of ordinary skill in the art would recognize that the duration of epochs is optimizable based on the parameters chosen to monitor. The particular time spans and epoch durations do not produce a surprising technical affect and are thus considered to be obvious in view of the teachings of Fox.
Regarding claim 34 Fox in view of Ferreira teaches the system of claim 23. Fox further teaches the system, wherein the system is configured and designed to assign a sleeping phase and/or a waking phase to at least one time period on the basis of the at least one movement signal and/or the at least one cardiac signal and/or the at least one respiration signal and/or wherein the system is configured and designed to assign a sleeping phase and/or a waking phase to at least one time period on the basis of the at least one movement feature and/or the at least one cardiac feature and/or the at least one respiration feature (Paragraphs 0157-0159: the classifier receives a plurality of parameters and/or raw values and classifies them into sleep state).
Regarding claim 35 Fox in view of Ferreira teaches the system of claim 23. Fox further teaches the system, wherein an analysis of different movement, cardiac and/or respiration features is weighted differently, for which purpose at least one weighting value is stored and retrievable in the at least one classification unit (Paragraphs 0128 and 0162: the various input parameters may be weighted differently based on their signal quality. This teaching is considered to at least suggest that the various weighting values for a given signal quality are stored and retrievable).
Regarding claim 36 Fox in view of Ferreira teaches the system of claim 21. Fox further teaches the system wherein the system is configured to determine a sleep quality based on a number of sleeping phases and/or a number of waking phases (Paragraphs 0081-0084: the system creates a sleep-wake signal which illustrates the number and duration of sleep and wake phases and may determine sleep quality therefrom).
Regarding claim 37, Fox in view of Ferreira teaches the system of claim 21. Fox further teaches a method for determining at least one sleeping phase and/or at least one waking phase for at least one time span by using the system of claim 21 (Fox in view of Ferreira as presented in the above rejection of claim 21), wherein the method comprises
- acquiring at least one signal of at least one movement parameter by the at least one first sensor (Fig. 1 reference 138; Paragraphs 0115, 0129 and 0132: actigraphy sensors and/or accelerometers for capturing body motion) and/or
- acquiring at least one signal of at least one cardiac parameter by the at least one second sensor (Fig. 1 reference 154; Paragraphs 0074 and 0105 the PPG, blood flow, oximetry, and pulse sensor sensor) and/or
- acquiring at least one signal of at least one respiration parameter by the at least one third sensor (Fig. 1 reference 134; Paragraphs 0089-0090: the respiratory flow rate sensor), and
- determining the presence and assessing the quality of the acquired movement signals and/or the acquired cardiac signals and/or the acquired respiration signals by the at least on monitoring unit (Paragraphs 0023 and 0027: metrics are selected for consideration based on their quality; 0161-0162: the system determines the quality of data provided by each modality), and
- determining at least one sleeping phase and/or at least one waking phase from the acquired movement, cardiac and respiration signals on the basis of determinations and assessments of the monitoring unit by the at least one classification unit (Paragraphs 0157-0159: the classifier receives a plurality of parameters and/or raw values and classifies them into sleep state; Paragraphs 0023, 0027, and 0161-0162 describe how a quality metric may be used to select which parameters are input into the classifier and thus the determination of the sleeping stage is based on the quality assessment).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Fox US Patent Application Publication Number US 2023/0099622 A1 hereinafter Fox in view of Ferreira US Patent Application Publication Number US 2019/0183414 A1 hereinafter Ferreira as applied to claim 1 and further in view of Williams US Patent Number US 11589815 B1 hereinafter Williams.
Regarding claim 22, Fox teaches the system of claim 21. Fox further teaches the system wherein the monitoring unit is configured to receive the at least one movement signal and/or the at least one cardiac signal and/or the at least one respiration signals from the first, second and third sensors (Paragraph 0157 and 0161: movement, flow and cardiac activity are among the parameters received), wherein at least one threshold value is stored in the at least one monitoring unit (Paragraph 0162: a threshold determination metric).
Fox further teaches a threshold passing technique for cardiac signals (Paragraph 0143), and a threshold determination metric for conflicting parameters (Paragraph 0162). Fox fails to further teach the system wherein at least one threshold value is stored in a memory of the system, and wherein the quality of the movement and/or cardiac and/or respiration signals is assessed on the basis of the at least one predefined threshold value.
Williams teaches an adjustable measurement device including a housing, a power supply, a processor, a communication device, an elastic coupling member, a physiological sensor, and/or a clamp. The housing may be configured to attach to a wearable band that is wearable by a subject. The housing may include a chamber within the housing. The power supply, the processor, the communication device, the elastic coupling member, and or the physiological sensor may be disposed within the chamber. The elastic coupling member may couple the physiological sensor to the housing. A force exerted by the elastic coupling member on the physiological sensor may be in a direction through an opening towards a body part of a subject (Abstract). Thus, Williams is reasonably pertinent to the problem at hand.
Williams teaches a device which receives a physiological signal from a sensor and determines the quality of the received signal by determining a signal to noise ratio. The signal to noise ratio (SNR) is compared to a minimum threshold and if the SNR does not exceed the minimum ratio then the device may skip taking a measurement (Col 72 line 55 – Col 73 line 8).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the SNR threshold comparison of Williams into the system of Fox because Fox contemplates selecting data for later processing based on signal quality (Fox: Paragraph 0161) and the SNR threshold evaluation of Williams provides a suitable metric for the signal quality evaluation of Fox to take place. Thus it is a simple substitution of one known elements (the signal quality evaluation of Fox) for another (the signal quality evaluation of Williams) with no surprising technical effect.
Response to Arguments
Applicant’s arguments with respect to the prior art have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument and the claims argued have been cancelled.
Applicant argues that het specification recites sufficient structure for the limitations of “a control unit” and “a monitoring unit” and that one of ordinary skill in the art would recognize what these structures are.
Applicant’s argument is not found to be persuasive because these limitations are interpreted under 35 USC 112(f) and thus the specification must explicitly describe the particular structure or algorithm which comprise these elements.
Applicant argues that the specification need not describe each and every sensor to support the claimed sensors.
This argument is not found to be persuasive because Applicant claims a large genus of sensors and their corresponding signals but the specification does not contemplate how the widely different parameters that may be measured by the wide array of different sensors may be considered in different manners. Applicant claims a large genus of sensors and their parameters but discloses only a single species of each. See MPEP 2163 (II)(A)(3)(a)(ii). The claimed genus of each sensor type and the subsequent claim to each type of parameter are considered broad genuses which include significant variation.
Applicant argues that the claimed system and method could not reasonably be performed in the human mind with sufficient accuracy or speed.
Applicant’s arguments are not commensurate in scope with the claim language. No particular accuracy or speed of determination is required. Additionally, claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures | LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). MPEP 2106.05(f)(2)
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.
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791