DETAILED ACTION
Applicant' s arguments, filed 06/15/2026, 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 10/20/2023, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 3-4, 7, 14-16, 18-19, 22, 29-31 are the current claims hereby under examination.
Claim 32 is withdrawn from consideration for the reasons presented below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Newly submitted claim 32 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 32 is directed towards a process of determining tissue arterial oxygen saturation by first determining an oxyhemoglobin and deoxyhemoglobin parameters using respective sensed first and second signals, the determination of the parameters includes using the AC component and the DC components of the sensed signals in order to determine the oxy and deoxy hemoglobin parameters. These parameters are then processed in some manner to separate out the AC components for each of oxy and deoxy hemoglobin which are then used in a ratio to determine tissue arterial oxygen saturation.
This method is considered to be separate and distinct from the method of the previously presented claims which were not drawn towards such a combined determination using AC and DC components to determine oxy and deoxy hemoglobin then filtering out the AC components thereof.
In particular, while the previously presented independent claims are sufficiently broad to have encompassed the method of claim 32 within their scope, the method of claim 32 was not previously presented in any dependent claim from previously presented claim 1. Previously presented claims 2-15 did not previously set forth the embodiment of the invention now claimed in claim 32. If the embodiment of claim 32 had been previously presented it would have been subject to an election of species as it is considered to be a non-obvious variation of, and separate and distinct to, the method of previously presented claims 2-7, and 11-13. Previously presented claims 16-31 are further directed towards the generic method of claim 1 with the dependent claims being drawn toward the embodiment of the invention now recited in amended claims 1, 16, and 31.
The embodiment of current claim 1 and previously presented claim 2-7, and 11-13 are considered separate and distinct from the embodiment of presently presented claim 32 because they are mutually exclusive and recite materially different modes of operation, in particular, the embodiment of current claim 1 and previously presented claim 2-7, and 11-13 requires the separation of the AC and DC elements before determining the AC components of oxy and deoxy hemoglobin, by contrast the presently presented method of claim 32 does not require the separation of the AC and DC components of the sensed signal but rather uses the combined signal to determine oxy and deoxy hemoglobin concentrations then implements a separate and distinct processing method to separate out the AC and DC components from the combined oxy and deoxy hemoglobin parameters.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 32 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Thus, claims 1, 3-4, 7, 14-16, 18-19, 22, 29-31 are the current claims hereby under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-4, 7, 14-16, 18-19, 22, and 29-31 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 1, 3-4, 7, 14-16, 18-19, 22, and 29-31 are directed to a method of processing PPG signals using a computational algorithm, which is an abstract idea. Claims 1, 3-4, 7, 14-16, 18-19, 22, and 29-31 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) and the 2024 Update on Subject Matter Eligibility (Federal Register, Vol 89, No. 137, page 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a process
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] processing the first signals to isolate the AC component of the first signals and determine an amplitude of the AC component of the first signals
[B1] determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals
[C1] processing the second signals to isolate an AC component of the second signals and determine an amplitude of the AC component of the second signals
[D1] determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals
[E1] determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter.
These elements [A1]-[E1] 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. In particular all of the recited processing and determination steps are recited at a high level of generality and are readily performed in the human mind.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] using a light source to transmit at least a first wavelength of near-infrared light and a second wavelength of near-infrared light into a tissue body, wherein the first wavelength is different from the second wavelength
[B2] using at least one light detector to sense the tissue body for the first wavelength of near-infrared light and the second wavelength of near-infrared light, and to produce first signals representative of the sensed first wavelength of near-infrared light and to produce second signals representative of the sensed second wavelength of near-infrared light
These elements [A2]-[B2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the elements [A2]-[B2] 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).
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the recitations of [A2] and [B2] 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 a near infrared transmitter and receptor pair detecting light though the skin. Such sensors are well known and are conventional as evidenced by Applicant’s specification paragraphs 0049-0050 which describes one acceptable NIRS sensor configuration and states that other configurations are acceptable. Applicant further cites US Patent Application Publication Number US 2014/0171761 A1 and US Patent Number US 8428674 B2 to illustrate that such sensors are known. US Patent Number US 8428674 B2 itself further recites that NIRS sensors are typical and generally include at least one light source and one or more light detectors to produce and subsequently sense near-infrared light (Col 1 line 44 – Col 2 line 24). As such, the recited transmittal and receiving of near-infrared light is considered to be mere data gathering at a higher level of generality which uses well-known, routine, and conventional sensors.
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 3-4, 7, and 14-15 depend from claim 1, and recite the same abstract idea as claim 1. 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 14: the at least one light detector comprises at least one near light detector and at least one far light detector, wherein the at least one near light detector is located a first distance from the light source and the at least one far light detector is located a second distance from the light source and the second distance is greater than the first distance; and wherein the step of using at least one light detector to sense the tissue body utilizes the at least one near light detector and the at least one far light detector;
Claim 15: a sensor transducer comprises the light source and the at least one light detector, and the sensor transducer is configured to receive the tissue body in a manner such that the tissue body is disposed between the light source and the at least one light detector and the transmitted near-infrared light is transmitted from the light source, through the tissue body in a direction toward the at least one light detector; and
Each of these claim limitations do not integrate the exception into a practical application. In particular, the elements of claims 14 and 15 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).
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they 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. In particular, the described sensor transducers having light emitter and receivers in a particular configuration are well-known routine and conventional as evidenced by Applicant’s specification paragraphs 0049-0050, US Patent Application Publication Number US 2014/0171761 A1 and US Patent Number US 8428674 B2 as described above and further evidenced by US Patent Application Publication Number US 2007/0244399 A1 paragraph 0010 and Figs. 1A-C which illustrate a conventional configuration of emitters and detectors in a finger pulse oximeter.
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.
Claims 16 and 31 recites the same abstract idea as claim 1 and are thus rejected on the same basis as claim 1. The additional elements of these claims not already addressed above, are addressed below.
Step 1: Claim 16 and 31 are drawn to machines
Step 2A – Prong One: Claims 16 and 31 recites an abstract idea. In particular, they recite the same abstract idea as claim 1.
Step 2A – Prong Two: Claims 16 and 31 recite the following limitations that are beyond the judicial exception and not already addressed in the above analysis of claim 1:
[A2] at least one sensor transducer
[B2] a controller, the controller including at least one processor and a memory device
[C2] A non-transitory computer-readable medium
These elements [A2]-[C2] of claims 16 and 31 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is 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 [B2]-[C2] 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).
Step 2B: The element [A2] does not qualify as significantly more than the abstract idea because they 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 as evidenced by Applicant’s specification, US Patent Application Publication Number US 2014/0171761 A1, US Patent Number US 8428674 B2, and US Patent Application Publication Number US 2007/0244399 A1 as described in the above analysis of claims 1-15.
Further, the elements [B2]-[C2] do 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)).
Claims 18-19, 22, and 29 depend from claim 16, and recite the same abstract idea as claim 16. 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 exceptions of claims 29 and 30 which recite substantially the same sensor configurations already addressed in the above analysis of claims 14-15.
Each of these claim limitations do not integrate the exception into a practical application. In particular, the elements of claims 29 and 30 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). As described in the above analysis of claims 14 and 15.
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 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 1, 3, 14, 16, 18, 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker US Patent Application Publication Number US 2019/0374140 A1 hereinafter Tucker in view of Chen US Patent Application Publication Number US 2004/0024297 A1 hereinafter Chen further in view of Barthelemy US Patent Number US 5413100 A hereinafter Barthelemy
Regarding claim 1, Tucker discloses a method of non-invasively determining a tissue arterial oxygen saturation value of a tissue body (Abstract; Paragraphs 0006-0007: the determination of peripheral oxygen saturation; It is noted that SpO2 denotes the arterial oxygen saturation), comprising:
using a light source to transmit at least a second wavelength of near-infrared light into a tissue body, the first wavelength different from the second wavelength (Paragraphs 0110 and 0115: two different wavelengths are used, one is NIR);
using at least one light detector to sense the tissue body for the near-infrared light, and to produce signals representative of the sensed second wavelength of near-infrared light, wherein the second signals have an AC component and a DC component (Paragraphs 0110-0112: the sensed signals including the AC and DC components thereof);
processing the first signals to isolate the AC component of the first signals and determine an amplitude of the AC component of the first signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength are the average peak-to-peak values);
processing the second signals to isolate an AC component of the second signals and determine an amplitude of the AC component of the second signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength are the average peak-to-peak values); and
Tucker fails to further disclose the method using a first wavelength of near-infrared light and producing signals representative thereof, and determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter.
Chen teaches a method and apparatus for non-invasively determining the blood oxygen saturation level within a subject's tissue is provided that utilizes a near infrared spectrophotometric (NIRS) sensor (Abstract). Thus, Chen falls within the same field of endeavor as Applicant’s invention.
Chen teaches that different wavelengths of near-infrared light may be used to monitor changes in concentration of oxyhemoglobin and deoxyhemoglobin since each act as a distinct chromophore. Monitoring these changes may be used to monitor oxygen levels (Paragraph 0010). Concentrations of Hb and HbO2 can be monitored using various wavelengths by accounting for the wavelength dependent absorption coefficient (Paragraphs 0011-0013).
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 method of Tucker to utilize near-infrared wavelengths for both the first and second wavelengths for SpO2 calculation as taught by Chen because Tucker already contemplates performing the SpO2 imaging separately from the MSPV imaging using its own distinct set of wavelengths (Tucker: Paragraphs 0130-0131) and Chen teaches that multiple different near-infrared wavelengths are well suited for SpO2 calculations. Thus it is a simple substitution of one known element (the visible wavelength of Tucker) for another (a second NIR wavelength of Chen) with no surprising technical effect since the absorption spectra is wavelength dependent and the equations of Tucker are readily adapted to any wavelength suitable for measuring HbO2 and Hb.
Tucker in view of Chen fails to further teach determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter.
Barthelemy teaches an apparatus comprising three laser diodes emitting at 660, 750 and 940 nm respectively, excited cyclically at the rate of a timer. The light emitted is channeled by three optical fibers to traverse a fully-vascularized tissue region of a subject along three virtually merged optical paths, and to terminate at an opto-electronic sensor, which generates overlapping signals representative of the molecular absorption. The pulsation of the arterial blood in the region induces variable components which are exclusively a function of the molecular absorptions due to oxyhemoglobin, deoxyhemoglobin and carboxyhemoglobin. The signals are switched by gates on three channels where the variable components are picked up and digitized, and then processed in a microprocessor to yield the oxygen saturation SaO.sub.2 and the carbon monoxide fixation of the hemoglobin (Abstract). Thus Barthelemy falls within the same field of endeavor as Applicant’s invention.
Barthelemy teaches determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter (Col 2 line 45 – Col 3 line 17: the variable component of the absorption measurement is used to determine a oxyhemoglobin parameter and a deoxyhemoglobin parameter as in equation 2. The wavelength that has greater absorption for oxyhemoglobin may be considered the first signals which are used to determine an “AC component of a tissue oxyhemoglobin parameter”, and the other wavelength is considered the second signals used to determine an “AC component of a tissue deoxyhemoglobin parameter”. The determined oxy and deoxy hemoglobin values are used to determine the arterial oxygen saturation using a ratio of the oxyhemoglobin component over the sum of the oxy and deoxyhemoglobin components as depicted in Fig. 3.
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 method of Tucker in view of Chen to calculate the oxygen saturation value in the manner described by Barthelemy because such a change in the calculation method is a simple substitution of one known element (the calculation method of Tucker) for another known calculation method (the calculation method of Barthelemy) with no surprising technical effect (the arterial oxygen saturation is determined). Additionally, as taught by Chen, various wavelengths can be used for the measurements by accounting for the wavelength dependent absorption coefficient.
Regarding claim 16, Tucker discloses an apparatus for non-invasively determining a tissue arterial oxygen saturation value of a tissue body (Abstract; Paragraphs 0006-0007: the determination of peripheral oxygen saturation), comprising:
at least one sensor transducer having a light source configured to produce at least a second wavelength of near-infrared light, and at least one light detector configured to sense the at least said second wavelength of near-infrared light (Paragraph 0110 and 0112: the first and second wavelength and the LEDs and camera); and
a controller in communication with the at least one sensor transducer, the controller including at least one processor and a memory device configured to store instructions, the stored instructions when executed cause the controller to (Paragraph 0059-0060: the data processing system including a processor and memory for carrying out the function of the various embodiments):
control the light source to transmit at least the second wavelength of near-infrared light into a tissue body, the first wavelength different from the second wavelength (Paragraphs 0110 and 0115: two different wavelengths are used, one is NIR);
control the at least one light detector to sense the tissue body for the second wavelength of near-infrared light, and produce second signals representative of the sensed second near-infrared light, wherein the second signals have an AC component and a DC component (Paragraphs 0110-0112: the sensed signals including the AC and DC components thereof);
processing the first signals to isolate the AC component of the first signals and determine an amplitude of the AC component of the first signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength are the average peak-to-peak values);
processing the second signals to isolate an AC component of the second signals and determine an amplitude of the AC component of the second signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength are the average peak-to-peak values); and
Tucker fails to further disclose the system wherein the first wavelength is near-infrared light and sensing signals representative thereof, and determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter.
Chen teaches that different wavelengths of near-infrared light may be used to monitor changes in concentration of oxyhemoglobin and deoxyhemoglobin since each act as a distinct chromophore. Monitoring these changes may be used to monitor oxygen levels (Paragraph 0010). Concentrations of Hb and HbO2 can be monitored using various wavelengths by accounting for the wavelength dependent absorption coefficient (Paragraphs 0011-0013).
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 apparatus of Tucker to utilize near-infrared wavelengths for both the first and second wavelengths for SpO2 calculations as taught by Chen because Tucker already contemplates performing the SpO2 imaging separately from the MSPV imaging using its own distinct set of wavelengths (Paragraphs 0130-0131) and Chen teaches that multiple different near-infrared wavelengths are well suited for SpO2 calculations. Thus it is a simple substitution of one known element (the visible wavelength of Tucker) for another (a second NIR wavelength of Chen) with no surprising technical effect since the absorption spectra is wavelength dependent and the equations of Tucker are readily adapted to any wavelength suitable for measuring HbO2 and Hb.
Tucker in view of Chen fails to further disclose the system comprising determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter.
Barthelemy teaches determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter (Col 2 line 45 – Col 3 line 17: the variable component of the absorption measurement is used to determine a oxyhemoglobin parameter and a deoxyhemoglobin parameter as in equation 2. The wavelength that has greater absorption for oxyhemoglobin may be considered the first signals which are used to determine an “AC component of a tissue oxyhemoglobin parameter”, and the other wavelength is considered the second signals used to determine an “AC component of a tissue deoxyhemoglobin parameter”. The determined oxy and deoxy hemoglobin values are used to determine the arterial oxygen saturation using a ratio of the oxyhemoglobin component over the sum of the oxy and deoxyhemoglobin components as depicted in Fig. 3.
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 system of Tucker in view of Chen to calculate the oxygen saturation value in the manner described by Barthelemy because such a change in the calculation method is a simple substitution of one known element (the calculation method of Tucker) for another known calculation method (the calculation method of Barthelemy) with no surprising technical effect (the arterial oxygen saturation is determined). Additionally, as taught by Chen, various wavelengths can be used for the measurements by accounting for the wavelength dependent absorption coefficient.
Regarding claim 31, Tucker discloses a non-transitory computer-readable medium containing computer program instructions, wherein the computer program instructions are executable by the at least one computer processor to perform a method of non-invasively determining a tissue arterial oxygen saturation value of a tissue body (Abstract; Paragraphs 0006-0007: the determination of peripheral oxygen saturation; Paragraph 0059-0060: the data processing system including a processor and memory for carrying out the function of the various embodiments), the method comprising:
controlling a light source to transmit at least a second wavelength of near-infrared light into a tissue body, the first wavelength different from the second wavelength (Paragraphs 0110 and 0115: two different wavelengths are used, one is NIR);
controlling at least one light detector to sense the tissue body for the second wavelength of near-infrared light, and producing signals representative of the sensed second wavelength of near-infrared light wherein the second signals have an AC component and a DC component (Paragraphs 0110-0112: the sensed signals including the AC and DC components thereof);
processing the first signals to isolate the AC component of the first signals and determine an amplitude of the AC component of the first signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength are the average peak-to-peak values);
processing the second signals to isolate an AC component of the second signals and determine an amplitude of the AC component of the second signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength are the average peak-to-peak values); and
Tucker fails to further disclose the system wherein the first wavelength is near-infrared light and sensing signals representative thereof, and determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter.
Chen teaches that different wavelengths of near-infrared light may be used to monitor changes in concentration of oxyhemoglobin and deoxyhemoglobin since each act as a distinct chromophore. Monitoring these changes may be used to monitor oxygen levels (Paragraph 0010). Concentrations of Hb and HbO2 can be monitored using various wavelengths by accounting for the wavelength dependent absorption coefficient (Paragraphs 0011-0013).
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 apparatus of Tucker to utilize near-infrared wavelengths for both the first and second wavelengths for SpO2 calculations as taught by Chen because Tucker already contemplates performing the SpO2 imaging separately from the MSPV imaging using its own distinct set of wavelengths (Paragraphs 0130-0131) and Chen teaches that multiple different near-infrared wavelengths are well suited for SpO2 calculations. Thus it is a simple substitution of one known element (the visible wavelength of Tucker) for another (a second NIR wavelength of Chen) with no surprising technical effect since the absorption spectra is wavelength dependent and the equations of Tucker are readily adapted to any wavelength suitable for measuring HbO2 and Hb.
Tucker in view of Chen fails to further disclose the system comprising determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter.
Barthelemy teaches determining an AC component of a tissue oxyhemoglobin parameter using the determined amplitude of the AC component of the first signals; determining an AC component of a tissue deoxyhemoglobin parameter using the determined amplitude of the AC component of the second signals; and determining a tissue arterial oxygen saturation value of the tissue body using a ratio of the determined AC component of the tissue oxyhemoglobin parameter and a sum of the determined AC component of the tissue oxyhemoglobin parameter and the determined AC component of the tissue deoxyhemoglobin parameter (Col 2 line 45 – Col 3 line 17: the variable component of the absorption measurement is used to determine a oxyhemoglobin parameter and a deoxyhemoglobin parameter as in equation 2. The wavelength that has greater absorption for oxyhemoglobin may be considered the first signals which are used to determine an “AC component of a tissue oxyhemoglobin parameter”, and the other wavelength is considered the second signals used to determine an “AC component of a tissue deoxyhemoglobin parameter”. The determined oxy and deoxy hemoglobin values are used to determine the arterial oxygen saturation using a ratio of the oxyhemoglobin component over the sum of the oxy and deoxyhemoglobin components as depicted in Fig. 3.
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 system of Tucker in view of Chen to calculate the oxygen saturation value in the manner described by Barthelemy because such a change in the calculation method is a simple substitution of one known element (the calculation method of Tucker) for another known calculation method (the calculation method of Barthelemy) with no surprising technical effect (the arterial oxygen saturation is determined). Additionally, as taught by Chen, various wavelengths can be used for the measurements by accounting for the wavelength dependent absorption coefficient.
Examiner’s Note: All dependent claims are rejected with the understanding that Tucker in view of Chen further in view of Barthelemy as presented above teaches that both the first and second wavelengths of Tucker may be near-infrared wavelengths.
Regarding claims 3 and 18, Tucker in view of Chen further in view of Barthelemy teaches the method and apparatus of claims 2 and 17 respectively. Modified Tucker further teaches the method and apparatus wherein the step of processing the first signals to determine an amplitude of the AC component of the first signals includes determining a peak-to-peak amplitude of the AC component of the first signals, and the step of determining the AC component of the tissue oxyhemoglobin parameter of the tissue uses the determined peak-to-peak amplitude of the AC component of the first signals (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined); and
wherein the processing the second signals to determine an amplitude of the AC component of the second signals includes determining a peak-to-peak amplitude of the AC component of the second signals, and the step of determining the AC component of the tissue deoxyhemoglobin parameter of the tissue uses the determined peak-to-peak amplitude of the AC component of the second signals (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined).
Regarding claims 14 and 29, Tucker in view of Chen further in view of Barthelemy teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the at least one light detector (Paragraphs 0112 and 0130-0131: the LEDs and camera).
Modified Tucker fails to further teach the method including: the at least one light detector comprising at least one near light detector and at least one far light detector, wherein the at least one near light detector is located a first distance from the light source and the at least one far light detector is located a second distance from the light source and the second distance is greater than the first distance; and wherein the step of using at least one light detector to sense the tissue body utilizes the at least one near light detector and the at least one far light detector.
Chen teaches a NIRS sensor including one or more light sources and detectors including a shallow, or near, detector and a deep, or far detector. The shallow detector is located closer to the emitter than the deep detector. (Paragraph 0039 and 0041; Fig. 1 references 18-20).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the method of modified Tucker to perform the SpO2 measurement using a sensor device such as the one taught by Chen with at least one source and a near and far detector because it is a simple substitution of one known element (the emitter and detectors of Tucker) for another (the emitters and detectors of Chen) with no surprising technical effect. Chen teaches that the device is well suited for arterial blood oxygen determination (Paragraph 0030-0031). Additionally using a device having a configuration such as is depicted by Chen may improve the accuracy of measurement since the device contacts the skin and thus may block more interference from outside sources than the configuration of Tucker.
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker US Patent Application Publication Number US 2019/0374140 A1 hereinafter Tucker in view of Chen US Patent Application Publication Number US 2004/0024297 A1 hereinafter Chen further in view of Barthelemy US Patent Number US 5413100 A hereinafter Barthelemy as applied to claims 3 and 18 as described above and further in view of Bedingham US Patent Application Publication Number US 2020/0113498 A1 hereinafter Bedingham.
Regarding claims 4 and 19, Tucker in view of Chen further in view of Barthelemy teaches the method and apparatus of claims 3 and 18 respectively. Modified Tucker further teaches the method and apparatus wherein the step of determining the peak-to-peak amplitude of the AC component of the first signals includes extracting the AC component of the first signals; and wherein the step of determining the peak-to-peak amplitude of the AC component of the second signals includes extracting the AC component of the second signals (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined).
Modified Tucker fails to further disclose the method wherein the determination of the AC components includes filtering the AC component.
Bedingham teaches a wireless pulse oximeter device can include a front-end circuit. The device also include a wireless communications module to communicate with a medical monitor or wireless receiver device. The device can also have a controller communicatively coupled to the front-end circuit and the wireless communication module. The controller can have one or more processors configured to receive the at least two photodiode readings, determine an AC component value and a DC component value of a first one of the at least two photodiode readings, transmit the AC component value, determine an R-value corresponding to a ratio of an optical absorption of a first wavelength of light to an optical absorption of a second wavelength of light, for a first set of photodiode readings, and transmit the R-value for the first set of photodiode readings (Abstract). Thus, Bedingham falls within the same field of endeavor as Applicant’s invention.
Bedingham teaches that AC component values can be determined using a variety of different methods including peak to peak values, or root mean square values (Paragraphs 0106-0107).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize root mean square (RMS) values as a metric of AC amplitude instead of peak-to-peak values as taught by Bedingham in the method of modified Tucker because Bedingham teaches that either metric is an acceptable representation of the AC component (Bedingham: Paragraphs 0106-0107) and thus the change is a simple substitution of one known element (the extraction method for peak to peak values of Tucker) for another (the RMS calculation value of Bedingham) with no surprising technical effect since the AC component is still represented in a consistent manner. It is noted that the use of RMS calculations and values are considered to anticipate the limitation of “filtering the AC component of the first signals to determine a value representative of the peak-to-peak amplitude” as Applicant’s specification paragraph 0066 refers to RMS calculations as “RMS filters”
Claims 7, 15, 22, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Tucker US Patent Application Publication Number US 2019/0374140 A1 hereinafter Tucker in view of Chen US Patent Application Publication Number US 2004/0024297 A1 hereinafter Chen further in view of Barthelemy US Patent Number US 5413100 A hereinafter Barthelemy as applied to claims 1 and 16 as described above and further in view of Kontron US Patent Number US 6181959 B1 hereinafter Kontron.
Regarding claims 7 and 22, Tucker in view of Chen further in view of Barthelemy teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the step of processing the first signals to isolate the AC component of the first signals includes extracting the first signals to remove the DC component of the first signals; and wherein the step of processing the second signals to isolate the AC component of the second signals includes extracting the second signals to remove the DC component of the second signals (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined).
Modified Tucker fails to further disclose the method wherein the determination of the AC components includes filtering the AC component to remove the DC component.
Kontron teaches that filtering may be used to remove the DC components of a PPG signal from the AC components (Col 6 line 55 – Col 7 line 12).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to utilize filtering to separate the AC component from the DC component as taught by Kontron in the method of Tucker in view of Chen because the use of filtering is a simple substitution of one known element (the extraction method of Tucker) for another (filtering of Kontron) with no surprising technical effect.
Regarding claims 15 and 30, Tucker in view of Chen further in view of Barthelemy teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein a sensor transducer comprises the light source and the at least one light detector (Paragraph 0112 and 013-0131: the LEDs and camera).
Modified tucker fails to further disclose the method wherein the sensor transducer is configured to receive the tissue body in a manner such that the tissue body is disposed between the light source and the at least one light detector and the transmitted near-infrared light is transmitted from the light source, through the tissue body in a direction toward the at least one light detector.
Kontron teaches a method utilizing a clamp with LEDs and photodiodes disposed on either side such that light emitted from the LEDs passes through the tissue and towards the photodiodes (Col 6 lines 10-39; Fig. 1A references 4-5 and 7-8).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to alter the method of modified Tucker to perform the SpO2 measurement using a sensor device in a configuration such as the one taught by Kontron because it is a simple substitution of one known element (the emitter and detectors of Tucker) for another (the emitters and detectors of Kontron) with no surprising technical effect. Kontron teaches that the device is well suited for arterial blood oxygen determination (Col 1 lines 43-60). Additionally using a device having a configuration such as is depicted by Kontron may improve the accuracy of measurement since the device contacts the skin and thus may block more interference from outside sources than the configuration of Tucker.
Response to Arguments
Applicant’s arguments directed towards the rejections presented under 35 SUC 103 to claims 1, 16 and 31 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. Examiner further notes that Applicant’s arguments are not fully commensurate in scope with the present claims. Applicant argues that presently presented claim 1 prohibits the use of DC signals in the determination of the oxygen saturation but this argument is not considered to be commensurate in scope with the presently presented claims. The claims require that the AC component be utilized for the recited steps but do not explicitly prohibit the DC component from also being utilized. The AC component is isolated and the amplitude is determined but the following steps of determining the “AC component of tissue oxy/deoxy-hemoglobin” do not appear to prohibit the use of the DC component in conjunction with the AC amplitude.
Applicant argues that the claims are directed towards patent eligible subject matter because the method is implemented onto a particular machine. Applicant further argues that steps directed towards the abstract idea cannot practically be performed in the human mind.
Applicant’s arguments are not found to be persuasive because the claims recite only generic sensor and computer components at a high level of generality. The claims light sources and detectors are well known as evidenced by Applicant’s own specification and the cited documents presented in the above 35 USC 101 rejection. The generic sensor elements are used for mere data gathering purposes. The computer is further utilized as a mere tool for carrying out the process and is also recited at a high level of generality. Finally, the recited steps of processing signals, determining amplitudes, and determining a ratio are all readily performed in the human mind. The human mind is capable of performing signal processing and filtering, determining amplitudes, and generating ratios.
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
/RENE T TOWA/Primary Examiner, Art Unit 3791
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