DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-31 are hereby the present claims under consideration.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 it appears that “a light source from a sensor transducer having at least one near detector and at least one far detector” should read “a light source from a sensor transducer further comprising at least one near detector and at least one far detector” to indicate that the sensor transducer is not comprised only of the detectors but also includes the light source.
Appropriate correction is required.
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 4 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “determining a peak-to-peak amplitude of the AC component of the first signals includes filtering the AC component of the first signals to determine a value representative of the peak-to-peak amplitude of the AC component of the first signals” but it is unclear whether the filtering results in “a peak-to-peak amplitude of the AC component of the first signals” or “a value representative of the peak-to-peak amplitude of the AC component of the first signals”. It would seem that the determination of the peak to peak amplitude is intended to be limited to filtering but the outcome of said filtering is a value “representative of” the peak to peak amplitude which is broader in scope that “a peak-to-peak amplitude”. It is unclear how a determination is further limited by determining a broader values than the original determination. It is further unclear what “filtering” is used to determine peak to peak amplitude. For the purposes of this examination, the limitation is interpreted as determining an RMS value as a value “representative of” the peak-to-peak amplitude. This rejection is further applied to Claim 19.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 5 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In particular, claim 5 recites “wherein the step of determining the AC component of the first/second tissue oxygen parameter includes determining a peak-to-peak amplitude of the AC component of the first/second tissue oxygen parameter” which indicates the step of “determining the AC component of the first/second tissue oxygen parameter” includes determining a peak-to-peak amplitude. However, claim 3 from which claim 5 depends recites “the step of determining an amplitude of the AC component of the first/second signals includes determining a peak-to-peak amplitude of the AC component of the first/second signals, and the step of determining the AC component of the first/second tissue oxygen parameter of the tissue uses the determined peak-to-peak amplitude of the AC component of the first/second signals” which appears to indicate that the determination of the peak-to-peak amplitude is implicitly required by the steps of claim 3. Thus, claim 5 does not appear to further limit claim 3. This rejection is further applies to claim 20
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-31 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 1-31 are directed to a method of processing PPG signals using a computational algorithm, which is an abstract idea. Claims 1-31 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] determining an AC component of a first tissue oxygen parameter using the signals
[B1] determining an AC component of a second tissue oxygen parameter using the signals
[C1] determining a tissue arterial oxygen saturation value of a tissue body using the determined AC component of the first tissue oxygen parameter and the determined AC component of the second tissue oxygen parameter
These elements [A1]-[C1] 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] transmitting at least a first wavelength and a second wavelength of near-infrared light into a tissue body, the first wavelength different from the second wavelength
[B2] sensing the tissue body for the near-infrared light, and producing signals representative of the sensed 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 “transmitting at least a first wavelength and a second wavelength of near-infrared light into a tissue body, the first wavelength different from the second wavelength” and “sensing the tissue body for the near-infrared light, and producing signals representative of the sensed near-infrared light” 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 B2to 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 2-15 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: a light source and a sensor transducer having at least one near detector and at least one far detector, wherein the at least one near detector is located a first distance from the light source and the at least one far detector is located a second distance from the light source and the second distance is greater than the first distance; and wherein the sensing step utilizes the at least one near detector and the at least one far detector;
Claim 15: a sensor transducer having a light source and a light detector, the sensor transducer configured to receive the tissue body in a manner such that the tissue body is disposed between the light source and the light detector and the transmitted near-infrared light is transmitted from the light source, through the tissue body in a direction toward the 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] at least one light detector
[C2] a controller, the controller including at least one processor and a memory device
[D2] A non-transitory computer-readable medium
These elements [A2]-[D2] of claims 16 and 31 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). Furthermore, the elements [C2]-[D2] 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 elements [A2]-[B2] do 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 [C2]-[D2] 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 17-30 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, 5-6, 8-14, 16-18, 20-21, 23-29, 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.
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:
transmitting 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);
sensing the tissue body for the near-infrared light, and producing signals representative of the sensed near-infrared light (Paragraphs 0110-0112: the sensed signals);
determining an AC component of a first tissue oxygen parameter using the signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength );
determining an AC component of a second tissue oxygen parameter using the signals (Paragraphs 0110-0112: the pulsatile or AC component of the second wavelength); and
determining a tissue arterial oxygen saturation value of a tissue body using the determined AC component of the first tissue oxygen parameter and the determined AC component of the second tissue oxygen parameter (Paragraphs 0110-0112: the oxygen saturation percentage is calculated using the pulsatile components).
Tucker fails to explicitly disclose the method including a first wavelength of infrared light. In particular, Tucker utilizes a visible wavelength and a near-infrared wavelength for joint MSVP and SpO2 measurement (Paragraph 0112 and 0115-0116). Tucker further recites that the SpO2 measurement may be performed separately from the MSPV imaging using its own set of wavelengths which may be in a range of 700-800 nm. (Paragraphs 0130-0131: “in some embodiments a first set of wavelengths may be used to illuminate the sample to obtain MSPV data and a second set of wavelengths may be used to illuminate the sample to obtain other data including SpO.sub.2 data”; “the one of the light sources may have a wavelength in a red spectrum from 700 nm to 800 nm, which is used to determine peripheral oxygen saturation (SpO.sub.2). In other embodiments, the SpO2 data may be provided by first and second light emitting diodes (LEDs)”)
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 capable of transmitting a light signal into the tissue of a subject and sensing the light signal once it has passed through the transmitting a light signal into the subject's tissue, wherein the transmitted light signal includes a first wavelength, a second wavelength, and a third wavelength; (2) sensing a first intensity and a second intensity of the light signal, along the first, second, and third wavelengths after the light signal travels through the subject at a first and second predetermined distance; (3) determining an attenuation of the light signal for each of the first, second, and third wavelengths using the sensed first intensity and sensed second intensity of the first, second, and third wavelengths; (4) determining a difference in attenuation of the light signal between the first wavelength and the second wavelength, and between the first wavelength and the third wavelength; and (5) determining the blood oxygen saturation level within the subject's tissue using the difference in attenuation between the first wavelength and the second wavelength, and the difference in attenuation between the first wavelength and the third wavelength (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 (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.
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 first wavelength and 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 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);
control the at least one light detector to sense the tissue body for the near-infrared light, and produce signals representative of the sensed near-infrared light (Paragraphs 0110-0112: the sensed signals);
determine an AC component of a first tissue oxygen parameter using the signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength);
determine an AC component of a second tissue oxygen parameter using the signals (Paragraphs 0110-0112: the pulsatile or AC component of the second wavelength); and
determine a tissue arterial oxygen saturation value of the tissue body using the determined AC component of the first tissue oxygen parameter and the determined AC component of the second tissue oxygen parameter (Paragraphs 0110-0112: the oxygen saturation percentage is calculated using the pulsatile components).
Tucker fails to explicitly disclose the apparatus emitting a first wavelength of infrared light. In particular, Tucker utilizes a visible wavelength and a near-infrared wavelength for joint MSVP and SpO2 measurement (Paragraph 0112 and 0115-0116). Tucker further recites that the SpO2 measurement may be performed separately from the MSPV imaging using its own set of wavelengths which may be in a range of 700-800 nm. (Paragraphs 0130-0131)
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.
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 near-infrared light, and producing signals representative of the sensed near-infrared light (Paragraphs 0110-0112: the sensed signals);
determining an AC component of a first tissue oxygen parameter using the signals (Paragraphs 0110-0112: the pulsatile or AC component of the first wavelength);
determining an AC component of a second tissue oxygen parameter using the signals (Paragraphs 0110-0112: the pulsatile or AC component of the second wavelength); and
determining a tissue arterial oxygen saturation value of a tissue body using the determined AC component of the first tissue oxygen parameter and the determined AC component of the second tissue oxygen parameter (Paragraphs 0110-0112: the oxygen saturation percentage is calculated using the pulsatile components).
Tucker fails to explicitly disclose the instructions including emitting a first wavelength of infrared light. In particular, Tucker utilizes a visible wavelength and a near-infrared wavelength for joint MSVP and SpO2 measurement (Paragraph 0112 and 0115-0116). Tucker further recites that the SpO2 measurement may be performed separately from the MSPV imaging using its own set of wavelengths which may be in a range of 700-800 nm. (Paragraphs 0130-0131).
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.
Examiner’s Note: All dependent claims are rejected with the understanding that Tucker in view of Chen as presented above teaches that both the first and second wavelengths of Tucker may be near-infrared wavelengths.
Regarding claims 2 and 17, Tucker in view of Chen teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the signals produced representative of the sensed near-infrared light include first signals representative of the first wavelength of near-infrared light, the first signals having an AC component and a DC component, and second signals representative of the second wavelength of near-infrared light, the second signals having an AC component and a DC component (Paragraph 0111: the AC and DC component for the first and second sensed signals); and
the method further comprising:
processing the first signals to isolate an AC component of the first signals (Paragraph 0112: the AC components of both wavelengths are extracted);
determining an 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);
wherein the step of determining the AC component of the first tissue oxygen parameter uses the determined amplitude of the AC component of the first signals (Paragraphs 0110-0112: the SpO2 calculations utilize the average peak to peak amplitude of the AC component);
processing the second signals to isolate an AC component of the second signals (Paragraph 0112: the AC components of both wavelengths are extracted);
determining an 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); and
wherein the step of determining the AC component of the second tissue oxygen parameter uses the determined amplitude of the AC component of the second signals (Paragraphs 0110-0112: the SpO2 calculations utilize the average peak to peak amplitude of the AC component).
Regarding claims 3 and 18, Tucker in view of Chen teaches the method and apparatus of claims 2 and 17 respectively. Modified Tucker further teaches the method and apparatus wherein the step of determining 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 first tissue oxygen 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 step of determining 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 second tissue oxygen 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 5 and 20, Tucker in view of Chen 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 AC component of the first tissue oxygen parameter includes determining a peak-to-peak amplitude of the AC component of the first tissue oxygen parameter (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined); and
wherein the step of determining the AC component of the second tissue oxygen parameter includes determining a peak-to-peak amplitude of the AC component of the second tissue oxygen parameter (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined).
Regarding claims 6 and 21, Tucker in view of Chen teaches the method and apparatus of claims 5 and 20 respectively. Modified Tucker further teaches the method and apparatus wherein the first tissue oxygen parameter is oxyhemoglobin (HbO2) and the second tissue oxygen parameter is deoxyhemoglobin (Hb) (Paragraph 0110: one wavelength represents HbO2, the other represents Hb); and wherein the step of determining the arterial oxygen saturation value uses a ratio of the peak-to-peak amplitude of the AC component of the first tissue oxygen parameter and a sum of the peak-to-peak amplitude of the AC component of the first tissue oxygen parameter and the peak-to-peak amplitude of the AC component of the second tissue oxygen parameter (Paragraphs 0110-0112; Equation 11: the SpO2 is determined by the amount of HbO2 relative to the total hemoglobin, or sum of Hb and HbO2. The AC components, or AC peak to peak amplitudes are used in the determination).
Regarding claim 8 and 23, Tucker in view of Chen teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the step of determining the tissue arterial oxygen parameter value using the determined AC component of the first tissue oxygen parameter and the AC component of the second tissue oxygen parameter includes determining a peak-to peak value of the AC component of the first tissue oxygen parameter and a peak-to-peak value of the AC component of the second tissue oxygen parameter (Paragraph 0112: the AC component is an average peak to peak amplitude).
Regarding claims 9 and 24, Tucker in view of Chen teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the first tissue oxygen parameter is oxyhemoglobin (HbO2) and the second tissue oxygen parameter is deoxyhemoglobin (Hb); and wherein the step of determining the tissue arterial oxygen saturation uses a ratio of the first oxygen parameter and a sum of the first oxygen parameter and the second oxygen parameter (paragraph 0110; Equation 13: one wavelength represents HbO2 while the other represents Hb. SpO2 can be determined by the amount of HbO2 relative to the amount of total hemoglobin).
Regarding claims 10 and 25, Tucker in view of Chen teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the signals produced representative of the sensed near-infrared light include first signals representative of the first wavelength of near-infrared light, and second signals representative of the second wavelength of near-infrared light (Paragraph 0110: the first and second received wavelengths); and wherein the step of determining the AC component of the first tissue oxygen parameter uses the first signals, and the step of determining the AC component of the second tissue oxygen parameter uses the second signals (Paragraph 0110-0112: one wavelength represents HbO2 while the other represents Hb, the AC components are what represent the first and second sensed wavelengths).
Regarding claims 11 and 26, Tucker in view of Chen teaches the method and apparatus of claims 10 and 25 respectively. Modified Tucker further teaches the method and apparatus wherein the step of determining the AC component of the first tissue oxygen parameter includes determining an amplitude of the AC component of the first tissue oxygen parameter; and wherein the step of determining the AC component of the second tissue oxygen parameter includes determining an amplitude of the AC component of the second tissue oxygen parameter (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined); and
wherein the step of determining the tissue arterial oxygen saturation value uses the determined amplitude of the AC component of the first tissue oxygen parameter and the determined amplitude of the AC component of the second tissue oxygen parameter (Paragraphs 0110-0112: the AC components are used in the SpO2 calculations).
Regarding claims 12 and 27, Tucker in view of Chen teaches the method and apparatus of claims 11 and 26 respectively. Modified Tucker further teaches the method and apparatus wherein the step of determining the amplitude of the AC component of the first tissue oxygen parameter includes determining a peak-to-peak amplitude of the AC component of the first tissue oxygen parameter; and wherein the step of determining the amplitude of the AC component of the second tissue oxygen parameter of the tissue includes determining a peak-to-peak amplitude of the AC component of the second tissue oxygen parameter of the tissue (Paragraph 0112: the AC component of each wavelength signal is extracted and the average peak to peak amplitude is determined for each signal).
Regarding claims 13 and 28, Tucker in view of Chen teaches the method and apparatus of claims 12 and 27 respectively. Modified Tucker further teaches the method and apparatus wherein the first tissue oxygen parameter is oxyhemoglobin (HbO2) and the second tissue oxygen parameter is deoxyhemoglobin (Hb) (Paragraph 0110: one signal is associated with HbO2, the other with Hb); and wherein the step of determining the arterial oxygen saturation value uses a ratio of the peak-to-peak amplitude of the AC component of the first tissue oxygen parameter and a sum of the peak-to-peak amplitude of the AC component of the first tissue oxygen parameter and the peak-to-peak amplitude of the AC component of the second tissue oxygen parameter (Paragraphs 0110-0112; Equation 11: the SpO2 is determined by the amount of HbO2 relative to the total hemoglobin, or sum of Hb and HbO2. The AC components, or AC peak to peak amplitudes are used in the determination).
Regarding claims 14 and 29, Tucker in view of Chen teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the at least said first wavelength and said second wavelength are transmitted using a light source from a sensor transducer (Paragraphs 0112 and 0130-0131: the LEDs and camera).
Modified Tucker fails to further teach the method including: having at least one near detector and at least one far detector, wherein the at least one near detector is located a first distance from the light source and the at least one far detector is located a second distance from the light source and the second distance is greater than the first distance; and wherein the sensing step utilizes the at least one near detector and the at least one far 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 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 teaches the method and apparatus of claims 3 and 18 respectively. Modified Tucker further teaches the method and apparatus wherein the step of determining a peak-to-peak amplitude of the AC component of the first signals includes extracting the AC component of the first signals to determine a value representative of the peak-to-peak amplitude of the AC component of the first signals; and wherein the step of determining a peak-to-peak amplitude of the AC component of the second signals includes extracting the AC component of the second signals to determine a value representative of the 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).
Modified Tucker fails to further disclose the method wherein the determination of the AC components includes filtering the AC component to determine a value representative of the peak-to-peak amplitude.
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 as applied to claims 1-2 and 16-17 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 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 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 teaches the method and apparatus of claims 1 and 16 respectively. Modified Tucker further teaches the method and apparatus wherein the transmitting step and the sensing step utilize a sensor transducer having a light source and a light detector (Paragraph 0112 and 013-0131: the LEDs and camera).
Modified tucker fails to further disclose the method wherein the sensor transducer configured to receive the tissue body in a manner such that the tissue body is disposed between the light source and the light detector and the transmitted near-infrared light is transmitted from the light source, through the tissue body in a direction toward the 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.
Conclusion
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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791