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 .
Claim Objections
Claim 2 is objected to because of the following informalities:
In claim 2, line 2, “IMU” should be written “inertial measurement unit (IMU)”
Appropriate correction is required.
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.
Claim 1-5 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process to determines oxy- and deoxyhemoglobin values from the NIRS data and combines those values with collected motion tracking data) without significantly more.
Step 1:
The claimed invention is claim 1 is directed to statutory subject matter as the claims recites a system and a method for determining oxy- and deoxyhemoglobin values from the NIRS data and combines the oxy- and deoxyhemoglobin values with collected motion tracking data.
Step 2A, Prong One:
Regarding claim 1 and 3, the recited steps are directed to mental process, i.e., concepts that can be performed in a human mind (see MPEP 2106.04(a)(2) subsection (III)). The court have found that concepts performed in a human mind falls within the judicial exceptions, often labelled as “abstract ideas”.
Specifically, regarding claim 1, the limitation of “determining oxy- and deoxyhemoglobin values from the NIRS data and combines those values with collected motion tracking data” is a process that, under the broadest reasonable interpretation, encompasses performance in the human mind (including an observation, evaluation, judgement, and opinion). Regarding claim 3, the limitation, “generates a 2D map” is a mental process that a person can create a 2D map with a pen and paper, under the broadest reasonable interpretation, encompasses performance in the human mind (opinion).
For example, but for the “a processor” in claim 1 and 3, the “determining” step reasonably encompasses a user manually calculating and combining those values mentally or using pen and paper. Step 2A, Prong Two:
This judicial exception is not integrated into a practical application.
Regarding claim 1, the limitation of “processor” merely represents a generic computer component performing the abstract idea. The processor is described at a high level of generality and amounts to no more than instructions to apply the exception using a generic computer. Accordingly, the processor does not meaningfully limit the abstract idea and does not integrate the judicial exception into a practical application.
The claims, including dependent claims, are analyzed as a whole to determine whether additional limitations are recited such that the claims amount to significantly more than the abstract idea.
Regarding claim 2, the additional limitation of “the motion tracking circuitry” is nothing more than insignificant extra-solution activity, cush as data gathering. Regarding claim 3, the additional limitation, “the processor” is merely insignificant extra-solution activity. Regarding claim 4, the additional limitation of “the wireless communication circuitry” is nothing more than insignificant and conventional computer component for a mere pre-solution activity of data gathering and transfer. Regarding claim 5, the additional limitation of “the near-infrared light source”, which is well-understood, routine, and conventional in industry, amounts to nothing more than insignificant extra-solution activity, such as data gathering. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception. Regarding Claim 1-5, the judicial exception is not integrated into a practical application.
Step 2B:
The claim 1 does not include additional elements that are sufficient to amount significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements, including “Housing”,” Near-infrared light source”, “Optical detector”,” wireless communication” and “Motion tracking circuitry” are recited at a high level of generality and are used for extra-solution activity, such as data gathering necessary to perform the abstract idea. The additional element of wireless transmission via wireless communication circuitry also is merely a part of generic computer equipment used to perform extra-solutionary data delivery. As discussed above, the processor merely provides instructions to apply a judicial exception using a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)). Therefore, these elements do not provide an inventive concept sufficient to transform the claimed abstract idea into patent eligible subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-5 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "(NIR data)" renders the claim indefinite because it is unclear whether the limitation(s), “(NIR data)” that is in parenthesis, is intended to be claimed or not.
Regarding claim 1, the phrase "those values" renders the claim indefinite because it is unclear What the phrase is meant to refer to are part of the claimed invention.
Regarding claim2 the phrase "one or more of an inertial measurement circuitry included in an IMU and an optical tracker." renders the claim indefinite because it is unclear whether the limitation, (s) “one or more of an inertial measurement circuitry”, is modified by “included in an IMU” or “included in an IMU and an optical tracker”.
There may be two possible interpretations.1) Only the IMU has the “initial measurement circuitry” and 2) Both IMU and optical tracker include the circuitry.
Claim 3 recites the limitation "the oxygenation” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claim 1 ,2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over “Allen” (WO 2022212951 A1)) in view of “Siddiquee” (BioMed Eng OnLine (2018) 17: 120).
Regarding claim 1, Allen teaches a near-infrared tissue oxygenation scanner (Abstract: “A near-infrared spectroscopy system comprises a substrate, a light source emitting a set of wavelengths, an optical detector detecting the set of wavelengths, a processor in electronic communication with the light source bank and/or the optical detector, and a memory device in electronic communication with the processor” and “Program instructions direct the processor to calculate an oxygenation level”) comprising:
a mechanical housing (Figure 1; Paragraph 0097) containing
a near-infrared light source that emits near-infrared light (light source bank 220,230) (Paragraph 0037: “the first light source bank may be capable of emitting a first set of wavelengths of red or near-infrared light”);
an optical detector (optical detector 140) that detects the emitted near-infrared light after the emitted near-infrared light is absorbed and/or scattered by tissues (NIRS data) (Paragraph, 0076: “the optical detector may be configured to detect backscattered light from the first light source bank, the second light source bank, or a combination thereof, as the backscattered light travels through tissue”);
a processor that determines oxy- and deoxyhemoglobin values from the NIRS data (Paragraph 0084: “the system may further comprise program instructions stored on the memory device. In an embodiment, the program instructions may, when executed, direct the processor to perform various functions” and Paragraph 0086: “the functions may also include processing a signal from the optical detector to calculate an oxygenation level”) for wireless transmission via wireless communication circuitry (Paragraph 0139: “The system (100) of aspect 33, wherein the connection is selected from the group consisting of a wireless connection, a wired connection, a Bluetooth connection,”).
Allen teaches motion tracking circuitry configured to detect motion during operation and collect motion tracking data (Paragraph, 0096: “To aid in data correction to account for motion and signal variability, the system may use a motion sensing module to interpret and correct data as it is collected. This motion sensing module may also contribute unique physiological information to further enhance the quality and scope of the system’s monitoring capabilities.”). However, Allen is silent on motion tracking circuitry configured to detect motion of the scanner during operation, specifically, “to detect motion of the scanner”.
Siddiquee discloses motion tracking circuitry configured to detect motion of the scanner during operation and collect motion tracking data (Page 12, “this IMU was attached to the body of the NIR detector sensor OPT101 chip to record the true motion of this detector.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Allen’s teaching with Siddiquee’s teaching because it would provide improved correction of motion artefacts in NIRs data (Page 11 of Siddiquee: "implementation of multi-channel IMU data resulted in more accurate modelling of motion artefacts in NIRS, and thus we obtained more accurate motion artefacts free NIRS signal which can be used to detect physiological changes accurately.").
Regarding claim 2, Allen in view of Siddiquee teaches the scanner of claim 1 (See rejection of claim 1 above),
Allen does not teach “wherein the motion tracking circuitry includes one or more of an inertial measurement circuitry included in an IMU and an optical tracker”.
Siddiquee teaches teach wherein the motion tracking circuitry includes one or more of an inertial measurement circuitry included in an IMU and an optical tracker. (Page 1: “A wearable two-channel continuous wave NIRS system, incorporating an IMU sensor which contain accelerometer, gyroscope and magnetometer in it” and P12: “this IMU was attached to the body of the NIR detector sensor OPT101 chip to record the true motion of this detector as well as the movement of the subject body”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Allen’s teaching in view of Siddiquee’s teaching because such modification provides more accurate motion measurement and reduces motion-related artefacts. (Specifically, Siddinguee teaches that Page 3: “nine-channel Inertia Measurement Unit (IMU) data, namely accelerometer, gyroscope and magnetometer, are used to estimate the movement artefacts in NIRS signal and subsequently to remove the motion-related movement artefact.” (BioMed Eng OnLine (2018) 17: 120, Page 3))
Regarding claim 4, Allen in view of Siddiquee teaches the scanner of claim 2 (see rejection of claim 2 above),
Allen teaches wherein the wireless communication circuitry includes one or more of Bluetooth and WiFi communication circuitry (Paragraph,0140: “The system (100) of aspect 33, wherein the connection is selected from the group consisting of a wireless connection, a wired connection, a Bluetooth connection”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over “Allen” (WO 2022212951 A1)) in view of Siddiquee and “Cuccia” (WO2018175787 A1).
Regarding claim 3, Allen in view of Siddiquee teaches the scanner of claim 2 (see rejection of claim 2 above),
Allen does not teach “wherein the processor generates a 2D map of the oxygenation of the tissue”.
Supportively, Cuccia teaches teach wherein the processor generates a 2D map of the oxygenation of the tissue (Paragraph, 0062: “Accelerated Monte Carlo- based analysis of MTF data results in 2D maps of the quantitative absorption (μ.sub.3) and reduced scattering (μ.sub.δ') optical properties. Mapping the absorption coefficient at multiple wavelengths enables quantitative spectroscopy of tissue chromophores such as oxy- and deoxy-hemoglobin and water (ctOzHb, ctHHb, and ctH.sub.20”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Allen’s teaching in view of Siddinquee’s teaching because 2D map generation is a well-known technology for visualizing physiological parameters and spatial distribution of optical properties (Cuccia recites Page 17, Paragraph 0093: “Processor 2603 is configured to separately characterize multiple tissue compartments or regions, based on spatially distinct areas identified in the processed image data”)
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Allen in view of Siddiquee and “Scecina” (US 6741876).
Regarding claim 5, Allen in view of Siddiquee teaches the scanner of claim 1 (see rejection of claim 1 above),
Allen teaches “wherein the near-infrared light source generates multiple wavelengths” (Paragraph, 0075: “The second set of wavelengths may comprise 1 wavelength, 2 wavelengths, 3 wavelengths, 4 wavelengths, 5 wavelengths, 6 wavelengths, 7 wavelengths, 8 wavelengths, 9 wavelengths, 10 wavelengths, or any other number of wavelengths”). However, Allen is silent on “simultaneously”.
Scecina teaches that “the near-infrared light source generates multiple wavelengths simultaneously” by disclosing that “wherein, in respect of the AV and NIR region, there is used S50a polychromatic light Source or other radiation Source that emits a broad spectrum of light in the range from 500 nm to 1100 nm. For this range, the method comprises the steps of directing light at a continuum of wavelengths Simultaneously onto a body part of a Subject;” (Col 3. Line 14-27) and that “"According to another embodiment the radiation at all of the discrete wavelengths is provided simultaneously"(Col 4. Line 9-10). This disclosure indicates the near-infrared light source generates multiple wavelengths (a continuum or discrete wavelengths) simultaneously.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Allen’s teaching in view of Scecina’s teaching because one of ordinary skill in the art would have capable of generating multiple wavelengths of near-infrared light simultaneously, and such modification would have been predictable improvement. It would have been advantageous to apply multiple wavelengths simultaneously because simultaneous emission of multiple wavelengths would provide information not only about the desired analyte but also about interfering substances (Col 2. Line 7-11:" An advantage of full spectra measurements is that they provide information about the desired analyte as well as information about interfering Substances (e.g., other analytes) and effects (e.g., light Scattering)."
Conclusion
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/MORGAN SANGJO SHIM/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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