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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/31/2026 has been entered.
Claims 1, 3-5 and 12-14 are pending for examination. Claims 2 and 6-11 are cancelled.
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.
Claims 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kasahara et al. (USPGPUB 2015/0216454) in view of Rosenthal et al. (USPN 5,086,229). In regard to claims 1 and 14, Kasahara discloses a blood glucose measurement device capable of non- invasively measuring a blood glucose level (Figs. 1-13 and associated descriptions; glucose, abstract and [0034]), comprising: a light source (elements 53 and/or 53a and/or 210, Figs. 2-3, 7-10 and 13 and associated descriptions) configured to irradiate light having a wavelength selected from near infrared range (near infrared, [0040-0041]; a wavelength λ of light applied to the skin surface is changed within a near infrared region, [0063]); an image sensor having a plurality of pixels arranged in an array in a two-dimensional plane (elements 59/59a/59b and/or 220, Figs. 2-3, 7-10 and 13 and associated descriptions; CCD/ CMOS, [0041]; pixels, [0047-0049] and [0087]) and configured to receive light transmitted, reflected, or scattered in a living body and to output image information according to an amount of received light (image information generated in steps A3 and/or A15/A17, Figs. 2-3, 7-10 and 13 and associated descriptions; [0009-0010]; [0042]; [0053-0054]; [0060]); and blood glucose acquisition circuitry (element 310, Fig. 11 and associated descriptions) configured to analyze the image information to identify a blood vessel site in the living body (elements 312/314//316/318/320 and steps A5/A9/A11, Figs. 3-5, 11 and 13 and associated descriptions) and to acquire a blood glucose level based on an amount of received light at the identified blood vessel site (elements 318/320/322/324/326 and steps A11/A13/A15/A17/A19, Figs. 6-11 and 13 and associated descriptions; [0091-0092]) with reference to a calibration curve representing a relationship between the amount of received light and the blood glucose level (elements 324/326 and steps A19/A21, Figs. 11 and 13 and associated descriptions; calibration curve indicating a relationship between a predefined blood glucose level (a glucose concentration in blood) and an absorbance, [0067]).
Kasahara does not specifically disclose the light source configured to irradiate light having a wavelength selected from a wavelength band of 800 to 950 nm and the light having a wavelength of 810nm.
Rosenthal teaches an optical glucose monitoring device (Figs. 1-4 and 15 and associated descriptions) comprises a light source (elements 16/16’/116/116’, Figs. 1-2 and associated descriptions) and a wavelength of 810nm in the near infrared range is good for glucose measurement (810nm in K band, Fig. 15 and associated descriptions; Col 12 lines 9-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute at least one of the wavelengths in the near infrared range (Kasahara) with the 810nm as taught by Rosenthal to yield predictable results, since both devices are optical glucose monitoring systems and one of ordinary skill in the art would have recognized that 810nm is an alternative equivalent wavelength for glucose detection (see at least Col 12 lines 9-15 of Rosenthal). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
8. Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kasahara and Rosenthal as applied to claims 1 and 14 above, and further in view of Murata et al. “A 24.3Me— Full Well Capacity and High Near Infrared Sensitivity CMOS Image Sensor with Lateral Overflow Integration Trench Capacitor” Mar. 22, 2019 ITE Technical Report Vol. 43, No. 11 IST2019-17 – applicant cited. In regard to claims 3-5, Kasahara as modified by Rosenthal discloses all the claimed limitations except an SN ratio of the sensor is 60 dB or more, a saturation charge number of the sensor is 1,000,000 or more, and a photodiode quantum efficiency of the sensor with respect to a near-infrared light irradiated from the light source is 50% or more.
Murata teaches a CMOS image sensor suitable for non-invasive blood glucose measurements with spectral response form 200-1100nm (abstract; Figs. 1-10 and associated descriptions), the sensor achieved an SN ratio of the sensor is 60 dB or more (71.3 dB, abstract; Fig. 9 and associated descriptions), a saturation charge number of the sensor is 1,000,000 or more (a saturation charge number of 24,300,000, section 4, page 31; see also [0055] of the specification of the PGPUB of present application, AAPA), and a photodiode quantum efficiency of the sensor with respect to a near-infrared light irradiated from the light source is 50% or more (the photodiode quantum efficiency in the 200-1100nm range, Fig. 10 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device (Kasahara as modified by Rosenthal) to incorporate the CMOS sensor(s) as taught by Murata, since both sensors are CMOS sensors suitable for optical blood glucose measurements and one of ordinary skill in the art would have recognized that the CMOS sensor as taught by Murata has higher infrared sensitivity, SN ratio, saturation charge number, and photodiode quantum efficiency in the spectral range of 200-1100nm. The rationale would have been to obtain better optical detections/ measurements.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kasahara and Rosenthal as applied to claims 1 and 14 above, and further in view of Crothall (USPN 6,049,727). In regard to claims 12-13, Kasahara as modified by Rosenthal discloses the blood glucose acquisition circuitry is further configured to calculate a blood glucose level from an average absorption spectrum of each of a plurality of pieces of image information (blood vessel parts 6 and steps A11/A13/A15/A17/A19, Figs. 6 and 13 and associated descriptions; [0091-0092]; [0099] of Kasahara), wherein the plurality of pieces of image information are obtained from a plurality of frames constituting an image (a plurality sections of the image associated with each blood vessel parts, Figs. 6 and 13 and associated descriptions; [0091-0092]; [0099] of Kasahara) but does not specifically disclose to calculate a blood glucose level from each of a plurality of pieces of image information and output an average value or a median value of the calculated blood glucose levels.
Crothall teaches an optical glucose monitoring device (Figs. 1-10 and associated descriptions; glucose, abstract), wherein the calculation of a constituent concentration can be done by averaging each of the constituent concentrations obtained from N detected spectra or averaging N detected spectra then calculate the constituent concentration form the averaged spectra (Col 12 lines 33-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the average blood glucose calculation function (Kasahara as modified by Rosenthal) with the average calculation function as taught by Crothall, since both devices are optical glucose monitoring systems and one of ordinary skill in the art would have recognized that both calculation functions are alternative equivalent ways for obtaining improved optical measurements (see Crothall). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Response to Arguments
Applicant’s arguments with respect to claim 1 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Eguchi et al. (USPGPUB 2016/0218238) teaches a biological body information acquisition device (Figs. 1-2 and 6) comprises a light source (elements 40/43, Figs. 2 and 4) irradiate light in the near infrared range ([0045]); an image sensor (element 10, Figs. 2 and 4) obtains image information from the wrist area (Figs. 1-2 and 4); and circuitry (elements 165/168, Fig. 2), wherein the circuitry can, on the basis of image information on a blood vessel inside the wrist, identify the position of the blood vessel in the biological body and identify the blood sugar level by detection of the content of a specific component, for example, glucose, in the blood in the blood vessel in a noninvasive, optical manner ([0038]).
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/CHU CHUAN LIU/ Primary Examiner, Art Unit 3791
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