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 .
The preliminary amendments filed on 09/01/2023 are acknowledged.
Claims 36-55 are pending for examination. Claims 1-35 are cancelled.
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.
Claims 43-46 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. Claims that depend directly or indirectly from claim 43 is/are also rejected due to said dependency.
In regard to claim 43, the claim is a dependent claim of the cancelled claim 1. The dependency is not clearly recited. Clarification is requested by amendments.
In regard to claim 45, the claim recites “the first wavelength is longer than the thickness of the biological material, and wherein the second wavelength is shorter than the thickness of the biological material”. However, claim 36 recites “first wavelength between 400 nanometers and 25 micrometers… a second wavelength between 1 millimeter and 30 centimeters”. It is unclear what thickness recited in claim 45 is intended, since it is required that 400nm - 25µm is LONGER than the thickness AND 1mm – 30cm is SHORTER than the thickness. Clarification is requested by amendments.
In regard to claim 46, the claim recites “the first signal at approximately 1370 nm and approximately 1630 nm and the second signal at approximately 8.2 mm”. The term “approximately “ is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what degree of variance is approximately considered as approximately of the recited lengths.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 36-42, 44-51 and 54-55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sharma et al. (WO 2016/080911 – applicant cited). In regard to claims 36 and 48, Sharma discloses a method and an associated system for measuring glucose concentration in a biological material, (Figs. 1-14 and associated descriptions), the method comprising: irradiating the biological material with optical radiation having a first wavelength between 400 nanometers and 25 micrometers (element 126, Fig. 2 and associated descriptions; wavelength(s) in the light spectroscopy section, Fig. 13 and associated descriptions; lines 6-18 of page 14); detecting a first signal from the biological material at the first wavelength (element 126, Fig. 2 and associated descriptions; light spectroscopy section, Fig. 13 and associated descriptions; lines 6-18 oof page 14); irradiating the biological material with radio-frequency (RF) radiation having a second wavelength between 1 millimeter and 30 centimeters ( ); detecting a second signal from the biological material at the second wavelength (antenna, lines 6-18 of page 14; RF wave section, Fig. 13 and associated descriptions); and determining a concentration of glucose in the biological material based on the first signal and the second signal (elements in 102/104/108 and “final glucose value”, Figs. 1-2, 5-6 and 13 and associated descriptions).
In regard to claim 37, Sharma discloses the first wavelength is between 780 and 2500 nm (wavelengths in the in the light spectroscopy section, Fig. 13 and associated descriptions).
In regard to claim 38, Sharma discloses the second wavelength is less than 2 centimeters (24-24.25 GHz, equivalent to about 1.18 - 1.24 cm, lines 14-25 of page 11; lines 6-18 of page 14; RF wave section, Fig. 13 and associated descriptions).
In regard to claim 39, Sharma discloses irradiating the biological material at a third wavelength between 400 nanometers and 25 micrometers (1450nm, Fig. 13 and associated descriptions), wherein an interaction of glucose with the optical radiation at the third wavelength is independent of the concentration of glucose (It is noted that 1450nm is a strong absorption wavelength as compared to glucose; evidence can be found at least in Fig. 4 and associated descriptions of Amano et al, USPGPUB 2010/0256920); and detecting a third signal at an optical radiation detector, wherein the determining the concentration of glucose is further based on the third signal (light spectroscopy and final glucose value sections, Fig. 13 and associated descriptions).
In regard to claim 40, Sharma discloses the third wavelength is between 1400 and 1550 nm (1450 nm, Fig. 13 and associated descriptions).
In regard to claim 41, Sharma discloses the first signal is a reflection signal reflected off the biological material (hermetic sensor patch for arm, lines 16-20 of page 8; Fig. 5 and 6 and associated descriptions; it is interpreted that when the sensors are being integrated in a sensor patch for arm, the detected optical signal comprises reflection signals).
In regard to claim 42, Sharma discloses the first signal is a transmission signal transmitted through the biological material (folding, Fig. 5 and 6 and associated descriptions).
In regard to claim 44, Sharma discloses creating a fast Fourier transform (FFT) of the second signal, wherein the determining the concentration of glucose includes using the FFT of the second signal (FFT, line 20 of page 29 – line 15 of page 32).
In regard to claim 45, Sharma discloses the biological material has a thickness (the skin tissue comprises many structures and/or substructures with thickness(es) in the nm, micron, mm and/or cm ranges, such as cell membrane or skin layer; Fig. 6 and associated descriptions), wherein the first wavelength is longer than the thickness of the biological material (wavelength(s) in the light spectroscopy section, Fig. 13 and associated descriptions; lines 6-18 of page 14), and wherein the second wavelength is shorter than the thickness of the biological material (24-24.25 GHz, equivalent to about 1.18 - 1.24 cm, or 61-61.5 GHz, line 14 of page 11 – line 9 of page 5; lines 6-18 of page 14; RF wave section, Fig. 13 and associated descriptions).
In regard to claim 46, Sharma discloses the determining the concentration of glucose involves inputting the first signal and the second signal into a machine learning model (machine learning, Fig. 4 and associated descriptions) based on the first signal at approximately 1370 nm and approximately 1630 nm and the second signal at approximately 8.2 mm (rejected as best understood, see the 35 USC 112(b) rejection above; wavelengths and Mm-wave/ RF wave, Fig. 13 and associated descriptions).
In regard to claim 47, Sharma discloses the biological material is selected from the group consisting of: a web of skin between a finger and a thumb, an earlobe, an armpit, a wrist, a lip, and a foodstuff (Fig. 6 and associated descriptions; lines 4-10 of page 26).
In regard to claim 49, Sharma discloses a holder that secures the biological material in a fixed position with respect to the optical radiation source, the optical radiation detector, the RF radiation source, and the RF radiation detector (Fig. 5 and associated descriptions; hermetic sensor patch for arm, lines 16-20 of page 8).
In regard to claim 50, Sharma discloses the holder is configured to secure the optical radiation source and the optical radiation detector on opposite sides of the biological material, and to secure the RF radiation source and the RF radiation detector on opposite sides of the biological material (folding, Figs. 5-6 and associated descriptions).
In regard to claim 51, Sharma discloses the first signal is a reflection signal, and wherein the holder is configured to secure the optical radiation source and the optical radiation detector on the same side of the biological material (referring to claim 41 above; Fig. 5 and associated descriptions; hermetic sensor patch for arm, lines 16-20 of page 8).
In regard to claim 54, Sharma discloses the RF radiation source and the RF radiation detector are a single antenna (lines 7-10 of page 14; element 124, Fig. 2 and associated descriptions),
In regard to claim 55, Sharma discloses a communication interface coupled between the RF radiation detector and the processing device, wherein the communication interface comprises a wireless connection (wireless communications 144/146/148, Figs. 1-2 and associated descriptions).
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.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Sharma as applied to claims 36-42, 44-51 and 54-55 above, and further in view of Boyden et al. (USPGPUB 2009/0281412). In regard to claim 42, Sharma discloses all the claimed limitations except modulating the optical radiation and the RF radiation, wherein the modulating is selected from the group consisting of: amplitude modulation, frequency modulation, and phase modulation.
Boyden teaches a wearable biological system (Figs. 1-5 and associated descriptions) comprises an energy emitter (elements 104/106, Figs. 1-5 and associated descriptions) configured to emit energy in infrared, near infrared, microwave, and radio frequency spectrum ([0099]) and a modulation component for modulating the amplitude, frequency or phase of the energy ([0227]).
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 method (Sharma) to incorporate the modulation(s) as taught by Boyden to the optical and RF radiations, since both devices are biological monitoring systems and one of ordinary skill in the art would have recognized that amplitude, frequency or phase modulation(s) of emitted energy facilitate modulating the emitted infrared, near infrared and/or RF energy to be emitted into the tissue site (see Boyden). The rationale would have been to modulate the optical and RF radiations and facilitate detection of the radiations.
Claims 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Sharma as applied to claims 36-42, 44-51 and 54-55 above, and further in view of Della et al. (USPGPUB 2012/0271121). In regard to claims 53-53, Sharma discloses the system can be worn on the wrist of the user (lines 4-10 of page 26) but does not specifically discloses a holder comprises a wearable strap for attaching to the biological material and an optical filter disposed between the biological material and the optical radiation detector, wherein the optical filter transmits the first wavelength and filters out other wavelengths.
Della teaches a biological sensing device (Figs. 1-6 and associated descriptions) comprises a holder (element 100, Figs. 1 and 6 and associated descriptions) comprises a wearable strap for attaching to the biological material (element 110, Fig. 6 and associated descriptions; [0026]), wherein the device includes a plurality of sensors (Figs. 1-6 and associated descriptions; [0018] and an optical filter disposed between the biological material and the optical radiation detector (element 304, Fig. 3 and associated descriptions; [0033]; claims 1-2), wherein the optical filter transmits the first wavelength and filters out other wavelengths (glucose, [0033]).
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 method (Sharma) to incorporate the holder and associated wearable strap and optical filter(s) and associated elements/functions as taught by Della, since both devices tissue/ glucose monitoring systems with multiple sensors and one of ordinary skill in the art would have recognized that a strap facilitates securing the sensor system on the wrist of the user and optical filter(s) passes particular wavelength(s) or range of wavelengths (see Della). The rationale would have been to better secure the device on the wrist and reduce optical noise.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lee et al. (USPGPUB 2020/0178822) teaches a far-infrared emitter device (Figs. 1-4) comprises a far-infrared module (element 20, Figs. 1 and 3) and a microwave detecting module (element 10, Figs. 1-3) including an antenna (element 111, Fig. 2), wherein the antenna is utilized to transmit and detect RF signals ([0027]).
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791