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 Accounting
Applicant's arguments, filed 06/10/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 06/10/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 5, 8, 10-12, 14-15, and 18-19 have been amended.
Claims 4 and 9 have been cancelled.
Claims 1-3, 5-8, and 10-20 are the current claims hereby under examination.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 recites “the plurality of temperature control unit” in line 8. This should read “the plurality of temperature control units”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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 1-2, 5-8, 10-13, 15-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication 2004/0132171 by Rule et al. – previously cited (hereinafter “Rule”).
Regarding claim 1, Rule teaches a biological information acquisition device (Fig. 21, noninvasive system 500) comprising:
a light reception element (Fig. 21, [0181]; optical window assembly 12 and detectors 28 are considered the light reception element, optical window assembly 12 is a part of optical input 506) configured to measure a radiation spectrum ([0200]; “electromagnetic radiation E omitted by the body can enter said first wearable module 503 via the optical input 506) emitted from a measurement part (the radiation is emitted from a portion of the wearer’s body that contacts optical input 506), wherein the light reception element includes a thermal conductor (Fig. 21, [0049]; Cooling system 14 comprises surface 14b which is in thermally conductive relation to heat sink 18 and is therefore considered a thermal conductor);
a temperature control unit (Fig. 21; cooling system 14 and heater layer 34 of window assembly 12) configured to control temperature of the light reception element ([0073]; “It is contemplated that the cooling system 14, the heater layer 34, or both, can be operated to induce a desired time-varying temperature in the window assembly 12 to create an oscillating thermal gradient in the sample S”); and
circuitry (Fig. 21, [0185]; control system 512, which is generally similar to control system 30) configured to: extract signals synchronized with heat transfers performed by the temperature control unit ([0138-0139]; The induced temperature gradients are used to determine the magnitude of the phase signal and therefore the analyte concentration. The induced temperature gradients are determined by the signals at the times of cooling and heating, and are therefore synchronized with the heat transfers.), and acquire biological information ([0047, 0116]; detecting the concentration of an analyte) based on the extracted signals, and a plurality of measurement results obtained from the light reception unit ([0116, 0138-0139]; concentration of an analyte of interest can be determined by comparing the time-varying intensity profiles of the various measured wavelengths, which is based on the synchronized signals pertaining to the heating and cooling).
Regarding claim 2, Rule teaches the biological information acquisition device according to claim 1, wherein the radiation spectrum is radiation from a plurality of measurement parts, and the plurality of measurement parts include the measurement part. The device of claim 1 is capable of measuring a plurality of measurement parts and therefore the radiation spectrum can contain radiation from a plurality of measurement parts (The radiation is obtained from portion 514 of the wearer’s body that is in contact with the optical input 506. There are more locations along portion 514 that can be used as measurement parts.).
Regarding claim 5, Rule teaches the biological information acquisition device according to claim 1, wherein the light reception element further includes an optical filter (Fig. 21, [0201]; filters 24).
Regarding claim 6, Rule teaches the biological information acquisition device according to claim 5, wherein the light reception unit is further configured to receive light transmitted through the optical filter (Fig. 21, [0051]; concentrators 26 concentrate the infrared energy E after it passes through the optical filters 24 before reaching the detectors 28. The detectors 28 are considered a part of the light reception element).
Regarding claim 7, Rule teaches the biological information acquisition device according to claim 5, wherein the light reception element further includes a lens (Fig. 21, collimator 22) that makes light incident on the optical filter. It is noted that in par. [0054] of the written description of the published instant application, Applicant defines the lens as “not particularly limited as long as the light incident on an optical filter 113 described later can be made substantially parallel.” Par. [0095] of Rule teaches: “The collimator 22 aligns the infrared energy E to propagate in a direction that is generally parallel to the longitudinal axis A-A of the mixer 20 and the collimator 22, so that the infrared energy E will strike the surface of the filters 24 at an angle as close to 90 degrees as possible.” Therefore, the collimator 22 of Rule is considered to be a lens.
Regarding claim 8, Rule teaches the biological information acquisition device according to claim 1, further comprising a spectroscope (Fig. 21; The spectroscope is defined as second module 525) configured to separate the radiation spectrum incident on the light reception element into spectral components ([0101]; the array of filters separate the incident radiation by filtering in four separate bandpass wavelengths), wherein the radiation spectrum emitted from the corresponding measurement part is introduced into the spectroscope (Fig. 21; The spectroscope is defined as second module 525) via an optical fiber (Fig. 21, [0202]; Fiber optic cable 550 receives electromagnetic radiation from the optical input 506 and transmits it to the spectroscope).
It is noted that the limitation of “the radiation spectrum emitted from the measurement part is introduced into a spectroscope via an optical fiber” does not impart any structure on the biological information acquisition device or the light reception element, as it is directed towards the radiation spectrum which is not a claimed element of the device. Therefore, any device meeting the limitations of a light reception element configured to measure a radiation spectrum emitted from a measurement part is capable of measuring any incident radiation spectrum on the light reception element.
Regarding claim 10, Rule teaches the biological information acquisition device according to claim 2, wherein the control of the temperature is based on a Peltier effect ([0073]; the cooling system 14 is used for control of the temperature and the cooling system is preferably comprises a Peltier-type thermoelectric device.).
Regarding claim 11, Rule teaches the biological information acquisition device according to claim 10, wherein the plurality of measurement parts are arranged in a plane (The plurality of measurement parts can comprise a tissue such as a forearm ([0048]). Therefore multiple sites on the forearm can comprise a plane.) and the temperature control unit is positioned such that the heat transfers occur in a direction parallel to the plane including the plurality of measurement parts. As the heater layer is employed to heat the material sample S ([0049]), the heat transfers occur in a direction parallel to longitudinal axis A-A (Fig. 1). This direction would be parallel to the measurement window 12 and parallel to a flat plan of measurement parts.
Regarding claim 12, Rule teaches the biological information acquisition device according to claim 1, wherein the temperature control unit in configured to change temperature over time ([0073]; cooling system 14 and the heater layer 34 can be operated to induce a time-varying temperature).
Regarding claim 13, Rule teaches the biological information acquisition device according to claim 12, wherein the temperature control unit is further configured to raise and lower temperature over time. An oscillating thermal gradient can be obtained by heating and cooling (i.e. raising and lowering the temperature) in a cyclic pattern ([0137]).
Regarding claim 15, Rule teaches the biological information acquisition device according to claim 1, wherein the control of the temperature is based on adjustment of a current flowing through the temperature control unit. Current drivers 78 are a part of the control system 30 (and thereby the control system 511) and regulate the power ([0055, 0073]; via an electrical current) supplied to the heater layer 34 and/or to the cooling system 14 in the temperature control subsystem based on adjustments to the control signal(s) ([0108]).
Regarding claim 16, Rule teaches the biological information acquisition device according to claim 15, wherein a constant current circuit is configured to ([0108]; current driver 78 in the temperature control subsystem of the control system 30 (and thereby control system 511)) adjust the current flowing through the temperature control unit (See the rejection of claim 15).
Regarding claim 17, Rule teaches the biological information acquisition device according to claim 1, wherein the circuitry is further configured to acquire biological information based on differential signals from the plurality of measurement results. The concentration of an analyte (e.g. biological information) is determined by changes in the phase difference (e.g. differentials based on the plurality of measurement results) ([0122-0134] and [0135-0148]).
Regarding claim 19, Fig. 21 of Rule teaches a biological information acquisition method comprising: measuring, by a light reception element (Fig. 21, [0181]; Optical input 506 comprises window assembly 12 and detectors 28), a radiation spectrum emitted from a measurement part (Fig. 21, [0116]; Radiation travels through window assembly 12 and to detectors 28 are used to detect the infrared energy emitted by the material sample S in various desired wavelengths), wherein the light reception element includes a thermal conductor (Fig. 21, [0049]; Cooling system 14 comprises surface 14b which is in thermally conductive relation to heat sink 18 and is therefore considered a thermal conductor); controlling, by a temperature control unit (Fig. 21; cooling system 14 and heater layer 34 of window assembly 12), temperature of the light reception element ([0073]; “It is contemplated that the cooling system 14, the heater layer 34, or both, can be operated to induce a desired time-varying temperature in the window assembly 12 to create an oscillating thermal gradient in the sample S”); extracting, by circuitry, signals synchronized with heat transfers performed by the temperature control unit ([0138-0139]; The induced temperature gradients are used to determine the magnitude of the phase signal and therefore the analyte concentration. The induced temperature gradients are determined by the signals at the times of cooling and heating, and are therefore synchronized with the heat transfers.) and acquiring, by the circuitry (Fig. 21, control system 511), biological information on based on the extracted signals and a plurality of measurement results obtained from the light reception element ([0179, 0185]; The control system 511 is generally similar to control system 30, wherein “concentration of an analyte of interest can be determined by comparing the time-varying intensity profiles of the various measured wavelengths”. [0116, 0138-0139]; concentration of an analyte of interest can be determined by comparing the time-varying intensity profiles of the various measured wavelengths, which is based on the synchronized signals pertaining to the heating and cooling).
Regarding claim 20, Rule teaches the biological acquisition device according to claim 1, wherein the spectroscope corresponds to one of a Fourier Transform Infrared (FT-IR) spectroscope or a dispersive spectroscope. Par. [0148] of Rule teaches that “During analysis, the data can be separated by frequency (using Fourier transform or other techniques) and independent measurements of phase delay at each of the driving frequencies may be calculated. Once resolved, the two sets of phase delay data are processed to determine absorbance and analyte concentration.” As the spectrometer may use a Fourier transform to analyze the received radiation spectrum, the spectrometer corresponds to an FT-IR spectrometer.
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 3, 14, and 18 is rejected under 35 U.S.C. 103 as being unpatentable over Rule.
Regarding claim 3, Rule teaches the biological information acquisition device according to claim 2, but does not teach the device further comprising a plurality of light reception elements, wherein each of the light reception elements is associated with a corresponding measurement part of the plurality of measurement parts, and the plurality of light reception elements include the light reception element.
However, according to MPEP § 2144.04-VI-B, the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified Rule to include a plurality of light reception elements and associated elements (such as temperature control units, as Rule teaches a temperature control unit to be provided for each light reception element). The modification to Rule would increase the number of measurement parts that can be monitored, increasing the amount of biological information that can be monitored. In the modification, each of the plurality of light reception elements would be associated with a corresponding measurement part. No unexpected results would occur from the duplication of the light reception elements, and the plurality of light reception elements would include the light reception element.
Regarding claim 14, Rule teaches the biological information acquisition device according to claim 13, but does not teach further comprising a plurality of the temperature control units, wherein each of the plurality of temperature control units is adjusted to a different temperature, and the plurality of temperature control units includes the temperature control unit.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the device of Rule to include a plurality of light reception elements and associated elements, as described above in claim 3, in order to increase the number of measurement parts that can be monitored, increasing the amount of biological information that can be monitored. The resulting device would further comprise a plurality of the temperature control units (the modification of claim 3 duplicated the light reception elements, which would result in a duplication in each of the components associated with a light reception element. Components associated with each light reception element includes the temperature control unit, as each light reception element comprises is associated with a temperature control unit.).
It is noted that each of the temperature control units modified Rule is capable of varying the temperature, thereby adjusting the temperatures ([0073, 0137]). Therefore, each of the plurality of temperature control units is capable of being adjusted to a different temperature, and the plurality of temperature control units includes the temperature control unit.
Regarding claim 18, Rule teaches a biological information acquisition system, comprising: a plurality of light reception elements configured to measure a radiation spectrum emitted from a plurality of measurement parts (See the rejections of claims 1-3), wherein each of the plurality of light reception elements includes a thermal conductor (See the rejection of claims 1 and 3); a plurality of temperature control units, wherein each temperature control unit of the plurality of temperature control units is configured to control temperature of a corresponding light reception element of the plurality of light reception elements (See the rejections of claims 1-3); and circuitry configured to: extract signals synchronized with heat transfers performed by the plurality of temperature control units (See the rejection of claim 1), and acquire biological information based on the extracted signals (See the rejection of claim 1), and a plurality of measurement results obtained from the plurality of light reception elements (See the rejection of claims 1-3).
It is noted that a plurality of measurement results would be obtained from each of the plurality of light reception elements. Biological information is obtained from each of the plurality of measurement results of the plurality of light reception elements. This set of biological information can simply be considered biological information.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered.
The amendments to claims 14 and 20 overcome the objections of record.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claims 8 and 20.
The amendments to the claims overcome the rejections under 35 U.S.C. 101.
Applicant’s assertions regarding the rejection of claims 1 and 19 under 35 U.S.C. 102(a)(1) and claim 18 under 35 U.S.C. 103 are acknowledged. These assertions are moot as they are based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON A GLOVER whose telephone number is (571)270-0971. The examiner can normally be reached Mon-Fri 8:00-5:00 EST.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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