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 .
Drawings
The drawings were received on 3/16/2024. These drawings are acceptable.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“light emitting unit” in claims 1 and 5;
“light receiving unit” in claims 1 and 5;
“calculation unit” in claim 3;
“communication unit” in claim 5;
“terminal communication unit” in claim 5; and
“analysis unit” in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification (reference will be made to US PGPub 2024/0310279 A1) as performing the claimed function, and equivalents thereof:
Light emitting unit: Para. 0032 recites that a laser light emitting element 11 corresponds to an example of a light emitting unit;
Light receiving unit: Para. 0033 recites that a light receiving element 21 corresponds to an example of a light receiving unit; there is no specific recitation of what may correspond to a light receiving unit;
Calculation unit: Para. 0044 recites that a data processing unit 33 corresponds toa n example of a calculation unit. Para. 0044 further recites that the data processing unit calculates biological information using the light detection signal. The data processing unit 33 performs frequency analysis such as fast Fourier transform on the light detection signal. The data processing unit 33 calculates an intensity spectrum from the light detection signal by performing the frequency analysis. The data processing unit 33 calculates a blood volume, a blood flow, and the like from the intensity spectrum. The blood volume is an index related to the number of red blood cells per unit volume. The blood volume is an index related to a blood volume of the user M. The blood flow is a volume of blood moving in an artery per unit time. The blood flow is an index related to the blood flow of the user M. The data processing unit 33 may calculate a blood pressure or the like using the blood flow. The data processing unit 33 may calculate a pulse or the like using the light detection signal. The data processing unit 33 outputs the biological information such as the blood volume and the blood flow to the display control unit 35. The data processing unit 33 may transmit the biological information such as the blood volume and the blood flow to the memory 40, the communication interface 50, and the like;
Communication unit: Para. 0047 describes that a communication interface 50 corresponds to an example of a communication unit. The communication interface 50 is an interface circuit communicably connected with a tablet terminal 200. The communication interface 50 is connected to the tablet terminal 200 in a wired or wireless manner according to a predetermined protocol. The communication interface 50 includes, for example, a connection port for wired communication, an antenna for wireless communication, and the like. The communication interface 50 receives control data, information related to the user M, and the like from the tablet terminal 200. The communication interface 50 transmits various biological information to the tablet terminal 200. The communication interface 50 may transmit measurement data such as the light detection signal. The communication interface 50 may be communicably connected to an external apparatus other than the tablet terminal 200;
Terminal communication unit: Para. 0091 describes that a terminal communication interface 240 corresponds to an example of a terminal communication unit. The terminal communication interface 240 is a terminal interface circuit communicably connected with the measurement apparatus 100. The terminal communication interface 240 is connected to the measurement apparatus 100 in a wired or wireless manner according to a predetermined protocol. The terminal communication interface 240 includes, for example, a connection port for wired communication, an antenna for wireless communication, and the like; and
Analysis unit: Para. 0026 describes that a terminal control unit 220 corresponds to an example of an analysis unit. Para. 0085 describes that the terminal control unit is, for example, a terminal processor including a CPU.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-5 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 1 recites “has a first surface where the laser light enters and a second surface where the laser light entering the first surface enters”, which is unclear. Light is entering one surface. It is not understood what the second surface is for or where it is located relative to the second surface.
Claim 1 recites “a parallel axis parallel to an intersection line…is defined as a first axis” in lines 15-18. It is not understood what the intersection line is, parallel axis and its relationship with the light elements. Fig 4 is just a schematic. Items 21, 11 are three dimensional equipment placed in three dimensional spaces. Multiple lines can be drawn between the elements in space.
Claims 2-4 are ultimately dependent up on claim 1, and thus, inherit the same deficiencies.
Claim 5 recites “has a first surface where the laser light enters and a second surface where the laser light entering the first surface enters”, which is unclear. Light is entering one surface. It is not understood what the second surface is for or where it is located relative to the second surface.
Claim 5 recites “a parallel axis parallel to an intersection line…is defined as a first axis” in lines 19-22. It is not understood what the intersection line is, parallel axis and its relationship with the light elements. Fig 4 is just a schematic. Items 21, 11 are three dimensional equipment placed in three dimensional spaces. Multiple lines can be drawn between the elements in space.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sawada et al (US 2020/0323438 A1) in view of Ginner et al (US 2020/0201058 A1).
With respect to claim 1 Sawada discloses a biological information measurement apparatus (See Fig. 3) comprising:
a light emitting unit (VCSEL 20) configured to emit laser light to a living body (See Fig 3 and Para. 0055);
a light receiving unit (first photodiode 30) configured to receive scattered light generated when the laser light enters the living body (See Fig. 3 and Para. 0054);
a case (base 10 in combination with upper portion of sensor 200) accommodating the light emitting unit and the light receiving unit (See Figs. 1a and 3 and Para. 0054);
a light transmission member (acrylic plate 50) attached to the case at a position facing the living body (See Fig. 3, a part emitted light L1 is reflected by 52 and light beam L3, rest is passed through via 50 into skin); wherein
the light transmission member has a first surface where the laser light enters and a second surface where the laser light entering the first surface enters (In view of 112 rejection above, See Fig 3, mirror 52 and acrylic plate 50 have first and second surfaces where light enters).
Sawada fails to disclose D1 < D2, in which a parallel axis parallel to an intersection line between the first surface and an entering surface on which the light emitting unit and the first light receiving unit are disposed is defined as a first axis, an orthogonal axis orthogonal to the first axis on the first surface is defined as a second axis, Dl is a first diameter of the laser light along the first axis, and D2 is a second diameter of the laser light along the second axis.
Ginner, in a field of illumination systems that use light from semiconductor light sources teaches, D1 < D2 (See Fig. and Paras. 0033-0034, b for short / minor y-axis, is less than a for major long x-axis),
in which a parallel axis parallel to an intersection line between the first surface and an entering surface on which the light emitting unit and the first light receiving unit are disposed is defined as a first axis, an orthogonal axis orthogonal to the first axis on the first surface is defined as a second axis, Dl is a first diameter of the laser light along the first axis, and D2 is a second diameter of the laser light along the second axis (See Fig 1).
Ginner provides a light source that provides a light source that provides at least features like full output power, in line focusing, and flexible aspect rations (See Paras. 0009-0013).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in Sawada by utilizing the semiconductor light source in Ginner, as the LED 20 in Sawada, so as to achieve one or more of the performance improvements described in Ginner (See Paras. 0009-0013 of Ginner).
Claim(s) 3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sawada et al (US 2020/0323438 A1) in view of Ginner et al (US 2020/0201058 A1), and further in view of Peng (US 2005/0219526 A).
Refer above for the combined teachings of Sawada and Ginner.
With respect to claim 3 the combination of Sawada and Ginner does not teach a calculation unit configured to calculate biological information using a detection signal obtained by the light receiving unit receiving the scattered light.
Peng teaches, in a related field of monitoring biological substances teaches a basic probe 100 based on the scattering technique is schematically shown in FIGS. 1a & lb. The probe includes a light source 110 (or multiple light sources) and a photodetector 120 (or multiple photodetectors) such as a photodiode, a phototransistor or a photoconductive cell (CdS). The source 110 can be a monochromic source like a semiconductor laser source, Light Emission Diode (LED) or a non-monochromic source like ordinary flash lamp, tungsten lamp and broadband LED. The source 110 can be in UV, visible or NIR wavelength. The detector 120 is to detect the scattered light from a medium 550 through a transparent wall of a biological medium container 500 when the light source 110 emits light on the medium 550. The calculation unit is being interpreted as the detector 120 (See Para. 0030 and Figs. 1b and 11). A differential detection scheme with a precision instrumentation amplifier as shown in FIG. 11 can reduce the detector electronic noise that including light source and sensor noise. This scheme also reduces the influence of thermal drift (See Para. 0048).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in combined Sawada and Ginner by integrating differential detection, as taught by Peng, in order to reduce the detector electronic noise and influence of thermal drift (See Para. 0048 of Peng).
With respect to claim 5 Sawada discloses a biological information measurement system comprising:
A biological measurement apparatus (See Fig. 3) including a light emitting unit (VCSEL 20) configured to emit laser light to a living body (See Fig 3 and Para. 0055);
a light receiving unit (first photodiode 30) configured to receive scattered light generated when the laser light enters the living body (See Fig. 3 and Para. 0054);
a case (base 10 in combination with upper portion of sensor 200) accommodating the light emitting unit and the light receiving unit (See Figs. 1a and 3 and Para. 0054);
a light transmission member (acrylic plate 50) attached to the case at a position facing the living body (See Fig 3, tems 50, 52, a part emitted light L1 is reflected by 52 and light beam L3, rest is passed through via 50 into skin); and
a communication unit configured to transmit the detection signal (See Para. 0051 for discussion of how the blood flow volume sensor and the electronic equipment 300 are connected to each other through a wire or wirelessly); and
a control apparatus including a terminal communication unit configured to receive the detection signal (See Paras. 0084 and 0088 for discussion of a processor in the electronic equipment 300), wherein
the light transmission member has a first surface where the laser light enters and a second surface where the laser light entering the first surface enters (In view of 112 rejection above, See Fig 3, mirror 52 and acrylic plate 50 have first and second surfaces where light enters).
Sawada fails to disclose and an analysis unit configured to analyze biological information of the living body using the detection signal D1 < D2, in which a parallel axis parallel to an intersection line between the first surface and an entering surface on which the light emitting unit and the first light receiving unit are disposed is defined as a first axis, an orthogonal axis orthogonal to the first axis on the first surface is defined as a second axis, Dl is a first diameter of the laser light along the first axis, and D2 is a second diameter of the laser light along the second axis.
Ginner, in a field of illumination systems that use light from semiconductor light sources teaches, D1 < D2 (See Fig. and Paras. 0033-0034, b for short / minor y-axis, is less than a for major long x-axis),
in which a parallel axis parallel to an intersection line between the first surface and an entering surface on which the light emitting unit and the first light receiving unit are disposed is defined as a first axis, an orthogonal axis orthogonal to the first axis on the first surface is defined as a second axis, Dl is a first diameter of the laser light along the first axis, and D2 is a second diameter of the laser light along the second axis (See Fig 1).
Ginner provides a light source that provides a light source that provides at least features like full output power, in line focusing, and flexible aspect rations (See Paras. 0009-0013).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in Sawada by utilizing the semiconductor light source in Ginner, as the LED 20 in Sawada, so as to achieve one or more of the performance improvements described in Ginner (See Paras. 0009-0013 of Ginner).
The combination of Sawada and Ginner fails to teach analysis unit configured to analyze biological information of the living body using the detection signal.
Peng teaches, in a related field of monitoring biological substances teaches a basic probe 100 based on the scattering technique is schematically shown in FIGS. 1a & lb. The probe includes a light source 110 (or multiple light sources) and a photodetector 120 (or multiple photodetectors) such as a photodiode, a phototransistor or a photoconductive cell (CdS). The source 110 can be a monochromic source like a semiconductor laser source, Light Emission Diode (LED) or a non-monochromic source like ordinary flash lamp, tungsten lamp and broadband LED. The source 110 can be in UV, visible or NIR wavelength. The detector 120 is to detect the scattered light from a medium 550 through a transparent wall of a biological medium container 500 when the light source 110 emits light on the medium 550. The calculation unit is being interpreted as the detector 120 (See Para. 0030 and Figs. 1b and 11). A differential detection scheme with a precision instrumentation amplifier as shown in FIG. 11 can reduce the detector electronic noise that including light source and sensor noise. This scheme also reduces the influence of thermal drift (See Para. 0048).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in combined Sawada and Ginner by integrating differential detection, as taught by Peng, in order to reduce the detector electronic noise and influence of thermal drift (See Para. 0048 of Peng).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sawada et al (US 2020/0323438 A1) in view of Ginner et al (US 2020/0201058 A1), and further in view of Varadan et al (US 2013/0211208 A1).
Refer above for the combined teachings of Sawada and Ginner.
With respect to claim 4 the combination of Sawada and Ginner fails to teach a band to be attached to the case and wound around the living body, wherein the band is attached parallel or substantially parallel to an arrangement direction of the light emitting unit and the second light receiving unit.
Varadan, in a related field of electronic and optical sensor technologies, teaches a band to be attached to the case and wound around the living body (See Fig. 1 and Para. 0029 for discussion of an arm band for estimation of arterial blood pressure or blood flow volume), wherein the band is attached parallel or substantially parallel to an arrangement direction of the light emitting unit and the second light receiving unit (In view of 112 (b) rejection, emitter and detector array are substantially parallel to band).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus in combined Sawada and Ginner by mounting sensors in textiles in order to achieve un-obstructive and long term health monitoring (See Paras. 0010 and 0013 of Varadan).
Allowable Subject Matter
Claim 2 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest cited prior art of reference fails to disclose or fairly teach the incorporation of equation D1 < (t x sinϴ)/n, in which D1 is the first diameter, θ is an entering angle of the laser light to the first surface, t is a thickness of the light transmission member, and n is a refractive index of the light transmission member.
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Conclusion
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/BRITTANY I FISHER/Examiner, Art Unit 1796 August 8, 2026
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