DETAILED ACTION
Applicant’s arguments, filed on 01/07/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 01/07/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-3, 7-12, and 14-20 are the current claims hereby under examination.
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
Claims 1 and 17 are objected to because of the following informalities:
In claim 1, line 6, “a wavelength region” should read “the wavelength region”
In claim 17, line 5, “a wavelength region” should read “the wavelength region”
In claim 17, lines 8-9, “ a wavelength region” should read “the wavelength region”
In claim 17, line 10, “a wavelength region” should read “the wavelength region”
Appropriate correction is required.
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 1-3, 7-12, and 14-20 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.
Regarding claim 1, the claim recites the limitation “the light reflection signal for the first reference wavelength channel” in line 24. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to refer to the light reflection signal from line 10, or a different light reflection signal. If it is referring to the light reflection signal from line 10, it needs to refer back to it. If it is referring to a different light reflection signal, it needs to be distinguished from the light reflection signal from line 10. For purposes of examination, it is being interpreted as referring to the light reflection signal from line 10. Claims 2-3, 7-12, and 14-16 are also rejected due to their dependence on claim 1.
Further regarding claim 1, the claim recites the limitation “the light reflection signal for the first blood glucose search wavelength channel or the second blood glucose search wavelength channel” in lines 24-26. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to refer to the light reflection signal from line 10, or a different light reflection signal. If it is referring to the light reflection signal from line 10, it needs to refer back to it. If it is referring to a different light reflection signal, it needs to be distinguished from the light reflection signal from line 10. For purposes of examination, it is being interpreted as referring to the light reflection signal from line 10. Claims 2-3, 7-12, and 14-16 are also rejected due to their dependence on claim 1.
Further regarding claim 1, the claim recites the limitation “the transmission signal for the second reference wavelength channel” in line 27. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to refer to the transmission signal from line 8, or a different transmission signal. If it is referring to the transmission signal from line 8, it needs to refer back to it. If it is referring to a different transmission signal, it needs to be distinguished from the transmission signal from line 8. For purposes of examination, it is being interpreted as referring to the transmission signal from line 8. Claims 2-3, 7-12, and 14-16 are also rejected due to their dependence on claim 1.
Further regarding claim 1, the claim recites the limitation “the transmission signal for the first blood glucose search wavelength or the second blood glucose search wavelength channel” in lines 27-29. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to refer to the transmission signal from line 8, or a different transmission signal. If it is referring to the transmission signal from line 8, it needs to refer back to it. If it is referring to a different transmission signal, it needs to be distinguished from the transmission signal from line 8. For purposes of examination, it is being interpreted as referring to the transmission signal from line 8. Claims 2-3, 7-12, and 14-16 are also rejected due to their dependence on claim 1.
Further regarding claim 1, the claim recites the limitation “the second light source unit and the second receiving unit are arranged on both sides of the first light source unit” in lines 36-37. It is unclear if this limitation is requiring the second light source unit to be on both sides of the first light source unit, the second receiving unit is on both sides of the first light source unit, or the light source on one side of the first light source unit and the receiving unit on the other side. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to any of these configurations. Claims 2-3, 7-12, and 14-16 are also rejected due to their dependence on claim 1.
Regarding claim 17, the claim recites the limitation “a light reflection signal” in line 18 and line 19. It is unclear if this limitation is meant to be included in the light reflection signal from line 12, or is a different light reflection signal. If it is meant to be included in the light reflection signal from line 12, it needs to refer back to it. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as being included in the light reflection signal from line 12. Claims 18-20 are also rejected due to their dependence on claim 17.
Further regarding claim 17, the claim recites the limitation “a transmission signal” in lines 21 and 22. It is unclear if this limitation is meant to be included in the transmission signal from line 14, or is a different transmission signal. If it is meant to be included in the transmission signal from line 14, it needs to refer back to it. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as being included in the transmission signal from line 14. Claims 18-20 are also rejected due to their dependence on claim 17.
Further regarding claim 17, the claim recites the limitation “the transmission signal” in line 26. It is unclear if this is meant to refer to the transmission signal from line 14, the transmission signal from line 21, the transmission signal from line 22, or a different transmission signal. If it is meant to refer to any of the previously introduced transmission signals, it needs to refer back to it. If it is referring to a different transmission signal, it needs to be distinguished from all of the previously presented transmission signal. For purposes of examination, it is being interpreted as referring to any of the previously presented transmission signals. Claims 18-20 are also rejected due to their dependence on claim 17.
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.
Claims 1, 3, 9, 12, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Maguluri (US 20220142520) in view of Gerber (US 6952603).
Regarding independent claim 1, Maguluri teaches a noninvasive blood glucose measurement apparatus ([0002]: “The present invention relates to a non-invasive glucometer for monitoring glucose levels in blood”) comprising:
a first light source unit disposed in a probe ([0013]: “The glucometer comprises a curved test surface with a transparent test site. The curved test surface is configured to accommodate a finger-tip when the finger-tip is placed on the transparent test site for non-invasively measuring concentration of glucose in blood. The glucometer further comprises an enclosing lid configured to enclose the finger-tip placed on the transparent test site. The glucometer further comprises a light source assembly comprising light emitting diodes (LEDs), placed underneath the transparent test site.”. The glucometer is the probe and one of the light emitting diodes is the first light source unit.) and configured to irradiate light of at least one wavelength channel in a wavelength region of 900 nm to 1700 nm to a biological tissue ([0031]: “the light source assembly 108 comprises multiple LEDs 108a-108c. In an embodiment, the light source assembly 108 comprises three distinct wavelengths of light emitting diodes (LEDs) 108a-108c. Therefore, the value of ‘n’ in the dimension of the data matrix ranges from 1 to 3. A first of the distinct LEDs, for example, 108a, is a red LED operating with a wavelength of 650 nanometers, a second of the distinct LEDs, for example, 108b, is a near-infrared (NIR) LED operating at a wavelength of 940 nanometers, and a third of the distinct light emitting diodes, for example, 108c, is a near-infrared (NIR) LED operating at a wavelength of 1160 nanometers”);
a second light source unit disposed in the probe ([0013]: “The glucometer comprises a curved test surface with a transparent test site. The curved test surface is configured to accommodate a finger-tip when the finger-tip is placed on the transparent test site for non-invasively measuring concentration of glucose in blood. The glucometer further comprises an enclosing lid configured to enclose the finger-tip placed on the transparent test site. The glucometer further comprises a light source assembly comprising light emitting diodes (LEDs), placed underneath the transparent test site.”. One of the light emitting diodes is the second light source.) and configured to irradiate light of at least one wavelength channel in a wavelength region of 900 nm to 1700 nm, which is different from that of the light of the first light source unit, to the biological tissue ([0031]: “the light source assembly 108 comprises multiple LEDs 108a-108c. In an embodiment, the light source assembly 108 comprises three distinct wavelengths of light emitting diodes (LEDs) 108a-108c. Therefore, the value of ‘n’ in the dimension of the data matrix ranges from 1 to 3. A first of the distinct LEDs, for example, 108a, is a red LED operating with a wavelength of 650 nanometers, a second of the distinct LEDs, for example, 108b, is a near-infrared (NIR) LED operating at a wavelength of 940 nanometers, and a third of the distinct light emitting diodes, for example, 108c, is a near-infrared (NIR) LED operating at a wavelength of 1160 nanometers”. The second light source is one of the distinct LEDs, which is a different wavelength from the first light source.);
a first receiving unit disposed in the probe and configured to receive a transmission signal generated as the light irradiated to the biological tissue passes through the biological tissue ([0031]: “the glucometer 100 comprises ten detectors 110a-110j … The ten detectors comprise a first detector set comprising … a second detector set comprising a detector 110g for detecting the transmissive light”; Fig. 2 shows the detector 110g being across from the light sources, which indicates that it detects light that passes through the biological tissue.);
a second receiving unit configured to receive a light reflection signal generated as the light irradiated to the biological tissue is reflected by the biological tissue ([0031]: “the glucometer 100 comprises ten detectors 110a-110j … The ten detectors comprise a first detector set comprising … a third detector set comprising three detectors 110h-110j for detecting the reflective light”; Fig. 2 shows the detectors 110h-110j being on the same side as the light sources, which indicates that they detect light that is reflected by the biological tissue.); and
a measurement unit (Abstract: “The glucometer further comprises a software module comprising a first sub-module that comprises a first set of algorithms for generating a data matrix. The transflective, transmissive light, and reflective light from blood capillaries are measured and recorded in data matrix. A second sub-module comprises a second set of algorithms for non-invasive measurement of concentration of glucose in the blood by processing data within the data matrix.”. The software module is the measurement unit.) configured to measure light reflection characteristics of the biological tissue by using the light reflection signal received by the second receiving unit, measure transmission characteristics of the biological tissue by using the transmission signal received by the first receiving unit, and measure blood glucose of the biological tissue on the basis of the light reflection characteristics and the transmission characteristics ([0037]: “FIG. 5A illustrates a flowchart showing a reading cycle of the detectors for each of the LEDs. Each of the light emitting diodes 108a-108c is configured to be individually activated in a loop comprising 1200 cycles and the transflective light, the transmissive light, and the reflective light from the blood capillaries are measured and recorded in the data matrix of dimension (n×1200×m). The second set of algorithms in the second sub-module 310 measures the concentration of the glucose in the blood by processing data within the data matrix.”; Fig. 5A shows the algorithm of the second sub-module, which is used to measure the transmission characteristics and the reflection characteristics to determine the blood glucose concentration. The transmission characteristics and the reflective characteristics are the processed data from the second sub-module used to determine the glucose concentration.).
However, Maguluri does not teach wherein the second light source unit irradiates light of a first reference wavelength channel and light of a first blood glucose search wavelength channel having a higher reactivity to glucose than the first reference wavelength channel and wherein the first light source unit irradiates light of a second reference wavelength channel and light of a second blood glucose search wavelength channel having a higher reactivity to glucose than the second reference wavelength channel.
Gerber teaches an analyte sensor. Specifically, Gerber teaches wherein the second light source unit irradiates light of a first reference wavelength channel and light of a first blood glucose search wavelength channel having a higher reactivity to glucose than the first reference wavelength channel (Column 4, lines 39-41: “One or more light sources provide light of a first wavelength and a second wavelength into the cavity”; Column 13, lines 47-49: “By using previously measured reference values, the signal-processing and computing element converts the differences in light intensity to a signal relating to analyte concentration”. The different wavelengths have different reactivity to glucose, therefore one of the wavelengths can be selected to have a higher reactivity to glucose.), wherein the first light source unit irradiates light of a second reference wavelength channel and light of a second blood glucose search wavelength channel having a higher reactivity to glucose than the second reference wavelength channel (Column 4, lines 39-41: “One or more light sources provide light of a first wavelength and a second wavelength into the cavity”; Column 13, lines 47-49: “By using previously measured reference values, the signal-processing and computing element converts the differences in light intensity to a signal relating to analyte concentration”. The different wavelengths have different reactivity to glucose, therefore one of the wavelengths can be selected to have a higher reactivity to glucose.). Maguluri and Gerber are analogous arts as they are both related to sensors that use light to detect glucose.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the light source irradiating a reference wavelength and a glucose search wavelength as it allows the apparatus to have a comparison of the reference wavelength to the glucose search wavelength, which can allow for a more accurate comparison and can lead to a more comprehensive analysis of the user’s blood glucose.
However, the Maguluri/Gerber combination is silent on how the characteristics are measured.
Gerber teaches wherein the measurement unit measures the light reflection characteristics of the biological tissue by comparing the light reflection signal for the first reference wavelength channel with the light reflection signal for the first blood glucose search wavelength channel or the second blood glucose search wavelength channel, and measures the transmission characteristics of the biological tissue by comparing the transmission signal for the second reference wavelength channel with the transmission signal for the first blood glucose search wavelength channel or the second blood glucose search wavelength channel (Column 4, lines 49-53: “A signal-processing and computing element is optically coupled to the detector for comparing the intensities of light received at the first wavelength to the intensities of light received at the second wavelength, and for relating the intensities to analyte concentration.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis from Gerber into the Maguluri/Gerber combination as the combination is silent on the computation, and Gerber provides a suitable computation in an analogous device.
The Maguluri/Gerber combination teaches wherein the probe includes a first part positioned on one side of the biological tissue and a second part positioned on the opposite side of the biological tissue (Maguluri, [0027]: “The glucometer 100 further comprises an enclosing lid 106 configured to enclose the finger-tip placed on the transparent test site”; Fig. 1. The enclosing lid 106 is the first part, and the curved test surface 102 is the second part.),
wherein the first receiving unit is installed on the first part of the probe (Maguluri, Fig. 1 shows the detector 110g on the first part.), and the first light source unit, the second light source unit, and the second receiving unit are installed on the second part of the probe (Maguluri, Fig. 1 shows the light emitting diodes (the first light source and second light source) and the detectors (second receiving unit) on the second part.), and
wherein an output light's central axis of the first light source unit is aligned with a center portion of the first receiving unit (Maguluri, Fig. 2 shows the light emitting diode 108a on the same central axis as the detector 110g), and the second light source unit and the second receiving unit are arranged on both sides of the first light source unit to have a predetermined inclination (Maguluri, Fig. 2 shows light emitting diodes 108b and 108c on both sides of the light emitting diode 108a at a predetermined angle, as well as the detectors 110i and 110j on both sides of the light emitting diode 108a at a predetermined angle).
Regarding claim 3, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 1, wherein the transmission signal received by the first receiving unit is a light transmission signal (Maguluri, [0013]: “a plurality of detectors for detecting … transmissive light”), and the measurement unit is configured to measure light transmission characteristics of the biological tissue by using the light transmission signal received by the first receiving unit (Maguluri, [0037]: “FIG. 5A illustrates a flowchart showing a reading cycle of the detectors for each of the LEDs. Each of the light emitting diodes 108a-108c is configured to be individually activated in a loop comprising 1200 cycles and the transflective light, the transmissive light, and the reflective light from the blood capillaries are measured and recorded in the data matrix of dimension (n×1200×m). The second set of algorithms in the second sub-module 310 measures the concentration of the glucose in the blood by processing data within the data matrix.”; Fig. 5A shows the algorithm of the second sub-module, which is used to measure the transmission characteristics and the reflection characteristics to determine the blood glucose concentration. The transmission characteristics and the reflective characteristics are the processed data from the second sub-module used to determine the glucose concentration.).
Regarding claim 9, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 1, further comprising a second sensor unit configured to measure a thickness of the biological tissue (Maguluri, [0042]: “The average value of the seventh detector 110g output is proportional to the finger thickness”), wherein the measurement unit measures the blood glucose of the biological tissue by using the thickness of the biological tissue (Maguluri, [0042]: “the artificial neural network and error correction module 310g involve error cancellation due to finger thickness as the algorithms take finger thickness as a factor. With the help of the seventh detector 110g output, the artificial neural network and error correction module 310g learns the error caused due to finger thickness of a person and compensates for that error”).
Regarding claim 12, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 1, wherein the second light source unit includes a light source element configured to irradiate light of different inclination angles to the biological tissue, and the second receiving unit includes a receiving element configured to receive the light reflection signal at different inclination angles at a position corresponding to the light source element (Maguluri, Fig. 2 shows different angles of the light source elements and the receiving elements).
Regarding claim 14, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 1, wherein the probe includes: an upper frame (Maguluri, Fig. 1, front side 116c); a lower frame spaced apart from and fixed to the upper frame (Maguluri, Fig. 1, enclosing lid 106); and a moving frame that is located between the upper frame and the lower frame (Maguluri, Fig. 1, curved test surface 102), has a space separated from the lower frame, into which the biological tissue is inserted (Maguluri, Fig. 1 shows the space in between the frames where the finger is placed; “The curved test surface 102 is configured to accommodate a finger-tip when the finger-tip is placed on the transparent test site”), and moves between the upper frame and the lower frame so that the space separated from the lower frame is changed, wherein the moving frame is configured to apply a pressure to the biological tissue by an elastic element placed between the moving frame and the upper frame (Maguluri, [0029]: “The enclosing lid 106 is attached to the body 116 through a hinge 114. In an embodiment, the hinge 114 is spring loaded. The hinge 114 is configured to apply a predetermined amount of pressure on the finger placed on the transparent test site 104”).
Regarding claim 16, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 14, wherein the first light source unit, the second light source unit, and the second receiving unit are installed in the upper frame (Maguluri, Fig. 1 shows the curved test surface 103 containing the light source units and detectors used for reflection), and the first receiving unit is installed in the lower frame (Maguluri, Fig. 1 shows the enclosing lid 106 containing the detector used for transmission).
Regarding independent claim 17, Maguluri teaches a noninvasive blood glucose measurement method by using a noninvasive blood glucose measurement apparatus ([0002]: “the present invention relates to a non-invasive glucometer and method for performing data analytics and trends over the period of time, on the data obtained from the glucometer”), the method comprising:
irradiating, to a biological tissue, light of a wavelength channel in a wavelength region of 900 nm to 1700 nm ([0031]: “the light source assembly 108 comprises multiple LEDs 108a-108c. In an embodiment, the light source assembly 108 comprises three distinct wavelengths of light emitting diodes (LEDs) 108a-108c. Therefore, the value of ‘n’ in the dimension of the data matrix ranges from 1 to 3. A first of the distinct LEDs, for example, 108a, is a red LED operating with a wavelength of 650 nanometers, a second of the distinct LEDs, for example, 108b, is a near-infrared (NIR) LED operating at a wavelength of 940 nanometers, and a third of the distinct light emitting diodes, for example, 108c, is a near-infrared (NIR) LED operating at a wavelength of 1160 nanometers”), using a second light source unit ([0013]: “The glucometer comprises a curved test surface with a transparent test site. The curved test surface is configured to accommodate a finger-tip when the finger-tip is placed on the transparent test site for non-invasively measuring concentration of glucose in blood. The glucometer further comprises an enclosing lid configured to enclose the finger-tip placed on the transparent test site. The glucometer further comprises a light source assembly comprising light emitting diodes (LEDs), placed underneath the transparent test site.”. One of the light emitting diodes is the second light source.), and irradiating, to a biological tissue, light of a wavelength channel in a wavelength region of 900 nm to 1700 nm ([0031]: “the light source assembly 108 comprises multiple LEDs 108a-108c. In an embodiment, the light source assembly 108 comprises three distinct wavelengths of light emitting diodes (LEDs) 108a-108c. Therefore, the value of ‘n’ in the dimension of the data matrix ranges from 1 to 3. A first of the distinct LEDs, for example, 108a, is a red LED operating with a wavelength of 650 nanometers, a second of the distinct LEDs, for example, 108b, is a near-infrared (NIR) LED operating at a wavelength of 940 nanometers, and a third of the distinct light emitting diodes, for example, 108c, is a near-infrared (NIR) LED operating at a wavelength of 1160 nanometers”), using a first light source unit ([0013]: “The glucometer comprises a curved test surface with a transparent test site. The curved test surface is configured to accommodate a finger-tip when the finger-tip is placed on the transparent test site for non-invasively measuring concentration of glucose in blood. The glucometer further comprises an enclosing lid configured to enclose the finger-tip placed on the transparent test site. The glucometer further comprises a light source assembly comprising light emitting diodes (LEDs), placed underneath the transparent test site.”. One of the light emitting diodes is the first light source unit.).
However, Maguluri does not teach irradiating a reference wavelength channel and a glucose search wavelength channel using the first light source unit and the second light source unit.
Gerber teaches irradiating a reference wavelength channel and a glucose search wavelength channel using the first light source unit and the second light source unit (Column 4, lines 39-41: “One or more light sources provide light of a first wavelength and a second wavelength into the cavity”; Column 13, lines 47-49: “By using previously measured reference values, the signal-processing and computing element converts the differences in light intensity to a signal relating to analyte concentration”. The different wavelengths have different reactivity to glucose, therefore one of the wavelengths can be selected to have a higher reactivity to glucose.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the light source irradiating a reference wavelength and a glucose search wavelength as it allows the method to have a comparison of the reference wavelength to the glucose search wavelength, which can allow for a more accurate comparison and can lead to a more comprehensive analysis of the user’s blood glucose.
The Maguluri/Gerber combination teaches receiving a light reflection signal generated as the light irradiated to the biological tissue is reflected by the biological tissue, using a second receiving unit (Maguluri, [0031]: “the glucometer 100 comprises ten detectors 110a-110j … The ten detectors comprise a first detector set comprising … a third detector set comprising three detectors 110h-110j for detecting the reflective light”; Fig. 2 shows the detectors 110h-110j being on the same side as the light sources, which indicates that they detect light that is reflected by the biological tissue.);
receiving a transmission signal generated as the light irradiated to the biological tissue passes through the biological tissue, using a first receiving unit (Maguluri, [0031]: “the glucometer 100 comprises ten detectors 110a-110j … The ten detectors comprise a first detector set comprising … a second detector set comprising a detector 110g for detecting the transmissive light”; Fig. 2 shows the detector 110g being across from the light sources, which indicates that it detects light that passes through the biological tissue.);
measuring, using the measurement unit (Maguluri, Abstract: “The glucometer further comprises a software module comprising a first sub-module that comprises a first set of algorithms for generating a data matrix. The transflective, transmissive light, and reflective light from blood capillaries are measured and recorded in data matrix. A second sub-module comprises a second set of algorithms for non-invasive measurement of concentration of glucose in the blood by processing data within the data matrix.”. The software module is the measurement unit.), light reflection characteristics of the biological tissue and transmission characteristics of the biological tissue (Maguluri, [0037]: “FIG. 5A illustrates a flowchart showing a reading cycle of the detectors for each of the LEDs. Each of the light emitting diodes 108a-108c is configured to be individually activated in a loop comprising 1200 cycles and the transflective light, the transmissive light, and the reflective light from the blood capillaries are measured and recorded in the data matrix of dimension (n×1200×m). The second set of algorithms in the second sub-module 310 measures the concentration of the glucose in the blood by processing data within the data matrix.”; Fig. 5A shows the algorithm of the second sub-module, which is used to measure the transmission characteristics and the reflection characteristics to determine the blood glucose concentration. The transmission characteristics and the reflective characteristics are the processed data from the second sub-module used to determine the glucose concentration.).
However, the Maguluri/Gerber combination is silent on the calculations used.
Gerber teaches measuring the light reflection characteristics of the biological tissue by comparing a light reflection signal for the first reference wavelength channel with a light reflection signal for the first blood glucose search wavelength channel or the second blood glucose search wavelength channel, and measuring the transmission characteristics of the biological tissue by comparing a transmission signal for the second reference wavelength channel with a transmission signal for the first blood glucose search wavelength channel or the second blood glucose search wavelength channel (Column 4, lines 39-41: “One or more light sources provide light of a first wavelength and a second wavelength into the cavity”; Column 13, lines 47-49: “By using previously measured reference values, the signal-processing and computing element converts the differences in light intensity to a signal relating to analyte concentration”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the analysis from Gerber into the Maguluri/Gerber combination as the combination is silent on the computation, and Gerber provides a suitable computation in an analogous device.
The Maguluri/Gerber combination teaches estimating, using the measurement unit, blood glucose of the biological tissue on the basis of the light reflection characteristics and the transmission characteristics (Maguluri, [0037]: “FIG. 5A illustrates a flowchart showing a reading cycle of the detectors for each of the LEDs. Each of the light emitting diodes 108a-108c is configured to be individually activated in a loop comprising 1200 cycles and the transflective light, the transmissive light, and the reflective light from the blood capillaries are measured and recorded in the data matrix of dimension (n×1200×m). The second set of algorithms in the second sub-module 310 measures the concentration of the glucose in the blood by processing data within the data matrix.”; Fig. 5A shows the algorithm of the second sub-module, which is used to measure the transmission characteristics and the reflection characteristics to determine the blood glucose concentration. The transmission characteristics and the reflective characteristics are the processed data from the second sub-module used to determine the glucose concentration.),
wherein the transmission signal includes at least one of a photoacoustic transmission signal and a light transmission signal (Maguluri, [0013]: “a plurality of detectors for detecting … transmissive light”), and
the transmission characteristics include at least one of photoacoustic transmission characteristics and light transmission characteristics (Maguluri, [0037]: “FIG. 5A illustrates a flowchart showing a reading cycle of the detectors for each of the LEDs. Each of the light emitting diodes 108a-108c is configured to be individually activated in a loop comprising 1200 cycles and the transflective light, the transmissive light, and the reflective light from the blood capillaries are measured and recorded in the data matrix of dimension (n×1200×m). The second set of algorithms in the second sub-module 310 measures the concentration of the glucose in the blood by processing data within the data matrix.”; Fig. 5A shows the algorithm of the second sub-module, which is used to measure the transmission characteristics and the reflection characteristics to determine the blood glucose concentration. The transmission characteristics are the processed data from the second sub-module used to determine the glucose concentration.).
Regarding claim 18, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement method of claim 17, further comprising measuring at least one of a temperature and a thickness of the biological tissue by using a sensor (Maguluri, [0042]: “The average value of the seventh detector 110g output is proportional to the finger thickness”; [0042]: “the artificial neural network and error correction module 310g involve error cancellation due to finger thickness as the algorithms take finger thickness as a factor. With the help of the seventh detector 110g output, the artificial neural network and error correction module 310g learns the error caused due to finger thickness of a person and compensates for that error”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over the Maguluri/Gerber combination as applied to claim 1 above, and further in view of Yamada (US 20190247021).
Regarding claim 2, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 1.
However, the Maguluri/Gerber combination does not teach wherein the transmission signal received by the first receiving unit is a photoacoustic transmission signal.
Yamada discloses an information processing apparatus. Specifically, Yamada teaches wherein the transmission signal received by the first receiving unit is a photoacoustic transmission signal ([0035]: “the probe 103 irradiates the subject with the light from the irradiation unit 106 and receives the photoacoustic wave by the transmission and reception unit 105. The probe 103 is preferably controlled such that, when information indicating a contact with the subject is received, the transmission of the ultrasound wave for obtaining the ultrasound signal and the light irradiation for obtaining the photoacoustic signal are executed.”). Maguluri, Gerber, and Yamada are analogous arts as they are all related to devices that irradiate light to a user to measure parameters.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the transmission signal being a photoacoustic transmission signal as it is a known transmission signal, and it would be a simple substitution to use the photoacoustic transmission signal from an analogous art.
The Maguluri/Gerber/Yamada combination teaches the measurement unit is configured to measure photoacoustic transmission characteristics of the biological tissue by using the photoacoustic transmission signal received by the first receiving unit (Maguluri, [0037]: “FIG. 5A illustrates a flowchart showing a reading cycle of the detectors for each of the LEDs. Each of the light emitting diodes 108a-108c is configured to be individually activated in a loop comprising 1200 cycles and the transflective light, the transmissive light, and the reflective light from the blood capillaries are measured and recorded in the data matrix of dimension (n×1200×m). The second set of algorithms in the second sub-module 310 measures the concentration of the glucose in the blood by processing data within the data matrix.”; Fig. 5A shows the algorithm of the second sub-module, which is used to measure the transmission characteristics and the reflection characteristics to determine the blood glucose concentration. The transmission characteristics and the reflective characteristics are the processed data from the second sub-module used to determine the glucose concentration.).
Claims 7-8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over the Maguluri/Gerber combination as applied to claims 1 and 14 above, and further in view of Cho (US 20210145363).
Regarding claim 7, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 1.
However, the Maguluri/Gerber combination teaches wherein the measurement unit measures the blood glucose of the biological tissue by using the temperature of the biological tissue (Maguluri, [0045]: “The method further comprises applying 414 compensation coefficient algorithms to mitigate effects of temperature”), but the combination does not teach further comprising a first sensor unit configured to measure a temperature of the biological tissue.
Cho discloses a measuring device. Specifically, Cho teaches the device further comprising a first sensor unit configured to measure a temperature of the biological tissue, wherein the measurement unit measures the blood glucose of the biological tissue by using the temperature of the biological tissue ([0037]: “A temperature sensor 8 is positioned on the outside, which measures the finger temperature when it comes into contact with a finger. For example, the temperature sensor 8 may also be integrated in the chamber 9”). Maguluri, Gerber, and Cho are analogous arts as they are all related to sensors that use light to detect glucose.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the temperature sensor from Cho into the Maguluri/Gerber combination as the combination is silent on how the temperature data is gathered, and Cho discloses a suitable sensor in an analogous device.
Regarding claim 8, the Maguluri/Gerber/Cho combination teaches the noninvasive blood glucose measurement apparatus of claim 7.
However, the Maguluri/Gerber/Cho combination does not teach the device further comprising: a first temperature sensor configured to monitor a temperature of at least one of the first light source unit, the second light source unit, the first receiving unit, and the second receiving unit; and a second temperature sensor configured to monitor a change in ambient air temperature of the probe.
Cho teaches the device further comprising: a first temperature sensor configured to monitor a temperature of at least one of the first light source unit, the second light source unit, the first receiving unit, and the second receiving unit ([0037]: “The module 11 may have an additional temperature sensor, which can provide information relating to the temperature of the light sources 12 within the module”); and a second temperature sensor configured to monitor a change in ambient air temperature of the probe ([0014]: “It may also be expedient to integrate additional sensors for measuring the air pressure, humidity and/or the ambient temperature. As a result, the influence of the environmental parameters can be included in the measured-data analysis”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the temperature sensors from Cho into the Maguluri/Gerber/Cho combination as Maguluri discusses the importance of temperature in the calculations ([0045]: “The method further comprises applying 414 compensation coefficient algorithms to mitigate effects of temperature”), and Cho discloses sensors to measure important temperature information.
Regarding claim 15, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 14.
However, the Maguluri/Gerber combination is silent on how the upper frame and lower frame are widened.
Cho teaches wherein the moving frame further includes a separation space expansion mechanism configured to widen the space separated from the lower frame when a force is applied against the elastic element ([0030]-[0031]: “The upper shell 2 and lower shell 3 are interconnected by a spring mechanism which acts as a hinge mechanism 4. When the finger is inserted and the upper shell 2 and lower shell 3 pressed together at the rear part of the measuring device are released, the upper shell 2 and lower shell 3 come together and a defined pressure is exerted on the finger by the spring mechanism.”; Figs. 1-2).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the mechanism from Cho into the Maguluri/Gerber combination as the combination is silent on the mechanism, and Cho discloses a suitable mechanism in an analogous device.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the Maguluri/Gerber combination as applied to claim 9 above, and further in view of Nakamura (US 20210212609).
Regarding claim 10, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 9, wherein the second sensor unit includes: a light-sending element disposed at a position of a first part of the probe (Maguluri, Fig. 2 shows light emitting diodes to send light); two or more light-receiving elements disposed at different positions of the first part of the probe (Maguluri, Fig. 2 shows two or more detectors to receive light).
However, the Maguluri/Gerber combination does not teach a reflecting element disposed at a position of a second part of the probe; wherein the measurement unit is configured to measure the thickness of the biological tissue by measuring an intensity difference or ratio of light signals generated as light irradiated from the light-sending element is reflected by the reflecting element and then received by the two or more light-receiving elements.
Nakamura discloses a component concentration measurement device. Specifically, Nakamura teaches a reflecting element disposed at a position of a second part of the probe; wherein the measurement unit is configured to measure the thickness of the biological tissue by measuring an intensity difference or ratio of light signals generated as light irradiated from the light-sending element is reflected by the reflecting element and then received by the two or more light-receiving elements ([0040]: “The light that has thus returned from the site of measurement 151 and the light reflected on the mirror 133 are superposed in the beam splitter 132. At this point, due to interference of light, the two lights strengthen one another if the distances they have traveled are equal, whereas they cancel one another out if there is a disparity in their distances. By moving the mirror 133 and determining a position where the two lights interfere with and strengthen one another via detection of light intensity with the light detector 134, the distances traveled by the lights through the site of measurement 151 can be known and the thickness of the site of measurement 151 can be known.”). Maguluri, Gerber, and Nakamura are analogous arts as they are all related to sensors that use light to detect glucose.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the reflecting element and the calculation of the thickness of the biological tissue from Nakamura into the Maguluri/Gerber combination as it is an alternative method to determine the thickness of the biological tissue, and therefore would be a simple substitution.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the Maguluri/Gerber combination as applied to claim 9 above, and further in view of Harris (US 11596291).
Regarding claim 11, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement apparatus of claim 9.
However, the Maguluri/Gerber combination does not teach wherein the second sensor unit includes a pressure sensor configured to measure a pressure applied by the probe to the biological tissue and output the measured pressure as an electrical signal, and the measurement unit is configured to estimate the thickness of the biological tissue by using the electrical signal output from the pressure sensor.
Harris discloses a method and device to compress tissue. Specifically, Harris teaches wherein the second sensor unit includes a pressure sensor configured to measure a pressure applied by the probe to the biological tissue and output the measured pressure as an electrical signal, and the measurement unit is configured to estimate the thickness of the biological tissue by using the electrical signal output from the pressure sensor (Column 55, lines 21-32: “the one or more sensors 738 may comprise a strain gauge, such as a micro-strain gauge, configured to measure the magnitude of the strain in the anvil 716 during a clamped condition. The strain gauge provides an electrical signal whose amplitude varies with the magnitude of the strain. The sensors 738 may comprise a pressure sensor configured to detect a pressure generated by the presence of compressed tissue between the anvil 716 and the staple cartridge 718. The sensors 738 may be configured to detect impedance of a tissue section located between the anvil 716 and the staple cartridge 718 that is indicative of the thickness and/or fullness of tissue located therebetween.”). Maguluri and Harris are analogous arts as they are both related to devices used to measure thickness of a biological tissue.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pressure sensor and thickness measurement from Harris into the Maguluri/Gerber combination as it is another known method to determine thickness, therefore it is a simple substitution.
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over the Maguluri/Gerber combination as applied to claim 17 above, and further in view of Gal (US 20200352482) and Herrmann (US 8391939).
Regarding claim 19, the Maguluri/Gerber combination teaches the noninvasive blood glucose measurement method of claim 17, wherein the estimating of the blood glucose by using the measurement unit includes measuring over time (Maguluri, [0002]: “the present invention relates to a non-invasive glucometer and method for performing data analytics and trends over the period of time”).
However, the Maguluri/Gerber combination is silent on the method used to monitor over the period of time.
Gal discloses a device for non-invasively measuring glucose concentration. Specifically, Gal teaches deriving an average value by repeating measuring the light reflection characteristics and measuring the transmission characteristics multiple times ([0169]: “an application of the moving average procedure to the linear combination of the number of measuring channels created by adding outputs of pairs of measuring sub-channels (13), and (17) creates a configuration of the BG measuring apparatus with the improved accuracy and precision if compared with the accuracy and precision of each individual sub-channel”). Maguluri, Gerber, and Gal are analogous arts as they are all related to devices that measure a user’s glucose non-invasively.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the average from Gal into the Maguluri/Gerber combination as the combination is silent on how the method monitors the glucose over time, and Gal discloses a suitable method to monitor the measurements over time.
However, the Maguluri/Gerber/Gal combination does not teach deriving a blood glucose value by comparing the average value with a reference comparison table obtained in advance through prior learning data.
Herrmann discloses a method for continuous measurement of glucose concentration. Specifically, Herrmann discloses deriving a blood glucose value by comparing the value with a reference comparison table obtained through prior learning data (Claim 1: “determining a value for the glucose level in succeeding and nonoverlapping time windows of the same length of a first measurement cycle; repeating the determination of this value in subsequent measurement cycles with the same number of nonoverlapping time windows of the same length such that there is multiple detection within each measurement cycle of the transmission or scattering power of the blood for at least two incident NIR wavelengths, calculation of an indicator value dependent on the blood-glucose level and ascertaining the blood-glucose level by comparing the indicator value with a previously determined calibration table”). Maguluri, Gerber, Gal, and Herrmann are analogous arts as they are all related to devices that measure a user’s glucose concentration.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the comparison from Herrmann into the Maguluri/Gerber/Gal combination as it allows the method to compare the measurements to known results, which can determine how accurate they are, which can provide important information to the user.
Regarding claim 20, the Maguluri/Gerber/Gal/Herrmann combination teaches the noninvasive blood glucose measurement method of claim 19, further comprising repeatedly performing, using the measurement unit, the deriving of the blood glucose value to output accumulated blood glucose value data for a predetermined period of time (Herrmann, Claim 1: “determining a value for the glucose level in succeeding and nonoverlapping time windows of the same length of a first measurement cycle; repeating the determination of this value in subsequent measurement cycles with the same number of nonoverlapping time windows of the same length such that there is multiple detection within each measurement cycle of the transmission or scattering power of the blood for at least two incident NIR wavelengths”).
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant has amended the claims to overcome the 112(b) rejections, however the amendments have introduced new claim objections and 112(b) rejections.
Applicant’s arguments with respect to claims 1-20 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
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.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791