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 .
Response to Amendment
The amendment filed on 01/29/2026 has been entered. Claims 1-4, 8-9, 12-15 and 18-19 have been amended. Claims 6-7 and 17 have been cancelled. Claims 1-5, 8-16 and 18-20 remain pending.
The previously raised objections for Claims 2, 7-9, 13 and 18-19 are withdrawn because the issues have been properly corrected.
The previously raised rejections under 35 U.S.C. 112(b) for Claims 1-11, 13-15 and 19 are withdrawn because the issues have been properly corrected.
The previously raised rejections under 35 U.S.C. 101 for Claims 6-9 are withdrawn because the issues have been properly corrected.
Response to Arguments
On Page 7 of Remarks, Applicant argues that amended Claims 1 and 12 now recites “the skin autofluorescence sensor utilizes a diffuse optical geometry …, and wherein the light blocking material is disposed … such that the one or more emitted light signals is forced into the user’s skin with a banana-shaped path trajectory … ”, and that reference Graaff fails to disclose such a light blocking material, and reference LeBouef’s disclosed light blocking region is “concerned with internal optical crosstalk and detector saturation caused by light leakage within the device” and fails to disclose the claimed light blocking material. On Page 8 of Remarks, Applicant further emphasizes the difference between “blocking internal light leakage of LeBouef” and “blocking surface glare to force a specific light migration path”, and also further explains that the measured returned light has wavelength increased by AGEs so the measured light intensity correlates with level of AGEs. The argument is moot in view of the new grounds of rejection which relies on Sato (US 20140316224 A1) to disclose the limitations in the claims.
On Page 9 of Remarks, Applicant argues that, regarding Claim 4’s limitation of “a distance ranging from 0.5 millimeters to 6 millimeters”, reference Graaff fails to disclose the feature, and there is no motivation to combine reference Shultz and reference Graaff, two references with different applications (Shultz being monitoring a fluorescent tracer agent, and Graaff being AGE spectrometer). On Pages 9-10 of Remarks, Applicant further explains that Shultz “teaches spacing detectors to reject unfiltered light … and isolate the fluorescence of the tracer by physically distancing the detector from the noise (e.g., excitation backscatter)”, and in contrast, Graaff explicitly measures the excitation light reflected off the skin “to normalize endogenous skin autofluorescence”. Examiner respectfully disagrees. First, contrary to the above argument, Shultz is the same as Graaff in detecting both unfiltered and filtered light: Shultz, Column 18, Lines 24-31; “the first light detector 222 is configured to measure unfiltered light emitted from the tissue of the patient 202 at the second region 208, and the second light detector 224 is configured to measure filtered light emitted from the tissue of the patient 202 at the third region 210. In this aspect, the second light detector 224 further comprises an optical filter 244 configured to block light at the excitation wavelength.”; Graaff, Para 0030; “Arranged between the detector 122 and the skin 7 is a long pass filter 121, which passes only radiation of a wavelength greater than, for instance, 400 nm, so that the detector 122 only receives radiation from the skin 7 in the fluorescence-induced wavelength range. The detector 120 is preferably arranged for detecting the total amount of light arriving from the skin 7 at the accumulated wavelength ranges of the LEDs 102, 125, 126.”. This feature disclosed by Shultz and Graaff is also disclosed and claimed by the Application. Second, despite their different application, Shultz and Graaff are same in multiple aspects of structure. For example, both the references apply a sensor to directly contact a skin of a subject, comprise multiple light sources and at least 2 light detectors, detect a light with longer wavelength than the excitation light (Shultz being exogenous fluorescent tracer, and Graaff being skin autofluorescence), and quantify results by calculating a ratio of the signal intensity from the two detectors; all these features are also disclosed by the Application.
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.
Claims 1-3, 8-14 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Graaff et al (US 20130217984 A1; hereafter Graaff), in view of Sato (US 20140316224 A1; hereafter Sato) and Shin et al (US 20200121259 A1; hereafter Shin).
With regard to Claim 1, Graaff discloses a computing device for measuring skin autofluorescence (Graaff, Page 11, Claim 20; “An apparatus for determining an autofluorescence value of skin tissue of a subject …”), the computing device comprising:
a skin autofluorescence sensor configured for contact with a user’s skin (Graaff, Para 0035; “… the detectors and/or optical fiber(s) may also be arranged to be in contact with the skin when the pick-up unit is placed against the skin.”), the skin autofluorescence sensor comprising:
(i) one or more emitters configured to output one or more emitted light signals (Graaff, Para 0027; “as an excitation radiation source, a LED 102 is provided which … emits radiation of a wavelength of about 370 nm, or at least in a range of 300-420 nm …”); and
(ii) a first detector configured to receive a first returned light signal (Graaff, Para 0030; “… two detectors 120, 122 are used which can simultaneously detect radiation coming from the skin 7 …”), the first detector including an optical long pass filter (Graaff, Para 0030; “Arranged between the detector 122 and the skin 7 is a long pass filter 121 …”); and
(iii) a second detector configured to receive a second returned light signal (Graaff, Para 0030; “… two detectors 120, 122 are used which can simultaneously detect radiation coming from the skin 7 …”);
wherein the skin autofluorescence sensor utilizes a diffuse optical geometry where the one or more emitters and the first detector are separated from each other laterally by a distance (Graaff, Fig. 8 shows that detector 122 (corresponding to the claimed “first detector”) and the LEDs 102 125 126 (corresponding to the claimed “emitters”) are separated laterally by some distance) and also placed in contact with the user's skin (Graaff, Para 0035; “… the detectors and/or optical fiber(s) may also be arranged to be in contact with the skin when the pick-up unit is placed against the skin.”),
a processor (Graaff, Para 0031; “a computer 116”) configured to calculate a skin autofluorescence level based on a measured intensity level of the first returned light signal and a measured intensity level of the second returned light signal (Graaff, Para 0036; “The value of the measured skin AF is calculated as the ratio between the total emission intensity (420-600 nm) and the total excitation intensity (300-420 nm), multiplied by 100 and is expressed in arbitrary units (AU).”. Furthermore, the measured skin AF is then corrected, as in Paras 0076 and Eq. (13), and one major correcting factor is MI1, which is the ratio of reflectance at wavelength of 390 nm and of 360 nm (Para 0051, Eq. (3)). The abovementioned “total emission intensity (420-600)” would be the signal acquired from the detector 122 (with long pass filter 121), and the reflectance at 390 nm and 360 nm would be from the signal acquired from the detector 120.).
Graaff does not explicitly and clearly disclose:
the device being wearable,
comprising a light blocking material disposed between the one or more emitters and the first detector, and
wherein the light blocking material is disposed between the one or more emitters and the first detector to minimize specular reflection and reflection of light directly off a surface of the user's skin and into the first detector such that the one or more emitted light signals is forced into the user’s skin with a banana-shaped path trajectory and a penetration depth below the epidermis and into the dermis.
Sato in the same field of endeavor discloses:
comprising a light blocking material disposed between the one or more emitters and the first detector (Sato, Para 0057; “… a wall as illustrated in FIG. 3 is provided between the light source 111 and the detection unit 113 described later so that the wall can be employed as a light shielding wall for preventing light emitted from the light source 111 from entering the detection unit 113.”), and
wherein the light blocking material is disposed between the one or more emitters and the first detector to minimize specular reflection and reflection of light directly off a surface of the user's skin and into the first detector such that the one or more emitted light signals is forced into the user’s skin with a banana-shaped path trajectory and a penetration depth below the epidermis and into the dermis (Sato, Fig. 4 shows that the emitted light transmits from light source to light detectors with banana-shaped paths, and penetrates through the skin or deeper).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, as suggested by Sato, in order to include a light-blocking member to block light transmission directly from the emitter to the detector and to achieve a banana-shaped light path. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding saturation of light detectors and also measurement errors by preventing emitted light from directly transmitting into the detectors and collecting light that contains useful information of skin tissue (Sato, Para 0073; “measurement light detected by the sensor corresponding to the position may be measurement data including the knowledge on the cutaneous layer, the fat layer and the muscular layer illustrated in FIG. 4.”).
Graaff and Sato do not explicitly and clearly disclose the device being wearable.
Shin in the same field of endeavor discloses the device being wearable (Shin, Para 0054; “The bio-information estimating apparatuses 100a and 100b may be embedded … in a wearable device that may be worn on an object.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff and Sato, as suggested by Shin, in order to make the device be wearable. One of ordinary skill in the art would have been motivated to make the modification for the benefit of periodically monitoring potential changes in AGEs level of subcutaneous tissue and/or blood for subjects with high risk factors such as diabetes, so that early diagnosis and long-term monitoring can be performed.
With regard to Claim 2, Graaff, Sato and Shin disclose the wearable computing device of Claim 1. Graaff further discloses wherein the one or more emitted light signals have a wavelength ranging from 300 nanometers to 900 nanometers (Graaff, Para 0027; “as an excitation radiation source, a LED 102 is provided which … emits radiation of a wavelength of about 370 nm, or at least in a range of 300-420 nm …”).
With regard to Claim 3, Graaff, Sato and Shin disclose the wearable computing device of Claim 2. Graaff further discloses wherein the wavelength ranges from 350 nanometers to 500 nanometers (Graaff, Para 0027; “as an excitation radiation source, a LED 102 is provided which … emits radiation of a wavelength of about 370 nm, or at least in a range of 300-420 nm …”).
With regard to Claim 8, Graaff, Sato and Shin disclose the wearable computing device of Claim 1, but do not clearly and explicitly disclose wherein the one or more emitted light signals are configured to penetrate to the user’s subcutaneous tissue.
Sato further discloses wherein the one or more emitted light signals are configured to penetrate to the user’s subcutaneous tissue (Sato, Fig. 4 shows that the emitted light can penetrate to subcutaneous tissue). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, Sato and Shin, as further suggested by Sato, in order to have emitted light to penetrate to subcutaneous tissue. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling physiologic measurement for patients in subcutaneous tissue such as fat and muscles.
With regard to Claim 9, Graaff, Sato and Shin disclose the wearable computing device of Claim 1. Graaff further discloses wherein the one or more emitted light signals are configured to penetrate beneath the user’s skin by an average distance of 0.01 millimeters to 3 millimeters (Graaff, Para 0007; “… even with this broad excitation peak, dermal content of specific AGEs explains the major part of the variance (up to 76%) in the skin AF signal”. As evidenced by Fig. 1 of Sako, the dermic layer is about 0.05-4 mm deep below the skin. Hence, the emitted light in Graaff penetrates beneath the user’s skin by a distance of 0.05-4 mm).
With regard to Claim 10, Graaff, Sato and Shin disclose the wearable computing device of Claim 1. Graaff further discloses wherein the optical long pass filter prevents light having a wavelength that is equal to the wavelength of the one or more emitted light signals emitted by the one or more emitters from reaching the first detector (Graaff, Para 0030; “a long pass filter 121, which passes only radiation of a wavelength greater than, for instance, 400 nm, so that the detector 122 only receives radiation from the skin 7 in the fluorescence-induced wavelength range”).
With regard to Claim 11, Graaff, Sato and Shin disclose the wearable computing device of Claim 1, but do not clearly and explicitly disclose further comprising a photoplethysmography (PPG) sensor.
Shin further discloses further comprising a photoplethysmography (PPG) sensor (Shin, Para 0057; “the sensor part 110 may include a pulse wave sensor 21 for measuring a pulse wave signal … The pulse wave signal may include a photoplethysmogram (PPG) signal.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, Sato and Shin, as further suggested by Shin, in order to include a PPG sensor. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling monitoring of both skin AGEs level and blood pressure that could worsen in patients with cardiovascular disease (Shin, Para 0004; “Such protein denaturation in the blood vessels may be a factor in increasing cardiovascular disease risk such as arteriosclerosis and high blood pressure.” Para 0114; “various types of information may include criteria for estimating blood pressure as well as information associated with functions of the wearable device 900.”).
With regard to Claim 12, Graaff discloses a method for measuring skin autofluorescence (Graaff, Page 11, Claim 20; “An apparatus for determining an autofluorescence value of skin tissue of a subject …”) with a computing device, the method comprising:
emitting, by one or more emitters of a skin autofluorescence sensor of the computing device, one or more emitted light signals (Graaff, Para 0027; “as an excitation radiation source, a LED 102 is provided which … emits radiation of a wavelength of about 370 nm, or at least in a range of 300-420 nm …”), wherein the skin autofluorescence sensor is configured to direct contact with a user’s skin (Graaff, Para 0035; “… the detectors and/or optical fiber(s) may also be arranged to be in contact with the skin when the pick-up unit is placed against the skin.”);
obtaining, by a first detector of the skin autofluorescence sensor of the computing device, a first returned light signal (Graaff, Para 0030; “… two detectors 120, 122 are used which can simultaneously detect radiation coming from the skin 7 …”), the first detector including an optical long pass filter (Graaff, Para 0030; “Arranged between the detector 122 and the skin 7 is a long pass filter 121 …”);
obtaining, by a second detector of the skin autofluorescence sensor of the computing device, a second returned light signal (Graaff, Para 0030; “… two detectors 120, 122 are used which can simultaneously detect radiation coming from the skin 7 …”);
calculating, by a processor (Graaff, Para 0031; “a computer 116”), a skin autofluorescence level based on a measured intensity level of the first returned light signal and a measured intensity level of the second returned light signal (Graaff, Para 0036; “The value of the measured skin AF is calculated as the ratio between the total emission intensity (420-600 nm) and the total excitation intensity (300-420 nm), multiplied by 100 and is expressed in arbitrary units (AU).”. Furthermore, the measured skin AF is then corrected, as in Paras 0076 and Eq. (13), and one major correcting factor is MI1, which is the ratio of reflectance at wavelength of 390 nm and of 360 nm (Para 0051, Eq. (3)). The abovementioned “total emission intensity (420-600)” would be the signal acquired from the detector 122 (with long pass filter 121), and the reflectance at 390 nm and 360 nm would be from the signal acquired from the detector 120.),
wherein the skin autofluorescence sensor utilizes a diffuse optical geometry where the one or more emitters and the first detector are separated from each other laterally by a distance (Graaff, Fig. 8 shows that detector 122 (corresponding to the claimed “first detector”) and the LEDs 102 125 126 (corresponding to the claimed “emitters”) are separated laterally by some distance) and also placed in contact with the user's skin (Graaff, Para 0035; “… the detectors and/or optical fiber(s) may also be arranged to be in contact with the skin when the pick-up unit is placed against the skin.”).
Graaff does not clearly and explicitly disclose:
the device being wearable, and
wherein a light blocking material is disposed between the one or more emitters and the first detector to minimize specular reflection and reflection of light directly off a surface of the user's skin and into the first detector such that the one or more emitted light signals is forced into the user’s skin with a banana-shaped path trajectory and a penetration depth below the epidermis and into the dermis.
Sato in the same field of endeavor discloses wherein a light blocking material is disposed between the one or more emitters and the first detector (Sato, Para 0057; “… a wall as illustrated in FIG. 3 is provided between the light source 111 and the detection unit 113 described later so that the wall can be employed as a light shielding wall for preventing light emitted from the light source 111 from entering the detection unit 113.”) to minimize specular reflection and reflection of light directly off a surface of the user's skin and into the first detector such that the one or more emitted light signals is forced into the user’s skin with a banana-shaped path trajectory and a penetration depth below the epidermis and into the dermis (Sato, Fig. 4 shows that the emitted light transmits from light source to light detectors with banana-shaped paths, and penetrates through the skin or deeper). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, as suggested by Sato, in order to include a light-blocking member to block light transmission directly from the emitter to the detector and to achieve a banana-shaped light path. One of ordinary skill in the art would have been motivated to make the modification for the benefit of avoiding saturation of light detectors and also measurement errors by preventing emitted light from directly transmitting into the detectors and collecting light that contains useful information of skin tissue (Sato, Para 0073; “measurement light detected by the sensor corresponding to the position may be measurement data including the knowledge on the cutaneous layer, the fat layer and the muscular layer illustrated in FIG. 4.”).
Graaff and Sato do not explicitly and clearly disclose the device being wearable.
Shin in the same field of endeavor discloses the device being wearable (Shin, Para 0054; “The bio-information estimating apparatuses 100a and 100b may be embedded … in a wearable device that may be worn on an object.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff and Sato, as suggested by Shin, in order to make the device be wearable. One of ordinary skill in the art would have been motivated to make the modification for the benefit of periodically monitoring potential changes in AGEs level of subcutaneous tissue and/or blood for subjects with high risk factors such as diabetes, so that early diagnosis and long-term monitoring can be performed.
With regard to Claim 13, Graaff, Sato and Shin disclose the method of Claim 12. Graaff further discloses wherein the one or more emitted light signals have a wavelength ranging from 300 nanometers to 900 nanometers (Graaff, Para 0027; “as an excitation radiation source, a LED 102 is provided which … emits radiation of a wavelength of about 370 nm, or at least in a range of 300-420 nm …”).
With regard to Claim 14, Graaff, Sato and Shin disclose the method of Claim 12. Graaff further discloses wherein the wavelength ranges from 350 nanometers to 500 nanometers (Graaff, Para 0027; “as an excitation radiation source, a LED 102 is provided which … emits radiation of a wavelength of about 370 nm, or at least in a range of 300-420 nm …”).
With regard to Claim 18, Graaff, Sato and Shin disclose the method of Claim 12, but do not explicitly and clearly disclose wherein the one or more emitted light signals penetrate to both the user’s dermis and subcutaneous tissue.
Sato further discloses wherein the one or more emitted light signals penetrate to both the user’s dermis and subcutaneous tissue (Sato, Fig. 4 shows that the emitted light can penetrate to subcutaneous tissue). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, Sato and Shin, as suggested by Sato, in order to have emitted light to penetrate to subcutaneous tissue. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling physiologic measurement for patients in subcutaneous tissue such as fat and muscles.
With regard to Claim 19, Graaff, Sato and Shin disclose the method of Claim 12. Graaff further discloses wherein the one or more emitted light signals penetrate beneath the user’s skin by an average distance of 0.01 millimeters to 3 millimeters (Graaff, Para 0007; “… even with this broad excitation peak, dermal content of specific AGEs explains the major part of the variance (up to 76%) in the skin AF signal”. As evidenced by Fig. 1 of Sako, the dermic layer is about 0.05-4 mm deep below the skin. Hence, the emitted light in Graaff penetrates beneath the user’s skin by a distance of 0.05-4 mm.).
With regard to Claim 20, Graaff, Sato and Shin disclose the method of Claim 12. Graaff further discloses wherein the optical long pass filter prevents light having a wavelength that is equal to the wavelength of the one or more emitted light signals emitted by the one or more emitters from reaching the first detector (Graaff, Para 0030; “a long pass filter 121, which passes only radiation of a wavelength greater than, for instance, 400 nm, so that the detector 122 only receives radiation from the skin 7 in the fluorescence-induced wavelength range”).
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Graaff, Sato and Shin, further in view of Shultz et al (US 10952656 B2; hereafter Shultz).
With regard to Claim 4, Graaff, Sato and Shin disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the first detector is separated from the one or more emitters by a distance ranging from 0.5 millimeters to 6 millimeters.
Shultz in the same field of endeavor discloses wherein the first detector and/or the second detector are each separated from the one or more emitters by a distance ranging from 0.5 millimeters to 6 millimeters (Shultz, Column 19, Para 1; “In various other aspects, the nominal separation distance may range from about 1 mm to about 8 mm, from about 2 mm to about 6 mm, and from about 3 mm to about 5 mm.” Here the “nominal separation distance” is the distance between light source and light detector). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, Sato and Shin, as suggested by Shultz, in order to separate the detectors and the emitters by a distance of 0.5-6 mm. One of ordinary skill in the art would have been motivated to make the modification for the benefit of maximizing the intensity of the detected signal by reducing light scattering along the optical path (Shultz, Column 18, Para 4; “as the nominal separation distance increases, the total detected signal from the light detectors may decrease due to light scattering along the longer optical path between light source and light detector.”).
With regard to Claim 15, Graaff, Sato and Shin disclose all the limitations of Claim 12 as discussed above, but do not clearly and explicitly disclose wherein the first detector is separated from the one or more emitters by a distance ranging from 0.5 millimeters to 6 millimeters.
Shultz in the same field of endeavor discloses wherein the first detector is separated from the one or more emitters by a distance ranging from 0.5 millimeters to 6 millimeters (Shultz, Column 19, Para 1; “In various other aspects, the nominal separation distance may range from about 1 mm to about 8 mm, from about 2 mm to about 6 mm, and from about 3 mm to about 5 mm.” Here the “nominal separation distance” is the distance between light source and light detector). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, Sato and Shin, as suggested by Shultz, in order to separate the detectors and the emitters by a distance of 0.5-6 mm. One of ordinary skill in the art would have been motivated to make the modification for the benefit of maximizing the intensity of the detected signal by reducing light scattering along the optical path (Shultz, Column 18, Para 4; “as the nominal separation distance increases, the total detected signal from the light detectors may decrease due to light scattering along the longer optical path between light source and light detector.”).
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Graaff, Sato and Shin, further in view of Katra (US 20190209055 A1; hereafter Katra).
With regard to Claim 5, Graaff, Sato and Shin disclose all the limitations of Claim 1 as discussed above, but do not clearly and explicitly disclose wherein the skin autofluorescence level is measured continuously.
Katra in the same field of endeavor discloses wherein the skin autofluorescence level is measured continuously (Katra, Para 0024; “In one embodiment, a daily measurement of AGE concentration levels can detect increasing levels of an AGE protein or lipid before it reaches problematic levels.” Para 0027; “A benefit of utilizing an adherent device, implantable, injectable, and/or wearable device is that it may be utilized to collect physiological data from the patient while the patient goes about normal day-to-day activities outside of a hospital setting.” Further in Para 0085; “when a threshold is crossed, this triggers additional measurements … This may include increasing the frequency at which readings are taken, or simply continuing to monitor to ensure that the measured ratios are accurate.” Here these disclosures suggest that Katra’s device is worn by the user and can perform AGE measurements periodically for long-term monitoring.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, Sato and Shin, as suggested by Katra, in order to perform the measurement continuously or periodically. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling long-term monitoring of patient’s physiologic parameters non-invasively (Katra, Para 0031; “Adherent devices are often-times utilized for long-term monitoring of ambulatory patients, allowing physiological parameters of the patient to be monitored over a period of time (e.g., days, weeks, months).”).
With regard to Claim 16, Graaff, Sato and Shin disclose all the limitations of Claim 12 as discussed above, but do not clearly and explicitly disclose wherein the skin autofluorescence level is measured continuously.
Katra in the same field of endeavor discloses wherein the skin autofluorescence level is measured continuously (Katra, Para 0024; “In one embodiment, a daily measurement of AGE concentration levels can detect increasing levels of an AGE protein or lipid before it reaches problematic levels.” Para 0027; “A benefit of utilizing an adherent device, implantable, injectable, and/or wearable device is that it may be utilized to collect physiological data from the patient while the patient goes about normal day-to-day activities outside of a hospital setting.” Further in Para 0085; “when a threshold is crossed, this triggers additional measurements … This may include increasing the frequency at which readings are taken, or simply continuing to monitor to ensure that the measured ratios are accurate.” Here these disclosures suggest that Katra’s device is worn by the user and can perform AGE measurements periodically for long-term monitoring.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Graaff, Sato and Shin, as suggested by Katra, in order to perform the measurement continuously or periodically. One of ordinary skill in the art would have been motivated to make the modification for the benefit of enabling long-term monitoring of patient’s physiologic parameters non-invasively (Katra, Para 0031; “Adherent devices are often-times utilized for long-term monitoring of ambulatory patients, allowing physiological parameters of the patient to be monitored over a period of time (e.g., days, weeks, months).”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Colosimo et al (US 11571135 B1) discloses a wearable device that is in direct contact with skin and emit light that penetrates through skin and subcutaneous tissues. Shin et al (US 20210169338 A1) discloses a wearable device that uses light emission and detection to measure fluorescence emanating and estimating aging level. LeBoeuf et al (US 20100217102 A1) discloses a wearable device that involves light emission and detection and a light blocking region.
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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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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