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 .
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: Claim 1 recites “a wrist” in line 4, but instead should be --the--. Claim 7 recites “a first light receiver” in line 9, but instead should be --the first light receiver--. 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 3-5 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.
The term “about” in claims 3-5 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the term “about” can be interpreted to encompass any possible deviation therefrom.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-5, and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20160045143- Previously cited), hereinafter Lee, in view of Mischler et al. (US 20070191696- Previously cited), hereinafter Mischler.
Regarding claim 1, Lee teaches a noninvasive blood glucose meter attachable to a wrist, the noninvasive blood glucose meter comprising:
a sensor configured to be attached near an artery of wrist of human body (see abstract and ¶[0091], body part includes blood vessels and therefore capable of being attached near arteries in the body with prism sensor);
a light emitter in the body and configured to generate measurement light in a direction toward the artery (figs. 7-8, light source LS12-13);
and a first light receiver configured to receive reaction light and measure blood sugar from a photoreaction of blood flowing through the artery toward the measurement light ( ¶[0126], detector receives light to measure blood sugar).
Lee fails to teach a body configured to be attached near a wrist artery and configured to block external light.
Mischler teaches an analyte concentration device configured to be placed on the wrist (see abstract and figs. 1 and 5a-5d). The body (8) of the device is capable of being attached to wrist arteries and block external light (see abstract and figs. 1 and 5a-5d, one skilled in the art understands that the wearable body 8 would block external light).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee, such that the sensor comprises a body that is capable of blocking external light, as taught by Mischler, as it would merely combining prior art elements (analyte measuring devices) according to known methods (incorporated into a wearable body) to yield predictable results. Moreover, Lee requires positioning the ATR sensor on the subject (figs. 4-10, S10 represents the body part of the subject and B is an artery/vessel), but fails to provide details, and Mischler teaches that an ATR sensor can be integrated into a wrist wearable device comprising a body (see figs. 5A-6A of Mischler).
Regarding claim 4, Lee-Mischler teach a second light receiver configured to detect light having a wavelength of about 6.0μm to about 6.3μm or about 2.9μm to about 3.1μm to measure skin moisture (¶[0113-114] of Lee, multiple light receiving parts can be integrated into a single unit and measure at a plurality of wavelengths).
Regarding claim 5, Lee-Mischler teach comprising a third light receiver for detecting light of about 5μm to about 14μm to measure a temperature of skin (¶[0113-114] of Lee, multiple light receiving parts can be integrated into a single unit and measure at a plurality of wavelengths, “ the spectrometers SP10 through SP13 and the detectors D10 through D13 may be integrated into single units”).
Regarding claim 7, Lee-Mischler teach wherein the body additionally comprises: an external light blocking member, which blocks external light (fig. 5c-5d of Mischler, the outer surface/member of body 8 is the blocking external member); and
an ATR element inside the external light blocking member (figs. 7-8 of Lee, ATR prism AP12-13, and figs. 5c-5d of Mischler),
wherein a main light emitter is installed at one end of the ATR element, a main light receiving line of the first light receiving part is installed at another end of the ATR element and the ATR element is formed length wise along a horizontal reference line (see figs. 7-8 of Lee, light source/detector are at the ends of ATR prism).
Lee fails to teach wherein the emitting parts and receiving parts are angled at an inclination with respect to the horizontal reference line.
Mischler teaches that the light sources need to be angled based on the wavelength (see fig. 1 and ¶[0037]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler, such that the emitting parts and receiving parts are angled at an inclination with respect to the horizontal reference line, as taught by Mischler, because Lee requires that the light emitted towards the ATR prism is angled and the output light is angled, but fails to provide details of the orientation of the sensors. Mischler teaches that the sensor elements (emitter/receiver) are angled to effectively transmit light through an ATR prism.
Regarding claim 8, Lee-Mischler teach wherein the ATR element comprises:
a light guide having a thickness and a length, the thickness being less than the length such that a first portion of measurement light generated from the light emitter is reflected in the light guide in a zigzag pattern and received by the first light receiver, and a corresponding reaction light is collected after a second portion of the measurement light is delivered toward the artery of the wrist, the light guide having a rear surface, which reflects light (see fig. 7-8 of Lee, guides AP12-13 comprising a rear surface that reflects light thereby achieving the zig zag pattern);
a skin contact layer on a front of the light guide and made of a skin-friendly translucent material; and a reflective layer installed on a rear surface of the light guide and configured to reflect the measurement light that is not totally reflected (see fig. 7-8 of Lee, the rear portion allows for the zigzag path of the light).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Mischler, as applied to claim 1, further in view of Caduff et al. (US 20130053654- Previously cited).
Regarding claim 2, Lee-Mischler teach wherein an opening is formed on one side of the body, a light transmission space is formed inside the enclosed volume to surround a vicinity of the wrist artery (see fig. 5c-5d of Mischler, opening is formed where the light sensor is placed).
Lee-Mischler fail to teach wherein a reflector protrusion is formed between the light emitter and the first light receiver to prevent the measurement light from being directly irradiated to the first light receiver.
Caduff teaches an analyte measuring device with a light source 7 and light detector 8 and a barrier 12 that prevents direct light from the source to the detector (see abstract, ¶[0054,0064] and fig. 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler, such that a protrusion is provided between the light source and detector, as taught by Caduff, to aid in measuring analytes. Additionally, the modification is merely combining prior art elements (analyte measuring devices) according to known methods (comprising protrusions) to yield predictable results.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Mischler and Caduff, as applied to claim 2, further in view of Kouchnir (US 20040225206- Previously cited).
Regarding claim 3, Lee-Mischler-Caduff teach wherein the first light receiving part comprises:
a first optical sensor configured to detect light in a glucose emission wavelength band of about 9.4μm to about 9.8μm (see ¶[0096] of Lee, “may use short-wavelength IR (SIR) rays within a bandwidth between about 1.4 μm and about 2.5 μm or long-wavelength IR (LIR) rays within a bandwidth between about 8 μm and about 15 μm” );
and a second optical sensor configured to detect light having a wavelength of about 8.4μm to about 10.6 μm (see ¶[0114] of Lee, multiple detectors may be included in the system).
Lee-Mischler-Cuff fail to teach wherein the light detected by the second optical sensor is a reference light.
Kouchnir teaches an analyte measuring device based on ATR and configured to detect a reference signal “to ensure that the device ‘tracks’ changes in the frequency of the detected signal. As a result, the light signals detected by light sensors 176 and 178 have a maximum sensitivity” (see abstract and ¶[0052]).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler-Cuff, such that a second detected light is a reference light, as taught by Kouchnir, to aid in monitoring changes in frequency and increasing detection sensitivity for non-invasive analyte measurements.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Mischler, as applied to claim 1, further in view of Caduff.
Regarding claim 6, Lee-Mischler teach wherein the light emitter is a lamp (see ¶[0012]), but fail to teach that the lamp is capable of minimizing noise by using a differential signal for turning the lamp on and off.
Caduff teaches that modulating light of an analyte measurement device can aid in increasing signal sensitivity and improve signal-to-noise ratio (see abstract and ¶[0050-52], the square wave pattern is interpreted to encompass turning a light source off and on).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler, such that the light source is modulated to minimize noise, as taught by Caduff, to aid in increasing signal sensitivity and measuring analytes.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Mischler, as applied to claim 8, further in view of Vestel et al. (US 20100121163- Previously cited), hereinafter Vestel.
Regarding claim 9, Lee fails to disclose details of the materials for the light guide, but Mischler teaches that a light guide can be formed of “silver, silver halogenides, zinc selenide, diamond, germanium or silicon” (see ¶[0036] of Mischler). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler, such that the light guide is formed of Ge, Si, and ZnSe, as taught by Mischler, because Lee requires an ATR light guide, but fails to provide details. Mischler teaches the guide can be formed of Ge, Si, and ZnSe.
Lee-Mischler fail to teach wherein the skin contact layer comprises a High-Density PolyEthylene (HDPE) component.
Vestel teaches an analyte monitoring device, based on ATR, formed of HDPE (see ¶[0042] and abstract). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler, such that the light guide is formed of HDPE where contact with subject is made, as taught by Vestel, as it would merely be applying a known technique (HDPE contact surface of ATR element) to a known device (analyte measuring devices) ready for improvement to yield predictable results.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Mischler, as applied to claim 8, further in view of Deck et al. (US 20190336050), hereinafter Deck.
Regarding claim 10, Lee teaches wherein the first light receiver is configured to receive light through a first light filter (¶0163], “ a light source that generates light having a wavelength that penetrates only the tissue may be used or a filter that selectively filters (or receives) light that is scattered or reflected by the tissue may be used”(emphasis added)), but Lee-Mischler fail to teach wherein the filter is a bandpass light filter.
Deck teaches a sensor for detecting analytes such as blood glucose (¶[0002-3]). The sensor comprises optical detectors with bandpass filters that aid in permitting absorption for determining glucose (¶[0006,0133], “quantitative determination of glucose may be performed via absorption spectroscopy” and “In order to permit absorption measurements with a broadband illumination source, the sensor element 110 may comprise several optical detectors and suitable spectral bandpass filters or at least one tunable optical detector having at least one tunable, spectral bandpass filter”). Moreover the sensor is configured to perform ATR measurements (¶[0149-150], “sensor element 110 may be adapted to perform one or more of at least one reflection measurement, at least one absorption measurement, at least one attenuated total reflectance measurement”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler, such that the light receiver filter is a bandpass filter, as taught by Deck, to aid in detecting blood glucose. Moreover, Lee recognizes the use of a filter to aid in performing the disclosed steps of measuring analytes via absorption, but fails to provide details, and Deck teaches that a bandpass filter aids in permitting absorption measurements. (¶[0130] of Deck).
Regarding claim 1`, Lee teaches wherein the second light receiver is configured to receive light through a second light filter (¶0163], “ a light source that generates light having a wavelength that penetrates only the tissue may be used or a filter that selectively filters (or receives) light that is scattered or reflected by the tissue may be used”(emphasis added)), but Lee-Mischler fail to teach wherein the filter is a bandpass light filter.
Deck teaches a sensor for detecting analytes such as blood glucose (¶[0002-3]). The sensor comprises optical detectors with bandpass filters that aid in permitting absorption for determining glucose (¶[0006,0133], “quantitative determination of glucose may be performed via absorption spectroscopy” and “In order to permit absorption measurements with a broadband illumination source, the sensor element 110 may comprise several optical detectors and suitable spectral bandpass filters or at least one tunable optical detector having at least one tunable, spectral bandpass filter”). Moreover the sensor is configured to perform ATR measurements (¶[0149-150], “sensor element 110 may be adapted to perform one or more of at least one reflection measurement, at least one absorption measurement, at least one attenuated total reflectance measurement”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Lee-Mischler, such that the light receiver filter is a bandpass filter, as taught by Deck, to aid in detecting blood glucose. Moreover, Lee recognizes the use of a filter to aid in performing the disclosed steps of measuring analytes via absorption, but fails to provide details, and Deck teaches that a bandpass filter aids in permitting absorption measurements. (¶[0130] of Deck).
Response to Arguments
Applicant's arguments filed 12/26/2025 have been fully considered but they are not fully persuasive.
Applicant arguments and applicable amendments regarding the specification, objections, and 35 U.S.C. 112(f) invocations have been considered and found persuasive.
Applicant’s arguments with respect to added claims 10 and 12 have been considered but are moot because the amendment requires new grounds of rejection.
Applicant contends that one of ordinary skill in the art would not place the invention of Lee on the wrist of the user, on page 10 of the Remarks. The examiner disagrees. Lee generally discloses that the device is positioned on the user and provides figures that depict the device attached to the user’s skin with vessels (figs. 7-8). When viewed in combination with the widespread use of noninvasive medical devices positioned on the wrist that measure blood glucose, reasonably suggests to one of ordinary skill in the art that the device can be placed on the user’s wrist.
Applicant contends that Mischler is not an applicable reference because their glucose sensor requires a user’s skin to be pierced, on page 11 of the Remarks. The examiner disagrees that Mischler is not an applicable reference. Mischler does in fact disclose a microneedle electrode arrangement for collecting the fluid into the fluid collection chamber of the glucose (¶[0030] of Mischler). However, the rejection relies upon the ATR sensor (2) of Mischler, which is separate from the microneedle arrangement and the collection chamber (¶[0044] and fig. 4 and 5c). It is noted that a reference can contain more than what is claimed. As such, it is the ATR sensors in Lee and Mischler that are being combined, not the other elements in Mischler.
Thus, Applicant’s arguments are found unpersuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Liu teaches fluorescence excitation filter is configured as a bandpass filter, a short pass filter, or a tunable filter that only allows light having rays that are within a range of excitation wavelengths (i.e. excitation light) that are readily absorbable by the target object to pass therethrough. US 20180270474
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791