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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 4/20/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 29-31, 33, 35-37, 39-43, 52, 54, and 56 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (WO 2019/160272 A1 to Tempus Inc. from 5/2/23 IDS Foreign Patent Doc cite 1) .
For claim 29, Lee discloses a device comprising a non-invasive system for determining a physiological parameter in a bodily fluid of a subject (Figs 1-2) (Pgs 4-8), wherein the device comprises a casing (10), wherein the device includes:
(a) a radiation source (irradiating optical module 20) adapted for emitting visual (VIS)/near-infrared (NIR) radiation in the range of about 400 nm to about 1500 nm into a body part of said subject (Figs 1-2) (Pgs 4-8), wherein the body part is a palm (Figs 1-2) (Pgs 4-8), and wherein the radiation source is further adapted such that the irradiated body part absorbs electromagnetic energy resulting in a local increase of tissue temperature and in an increased emission of IR radiation in the wave-length range of about 5 micron to about 12 micron (Figs 1-2) (Pgs 4-8),
(b) a sensing unit (light receiving optical module 20) comprising at least one sensor (light receiving optical module 20) for detecting emitted IR radiation from the previously irradiated body part of said subject in the range of about 5 micron to about 12 micron(Figs 1-2) (Pgs 4-8), wherein said sensing unit is adapted for (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of the physiological parameter in the bodily fluid of said subject (Figs 1-2) (Pgs 4-8), wherein the intensity of the emitted IR decreases with an increasing concentration of the physiological parameter and the intensity of the emitted IR radiation increases with a decreasing concentration of the physiological parameter (Figs 1-2) (Pgs 4-8), and for (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is substantially independent from the concentration of the physiological parameter in the bodily fluid of said subject (Figs 1-2) (Pgs 4-8), and
(c) an analyzing unit (controller for calculating blood glucose level from 20, Pg 7) for the qualitative and/or quantitative determination of the physiological parameter based on the IR radiation detected in the sensing unit (b) (Figs 1-2) (Pgs 4-8), wherein said analyzing unit comprises a microcontroller (microcontroller for calculating blood glucose level from 20, particularly computer/laptop/smartphone/etc of Pg 7), and
wherein the casing comprises a first face (upper face of 10 in Fig 2) comprising a screen (80),
wherein the screen is at least partially made of a material, which is optically transparent for NIR/VIS radiation emitted by the radiation source (a) and for IR radiation detected by the sensing unit (b), (Figs 1-2) (Pgs 4-8)
wherein the radiation source (a), the sensing unit (b) and the analyzing unit (c) are incorporated within the casing (Fig 2).
For claim 30, Lee discloses the device of claim 29, wherein the radiation source (a) is adapted for emitting radiation through the screen (Figs 1-2) (Pgs 4-8).
For claim 31, Lee discloses the device of claim 29, wherein the sensing unit (b) is adapted for detecting radiation entering the casing through the screen (Figs 1-2) (Pgs 4-8).
For claim 33, Lee discloses the device of claim 29, wherein the screen is substantially planar (Fig 2).
For claim 35, Lee discloses the device of claim 29, which is a mobile device (Figs 1-2) (Pgs 4-8).
For claim 36, Lee discloses the device of claim 29, which is selected from a smart phone, a smart watch, a tablet, and a fitness tracker device (Figs 1-2) (Pgs 4-8).
For claims 37 and 54, Lee discloses the device of claim 29, wherein the optically transparent material is a organic plastic material (Figs 1-2) (synthetic resin of Pgs 4-8 includes organic acids on formation and at least partially organic resultant components).
For claim 39, Lee discloses the device of claim 29, which does not comprise a radiation source for emitting IR radiation in the wavelength range of about 5 micron to about 12 micron (Figs 1-2) (Pgs 4-8).
For claim 40, Lee discloses the device of claim 29, wherein the physiological parameter is glucose, and the bodily fluid is glucose (Figs 1-2) (Pgs 4-8).
For claims 41 and 56, and Lee discloses the device of claim 29, which further comprises lens (40, 70) element adapted for focusing IR radiation from the body part to the sensing unit (b) (Figs 1-2) (Pgs 4-8), particularly to the at least one sensor of the sensing unit (b) (Figs 1-2) (Pgs 4-8), wherein the lens element is incorporated within the casing (Figs 1-2) (Pgs 4-8).
For claim 42, Lee discloses the device of claim 29, wherein the sensing unit (b) is adapted for detecting IR radiation emitted from the irradiated body part over a time period (Figs 1-2) (Pgs 4-8), wherein the body part is irradiated by VIS/NIR radiation during at least a part of said time period (Figs 1-2) (Pgs 4-8).
For claim 43, Lee discloses the device of claim 29, wherein the analyzing unit (c) is adapted for a time-dependent analysis of the detected IR radiation (Figs 1-2) (Pgs 4-8), wherein a measurement signal is recorded over a time period (Figs 1-2) (Pgs 4-8).
For claim 52, Lee discloses the device of claim 29, wherein the body part is a hand including any of those selected from a fingertip, a plurality of fingertips, and a palm (Pgs 7-8).
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.
Claim(s) 32, 34, 38, 35, 53, and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Mouradian et al. (US 20180235489 A1, hereinafter Mouradian).
For claims 32, 34, 38, 53, and 55, Lee discloses the claimed invention as set forth hereinabove, except for explicitly disclosing (for claims 32 and 53) the screen has a size of about 2 cm2 to about 200 cm2, (for claim 34) is adapted for displaying a contact position for the body part on the screen, and/or (for claims 38 and 55) the optically transparent material has a thickness of about 0.3 mm to about 1 mm.
However, for claims 32, 34, 38, 53, and 55, Mouradian in the same field of smart wearable physiological measurement devices teaches (for claims 32 and 53) a screen (112) has a size of about 2 cm2 to about 200 cm2 ([0026]), (for claim 34) is adapted for displaying a contact position for the body part on the screen ([0041]), and/or (for claims 38 and 55) the optically transparent material has a thickness of about 0.3 mm to about 1 mm ([0026, 0041]).
Thus, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to incorporate the smartwatch sensing teachings of Mourdian to provide an appropriately sized smartwatch screen because doing so would aid in permitting a user to complete noninvasive physiological sensing.
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Laker (CN 114449942 A).
For claim 57, Lee discloses the claimed invention as set forth hereinabove, except for explicitly disclosing wherein the lens element comprises an IR Fresnel lens or an array comprising a plurality of IR Fresnel lenses.
However, for claim 57, Laker in the same field of smart wearable physiological measurement devices (Fig 7) teaches a lens element comprises an IR Fresnel lens (IR Fresnel lens of cover 3 in the description of Fig 7) or an array comprising a plurality of IR Fresnel lenses (IR Fresnel lens array of cover 3 in the description of Figure 7).
Thus, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to incorporate the smart wearable sensing teachings of Laker to provide a known alternate infrared lens solution(s) for focusing IR with lenses during physiological measurement because doing so would aid in permitting a user to complete noninvasive physiological sensing.
Response to Arguments
Applicant’s arguments, see pages 13-14, filed 4/20/26, with respect to the amendments in view of the previous 112(b) and 101 rejections have been fully considered and are persuasive. The 112(b) and 101 rejections have been withdrawn.
Applicant's arguments, see pages 14-15, filed 4/20/26, with respect to the 102 under Lee have been fully considered but they are not persuasive.
Applicant argues the following:
Lee does not teach or suggest separately detecting glucose-dependent and glucose- independent IR radiation because Lee does not disclose (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of the physiological parameter in the bodily fluid, and (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is substantially independent from the concentration of the physiological parameter in the bodily fluid. Further, Lee does not describe in any way how this spectrum should be sampled, and which parts of the wavelength bands or spectrum are used to determine glucose. Also, the "composition ratio" of the mid-infrared spectrum is not defined anywhere in Lee.
The device of Lee is directed to a different emission correlation and the device of claim 29 is adapted for absorption measurements, wherein the absorption of internally generated IR radiation by compounds such as glucose is measured to determine the concentration of said compounds. Accordingly, the intensity of the detected IR radiation decreases with an increasing concentration of the physiological parameter, and vice versa. Lee does not suggest in any way to specifically measure and analyze glucose- independent IR radiation in addition to glucose-dependent IR radiation.
In response the Examiner respectfully notes the following:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “separately detecting glucose-dependent and glucose- independent IR radiation”, “how this spectrum should be sampled, and which parts of the wavelength bands or spectrum are used to determine glucose”, “spectrum sampling”, “determine glucose”, “adapted for absorption measurements”, “the absorption of internally generated IR radiation by compounds such as glucose is measured to determine the concentration of said compounds”, and/or “measure and analyze glucose- independent IR radiation in addition to glucose-dependent IR radiation”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant’s argument -- (i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of the physiological parameter in the bodily fluid, and (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is substantially independent from the concentration of the physiological parameter in the bodily fluid --, the Examiner notes Lee states the following:
Referring to FIG. 1, in the non-invasive blood glucose measurement method according to an embodiment of the present invention, a temperature of a skin is locally increased through near-infrared absorption of components that absorb near-infrared rays among components of the skin by irradiating near-infrared rays on the skin to be measured. Step (S10) blood glucose level by measuring the mid-infrared spectrum radiated from the skin tissue with the elevated temperature (S20) and by measuring the proportion of the skin's rise temperature and the mid-infrared spectrum by the near-infrared absorption of the skin from the mid-infrared spectrum It may include the step (S30) to calculate. The mid-infrared spectrum may include a spectrum of light emitted by glucose in the blood flowing inside the skin.
Specifically, when the near-infrared light source is used, since the spectrum reflected from the skin is difficult to measure, the near-infrared light may emit infrared light having a wavelength band of 6 μm or less or light of an infrared lamp having a wavelength range of 400 nm to 6 μm. I use it. The infrared light having a wavelength band of about 6 μm or less may use green light having a wavelength range of 532 nm and a near infrared light source having a wavelength range of 1.5 μm to 3 μm.
When the near-infrared light source is irradiated to the skin to be measured, near-infrared absorption may occur in some of the components of the skin to locally increase the temperature of the skin. The elevated temperature of the skin emits infrared light, and the spectrum of emitted mid-infrared radiation is associated with the characteristic absorption spectrum of the components of the skin. That is, according to Kirchhoff's law, when a material having an absorption line at a specific wavelength becomes high temperature, it emits the same light as the absorption wavelength band. Therefore, the infrared spectrum generated in the skin with elevated temperature reflects the components of the skin. That is, by measuring the mid-infrared spectrum of the locally heated skin, the components of the skin can be specified. Here, the wavelength band of the mid-infrared may be a wavelength band of 8㎛ to 14㎛.
From the mid-infrared spectrum, blood glucose levels can be calculated by measuring the temperature rise of the skin by the near-infrared and the composition ratio of the mid-infrared spectrum. Here, it is important to maintain constant temperature of the measurement system when measuring the mid-infrared spectrum. It is very important that the temperature of the system is kept constant because the radiation spectrum due to body temperature varies according to the skin component ratio of the individual and, for example, changes in body temperature, skin condition, internal component composition and moisture content. .
In particular, the spectrum of individual wavelength bands differs depending on the ratio of glucose having an absorption line in the 9.4 μm wavelength band. In the wavelength band of 8 .Math.m to 14 .Math.m, which is the wavelength band of the mid-infrared spectrum, it is also affected by moisture and humidity in the air.
Therefore, in the present invention, in order to calculate a more accurate blood sugar level, in the step of calculating the blood sugar level (S30) may include the step of considering the effects of moisture contained in the skin, including the temperature and humidity of the system. .
Specifically, the step of correcting, after measuring the rising temperature of the skin and the composition ratio of the mid-infrared spectrum, the pulsation of the halmac and the skin located inside the skin by Bio-impedance analysis (BIA) The moisture content of can be measured. Here, the pulsation of the blood vessel can be understood as blood flow (pulse of the blood vessel). The moisture in the skin can be measured and the humidity in the air can be measured using the humidity sensor. Since the pulsation of the blood vein is a factor influencing the amount of radiation, the mid-infrared spectrum should be measured between the pulsation and the pulsation to minimize the effect of the heart rhythm.
The blood glucose content of the dermal interstitial fluid is then calculated from the measured moisture content of the skin and the composition ratio of the mid-infrared spectrum with respect to the humidity in the air, and from the corrected composition ratio of the mid-infrared spectrum. Can be. The present invention can accurately measure blood glucose levels in consideration of external influences through the correction.
Thus, Lee demonstrates express concern for and disclosure of at least “(i) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is dependent from the concentration of the physiological parameter in the bodily fluid (as per hereinabove, blood glucose level detection depending on mid-infrared spectrum), and (ii) detecting IR radiation having at least one wavelength or wavelength range where the intensity of the detected IR radiation is substantially independent from the concentration of the physiological parameter in the bodily fluid (as per hereinabove, causing and detecting elevated skin temperature change using near infrared)”.
Conclusion
Applicant's amendment necessitated any 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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/Primary Examiner, Art Unit 3791
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