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 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 4-5 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 4, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “substantially equal distance” in claim 5 is a relative term which renders the claim indefinite. The term “substantially equal distance” 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. Examiner interprets as equal distance.
Claim Rejections - 35 USC § 103
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, 7-8, 13, 15-16 rejected under 35 U.S.C. 103 as being unpatentable over Besling [US 20120259188 A1] in view of Peyser [US 20100312483 A1].
As per claim 1, Besling teaches a device to non-invasively determine a concentration of an analyte in a sampling volume (Besling Fig 4, ¶0001, ¶0058), the device comprising:
a pulsed light source (Besling Fig 4 item 110, ¶0055 “pulsing the light source 110 at a predefined frequency”);
a doped glass comprising dopants that are configured to emit fluorescence (Besling Fig 4 item 120, ¶0049 “suitable for bringing the light-responsive material 120 in the electronically excited state from which the fluorescence occurs”), the fluorescence having a fluorescence wavelength range that at least partially overlaps an absorption wavelength range of the analyte (Besling ¶0057-¶0058 “If for instance a green LED is used as photodiode emitting at 550 nm all fluorescence emission… An other aspect of the invention relates to the determination of the fluorescent decay time. In addition to the fluorescence intensity that increases proportionally to the glucose concentration the fluorescence lifetime is also a measure for the glucose concentration”),
the fluorescence having a first temporal fluorescence emission distribution in response to optical excitation by the pulsed light source (Besling ¶0058 “fluorescence intensity that increases proportionally to the glucose concentration”)
a semi-transparent mirror interposed between the doped glass and the sampling volume (Besling Fig 4, ¶0059-¶0060 , boundary of insert 100, which allows reflection, by TIR, when incidence is greater than critical angle . ¶0059 “the wearer of the lens is prevented from being exposed to significant amounts”, implying the boundary of insert is capable of transmission in accordance with laws of TIR. ¶0062 “relatively rigid transparent insert”, also the insert is for ophthalmic contact lens use implying it can allow transmission of visible / ambient light to the eye of the wearer. Hence the boundary surface is at least partially transparent and reflective, as defined by applicant),
such that the dopants emit fluorescence having a second temporal fluorescence emission distribution that is a function of the concentration of the analyte in the sampling volume (Besling ¶0058 “An other aspect of the invention relates to the determination of the fluorescent decay time. In addition to the fluorescence intensity that increases proportionally to the glucose concentration the fluorescence lifetime is also a measure for the glucose concentration” an increase implies at least two distributions were identified and determined to find the proportionality finding); and
a detector configured to measure the second temporal fluorescence emission distribution such that the concentration of the analyte in the sampling volume can be determined based on a change (Besling ¶0051 “the photodetector 130 for transmitting the readings from the photodetector 130 to a remote receiver (not shown)”, ¶0001 “determine the concentration of an analyte of interest such as glucose in tear fluid”)
Besling does not expressly teach first temporal fluorescence emission distribution in response to optical excitation by the pulsed light source when the analyte concentration in the sampling volume is zero; and determining concentration of the analyte based on a change between the first temporal fluorescence emission distribution and the second temporal fluorescence emission distribution.
Peyser, in a related field of algorithms and methods for calibrating an analyte sensor, teaches first temporal fluorescence emission distribution in response to optical excitation by the pulsed light source when the analyte concentration in the sampling volume is zero (Peyser ¶0134 “fluorescent response of certain analyte sensors disclosed herein may be characterized by a modified version of the Michaelis-Menten equation, … can be described by a modified form of the Michaelis-Menten equation in which three parameters (a, b, and c),”, ¶0135 “where "a" is the fluorescent signal intensity in the absence of glucose,”); and determining concentration of the analyte based on a change between the first temporal fluorescence emission distribution and the second temporal fluorescence emission distribution (Peyser ¶0138 “Given the values of the Michaelis-Menten parameters, the Michaelis-Menten equation can be inverted or solved for glucose (G): G=c*(I-a)/(a+b-I)”).
Hence Michaelis-Menten’s equation and variations thereof, as in Peyser for glucose concertation were known before the effective filing date of the claimed invention. As per MPEP 2143.I. examples of rationales that may support a conclusion of obviousness include combining prior art elements according to known methods to yield predictable results. In the instant case, the claim is directed to combine glucose concentration calculation of Peyser with a device of Besling. The predictable result would be to provide for calibration and accurate measurement of different chemical species, such as glucose.
As per claim 7, Besling in view of Peyser further teaches wherein a first optical efficiency between the semi-transparent mirror and the sampling volume is different to a second optical efficiency between the semi-transparent mirror and the dopant (In Besling Optical efficiency with respect to the LED wavelength with inherently be different since significant amount is reflected to the detector from the boundary).
As per claim 8, Besling in view of Peyser further teaches wherein the device comprises an optical element interposed between either the sampling volume and the semi-transparent mirror or between the semi-transparent mirror and the dopant in order to make the first optical efficiency different to the second optical efficiency (Examiner chooses latter. Material of insert 100 such as a silicone hydrogel between the boundary surface and 120 contributes to any TIR and efficiency therein).
As per claim 13, Besling in view of Peyser further teaches wherein the analyte is one of a blood analyte or a foodstuff analyte (Peyser ¶0006 “detect glucose concentration in the blood stream”).
As per claims 15-16, Besling in view of Peyser further teaches wherein the device further comprises a processor configured to determine the concentration of the analyte in the sampling volume based on the change between the first temporal fluorescence emission distribution and the second temporal fluorescence emission distribution or wherein the device further comprises means for transmitting the second temporal fluorescence emission distribution to a remote server for determining the concentration of the analyte in the sampling volume (Besling ¶0052-¶0053 “signal processing circuitry for converting the signal from the photodetector 130 into a digital value that can be transmitted to the receiver… the remote receiver may comprise signal processing circuitry for converting the value received from the transmitter 140 into a glucose reading”).
Claim 10 rejected under 35 U.S.C. 103 as being unpatentable over Besling in view of Peyser as applied to claim 1 above, and further in view of Asnawi [Simple Glucose Measurement System Based on Uncladded Fiber Bragg Grating Etched with Nitric Acid, Journal of Physics: Conference Series 1417 (2019) 012004].
As per claim 10, Besling in view of Peyser further teaches wherein the analyte is a glucose molecule (Besling abstract).
Besling in view of Peyser does not expressly teach and the dopants are erbium ions.
Aswani teaches measuring glucose concentration through optical systems consisting of an erbium-doped fibber laser (Aswani abstract).
As per MPEP 2144.06.II it is prima facie obvious to combine substitute equivalent substances, if the equivalency is recognized in the prior art. In the instant case erbium doping is known for glucose monitoring and hence it would have been obvious to substitute doping in Besling.
Claim 12 rejected under 35 U.S.C. 103 as being unpatentable over Besling in view of Peyser as applied to claim 1 above, and further in view of Lee [US 20210139772 A1].
As per claim 12, Besling in view of Peyser does not teach wherein the doped glass further comprises a sensitizer, optionally wherein the sensitizer comprises ytterbium ions.
Lee, in a field of luminescent materials teaches doping with ytterbium as sensitizer (Lee ¶0008 “each of the sensitizer dopants independently is or comprises a ytterbium ion”).
As per MPEP 2143.I., Examples of rationales that may support a conclusion of obviousness include (C) Use of known technique to improve similar devices (methods, or products) in the same way. Lee discloses sensitizer to increase absorption of light. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Besling in view of Peyser, using sensitizer so as to increase NIR absorption when method as in Besling ¶0015 uses NIR.
Allowable Subject Matter
Claims 2-3, 4-6, 9, 11, 14 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and any 112 rejections are overcome. The prior art made of record (PTO 892, IDS) are considered closest to the claimed invention.
As per claim 2, none of references recited teach utilizing a baseline / an analyte-induced spontaneous emission rate probability distribution based on the first /second temporal fluorescence emission distribution.
As per claims 4-5, none of references recited teach anything regarding distance in comparison with wavelength range as claimed. Examiner further does not find any reason that anyone would look to change distances in Besling, whereas application requires specific features for atomic interactions based on these distances. Note, these claims are not objected to as allowable in view of the pending 112 rejections.
As per claims 6, 9, none of references recited teach anything wherein the device further comprises a spacer or other optical elements a light absorbing component; a light absorbing layer on a surface of the semi-transparent mirror; or a roughened surface of an optical component. Examiner further does not find it obvious to modify the references, since TIR relationships would be affected if additional elements are added.
As per claims 11, 14 none of references recited teach wherein the analyte is an alcohol molecule and the dopants are thulium ions, and or analyte is blood analyte and a contact surface for receiving a skin surface having the blood analyte located at a subcutaneous depth, wherein the semi-transparent mirror is disposed between the contact surface and the doped glass. Examiner further does not find any reason to modify the non-invasive eye wear for alcohol / skin applications, as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797
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