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 Arguments
The objection to the title has been withdrawn. The Examiner thanks Applicant for providing a more informative title.
Applicant argues Zilkie does not show or suggest the Raman pump source and the plurality of Stokes sources as recited in claim 1 and points to paragraphs [0278]-[0279]. Although Examiner agreed with Applicant during the interview of June 8, 2026, after further review, the Examiner respectfully disagrees. Although there are embodiments such as that of paragraphs [0278]-[0279], there are teachings of other embodiments where a Raman pump source and a plurality of Stokes sources as recited in claim 1 are taught, e.g., "In some circumstances it may be beneficial to transmit a number of wavelengths simultaneously" (para. [00165]). This Office action also introduces a new reference Hasegawa
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 1-20 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.
Claims 1, 18, and 20 recite that the sources are "activated simultaneously" and the claims are not clear as to the manner in which they are activated. For instance, it is not clear if they are turned on simultaneously, if the pump light and plurality of Stokes wavelengths are emitted simultaneously, or if they are simultaneously incident on the skin. For examination purposes, it will be taken to encompass any of these alternatives. All the depended claims are rejected for the same reason by virtue of their dependence on claim 1 or 18.
Claim 2, which depends from claim 1, is assumed to be compliant with 35 U.S.C. § 112(d) but appears to recite a limitation that is already found in claim 1 and no other limitation is recited. It is not clear what limitation is imposed by claim 1 that further limits the device of claim 1.
Claim 3 recites that at least one of the plurality of Stokes sources provides the plurality of narrowband emissions. If this is so, then it is unclear what the remaining sources provide. It will be assumed that variable laser provides one of the center wavelengths.
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.
Claim(s) 1, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hasegawa (JP 2009258071).
Hasegawa shows the following:
1. (also claims 18 and 20). A device for non-invasively measuring a level of an analyte in a user using Stimulated Raman Scattering (para. [0001]: "nonlinear Raman spectroscopy"), comprising:
a Raman pump source that emits pump light toward a skin surface of the user at a pump wavelength (Para. [0008]: "the excitation light may include pump light and Stokes light having a wavelength longer than that of the pump light, and the Stokes light may have a plurality of peaks having wavelengths different from each other,"; Para. [0022]: "detects nonlinear Raman scattering light generated from the test particles by the irradiation with the excitation light"; The recitation of the skin does not serve to structurally distinguish as it is a statement of intended use/object to be worked upon by the apparatus. See MPEP 2115);
a plurality of Stokes sources that emits Stokes light toward the skin surface at a plurality of different Stokes wavelengths (e.g. Para. [0096]: "from the plurality of laser light sources, it is possible to generate narrowband Stokes light having a plurality of peaks having wavelengths different from each other.") within a window of Raman measurement wavelengths, wherein the Stokes light comprises a plurality of narrowband emissions at a plurality of respective center wavelengths within (ranging across) the window of Raman measurement wavelengths (Para. [0096]:"Accordingly, it is possible to generate the narrowband Stokes light having the wavelength range in which the light intensity does not substantially generate the nonlinear Raman scattering light in each wavelength range between the two peaks having the wavelengths adjacent to each other.");
a controller that causes the Raman pump source and two or more Stokes sources in the plurality of Stokes sources to be activated simultaneously (Para. [0092]: "synchronization signal generation unit Sy"; Para. [0034]: "By providing the delay line 13 in the optical path of one of the pump light and the Stokes light, it is possible to simultaneously irradiate the cell 8 with the pump light and the Stokes light");
a photodetector that measures light that emanates from the skin surface (Para. [0039]: "The detection unit 4 detects the CARS light"); and
a processor that processes the measured light to provide an estimated analyte level of the analyte in the user (Para. [0041]: "The analysis unit 5 performs signal processing on the electric signal output from the detection unit 4 on the basis of nonlinear Raman spectroscopy, identifies molecules inside the cell 8, acquires information on the internal structure of the cell 8, and analyzes the cell 8. As the analysis unit 5, for example, a computer system").
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.
Claim(s) 1-7 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zilkie et al. (WO 2021/116766 submitted in IDS of 04/11/2024) in view of Hasegawa.
1. (and claim 20). A device for non-invasively measuring a level of an analyte in a user using Stimulated Raman Scattering (Figs. 47-60: "Raman spectrometer"), comprising:
a Raman pump source that emits pump light toward a skin surface of the user at a pump wavelength (Para. [0047]: "Raman spectroscopy can be carried out using the pump-probe pairs of lasers"; Para. [00278]: "The plurality of lasers includes a plurality of fixed wavelength DBR pump lasers 4703"; The recitation of the skin does not serve to structurally distinguish as it is a statement of intended use/object to be worked upon by the apparatus. See MPEP 2115);
a plurality of Stokes sources that emits Stokes light toward the skin surface at a plurality of Stokes wavelengths (Para. [0004]: "each laser of the plurality of lasers operating at a wavelength that is different from the wavelength of the others;") within a window of Raman measurement wavelengths, wherein the Stokes light comprises a plurality of narrowband emissions at a plurality of respective center wavelengths within (ranging across ) the window of Raman measurement wavelengths (Para. [00278]:"the fixed wavelength of the DBR corresponds to a wavelength within the wavelength range of the RSOA gain spectrum…the Pump lasers 4703 correspond to wavelengths within the range of 1250-1700nm and the probe wavelengths correspond to wavelengths within the range of 1300-1850nm.");
a photodetector that measures light that emanates from the skin surface (Para. [00279]: "photodetectors 4702-1, 4702-L"); and
a processor that processes the measured light to provide an estimated analyte level of the analyte in the user (Para. [00166]: "The concentration of the analyte can then be calculated from the spectrum. Calculation may be achieved via the algorithms embedded or from an algorithm set up by the on-board computer, CPU, or FPGA.").
Zilkie does not show a controller that causes the Raman pump source and two or more Stokes sources in the plurality of Stokes sources to be activated simultaneously. Zilke, however, teaches many different schemes for illuminating the sample with different wavelengths such as "Each beam may include light at more than one wavelength," or "In some circumstances it may be beneficial to transmit a number of wavelengths simultaneously" (para. [00165]); "The control circuitry…capable of applying more than one wavelength successively or simultaneously" para. [00173]. For these reasons, it appears Zilkie does show a "controller that causes the Raman pump source and two or more Stokes sources in the plurality of Stokes sources to be activated simultaneously."
In the alternative, it would be obvious to modify Zilkie to have a controller as claimed . Hasegawa shows: "synchronization signal generation unit Sy" Para. [0092]; "By providing the delay line 13 in the optical path of one of the pump light and the Stokes light, it is possible to simultaneously irradiate the cell 8 with the pump light and the Stokes light;" Para. [0034]).
2. The device of claim 1, wherein the plurality of Stokes sources emits Stokes light that is narrowband relative to the window of Raman measurement wavelengths (Para. [0004]: "each laser of the plurality of lasers operating at a wavelength that is different from the wavelength of the others").
3. The device of claim 2, wherein at least one Stokes source in the plurality of Stokes sources comprises a variable wavelength narrowband laser configured to provide the plurality of narrowband emissions at the plurality of the respective center wavelengths (Para. [00298]: "A further embodiment is disclosed in FIG. 60 which differs from previous SRS Raman spectrometers disclosed in that the pump laser is tunable (e.g. by replacing the DBR grating with thermally tunable ring resonators) and therefore generates light of a variable wavelength").
4. The device of claim 3, wherein the variable wavelength narrowband laser is configured to be swept continuously from one end to another end of the window of Raman measurement wavelengths during non-invasive analyte measuring (Para. [00279]: "When in use, only one pump and probe laser pair is on at one time…The pairs may be cycled through in time").
5. The device of claim 2, wherein the plurality of Stokes sources comprises a plurality of fixed-wavelength narrowband laser sources, each having a different center wavelength within the window of Raman measurement wavelengths (Para. [0004]: "each laser of the plurality of lasers operating at a wavelength that is different from the wavelength of the others;").
6. The device of claim 5, wherein the photodetector is a photodiode that detects light across the window of Raman measurement wavelengths, and wherein the plurality of fixed-wavelength narrowband laser sources are activated one-at-a-time during non-invasive analyte measuring (This claim is not found to impart any structure, but rather states how the elements are intended to be operated and is not found to structurally distinguish from Zilkie. See also para. [00279]: "When in use, only one pump and probe laser pair is on at one time…The pairs may be cycled through in time").
7. The device of claim 5, wherein the photodetector detects light across a range of wavelengths including both the pump wavelength and the window of Raman measurement wavelengths, and wherein at least one of modulation of the Raman pump source, time modulation of the Stokes source, or different modulations of both the Raman pump source and the Stokes source are used to allow differentiation of Raman pump wavelength light from light having wavelengths lying within the window of Raman measurement wavelengths (This claim is not found to impart any structure, but rather states how the elements are intended to be operated and is not found to structurally distinguish from Zilkie).
16. The device of claim 1, wherein the photodetector is a broad-range photodiode (Para. [00279]: "photo detector e.g. InGaAs for highest sensitivity with a band pass DBR filter (e.g. transmitting same range as probe lasers ex 1700-1800). ").
17. The device of claim 1, wherein the analyte is glucose (Para. [00265]: "measuring blood glucose non-invasively").
18. A computer-implemented method (Para. [00166]:"Calculation may be achieved via the algorithms embedded or from an algorithm set up by the on-board computer, CPU, or FPGA." See citations given for claim 1 above for the claimed steps)
19. The computer-implemented method of claim 18, wherein the plurality of Stokes sources emits Stokes light that is narrowband relative to the window of Raman measurement wavelengths See citations given for claim 2 above.
Claim(s) 8-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zilkie and Hasegawa as applied to claim 7 above, and further in view of Cheng et al. (US 2014/0218726).
Zilkie shows all the elements of claim 7 as discussed above, and further teaches to use lock-in detection electronics (Paras. [00275],[00277]) but does not show that the lock-in detection electronics is a lock-in amplifier.
Cheng shows Stimulated Raman Scattering microscopy and that using lock-in amplifiers were common at para. [0010], "Lock-in amplifiers (analog or digital) are commonly used for extraction of heterodyne-detected signals like SRS."
Before the effective filing date of the claimed invention, it would have been obvious to a lock-in amplifier for the predictable result of extracting the detected signals with high signal-to-noise ratio.
9. The device of claim 8, wherein processing the measured light to provide an estimated analyte level of the user further comprises: determining a stimulated Raman gain for a particular wavelength of light based on the portion of the signal associated with the modulated source (Para. [00165]:"intensities of light of certain wavelengths received at low intensities (for example, as a result of high scattering or high absorbance) may be determined with greater accuracy").
10. The device of claim 9, wherein processing the measured light to provide an estimated analyte level of the user further comprises: determining a stimulated Raman gain for a plurality of wavelengths; and generating a Raman fingerprint for the skin surface of the user (Para. [00267]: "Raman fingerprints are Stokes energy down-shifts… and the fingerprints for in-vivo biomonitoring can range from 730 cm-1 for glucose")..
11. The device of claim 10, wherein processing the measured light to provide an estimated analyte level of the user further comprises: generating an estimated analyte level based on the Raman fingerprint for the skin surface of the user (Para. [00267]:"the fingerprints for in-vivo biomonitoring can range from 730 cm-1 for glucose up to 2845 cm-1 for CH2 stretch vibrations").
12. The device of claim 11, wherein:
the modulated source is the Raman pump source; and
the unmodulated source is a Stokes source in the plurality of Stokes sources (See para. [00290] where one or both are modulated).
13. The device of claim 8, wherein processing the measured light to provide an estimated analyte level of the user further comprises: determining a stimulated Raman loss for a particular wavelength of light based on the portion of the signal associated with the unmodulated source.
14. The device of claim 11, wherein: the modulated source is the Stokes source; and the unmodulated source is the Raman pump source (See para. [00290] where one or both are modulated).
15. The device of claim 5, wherein the Raman pump source and the fixed- wavelength narrowband laser sources of the Stokes source are VCSELs (Para. [00232]), and wherein no optical fibers or mirrors are used anywhere in the device (see Figs. 47-60 where photonic integrated chips are used. Furthermore, Zilkie does not each fiber and mirrors are critical).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hwa Andrew S Lee whose telephone number is (571)272-2419. The examiner can normally be reached Mon-Fri 9am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached at (571) 270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Hwa Andrew Lee/Primary Examiner, Art Unit 2877
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