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 .
Applicant’s preliminary amendments filed on 09/27/2023 are acknowledged.
Claims 1-20 are pending for examination. Claims 21-22 are cancelled.
Drawings
Figures 1a and 1b should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Duplicate Claims
Applicant is advised that should claim 15 be found allowable, claim 18 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In regard to claim 10, the claim recites “the lens is positioned in the optical path from the target to the plurality of sensors”. However, claim 7, which claim 10 depends from, recites “a lens positioned in the optical path from the laser source to the target”. According to paragraphs [0023] and [0025] of the PGPUB, it appears that the limitations associated with claims 7 and 10 are alternative embodiments. Examiner cannot find adequate supports for a lens positioned in the optical path at BOTH from the target to the plurality of sensors and from the laser source to the target.
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.
Claim 14 is 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. In regard to claim 14, the claim recites “an optical density value of between 10-12”. It is noted that there is no “unit” of the optical density value being recited. It is unclear what “unit” is associated with the numbers 10-12. Clarification is requested by amendments.
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)(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.
Claims 1-4, 12, 16, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Cucinelli et al. (USPGPUB 2023/0277063). In regard to claim 1, Cucinelli discloses an optical module for Raman spectroscopy (Figs. 1-7 and associated descriptions), the optical module comprising: a laser source (element 34, Figs. 4-7 and associated descriptions) mounted on a substrate (element 14, Figs. 4-7 and associated descriptions) and configured to emit electromagnetic radiation at a target (Figs. 4-7 and associated descriptions); a plurality of sensors (elements 36, Figs. 4-7 and associated descriptions) mounted on the substrate (element 14, Figs. 4-7 and associated descriptions) and configured to detect electromagnetic radiation scattered from the target (Figs. 4-7 and associated descriptions); and a first filter disposed over one or more of the plurality of sensors (elements 38 and/or 40, Figs. 4-7 and associated descriptions; [0041]), wherein the first filter is substantially transparent to a first wavelength band corresponding to a Raman scattering wavelength of a first molecule of the target and opaque to wavelengths outside the first wavelength band (narrow band filter for each λn, [0041]; [0048]; the spectroscopic bandpass filters 38 are each precisely tuned to one particular Raman peak, [0049]; glucose associated Raman peaks, [0051]).
In regard to claim 2, Cucinelli discloses a second filter disposed over one or more of the plurality of sensors (another elements 38 and/or 40, Figs. 4-7 and associated descriptions), wherein the second filter is substantially transparent to a second wavelength band corresponding to a Raman scattering wavelength of a second molecule of the target and opaque to wavelengths outside the second wavelength band (narrow band filter for each λn, [0041]; [0048]; the spectroscopic bandpass filters 38 are each precisely tuned to one particular Raman peak, [0049]; hemoglobin and/or other associated Raman peaks, [0051]).
In regard to claim 3, Cucinelli discloses an integrated circuit mounted on the substrate (element 32, Figs. 4-7 and associated descriptions).
In regard to claim 4, Cucinelli discloses wherein the integrated circuit is configured to control the laser source to emit modulated electromagnetic radiation at the target and to demodulate the detected electromagnetic radiation scattered from the target (circuit board and operation system, [0035-0036]; modulated, [0037]).
In regard to claim 12, Cucinelli discloses a plurality of said laser sources mounted on the substrate (a plurality of discrete light sources 34, [0038]).
In regard to claim 16, Cucinelli discloses a method of determining relative concentrations of first and second known molecules of a target (Figs. 1-7 and associated descriptions; glucose and hemoglobin or other molecules, [0051]) , the method comprising: with a laser source mounted on a substrate (referring to claim 1 above), emitting electromagnetic radiation at a target (referring to claim 1 above); with a plurality of sensors mounted on the substrate (referring to claim 1 above), detecting electromagnetic radiation scattered from the target (referring to claim 1 above), wherein first and second filters are disposed over the sensors (referring to claim 1 above), the first filter substantially transparent to a first wavelength band corresponding to a Raman scattering wavelength of the first molecule and opaque to wavelengths outside the first wavelength band (Raman peaks for glucose and first filter, referring to claim 1 above), and the second filter substantially transparent to a second wavelength band corresponding a Raman scattering wavelength of the second molecule and opaque to wavelengths outside the second wavelength band (hemoglobin and other Raman peaks and second filter, referring to claim 1 above); and calculating a ratio between intensities of the Raman scattering from the first and second molecules (ratiometric approach, [0051]); and determining a relative concentration of the first molecule to the second molecule from the ratio (ratiometric approach…glucose/ hemoglobin… remove any glucose Raman intensity variation due to changes other than glucose concentration in the blood, [0051]).
In regard to claim 20, Cucinelli discloses a Raman spectrometer, a wearable device or a hydration level monitor comprising the optical module of claim 1 (Figs. 2-7 and associated descriptions; Raman spectroscopy/ wearable, [0052]; [0055]).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Cucinelli as applied to claims 1-4, 12, 16, and 20 above, and further in view of Colvin JR. (USPGPUB 2013/0324819). In regard to claim 5, Cucinelli discloses all the claimed limitation except the integrated circuit is an application specific integrated circuit (ASIC) and comprises said plurality of sensors, said first and second filters.
Colvin JR. teaches am optical sensor (Fig. 3 and associated descriptions) comprises a substrate (element 116, Fig. 3 and associated descriptions; [0052]) including an ASIC ([0052]), wherein a plurality of sensors and filters with associated electronic elements are disposed on the substrate/ ASIC (Fig. 3 and associated descriptions; [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the configuration of the integrated circuit and associated components (Cucinelli) with the configurations of components disposed on an ASIC as taught by Colvin JR. to yield predictable results, since both devices are optical sensing systems and one of ordinary skill in the art would have recognized that the configuration as taught by Colvin JR. is an alternative equivalent configuration for control or detect optical signals. The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Cucinelli and Colvin JR. as applied to claim 5 above, and further in view of Glukhovsky et al. USPGPUB 2004/0087832). In regard to claim 6, Cucinelli as modified by Colvin JR. discloses signal amplification circuitry and laser source driving circuitry (inherent elements for signal processing and light source operation, element 32, Figs. 4-7 and associated descriptions of Cucinelli and [0052] of Colvin JR.) but does not specifically disclose the ASIC comprises phase lock loop detection circuitry.
Glukhovsky teaches an in vivo optical sensor (Figs. 1-4 and associated descriptions) comprises an ASIC (element 26, Fig. 1 and [0031]) including a phase lock loop detection circuitry (element 102, Fig. 4 and [0031]) facilitate data communication (Figs. 1 and 4 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ASIC ( Cucinelli as modified by Colvin JR) to incorporate the phase lock loop detection circuitry as taught by Glukhovsky, since both devices are optical sensing systems and one of ordinary skill in the art would have recognized that the phase lock loop detection circuitry increases the function of the ASIC. The rationale would have been to perform more functions.
Claims 7-10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cucinelli as applied to claims 1-4, 12, 16, and 20 above, and further in view of Chaiken et al. (USPN 6,352,502). In regard to claim 7, Cucinelli discloses all the claimed limitations except a lens positioned in the optical path from the laser source to the target, the lens being configured to focus the electromagnetic radiation emitted by the laser source onto one or more focal points at respective depths in a dermis layer of the target.
Chaiken teaches an Raman spectroscopy system (Figs. 1-2 and associated descriptions) comprises a lens positioned in the optical path from the laser source to the target (element 116, Fig. 1 and associated descriptions), the lens being configured to focus the electromagnetic radiation emitted by the laser source onto one or more focal points at respective depths in a dermis layer of the target (Fig. 1 and associated descriptions; abstract; Col 8 lines 21-45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical module (Cucinelli) to incorporate the lens and associated elements/function as taught by Chaiken, since both devices are Raman spectroscopy systems and one of ordinary skill in the art would have recognized that focus points associated with different depths from the skin surface facilitate obtain depth specific Raman information (see Chaiken). The rationale would have been to obtain more information of the tissue.
In regard to claim 8, Cucinelli as modified by Chaiken discloses the lens is positioned outside the optical path from the target to the plurality of sensors (Fig. 1 and associated descriptions) of Chaiken.
In regard to claim 9, Cucinelli as modified by Chaiken discloses the laser source is positioned spaced apart from the plurality of sensors on the substrate (Figs. 5-7 and associated descriptions of Cucinelli) and is configured to emit electromagnetic radiation out of the optical module at the target in a direction non-perpendicular to a plane of the substrate (it is noted that the emitted light would comprise off-center beams, Figs. 5-7 and associated descriptions of Cucinelli).
In regard to claim 10, Cucinelli as modified by Chaiken discloses the lens is positioned in the optical path from the target to the plurality of sensors (element 120, Fig. 1 and associated descriptions of Chaiken).
In regard to claim 13, Cucinelli as modified by Chaiken discloses a plurality of said laser sources mounted on the substrate (referring to claim 12 above) but does not specifically discloses a plurality of lenses positioned in respective optical paths of the laser sources and configured to focus the emitted electromagnetic radiation from the laser sources onto one or more focal points at a plurality of depths in a dermis layer of the target. Cucinelli as modified by Chaiken discloses a lens should be positioned in the optical path from a light source to the target (referring to claim 7 above). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical module to incorporate addition lens(es) for each light sources in order to focus light at different wavelengths to a plurality of focal points/ depths.
In regard to claim 14, Cucinelli as modified by Chaiken discloses different filters can be utilized in Raman spectrum detection (filters, [0041] and bandpass, multi-bandpass, notch, edgepass, spike, Rayleigh scatter rejection, diffraction grating, Fabry-Perot interferometer, MEMs based interferometry, dye, and nano-photonic types, including combinations thereof, [0042] of Cucinelli) but does not specifically disclose the first and second filter respectively have an optical density value of between 10-12 for wavelengths outside the first and second wavelength bands. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try different filters, including an optical density value of between 10-12 for wavelengths outside the first and second wavelength bands, through experiments/ investigations in order to find the optimal filter(s) for the Raman detection. The rationale would have been “obvious to try”, see KSR International Co. v. Teleflex Inc., 550 USPQ2d 398, 421(2007). (rejected as best understood, see the 35 USC 112(b) rejection above)
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Cucinelli and Chaiken as applied to claims 7-10 and 13-14 above, and further in view of Xie (USPGPUB 2005/0043597).In regard to claim 11, Cucinelli as modified by Chaiken discloses all the claimed limitations except a plurality of reflectors positioned in the optical path from the target to the plurality of sensors, the reflectors configured to direct the electromagnetic radiation scattered from the target to the plurality of sensors through the first and second filters.
Xie teaches a Raman spectroscopy system (Figs. 1-7 and associated descriptions) comprises a parabolic mirror positioned in the optical path from the target to a sensor (element 98, Fig. 7 and associated descriptions), the mirror configured to direct the electromagnetic radiation scattered from the target to the sensor through a filter (element 84, Fig. 7 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical module (Cucinelli as modified by Chaiken) to incorporate a parabolic mirror as taught by Xie for each filter/detector, since both devices are Raman spectroscopy systems and one of ordinary skill in the art would have recognized parabolic mirrors facilitate direct Raman scattered light beams to sensors (see Xie). The rationale would have been to collect more optical signals from the tissue.
Claims 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cucinelli as applied to claims 1-4, 12, 16, and 20 above, and further in view of Caspers et al., "In Vivo Confocal Raman Microspectroscopy of the Skin: Noninvasive Determination of Molecular Concentration Profiles", In Vivo Raman Spectroscopy of Skin, Vol. 116, No. 3, March 2001, pp. 434-442 – applicant cited. In regard to claims 15 and 17-19, Cucinelli discloses the electromagnetic radiation emitted by the laser source has a wavelength of between 600-785 nm (200-1500nm, [0036]; 660nm, [0052]) and controlling the laser source to emit modulated electromagnetic radiation at the target; and demodulating the detected electromagnetic radiation scattered from the target (referring to claim 4 above) but does not specifically disclose the first filter is transparent to a wavelength band corresponding to a Raman scattering wavelength of an OH molecule; and wherein the second filter is transparent to a wavelength band corresponding to a Raman scattering wavelength of a CH3 molecule and the first molecule is an OH molecule; wherein the second molecule is a CH3 molecule; and wherein the method comprises determining a hydration level of the target from the relative concentration of OH molecules to CH3 molecules
Caspers teaches a Raman spectroscopy system (Fig. 1 and associated descriptions) comprises a laser source has a wavelength of between 600-785 nm (730nm, Instrumentation sec. pages 435-436) and a hydration level of the target from the relative concentration of OH molecules to CH3 molecules can be calculated (Fig. 5 and associated descriptions), wherein a wavelength band corresponding to a Raman scattering wavelength of an OH molecule (water/ OH, Figs. 2 and 5 and associated descriptions) and a wavelength band corresponding to a Raman scattering wavelength of a CH3 molecule (protein/ CH3, Figs. 2 and 5 and associated descriptions) and the first molecule is an OH molecule; wherein the second molecule is a CH3 molecule (Figs. 2 and 5 and associated descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optical module (Cucinelli) to incorporate the wavelengths for OH molecule and CH3 molecule and associated calculations/ elements/ functions as taught by Caspers by utilizing associated filter(s) in the optical module, since both devices are Raman spectroscopy systems and one of ordinary skill in the art would have recognized that the use of Raman signals in water/OH and protein/CH3 bands facilitate monitoring the hydration information of the skin/ tissue (see Caspers). The rationale would have been to obtain more physiological information from the tissue site.
Conclusion
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791