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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/14/2026 has been entered.
Oath/Declaration
The affidavit under 37 CFR 1.132 filed 07/14/2026 is insufficient to overcome the rejection of claims 1-2, 5-14, and 16-24 based upon 35 U.S.C. 103 as set forth in the last Office action because: In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. (Examiner's Note: Addressed in the response to arguments below)
Claims Pending
Applicant’s previous cancellation of claims 3-4 and 15 is acknowledged.
Claims 1-2, 5-14, and 16-24 are the current claims hereby under examination.
Drawings- Objection Withdrawn
Applicant’s amendment’s, filed 07/14/2026, have been fully considered and the previous objection withdrawn.
(Examiner's Note: Withdrawn as a result of the removal of the following added material that was indicated as new matter “Fig. 13a contains laser device – 4 and fiber-optic cable 4a inside of wristband - 33a, which was not previously indicated within the applicant’s specification”)
Specification
The applicant’s amendments, filed 07/14/2026, have been fully considered, and the previous objection withdrawn.
(Examiner's Note: Withdrawn as a result of the applicant’s removal of the phrase “with a wristband 33a”, in the response filed 07/14/2026)
Claim Interpretation - Previously Withdrawn
The applicant’s amendment filed 04/30/2025, has been fully considered, and the previous 112(f) interpretation withdrawn.
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 1-2, 5-24, and 16-24 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “wherein said measuring surface is designed as a plane surface or comprises a concave surface or partial surface” and the claim also recites “wherein said substrate has a planar surface or a concave surface, with or without an additional coating, that forms a measuring surface” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 1 first recites the narrower of the limitations “wherein said substrate has a planar surface or a concave surface, with or without an additional coating, that forms a measuring surface”, which indicates a substrate with “a planar surface or a concave surface…” “…that forms a measuring surface”. The broader limitation, which is presented after the narrow limitation, recites “wherein said measuring surface is designed as a plane surface or comprises a concave surface or partial surface”, which indicates that “said measuring surface”, which refers to the same measuring surface as in the narrow limitation, “is designed as a plane surface or comprises a concave surface or partial surface”. The broader limitation recites another option of “partial surface” that is not present within the narrow limitation. As such, it is unclear as to the shape of the measurement surface. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the broader of the limitations.
Claims 2, 5-14, and 16-24 are dependent on claim 1, and as such are also rejected.
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.
The claims are generally directed towards a device for the analysis of a biological substance. The device includes a measuring surface, a laser source of excitation radiation, a modulator, and a detection device. The detection device includes a light source, an optical waveguide structure, and measuring device for the detection of light intensity.
Claim(s) 1-2, 5-13, 16-18, 20, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozental (US Pub. No. 20140114187), and further in view of Klein (US Pub. No. 20160143564) hereinafter Klein, and Bauer (US Pub. No. 20180328835) hereinafter Bauer.
Regarding claim 1, Rozental discloses Device for analyzing a substance (imaging apparatus – 60) (Par. 91 (imaged object – 1)), having:
a measuring body (ultrasound detector – 10), that forms a measuring surface (Fig. 15, (unlabeled surface of detector – 10)), and which is to be at least partially coupled with the substance (imaged object – 1) in the area of the measuring surface for measurement, or is to be brought into contact with the substance directly (Par. 94, “the optical fiber 11 of the ultrasound detector 10 is wrapped around the imaged object 1”) or else by means of a medium (Par. 91, “To perform the imaging, the space between the ultrasound detector 10 and the imaged object 1 should have acoustic properties similar to biological tissue. Specifically, water or ultrasound gel may be used.”), wherein said measuring surface is designed as a plane surface or comprises a concave surface or partial surface (Fig. 15, (unlabeled surface of detector – 10 is observably curved)),
a source of excitation radiation (excitation device – 61) (Par. 91, Fig. 15 (arrows pointing from excitation device 61 that signify electromagnetic pulses while the contact is occurring), and
a detection device which is at least partially integrated into or connected to the measuring body (Fig. 15, (light source – 31 and optical fiber -11 at least partially connected to ultrasound detector – 10)), comprising the following:
a source for detection light (Fig. 15, 16, light source – 31)(Par. 37, “preferably, the interrogation light source includes a pulsed laser source”),
a first optical waveguide structure (optical fiber – 11) which can be or is connected to the detection light source (Fig. 15, (schematically connected to light source - 31)) and which guides the detection light (Par. 62-63 (optical fiber guides light)), the refractive index of which, at least in some sections, is dependent on temperature and/or pressure (Par. 62-63 (refractive index based on pressure)), the first optical waveguide structure having at least one section in which the light intensity depends on a phase shift of detection light in at least one part of the first optical waveguide structure due to a change in temperature or pressure (Par. 62-63 (pressure changes result in a shift in the spectrum)).
Rozental fails to explicitly disclose a measuring body, which constitutes or contains a substrate, wherein said substrate has a planar surface or a concave surface, with or without an additional coating, that forms a measuring surface.
However, Rozental does disclose a substrate (Par. 95, “fiber 11 may be laid directly on the imaged object 1, or on a membrane or a rigid plate which is in contact with the imaged (directly or through an appropriate acoustic medium)”) and a measurement surface (Fig. 15, (unlabeled surface of detector – 10))(Par. 94, “In the cylindrical geometry (FIG. 15), the optical fiber 11 of the ultrasound detector 10 is wrapped around the imaged object 1”).
Rozental does teach in an alternate embodiment a measuring body (ultrasound detector – 10), which constitutes or contains a substrate (Par. 85, “the optical fiber 11 of the ultrasound detector 10 may be pre-processed to induce angular-dependent detection sensitivity. Specifically, the fiber may be coated with an acoustically dampening material for most of its circumference, excluding only a small-angle window.” (detector 10 contains optical fiber – 11, which is coated with a substrate, and as such the detector 10 contains a substrate)), wherein said substrate has a planar surface or a concave surface (Fig. 11 (observably curved shape of optical fiber – 11))(Par. 85, “the optical fiber 11 of the ultrasound detector 10 may be pre-processed to induce angular-dependent detection sensitivity. Specifically, the fiber may be coated with an acoustically dampening material for most of its circumference, excluding only a small-angle window.” (detector 10 contains optical fiber – 11, which is coated with a substrate, and as such the detector 10 contains a substrate)) (Examiner's Note: Interpreted under 112(b) as indicated above), with or without an additional coating.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental with an alternate embodiment of Rozental to include a measuring body of Rozental, which constitutes or contains a substrate, wherein said substrate has a planar surface or a concave surface, with or without an additional coating, that forms a measuring surface of Rozental through the combination of embodiments as it would have yielded the predictable result of improving the angular resolution (Rozental (Par. 85)).
Modified Rozental fails to explicitly disclose a source of excitation radiation configured to generate one or more excitation beams of different wavelengths, which are directed at the substance when the measuring body is coupled and/or in contact with the substance in the region of the measuring surface, wherein said wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1 (Examiners note: Rozental fails to explicitly disclose that this source is a laser that emits wavelengths within the indicated spectral range).
Rozental does disclose a source of excitation radiation (excitation device – 61) configured to generate one or more excitation beams of different wavelengths (Par. 91, “The excitation device 61 emits electromagnetic pulses in either the optical regime or radio-frequency regime.”) (Par. 48, “the delivered exciting electromagnetic energy comprises photon energy in the optical spectrum.” “…the excitation device includes a laser source device being adapted for emitting light pulses, preferably in the visible or near-infrared spectra”), which are directed at the substance when the measuring body is coupled and/or in contact with the substance in the region of the measuring surface (Par. 91, Fig. 15 (arrows pointing from excitation device 61 that signify electromagnetic pulses while the contact is occurring)).
However, Rozental does teach in an alternate embodiment differing sources of excitation radiation at differing wavelengths that include near-infrared (Par. 48, “the delivered exciting electromagnetic energy comprises photon energy in the optical spectrum.” “…the excitation device includes a laser source device being adapted for emitting light pulses, preferably in the visible or near-infrared spectra”).
Klein teaches a source of excitation radiation (Par. 60, Laser source – 2) configured to generate one or more excitation beams of different wavelengths (Par. 42, “The excitation source can be a tuneable quantum cascade laser. The wavelength of the radiation generated by the excitation source preferably lies in the range from 250 nm to 30 μm. Further preferably, the radiation generated can lie in the range from 7 μm to 14 μm, in which there is a distinct glucose absorption band from 8.5 μm to 10.5 μm, with a peak at approximately 9.6 μm.”) (Par. 60, “The measuring device 1 comprises a quantum cascade laser 2 which is tuneable in a pre-determined wavelength range. According to the exemplary embodiment described, the measuring device 1 is configured to tune the quantum cascade laser 2 for a measuring procedure in the range from 7 μm to 14 μm. In this range, there is a main absorption band of glucose, as shown in FIG. 4. The band extends from 8.8 μm to 10.5 μm and has a peak at approximately 9.6 μm.”), which are directed at the substance when the measuring body is coupled and/or in contact with the substance in the region of the measuring surface (Par. 59-61 (fingertip 9 is placed on measuring head 8, which receives laser light from laser 2)), wherein said wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1 (Par. 60, “The measuring device 1 comprises a quantum cascade laser 2 which is tuneable in a pre-determined wavelength range. According to the exemplary embodiment described, the measuring device 1 is configured to tune the quantum cascade laser 2 for a measuring procedure in the range from 7 μm to 14 μm. In this range, there is a main absorption band of glucose, as shown in FIG. 4. The band extends from 8.8 μm to 10.5 μm and has a peak at approximately 9.6 μm.”) (Par. 42, “The excitation source can be a tuneable quantum cascade laser. The wavelength of the radiation generated by the excitation source preferably lies in the range from 250 nm to 30 μm. Further preferably, the radiation generated can lie in the range from 7 μm to 14 μm, in which there is a distinct glucose absorption band from 8.5 μm to 10.5 μm, with a peak at approximately 9.6 μm.”) (Par. 38, 74 (glucose measurements)).
(Examiner's Note: Conversion of wavelength in micrometers (μm) to wavenumber (cm-1), which is Wavenumber (cm-1) = 10,000/ (Wavelength (μm)))
(Examiner's Note: Conversion of 8.5 μm to 10.5 μm into cm-1 is approximately 1177 cm-1 and 953 cm-1 respectively)
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental with that of Klein to include a source of excitation radiation configured to generate one or more excitation beams of different wavelengths, which are directed at the substance when the measuring body is coupled and/or in contact with the substance in the region of the measuring surface, wherein said wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1 through the substitution of light sources as the use of differing laser sources and wavelengths are known (Rozental (Par. 48)) (Klein (Par. 42)) and it would have yielded the predictable result of improving the quality of the data that is collected (Rozental (Par. 48)) and using a wavelength with a glucose absorption band to allow for glucose measurements (Klein (Par. 38, 42,60)).
Modified Rozental fails to explicitly disclose a modulation device configured to modulate the intensity of the excitation beam at a modulation rate between 1 Hz and 10 kHz.
However, Bauer teaches a modulation device (Par. 121, device – 104, “a device 104 for the intensity modulation of the excitation light beam or beams SA is provided, which is preferably formed by a modulation device for the excitation light source, in particular for controlling it, and/or by at least one controlled mirror…”) configured to modulate the intensity of the excitation beam at a modulation rate between 1 Hz and 10 kHz (Par. 129, “preferably with envelope frequencies of 1Hz-10 kHz”).
Rozental, Klein, and Bauer are considered to be analogous art to the claimed invention as they are involved with non-invasive detection devices for biological organisms.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental and Klein with that of Bauer to include a modulation device configured to modulate the intensity of the excitation beam at a modulation rate between 1 Hz and 10 kHz through the combination of references as it would have yielded the predictable result of customizing the light intensity over time (Bauer (Par. 60)).
Modified Rozental fails to explicitly disclose a measuring device for the direct or indirect detection of the light intensity in said section of the first optical waveguide structure, in which the light intensity depends on a phase shift of the detection light in said at least one part of the first optical waveguide structure due to a change in temperature or pressure.
However, Bauer further teaches a measuring device (detection device 106) for the direct or indirect detection of the light intensity in the first optical waveguide structure (optical medium – 108) (Par. 123, 127 (beam 112 irradiated into optical medium 108 which then reaches detection device 106)), in which the light intensity depends on a phase shift of the detection light in said at least one part of the first optical waveguide structure due to a change in temperature or pressure (Par. 133 (phase of beam induced based on modulation, where the extent is dependent on temperature)) (Par. 130, “The modulated excitation beams SA are coupled into the optical medium 108 and after passing through the interface GF arrive in the volume 103 within the tissue.”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include comprising a measuring device for the direct or indirect detection of the light intensity in said section of the first optical waveguide structure of Rozental, in which the light intensity depends on a phase shift of the detection light in said at least one part of the first optical waveguide structure of Rozental due to a change in temperature or pressure through the combination of references as it would have yielded the predictable result of improving data quality by accounting for temperature changes (Bauer (Par. 133)).
Modified Rozental fails to explicitly disclose wherein at least one optical waveguide of said first optical waveguide structure is integrated in said substrate of said measuring body.
However, Rozental does disclose a substrate (Par. 95, “fiber 11 may be laid directly on the imaged object 1, or on a membrane or a rigid plate which is in contact with the imaged (directly or through an appropriate acoustic medium)”).
Rozental does teach in an alternate embodiment wherein at least one optical waveguide of said first optical waveguide structure (optical fiber – 11) is integrated in said substrate (Par. 85, “the optical fiber 11 of the ultrasound detector 10 may be pre-processed to induce angular-dependent detection sensitivity. Specifically, the fiber may be coated with an acoustically dampening material for most of its circumference, excluding only a small-angle window.” (detector 10 contains optical fiber – 11, which is coated with a substrate, and as such the detector 10 contains a substrate)) of said measuring body (ultrasound detector – 10).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Rozental to include wherein at least one optical waveguide of said first optical waveguide structure is integrated in said substrate of said measuring body through the combination of embodiments as it would have yielded the predictable result of improving the angular resolution (Rozental (Par. 85)).
Regarding claim 2, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Rozental does teach in an alternate embodiment at least one section of a projection of the first optical waveguide (Fig. 16, “In the cylindrical geometry (FIG. 15), the optical fiber 11 of the ultrasound detector 10 is wrapped around the imaged object 1, or around a holder 4 in which it lies. In the case in which there are not sufficient gratings in the fiber for the desired application, the fiber 11 and/or holder may be translated and/or rotated to achieve additional detection points. Alternatively, the fiber 11 may be pulled along a rail to achieve that effect. In the planar geometry (FIG. 16), the fiber 11 is twisted to fit the rectangular detection area. Within the detection area, a set of straight parallel fiber sections is achieved, whereas at the edges the fiber is twisted.”) (Rozental) structure in the direction of the surface normal of the measuring surface is superimposed with said measuring surface (Fig. 16 (observable that unlabeled optical fiber 11 is placed on the surface of detector 10)) (Rozental).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Rozental to include at least one section of a projection of the first optical waveguide structure in the direction of the surface normal of the measuring surface is superimposed with said measuring surface through the combination of embodiments as the planar and cylindrical geometries are known variations (Rozental (Par. 94-96)) and would have yielded the predictable result of providing additional detection points (Rozental (Par. 94-96)).
Regarding claim 5, modified Rozental further discloses wherein the detection device (interrogation device – 30) (Rozental) comprises an interferometer (Par. 38 (MZ interferometer))(Fig. 7, (MZ modulator – 51 is included as part of interrogation device 30)) (Rozental) or an optical waveguide resonance element.
Regarding claim 6, modified Rozental further discloses wherein the first optical waveguide structure comprises at least one fiber-optic optical waveguide (optical fiber -11) (Rozental), which is connected to the measuring body (detector – 10) (Rozental) at least in some sections (Fig. 15, Par. 94, “the optical fiber 11 of the ultrasound detector 10 is wrapped around the imaged object 1”) (Rozental).
Regarding claim 7, Modified Rozental fails to explicitly disclose the first optical waveguide structure having at least one silicon optical waveguide, which is one of connected to an insulating substrate or integrated into an insulating substrate. However, Bauer further teaches the first optical waveguide structure (Bauer (Par. 33 (optical medium))) having at least one silicon optical waveguide (Bauer (Par. 33 (silicon as a material))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include the first optical waveguide structure of Rozental having at least one silicon optical waveguide, which is one of connected to an insulating substrate or integrated into an insulating substrate of Rozental through the combination of references as it would have yielded the predictable result of changing the material deformation (Bauer (Par. 33)).
Regarding claim 8, modified Rozental further discloses wherein the excitation beam passes through the material of the measuring body or a region adjacent to the measuring surface (Par. 32) (Rozental), wherein the measuring body or the region penetrated by the excitation beam is transparent to the excitation beam (Par. 32, “Particularly advantageously, the optical waveguide is transparent and insensitive to electromagnetic radiation at least at a position of the at least one .pi.-phase shifted FBG or WBG in the optical waveguide. Thus, positioning the ultrasound detector in the neighborhood of the object under investigation is possible without impairing the excitation of ultrasound in the object by the electromagnetic radiation”) (Rozental).
Regarding claim 9, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Rozental does teach in an alternate embodiment wherein the excitation beam is guided inside the measuring body or along the measuring body by means of a second optical waveguide structure (Par. 34 (multiple optical waveguides)) (Rozental).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Rozental to include wherein the excitation beam is guided inside the measuring body or along the measuring body by means of a second optical waveguide structure through the combination of references as it would have yielded the predictable result of allowing for multiplexed sensors that can cover an entire region (Rozental (Par. 34)).
Regarding claim 10, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Bauer further teaches wherein the excitation beam (Bauer (Fig. 8 (as indicated by the arrow that originated from transmission device 100))) between the source of excitation radiation and the substance analyzed passes through a continuous opening of the measuring body (Bauer (Fig. 8, (unlabeled structures bounded by supports 121))(Fig. 8, (observable that there is a gap between medium 108 and transmission device 100))) wherein the opening ends at a distance in front of the measuring surface (Bauer (Fig. 8, (observable that the above indicated gap ends prior to the measuring surface at the site of fingertip 126))), penetrates the measuring surface or is arranged in a region which is directly adjacent to the measuring surface or adjoins it.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include wherein the excitation beam between the source of excitation radiation and the substance analyzed passes through a continuous opening of the measuring body, wherein the opening ends at a distance in front of the measuring surface, penetrates the measuring surface or is arranged in a region which is directly adjacent to the measuring surface or adjoins it through the combination of references as it would have yielded the predictable result of providing a direct pathway for the light.
Regarding claim 11, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Rozental does teach in an alternate embodiment wherein the measuring body is formed as a flat body (Par. 94, “In the planar geometry (FIG. 16), the fiber 11 is twisted to fit the rectangular detection area. Within the detection area, a set of straight parallel fiber sections is achieved, whereas at the edges the fiber is twisted.”) (Rozental), wherein the thickness of the measuring body in the direction perpendicular to the measuring surface is less than 50% of the smallest extension of the measuring body in a direction extending in the measuring surface (Par. 94 (measuring body is flat, and as such the extensions are also flat)) (Rozental).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Rozental to include wherein the measuring body is formed as a flat body, wherein the thickness of the measuring body in the direction perpendicular to the measuring surface is less than 50% of the smallest extension of the measuring body in a direction extending in the measuring surface through the combination of embodiments as the planar and cylindrical geometries are known variations (Rozental (Par. 94-96)) and would have yielded the predictable result of providing additional detection points (Rozental (Par. 94-96)).
Regarding claim 12, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Bauer further teaches wherein the measuring body (Bauer (Fig. 1, device – 10)) comprises or carries a mirror device (Bauer (Par. 47, “Alternatively or additionally, the device for intensity modulation can comprise at least one controlled mirror arranged in the beam path, by the control of which the intensity of the excitation beam can be modulated by deflection.”)) for reflecting the excitation beam irradiated by the source of excitation radiation onto the measuring surface (Bauer (Par. 121, “In addition, a device 104 for the intensity modulation of the excitation light beam or beams SA is provided, which is preferably formed by a modulation device for the excitation light source, in particular for controlling it, and/or by at least one controlled mirror arranged in the beam path and/or by a layer, which is arranged in the beam path and is controllable with respect to its transparency.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include wherein the measuring body comprises or carries a mirror device for reflecting the excitation beam irradiated by the source of excitation radiation onto the measuring surface through the combination of references as it would have yielded the predictable result of enabling the beam path to be controlled.
Regarding claim 13, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Bauer further teaches wherein the excitation beam is oriented into the measuring body parallel to the measuring surface or at an angle less than 20 degrees (Bauer (Par. 77, (parallel to the surface))), and wherein the excitation beam is diverted or deflected towards the measuring surface (Bauer (Par. 121, “In addition, a device 104 for the intensity modulation of the excitation light beam or beams SA is provided, which is preferably formed by a modulation device for the excitation light source, in particular for controlling it, and/or by at least one controlled mirror arranged in the beam path and/or by a layer, which is arranged in the beam path and is controllable with respect to its transparency.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include wherein the excitation beam is oriented into the measuring body parallel to the measuring surface or at an angle less than 20 degrees, and wherein the excitation beam is diverted or deflected towards the measuring surface through the combination of references as it would have yielded the predictable result of enabling the beam path to be controlled.
Regarding claim 16, modified Rozental further discloses a method for operating a device according to claim 1 (device as taught by Rozental, Klein, and Bauer above) wherein a modulated excitation beam is directed onto the substance to be analyzed (Par. 52, “Focusing is applied to the exciting beam by known means. The fibers are positioned such that the offset between the phase shift in the grating and the tip of the illuminating fiber does not exceed a few millimeters. Thus, the FBG-based sensor measures the optoacoustic signal generated by the small portion of the blood vessel which is illuminated. By rotating the illuminating fiber or both fibers, and performing a pullback on both fibers, optoacoustic signals from the entire blood vessels can be acquired. The optoacoustic signals are then processed to obtain the optical absorption map within the blood vessel”) (Rozental) and a temporal light intensity profile or waveform or a periodic light intensity change is detected by the detection device (Par. 62-63 (pressure changes result in a shift in the spectrum)) (Rozental), these being detected for a plurality of wavelengths of the excitation beam by measuring the light intensity change in the first optical waveguide structure or by measuring the light intensity of light emitted from the first optical waveguide structure and obtaining an absorption spectrum of the substance to be analyzed from the acquired data (Par. 52, (plurality of signals for an absorption map)) (Par. 62-63) (Rozental).
Modified Rozental fails to explicitly disclose wherein said plurality of wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1.
However, Klein further teaches wherein said plurality of wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1 (Klein (Par. 60, “…tune the quantum cascade laser 2 for a measuring procedure in the range from 7 μm to 14 μm. In this range, there is a main absorption band of glucose, as shown in FIG. 4. The band extends from 8.8 μm to 10.5 μm and has a peak at approximately 9.6 μm.”) (Par. 42, “The excitation source can be a tuneable quantum cascade laser. The wavelength of the radiation generated by the excitation source preferably lies in the range from 250 nm to 30 μm. Further preferably, the radiation generated can lie in the range from 7 μm to 14 μm, in which there is a distinct glucose absorption band from 8.5 μm to 10.5 μm, with a peak at approximately 9.6 μm.”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Rozental, Klein, and Bauer with that of Klein to include wherein said plurality of wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1 for the reasoning as indicated in claim 1 above.
Regarding claim 17, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Rozental does teach in an alternate embodiment wherein the measurement is carried out for different modulation frequencies of the excitation beam (Par. 48, “The illumination light comprises at least one characteristic wavelength of at least 1 nm, preferably at least 400 nm, particularly preferred at least 650 nm, and below 5 .mu.m, preferably below 2 .mu.m, particularly preferred below 1.5 .mu.m. For this variant, the excitation device includes a laser source device being adapted for emitting light pulses, preferably in the visible or near-infrared spectra.”) (Rozental) and a corrected absorption spectrum is determined from the combination of absorption spectra obtained (Par. 48, (combination of signals)) (Rozental).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Rozental, Klein, and Bauer with that of Rozental to include wherein the measurement is carried out for different modulation frequencies of the excitation beam and a corrected absorption spectrum is determined from the combination of absorption spectra obtained through the combination of references as it would have yielded the predicable result of increasing the information content of the imaging (Rozental (Par. 48)).
Regarding claim 18, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Bauer further teaches wherein said source of excitation radiation is an array of quantum cascade lasers for generating excitation beams at different wavelengths (Bauer (Par. 282-283)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include wherein said source of excitation radiation is an array of quantum cascade lasers for generating excitation beams at different wavelengths through the combination of references as it would have yielded the predictable result of covering the spectral range of glucose (Bauer (Par. 282)).
Regarding claim 20, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Bauer further teaches wherein the excitation beam (Bauer (Fig. 22 (beam from excitation emission device 100))) passes through the measuring surface or an imaginary continuation of the measuring surface (Bauer (Par. 179, Fig. 22 (surface of optical medium 108 in contract with fingertip 126))) in the region of a continuous opening in the measuring body (Bauer (Fig. 22, (opening 161 is proximal the surface of optical medium 108))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer wherein the excitation beam passes through the measuring surface or an imaginary continuation of the measuring surface in the region of a continuous opening in the measuring body through the combination of references as it would have yielded the predictable result of providing a suction channel that secures the device in place (Bauer (Par. 180)).
Regarding claim 22, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Rozental does teach alternate embodiments wherein the first optical waveguide structure of the detection device comprises at least two measuring sections, arranged on different arms of an interferometer (Par. 67, (arms of MZ interferometer that is part of FBG 12)) (Rozental) and in which the refractive index changes as a function of a pressure and/or thermal wave (Par. 62-63 (phase shift as a result of pressure changes)) (Par. 67, (arms of MZ interferometer that is part of FBG 12 )) (Rozental), so that a phase shift occurs in the detection light passing through the measuring sections followed by a resulting intensity change in the detection light in a further section as a function of pressure and/or temperature changes (Par. 62-63 (phase shift as a result of pressure changes)) (Rozental), the two measuring sections being arranged in the measuring body in such a way that they are passed through by a pressure and/or thermal wave (Par. 62-63 (phase shift as a result of pressure changes)) (Par. 67, (arms of MZ interferometer that is part of FBG 12)) (Rozental), which propagates through the measuring body starting from the measuring surface one after the other (Par. 62 (pressure applied)) (Rozental).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Rozental to include wherein the first optical waveguide structure of the detection device comprises at least two measuring sections, arranged on different arms of an interferometer and in which the refractive index changes as a function of a pressure and/or thermal wave, so that a phase shift occurs in the detection light passing through the measuring sections followed by a resulting intensity change in the detection light in a further section as a function of pressure and/or temperature changes, the two measuring sections being arranged in the measuring body in such a way that they are passed through by a pressure and/or thermal wave, which propagates through the measuring body starting from the measuring surface one after the other through the substitution of FBG sensors in the embodiment of Par. 90 of Rozental for that in Par. 67 as it would have yielded the predictable result of providing additional data to the user of the device.
Regarding claim 23, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Bauer further teaches comprising a housing (Bauer (Fig. 8 (housing - 122))) that is designed as a wearable housing that can be worn on a person's wrist in the manner of a wristwatch, said housing comprising said measuring body and said detection device (Bauer (Fig. 8, housing – 122, Belt – 125, detection device – 106, optical medium - 108) (Par. 153, “FIG. 8 shows that the housing 122 is attached to the body 123 of a person by means of a belt 125 belonging to the housing 123, in one embodiment being in the form of a bracelet on a wrist. On the opposite side 124 from the wrist, the housing then has a window which is transparent to the excitation light beam SA, or the optical medium 108 is fitted directly into the outwards facing side 124 of the housing and itself forms the surface of some sections of the housing.” (the housing of Fig. 8 that includes Belt - 123)) (Par. 151, “The support can be formed by a plastic part, a printed circuit board or a metal sheet, which is mounted in a housing 122. The support, which in FIG. 8 is formed with a U-shaped cross section, can then at least partially surround the optical medium 108 in one embodiment. The optical medium can be attached to the support and adjusted relative to it.”)).
Therefore it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include comprising a housing that is designed as a wearable housing that can be worn on a person's wrist in the manner of a wristwatch, said housing comprising said measuring body and said detection device through the combination of references as it would have yielded the predictable result of directly attaching the device to the person (Bauer (Par. 153)) and the U-shaped structure would have provided additional support (Bauer (Par. 151)).
Regarding claim 24, modified Rozental fails to explicitly disclose wherein the source of excitation radiation is arranged outside the housing.
However, Bauer further teaches wherein the source of excitation radiation (Bauer (Par. 153, Fig. 8 (transmission device – 100))) is arranged outside the housing (Bauer (Par. 156 (difference light source attachment locations))).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include wherein the source of excitation radiation of Rozental is arranged outside the housing through the combination of references as differing attachment locations for the light source are known in the art (Bauer (Par. 156)), and it would have yielded the same or similar results.
Modified Rozental fails to explicitly disclose wherein the source of excitation radiation is designed to be coupled for a measurement by means of a fibre-optic cable.
However, Bauer further teaches wherein the source of excitation radiation (Bauer (Fig. 153 (transmission device – 100))) is designed to be coupled for a measurement by means of a fibre-optic cable (Bauer (Par. 150, “For the sake of completeness, it should be noted that the excitation transmission device can also send the excitation to the material surface either as a whole or section by section by means of one or more fibre-optic cables, and in one embodiment the excitation transmission device can be directly coupled to one or more fibre-optic cables, which are coupled to the optical medium”)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Bauer to include wherein the source of excitation radiation of Rozental is arranged outside the housing and is designed to be coupled for a measurement by means of a fibre-optic cable through the combination of references as fibre-optic cables are a known alternative for excitation transmission and it would have yielded the same or similar results (Bauer (Par. 151)).
Claim(s) 14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozental in view of Klein and Bauer as applied to claim 1 above, and further in view of Kanayama (US Pub. No. 20070015978) hereinafter Kanayama.
Rozental, Klein, and Bauer teach the device of claim 1 above.
Regarding claim 14, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Kanayama teaches wherein in the measuring body (Par. 37, body interface – 17), behind and/or next to the detection device (Par. 37, signal detection unit – 11) viewed from the measuring surface at least one heat sink (Par. 37, (Peltier device)) is arranged in the form of a solid body or material, wherein at least one of: the specific thermal capacity and the specific thermal conductivity of the body or the material of the heat sink is greater than the specific thermal capacity or thermal conductivity respectively of the material of the detection device (Par. 37 (thermoelectric cooler)).
Rozental, Klein, Bauer, and Kanayama are considered to be analogous art to the claimed invention as they are involved with non-invasive detection devices for biological organisms.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Kanayama to include wherein in the measuring body, behind and/or next to the detection device viewed from the measuring surface at least one heat sink is arranged in the form of a solid body or material, wherein at least one of: the specific thermal capacity and the specific thermal conductivity of the body or the material of the heat sink is greater than the specific thermal capacity or thermal conductivity respectively of the material of the detection device through the combination of references as it would have yielded the predictable result of improving the accuracy of the measurements (Kanayama (Par. 37)).
Regarding claim 21, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Kanayama teaches wherein a barrier is provided in the measuring body, which at least partially shields a part of the detection device from the effect of the thermal and/or pressure wave (Par. 47, (resin serving as matching layer – 32)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Kanayama to include wherein a barrier is provided in the measuring body, which at least partially shields a part of the detection device from the effect of the thermal and/or pressure wave through the combination of references as it would have yielded the predictable result of matching the acoustic impedance with the subject (Kanayama (Par. 47)).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rozental in view of Klein and Bauer as applied to claim 5 above, and further in view of Kajioka (US Pub. No. 20120071738) hereinafter Kajioka.
Rozental teaches the device of claim 5 above.
Regarding claim 19, modified Rozental fails to explicitly disclose the limitations of the claim.
However, Kajioka teaches wherein said waveguide resonance element or interferometer is a resonance ring or a resonance plate (Par. 13).
Rozental, Klein, Bauer, and Kajioka are considered to be analogous art to the claimed invention as they are involved with non-invasive detection devices for biological organisms.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental, Klein, and Bauer with that of Kajioka to include wherein said waveguide resonance element is a resonance ring or a resonance plate through the substitution of resonating structures as it would have yielded the predictable result of improving the light receiving power (Kajioka (Par. 26)).
Response to Arguments
Applicant's arguments, filed 07/14/2026, regarding the 112(b) rejection have been fully considered and deemed as not persuasive.
Firstly, the examiner has not stated that the applicant lacks support for the indicated limitations in the 112(b) rejection above.
Claim 1 first recites the narrower of the limitations “wherein said substrate has a planar surface or a concave surface, with or without an additional coating, that forms a measuring surface”, which indicates a substrate with “a planar surface or a concave surface…” “…that forms a measuring surface”. The broader limitation, which is presented after the narrow limitation, recites “wherein said measuring surface is designed as a plane surface or comprises a concave surface or partial surface”, which indicates that “said measuring surface”, which refers to the same measuring surface, “is designed as a plane surface or comprises a concave surface or partial surface”. The broader limitation also recites another option of a partial surface that is not present within the narrow limitation. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim as it is unclear as to the shape of the measurement surface. The 112(b) rejection above has been slightly modified to add further clarification regarding this point.
As such, the rejection has been maintained.
Applicant's arguments filed 07/16/2026, regarding the previous 103 rejection have been fully considered but they are deemed as not persuasive.
The applicant’s arguments, on Page 10 of the remarks, that a person of ordinary skill in the art would not have operated the detector of Rozental at a low frequency and the above combination with Bauer would have rendered the device as inoperable for its intended purpose, have been fully considered and deemed as not persuasive.
Firstly, the claim itself recites “a modulation device configured to modulate intensity of the excitation beam at a modulation rate between 1 Hz and 10 kHz”, where this limitation contains functional language. As the claims are given their broadest reasonably interpretation, the prior art need only teach the structure capable of the indicated function.
Rozental discloses a source of excitation radiation capable of generating one or more excitation beams: of different wavelengths (excitation device – 61) (Par. 48, “the delivered exciting electromagnetic energy comprises photon energy in the optical spectrum.” “…the excitation device includes a laser source device being adapted for emitting light pulses, preferably in the visible or near-infrared spectra”), “thermoacoustic signals acquired at the different illumination wavelengths and/or the different light/field polarizations” (Par. 48) and further indicates “The FBG-based ultrasound detector 10 described above is used in the thermoacoustic imaging apparatus 60.” (Par. 91).
Bauer teaches a modulation device configured to modulate the intensity of the excitation beam at a modulation rate between 1 Hz and 10 kHz (As indicated in the 103 rejection above).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental and Klein with that of Bauer to include a modulation device configured to modulate the intensity of the excitation beam at a modulation rate between 1 Hz and 10 kHz through the combination of references as it would have yielded the predictable result of customizing the light intensity over time (Bauer (Par. 60)). As such, the above modification would not have rendered the device of Rozental as inoperable for its intended purpose and the applicant’s arguments are deemed as not persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The applicant’s arguments, regarding the added amendments to the claims, have been fully considered and deemed as not persuasive. As the amendments were not previously addressed, the amendments have been addressed in the 103 rejection as indicated above.
The applicant’s arguments and provided declaration by Dr. Kaluza, that it would not have been obvious to a person of ordinary skill in the art to modify the device of Rozental to operate at the wavelength “wherein said wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1”, have been fully considered and deemed as not persuasive. Rozental does not teach away from the use of the device at the indicated wavelengths. As indicated above, Par. 48 of Rozental states “Preferably, the delivered exciting electromagnetic energy comprises photon energy in the optical spectrum, i.e., the object is illuminated with light. The illumination light comprises at least one characteristic wavelength of at least 1 nm, preferably at least 400 nm, particularly preferred at least 650 nm, and below 5 .mu.m, preferably below 2 .mu.m, particularly preferred below 1.5 .mu.m. For this variant, the excitation device includes a laser source device being adapted for emitting light pulses, preferably in the visible or near-infrared spectra.” (Par. 48 of Rozental), with emphasis added regarding “the excitation device includes a laser source device being adapted for emitting light pulses, preferably in the visible or near-infrared spectra.” (Par. 48 of Rozental). As such, Rozental’s own disclosure indicates the possibility of the excitation light source being adapted for emitting light pulses “in the visible or near-infrared spectra” (Par. 48 of Rozental).
As indicated in the 103 rejection above, Klein teaches wherein said wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1 (Par. 60, “The measuring device 1 comprises a quantum cascade laser 2 which is tuneable in a pre-determined wavelength range. According to the exemplary embodiment described, the measuring device 1 is configured to tune the quantum cascade laser 2 for a measuring procedure in the range from 7 μm to 14 μm. In this range, there is a main absorption band of glucose, as shown in FIG. 4. The band extends from 8.8 μm to 10.5 μm and has a peak at approximately 9.6 μm.”) (Par. 42, “The excitation source can be a tuneable quantum cascade laser. The wavelength of the radiation generated by the excitation source preferably lies in the range from 250 nm to 30 μm. Further preferably, the radiation generated can lie in the range from 7 μm to 14 μm, in which there is a distinct glucose absorption band from 8.5 μm to 10.5 μm, with a peak at approximately 9.6 μm.”) (Par. 38, 74 (glucose measurements)).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to a person of ordinary skill in the art to modify the device of Rozental with that of Klein to include a source of excitation radiation configured to generate one or more excitation beams of different wavelengths, which are directed at the substance when the measuring body is coupled and/or in contact with the substance in the region of the measuring surface, wherein said wavelengths are within a spectral range between 900 cm-1 and 1300 cm-1 through the substitution of light sources as the use of differing laser sources and wavelengths are known (Rozental (Par. 48)) (Klein (Par. 42)) and it would have yielded the predictable result of improving the quality of the data that is collected (Rozental (Par. 48)) and using a wavelength with a glucose absorption band to allow for glucose measurements (Klein (Par. 38, 42,60)). As such, the above modification would not have rendered the device of Rozental as inoperable for its intended purpose and the applicant’s arguments are deemed as not persuasive.
The applicant’s argument, regarding the absorption spectrum of Claim 16, has been fully considered and deemed as not persuasive. The examiner respectfully disagrees with the applicant’s assertion. The claim itself recites “wherein a modulated excitation beam is directed onto the substance to be analyzed and a temporal light intensity profile or waveform or a periodic light intensity change is detected by the detection device, these being detected for a plurality of wavelengths of the excitation beam by measuring the light intensity change in the first optical waveguide structure or by measuring the light intensity of light emitted from the first optical waveguide structure and obtaining an absorption spectrum of the substance to be analyzed from the acquired data”. The claimed absorption spectrum is “obtained’ from the acquired data, where the acquired data itself is from “wherein a modulated excitation beam is directed onto the substance to be analyzed and a temporal light intensity profile or waveform or a periodic light intensity change is detected by the detection device, these being detected for a plurality of wavelengths of the excitation beam by measuring the light intensity change in the first optical waveguide structure or by measuring the light intensity of light emitted from the first optical waveguide structure”. As such, under the broadest reasonable interpretation of the claim, the plurality of signals that make up an absorption map of Rozental (as indicated in the 103 rejection above) (Rozental (Par. 52, (plurality of signals for an absorption map)) (Par. 62-63)) reads on the claimed absorption spectrum.
The applicant’s arguments, regarding the dependent claims, rely on the arguments The applicant’s arguments regarding the dependent claims, rely on the arguments related to the independent claim, and as such are also deemed as not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI S PADDA/ Examiner, Art Unit 3791
/RENE T TOWA/ Primary Examiner, Art Unit 3791
