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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 23 July 2024 and 24 July 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1-5 and 7-20 are objected to because of the following informalities:
Claim 1: “the light source” in line 8 should be “the polarized light source”; “the body fluid sample” in lines 10, 11-12, and 13 respectively should be “the collected body fluid sample”; “the sample” in lines 14 and 15 respectively should be “the collected body fluid sample”; and “the fluid sample” in line 19 should be “the collected body fluid sample” for further clarity and continuity in the claim language.
Claim 2: “The sensor” in line 1 should be “The body fluid sensor” for further clarity and continuity in the claim language. (This also applies to claims 3-5, 7-11 and 18).
Claim 3: “the body fluid” in line 1 should be “the collected body fluid sample” for further clarity and continuity in the claim language.
Claim 5: “wherein the sensor comprises” in lines 1-2 should be “wherein the body fluid sensor” for further clarity and continuity in the claim language.
Claim 8: “the wall” in line 2 should be “the one or more walls” for further clarity and continuity in the claim language.
Claim 9: “as claimed in any of claim 7” in line 1 should be “as claimed in claim 7” for further clarity.
Claim 10: “the segments” in line 1 should be “the plurality of segments”; “the light source” in line 3 should be “the polarized light source”; and “the body fluid sample” in line 3 should be “the collected body fluid sample” for further clarity and continuity in the claim language.
Claim 12: “the light source” in lines 8 and 19 respectively should be “the polarized light source”; “the body fluid sample” in lines 11, 12-13, and 21 respectively should be “the collected body fluid sample”; “the sample” in lines 16 and 16-17 should be “the collected body fluid sample”; and “the light” in line 18 should be “the analysis light” for further clarity and continuity in the claim language.
Claim 13: “The sensor” in line 1 should be “The body fluid sensor” for further clarity and continuity in the claim language. (This also applies to claims 14-17). Additionally, “the light” in line 3 should be “the analysis light” and “the light source” in lines 3-4 should be “the polarized light source for further clarity and continuity in the claim language.
Claim 17: “the conduit” in line 2 should be “the at least one fluid conduit”; “the light source” in line 3 should be “the polarized light source”; and “the detector” in line 3 should be “the light detector” for further clarity and continuity in the claim language.
Claim 19: “the sensor” in lines 2 and 4 respectively should be “the body fluid sensor” for further clarity and continuity in the claim language.
Claim 20: “the sensor” in lines 2, 5, 7, and 9 respectively should be “the body fluid sensor” for further clarity and continuity in the claim language.
Appropriate correction is required.
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 1-5 and 7-20 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.
Regarding claim 1, “the detected light” in line 6 is unclear as this limitation lacks proper antecedent basis. Additionally, “a first stereoisomer of a molecule” in line 12 is unclear as this limitation has been mentioned previously. Is this limitation mentioned referring to a different molecule from the previously mentioned predefined molecule, or the same molecule? In light of the specification, the Examiner is interpreting this limitation to be referring to the same molecule previously mentioned. Additionally, “a polarization modification” in line 16 is unclear as this limitation has been mentioned previously. If this limitation referring to the same polarization modification mentioned previously or a different polarization modification? In light of the specification, the Examiner is interpreting this limitation to be referring to the same polarization modification mentioned previously.
Claims 2-5, 7-11, and 18-20 are rejected for their dependency on claim 1.
Regarding claim 5, “the measurement” in line 4 is unclear as it lacks proper antecedent basis.
Regarding claim 11, “the arc” in line 2 is unclear as it lacks proper antecedent basis.
Regarding claim 12, “the detected light” in line 6 is unclear as this limitation lacks proper antecedent basis. Additionally, “a predefined molecule” in lines 13-14 is unclear as this limitation has been mentioned previously. Is this limitation referring to the same molecule mentioned previously or a different molecule? In light of the specification, the Examiner is interpreting this limitation to be referring to the same molecule mentioned previously.
Claims 13-17 are rejected for their dependency on claim 12.
Regarding claim 17, “the arc” in line 2 is unclear as it lacks proper antecedent basis.
Regarding claim 19, “the measurement series” in line 6 is unclear as this limitation lacks proper antecedent basis.
Regarding claim 20, “the subject” in line 9 is unclear as this limitation lacks proper antecedent basis.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (The real-time determination of D1 and L-lactate based on optical weak measurement) in view of Gibbs et al. (USPGPub 20050094144 A1) and Guo et al. (USPGPub 20210223531 A1).
Regarding claim 1, Qiao teaches a fluid sensor comprising: a fluid collection system (SC) (see figure 1, sample cell SC; and page 2226, col. 1, paragraph 2, In the experimental device for chiral lactate detection, 1 ml of deionized water was firstly prepared in the SC. When the experimental system reached the steady state, the SC is completely emptied. Then 1 ml of D-lactate solution with a concentration of 0.8 g L-1 was added into the SC. When the system reached a new steady state, the SC is completely emptied again. Repeating the above process, 1 ml of D-lactate solution with a concentration of 2, 4, 6, 8 and 10 g L-1 was added into the SC in sequence); a light source (SLD) for directing analysis light to a collected fluid sample (see figure 1, super-luminescent diode SLD); at least one polarization state modifier (P1) (see figure 1, polarizer P1); a light detector (see figure 1, spectrograph (i.e. light detector)); and a processor for processing the detected light (page 2224, col. 2, paragraph 3, the spectrograph was connected to a computer which was used for spectral analysis), wherein, during operation, the polarization state modifier (P1) and the collected fluid sample are along a common optical path between the light source (SLD) and the light detector (see figure 1), and wherein the processor is adapted to derive an optical property of the detected light which has been modified by a polarization modification induced by the fluid sample, and thereby determine a concentration of at least a first stereoisomer of a predefined molecule in the fluid sample, or a ratio between a concentration of a first stereoisomer of a molecule and a concentration of a second stereoisomer of the molecule present in the fluid sample (page 2226, col. 2, paragraph 2, The real-time determination process of L-lactate and D-lactate are shown in Fig. 5. It denotes that the D-lactate solution rotated the polarization plane with an angle of α according to the theory of weak measurement mentioned above. In contrast, the L-lactate solution rotated the polarization plane with an angle of –α. And the DL-lactate solution rotated the polarization plane with a very small angle. With the increasing concentration of D-lactate, L-lactate and DL-lactate, the optical activity of the solution would be enhanced. According to the theory of weak measurement mentioned above (eqn (3)), the shift of the central wavelength of output spectra would be on the rise with the increasing concentration. Based on this real-time detection, we can easily observe the chirality change caused by the sample visually), wherein the polarization state modifier (P1) is arranged optically upstream from the sample, between the light source (SLD) and the sample (see figure 1), and wherein the optical property determined by the processor is a polarization modification induced by an optical activity of the fluid sample (page 2226, col. 2, paragraph 2, The real-time determination process of L-lactate and D-lactate are shown in Fig. 5. It denotes that the D-lactate solution rotated the polarization plane with an angle of α according to the theory of weak measurement mentioned above. In contrast, the L-lactate solution rotated the polarization plane with an angle of –α. And the DL-lactate solution rotated the polarization plane with a very small angle. With the increasing concentration of D-lactate, L-lactate and DL-lactate, the optical activity of the solution would be enhanced); and wherein the fluid sample is contained in the fluid collection system (SC) during analysis (see figure 1, sample cell SC; and page 2226, col. 1, paragraph 2, In the experimental device for chiral lactate detection, 1 ml of deionized water was firstly prepared in the SC. When the experimental system reached the steady state, the SC is completely emptied. Then 1 ml of D-lactate solution with a concentration of 0.8 g L-1 was added into the SC. When the system reached a new steady state, the SC is completely emptied again. Repeating the above process, 1 ml of D-lactate solution with a concentration of 2, 4, 6, 8 and 10 g L-1 was added into the SC in sequence). However, Qiao fails to explicitly teach wherein the fluid is a body fluid; wherein the light source is a polarized light source; and wherein the fluid collection system comprises a fluid conduit subsystem.
However, Gibbs teaches wherein the light source (602) is a polarized light source (see figure 6A, light source 602 and polarizer 606; and ¶180, Suitable light sources for use in the present invention include, without limitation, high intensity, monochromatic polarized laser light sources such as photo-emitting diodes, gas lasers such as He--Ne lasers, solid state laser or the like. Preferred light sources are high intensity, monochromatic polarized laser light sources).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Qiao to incorporate the teachings of Gibbs to instead have the light source be a polarized light source in order to further control the direction of light in order to provide enhanced contrast and detail as well as improving analysis. However, the combination fails to explicitly teach wherein the fluid is a body fluid; and wherein the fluid collection system comprises a fluid conduit subsystem.
However, Guo teaches wherein the fluid is a body fluid (¶1707, The disclosed low non-specific binding supports and associated nucleic acid hybridization and amplification methods may be used for the analysis of nucleic acid molecules derived from any of a variety of different cell, tissue, or sample types known to those of skill in the art; and see remainder of ¶1707 for further details); and wherein the fluid collection system comprises a fluid conduit subsystem (¶1457, The optical system of any of the Examples above, further comprising conduits configured to flow fluid through a flow cell).
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 combination of Qiao and Gibbs to incorporate the teachings of Guo to further provide a fluid conduit system in order to quickly move fluids to be tested through the system without the risk of contamination.
Regarding claim 2, Qiao as modified by Gibbs and Guo teaches the sensor as claimed in claim 1, wherein the first stereoisomer is D-Lactate and the second stereoisomer is L-lactate (Qiao, page 2226, col. 2, paragraph 2, The real-time determination process of L-lactate and D-lactate are shown in Fig. 5. It denotes that the D-lactate solution rotated the polarization plane with an angle of α according to the theory of weak measurement mentioned above. In contrast, the L-lactate solution rotated the polarization plane with an angle of –α. And the DL-lactate solution rotated the polarization plane with a very small angle. With the increasing concentration of D-lactate, L-lactate and DL-lactate, the optical activity of the solution would be enhanced).
Regarding claim 4, Qiao as modified by Gibbs and Guo teaches the sensor as claimed in claim 1, wherein the polarization state modifier (Qiao P1 | Gibbs 606/656/657) is adapted to apply a set of different polarization rotation angles (Gibbs, ¶142, The polarized light beam 658 is then forwarded to a Faraday modulator 657, which modulates the polarization of the polarized light beam 658 about a small angle to produce a modulated polarized light beam 659; and see ¶179 for further details).
Regarding claim 12, Qiao teaches a fluid sensor comprising: a fluid collection system (SC) (see figure 1, sample cell SC; and page 2226, col. 1, paragraph 2, In the experimental device for chiral lactate detection, 1 ml of deionized water was firstly prepared in the SC. When the experimental system reached the steady state, the SC is completely emptied. Then 1 ml of D-lactate solution with a concentration of 0.8 g L-1 was added into the SC. When the system reached a new steady state, the SC is completely emptied again. Repeating the above process, 1 ml of D-lactate solution with a concentration of 2, 4, 6, 8 and 10 g L-1 was added into the SC in sequence); a light source (SLD) for directing analysis light to a collected fluid sample (see figure 1, super-luminescent diode SLD); at least one polarization state modifier (P1) (see figure 1, polarizer P1); a light detector (see figure 1, spectrograph (i.e. light detector)); and a processor for processing the detected light (page 2224, col. 2, paragraph 3, the spectrograph was connected to a computer which was used for spectral analysis), wherein, during operation, the at least one polarization state modifier (P1) and the collected fluid sample are along a common optical path between the light source (SLD) and the light detector (see figure 1), and wherein the processor is adapted to derive an optical property of the detected light which has been modified by a polarization modification induced by the fluid sample, and thereby determine a concentration of at least a first stereoisomer of a predefined molecule in the fluid sample, or a ratio between concentrations of at least a first and second stereoisomer of a predefined molecule present in the fluid sample (page 2226, col. 2, paragraph 2, The real-time determination process of L-lactate and D-lactate are shown in Fig. 5. It denotes that the D-lactate solution rotated the polarization plane with an angle of α according to the theory of weak measurement mentioned above. In contrast, the L-lactate solution rotated the polarization plane with an angle of –α. And the DL-lactate solution rotated the polarization plane with a very small angle. With the increasing concentration of D-lactate, L-lactate and DL-lactate, the optical activity of the solution would be enhanced. According to the theory of weak measurement mentioned above (eqn (3)), the shift of the central wavelength of output spectra would be on the rise with the increasing concentration. Based on this real-time detection, we can easily observe the chirality change caused by the sample visually), wherein the at least one polarization state modifier (P1) is disposed optically upstream from the sample; a linear polarizer (P2) optically downstream from the sample, and wherein the optical property determined by the processor is a change in a central wavelength, δλ, of an optical spectrum of the detected light compared to an optical spectrum of the light generated by the light source (SLD) (see figure 1, polarizers P1 and P2; page 2224, col. 2, paragraph 3, P2 linear polarizer for post-selection; and abstract, The optical activity is not only relative to the concentration of the tested chiral sample but also can be quantitatively analyzed via the shift of the central wavelength of output spectra); and wherein the fluid sample is contained in the fluid collection system (SC) during analysis (see figure 1, sample cell SC; and page 2226, col. 1, paragraph 2, In the experimental device for chiral lactate detection, 1 ml of deionized water was firstly prepared in the SC. When the experimental system reached the steady state, the SC is completely emptied. Then 1 ml of D-lactate solution with a concentration of 0.8 g L-1 was added into the SC. When the system reached a new steady state, the SC is completely emptied again. Repeating the above process, 1 ml of D-lactate solution with a concentration of 2, 4, 6, 8 and 10 g L-1 was added into the SC in sequence). However, Qiao fails to explicitly teach wherein the fluid is a body fluid; wherein the light source is a polarized light source; wherein the polarization state modifier includes a birefringent element; and wherein the fluid collection system comprises a fluid conduit subsystem.
However, Gibbs teaches wherein the light source (602) is a polarized light source (see figure 6A, light source 602 and polarizer 606; and ¶180, Suitable light sources for use in the present invention include, without limitation, high intensity, monochromatic polarized laser light sources such as photo-emitting diodes, gas lasers such as He--Ne lasers, solid state laser or the like. Preferred light sources are high intensity, monochromatic polarized laser light sources).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Qiao to incorporate the teachings of Gibbs to instead have the light source be a polarized light source in order to further control the direction of light in order to provide enhanced contrast and detail as well as improving analysis. However, the combination fails to explicitly teach wherein the fluid is a body fluid; wherein the polarization state modifier includes a birefringent element; and wherein the fluid collection system comprises a fluid conduit subsystem.
However, Guo teaches wherein the fluid is a body fluid (¶1707, The disclosed low non-specific binding supports and associated nucleic acid hybridization and amplification methods may be used for the analysis of nucleic acid molecules derived from any of a variety of different cell, tissue, or sample types known to those of skill in the art; and see remainder of ¶1707 for further details); wherein the polarization state modifier includes a birefringent element (¶1576, Retarders such as half wave retarders or a plurality of quarter wave retarders or retarders having other amounts of retardance may be included to rotate the linear polarization in some designs); and wherein the fluid collection system comprises a fluid conduit subsystem (¶1457, The optical system of any of the Examples above, further comprising conduits configured to flow fluid through a flow cell).
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 combination of Qiao and Gibbs to incorporate the teachings of Guo to include a birefringent material as the polarizing element as it is merely an equivalent known for the same purpose of polarizing light (MPEP 2144.06 II). Additionally, it would have been obvious to further provide a fluid conduit system in order to quickly move fluids to be tested through the system without the risk of contamination.
Regarding claim 14, Qiao as modified by Gibbs and Guo teaches the sensor as claimed in claim 12, wherein the birefringent element is a half wave plate (Guo, ¶1576, Retarders such as half wave retarders or a plurality of quarter wave retarders or retarders having other amounts of retardance may be included to rotate the linear polarization in some designs).
Regarding claim 15, Qiao as modified by Gibbs and Guo teaches the sensor as claimed in claim 12, wherein the birefringent element comprises a birefringent material; or the birefringent element comprises an electrically addressable liquid crystal polarizer arrangement (Guo, ¶1576, Retarders such as half wave retarders or a plurality of quarter wave retarders or retarders having other amounts of retardance may be included to rotate the linear polarization in some designs; and NOTE: half wave plates are inherently birefringent).
Claims 3 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (The real-time determination of D1 and L-lactate based on optical weak measurement) in view of Gibbs et al. (USPGPub 20050094144 A1) and Guo et al. (USPGPub 20210223531 A1) as applied to claim 1 above, and further in view of Begtrup et al. (WO 2019210240 A1).
Regarding claim 3, Qiao as modified by Gibbs and Guo teaches the body fluid (Guo, ¶1707, The disclosed low non-specific binding supports and associated nucleic acid hybridization and amplification methods may be used for the analysis of nucleic acid molecules derived from any of a variety of different cell, tissue, or sample types known to those of skill in the art; and see remainder of ¶1707 for further details). However, the combination fails to explicitly teach wherein the body fluid is sweat.
However, Begtrup teaches wherein the body fluid is sweat (¶28, The sensing area 120 contains an analyte sensor (not shown), such as a colorimetric or enzymatic sensor for pH, an electrolyte, glucose, lactate or other sweat analyte).
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 combination of Qiao, Gibbs, and Guo to incorporate the teachings of Begtrup to measure for stereoisomers in sweat because [s]weat contains many of the same biomarkers, chemicals, or solutes that are carried in blood, which can provide significant information enabling the diagnosis of ailments, health status, toxins, performance, and other physiological attributes even in advance of any physical sign. Furthermore, sweat itself, and the action of sweating, or other parameters, attributes, solutes, or features on or near skin or beneath the skin, can be measured to further reveal physiological information. Accordingly, sweat sensing devices hold tremendous promise for use in workplace safety, athletic, military, and clinical diagnostic settings (Begtrup, ¶2).
Regarding claim 18, Qiao as modified by Gibbs and Guo teaches the sensor (Qiao, abstract, A simple transmission optical rotation (OR) configuration based on weak measurement was developed for the real-time and relatively high precision determination of chiral molecules). However, the combination fails to explicitly teach wherein the sensor is integrated in a wearable unit.
However, Begtrup teaches wherein the sensor is integrated in a wearable unit (¶3, What is needed, therefore, are flexible, body-conforming wearable devices configured to measure sweat rate or to measure characteristics of analytes in sweat that correlate to physiological conditions).
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 combination of Qiao, Gibbs, and Guo to incorporate the teachings of Begtrup to provide the sensor in a wearable device in order to provide useful information about the individual’s physiological state, including sweat rate, and sweat content (Begtrup, ¶3).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (The real-time determination of D1 and L-lactate based on optical weak measurement) in view of Gibbs et al. (USPGPub 20050094144 A1) and Guo et al. (USPGPub 20210223531 A1) as applied to claim 1 above, and further in view of Scarlett (USPGPub 20180149584 A1).
Regarding claim 5, Qiao as modified by Gibbs and Guo teaches the polarized light source (Gibbs, see figure 6A, light source 602 and polarizer 606; and ¶180, Suitable light sources for use in the present invention include, without limitation, high intensity, monochromatic polarized laser light sources such as photo-emitting diodes, gas lasers such as He--Ne lasers, solid state laser or the like. Preferred light sources are high intensity, monochromatic polarized laser light sources); and a processor configured to analyze concentrations of the first and second stereoisomer of the molecule (page 2224, col. 2, paragraph 3, the spectrograph was connected to a computer which was used for spectral analysis). However, the combination fails to explicitly teach wherein the sensor comprises a controller adapted to control the light source for generating analysis light of at least two different wavelengths, and wherein the processor is adapted to derive information about the molecule from the measurement of the optical property at different of the two or more wavelengths.
However, Scarlett teaches wherein the sensor comprises a controller adapted to control the light source for generating analysis light of at least two different wavelengths (¶24, the beam source 102 produces a beam incident on the wavelength selection system 104. Using the wavelength selection system 104, various wavelengths of beam energy may be selected from the beam source 102 for introduction into the cavity 106. In this way, the radiation impinging on the cavity 106 may be varied, allowing selected various wavelengths of beam energy to enter the cavity 106 for subsequent measurements; ¶10, the photodiode stage measures and records the frequency response of the output beam, thereby building a unique amplitude vs. wavelength signature for the sample material. This signature depends on the molecular makeup of the sample material. The sample material will alter beams of different wavelengths differently in response to molecular compositions in the sample; and ¶8, the light source is controlled by a programmable controller of the system), and wherein the processor is adapted to derive information about the molecule from the measurement of the optical property at different of the two or more wavelengths (¶10, the photodiode stage measures and records the frequency response of the output beam, thereby building a unique amplitude vs. wavelength signature for the sample material. This signature depends on the molecular makeup of the sample material. The sample material will alter beams of different wavelengths differently in response to molecular compositions in the sample; ¶30, For example, the composition of a sample medium can be identified by probing the sample with an input beam having a wavelength that is tuned across an entire spectral region and then examining the output beam from the system across that entire spectrum, for evidence of either circular dichroism or circular birefringence, as a function of input wavelength. Once either are detected, then the output beam spectral response as a functional of input wavelength can be examined to find key combinations of frequencies that indicate the presence of distinct materials, similar to identifying atoms from spectral absorption lines, examined by looking at the relative effects, degree of absorption/rotation for a given frequency, at different frequencies in cases where multiple structures may contribute at a single frequency value; and ¶38, The signal detection and processing device 124 includes one or more processors and one or more memories storing instructions executable by the one or more processors to analyze the output beams from the system 100 and identify materials in the sample medium 116).
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 combination of Qiao, Gibbs, and Guo to incorporate the teachings of Scarlett to further include a tunable light source because [t]his allows the system to achieve high sensitivity to even low concentrations of molecules on the order of 1-100 ppm depending on the number of cavity traversals and the quality of the rotational elements. As a result, the enhanced identification of materials exhibiting circular birefringence or circular dichroism may be used to better understand biological molecules and may be used in environments where rapid identification of organic materials is required (Scarlett, ¶10).
Claims 7-8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (The real-time determination of D1 and L-lactate based on optical weak measurement) in view of Gibbs et al. (USPGPub 20050094144 A1) and Guo et al. (USPGPub 20210223531 A1) as applied to claims 1 and 12 above, and further in view of Scarpaci et al. (USPGPub 20090116012 A1).
Regarding claim 7, Qiao as modified by Gibbs and Guo teaches the at least one polarization state modifier (Qiao P1) (Qiao, see figure 1); and fluid conduit subsystem (Guo, ¶1457, The optical system of any of the Examples above, further comprising conduits configured to flow fluid through a flow cell). However, the combination fails to explicitly teach wherein the at least one polarization state modifier is comprised by one or more walls of at least one fluid conduit of the fluid conduit subsystem.
However, Scarpaci teaches wherein the at least one polarization state modifier is comprised by one or more walls of at least one fluid conduit of the fluid conduit subsystem (see figure 5A; and ¶78, One embodiment of the apparatus is shown in FIG. 5A. In this embodiment, the Brewster's angle polarizers are molded into the fluid pathway such that the polarized light does not need to pass through anything other than the fluid under test).
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 combination of Qiao, Gibbs, and Guo to incorporate the teachings of Scarpaci to have the polarizer be one of the walls of the fluid conduit because it eliminates the probability of the polarized light angle being shifted upon passing through a surface before passing through the fluid under test (Scarpaci, ¶78).
Regarding claim 8, Qiao as modified by Gibbs, Guo, and Scarpaci teaches the sensor as claimed in claim 7, wherein the polarization state modifier is imprinted on the wall of said at least one fluid conduit (Scarpaci, see figure 5A; and ¶78, One embodiment of the apparatus is shown in FIG. 5A. In this embodiment, the Brewster's angle polarizers are molded into the fluid pathway such that the polarized light does not need to pass through anything other than the fluid under test).
Regarding claim 16, Qiao as modified by Gibbs and Guo teaches the at least one polarization state modifier (Qiao P1) (Qiao, see figure 1); and fluid conduit subsystem (Guo, ¶1457, The optical system of any of the Examples above, further comprising conduits configured to flow fluid through a flow cell). However, the combination fails to explicitly teach wherein the at least one polarization state modifier is comprised by one or more walls of at least one fluid conduit of the fluid conduit subsystem, and optionally wherein the at least one polarization state modifier is imprinted on at least one wall of said at least one fluid conduit.
However, Scarpaci teaches wherein the at least one polarization state modifier is comprised by one or more walls of at least one fluid conduit of the fluid conduit subsystem, and optionally wherein the at least one polarization state modifier is imprinted on at least one wall of said at least one fluid conduit (see figure 5A; and ¶78, One embodiment of the apparatus is shown in FIG. 5A. In this embodiment, the Brewster's angle polarizers are molded into the fluid pathway such that the polarized light does not need to pass through anything other than the fluid under test).
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 combination of Qiao, Gibbs, and Guo to incorporate the teachings of Scarpaci to have the polarizer be one of the walls of the fluid conduit because it eliminates the probability of the polarized light angle being shifted upon passing through a surface before passing through the fluid under test (Scarpaci, ¶78).
Claims 11 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Qiao et al. (The real-time determination of D1 and L-lactate based on optical weak measurement) in view of Gibbs et al. (USPGPub 20050094144 A1), Guo et al. (USPGPub 20210223531 A1), and Scarpaci et al. (USPGPub 20090116012 A1) as applied to claims 7 and 16 above, and further in view of Henley et al. (USPGPub 20210154673 A1).
Regarding claim 11, Qiao as modified by Gibbs, Guo, and Scarpaci teaches the fluid conduit subsystem (Guo, ¶1457, The optical system of any of the Examples above, further comprising conduits configured to flow fluid through a flow cell). However, the combination fails to explicitly teach wherein a fluid flow channel defined by at least one conduit of the fluid conduit subsystem is arcuate, the arc of the conduit lying in a plane, and wherein said common optical path has a directional component which is perpendicular to said plane.
However, Henley teaches wherein a fluid flow channel defined by at least one conduit of the fluid conduit subsystem is arcuate, the arc of the conduit lying in a plane (see figure 16; and ¶146, FIG. 16 illustrates that the fluid channels 15 can be arcuate fluid channels 15a), and wherein said common optical path has a directional component which is perpendicular to said plane (see figure 8, light source 225 and detector 222 disposed perpendicular to fluidic device 10 (i.e. the plane)).
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 combination of Qiao, Gibbs, Guo, and Scarpaci to incorporate the teachings of Henley to provide an arc shaped fluidic conduit because a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions (MPEP 2144.05 II A). See also (MPEP 2144.04 IV B).
Regarding claim 17, Qiao as modified by Gibbs, Guo, and Scarpaci teaches the fluid conduit subsystem (Guo, ¶1457, The optical system of any of the Examples above, further comprising conduits configured to flow fluid through a flow cell). However, the combination fails to explicitly teach wherein a fluid flow channel defined by at least one fluid conduit of the fluid conduit subsystem is arcuate, the arc of the conduit lying in a plane, and wherein said common optical path between the light source and the detector has a directional component which is perpendicular to said plane.
However, Henley teaches wherein a fluid flow channel defined by at least one fluid conduit of the fluid conduit subsystem is arcuate, the arc of the conduit lying in a plane (see figure 16; and ¶146, FIG. 16 illustrates that the fluid channels 15 can be arcuate fluid channels 15a), and wherein said common optical path between the light source and the detector has a directional component which is perpendicular to said plane (see figure 8, light source 225 and detector 222 disposed perpendicular to fluidic device 10 (i.e. the plane)).
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 combination of Qiao, Gibbs, Guo, and Scarpaci to incorporate the teachings of Henley to provide an arc shaped fluidic conduit because a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions (MPEP 2144.05 II A). See also (MPEP 2144.04 IV B).
Allowable Subject Matter
Claims 9-10, 13, and 19-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 9, the prior art of record individually or combined fails to teach the sensor as claimed in any of claim 7 and 1, more specifically in combination with wherein the polarization state modifier comprises a plurality of segments with different polarization angles along the fluid conduit subsystem and wherein the light detector is configured to separately detect light that has passed through different segments.
Claim 10 is rejected but would be considered allowable for its dependency on claim 9.
Regarding claim 13, the prior art of record individually or combined fails to teach the sensor as claimed in claim 12, more specifically in combination with wherein the polarized light source is linearly polarized in a first direction, wherein the birefringent element is arranged to receive the light generated by the light source and to output two linearly polarized light beams having respectively perpendicular polarization directions; and wherein the linear has a direction of polarization perpendicular to the first direction.
Regarding claim 19, the prior art of record individually or combined fails to teach a system comprising: the sensor as claimed in claim 1; and a controller adapted to: obtain from the sensor a data series of concentration measurements of the at least one stereoisomer for a subject, over a continuous measurement session; detect, in the measurement series, timings of either positive or negative inflection points in the data series; more specifically in combination with receive a data input indicative of timings of one or more stereoisomer injection events administered to the subject; determine a lag time (ΔT1, ΔT2) between at least one stereoisomer injection event and a temporally closest inflection point following the stereoisomer injection event.
Regarding claim 20, the prior art of record individually or combined fails to teach a system comprising: the sensor as claimed in claim 1, wherein the sensor is a sweat sensor; and a controller adapted to: obtain from the sensor a first measurement of a concentration of a stereoisomer of interest, obtain from the sensor a second measurement of a concentration of the stereoisomer of interest, more specifically in combination with where the second measurement follows administration of a stereoisomer injection to the subject of the stereoisomer of interest; and determine a conversion factor, c, between a sweat concentration of the stereoisomer of interest and a blood concentration of the stereoisomer of interest by computing the following equation:
c
=
(
S
a
f
t
e
r
-
S
b
e
f
o
r
e
)
/
(
I
∙
V
i
/
V
b
)
where c is the conversion factor from the sweat stereoisomer concentration to blood stereoisomer concentration,
S
b
e
f
o
r
e
is the concentration of the stereoisomer of interest in sweat before the stereoisomer injection,
S
a
f
t
e
r
is the concentration of the stereoisomer of interest in sweat after the stereoisomer injection, I is the concentration of the stereoisomer of interest in the stereoisomer injection solution, Vi is the volume of the stereoisomer solution injected, and Vb is the blood volume of the subject.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN R GARBER whose telephone number is (571)272-4663. The examiner can normally be reached M-F 0730-1730.
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/ERIN R GARBER/Examiner, Art Unit 2878
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