DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendments filed 07 April 2026 have been entered. Claims 1-5, 7-12, and 14-20 remain pending in the application, as well as newly added claims 21-22 (claims 6 and 13 have been cancelled). The Applicant’s amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Rejection dated 09 January 2026.
Response to Arguments
Applicant's arguments filed 07 April 2026 have been fully considered but they are not persuasive.
On pages 11-13, the Applicant argues against the combination of Qiao, Gibbs, and Guo used to teach claim 1. Specifically, the Applicant states that it was improper to use Guo to teach wherein the fluid is a bodily fluid and the fluid conduit system since Guo is directed to nucleic acid hybridization and amplification. While this is true, Guo is only brought in to teach the fluid conduit system which has nothing to do with the detection processes of the device. Guo is broadly drawn to analyzation of a fluid, as is Qiao, which makes these references analogous in that aspect. The mere addition of a fluid conduit system from Guo into Qiao would not disrupt the function of Qiao. Additionally, the Applicant argues against the combination reasoning, which was “in order to quickly move fluid to be tested through the system without the risk of contamination,” stating that this motivation is generic, not specific to the problem solved by the invention, and does not arise from the references themselves. The Applicant should note that there are a plurality of reasons and ways to combine references, including, but not limited to: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (see MPEP 2143 (I)). One of ordinary skill in the art knows what a fluid conduit system is used for.
Additionally, the Applicant argues that Qiao fails to teach the following limitation: “wherein the polarization state modifier is arranged optically upstream from the collected body fluid sample” specifically stating that Qiao doesn’t have a fluid conduit system. First, it has been acknowledged that Qiao does not teach a fluid conduit system, which is why the claim was rejected under U.S.C. 103 (Guo is brought in to teach the fluid conduit system). Second, the polarization state modifier is located upstream from the sample SC. For the above reasons, the arguments regarding claim 1 are not persuasive, and claim 1 remains rejected under 35 U.S.C. 103.
On page 13, the Applicant argues against the use of Gibbs to teach claim 4, stating that Gibbs “does not disclose or suggest a static set of spatially differentiated polarization rotations angles”. The Applicant’s claim does not state this either, it merely states “wherein the polarization state modifier is adapted to apply a set of different polarization rotation angles” which is still taught in ¶112-114, ¶142, and ¶179 of Gibbs. Therefore, the rejection of claim 4 is maintained.
On page 13, the Applicant argues against the combination of Begtrup with the previously mentioned references, stating specifically that Begtrup is directed to a different kind of sensor. Similarly to the response above, Begtrup is only brought in to teach that the body fluid is sweat and that the device is wearable which has nothing to do with the detection processes of the device. Additionally Begtrup is broadly drawn to analyzation of a fluid, as is Qiao, which makes these references analogous in that aspect. Further, the Applicant argues that there would be no reason to make the device of Qiao a wearable device as the different optical system and alignment thereof would fail to be preserved. The Examiner disagrees with this sentiment as changing the size of a device is not a novel concept (see MPEP 2144.04 (IV)(A)). Additionally, Qiao teaches a generic biological sensor and does not teach away from the device being portable, handheld, or wearable. Any light detection system, no matter the size/wearability, requires alignment in order for the detector to receive light. Therefore, the rejections of claims 3 and 18 are maintained.
On pages 13-14, the Applicant argues against the combination of Scarlett with the previously mentioned references, stating that Scarlett operates on a spectroscopy principle that differs from the claimed polarization driven system. Similarly again to the response above, Scarlett is only brought in to teach the light source generating different wavelengths, and those wavelengths being used to detect specific biological molecules as Qiao already teaches the stereoisomer detection. Additionally Scarlett is broadly drawn to analyzation of a fluid, as is Qiao, which makes these references analogous in that aspect. Scarlett clearly uses different wavelengths of light to receive responses from different molecules that react differently to said different wavelengths of light, which is what claim 5 is claiming (see ¶10, ¶30, and ¶38 of Scarlett). For these reasons, the rejection of claim 5 is maintained.
On pages 14-15, the Applicant argues against the combination of Scarpaci with the previously mentioned references, stating that Scarpaci teaches a device for measuring glucose and not sweat lactates. Similarly again to the response above, Scarpaci is only brought in to teach the polarizer being comprised by one or more walls of the fluid conduit system, as Qiao already teaches the stereoisomer detection of lactates as well as a polarizer. Additionally Scarpaci is broadly drawn to analyzation of a fluid, as is Qiao, which makes these references analogous in that aspect. While the polarizers in Scarpaci are reflective and not transmissive, these are both very well-known polarizers in the art. Additionally, the reason for combining Scarpaci with the other references “it eliminates the probability of the polarized light angle being shifted upon passing through a surface before passing through the fluid under test” would apply to Qiao as well since light is polarized by a polarizer and then passed to a sample cell that contains an additional barrier prior to the fluid that could alter the polarization. For these reasons, the rejection of claims 7-8 and 16 are maintained. It should be noted that additional reasons for combination, including but not limited to: Making Integral and Rearrangement of Parts (see MPEP 2144.04), can be used to obviate the above combination.
On page 16, the Applicant argues against the combination of Henley with Qiao, Gibbs, Guo, and Scarpaci, stating that the arcuate fluid channel of the instant application is used for a specific purpose. This is not persuasive as there can be a plurality of reasons for changing the shape, size, or proportion of an element. As stated in the MPEP, “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). Therefore, the rejection of claim 11 is maintained.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 and 4 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 for detecting the analysis light directed to the collected fluid sample (see figure 1, spectrograph (i.e. light detector)); and a processor for processing the analysis light detected by the light detector (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 collected fluid sample, and thereby determine a concentration of at least a first stereoisomer of a predefined molecule in the collected fluid sample, or a ratio between a concentration of the first stereoisomer of a molecule and a concentration of a second stereoisomer of the molecule present in the collected 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 collected fluid sample, between the light source (SLD) and the collected fluid sample (see figure 1), and wherein the optical property determined by the processor is the polarization modification induced by an optical activity of the collected 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 collected 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 body fluid 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 body fluid 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).
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 collected body fluid sample (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 collected body fluid sample is sweat.
However, Begtrup teaches wherein the collected body fluid sample 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 body fluid 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 body fluid 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 body fluid 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 a measurement of the optical property at different of the two or more wavelengths.
However, Scarlett teaches wherein the body fluid 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 a 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 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 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 body fluid sensor as claimed in claim 7, wherein the polarization state modifier is imprinted on the one or more walls 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).
Claim 11 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), Guo et al. (USPGPub 20210223531 A1), and Scarpaci et al. (USPGPub 20090116012 A1) as applied to claim 7 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, an arc of the at least one 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, an arc of the at least one 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).
Allowable Subject Matter
Claims 9-10, 12, 14-17, and 21-22 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 9, the prior art oof record individually or combined fails to teach a body fluid sensor as claimed comprising: a body fluid collection system; a polarized light source for directing analysis light to a collected body fluid sample; at least one polarization state modifier; a light detector for detecting the analysis light directed to the collected body fluid sample; and a processor for processing the analysis light detected by the light detector, wherein, during operation, the polarization state modifier and the collected body fluid sample are along a common optical path between the polarized light source and the light detector, 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 collected body fluid sample, and thereby determine a concentration of at least a first stereoisomer of a predefined molecule in the collected body fluid sample, or a ratio between a concentration of the first stereoisomer of a molecule and a concentration of a second stereoisomer of the molecule present in the collected body fluid sample, wherein the polarization state modifier is arranged optically upstream from the collected body fluid sample, between the polarized light source and the collected body fluid sample, and wherein the optical property determined by the processor is the polarization modification induced by an optical activity of the collected body fluid sample, wherein the body fluid collection system comprises a fluid conduit subsystem, and wherein the collected body fluid sample is contained in the fluid conduit subsystem during analysis, 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 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 allowed for its dependency on claim 9.
Regarding claim 12, the prior art of record individually or combined fail to teach a body fluid sensor as claimed comprising: a body fluid collection system; a polarized light source for directing analysis light to a collected body fluid sample; at least one polarization state modifier; a light detector for detecting the analysis light directed to the collected body fluid sample; and a processor for processing the analysis light detected by the light detector, wherein, during operation, the at least one polarization state modifier and the collected body fluid sample are along a common optical path between the polarized light source and the light detector,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 analysis light generated by the polarized light source and to output two linearly polarized light beams having respectively perpendicular polarization directions; and wherein the linear polarizer has a direction of polarization perpendicular to the first direction.
Claims 14-17 and 21-22 are allowed for their dependency on claim 12.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 19-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 19, the prior art of record individually or combined fails to teach a system comprising: the body fluid 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 data series of concentration measurements, 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 body fluid sensor as claimed in claim 1, wherein the body fluid sensor is a sweat sensor; and a controller adapted to: obtain from the body fluid sensor a first measurement of a concentration of a stereoisomer of interest, obtain from the body fluid 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 a test 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
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN R GARBER whose telephone number is (571)272-4663. The examiner can normally be reached M-F 0730-1730.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Georgia Y Epps can be reached at (571)272-2328. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIN R GARBER/Examiner, Art Unit 2878
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