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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7-9, and 18-20 are rejected under 35 U.S.C. 102(a) as being anticipated by Yi et al (WO 2020047606 A1, as cited in the IDS).
Regarding claim 1, Yi et al teaches a method of determining a concentration of an analyte in a fluid (see [00013], Abstract, A system, sensor or method for determining the concentration of an analyte in a fluid), said method comprising the following steps: providing a sorbent material having a hydroxylamine salt and a halochromic indicator sorbed thereon and/or therein, or a combination thereof (see [00054], The sensor comprises a hydroxylamine salt, halochromic indicator in/or on the sorbent material); measuring an initial color value of the sorbent material at an initial time point; contacting a fluid with the sorbent material to produce a color change in the sorbent material; measuring a final color value of the sorbent material at a final time point (see [000346], the sensor response to the analyte produces a color change. The acquisition device may measure data from the sensor over a period of time, such that the final color of a detection position of the sensor is measured); and determining the concentration of analyte in the fluid by: when a change in color value of the sorbent material from the initial time point to the final time point is smaller than a threshold color value: using the change in color value of the sorbent material from the initial time point to the final time point; and when the change in color value of the sorbent material from the initial time point to the final time point is greater than or equal to the threshold color value: using a rate of change in color value of the sorbent material over a time range, wherein the time range is between the initial time point and the final time point (see [00056], measuring a differential response of the sensor to the acetone, time required to reach a saturated response level for at least one of the detection positions on the sensor that reaches a saturated response level and a response that does not reach a saturated response level, comprising of exposing breath to a hydroxylamine salt in the presence of a liquid, as to produce a change in a variable such as absorbance, measuring a change in the variable, and determining the concentration of the acetone in the breath from the change in the variable).
Regarding claim 2, Yi et al teaches wherein the color value is an absorbance (see [000290], change in absorption spectrum, absorbance of electromagnetic radiation).
Regarding claim 3, Li et al teaches wherein the color value is a wavelength (see [000290], the change in the absorption spectrum of the indicator may comprise a change in intensity of the absorption of the indicator at a particular wavelength or at more than one wavelength. It may be a change in color, or a change in absorption e.g.).
Regarding claim 7, Yi et al teaches wherein the hydroxylammonium salt is hydroxylammonium chloride (see [00031], Hydroxylammonium salt, selected from a group consisting of hydroxylammonium chloride).
Regarding claim 8, Yi et al teaches wherein the halochromic indicator is selected from the group consisting of methyl orange, methyl red, methyl yellow, methyl green, methyl violet, chlorophenol red, bromocresol green, conga red, thymol blue, bromophenol blue, cresol red, metacresol purple, malachite green, ethyl violet, crystal violet, 2,4-dinitrophenol, orange IV, erythrosin B, p-(phenylazo)diphenylamine, p-phenylazoaniline and mixtures thereof (see [000291], halochromic indicator may be selected from the group consisting of methyl orange, methyl red, methyl yellow chlorophenol red, bromocresol green, congo red, thymol blue, bromophenol blue, cresol red, metacresol purple, malachite green, ethyl violet, crystal violet, 2,4-dinitrophenol, orange IV, erythrosin B, p-(phenylazo)diphenylamine, p-phenylazoaniline, phenol blue, and mixtures thereof. It may, for example, be selected from the group consisting of thymol blue, bromophenol blue, and mixtures thereof).
Regarding claim 9, Yi et al teaches wherein the initial and final color change values of the sorbent material are measured using a photosensor (see [000349], spectroscopic or colorimetric sensors, sensitive to a defined range of electromagnetic radiation).
Regarding claim 18, Yi et al teaches wherein the fluid is breath (see [00033], the fluid may be breath).
Regarding claim 19, Yi et al teaches wherein the analyte is acetone (see [00012]-[00013], analytes are ketone bodies: carbonyl containing compounds, which include acetone).
Regarding claim 20, Yi et al teaches a method of managing diabetes in a patient on a diabetes treatment plan, said method comprising: determining an acetone concentration of a breath sample of the patient using the method of claim 19; comparing the acetone concentration to a reference acetone concentration range; and if the acetone concentration is outside the acetone concentration reference range, adjusting the diabetes treatment plan (see [00057], method for managing diabetes in a patient on a diabetes treatment plan, wherein the carbonyl-containing compound is acetone, the fluid is breath, and the method comprises determining an acetone concentration of a breath sample of the patient by the method described earlier; comparing the acetone concentration to a reference acetone concentration range; and if the acetone concentration is outside the acetone concentration reference range, adjusting the diabetes treatment plan).
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 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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Yi et al as applied to claim 1 above.
Regarding claim 6, Yi et al teaches the device being sensitive to the carbonyl-containing compound, defined as one of the analytes that can produce a change in a variable such as absorbance. The device has a dynamic and working range of 100 ppm (v/v) to 10,000 ppm (v/v). While Yi et al does not explicitly teach that the color value corresponding to a concentration of analyte of from about 300 to 400 ppm (v/v) in the fluid (see [000254]-[000256]), 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 ranges of Yi et al to be within 300 to 400 ppm (v/v), as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yi et al as applied to claim 1 above, and further in view of Wang et al (“Colorimetric Sensor for Online Accurate Detection of Breath Acetone”, as cited in the IDS).
Regarding claim 10, Yi et al teaches a system that comprises a detector such as a spectroscopic or colorimetric sensor. It may comprise a camera with a light source, as well as optical filters to selectively allow particular wavelengths to reach the spectroscopic sensor [000349]. Light source 911 irradiates the sensing region, using electromagnetic radiation, such as visible light, where light is absorbed by sorbent materials (see Yi et al, [000284], Fig 9). The system may further comprise a flow channel or an analysis channel, and a flow and volume controller configured to control and/or monitor flow and volume rate of a fluid into said analysis chamber or through said flow channel (See Yi et al, [00077]). Yi et al further teaches an acquisition device that may be configured to determine the concentration of the analyte from the differential response, measuring a response of the sensor to the analyte as a function of time, where it may be able to determine the concentration of the analyte utilizing at least one detection position of the sensors. It can use a defined time after exposure of the sensor to the analyte, such as 0.01 seconds to 20 minutes, or about 1, 2, 5, 10 etc. minutes, as an example (see Yi et al, [000338]).
Yi et al fails to teach collecting a fluid sample from a subject in a vessel, and a filter.
However, in the analogous art of colorimetric sensors for online accurate detection of breath acetone, Wang et al teaches collecting subject's breath samples in a 4L air bag to be analyzed immediately, with calcium chloride as a desiccant to reduce water absorption of the sensor from the breath (See Wang et al, Materials and Methods, BrAce Measurements). 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 system of Yi et al to incorporate an airbag and a desiccant (as taught by Wang et al) for the benefit of accurate detection of low concentration breath acetone to enable management of diet and exercise, monitoring of lifestyle and preventing onset of diseases (see Wang et al, Introduction).
Claims 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yi et al, in view of Wang et al.
Regarding claim 11, Yi et al teaches a system that comprises a detector such as a spectroscopic or colorimetric sensor. It may comprise a camera with a light source, as well as optical filters to selectively allow particular wavelengths to reach the spectroscopic sensor [000349]. Light source 911 irradiates the sensing region, using electromagnetic radiation, such as visible light, where light is absorbed by sorbent materials (see Li et al, [000284], Fig 9.) The system may further comprise a flow channel or an analysis channel, and a flow and volume controller configured to control and/or monitor flow and volume rate of a fluid into said analysis chamber or through said flow channel (see Yi et al, [00077]). Yi et al further teaches an acquisition device measuring a differential response of the sensor to the acetone, measuring the response of the sensor to the analyte as a function of time, and finding the time required to reach a saturated response level for at least one of the detection positions on the sensor that reaches a saturated response level and a response that does not reach a saturated response level, comprising of exposing breath to a hydroxylamine salt in the presence of a liquid, as to produce a change in a variable such as absorbance, measuring a change in the variable, and determining the concentration of the acetone in the breath from the change in the variable (see Yi et al, [00056]).
Yi et al fails to teach a vessel receiving unit, capable of receiving a fluid sample vessel.
However, Wang et al teaches collecting subject's breath samples in a 4L air bag to be analyzed immediately. 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 system of Yi et al to incorporate an air bag (as taught by Wang et al), for the benefit of noninvasive sample collection of low concentration breath acetone to enable management of diet and exercise, monitoring of lifestyle and preventing onset of diseases (see Wang et al, Introduction).
Regarding claim 12, the combination of Yi et al and Wang et al teaches wherein the pump is capable of pumping the fluid from the fluid sample vessel to the sorbent material at a constant flow rate (see Yi et al, a flow channel or an analysis channel, and a flow and volume controller configured to control and/or monitor flow and volume rate of a fluid into said analysis chamber or through said flow channel [00077]). Therefore, Yi et al teaches the exact limitations of claim 12.
Regarding claim 13, Yi et al fails to teach the system further comprising a filter for removing moisture from the fluid.
However, Wang et al teaches calcium chloride as a desiccant to reduce water absorption of the sensor from the breath. (See Wang et al, Materials and Methods, BrAce Measurements). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Yi et al to incorporate a desiccant (as taught by Wang et al) for the benefit of accurate detection of low concentration breath acetone to enable management of diet and exercise, monitoring of lifestyle and preventing onset of diseases (see Wang et al, Introduction).
Regarding claim 14, the combination of Yi et al and Wang et al teaches wherein the color value is an absorbance (see Yi et al, [000290], change in absorption spectrum, absorbance of electromagnetic radiation). Therefore, Yi et al teaches the exact limitations of claim 14.
Regarding claim 15, the combination of Yi et al and Wang et al teaches wherein the color value is a wavelength (see Yi et al, [000290], the change in the absorption spectrum of the indicator may comprise a change in intensity of the absorption of the indicator at a particular wavelength or at more than one wavelength. It may be a change in color, or a change in absorption e.g). Therefore, Yi et al teaches the exact limitations of claim 15.
Regarding claim 16, the combination of Yi et al and Wang et al teaches wherein the hydroxylammonium salt is hydroxylammonium chloride (see Yi et al, [00031], Hydroxylammonium salt, selected from a group consisting of hydroxylammonium chloride). Therefore, Yi et al teaches the exact limitations of claim 16.
Regarding claim 17, the combination of Yi et al and Wang et al teaches wherein the halochromic indicator is selected from the group consisting of methyl orange, methyl red, methyl yellow, methyl green, methyl violet, chlorophenol red, bromocresol green, conga red, thymol blue, bromophenol blue, cresol red, metacresol purple, malachite green, ethyl violet, crystal violet, 2,4-dinitrophenol, orange IV, erythrosin B, p-(phenylazo)diphenylamine, p-phenylazoaniline and mixtures thereof (see Yi et al, [000291], halochromic indicator may be selected from the group consisting of methyl orange, methyl red, methyl yellow chlorophenol red, bromocresol green, congo red, thymol blue, bromophenol blue, cresol red, metacresol purple, malachite green, ethyl violet, crystal violet, 2,4-dinitrophenol, orange IV, erythrosin B, p-(phenylazo)diphenylamine, p-phenylazoaniline, phenol blue, and mixtures thereof. It may, for example, be selected from the group consisting of thymol blue, bromophenol blue, and mixtures thereof). Therefore, Yi et al teaches the exact limitations of claim 17.
Allowable Subject Matter
Claims 4 and 5 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 claims 4, the cited prior art neither teaches nor fairly suggests that the change in color value of the sorbent material from the initial time point to the final time point is smaller than the threshold color value, the concentration of analyte is calculated using the equation:
A
C
=
M
C
C
*
C
C
+
A
C
I
1
wherein AC is the analyte concentration; CC is the change in color value of the sorbent material from the initial time point to the final time point; and MCC is a slope and ACI1 is a y-intercept, respectively, of a standard plot of color change value of the sorbent material versus analyte concentration.
Regarding claims 5, the cited prior art neither teaches nor fairly suggests that the change in color value of the sorbent material from the initial time point to the final time point is greater than or equal to the threshold color value, the concentration of analyte is calculated using the equation:
A
C
=
M
C
C
R
*
C
C
R
+
A
C
I
2
wherein AC is the analyte concentration; CCR is the rate of change in color value of the sorbent material over the time range; and MCCR is a slope and ACI2 is a y-intercept, respectively, of a standard plot of rate of color change value of the sorbent material versus analyte concentration.
Conclusion
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/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797 /LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797