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 .
Information Disclosure Statement
The information disclosure statement filed January 10, 2025 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 14 is objected to because of the following informalities: in lines 4-5, “one or more calibration solutions” should read “the one or more calibration solutions”. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in lines 7-8, “one or more calibration solutions” should read “the one or more calibration solutions”. 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 16 and 19 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.
Claim 16 recites the limitation “a temperature probe” in line 2 of the claim. It is unclear whether “a temperature probe” in claim 16 is the same as or different from the previously recited “one or more temperature probes” in lines 21-22 of claim 14. For the purpose of examination, Examiner interprets them to be the same.
Claim 16 recites the limitation “the creatinine solutions” in lines 2-3 of the claim. It is unclear whether “the creatinine solutions” in claim 16 refers to the previously recited “creatinine in a solution” in line 4 of claim 14, “a creatinine (Crn) calibration solution” in line 10 of claim 14, or “the one or more calibration solutions” in line 21 of claim 14. For the purpose of examination, Examiner interprets “the creatinine solutions” in claim 16 to refer to the previously recited “the one or more calibration solutions” in line 21 of claim 14.
Claim 19 recites the limitation “a temperature probe” in line 1 of the claim. It is unclear whether “a temperature probe” in claim 19 is the same as or different from the previously recited “one or more temperature probes” in line 25 of claim 17. For the purpose of examination, Examiner interprets them to be the same.
Claim 19 recites the limitation “the creatinine solutions” in line 2 of the claim. It is unclear whether “the creatinine solutions” in claim 19 refers to the previously recited “creatinine in a solution” in line 7 of claim 17, “a creatinine (Crn) calibration solution” in line 13 of claim 17, or “the one or more calibration solutions” in line 24 of claim 17. For the purpose of examination, Examiner interprets “the creatinine solutions” in claim 19 to refer to the previously recited “the one or more calibration solutions” in line 24 of claim 17.
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 14-15 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ABL800 FLEX Reference Manual, Radiometer, pp. 1-1 - 7-18 (2012) (hereinafter “Manual”) (provided in Applicant’s IDS filed on January 10, 2025).
Regarding claim 14, Manual teaches a package comprising one or more calibration solutions comprising a creatine (Cr) calibration solution and/or a creatinine (Crn) calibration solution (S1827 Calibration Solution 1 contains creatinine, and S1837 Calibration Solution 2 contains creatine, pg. 2-25, first and second paragraphs, Calibration material), the package containing instructions (an analyzer performs calibrations and calculations, pg. 2-25, third paragraph, Calibration material, pg. 2-26, Sensitivity, pg. 2-30, Measurements and corrections, Whole blood correction).
The limitations “for use with a method for recalibrating a measuring device for measuring a concentration of creatinine in a solution using one or more calibration solutions, the method comprising: providing the measuring device for determining the concentration of creatinine in the solution, wherein the measuring device comprises a sensor having a sensitivity in need of recalibration; providing the one or more calibration solutions comprising a creatine (Cr) calibration solution and/or a creatinine (Crn) calibration solution for the sensor; receiving concentrations at an initial time of Cr and/or Crn in the one or more calibration solutions; receiving outputs of the measuring device at an end time; calculating the concentration of Cr and/or Crn in the one or more calibration solutions at the end time using a two-temperature temperature model, rate equations for an equilibrium reaction of Cr and Crn, and the Arrhenius equation, wherein the two-temperature temperature model is determined by receiving measurements of one or more changes in temperature of the one or more calibration solutions from one or more temperature probes from the initial time to the end time; determining the sensitivity of the sensor based on a relationship between the outputs of the measuring device and the calculated concentration of Cr and/or Crn; and recalibrating the sensitivity of the sensor for subsequent determination of the concentration of Cr and/or Cm in a sample” are interpreted as intended use language. Examiner notes that “a measuring device,” “a sensor,” and “one or more temperature probes” are not positively recited elements of the claim, and therefore, are not elements of the claimed package. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The analyzer and calibration solutions disclosed by Manual teaches all of the structural limitations of the claimed package and thus is configured for and capable of the intended use language.
Regarding claim 15, Manual teaches an indication of the initial time and the concentrations at the initial time of Cr and/or Crn of the one or more calibration solutions (the precise start concentrations of creatinine and creatine are contained in the barcodes of the S1827 and S1837 Calibration Solutions that are scanned before the calibration solutions are installed on the analyzer, pg. 2-25, first through third paragraph, Calibration material).
Regarding claim 17, Manual teaches a package comprising one or more calibration solutions comprising a creatine (Cr) calibration solution and/or a creatinine (Crn) calibration solution (S1827 Calibration Solution 1 contains creatinine, and S1837 Calibration Solution 2 contains creatine, pg. 2-25, first and second paragraphs, Calibration material), the package containing instructions (an analyzer performs calibrations and calculations, pg. 2-25, third paragraph, Calibration material, pg. 2-26, Sensitivity, pg. 2-30, Measurements and corrections, Whole blood correction).
The limitations “for use with an electronic device comprising: one or more processors; and memory comprising instructions which when executed by one or more of the one or more processors cause the electronic device to operate in accordance with a method for recalibrating a measuring device for measuring a concentration of creatinine in a solution using one or more calibration solutions, the method comprising: providing the measuring device for determining the concentration of creatinine in the solution, wherein the measuring device comprises a sensor having a sensitivity in need of recalibration; providing the one or more calibration solutions comprising a creatine (Cr) calibration solution and/or a creatinine (Crn) calibration solution for the sensor; receiving concentrations at an initial time of Cr and/or Crn in the one or more calibration solutions; receiving outputs of the measuring device at an end time; calculating the concentration of Cr and/or Crn in the one or more calibration solutions at the end time using a two-temperature temperature model, rate equations for an equilibrium reaction of Cr and Crn, and the Arrhenius equation, wherein the two-temperature temperature model is determined by receiving measurements of one or more changes in temperature of the one or more calibration solutions from one or more temperature probes from the initial time to the end time; determining the sensitivity of the sensor based on a relationship between the outputs of the measuring device and the calculated concentration of Cr and/or Crn; and recalibrating the sensitivity of the sensor for subsequent determination of the concentration of Cr and/or Cm in a sample” are interpreted as intended use language. Examiner notes that “an electronic device,” “one or more processors,” “memory,” “a measuring device,” “a sensor,” and “one or more temperature probes” are not positively recited elements of the claim, and therefore, are not elements of the claimed package. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The analyzer and calibration solutions disclosed by Manual teaches all of the structural limitations of the claimed package and thus is configured for and capable of the intended use language.
Regarding claim 18, Manual teaches an indication of the initial time and the concentrations at the initial time of Cr and/or Crn of the one or more calibration solutions (the precise start concentrations of creatinine and creatine are contained in the barcodes of the S1827 and S1837 Calibration Solutions that are scanned before the calibration solutions are installed on the analyzer, pg. 2-25, first through third paragraph, Calibration material).
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.
Claims 16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Manual as applied to claims 14 and 17 above, and further in view of Berner et al. (US 6,233,471 B1).
Regarding claims 16 and 19, Manual teaches that nominal concentrations of creatinine and creatine in the calibration solutions vary with time and temperature, and the analyzer automatically calculates the actual concentrations from the time the calibration solutions are installed and from the temperature (Manual, pg. 2-26, fourth paragraph, Sensitivity). Manual fails to teach a temperature probe for measuring the temperatures of the creatinine solutions from the initial time to the end time, and memory for storing the measured temperatures.
Berner teaches a method for measuring the concentration of target chemical analytes present in a biological system (Berner, abstract). Berner teaches a temperature sensor that is used to monitor changes in temperature over time in collection reservoirs to enable temperature correction of sensor signals (Berner, col. 16, lns. 27-30, col. 19, lns. 66-67, col. 20, lns. 13-17). Berner teaches a calibration step of calibrating the sensor to correct for signal differences (Berner, col. 3, lns. 60-67, col. 12, lns. 35-44, col. 28, lns. 14-18). Berner teaches that the temperature sensor can enable temperature correction of sensor signals or provide a threshold criteria that can invalidate a measurement (Berner, col. 16, lns. 29-30, col. 20, lns. 1-10). Berner teaches that the microprocessor comprises a memory for storing readings and calibration parameters (Berner, col. 19, lns. 15-30).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the package of Manual to incorporate a temperature sensor to monitor the temperature of calibration solutions and a memory for storing the readings and calibration parameters as taught by Berner because they can enable temperature correction of sensor signals or provide a threshold criteria that can invalidate a measurement (Berner, col. 16, lns. 29-30, col. 20, lns. 1-10). Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A).
The limitations “for measuring the temperatures of the creatinine solutions from the initial time to the end time” and “for storing the measured temperatures” are interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The temperature sensor and memory disclosed by Modified Manual teaches all of the structural limitations of the claimed package and thus is configured for and capable of the intended use and/or functional language.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIVIAN A TRAN whose telephone number is (571)272-3232. The examiner can normally be reached Mon - Fri 9am-5pm.
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794