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
This is an office action in response to applicant’s arguments and remarks filed on April 27, 2026. Claims 20-31 are currently pending in the application. Claims 24-27 are withdrawn as discussed below, and claims 20-23 and 28-31 are being examined herein.
Election/Restrictions
Newly submitted claims 24-27 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Inventions I (claims 20-23 and 28-31) and II (claims 24-27) are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process such as storing and shipping the package.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 24-27 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Objections and Rejections
The objections and rejections from the previous office action are obviated by Applicant’s cancellation.
New grounds of rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, and 35 U.S.C. 103 are necessitated by the amendments.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-23 and 28-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 recites the limitation “the measuring device is configured to execute instructions for: calculating the concentration of Cr and/or Crn in the one or more calibration solutions at the end time using a multiple-temperature temperature model, rate equations for an equilibrium reaction of Cr and Crn, and the Arrhenius equation, the multiple-temperature temperature model being determined by the measurements of the one or more changes in temperature of the one or more calibration solutions from the initial time to the end time; determining the sensitivity of the sensor based on a relationship between 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 Crn in a sample”. The specification does not contain support for the measuring device being configured to execute instructions for the above claimed limitations. Instead, the specification discloses that the one or more processors of an electronic device execute instructions which cause the electronic device to operate in accordance with the aforementioned methods (see para. [0025]-[0026] of the instant US PGPub). The measuring device and the electronic device are distinct devices. The measuring device merely includes a sensor for measuring creatine and/or creatinine (see para. [0014]-[0016] of the instant US PGPub), and does not execute instructions for calculating, determining, and recalibrating. Applicant is required to cancel the new matter in reply to this Office Action.
Claim 23 recites the limitation “the measuring device is configured to execute instructions from a computer readable medium to: calculate the concentration of Cr and/or Crn in the one or more calibration solutions at the end time using a multiple-temperature temperature model, rate equations for an equilibrium reaction of Cr and Crn, and the Arrhenius equation, the multiple-temperature temperature model being determined by the measurements of the one or more changes in temperature of the one or more calibration solutions from the initial time to the end time, determine the sensitivity of the sensor based on a relationship between outputs of the measuring device and the calculated concentration of Cr and/or Crn, and recalibrate the sensitivity of the sensor for subsequent determination of the concentration of Cr and/or Crn in a sample”. The specification does not contain support for the measuring device being configured to execute instructions from a computer readable medium to do the above claimed limitations. Instead, the specification discloses that the one or more processors of an electronic device execute instructions from a computer readable medium which cause the electronic device to operate in accordance with the aforementioned methods (see para. [0025]-[0026] of the instant US PGPub). The measuring device and the electronic device are distinct devices. The measuring device merely includes a sensor for measuring creatine and/or creatinine (see para. [0014]-[0016] of the instant US PGPub), and does not execute instructions for calculating, determining, and recalibrating. Applicant is required to cancel the new matter in reply to this Office Action.
Claim 28 recites the limitation “an electronic device comprising: a sensor for determining creatine and/or creatinine concentration” in lines 4-5 of the claim. The specification does not contain support for the electronic device comprising a sensor for determining creatine and/or creatinine concentration. Instead, the specification discloses that the electronic device comprises one or more processors and a memory (see para. [0025]-[0026], [0109] of the instant US PGPub), whereas a measuring device includes a sensor for measuring creatine and/or creatinine (see para. [0014]-[0016] of the instant US PGPub). The measuring device and the electronic device are distinct devices. Applicant is required to cancel the new matter in reply to this Office Action. Claims 29-31 are rejected as dependent thereon.
Claim 28 recites the limitation “determine the sensitivity of the sensor based on a relationship between outputs of the electronic device and the calculated concentration of Cr and/or Crn” in lines 14-16 of the claim. The specification does not contain support for outputs of the electronic device being used to determine the sensitivity of the sensor. Instead, the specification discloses determining a relationship between the outputs of the measuring device and the calculated concentrations of Cr and/or Crn to calculate sensor sensitivities of the measuring device (see para. [0012], [0022] of the instant US PGPub). The measuring device and the electronic device are distinct devices. Applicant is required to cancel the new matter in reply to this Office Action. Claims 29-31 are rejected as dependent thereon.
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 22-23 and 28-31 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 22 recites the limitation "the sensitivity" in in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the sensitivity" in in line 9 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites the limitation "the sensitivity" in in line 14 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claims 29-31 are rejected as dependent thereon.
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 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over ABL800 FLEX Reference Manual, Radiometer, pp. 1-1 – 7-18 (2012) (hereinafter “Manual”) (provided in Applicant’s IDS filed on January 10, 2025) in view of Markle et al. (US 2009/0018426 A1) and further in view of Mansouri et al. (US 2003/0062262 A1).
Regarding claim 20, Manual teaches a package (a system, Manual, pg. 2-23, first paragraph, Introduction), comprising:
one or more calibration solutions comprising a creatine (Cr) calibration solution and/or a creatinine (Crn) calibration solution, the one or more calibration solutions being configured to recalibrate a sensor for determining creatinine concentration (S1827 Calibration Solution 1 contains creatinine, and S1837 Calibration Solution 2 contains creatine, Manual, pg. 2-25, first and second paragraphs, Calibration material; calibrating Crea A and Crea B electrodes in a two-electrode system for measuring concentration of creatinine using the Calibration Solutions 1 and 2, Manual, pg. 2-23, first paragraph, Introduction, pg. 2-25, first and second paragraphs, Calibration material);
an indication of an initial time of the one or more calibration solutions, the initial time being when the one or more calibration solutions are placed in the package (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, Manual, pg. 2-25, first through third paragraph, Calibration material);
an indication of an initial concentration of Cr and/or Crn at the initial time 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, Manual, pg. 2-25, first through third paragraph, Calibration material);
the package being distinct from a measuring device containing the sensor (the system comprising the S1827 and S1837 Calibration Solutions is distinct from the Crea A and Crea B electrodes, Manual, pg. 2-23, first through third paragraphs, pg. 2-25, first through third paragraphs). Examiner further notes that “a measuring device containing the sensor” is not a positively recited element of the claim, and therefore, is not an element of the claimed package since the package is distinct from the measuring device. Furthermore, the limitations “a sensor for determining creatinine concentration” and “a measuring device containing the sensor” are with respect to an article worked upon (measuring device containing the sensor) and not a positively recited element of the package. Inclusion of the material or article worked upon (measuring device containing the sensor) by a structure (package) being claimed does not impart patentability to the claims. MPEP § 2115.
Manual teaches that the nominal concentrations of creatinine and creatine in the calibration solutions vary with time and temperature (Manual, pg. 2-26, fourth paragraph, Sensitivity). Manual fails to teach a temperature probe.
Markle teaches calibration of an analyte sensor (Markle, abstract). Markle teaches that the temperature of the calibration solution can be monitored by a temperature sensor (Markle, para. [0080]). Markle teaches that the temperature sensor can send data to the analyte monitor 704 which comprises a display 710 that shows the temperature of the calibration fluid and the results of each measurement and provides the desired temperature (Markle, para. [0078]-[0080]). Markle teaches that the accuracy of measurements can be improved when the calibration fluid is at the desired temperature (Markle, para. [0078]-[0079]).
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 system of Manual to include a temperature sensor as taught by Markle in order to yield the predictable result of monitoring temperature of the calibration solutions to determine whether they are at the desired temperature. 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).
Modified Manual teaches the temperature sensor for monitoring temperature of the calibration solutions (see modification supra). Modified Manual fails to teach a memory.
Mansouri teaches an electrochemical sensor system that continuously monitors and calibrates the sensors included in the system (Mansouri, abstract). Mansouri teaches that the sensor to be calibrated is exposed to at least two internal reference solutions having known concentration of the analyte (Mansouri, para. [0027]). Mansouri teaches a thermistor to monitor and control the temperature (Mansouri, para. [0057]). Mansouri teaches that the electrochemical sensor system can record any or all information and measured data in a storage element such as a memory (Mansouri, para. [0096]).
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 system of Modified Manual to include a memory in order to yield the predictable result of storing the measured temperature data of the calibration solutions. 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 “being configured to recalibrate a sensor for determining creatinine concentration,” “when the one or more calibration solutions are placed in the package,” “measure one or more changes in temperature of the one or more calibration solutions in the package from the initial time to an end time, the end time being when the one or more calibration solutions are used to recalibrate the sensor,” and “storing the one or more changes in temperature of the one or more calibration solutions” 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 system disclosed by Modified Manual teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as recited in the rejection supra.
Regarding claim 21, the limitation “wherein the end time is more than fourteen days after the initial time” is 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 system disclosed by Modified Manual teaches all of the structural limitations of the claim and thus is configured for and capable of the intended use and/or functional language as recited in the rejection supra.
Regarding claim 22, Examiner notes that “the measuring device” is not a positively recited element of the claim, and therefore, is not an element of the claimed package since claim 20 recites that the package is distinct from the measuring device. Therefore, the limitation “the measuring device is configured to execute instructions for: calculating the concentration of Cr and/or Crn in the one or more calibration solutions at the end time using a multiple-temperature temperature model, rate equations for an equilibrium reaction of Cr and Crn, and the Arrhenius equation, the multiple-temperature temperature model being determined by the measurements of the one or more changes in temperature of the one or more calibration solutions from the initial time to the end time; determining the sensitivity of the sensor based on a relationship between 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 Crn in a sample” is not positively recited and thus is not given patentable weight. Furthermore, the limitation “the measuring device” is with respect to an article worked upon (measuring device) and not a positively recited element of the package. Inclusion of the material or article worked upon (measuring device) by a structure (package) being claimed does not impart patentability to the claims. MPEP § 2115.
Regarding claim 23, Examiner notes that “the measuring device” is not a positively recited element of the claim, and therefore, is not an element of the claimed package since claim 20 recites that the package is distinct from the measuring device. Therefore, the limitation “the measuring device is configured to execute instructions from a computer readable medium to: calculate the concentration of Cr and/or Crn in the one or more calibration solutions at the end time using a multiple-temperature temperature model, rate equations for an equilibrium reaction of Cr and Crn, and the Arrhenius equation, the multiple-temperature temperature model being determined by the measurements of the one or more changes in temperature of the one or more calibration solutions from the initial time to the end time; determine the sensitivity of the sensor based on a relationship between outputs of the measuring device and the calculated concentration of Cr and/or Crn; and recalibrate the sensitivity of the sensor for subsequent determination of the concentration of Cr and/or Crn in a sample” is not positively recited and thus is not given patentable weight. Furthermore, the limitation “the measuring device” is with respect to an article worked upon (measuring device) and not a positively recited element of the package. Inclusion of the material or article worked upon (measuring device) by a structure (package) being claimed does not impart patentability to the claims. MPEP § 2115.
Response to Arguments
Applicant’s arguments with respect to claim 20 have been considered but are moot in light of new grounds of rejection. Prior art Manual in view of Markle and Mansouri are now relied on for the new claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/V.T./ Examiner, Art Unit 1794
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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