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 .
Status of Claims
Applicant's arguments, filed 12/12/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/12/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1, 3-4, 7, 13-15, and 18-20.
Applicants have left claims 2, 5-6, 8-12, and 16-17 as originally filed/previously presented.
Claims 1-20 are the current claims hereby under examination.
Claim Objections - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
Claims 1, 13, and 18 are objected to because of the following informalities:
Regarding claim 1, lines 19-20 recite “the electrode”, however it appears it should read --the at least one electrode-- (emphasis added).
Regarding claim 13, line 22 recites “the electrode”, however it appears it should read --the at least one electrode-- (emphasis added).
Regarding claim 18, line 26 recites “the electrode”, however it appears it should read --the at least one electrode-- (emphasis added).
Response to Arguments
Applicant’s arguments, see page 9 of Remarks, filed 12/12/2025, with respect to claims 1, 7, 13, and 18 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 1, 7, 13, and 18 have been withdrawn. However, there are new grounds for objections.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Bong Oh (US 20160178571 A1) (previously cited), hereinafter referred to as Oh, in view of Kroneis et al. (US 5185263 A) (previously cited), hereinafter referred to as Kroneis.
The claims are generally directed towards a method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system, the method comprising the steps of: (i) inserting a sensor cartridge into a blood gas, electrolyte, and/or metabolite instrument, the sensor cartridge comprising: an amperometric sensor array comprising at least one sensor and at least one electrode, wherein the at least one sensor includes an amperometric partial pressure of oxygen (pO2) sensor; at least one calibration and/or quality control reagent; and aqueous pyrogallol; (ii) activating the sensor cartridge to add aqueous pyrogallol to the at least one calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form at least one calibration and/or quality control fluid having a desired oxygen level; and (iii) contacting the at least one calibration and/or quality control fluid with the at least one electrode and the at least one sensor of the amperometric sensor array, wherein: the at least one calibration and/or quality control fluid is contacted with the at least one electrode to determine a concentration of oxygen present therein based on an electrochemical current generated between the electrode and oxygen present in the at least one calibration and/or quality control fluid, whereby the concentration of oxygen is directly proportional to the electrochemical current generated; and the at least one calibration and/or quality control fluid is contacted with the at least one sensor of the amperometric sensor array for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument.
Regarding claim 1, Oh discloses a method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system (Abstract, para. [0016], “method of controlling and/or generating desired oxygen levels in-situ for on-board QC within a sensor cartridge … methods of accurately measuring the oxygen levels …”), the method comprising the steps of:
(i) inserting a sensor cartridge into a blood gas, electrolyte, and/or metabolite instrument (para. [0035], “device is a sensor cartridge …”, para. [0044], “devices … disposed into a blood gas, electrolyte, and/or metabolite instrumentation …”), the sensor cartridge comprising:
an amperometric sensor array comprising at least one sensor and at least one electrode, wherein the at least one sensor includes an amperometric partial pressure of oxygen (pO2) sensor (para. [0023], “any electrode may function as an electrode … as long as the electrode is electrochemically active and is capable of being electrochemically reduced by the by-product of the oxygen scavenger … calculated out from the electrochemical current generated …”, para. [0036], “device may further include a sensor array … a sensor (such as, but not limited to, a pO.sub.2 sensor) and an electrode …”);
at least one calibration and/or quality control reagent (para. [0035], “predetermined amount of the calibration and/or quality control reagent is disposed in a first cavity …”); and
an oxygen scavenger (para. [0035], “predetermined amount of the oxygen scavenger-containing reagent is disposed in a second cavity …”);
(ii) activating the sensor cartridge to add the oxygen scavenger to the at least one calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form at least one calibration and/or quality control fluid having a desired oxygen level (para. [0026], “reaction time …”, para. [0027], “reaction temperature …”, para. [0035], “upon activation of the activatable cavity … calibration and/or quality control reagent moves from the activatable cavity into the second cavity …”, para. [0044], “device is activated at a certain temperature and for a certain period of time to provide a desired oxygen level for the calibration and/or quality control reagent …”); and
(iii) contacting the at least one calibration and/or quality control fluid with the at least one electrode and the at least one sensor of the amperometric sensor array (para. [0035-0036], para. [0044], “reagent containing the desired oxygen level is then brought into contact with a pO.sub.2 sensor for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument …”), wherein:
the at least one calibration and/or quality control fluid is contacted with the at least one electrode to determine a concentration of oxygen present therein based on an electrochemical current generated between the electrode and oxygen present in the at least one calibration and/or quality control fluid (para. [0035-0036], “desired oxygen level is generated, the oxygen level so generated can be accurately measured using the electrode …” , para. [0044], “reagent containing the desired oxygen level is then brought into contact with a pO.sub.2 sensor for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument …”, para. [0046]); and
the at least one calibration and/or quality control fluid is contacted with the at least one sensor of the amperometric sensor array for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument (para. [0035-0036], para. [0044], “reagent containing the desired oxygen level is then brought into contact with a pO.sub.2 sensor for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument …”).
Oh suggests, but does not explicitly disclose, the oxygen scavenger is aqueous pyrogallol. Oh suggests this because Oh discloses any reducing agent may function as an oxygen scavenger as along as the reducing agent is capable of (i) removing dissolved oxygen from a solution and (ii) capable of generating an electrochemically active by-product upon oxidation thereof that is chemically stable in aqueous solution (para. [0022]). Oh further does not explicitly disclose whereby the concentration of oxygen is directly proportional to the electrochemical current generated.
Kroneis teaches of an analogous method for producing a calibration fluid for blood gas analysis devices (Abstract, col. 1, lines 20-24). Kroneis further teaches the calibration fluid includes pyrogallol in excess in aqueous solutions (col. 8, lines 1-24). Kroneis further teaches whereby the concentration of oxygen is directly proportional to the electrochemical current generated (col. 7, line 45 - col. 8, line 12). 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 oxygen scavenger disclosed by Oh with aqueous pyrogallol, and use zero point calibration whereby the concentration of oxygen is directly proportional to the electrochemical current generated, as taught by Kroneis. This is because Kroneis teaches pyrogallol in excess in aqueous solutions is a known and suitable oxygen reducing agent for calibrating the zero point of a pO2 sensor (col. 8, lines 1-12). Further, one of ordinary skill in the art would have recognized aqueous pyrogallol is a simple substitution of other oxygen scavengers capable of removing dissolved oxygen from a solution, and capable of generating a chemically stable aqueous solution, as taught by Kroneis and suggested by Oh.
Regarding claim 2, modified Oh discloses the method of claim 1, wherein each of the at least one calibration and/or quality control reagent and the aqueous pyrogallol is separately disposed in a substantially air tight environment in the sensor cartridge until activation of the sensor cartridge (para. [0029], “calibration and/or quality control reagent(s) and/or oxygen scavenger-containing reagent(s) may be disposed in the kit in any form … maintain in a substantially air tight environment …”, para. [0040], “sealed to maintain the calibration and/or quality control reagent in a substantially airtight environment …”, claim 3, “disposed in a substantially air tight environment until use thereof” - further, see the rejection of claim 1 regarding aqueous pyrogallol).
Regarding claim 3, modified Oh discloses the method of claim 1.
However, modified Oh does not explicitly disclose wherein in the activating step, the aqueous pyrogallol is added to the at least one calibration and/or quality control reagent in an amount that provides a concentration in a range of from about 0.05% to about 1% of the calibration and/or quality control fluid.
As to concentration of the calibration and/or quality control fluid, Oh teaches the resulting concentration of the calibration and/or quality control fluid is related to the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs (para. [0025]). The resulting concentration of the pyrogallol within the calibration and/or quality control reagent will depend upon these variables. As such, the concentration of the calibration and/or quality control fluid is a results-effective variable that would have been optimized through routine experimentation based on the desired resulting oxygen concentration, the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs. It would have been obvious to one of ordinary skill in the art at the time of invention to have a concentration in a range of from about 0.05% to about 1% of the calibration and/or quality control fluid, based upon the teachings of Oh.
Regarding claim 4, modified Oh discloses the method of claim 3.
However, modified Oh does not explicitly disclose wherein the aqueous pyrogallol is present in the calibration and/or quality control fluid at a concentration in a range of from about 0.05% to about 0.5%.
As to concentration of the calibration and/or quality control fluid, Oh teaches the resulting concentration of the calibration and/or quality control fluid is related to the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs (para. [0025]). The resulting concentration of the pyrogallol within the calibration and/or quality control reagent will depend upon these variables. As such, the concentration of the calibration and/or quality control fluid is a results-effective variable that would have been optimized through routine experimentation based on the desired resulting oxygen concentration, the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs. It would have been obvious to one of ordinary skill in the art at the time of invention to have a concentration in a range of from about 0.05% to about 0.5%, based upon the teachings of Oh.
Regarding claim 5, modified Oh discloses the method of claim 1, wherein in the activating step, the specific reaction temperature is in a range of from about 20°C to about 26°C (para. [0027], “any reaction temperature … reaction temperature may be about 20°C … about 26°C …”, para. [0032-0033], “reagent contains a desired oxygen level based upon … the reaction time and the reaction temperature of the exposure …”), and the specific reaction time is in a range of from about 0.01 second to about 60 seconds (para. [0026], “reaction time may be any amount of time that allows for the oxygen scavenger-containing reagent to complex with oxygen … reaction time may be about … 0.01 second … 60 seconds …”, para. [0032-0033], “reagent contains a desired oxygen level based upon … the reaction time and the reaction temperature of the exposure …”).
Regarding claim 6, modified Oh discloses the method of claim 5, wherein the specific reaction time is in a range of from about 30 seconds to about 40 seconds (para. [0026], “reaction time may be any amount of time that allows for the oxygen scavenger-containing reagent to complex with oxygen … reaction time may be about … 0.01 second … 60 seconds …”, para. [0032-0033], “reagent contains a desired oxygen level based upon … the reaction time and the reaction temperature of the exposure …”).
Regarding claim 7, modified Oh discloses the method of claim 1.
However, modified Oh does not explicitly disclose wherein in the activating step, the desired oxygen level comprises a pO2 of about zero millimeters of mercury (mmHg).
Kroneis further teaches the pyrogallol calibration solution is used for calibration the pO2 zero point of the instrument (col. 8, lines 1-12). 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 method disclosed by modified Oh to explicitly have the desired oxygen level comprise a pO2 of about zero millimeters of mercury (mmHg), as taught by Kroneis. This is because Kroneis teaches a pyrogallol calibration fluid with an oxygen level of about zero mmHg allows for accurate zero point calibration to provide accurate results (col. 8, lines 1-12).
Regarding claim 8, modified Oh discloses the method of claim 1, wherein the contacting step is performed within about 30 seconds of completion of the activating step (para. [0024], “desired oxygen level can be provided in the calibration and/or quality control reagent(s) immediately before and/or at the time of use of such reagent(s)”, para. [0032-0033], para. [0044]).
Regarding claim 9, modified Oh discloses the method of claim 1, wherein the sensor cartridge is further defined as a single-use sensor cartridge (para. [0035], “single-use sensor cartridge”).
Regarding claim 12, modified Oh discloses the method of claim 1, wherein the at least one electrode in the sensor cartridge is a bar metal electrode (para. [0023], “any electrode known … bare metal electrode …”).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bong Oh (US 20160178571 A1) (previously cited), hereinafter referred to as Oh, in view of Kroneis et al. (US 5185263 A) (previously cited), hereinafter referred to as Kroneis as applied to claim 1 above, and further in view of Mansouri et al. (US 20030062262 A1) (previously cited), hereinafter referred to as Mansouri.
Regarding claim 10, modified Oh discloses the method of claim 1.
However, modified Oh does not explicitly disclose wherein the sensor cartridge is further defined as a multiple-use sensor cartridge.
Mansouri teaches an analogous method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system using a sensor cartridge and calibration fluids (Abstract, Fig. 1, para. [0051]). Mansouri further teaches the sensor cartridge is further defined as a multiple-use sensor cartridge (para. [0095], “initial verification of the calibration … does not need any further hands-on monitoring by the operator during the useful life of the cartridge … determined to be outside of the predetermined acceptable range … calibration of the cartridge … automatically initiated …”). 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 sensor cartridge to be defined as a multiple-use sensor cartridge, as taught by Mansouri. This is because Mansouri teaches recalibration can be performed automatically in the event of a sensor operating outside of an acceptable range, improving the sensor accuracy (para. [0095]).
Regarding claim 11, modified Oh discloses the method of claim 10.
However, modified Oh does not explicitly disclose further comprising repeating steps (ii) and (iii).
Mansouri further teaches repeating the calibration operation. 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 method disclosed by modified Oh to additionally repeat the calibration operation by repeating steps (ii) and (iii), as taught by Mansouri. This is because Mansouri teaches recalibration can be performed automatically in the event of a sensor operating outside of an acceptable range, improving the sensor accuracy (para. [0095]).
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bong Oh (US 20160178571 A1) (previously cited), hereinafter referred to as Oh, in view of Kroneis et al. (US 5185263 A) (previously cited), hereinafter referred to as Kroneis, in view of Mansouri et al. (US 20030062262 A1) (previously cited), hereinafter referred to as Mansouri.
Regarding claim 13, Oh discloses a method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system (Abstract, para. [0016], “method of controlling and/or generating desired oxygen levels in-situ for on-board QC within a sensor cartridge … methods of accurately measuring the oxygen levels …”), the method comprising the steps of:
(i) inserting a sensor cartridge into a blood gas, electrolyte, and/or metabolite instrument (para. [0035], “device is a sensor cartridge …”, para. [0044], “devices … disposed into a blood gas, electrolyte, and/or metabolite instrumentation …”), the sensor cartridge comprising:
(a) an amperometric sensor array comprising at least one sensor and at least one electrode, wherein the at least one sensor includes an amperometric partial pressure of oxygen (pO2) sensor (para. [0023], “any electrode may function as an electrode … as long as the electrode is electrochemically active and is capable of being electrochemically reduced by the by-product of the oxygen scavenger … calculated out from the electrochemical current generated …”, para. [0036], “device may further include a sensor array … a sensor (such as, but not limited to, a pO.sub.2 sensor) and an electrode …”);
(b) a first calibration and/or quality control reagent (para. [0035], “predetermined amount of the calibration and/or quality control reagent is disposed in a first cavity …”);
(d) an oxygen scavenger (para. [0035], “predetermined amount of the oxygen scavenger-containing reagent is disposed in a second cavity …”); and
wherein each of (b), and (d) is separately disposed in a substantially air tight environment in the sensor cartridge until activation of the sensor cartridge (para. [0029], “calibration and/or quality control reagent(s) and/or oxygen scavenger-containing reagent(s) may be disposed in the kit in any form … maintain in a substantially air tight environment …”, para. [0040], “sealed to maintain the calibration and/or quality control reagent in a substantially airtight environment …”);
(ii) activating the sensor cartridge to add the oxygen scavenger to the first calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form a first calibration and/or quality control fluid having a desired oxygen level (para. [0026], “reaction time …”, para. [0027], “reaction temperature …”, para. [0035], “upon activation of the activatable cavity … calibration and/or quality control reagent moves from the activatable cavity into the second cavity …”, para. [0044], “device is activated at a certain temperature and for a certain period of time to provide a desired oxygen level for the calibration and/or quality control reagent …”); and
(iii) contacting the first calibration and/or quality control fluid with the amperometric sensor array, wherein an electrochemical current is generated between the electrode of the amperometric sensor array and oxygen present in the calibration and/or quality control fluid (para. [0035-0036], para. [0044], “reagent containing the desired oxygen level is then brought into contact with a pO.sub.2 sensor for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument …”), and wherein the first calibration and/or quality control fluid sets a floor calibration measurement of the at least one pO2 sensor (para. [0035-0036], “desired oxygen level is generated, the oxygen level so generated can be accurately measured using the electrode … directly proportional to the concentration of oxygen removed …”, para. [0044], “reagent containing the desired oxygen level is then brought into contact with a pO.sub.2 sensor for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument …”, para. [0046]).
Oh suggests, but does not explicitly disclose, the oxygen scavenger is aqueous pyrogallol. Oh suggests this because Oh discloses any reducing agent may function as an oxygen scavenger as along as the reducing agent is capable of (i) removing dissolved oxygen from a solution and (ii) capable of generating an electrochemically active by-product upon oxidation thereof that is chemically stable in aqueous solution (para. [0022]). Oh further does not explicitly disclose whereby the concentration of oxygen is directly proportional to the electrochemical current generated.
Kroneis teaches of an analogous method for producing a calibration fluid for blood gas analysis (Abstract, col. 1, lines 20-24). Kroneis further teaches the calibration fluid includes pyrogallol in excess in aqueous solutions (col. 8, lines 1-24). Kroneis further teaches whereby the concentration of oxygen is directly proportional to the electrochemical current generated (col. 7, line 45 - col. 8, line 12). 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 oxygen scavenger disclosed by Oh with aqueous pyrogallol, and use zero point calibration whereby the concentration of oxygen is directly proportional to the electrochemical current generated, as taught by Kroneis. This is because Kroneis teaches pyrogallol in excess in aqueous solutions is a known and suitable oxygen reducing agent for calibrating the zero point of a pO2 sensor (col. 8, lines 1-12). Further, one of ordinary skill in the art would have recognized aqueous pyrogallol is a simple substitution of other oxygen scavengers capable of removing dissolved oxygen from a solution, and capable of generating a chemically stable aqueous solution, as taught by Kroneis and suggested by Oh.
However, modified Oh does not explicitly disclose (c) a second calibration and/or quality control reagent having a pO2 value above zero millimeters of mercury (mmHg); (c) is separately disposed in a substantially air tight environment in the sensor cartridge until activation of the sensor cartridge; and (iv) contacting the second calibration and/or quality control reagent with amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor.
Mansouri teaches an analogous method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system using a sensor cartridge and calibration fluids (Abstract, Fig. 1, para. [0051]). Mansouri further teaches the sensor cartridge comprises a second calibration and/or quality control reagent having a pO2 value above zero mmHg (para. [0064], “composition of internal reference solution B … pO2 = 180 mmHg …”); the second calibration and/or quality control reagent is separately disposed in a substantially air tight environment (para. [0074]); and contacting the second calibration and/or quality control reagent with amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor (para. [0025-0026], para. [0044], para. [0064], para. [0082]).
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 cartridge disclosed by modified Oh to additionally include (c) a second calibration and/or quality control reagent having a pO2 value above zero mmHg; (c) is separately disposed in a substantially air tight environment in the sensor cartridge until activation of the sensor cartridge; and (iv) contacting the second calibration and/or quality control reagent with amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor, as taught by Mansouri. This is because Mansouri teaches more than one calibration fluid allows for the electrode assembly to create a calibration curve for each of the measured parameters, deriving more accurate measurements from a blood sample (para. [0059]).
Regarding claim 14, modified Oh discloses the method of claim 13.
However, modified Oh does not explicitly disclose wherein the second calibration and/or quality control reagent has a pO2 value of about 160 mmHg.
Mansouri further teaches the second calibration and/or quality control reagent has a pO2 value of about 160 mmHg (para. [0064], “composition of internal reference solution B … pO2 = 180 mmHg …”). 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 pO2 value of the second calibration and/or quality control reagent to explicitly be about 160 mmHg, as taught by Mansouri. This is because Mansouri teaches multiple calibration fluids, including one at 180 mmHg allows for the electrode assembly to create a calibration curve for each of the measured parameters, deriving more accurate measurements from a blood sample (para. [0059]).
However, modified Oh does not explicitly disclose wherein the desired oxygen level generated in the first calibration and/or quality control fluid comprises a pO2 value about 0 mmHg.
Kroneis further teaches the first calibration and/or quality control fluid comprises a pO2 value about 0 mmHg (col. 8, lines 1-12). 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 method disclosed by modified Oh to explicitly have the first calibration and/or quality control fluid comprise a pO2 value about 0 mmHg, as taught by Kroneis. This is because Kroneis teaches a pyrogallol calibration fluid with an oxygen level of about zero mmHg allows for accurate zero point calibration to provide accurate results (col. 8, lines 1-12).
Regarding claim 15, modified Oh discloses the method of claim 13.
However, modified Oh does not explicitly disclose wherein in the activating step, the aqueous pyrogallol is present in the first calibration and/or quality control fluid at a concentration in a range of from about 0.05% to about 1%.
As to concentration of the calibration and/or quality control fluid, Oh teaches the resulting concentration of the calibration and/or quality control fluid is related to the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs (para. [0025]). The resulting concentration of the pyrogallol within the calibration and/or quality control reagent will depend upon these variables. As such, the concentration of the calibration and/or quality control fluid is a results-effective variable that would have been optimized through routine experimentation based on the desired resulting oxygen concentration, the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs. It would have been obvious to one of ordinary skill in the art at the time of invention to have a concentration in a range of from about 0.05% to about 1%, based upon the teachings of Oh.
Regarding claim 16, modified Oh discloses the method of claim 13, wherein in the activating step, the specific reaction temperature is in a range of from about 20°C to about 26°C (para. [0027], “any reaction temperature … reaction temperature may be about 20°C … about 26°C …”, para. [0032-0033], “reagent contains a desired oxygen level based upon … the reaction time and the reaction temperature of the exposure …”), and the specific reaction time is in a range of from about 0.01 second to about 60 seconds (para. [0026], “reaction time may be any amount of time that allows for the oxygen scavenger-containing reagent to complex with oxygen … reaction time may be about … 0.01 second … 60 seconds …”, para. [0032-0033], “reagent contains a desired oxygen level based upon … the reaction time and the reaction temperature of the exposure …”).
Regarding claim 17, modified Oh discloses the method of claim 13, wherein step (iii) is performed within about 30 seconds of completion of step (ii) (para. [0024], “desired oxygen level can be provided in the calibration and/or quality control reagent(s) immediately before and/or at the time of use of such reagent(s)”, para. [0032-0033], para. [0044]).
Regarding claim 18, Oh discloses a method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system (Abstract, para. [0016], “method of controlling and/or generating desired oxygen levels in-situ for on-board QC within a sensor cartridge … methods of accurately measuring the oxygen levels …”), the method comprising the steps of:
(i) inserting a sensor cartridge into a blood gas, electrolyte, and/or metabolite instrument (para. [0035], “device is a sensor cartridge …”, para. [0044], “devices … disposed into a blood gas, electrolyte, and/or metabolite instrumentation …”), the sensor cartridge comprising:
an amperometric sensor array comprising at least one sensor and at least one electrode, wherein the at least one sensor includes an amperometric partial pressure of oxygen (pO2) sensor (para. [0023], “any electrode may function as an electrode … as long as the electrode is electrochemically active and is capable of being electrochemically reduced by the by-product of the oxygen scavenger … calculated out from the electrochemical current generated …”, para. [0036], “device may further include a sensor array … a sensor (such as, but not limited to, a pO.sub.2 sensor) and an electrode …”);
a first calibration and/or quality control reagent (para. [0035], “predetermined amount of the calibration and/or quality control reagent is disposed in a first cavity …”);
an oxygen scavenger (para. [0035], “predetermined amount of the oxygen scavenger-containing reagent is disposed in a second cavity …”);
(ii) activating the sensor cartridge to add the oxygen scavenger to the first calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form a first calibration and/or quality control fluid (para. [0026], “reaction time …”, para. [0027], “reaction temperature …”, para. [0035], “upon activation of the activatable cavity … calibration and/or quality control reagent moves from the activatable cavity into the second cavity …”, para. [0044], “device is activated at a certain temperature and for a certain period of time to provide a desired oxygen level for the calibration and/or quality control reagent …”);
(iii) activating the sensor cartridge to add the oxygen scavenger to the calibration and/or quality control reagent and incubating at a specific reaction temperature and for a specific reaction time sufficient to form a calibration and/or quality control fluid having a pO2 value between 0 mmHg and the pO2 value of the second calibration and/or quality control reagent (para. [0024], “at least one calibration and/or quality control reagent …”, para. [0026], “reaction time …”, para. [0027], “reaction temperature …”, para. [0035], “upon activation of the activatable cavity … calibration and/or quality control reagent moves from the activatable cavity into the second cavity …”, para. [0044], “device is activated at a certain temperature and for a certain period of time to provide a desired oxygen level for the calibration and/or quality control reagent …”); and
(iv) contacting the first calibration and/or quality control fluid with the amperometric sensor array, wherein an electrochemical current is generated between the electrode of the amperometric sensor array and oxygen present in the calibration and/or quality control fluid (para. [0035-0036], para. [0044], “reagent containing the desired oxygen level is then brought into contact with a pO.sub.2 sensor for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument …”), and wherein the first calibration and/or quality control fluid sets a floor calibration measurement of the at least one pO2 sensor (para. [0035-0036], “desired oxygen level is generated, the oxygen level so generated can be accurately measured using the electrode …” , para. [0044], “reagent containing the desired oxygen level is then brought into contact with a pO.sub.2 sensor for calibration and/or quality control of the blood gas, electrolyte, and/or metabolite instrument …”, para. [0046]).
Oh suggests, but does not explicitly disclose, the oxygen scavenger is aqueous pyrogallol, and the first calibration and/or quality control fluid having a pO2 value of about 0 mmHg. Oh suggests this because Oh discloses any reducing agent may function as an oxygen scavenger as along as the reducing agent is capable of (i) removing dissolved oxygen from a solution and (ii) capable of generating an electrochemically active by-product upon oxidation thereof that is chemically stable in aqueous solution (para. [0022]). Oh further does not explicitly disclose whereby the concentration of oxygen is directly proportional to the electrochemical current generated.
Kroneis teaches of an analogous method for producing a calibration and/or quality control fluid for blood gas analysis (Abstract, col. 1, lines 20-24). Kroneis further teaches the calibration fluid includes pyrogallol in excess in aqueous solutions (col. 8, lines 1-24). Kroneis further teaches the first calibration and/or quality control fluid comprises a pO2 value about 0 mmHg (col. 8, lines 1-12). Kroneis further teaches whereby the concentration of oxygen is directly proportional to the electrochemical current generated (col. 7, line 45 - col. 8, line 12). 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 oxygen scavenger disclosed by Oh with aqueous pyrogallol, have the first calibration and/or quality control fluid have pO2 value of about 0 mmHg, and use zero point calibration whereby the concentration of oxygen is directly proportional to the electrochemical current generated, as taught by Kroneis. This is because Kroneis teaches pyrogallol in excess in aqueous solutions is a known and suitable oxygen reducing agent for calibrating the zero point of a pO2 sensor (col. 8, lines 1-12), and Kroneis teaches a pyrogallol calibration fluid with an oxygen level of about zero mmHg allows for accurate zero point calibration to provide accurate results (col. 8, lines 1-12). Further, one of ordinary skill in the art would have recognized aqueous pyrogallol is a simple substitution of other oxygen scavengers capable of removing dissolved oxygen from a solution, and capable of generating a chemically stable aqueous solution, as taught by Kroneis and suggested by Oh.
However, modified Oh does not explicitly disclose a second calibration and/or quality control reagent having a pO2 value above zero millimeters of mercury (mmHg); a third calibration and/or quality control reagent having a pO2 value above zero mmHg; (v) contacting the second calibration and/or quality control reagent with the amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor; and (vi) contacting the third calibration and/or quality control fluid with the amperometric sensor array, wherein the third calibration and/or quality control fluid sets calibration measurement of the at least one pO2 sensor between the floor and ceiling measurements.
Mansouri teaches an analogous method for monitoring the performance of a blood gas, electrolyte, and/or metabolite analyzer system using a sensor cartridge and calibration fluids (Abstract, Fig. 1, para. [0051]). Mansouri further teaches a second calibration and/or quality control reagent having a pO2 value above zero mmHg; a third calibration and/or quality control reagent having a pO2 value above zero mmHg (para. [0064], “composition of internal reference solution B … pO2 = 180 mmHg …”). Mansouri further teaches a third calibration fluid having a pO2 value between 0 mmHg and the pO2 value of the second calibration and/or quality control reagent (para. [0063], “composition of internal reference solution A … pO2 = 100 mmHg”). Mansouri further teaches (v) contacting the second calibration and/or quality control reagent with the amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor (para. [0025-0026], para. [0044], para. [0064], para. [0082]). Mansouri further teaches (vi) contacting the third calibration and/or quality control fluid with the amperometric sensor array, wherein the third calibration and/or quality control fluid sets calibration measurement of the at least one pO2 sensor between the floor and ceiling measurements (para. [0025-0026], para. [0055], para. [0063]).
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 method disclosed by modified Oh to additionally include a second calibration and/or quality control reagent having a pO2 value above zero mmHg; a third calibration and/or quality control reagent having a pO2 value above zero mmHg; a third calibration fluid; (v) contacting the second calibration and/or quality control reagent with the amperometric sensor array, wherein the second calibration and/or quality control reagent sets a ceiling calibration measurement of the at least one pO2 sensor; and (vi) contacting the third calibration and/or quality control fluid with the amperometric sensor array, wherein the third calibration and/or quality control fluid sets calibration measurement of the at least one pO2 sensor between the floor and ceiling measurements, as taught by Mansouri. This is because Mansouri teaches second and third calibration and/or quality control reagents allows for the electrode assembly to create a calibration curve for each of the measured parameters, driving more accurate measurements from a blood sample (para. [0059]).
Regarding claim 19, modified Oh discloses the method of claim 18.
However, modified Oh does not explicitly disclose wherein the second calibration and/or quality control reagent has a pO2 value of about 160 mmHg, and wherein in step (iii), the desired pO2 value generated in the third calibration and/or quality control fluid is in a range between 0 mmHg and 160 mmHg.
Mansouri further teaches wherein the second calibration and/or quality control reagent has a pO2 value of about 160 mmHg (para. [0064], “composition of internal reference solution B … pO2 = 180 mmHg …”), and wherein in step (iii), the desired pO2 value generated in the third calibration and/or quality control fluid is in a range between 0 mmHg and 160 mmHg (para. [0063], “composition of internal reference solution A … pO2 = 100 mmHg”). 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 pO2 values of the second calibration and/or quality control reagent and the third calibration and/or quality control fluid to explicitly be about 160 mmHg and between 0 mmHg and 160 mmHg, as taught by Mansouri. This is because Mansouri teaches multiple calibration fluids allows for the electrode assembly to create a calibration curve for each of the measure parameters, deriving more accurate measurements from a blood sample (para. [0059]).
Regarding claim 20, modified Oh discloses the method of claim 18, wherein at least one of: in steps (ii) and (iii), the specific reaction temperature is in a range of from about 20°C to about 26°C (para. [0027], “any reaction temperature … reaction temperature may be about 20°C … about 26°C …”, para. [0032-0033], “reagent contains a desired oxygen level based upon … the reaction time and the reaction temperature of the exposure …”), and the specific reaction time is in a range of from about 0.01 second to about 60 seconds (para. [0026], “reaction time may be any amount of time that allows for the oxygen scavenger-containing reagent to complex with oxygen … reaction time may be about … 0.01 second … 60 seconds …”, para. [0032-0033], “reagent contains a desired oxygen level based upon … the reaction time and the reaction temperature of the exposure …”); and/or step (iv) is performed within about 30 seconds of completion of step (ii) (para. [0024], “desired oxygen level can be provided in the calibration and/or quality control reagent(s) immediately before and/or at the time of use of such reagent(s)”, para. [0032-0033], para. [0044]), and step (vi) is performed within about 30 seconds of completion of step (iii) (para. [0024], “desired oxygen level can be provided in the calibration and/or quality control reagent(s) immediately before and/or at the time of use of such reagent(s)”, para. [0032-0033], para. [0044]).
However, modified Oh does not explicitly disclose in step (ii), the aqueous pyrogallol is present in the first calibration and/or quality control fluid at a concentration in a range of from about 0.05% to about 1%.
As to concentration of the calibration and/or quality control fluid, Oh teaches the resulting concentration of the calibration and/or quality control fluid is related to the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs (para. [0025]). The resulting concentration of the pyrogallol within the calibration and/or quality control reagent will depend upon these variables. As such, the concentration of the calibration and/or quality control fluid is a results-effective variable that would have been optimized through routine experimentation based on the desired resulting oxygen concentration, the initial concentration of oxygen in the calibration and/or quality control reagent, the concentration of the oxygen scavenger, the amount of time the scavenger is allowed to come into contact with the calibration and/or quality control reagent, and the temperature at which the reaction occurs. It would have been obvious to one of ordinary skill in the art at the time of invention to have a concentration in a range of from about 0.05% to about 1%, based upon the teachings of Oh.
Response to Arguments
Applicant's arguments filed 12/12/2025 have been fully considered but they are not persuasive.
Applicants have argued on pages 9-13 of Remarks, filed 12/12/2025, that “if the oxygen scavengers of Oh were replaced with pyrogallol, the methods of Oh would be rendered defective, because a measurable by-product would not be produced that is proportional to an amount of oxygen consumed by the scavenger and thus utilized in an indirect determination of oxygen by subtracting the concentration of the by-product from the original oxygen concentration”.
The Examiner respectfully disagrees. As recited in the modified rejection above, Oh explicitly disclose any oxygen scavenger may be used that removes dissolved oxygen from a solution and capable of generating an electrochemically active by-product upon oxidation (para. [0022]). Kroneis teaches pyrogallol is 1) a suitable oxygen scavenger, and 2) produces a by-product that is electrochemically active to produce a solution for zero point calibration (col. 8, lines 1-12).
Applicants have argued on pages 13-15 of Remarks, filed 12/12/2025, that “Kroneis et al. also explicitly discloses that the use of the chemical reducing agent sodium sulfite is preferred over pyrogallol” and “there is no indication in Kroneis et al. that the pyrogallol-containing reagents taught therein can be used with an amperometric sensor array”.
The Examiner respectfully disagrees. While Kroneis does state sodium sulfite is preferred, Kroneis further explicitly recites alternatives to sodium sulfite, including pyrogallol, that are suitable oxygen scavengers for zero point calibration. That is, Kroneis does not state pyrogallol cannot be used. Further, Kroneis explicitly states the use of amperometric sensor arrays (col. 7, lines 45-68).
Applicants have argued on page 16, of Remarks, filed 12/12/2025, that “there must be some motivation and/or reasonably expectation of success in modifying the prior art to arrive at the claimed invention”, and “if a proposal for modifying the prior art in an effort to attain the claimed invention causes the art to become inoperable or destroys its intended function, then the requisite motivation to make the modification would not have existed”.
The Examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Kroneis teaches pyrogallol in excess in aqueous solutions is a known and suitable oxygen reducing agent for calibrating the zero point of a pO2 sensor (col. 8, lines 1-12), and Kroneis teaches a pyrogallol calibration fluid with an oxygen level of about zero mmHg allows for accurate zero point calibration to provide accurate results (col. 8, lines 1-12). Further, one of ordinary skill in the art would have recognized aqueous pyrogallol is a simple substitution of other oxygen scavengers capable of removing dissolved oxygen from a solution, and capable of generating a chemically stable aqueous solution to allow for a zero point calibration, as taught by Kroneis and suggested by Oh.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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, Jason M Sims can be reached at (571)272-7540. 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.
/K.W.K./Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791