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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, in the reply filed on May 4, 2026 is acknowledged.
Claims 9-10 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 4, 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement filed April 19, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. 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 1 is objected to because of the following informalities: in lines 3, 4, and 7, “the reactor” should read “the enclosed reactor”. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: in line 2, “CO2 concentration” should read “the CO2 concentration”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities:
In line 2, “and the source” should read “or the source”.
In line 3, “and the gas mixture” should read “or the gas mixture”.
Appropriate correction is required.
Claim 8 is objected to because of the following informalities: in line 5, “the pH sensor signal” should read “the pH signal”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “temperature control subsystem” in claim 1 (the corresponding structures in the instant specification include a temperature sensor, a heater, a cooling unit, and equivalents thereof, see para. [0092] of the instant US PGPub).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 7 is 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 7 recites the limitation "the headspace gas total composition" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. Claim 1 recites calculating a pH value from a CO2 concentration measurement obtained by the CO2 sensor with a calibration curve for the buffer, and calculating a calibration parameter for the pH sensor from a pH signal obtained by the pH sensor and the pH value with a calibration curve for the pH sensor.
The limitations of calculating a pH value from a CO2 concentration measurement obtained by the CO2 sensor with a calibration curve for the buffer and calculating a calibration parameter for the pH sensor from a pH signal obtained by the pH sensor and the pH value with a calibration curve for the pH sensor, as drafted, are processes that, under its broadest reasonable interpretation, cover performance of the limitations in the mind or performing the calculations with pen and paper. Nothing in the claim precludes the steps from practically being performed in the mind or with pen and paper. The courts consider a mental process that can be performed by a human using a pen and paper to be an abstract idea. See MPEP § 2106.04(a)(2)(III). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the "Mental Processes" grouping of abstract ideas. Accordingly, the claims recite an abstract idea. The limitations of calculating a pH value from a CO2 concentration measurement obtained by the CO2 sensor with a calibration curve for the buffer and calculating a calibration parameter for the pH sensor from a pH signal obtained by the pH sensor and the pH value with a calibration curve for the pH sensor, as drafted, are process that, under its broadest reasonable interpretation, cover mathematical concepts such as mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers mathematical calculations, then it falls within the "Mathematical Concepts" grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional element of calibrating the pH sensor with the calibration parameter. The calibration parameter resulting from the abstract idea is merely applied to calibrate the pH sensor, so the abstract idea has not been integrated into a particular practical application. The courts have held that merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea does not integrate a judicial exception into a practical application. MPEP § 2106.04(d), 2106.05(f).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. In particular, claim 1 recites the additional elements of an enclosed reactor fluidly connectable to a source of a buffer and having a pH sensor positioned to measure pH of a fluid within the reactor and a CO2 sensor positioned to measure CO2 concentration within the reactor, a source of a gas mixture comprising CO2 fluidly connected to the enclosed reactor, a temperature control subsystem configured to control temperature of the fluid within the reactor, and a controller operably connected to the pH sensor and the CO2 sensor. These additional elements amount to no more than mere data gathering steps required to use the judicial exception. Mere data gathering steps and insignificant extra-solution activity linked to the judicial exception cannot provide an inventive concept, particularly when the activity is well-understood or conventional. Parker V. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978). See MPEP § 2106.05(g). For example: Eisenkraetzer et al. (US 2018/0216059 A1) teaches a bioreactor 104 coupled to a pipe or hose for transferring fresh buffer medium M1 into the bioreactor 104 (Figs. 1 & 3, para. [0286], [0290], [0302], [0305]), a pH measuring device 108 operatively coupled to the bioreactor 104 for measuring a pH of the medium M1 within the bioreactor 104 (Fig. 1, para. [0011], [0291], [0295]), a CO2 off gas analyzer 124 for measuring CO2 concentration in the off gas above the medium M1 of the bioreactor 104 (Fig. 1, para. [0289], [0291], [0293], [0373]), the bioreactor 104 is coupled to another pipe or hose for transferring CO2 gas into the bioreactor 104 (Figs. 1 & 3, para. [0290], [0305]), the temperature of the first bioreactor 104 can be controlled and adapted (Fig. 1, para. [0150], [0290], [0304]), and a comparison unit 130 and control unit 132 operably connected to the pH measuring device 108 and the CO2 off gas analyzer 124 (Fig. 1, para. [0284], [0289], [0301], [0303]). The claims do not invoke any of the considerations that courts have identified as provided significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, claim 1 as a whole does not amount to significantly more than the exception itself. The claims are not patent eligible.
Claims 2-8 are rejected under 35 U.S.C. 101 as dependent thereon and also do not include additional elements that are sufficient to amount to significantly more or integrate the exception into a practical application. Appropriate correction is requested.
Claims 7-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. Claims 7-8 recite mathematical formulas for the calibration curve for the buffer and the calibration curve for the pH sensor, and calculating the fitting parameters in the mathematical formulas.
The limitations of the mathematical formulas for the calibration curve for the buffer and the calibration curve for the pH sensor and calculating the fitting parameters in the mathematical formulas, as drafted, are process that, under its broadest reasonable interpretation, cover mathematical concepts such as mathematical formulas and calculations. If a claim limitation, under its broadest reasonable interpretation, covers mathematical formulas and calculations, then it falls within the "Mathematical Concepts" grouping of abstract ideas. Accordingly, the claims recite an abstract idea. The limitations of calculating the fitting parameters in the mathematical formulas, as drafted, are processes that, under its broadest reasonable interpretation, cover performance of the limitations in the mind or performing the calculations with pen and paper. Nothing in the claim precludes the steps from practically being performed in the mind or with pen and paper. The courts consider a mental process that can be performed by a human using a pen and paper to be an abstract idea. See MPEP § 2106.04(a)(2)(III). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the "Mental Processes" grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claims 7-8 recite the additional element of a controller. The controller is merely used to perform the judicial exceptions, so the abstract idea has not been integrated into a particular practical application. The courts have held that merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea does not integrate a judicial exception into a practical application. MPEP § 2106.04(d), 2106.05(f).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of a controller amounts to no more than merely using a computer as a tool to perform an abstract idea. Implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer. MPEP § 2106.05(f). The claims do not invoke any of the considerations that courts have identified as provided significantly more than an exception. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. The claims are not patent eligible.
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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Eisenkraetzer et al. (US 2018/0216059 A1) in view of Wong et al. (US 6,123,827 A).
Regarding claim 1, Eisenkraetzer teaches a reactor system (a system for monitoring and/or controlling one or more bioreactors, Eisenkraetzer, Fig. 1, para. [0274], [0284]-[0285]), comprising:
an enclosed reactor fluidly connectable to a source of a buffer and having a pH sensor positioned to measure pH of a fluid within the reactor and a CO2 sensor positioned to measure CO2 concentration within the reactor (a bioreactor 104 coupled to a pipe or hose for transferring fresh buffer medium M1 into the bioreactor 104, Eisenkraetzer, Figs. 1 & 3, para. [0286], [0290], [0302], [0305]; a pH measuring device 108 operatively coupled to the bioreactor 104 for measuring a pH of the medium M1 within the bioreactor 104, Eisenkraetzer, Fig. 1, para. [0011], [0291], [0295]; a CO2 off gas analyzer 124 for measuring CO2 concentration in the off gas above the medium M1 of the bioreactor 104, Eisenkraetzer, Fig. 1, para. [0289], [0291], [0293], [0373]),
a source of a gas mixture comprising CO2 fluidly connected to the enclosed reactor (the bioreactor 104 is coupled to another pipe or hose for transferring CO2 gas into the bioreactor 104, Eisenkraetzer, Figs. 1 & 3, para. [0290], [0305]);
a temperature control subsystem configured to control temperature of the fluid within the reactor (the temperature of the first bioreactor 104 can be controlled and adapted, Eisenkraetzer, Fig. 1, para. [0150], [0290], [0304]); and
a controller operably connected to the pH sensor and the CO2 sensor (a comparison unit 130 and control unit 132 operably connected to the pH measuring device 108 and the CO2 off gas analyzer 124, Eisenkraetzer, Fig. 1, para. [0284], [0289], [0301], [0303]), the controller being configured to:
calculate a pH value from a CO2 concentration measurement obtained by the CO2 sensor with a calibration curve for the buffer (a storage medium 114 comprises a data structure 136 indicative of a pH-CO2 concentration relation for the buffer medium M1 contained in the bioreactor 104 since the CO2 concentration in the gas above the buffer medium M1 has an impact on the pH value of the buffer medium M1, and the comparison unit 130 uses the received CO2 concentration measurement value and the medium-specific relation 136 of the buffer medium M1 to determine if the pH measuring device outputs a correct absolute pH value, Eisenkraetzer, Fig. 1, para. [0287], [0289], [0291], [0302]; a curve 502 is fitted to the plot to determine the medium-specific relation 136 used as input by the comparison unit 130 for predicting the absolute pH value of the buffer medium M1 given a measured CO2 off gas concentration, Eisenkraetzer, Figs. 4D & 5, para. [0316]-[0317]).
Eisenkraetzer teaches a pH signal obtained by the pH sensor (the pH measuring device 108 measures a pH of the medium M1 within the bioreactor 104, Eisenkraetzer, Fig. 1, para. [0011], [0291], [0295]), and the pH value (the predicted absolute pH value of the medium M1 given the measured CO2 off gas concentration, Eisenkraetzer, Figs. 4D & 5, para. [0316]-[0317]). Eisenkraetzer teaches that the absolute pH value can be used for calibrating the pH measuring device by the comparison unit 130 and/or the control unit 132 (Eisenkraetzer, para. [0207], [0303]). Eisenkraetzer fails to teach the controller being configured to calculate a calibration parameter for the pH sensor from a pH signal obtained by the pH sensor and the pH value with a calibration curve for the pH sensor, and calibrate the pH sensor with the calibration parameter.
Wong teaches calibrating a pH sensor in a calibration solution using an analyzer (Wong, abstract, col. 5, lns. 58-59, col. 6, lns. 27-36). Wong teaches that the pH of the calibrant varies in a predetermined fashion with the calibrant's partial pressure of CO2 (Wong, col. 8, lns. 10-18). Wong teaches that CO2 partial pressure and pH are subject to variation from their initial values because CO2 escapes from the solution over time (Wong, col. 5, lns, 5-9). Wong teaches that the pH sensor is calibrated by exposing the pH sensor to the calibration solution, whereupon the pH sensor produces a calibration solution pH signal, and the pH of the calibration solution supplied to the pH sensor is calculated based on the expected escape of CO2 from the container over time (Wong, col. 5, lns. 28-35). Wong teaches that the calculated pH is then compared with the calibration solution pH signal actually produced by the pH sensor, to produce a pH calibration factor (Wong, col. 5, lns. 35-38). Wong teaches that the pH sensor also is exposed to the test fluid, whereupon the sensor produces a test fluid pH signal, and finally, the test fluid pH signal is adjusted in accordance with the pH calibration factor (Wong, col. 5, lns. 38-41).
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 comparison unit 130 and control unit 132 of Eisenkraetzer to calculate a pH calibration factor from the pH signal and the calculated (predicted) pH value and then calibrate the pH sensor in accordance with the pH calibration factor as taught by Wong because it would properly characterize and calibrate the pH sensor sensitivity so that the signals they produce have the requisite degree of accuracy (Wong, col. 6, lns. 27-36). MPEP § 2143(I)(C), 2143(I)(D).
The limitations “connectable to a source of a buffer,” “measure pH of a fluid within the reactor,” and “measure CO2 concentration within the reactor” 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 bioreactor system disclosed by Modified Eisenkraetzer 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 2, Modified Eisenkraetzer teaches wherein the enclosed reactor is a microbioreactor (the bioreactor 104 has a size of milliliters for microorganisms, Eisenkraetzer, Fig. 1, para. [0252], [0269], [0290]).
Regarding claim 3, Modified Eisenkraetzer teaches the enclosed reactor (the bioreactor 104, Eisenkraetzer, Fig. 1, para. [0290]), but fails to teach wherein the enclosed reactor is sterile.
Another embodiment of Eisenkraetzer teaches autoclaving the bioreactor (Eisenkraetzer, para. [0354]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Modified Eisenkraetzer to include autoclaving the bioreactor as taught by another embodiment of Eisenkraetzer because it can ensure sterilization of the equipment and materials to prevent contamination. Therefore, Modified Eisenkraetzer teaches that the bioreactor is sterilized.
Regarding claim 4, Modified Eisenkraetzer teaches wherein the enclosed reactor is fluidly connectable to a source of a humidification solution (the bioreactor 104 is coupled to a pipe or hose for transferring one or more further liquids including a water-based solution into the bioreactor 104, Eisenkraetzer, Figs. 1 & 3, para. [0269], [0290], [0305]).
The limitation “connectable to a source of a humidification solution” 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 bioreactor system disclosed by Modified Eisenkraetzer 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 5, Modified Eisenkraetzer teaches wherein the CO2 sensor is positioned to measure CO2 concentration of a headspace gas within the enclosed reactor (the CO2 off gas analyzer 124 for measuring CO2 concentration in the off gas above the medium M1 of the bioreactor 104, Eisenkraetzer, Fig. 1, para. [0289], [0291], [0293], [0373]).
The limitation “measure CO2 concentration of a headspace gas within the enclosed reactor” 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 CO2 off gas analyzer disclosed by Modified Eisenkraetzer 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 6, Modified Eisenkraetzer teaches wherein the controller is operably connected to at least one of the source of the buffer and the source of the gas mixture, and further configured to introduce at least one of the buffer and the gas mixture into the enclosed reactor (the control unit 132 controls the state of the bioreactor 104 by modifying the CO2 gas influx rate and the influx of the liquids into the bioreactor 104, Eisenkraetzer, Fig. 1, para. [0094], [0177], [0284], [0301]).
Regarding claim 7, Modified Eisenkraetzer teaches that the pH can be computed as pH=log10(
K
*
[
C
O
2
(
a
q
)
]
)
(Eisenkraetzer, para. [0055]). Modified Eisenkraetzer teaches the calibration curve for the buffer (a curve 502 is fitted to the plot to determine the medium-specific relation 136 used as input by the comparison unit 130 for predicting the absolute pH value of the medium M1 given a measured CO2 off gas concentration, Eisenkraetzer, Figs. 4D & 5, para. [0316]-[0317]). Modified Eisenkraetzer teaches that the medium-specific relation 136 of medium M1 is an equation PPH(pH) = REL - M1(CO2) obtained by mathematically fitting multiple empirically determined pairs of a pH-value and a respective CO2 concentration [%] in the gas phase above said medium (Eisenkraetzer, Figs. 4D & 5, para. [0321]). Modified Eisenkraetzer teaches that REL-M1 is a set of one or more parameters connected by operators that are derived from the fitted curve (Eisenkraetzer, Figs. 4D & 5, para. [0324]-[0326]). Modified Eisenkraetzer does not explicitly teach wherein the controller is configured to calculate parameters A, B, and C in the calibration curve for the buffer having a formula in the form of: pHfit = A + B*log10(C+CO2perc) where A, B, and C are fitting parameters and CO2perc is the measured CO2 concentration as a percentage the headspace gas total composition.
However, Eisenkraetzer teaches that the curve 502 is fitted to determine the medium- specific relation PPH(pH) = REL - M1(CO2) for predicting the absolute pH value of the medium M1 given a measured CO2 off gas concentration, where REL-M1 is a set of one or more parameters connected by operators that are derived from the fitted curve (Eisenkraetzer, Figs. 4D & 5, para. [0316]-[0317], [0324]-[0326]). In other words, the relationship between the pH of the medium M1 and the concentration of the CO2 off gas was known because Eisenkraetzer teaches fitting the pH vs. CO2 concentration [%] curve in Fig. 5 (Eisenkraetzer, para. [0321]-[0322], [0324]), which is the same fit as shown in Figs. 4B, 5A, and 5B of the instant application (see para. [0147]-[0148] of the instant US PGPub). Examiner asserts that fitting the same curve would lead to the same equation, so the fitted curve taught by Eisenkraetzer would be described by the claimed equation and its fitting parameters. Although the claimed equation is not explicitly disclosed by Eisenkraetzer for Fig. 5, the disclosed fitted curve in Fig. 5 of Eisenkraetzer would be described by the claimed equation. Therefore, the claimed equation and its fitting parameters would naturally flow from the fitted curve 502 of Fig. 5 of Eisenkraetzer.
Regarding claim 8, Modified Eisenkraetzer teaches a pH signal obtained by the pH sensor (the pH measuring device 108 measures a pH of the medium M1 within the bioreactor 104, Eisenkraetzer, Fig. 1, para. [0011], [0291], [0295]), and the pH value (the predicted absolute pH value of the medium M1 given the measured CO2 off gas concentration, Eisenkraetzer, Figs. 4D & 5, para. [0316]-[0317]). Modified Eisenkraetzer teaches that the comparison unit 130 and control unit 132 calculate a pH calibration factor from the pH signal and the calculated (predicted) pH value and then calibrate the pH measuring device in accordance with the pH calibration factor (Eisenkraetzer, para. [0207], [0303], Wong, col. 5, lns. 28-41, see modification supra). Modified Eisenkraetzer does not explicitly teach wherein the controller is configured to calculate parameters W, X, Y, and Z in the calibration curve for the pH sensor having a formula in the form of: pHsensor = (log2(S-W) – log2(X-S))*Y + Z, where W, X, Y, and Z are fitting parameters and S is the pH sensor signal.
However, Modified Eisenkraetzer teaches that the comparison unit 130 and control unit 132 calculate a pH calibration factor from the pH signal and the calculated (predicted) pH value and then calibrate the pH measuring device in accordance with the pH calibration factor (Eisenkraetzer, para. [0207], [0303], Wong, col. 5, lns. 28-41, see modification supra). In other words, the relationship between the measured pH signal and the calculated (predicted) pH value was known because Modified Eisenkraetzer teaches calculating a pH calibration factor from the pH signal and the calculated (predicted) pH value (Eisenkraetzer, para. [0207], [0303], Wong, col. 5, lns. 28-41, see modification supra). Examiner asserts that calculating the pH calibration factor from the pH signal and the calculated (predicted) pH value would lead to the same equation as claimed, so the calculations taught by Modified Eisenkraetzer would be described by the claimed equation and its fitting parameters. Although the claimed equation is not explicitly disclosed by Modified Eisenkraetzer, the disclosed calculations taught by Modified Eisenkraetzer would be described by the claimed equation. Therefore, the claimed equation and its fitting parameters would naturally flow from the teachings of Modified Eisenkraetzer.
Conclusion
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794
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