DETAILED ACTION
Applicant’s response, filed 28 Oct. 2025 and entered 28 Jan. 2026 has 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.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 Jan. 2026 has been entered.
Status of Claims
Claims 1-20 are pending.
Claims 1-20 are rejected.
Claims 1, 13, and 19 are objected to.
Priority
Accordingly, the effective filing date of claims 1-20 is 12 Sept. 2009.
Claim Objections
The objection to claim 20 in the Office action mailed 28 July 2025 has been withdrawn in view of claim amendments received 28 Oct. 2025.
Claims 1, 13, and 19 are objected to because of the following informalities. This objection is newly recited and necessitated by claim amendment.
Claims 1, 13, and 19 recite “at least one operating parameter of the apparatus…” in the last limitation of the claim, which should be amended to recite “of the reaction apparatus” to use consistent language and increase clarity.
Appropriate correction is required.
Claim Interpretation - 35 USC § 112 (pre-AIA ), sixth paragraph
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 limitations are:
“a property value receiver…configured to receive the plurality of values…” in claims 1-2;
a linear function calculator…configured to calculate a linear function…” in claims 1-2;
“a difference calculator…configured to calculate a difference between….” in claims 1-2;
“a transition point identifier…configured to identify at least one transition point…” in claims 1-2;
“a control operation initiator…configured to dynamically adjust at least one operating parameter of the apparatus in real time…”. in claims 1-2.
“a monitoring data generator…configured to generate monitoring data…” in claim 11
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.
In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239.
The structure for the above means-plus function limitations in the specification are as follows:
Regarding the physical structure for the property value receiver, linear function calculator, difference calculator, and transition point identifier in claims 1-2, Applicant’s specification at FIG. 1, and pg. 12, lines 19-25 discloses these are modules of the apparatus 1000, and that the apparatus 1000 is implemented using electric circuits, computer instructions, etc., and may be implemented on a dedicated computer. Therefore, the hardware for these limitations will be interpreted to be a computer.
Regarding the “property value receiver…configured to receive”, Applicant’s specification at pg. 9, line 5 discloses the apparatus 1000 includes a property value receiver. Because receiving data is a function ‘coextensive’ with a microprocessor itself, the specification need not disclose any special programming to perform the recited function. See MPEP 2181 II. B.
Regarding the “linear function calculator”, the algorithm for the linear function is recited in the claims and also disclosed in Applicant’s specification at pg. 13, lines 3 to 19. Therefore, the linear function calculator is interpreted to be a computer configured to select a predefined time period and calculating a linear function between the two values pertaining to the start and end of the selected time period.
Regarding the “transition point identifier”, Applicant’s specification at pg. 10, lines 14-32 discloses the transition point identifier identifies transition points by finding points where the difference between the linear function and the received values is maximal or minimal, were the value starts increasing substantially exponentially, stops increasing substantially exponentially, starts decreasing substantially exponentially, or stops decreasing substantially exponentially. Thus the transition point identifier is interpreted to be a computer programmed by this algorithm, including equivalents thereof.
Regarding the “difference calculator”, the algorithm for the difference calculator is discussed at pg. 13, lines 15 to 19, and pg. 15, lines 26-30, to calculate a difference between the linear function and two or more received values in the selected time period of the linear function calculator.
Regarding the control operation initiator, Applicant’s specification at pg. 11, lines 5-11 discloses the apparatus 1000 includes the control operation initiator, and the control operation initiator initiates a control operation not limited to initiating cooling of a chamber where the chemical reaction takes place, opening a pressure valve, or instruction a PCR robot to stop rotating, etc. Given the apparatus 1000 is a computer, as discussed above, the control operation initiator is interpreted to output/transmit instructions (i.e. initiate the control operation) to dynamically adjust at least one operating parameter, which is a function ‘coextensive’ with a microprocessor itself, and thus does not require any special programming to perform the recited function. See MPEP 2181 II. B.
Regarding the monitoring data generator, Applicant’s specification at pg. 11, lines 12-20 discloses the apparatus 1000 further includes the monitoring data generator, and the monitoring data generator further presents the generated data to a user using a computer screen. Therefore, the hardware for the monitoring data generator is also interpreted to be a computer with a screen. However, Applicant’s specification does not disclose an algorithm for how the monitoring data is generated by the monitoring data generator, and instead merely repeats the function recited in the claims.
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 Interpretation
Claims 13 and 19 recite “initiating a control operation configured to dynamically adjust at least one operating parameter of the apparatus in real time upon said identifying of the transition point” and “initiating a control operation comprising dynamically adjusting at least one operating parameter of the apparatus in real time…”. The claims only require “initiating” a control operation that comprises dynamically adjusting an operating parameter, and claim 19 recites the step is stored as instructions in a non-transitory computer readable medium and is executed by a computer. Therefore, the limitation is interpreted to encompass a computer transmitting instructions (i.e. initiating) the control operation of dynamically adjusting the at least one operating parameter.
Claim Rejections - 35 USC § 112 (pre-AIA ), first paragraph
The rejection of claims 8-10 under 35 U.S.C. (pre-AIA ), first paragraph in the Office action mailed 28 July 2025 has been withdrawn in view of claim amendments received 28 Oct. 2025.
Claim Rejections - 35 USC § 112 (pre-AIA ), second paragraph
The rejection of claims 8-10 under 35 U.S.C. (pre-AIA ), second paragraph in the Office action mailed 28 July 2025 has been withdrawn in view of claim amendments received 28 Oct. 2025.
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 1-20 are rejected under 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 pre-AIA the applicant regards as the invention. This rejection is newly recited after further consideration of the claims and/or necessitated by claim amendment.
Claims 1-2, 13, and 19, and claims dependent therefrom, are indefinite for recitation of “upon the transition point being identified” in the last line of the claims. The claims previously recite identifying “at least one transition point”. As a result, in embodiments in which there are multiple transition points, it is unclear which transition point, “the transition point” is referring to. For purpose of examination, the limitation is interpreted to mean “upon the at least one transition point being identified”.
Claims 1-2, 13, and 19, and claims dependent therefrom, recite “a control operation initiator…configured to dynamically adjust at least one operating parameter…” in claims 1-2, “a control operation configured to dynamically adjust at least one operating parameter” in claim 13 and “a control operation comprising dynamically adjusting at least one operating parameter…” in claim 19. The plain meaning of the term “dynamically” means in a manner characterized by constant change, activity, or progress. However, the claims only require changing on operating parameter of a reaction apparatus a single time upon the transition point being identified, and specify this occurs “in real time” which is interpreted to mean immediately upon the transition point being identified. Therefore, it is unclear what embodiments of adjusting a single operating parameter in real time are intended to fall within the metes and bounds of “dynamically adjusting at least one operating parameter…in real time”, and it is unclear in what way dynamically adjusting a parameter is intended to be different than simply adjusting the parameter in real time. Furthermore, a review of the specification does not serve to clarify the metes and bounds of the term, as the specification does not mention “dynamically”. For purpose of examination, the limitation is interpreted to mean that the control operation is configured to adjust at least one operating parameter of the reaction apparatus in real time.
Claim 2, and claims dependent therefrom, are indefinite for recitation of “a control operation initiator…configured to dynamically adjust at least one parameter of the apparatus in real time upon the transition point being identified…”. Claim 2 recites “An apparatus for identifying…., the apparatus comprising:…a property value receiver…configured to receive values…from a reaction apparatus”. Therefore, it is unclear if “the apparatus” in the control operation initiator is referring to the apparatus of claim 2 or the chemical reaction apparatus from which the received plurality of values originate. If Applicant intends for the apparatus to refer to the apparatus of claim 2, it is further unclear if Applicant intends for: (1) the apparatus of claim 2 to also include a reaction apparatus (like in claim 1), such that an operating parameter of the apparatus may be adjusted; or (2) if Applicant intends to adjust some data parameter of a computer (Apparatus #1000 in FIG. 2). As such, the metes and bounds of the claims are unclear. It is noted that Applicant’s specification at FIG. 2 and [0080] discloses that the control initiator initiates a control operation such as cooling a chamber where the chemical reaction takes place, opening a pressure valve, etc., such that the adjusted parameter is of a chemical reaction apparatus (#2000 in FIG. 2). Therefore, for purpose of examination, the limitation will be interpreted to mean that the control operation initiator is configured to dynamically adjust at least one operating parameter of the chemical reaction apparatus, but the chemical reaction apparatus is not required to be part of the claimed system, and thus claim 2 only requires the control operation initiator transmits data to the chemical reaction apparatus outside the metes and bounds of the claimed apparatus, similar to the interpretation of claims 13 and 19 above.
Response to Arguments
Applicant's arguments filed 28 Oct. 2025 regarding 35 U.S.C. 112(pre-AIA ), second paragraph have been fully considered but they are not persuasive because they do not pertain to the new grounds of rejection set forth above.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Any newly recited portions is newly recited and necessitated by claim amendment.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claims 1-2, 13, and 19 being representative) is directed to a system, method, and product. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claims 1-2, 13, and 19 recite the following steps which fall under the mathematical concepts and mental processes groupings of abstract ideas:
calculate/calculating a linear function spanning over at least a part of the chemical reaction, the at least a part of the chemical reaction spanning over a predefined time period having a start and end, the linear function connecting two of the received values, the two values pertaining to the start and end of the time period, the linear function having a first value pertaining to the start of the time period and being a same value as the received value pertaining to the start of the time period, and a second value pertaining to the end of the time period and being a same value as the received value pertaining to the end of the time period;
calculate/calculating a difference between the linear function and a plurality of the received values pertaining to the part; and
identify/identifying at least one transition point of the chemical reaction within the part, using the calculated difference; and
The identified claim limitations falls into one of the groups of abstract ideas of mathematical and mental processes for the following reasons. In this case, calculating a linear function spanning at least two data points can be performed mentally aided with pen and paper by merely fitting numerical values spanning time points using a linear equation, y = mx + b. Calculating a linear function spanning data points over a time period further recites a mathematical calculation and mathematical relationship. In addition, calculating a difference between points can be performed mentally by performing subtraction between two numerical values; furthermore, calculating a difference/performing subtraction also recites a mathematical calculation. Last, the step of identifying a transition point involves analyzing the calculating differences to identify a minimum or maximum difference (see claim interpretation above), which can be performed mentally and also represents a mathematical relationship. Furthermore, other than reciting these limitations are performed by a computer, nothing in the claims precludes the steps from being practically performed in the mind. Therefore, these limitations both recite a mental process and mathematical concept. See MPEP 2106.04(a)(2) I. and III.
Dependent claims 3-11 and 14-17 further recite an abstract idea and/or are part of the abstract idea of the independent claims. Dependent claim 3 further limits the values being analyzed to be photometric measurement values. Dependent claims 4-7 further limit the mental process and mathematical concept of identifying the transition point of claim 2. Dependent claims 8-10 and 14-16 further recite a mental process of indicating a particular phase of the chemical reaction upon identifying the transition point, which involves analyzing the measurement values and transition point to determine the appropriate phase of the reaction. Dependent claims 11 and 17 further recite the mental process of generating monitoring data based on the identified transition point, which encompasses selecting data to be monitored based on the transition point. Therefore, claims 1-20 recite an abstract idea. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
Dependent claims 4-7 and 14-16 do not recite any elements in addition to the judicial exception, and thus are part of the judicial exception.
The additional elements of independent claims 1-2, 13, and 19 include:
a reaction apparatus, comprising at least one sensor configured to measure a plurality of values of a physical property of a chemical reaction (claim 1);
an electronic computing device (in communication with said reaction apparatus in claim 1) configured to process data (claims 1-2);
a computer (claim 13);
a non-transitory computer readable medium (i.e. memory) (claim 19);
a property value receiver, a linear function calculator, a difference calculator, a transition point identifier, and a control operation initiator (i.e. a computer, as discussed in claim interpretation) (claims 1-2);
receive/receiving a plurality of values of a physical property of the chemical reaction from a reaction apparatus (claims 1-2, 13, and 19);
a control operation initiator…configured to dynamically adjust at least one operating parameter of the [reaction] apparatus in real time upon the transition point being identified (claims 1-2); and
initiating a control operation configured to/comprising dynamically adjust/adjusting at least one operating parameter of the [reaction] apparatus in real time upon the transition point being identified (i.e. transmitting data, as discussed in claim interpretation) (claim 13 and 19);
The additional elements of claims 8-11 include “a computer/processor” and “monitoring data generator”, which are interpreted to be a computer and part of the computer of claim 2, respectively above.
The additional elements of dependent claims 11-12, 17-18, and 20 include:
a measurement device, associated with said property value receiver, configured to measure values of the physical property (claim 12);
present/presenting monitoring data to a user of the reaction apparatus (i.e. displaying data) (claims 11 and 17);
measuring the values of the physical property (claim 18); and
instructing a robot based on the identified transition point (i.e. transmitting data) (claim 20).
First, the reaction apparatus and measurement device configured to measure values of a physical property of a chemical reaction (claims 1 and 12), receiving the plurality of values of the physical property of the chemical reaction (claims 1-2, 13, and 19), and measuring values of the physical property (claim 18) only serves to collect data for use by the abstract idea. Similarly, the step of presenting monitoring data in claims 11 and 17 only serves to output data generated by the abstract idea. Therefore, these limitations amount to necessary data gathering and outputting and thus are insignificant extra-solution activity. See MPEP 2106.05(g).
Furthermore, the additional elements of the computer or electronic computing device that carries out the abstract idea, the computer readable medium (memory) storing instructions), receiving data, transmitting data (i.e. to initiate a control operation), and displaying data are generic computer components and/or functions. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f).
The additional element of a control operation initiator configured to dynamically adjust at least one operating parameter of the reaction apparatus in real time upon the at least one transition point being identified in claims 1-2 is not sufficient to integrate the recited judicial exception into a practical application for the following reasons:
First, as discussed above in the 35 U.S.C. (pre-AIA ), second paragraph rejection of claim 2, the limitation is interpreted to mean that the control operation initiator transmits instructions configured to dynamically adjust an operating parameter to a reaction apparatus outside the metes and bounds of the claimed apparatus. Claim 2 does not require that the apparatus includes a reaction apparatus that receives any control signals from the control operation initiator. As discussed above, the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f).
With respect to claim 1, claim 1 requires that the chemical reaction system includes “a reaction apparatus” and the control operation initiator is configured to dynamically adjust an operating parameter of the reaction apparatus in real time (i.e. transmit a control instruction to the reaction apparatus during a reaction). Therefore, the system of claim 1 is configured to use a control operation initiator to adjust an operating parameter of the reaction apparatus of the system. However, the limitation is not sufficient to integrate the recited judicial exception into a practical application, including the practical application of applying the judicial exception by a particular machine, because it amounts to mere instructions to apply the exception. MPEP 2106.05(b) states that Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)) when making a determination of whether an element (or combination of elements) is a particular machine, and further states the particularity or generality of the elements of the machine or apparatus are relevant to whether a claim integrates a judicial exception by a particular machine.
In the instant case, the “chemical reaction system” comprising a reaction apparatus and a generic computer encompasses any type of reaction apparatus, ranging from a PCR system, a chemical synthesis apparatus, a flow reactor, etc. Therefore, the system of claim 1 is not particular, and instead encompasses any apparatus capable of carrying out a chemical reaction. Furthermore, under 35 U.S.C. 112(f) with respect to the control operation initiators, Applicant’s specification at para. [0080], discloses that the control operation (e.g. an operation parameter) may include “initiating a cooling chamber where the chemical reaction takes place, opening of a pressure valve of a reaction chamber, instructing a PCR Robot to stop rotation, etc., as known in the art”. However, the claims provide no detail on how the identified transition point actually relates to the control of the reaction apparatus. That claims do not specify what the chemical reaction is, what the transition point is, and how the adjusted operating parameter relates to the chemical reaction and/or transition point. For example, the claims encompass identifying a transition to an exponential phase in a PCR reaction, and then opening any pressure valve of a reaction chamber. Therefore, the claims simply recite the idea of a solution of controlling a reaction apparatus but fails to recite details of how the control of the reaction apparatus is accomplished. See MPEP 2106.05(f).
Regarding the step of “initiating a control operation configured to/comprising adjust/adjusting at least one operating parameter of the [reaction] apparatus in real time…” in claims 13 and 19 and also “instructing a robot” in claim 20, the limitations encompass simply transmitting data to initiate a control operation or instruct a robot, which does not integrate the recited judicial exception into a practical application for the same reasons discussed above for claim 2. Furthermore, even if the claims did include an active step of adjusting an operating parameter or instructing a robot, this would be mere instructions to apply an exception in a generic way. Similar to the reasons discussed above for claim 1, the claims provide no detail on how the operation or robot would be controlled, and furthermore, do not provide any detail on how the judicial exception is applied to control the operation and/or robot. Instead, the claims only recite the idea of an outcome of controlling an operation or robot, without reciting details on how the outcome is accomplished. See MPEP 2106.05(f).
Therefore, the additionally recited elements amount to insignificant extra-solution activity and/or mere instructions to apply an exception, as such, the claims as a whole do no integrate the abstract idea into practical application. Thus, claims 1-20 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05.
The additional elements of the claims are identified above.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception for the following reasons.
First, the additional elements of a reaction apparatus and measurement device configured to measure values of a physical property of a chemical reaction (claims 1 and 12) and measuring values of the physical property (claim 18) are well-understood, routine and conventional. This position is supported by Applicant’s own specification at pg. 8, which discloses a Polymerase chain reaction apparatus are known in the art, at pg. 8, lines 19-32, and that photometric sensors that measure emission of light from a reaction chamber of a PCR include standard fluorescence methods known in the art at pg. 11, lines 27 to pg. 12, para. 2). Applicant’s specification at pg. 2, lines 3-8 further discloses that two common methods for QF-PCR include using fluorescent dyes and modified DNA probes. Thus Applicant’s specification demonstrates the conventionality of using a PCR apparatus to measure values of a chemical reaction.
The additional elements of the computer or electronic computing device that carries out the abstract idea, the computer readable medium (memory) storing instructions), receiving data, and transmitting data (i.e. to initiate a control operation configured to adjust an operating parameter) are conventional computer components and/or functions. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Last, a system comprising a reaction apparatus and a control operation initiator that controls/adjusts an operating parameter of the reaction apparatus in real time is well-understood, routine, and conventional. This position is supported by Applicant’s own specification and Hussain et al. (Review of the applications of neural networks in chemical processes control- simulating and online implementation, 1999, Artificial Intelligence in Engineering, pg. 55-68; newly cited). Applicant’s specification at para. [0080] discloses that control operations may include initiating cooling of a reaction chamber, opening a pressure valve of a reaction chamber, instructing a PCR robot to stop rotating, as known in the art, and further discloses at para. [0119] that computers connectable to a laboratory device such as a PCR apparatus are known in the art. Furthermore, Hussain reviews the applications of artificial intelligence in controlling chemical processes (Abstract), and discloses nonlinear control occupies an increasingly important position in process control engineering (pg. 55, col. 1, para. 1), and applications utilizing neural-network based control strategies typically involve chemical process systems, including stirred tank reactors and bioreactors (pg. 56, col. 2, para. 2). Hussain explains that these control strategies incorporate feedback in the predictive control scheme by using the measurements of the reaction to update an optimization problem for a next step, and then implements a control action on the reaction system (pg. 57, col. 1, para. 3; Fig. 1; Table 1-2).
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). 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. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106.
Response to Arguments
Applicant's arguments filed 28 Oct. 2025 regarding 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant remarks that claims 1-2, 13, and 19 have been amended to clarify that the identified transition points are used by a control operation to adjust an operating parameter of a reaction apparatus in real time upon identification of a transition point, and thus the claims apply the computational results to actively and dynamically control a physical process as it occurs, and the claims are directed to a practical technological process rather than an abstract computation (Applicant’s remarks at pg. 8, para. 5 to pg. 9, para. 2).
This argument is not persuasive. First, with respect to claims 13 and 19, the claims recite “initiating a control operation configured to dynamically adjust” and “initiating a control operation comprising dynamically adjusting…”, respectively. Therefore, the claims do not require actually carrying out a control operation to adjust an operating parameter of the reaction apparatus, and instead only require “initiating” the control operation, which is interpreted to encompass simply transmitting instructions for the control operation. This position is supported by claim 19, which recites the step is stored as instructions in a non-transitory computer readable medium that are carried out by a generic computer. Claim 2 has been interpreted similarly to claims 13 and 19 in only requiring the transmitting of instructions to dynamically adjust an operating parameter, since the apparatus of claim 2 does not actually comprise the reaction apparatus.
With respect to claim 1, claim 1 does require the chemical reaction system comprises both the reaction apparatus and the control operation initiator. Therefore, given the control operation initiator is interpreted to transmit signals configured to dynamically adjust an operating parameter of the reaction apparatus (see 112(f) interpretation above) and the reaction apparatus is part of the system, the system of claim 1 is configured to adjust an operating parameter of the reaction apparatus. However, for the reasons discussed in the above rejection, the limitation is not sufficient to integrate the recited judicial exception into a practical application because the reaction apparatus is not a particular machine, and instead the limitation amounts to mere instructions to apply the exception because the claim attempts to cover any solution to a problem with no restriction on how the result is accomplished (e.g. adjusting any operating parameter of any chemical reaction based on any transition point of the reaction). Therefore, it is further noted that even if claims 2, 13, and 19 were amended such that the adjusting of a control operating parameter is actively required by the claims, this would not be sufficient to overcome the rejection for the same reasons applied to claim 1 above.
Last, it is noted that Applicant’s arguments regarding adjusting an operating parameter during the chemical reaction do not appear commensurate with the scope of the claims. While the claims were amended to recite “dynamically adjust” and “in real time upon identifying of the transition point”, there is no requirement that the chemical reaction is still ongoing. Instead, the claims encompass analyzing data from an already completed chemical reaction, and then adjusting an operating parameter of the apparatus immediately (in real time) once a transition point is identified in the data of the chemical reaction. As discussed above under 35 U.S.C. 112(b), the meaning of “dynamically adjust” in the context of the independent claims is not clear. If Applicant intends to require dynamic adjusts of operating parameters of a reaction apparatus during a chemical reactions, the claims should be amended to reflect this is appropriately supported by Applicant’s specification. However, the limitations would still amount to mere instructions to apply the exception in a generic way for the reasons discussed above.
Terminal Disclaimer
A terminal disclaimer between App. 15/968,429, now U.S. Patent 12,467,084 B2 and the instant application was filed and approved 08 Aug. 2023 in App. 15/968,429 (now issued).
Double Patenting
The provisional rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-20 of copending Application No. 15/968,429 (reference application) in view of Ward (2007) in the previous Office action has been withdrawn in view of the terminal disclaimer filed and approved 08 Aug. 2023 in App. 15/968,429 (now issued).
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. US 11,072,821 B2. Any newly recited portion is necessitated by claim amendment.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claim 1, reference claim 1 discloses the exact limitations of instant claim 1, except reference claim 1 anticipates the broader instant claim 1 by requiring the reaction apparatus is a “PCR reaction apparatus” and the chemical reaction is a “PCR process”. While reference claim 1 does not specify the adjusting is “in real time”, MPEP 2144.04 III states broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
Regarding instant claim 2, reference claim 3 discloses the exact limitations of instant claim 2, except reference claim 3 anticipates the broader instant claim 2 by requiring the chemical reaction of the reaction apparatus is a “PCR process” from a PCR reaction apparatus.
Regarding instant claims 3-12, reference claim 4-13 respectively disclose the exact limitations of instant claims 3-12.
Regarding instant claim 13, reference claim 14 discloses the exact limitations of instant claim 13, except reference claim 14 anticipates the broader instant claim 13 by requiring the chemical reaction of the reaction apparatus is a “PCR process” from a PCR reaction apparatus.
Regarding instant claims 14-18, reference claims 20-24 respectively disclose the exact limitations of instant claims 14-18.
Regarding instant claims 19-20, reference claims 25-26 disclose the exact limitations of instant claims 19-20, but are narrower and thus anticipate instant claims 19-20 by requiring the received plurality of values are for a PCR process of a PCR reaction apparatus.
Response to Arguments
Applicant's arguments filed 28 Oct. 2025 regarding the double patenting rejections have been fully considered but they are not persuasive.
Applicant remarks that Applicant disagrees with the rejections, but to advance prosecution, terminal disclaimers with respect to the two cited applications have been filed (Applicant’s remarks at pg. 9, para. 3).
This argument is not persuasive because no Terminal Disclaimer has been filed for the U.S. Patent in the above outstanding rejection.
Conclusion
No claims are allowed.
Claims 1-20 are free of the prior art for the reasons discussed in the Office action mailed 11 March 2025.
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/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685