DETAILED ACTION
The Applicant’s response, received 08 July 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, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 16-19 and 22-33 are pending.
Claims 16-19 and 22-33 are rejected.
Priority
This application is a 371 of PCT/EP2021/060289, filed 21 April 2021,
which claims benefit of foreign application:
EUROPEAN PATENT OFFICE (EPO) 20171236.1, filed 24 April 2020.
Drawings
The objections to the drawings in the Office action mailed 08 April 2026 have been withdrawn in view of the amendment received 08 July 2026.
The replacement drawings received 08 July 2026 have been accepted.
Specification
The substitute specification received 08 July 2026 has been accepted. The substitute specification has been provided to show the amendments to the drawings.
Claim Objections
The claim advisory regarding claim 20 being a substantial duplicate of claim 19 in the Office action mailed 08 April 2026 has been withdrawn in view of the amendment received 08 July 2026, as noted below.
The objection has been withdrawn in view of claim 20 having been canceled in the amendment.
Claim Interpretation
The claim limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, in the Office action mailed 08 April 2026 have been maintained in view of the amendment received 08 July 2026.
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) are:
a retrieving module configured to …, in claims 24, 25, 26, 27, and 28; and
a computing module configured to …, in claims 24, 25, 26, 27, 28, and 31.
Because these claim limitation(s) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The written description discloses a corresponding structure for:
a retrieving module configured to …, in claims 24, 25, 26, 27, and 28 (i.e., “program modules” (e.g., software) at page 62, lines 1-10, in the Specification; and “the computer system may particularly comprise a memory and a processor (i.e., hardware) to operate the modules” at page 56, lines 23-24); and
a computing module configured to …, in claims 24, 25, 26, 27, 28, and 31, (i.e., “program modules” (e.g., software) at page 62, lines 1-10, in the Specification; and “the computer system may particularly comprise a memory and a processor (i.e., hardware) to operate the modules” at page 56, lines 23-24).
If applicant does not intend to have 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 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 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 rejection of claims 17, 25, and 27 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, in the Office action mailed 08 April 2026 has been maintained in view of the amendment received 08 July 2026, as noted below.
Claims 17 and 25 contain the trademark/trade name “akin”.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17, 25, and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 17 and 25 contain the trademark/trade name “akin”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name “akin” is used to identify/describe data and, accordingly, the identification/description is indefinite.
Claim 27 is indefinite for depending from claim 25 and for failing to remedy the indefiniteness of claim 25.
Response to Arguments
The Applicant’s arguments/remarks received 08 July 2026 have been fully considered, but are not persuasive.
The Applicant states on page 12 (as filed) of the Remarks that the term “akin” is not used in the claims as a trademark or trade name, and it is not used to identify a source of goods, but rather, “akin” is used as an ordinary adjective meaning similar or related, and that this usage is consistent with the claim language itself. The Applicant further states that a person of ordinary skill in the art would understand “akin” in the claims to mean similar or related, not as a trademark or trade name.
These arguments/remarks are not persuasive, because claims 17 and 25 contain the trademark/trade name “akin”, which is used to identify/describe data and, accordingly, the identification/description is indefinite, as noted in the above rejection. Given the argument/remark that the term “akin” is used as an ordinary adjective meaning similar or related, the Applicant is advised that a potential remedy to the indefiniteness rejection would be to amend the claims to recite either ‘similar’ or ‘related’ in place of the term ‘akin.’
Claim Rejections - 35 USC § 101
The rejection of claim 23 under 35 U.S.C. 101 at Step 1 in the Office action mailed 08 April 2026 because the claimed invention is directed to non-statutory subject matter has been withdrawn in view of the amendment received 08 July 2026.
The rejection of claims 16-31 under 35 U.S.C. 101 in the Office action mailed 08 April 2026 has been maintained with modification in view of the amendment received 08 July 2026, as noted below.
The rejection of claims 20 and 21 has been withdrawn in view of these claims having been canceled in the amendment.
The rejection has been modified to incorporate the claim amendments, as further noted below.
The rejection has been modified to incorporate newly added claims 32 and 33 and a reference to show conventionality at Step 2B in view of newly added claim 32.
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 16-19 and 22-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite: (a) mathematical concepts, (e.g., mathematical relationships, formulas or equations, mathematical calculations); and (b) mental processes, i.e., concepts performed in the human mind, (e.g., observation, evaluation, judgement, opinion).
Subject matter eligibility evaluation in accordance with MPEP 2106.
Eligibility Step 1: Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter?
Claims 16-19, 22, 32, and 33 recite a computer-implemented method (i.e., a process); claim 23 recites a non-transitory computer-readable storage medium comprising computer-readable instructions (i.e., a machine and/or a manufacture); and claims 24-31 recite a computer system (i.e., a machine and/or a manufacture).
Therefore, these claims are encompassed by the categories of statutory subject matter, and thus, satisfy the subject matter eligibility requirements under step 1.
[Step 1: YES]
Eligibility Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in Prong Two whether the recited judicial exception is integrated into a practical application of that exception.
Eligibility Step 2A Prong One: In determining whether a claim is directed to a judicial exception, examination is performed that analyzes whether the claim recites a judicial exception, i.e., whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim.
Independent claim 16 recites the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas:
selecting a recipe template composite and performing a first optimization step (i.e., mental processes and mathematical concepts)
comprising:
providing a set of input values for the at least one variable recipe parameter in the recipe template composite (i.e., mental processes);
performing a second optimization step providing a utility score (i.e., mental processes and mathematical concepts);
repeating the second optimization step for at least another set of input values, thereby obtaining a plurality of utility scores (i.e., mental processes and mathematical concepts);
identifying the optimal utility score from the plurality of utility scores (i.e., mental processes);
if only one recipe template composite was retrieved, selecting the set of input values that yields the optimal utility score together with the one recipe template composite as the at least one recipe for the production process (i.e., mental processes); or
if more than one recipe template composite was retrieved (i.e., mental processes):
repeating the first optimization step for each recipe template composite, thereby obtaining a plurality of optimal utility scores (i.e., mental processes and mathematical concepts);
identifying the best optimal utility score among the plurality of optimal utility scores (i.e., mental processes);
selecting the recipe template composite and the set of input values that yield the best optimal utility score as the at least one recipe for the production process (i.e., mental processes);
wherein:
the second optimization step comprises:
providing a set of likely values for the at least one variable evolution parameter based on the likelihood function (i.e., mental processes);
performing a third optimization step providing a utility tally (i.e., mental processes and mathematical concepts);
if there is at least another set of likely values that is suitable, repeating the third optimization step for the at least another set of likely values, thereby obtaining a plurality of utility tallies (i.e., mental processes and mathematical concepts);
computing the utility score by weighting the utility tally(ies) by the likelihood function (i.e., mental processes and mathematical concepts);
the third optimization step comprises:
performing a fourth optimization step providing a utility value (i.e., mental processes and mathematical concepts);
if a stochasticity flag is set, repeating the fourth optimization step, thereby obtaining a plurality of utility values (i.e., mental processes and mathematical concepts);
computing the utility tally as the utility value or by compounding the plurality of utility values (i.e., mental processes and mathematical concepts);
the fourth optimization step comprises:
generating a simulation by simulating the execution of the production process using a recipe template in the recipe template composite with the set of input values for the at least one variable recipe parameter, the process evolution information and the set of likely values for the at least one variable evolution parameter (i.e., mental processes and mathematical concepts);
if the recipe template composite comprises more than one recipe template, repeating the step of generating the simulation for each recipe template in the recipe template composite (i.e., mental processes and mathematical concepts);
determining, from the one or more simulations, trajectory(ies) for the process variable(s), wherein a trajectory corresponds to a time-based profile of values recordable during the simulated execution of the production process (i.e., mental processes and mathematical concepts);
computing the utility value by evaluating the utility function using the process variable(s) of the trajectory(ies) and the mapping (i.e., mental processes and mathematical concepts).
Independent claim 23 recites a non-transitory computer-readable storage medium comprising computer-readable instructions, which, when loaded and executed on a computer system, cause the computer system to perform the abstract ideas recited by independent claim 16, as noted above.
Independent claim 24 recites a computer system operable to perform the abstract ideas recited by independent claim 16, as noted above, and additionally:
a retrieving module (i.e., a software program); and
a computing module (i.e., a software program).
Dependent claims 17-19, 22, 25-28, and 31 further recite the following steps which fall within the mental processes and/or mathematical concepts groupings of abstract ideas, as noted below.
Dependent claim 17 further recites:
the chemical, pharmaceutical and/or biotechnological product is a first product (i.e., mental processes); and
computing the likelihood function based on the akin data and the relatedness information (i.e., mental processes and mathematical concepts).
Dependent claim 18 further recites:
computing the likelihood function based on the current data (i.e., mental processes and mathematical concepts).
Dependent claim 19 further recites:
computing the likelihood function based on the historical data (i.e., mental processes and mathematical concepts).
Dependent claim 22 further recites:
updating the likelihood function based on the trajectory(ies) (i.e., mental processes and mathematical concepts).
Dependent claim 25 further recites:
the chemical, pharmaceutical and/or biotechnological product is a first product (i.e., mental processes);
retrieving module (i.e., software program) (i.e., mental processes);
computing module (i.e., software program) (i.e., mental processes); and
compute the likelihood function based on the akin data and the relatedness information (i.e., mental processes and mathematical concepts).
Dependent claim 26 further recites:
retrieving module (i.e., software program) (i.e., mental processes);
computing module (i.e., software program) (i.e., mental processes); and
compute the likelihood function based on the current data (i.e., mental processes and mathematical concepts).
Dependent claim 27 further recites:
retrieving module (i.e., software program) (i.e., mental processes);
computing module (i.e., software program) (i.e., mental processes); and
compute the likelihood function based on the current data (i.e., mental processes and mathematical concepts).
Dependent claim 28 further recites:
retrieving module (i.e., software program) (i.e., mental processes);
computing module (i.e., software program) (i.e., mental processes); and
compute the likelihood function based on the historical data (i.e., mental processes and mathematical concepts).
Dependent claim 31 further recites:
computing module (i.e., software program) (i.e., mental processes); and
update the likelihood function based on the trajectory(ies) (i.e., mental processes and mathematical concepts).
The abstract ideas recited in the claims are evaluated under the broadest reasonable interpretation (BRI) of the claim limitations when read in light of and consistent with the specification. As noted in the foregoing section, the claims are determined to contain limitations that can practically be performed in the human mind with the aid of a pen and paper (e.g., selecting a recipe template composite), and therefore recite judicial exceptions from the mental process grouping of abstract ideas. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas (e.g., performing a second optimization step providing a utility score) are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind.
Therefore, claims 16-19 and 22-33 recite an abstract idea.
[Step 2A Prong One: YES]
Eligibility Step 2A Prong Two: In determining whether a claim is directed to a judicial exception, further examination is performed that analyzes if the claim recites additional elements that when examined as a whole integrates the judicial exception(s) into a practical application (MPEP 2106.04(d)). A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. The claimed additional elements are analyzed to determine if the abstract idea is integrated into a practical application (MPEP 2106.04(d)(I); MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the abstract idea, the claim fails to integrate the abstract idea into a practical application (MPEP 2106.04(d)(III)).
The judicial exceptions identified in Eligibility Step 2A Prong One are not integrated into a practical application because of the reasons noted below.
In the instant application, the independent claims provide additional elements to retrieve data, e.g., of one or more ‘recipe template composites’ and to process the data, e.g., a computer. However, once the data is received, the subsequent steps only perform analysis and/or calculations using the data, e.g., optimization steps and simulations, to determine one or more trajectories for a process variable and subsequently computing a utility value. Thus, the claims do not recite any limitations (i.e., additional elements) to which the ‘utility value’ (i.e., the result of the data analysis) is practically applied.
Dependent claim 31 does not recite any elements in addition to the judicial exception, and thus is part of the judicial exception.
The additional elements in independent claim 16 include:
a computer; and
retrieving (i.e., retrieving data):
one or more recipe template composites, wherein a recipe template composite comprises one or more recipe templates and a recipe template is a recipe in which at least one of the recipe parameter(s) specifying the plurality of steps is a variable recipe parameter being variable and having no predetermined value at the outset;
process evolution information that describes the time evolution of process variable(s) that describe a state of the production process, wherein the process evolution information comprises evolution parameter(s) and at least one of the evolution parameter(s) is a variable evolution parameter being variable and having no predetermined value at the outset;
a likelihood function for the evolution parameter(s), wherein the likelihood function provides a likelihood that value(s) for the evolution parameter(s) are feasible for the production process;
a mapping that maps the process variable(s) onto performance indicator(s); and
a utility function for at least one of the performance indicator(s), wherein the utility function provides a desirability value associated to the performance indicator(s).
The additional elements in independent claim 23 include:
a non-transitory computer-readable storage medium;
a computer system; and
retrieving (i.e., retrieving data):
one or more recipe template composites, wherein a recipe template composite comprises one or more recipe templates and a recipe template is a recipe in which at least one of the recipe parameter(s) specifying the plurality of steps is a variable recipe parameter being variable and having no predetermined value at the outset;
process evolution information that describes the time evolution of process variable(s) that describe a state of the production process, wherein the process evolution information comprises evolution parameter(s) and at least one of the evolution parameter(s) is a variable evolution parameter being variable and having no predetermined value at the outset;
a likelihood function for the evolution parameter(s), wherein the likelihood function provides a likelihood that value(s) for the evolution parameter(s) are feasible for the production process;
a mapping that maps the process variable(s) onto performance indicator(s); and
a utility function for at least one of the performance indicator(s), wherein the utility function provides a desirability value associated to the performance indicator(s).
The additional elements in independent claim 24 include:
a computer system; and
retrieve (i.e., retrieve data):
one or more recipe template composites, wherein a recipe template composite comprises one or more recipe templates and a recipe template is a recipe in which at least one of the recipe parameter(s) specifying the plurality of steps is a variable recipe parameter being variable and having no predetermined value at the outset;
process evolution information that describes the time evolution of process variable(s) that describe a state of the production process, wherein the process evolution information comprises evolution parameter(s) and at least one of the evolution parameter(s) is a variable evolution parameter being variable and having no predetermined value at the outset;
a likelihood function for the evolution parameter(s), wherein the likelihood function provides a likelihood that value(s) for the evolution parameter(s) are feasible for the production process;
a mapping that maps the process variable(s) onto performance indicator(s); and
a utility function for at least one of the performance indicator(s), wherein the utility function provides a desirability value associated to the performance indicator(s).
Dependent claims 17-19, 22, 25-30, 32, and 33 further recite the following additional elements, as noted below.
The additional elements in dependent claim 17 include:
retrieving the likelihood function comprises retrieving (i.e., retrieving data):
akin data related to at least one akin production process to produce a second chemical, pharmaceutical and/or biotechnological product, wherein the at least one akin production process has been at least partially performed and wherein the at least one akin production process is different from the production process; and
relatedness information providing a quantitative indication of similarity between the production process and the akin production process.
The additional elements in dependent claim 18 include:
retrieving the likelihood function comprises retrieving (i.e., retrieving data):
current data related to an ongoing run of the production process
The additional elements in dependent claim 19 include:
retrieving the likelihood function comprises retrieving (i.e., retrieving data):
historical data related to one or more past runs of the production process.
The additional elements in dependent claim 22 include:
storing the updated likelihood function.
The additional elements in dependent claim 25 include:
retrieve (i.e., retrieving data):
akin data related to at least one akin production process to produce a second chemical, pharmaceutical and/or biotechnological product, wherein the at least one akin production process has been at least partially performed and wherein the at least one akin production process is different from the production process; and
relatedness information providing a quantitative indication of similarity between the production process and the akin production process.
The additional elements in dependent claim 26 include:
retrieve (i.e., retrieving data):
current data related to an ongoing run of the production process.
The additional elements in dependent claim 27 include:
retrieve (i.e., retrieving data):
current data related to an ongoing run of the production process.
The additional elements in dependent claim 28 include:
retrieve (i.e., retrieving data):
historical data related to one or more past runs of the production process.
The additional elements in dependent claim 29 include:
the computer system is further configured to be interfaced with a control system for controlling a production process equipment, wherein:
the computer system is configured to provide (i.e., configured to output and/or transmit data) the at least one recipe to the control system; and
the control system is configured to execute (i.e., configured to output and/or transmit data) the production process based on the at least one recipe.
The additional elements in dependent claim 30 include:
store data from the executed production process as historical data; and/or
store data from the executing production process as current data.
The additional elements in dependent claim 32 include:
providing the at least one recipe to a control system; and
executing, by the control system, the production process based on the at least one recipe.
The additional elements in dependent claim 33 include:
storing data from the executed production process as historical data; and/or
storing data from the executing production process as current data.
The additional elements of a computer (claim 16); a non-transitory computer-readable storage medium (claim 23); and a computer system (claims 23 and 24); invoke a computer and/or computer-related components merely as tools for use in the claimed process, and therefore are not an improvement to computer functionality itself, or an improvement to any other technology or technical field, and thus, do not integrate the judicial exceptions into a practical application (MPEP 2106.04(d)(1)).
The additional element of the computer system is configured to provide the at least one recipe to the control system (claim 29); is merely a post-solution activity of outputting and/or transmitting data – a nominal addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)), and furthermore is an intended use because the system does not actually comprise a controller and does not actually comprise any production process equipment for controlling (i.e., the claims do not include the physical components of a control system and/or the physical components of production process equipment). Further still, this limitation amounts to mere instructions to apply the exception since the intended use “to provide the at least one recipe” is based on recipe parameter(s) that are determined based on the optimization steps (MPEP 2106.05(f)).
The additional element of providing the at least one recipe to a control system (claim 32) is merely a post-solution activity of outputting and/or transmitting data – a nominal addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
The additional elements of the computer system is configured to be interfaced with a control system for controlling a production process equipment, wherein: the control system is configured to execute the production process based on the at least one recipe (claim 29); is merely a post-solution activity of outputting and/or transmitting data – a nominal addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)), do not add meaningfully limitations beyond generally linking the use of the judicial exceptions to a particular technological environment (MPEP 2106.05(e)). Furthermore, the limitations reciting “configured to be interfaced with a control system for controlling a production process equipment,” and “configured to execute the production process based on the at least one recipe,” are intended uses of the outputted and/or transmitted data, and are not actually controlling anything (i.e., the claims do not include the physical components of a control system and/or the physical components of production process equipment). Further still, these limitations are mere instructions to apply the exception since the intended use “to execute the production process” is based on recipe parameter(s) that are determined based on the optimization steps (MPEP 2106.05(f)).
The additional element of executing, by the control system, the production process based on the at least one recipe (claim 29) amounts to mere instructions to apply the exception since the intended use of “executing the production process” is based on recipe parameter(s) that are determined based on the optimization steps (MPEP 2106.05(f)).
The additional element of retrieving data (claims 16, 17-19, 23, 24, and 25-28) is merely a pre-solution activity of gathering data for use in the claimed process – a nominal addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
The additional element of storing data (claims 22, 30, and 33) is merely a post-solution activity used in the claimed process – a nominal addition to the claims that does not meaningfully limit the claims, and therefore does not add more than insignificant extra-solution activity to the judicial exceptions (MPEP 2106.05(g)).
Thus, the additionally recited elements merely invoke a computer and/or computer related components as tools; and/or amount to insignificant extra-solution activity; and/or are mere instructions to apply an exception; and/or do not add meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment; and as such, when all limitations in claims 16-19 and 22-33 have been considered as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), the claims are deemed to not recite any additional elements that would integrate a judicial exception into a practical application, and therefore claims 16-19 and 22-33 are directed to an abstract idea (MPEP 2106.04(d)).
[Step 2A Prong Two: NO]
Eligibility Step 2B: Because the claims recite an abstract idea, and do not integrate that abstract idea into a practical application, the claims are probed for a specific inventive concept. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). Identifying whether the additional elements beyond the abstract idea amount to such an inventive concept requires considering the additional elements individually and in combination to determine if they amount to significantly more than the judicial exception (MPEP 2106.05A i-vi).
The claims do not include any additional elements that are sufficient to amount to significantly more than the judicial exception(s) because of the reasons noted below.
Dependent claim 31 does not recite any elements in addition to the judicial exception(s).
The additional elements recited in independent claims 16, 23, and 24 and dependent claims 17-19, 22, 25-30, 32, and 33 are identified above, and carried over from Step 2A Prong Two along with their conclusions for analysis at Step 2B. Any additional element or combination of elements that was considered to be insignificant extra-solution activity at Step 2A Prong Two was re-evaluated at Step 2B, because if such re-evaluation finds that the element is unconventional or otherwise more than what is well-understood, routine, conventional activity in the field, this finding may indicate that the additional element is no longer considered to be insignificant; and all additional elements and combination of elements were evaluated to determine whether any additional elements or combination of elements are other than what is well-understood, routine, conventional activity in the field, or simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, per MPEP 2106.05(d).
The additional elements of a computer (claim 16); a non-transitory computer-readable storage medium (claim 23); a computer system (claims 23 and 24); retrieving data (claims 16, 17-20, 23, 24, and 25-28); storing data (claims 22, 30, and 33); and outputting and/or transmitting data (claims 29 and 32); are conventional computer components and/or functions (see MPEP at 2106.05(b) and 2106.05(d)(II) regarding conventionality of computer components and computer processes).
The additional element of executing, by the control system, the production process based on the at least one recipe (claim 32) is conventional. Evidence of conventionality is shown by:
Stanke et al. (2012). “Automatic Control of Bioprocesses.” In: Mandenius, CF., Titchener-Hooker, N. (eds) Measurement, Monitoring, Modelling and Control of Bioprocesses. Advances in Biochemical Engineering/Biotechnology, vol 132, pp. 35-63. Springer, Berlin, Heidelberg (newly cited).
Stanke et al. reviews automatic control of bioprocesses (Title) and discusses different approaches for open-loop and closed-loop control applied in bioprocess automation (throughout the review), and further discusses a wide variety of state-of-the-art control applications for bioprocess automations, including PID-based controllers in combination with different soft sensors; model linearization approaches; and fuzzy logic- and artificial neural network-based controllers, a model predictive controller, as well as combinations of the these methods (page 42, Section 2.3, para. 2); and further shows an example scheme of a cascade process control system (page 46, Fig. 3).
Therefore, when taken alone (i.e., individually), all additional elements in claims 16-19 and 22-33 do not amount to significantly more than the above-identified judicial exception(s). Even when evaluated as an ordered combination, the additional elements fail to transform the exception(s) into a patent-eligible application of that exception. Thus, claims 16-19 and 22-33 are deemed to not contribute an inventive concept, i.e., amount to significantly more than the judicial exception(s) (MPEP 2106.05(II)).
[Step 2B: NO]
Response to Arguments
The Applicant’s arguments/remarks received 08 July 2026 have been fully considered, but are not persuasive.
The Applicant states on page 13 (as filed) (para. 3) of the Remarks that even assuming that the claims recite mathematical concepts or mental processes, the claims integrate those operations into a practical application. The Applicant further states that claim 16 is directed to a computer-implemented method of determining at least one recipe for a production process to produce a chemical, pharmaceutical, and/or biotechnological product, and the claimed production process is not an abstract business process; it is defined by a plurality of process steps specified by recipe parameters that control execution of the production process. The Applicant further states (para. 4) that claim 16 requires retrieving recipe template composites, process evolution information describing time evolution of process variables of the production process, a likelihood function for evolution parameters, a mapping from process variables to performance indicators, and a utility function for performance indicators, and the claim then uses these production-process inputs in nested optimization and simulation operations to select a recipe template composite and input values that define at least one recipe for the production process. The Applicant further states (para. 5) that the Office action’s analysis treats individual recitations such as ‘performing a second optimization step,’ ‘computing the utility score,’ and ‘generating a simulation’ in isolation, however, the claims must be considered as a whole, and when considered as a whole, claim 16 does not merely calculate a number for its own sake, but rather, the claim uses process evolution information, a likelihood function for variable evolution parameters, simulations of execution of the production process, trajectories or process variables, a mapping to performance indicators, and a utility function to select a recipe template composite and input values as at least one recipe for producing a chemical, pharmaceutical, and/or biotechnological product. The Applicant further states (para. 6) that the claims therefore integrate any recited mathematical operations into a practical application, and in particular, claim 16 requires generating a simulation by simulating execution of the production process using a recipe template with input values for at least one variable recipe parameter, process evolution information, and likely values for at least one variable evolution parameter. The Applicant further states on page 14 (para. 1) that the simulation produces trajectories corresponding to time-based profiles of process variables recordable during simulated execution of the production process, and that the utility value is then computed by evaluating the utility function using the process variables of those trajectories and the mapping. The Applicant further states that the result of the claimed optimization is not merely displayed or stores as abstract information; it is used to select the recipe template composite and set of input values as the at least one recipe for the production process. The Applicant further states (para. 2) that the claimed invention addresses a technical problem in chemical, pharmaceutical, and biotechnological production process optimization, and as explained in the specification, such production processes can involve complex, non-linear dynamics, large spaces of possible recipe parameters, and uncertainty in process evolution parameters. The Applicant further states that conventional approaches that rely on fixed models or predetermined parameter values can over-represent certainty about the mechanisms underlying the process and under-represent uncertainty associated with observed process data. The Applicant further states (para. 3) that the claims provide a technical solution to this problem, and further states that at least one evolution parameter is a variable evolution parameter having no predetermined value at the outset, and further states that a likelihood function provides a likelihood that values for the evolution parameters are feasible for the production process, and further states that sets of likely values for the variable evolution parameter are used to generate simulations, and utility tallies are weighted by the likelihood function to compute a utility score, and further states that if stochasticity is considered, plural utility values are compounded to compute a utility tally, and thus, the claims account for uncertainty in the process evolution information when selecting the recipe, rather than reducing the process to a single fixed model or a single assumed set of parameters. The Applicant further states (para. 4) that the dependent claims, including new claims 32 and 33, further reinforce the practical application, e.g., claim 29 recites that the computer system is configured to be interfaced with a control system for controlling production process equipment, that the computer system provides the selected recipe to the control system, and that the control system is configured to execute the production process based on the selected recipe.
These arguments/remarks are not persuasive, because first, regarding the Applicant’s argument that the claims integrate the judicial exceptions into a practical application, it is noted that a claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception (MPEP 2106.04(d)), however, as discussed in the above rejection, the independent claims provide additional elements to retrieve data, e.g., of one or more ‘recipe template composites’ and to process the data, e.g., a computer. However, once the data is received, the subsequent steps only perform analysis and/or calculations using the data, e.g., optimization steps and simulations, to determine one or more trajectories for a process variable and subsequently computing a utility value. Thus, the claims do not recite any limitations (i.e., additional elements) to which the ‘utility value’ (i.e., the result of the data analysis) is practically applied.
Second, regarding the Applicant’s argument that the Office action treats individual recitations in isolation, and that when considered as a whole, claim 16 is integrated into a practical application, it is noted that Step 2A of the eligibility analysis is a two-prong inquiry, in which examiners determine in Prong One whether a claim recites a judicial exception, and if so, then determine in Prong Two if the recited judicial exception is integrated into a practical application of that exception. Prong One asks does the claim recite an abstract idea, law of nature, or natural phenomenon? In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. If the claim recites a judicial exception, the claim requires further analysis in Prong Two, and as noted in the above rejection, the claims are determined to recite at least one judicial exception. Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole (i.e., the analysis takes into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application), integrates the exception into a practical application of that exception, i.e., a claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. However, as discussed in the above rejection, the independent claims provide additional elements to retrieve data, e.g., of one or more ‘recipe template composites’ and to process the data, e.g., a computer. However, once the data is received, the subsequent steps only perform analysis and/or calculations using the data, e.g., optimization steps and simulations, to determine one or more trajectories for a process variable and subsequently computing a utility value. Thus, the claims do not recite any limitations (i.e., additional elements) to which the ‘utility value’ (i.e., the result of the data analysis) is practically applied.
Third, regarding the Applicant’s argument that “the result of the claimed optimization is not merely displayed or stored as abstract information; it is used to select the recipe template composite and set of input values as the at least one recipe for the production process” it is noted that steps of using information, e.g., an output result, to further select other information comprise at least a judicial exception from the mental processes grouping of abstract ideas.
Fourth, regarding the Applicant’s argument that the “claimed invention addresses a technical problem in chemical, pharmaceutical, and biotechnological production process optimization” and that the “claims provide a technical solution to this problem,” it is noted that the claims do not recite any elements in addition (i.e., additional elements) to the judicial exceptions that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. As noted in the above rejection and discussed in the foregoing responses to arguments, the independent claims provide additional elements to retrieve data, e.g., of one or more ‘recipe template composites’ and to process the data, e.g., a computer. However, once the data is received, the subsequent steps only perform analysis and/or calculations using the data, e.g., optimization steps and simulations, to determine one or more trajectories for a process variable and subsequently computing a utility value. Thus, the claims do not recite any limitations (i.e., additional elements) to which the ‘utility value’ (i.e., the result of the data analysis) is practically applied.
Claim Rejections - 35 USC § 103
The rejection of claims 16-31 under 35 U.S.C. 103 as being unpatentable over Stacey et al. and Rajamanickam et al. in the Office action mailed 08 April 2026 has been withdrawn in view of the amendment and arguments/remarks, as noted below.
Response to Arguments
The Applicant’s arguments/remarks received 08 July 2026 have been fully considered, and are persuasive.
The Applicant provides arguments/remarks regarding the rejection of claims 16-31 under 35 U.S.C. 103 as being unpatentable over Stacey et al. and Rajamanickam et al. on pages 15-17 of the Remarks (as filed) and states on page 15 (paras. 3-4) and page 16 (para. 2) the claimed features not shown by Stacey et al. and further states on page 16 (para. 3) that Rajamanickam et al. does not cure these deficiencies. In particular, the Applicant states on page 16 (para. 4) that the proposed combination would require substantially more than incorporating a known likelihood function into Stacey, and the proposed combination would require redesigning the procedure so that uncertainty about process evolution parameters is maintained as a probability landscape throughout nested optimization loops and directly affects simulated trajectories, utility values, utility tallies, and final utility scores. The Applicant further states on page 16 (para. 5) and page 17 (para. 1) that by using the likelihood function for variable evolution parameters and, where applicable, stochasticity, the claimed invention accounts for ignorance about the production process while maintaining probability landscapes throughout the optimization procedure, and that this minimizes the role of assumptions during optimization and enables identification of a global optimum for executing the production process, rather than a local optimum tied to a fixed model or predetermined parameter values, and further states (para. 2) that the cited combination fails to teach or suggest at least the following limitations of independent claim 16: retrieving process evolution information comprising at least one variable evolution parameter having no predetermined value at the outset; providing a set of likely values for the variable evolution parameter based on the likelihood function; computing a utility score by weighting utility tallies by the likelihood function; computing utility tallies from utility values, including compounding plural utility values when a stochasticity flag is set; generating simulations using the recipe template, input values for the variable recipe parameter, process evolution information, and likely values for the variable evolution parameter; determining trajectories from the simulations; and computing the utility value by evaluating the utility function using the process variables of the trajectories and the mapping.
These arguments/remarks are persuasive.
Conclusion
No claims are allowed.
The closest art of record is Stacey et al. (“Scaling Tool.” WO 2019/154700, as cited in the Office action mailed 08 April 2026), for the reasons noted in the Office action mailed 08 April 2026.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.W.B./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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