DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-24 are pending and under consideration in this action. Claims 21-24 are newly added.
Priority
This application claims foreign priority from German Application No. 102021100531.0, filed 01/13/2021, as reflected in the filing receipt mailed 01/25/2022. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claims to the benefit of priority are acknowledged and the effective filing date of claims 1-24 is 01/13/2021.
Specification
The objections to the Specification are withdrawn in view of Applicant’s amendments to the Specification filed 11/26/2025 (Applicant’s Remarks, Pg. 11-12).
Claim Objections
The objections to claims 9, 14, 16, and 18-20 are withdrawn in view of Applicant’s amendments to the claims filed 11/26/2025 (Applicant’s Remarks, Pg. 12).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is newly recited and necessitated by claim amendment.
Claims 1 and 17 recite the limitations “wherein at least one optimized set value for the at least one action parameter (3) is learned autonomously by the apparatus (1) in a computer-implemented manner” and “the controller is further configured to learn at least one optimized set value for the at least one action parameter (3) autonomously in a computer-implemented manner”, respectively. Claims 21 and 23 recite the limitations “wherein the learning is based on several evaluations (6), which the apparatus (1) has derived autonomously from a respective measured process response (4), respectively” and “wherein the controller (16) is configured to learn the at least one optimized set value based on several evaluations (6), which the apparatus (1) controller (16) has derived autonomously from a respective measured process response (4)”, respectively.
MPEP 2161.01(I) recites:
“Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. … When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing.”
For these claim elements, the disclosure “does not sufficiently describe how the function is performed or the result is achieved”. The instant Specification (see Para. [0051]) recites “the adjustment of the respective set value of the at least one action parameter, preferably and the preceding evaluation of the measured process response, can take place by means of an artificial intelligence (AI) in a computer-implemented manner. Such an AI can be realized for example by means of a method of machine learning, preferably by means of a method of deep learning and/or using artificial neural networks (ANN). The ANNs may comprise numerous non-accessible hidden layers”. The instant Specification (see Para. [0053]) further recites “at least one optimized set value for the at least one action parameter can be independently learned by the apparatus in a computer-implemented manner based on several evaluations derived by the apparatus from a respective process response (in each case in reaction to set values of the at least one action parameter specified by the apparatus)”. The Specification (see Para. [0068]) further recites an example, where “an artificial intelligence can learn, based on a first acquired measurement parameter, how a second measurement parameter is to be correctly evaluated in order to carry out an appropriate adjustment of a set value of the at least one action parameter based on this learned and thus improved evaluation. The AI thus learns the correct evaluation of a second measurement parameter based on the acquisition of a first measurement parameter (which is used as a label). For example, acquired spectra can be used in order to label/classify training data in the form of accompanying microscopic images in order in this manner to learn correct image recognition of healthy organisms in the microscopic images”. Aside from generally disclosing an artificial neural network, the Specification is silent on, for example, the specific structure or network architecture of the autonomous learning process. Additionally, aside from reiterating the claim language, the Specification is silent on a training methodology to use the “several evaluations” to derive the autonomously learned process. Accordingly, the disclosure is not commensurate with the written description scope of the claim. This is a NEW MATTER rejection.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 2, 9-11, and 16-20 under 35 U.S.C. 112(b) as being indefinite is withdrawn in view of Applicant’s amendments to the claims filed 11/26/2025 (Applicant’s Remarks, Pg. 12).
Claim Rejections - 35 USC § 101
Maintained Rejections
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 1-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite both (1) mathematical concepts (mathematical relationships, formulas or equations, or mathematical calculations) and (2) mental processes, i.e., concepts performed in the human mind (including observations, evaluations, judgements or opinions) (see MPEP § 2106.04(a)).
Any newly recited portion is necessitated by claim amendment.
Step 1:
In the instant application, claims 1-16 and 21-22 are directed towards a method, and claims 17-20 and 23-24 are directed towards an apparatus (i.e., a machine) which falls into one of the categories of statutory subject matter (Step 1: YES).
Step 2A, Prong One:
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong One). The following instant claims recite limitations that equate to one or more categories of judicial exceptions:
Claim 1 recites a mental process (i.e., an evaluation of the system) in “in which a process (2) takes place that is carried out by a biological system (34) or a non-biological system”; a mental process (i.e., an observation of the process) in “wherein the process (2) is a biological, or a chemical, or a physical process”; a mental process (i.e., an evaluation of the response) in “evaluating the process response (4) with a computer-implemented evaluation (6) using a preset target specification (5)”; and a mathematical concept (see Specification Para. [0051]) in “wherein at least one optimized set value for the at least one action parameter (3) is learned autonomously by the apparatus (1) in a computer-implemented manner”.
Claim 2 recites a mental process (i.e., an evaluation of both the preset target specification and the adjusting) in “the preset target specification (5) is a reference response (5) for the process response (4), and the adjusting is for aligning the process response (4) with the predetermined target specification (5)”, and a mental process (i.e., an observation of where the process takes place) in “process (2) takes place in a sample (12) that comprises a culture medium (13) and the process response (4) is measured in the culture medium (13)”.
Claim 3 recites a mental process (i.e., an observation of the setup of the system) in “and the system (34) is embedded in the medium (13) which forms a culture medium (13)”.
Claim 5 recites a mental process (i.e., an evaluation of the process) in “the process (2) is influenced by setting the at least one action parameter (3)”, and a mental process (i.e., an evaluation of which activities were acquired) in “by measuring the process response (4), an activity of the system (34) including at least one of (i) a thermogenesis (production of heat by metabolic activity), (ii) a chemo- or biogenesis (production of chemical substances or biological organisms by metabolic activity), (iii) a photogenesis (production of light by metabolic activity), an energy consumption, or (iv) a material consumption or a material production, is acquired”.
Claim 6 recites a mental process (i.e., a judgement of which environmental factor to change) in “wherein the process (2) changes at least one environmental factor, including at least one of a material composition, a temperature, a pH, a permittivity, an electrical conductivity, an optical transmission or reflection behavior, or an environmental factor of a culture medium (13) in which the biological system (34) is cultured”.
Claim 9 recites mathematical concepts (i.e., using an AI algorithm) in “wherein the AI uses data sets comprising: a respective measured process response (4) and an accompanying set of action parameter values producing said process response (4)”, “in order to at least one of prepare or optimize a prediction model for the system response (4)”, and “the AI, with the help of the prediction model, generating virtual system responses in reaction to respective virtual sets of action parameter values, and validating said virtual system responses using real tests”.
Claim 10 recites a mathematical concept (i.e., learning via an AI algorithm) in “wherein at least one optimized set value for the at least one action parameter (3) is independently learned in a computer-implemented manner by the apparatus (1) based on several evaluations (6) derived by the apparatus (1) from respective ones of the process responses (4), in each case in reaction to set values of the at least one action parameter (3) specified by the apparatus (1)”.
Claim 13 recites a mental process (i.e., a judgement of which parameters to include from a group) in “the measurement parameters (8a, 8b, 8c) are selected from the following group of measurement parameters (8): optical measurement variables including at least one of an absorption spectrum, an emitted light intensity, or a fluorescence; electrical variables, including at least one of an electrical conductivity or permeability; thermal variables, including a self-heating of a biological sample; or pH values”.
Claim 14 recites a mathematical concept (i.e., using an algorithm to evaluate parameters) in “evaluating each of the measurement parameters (8), using a respective preset target specification (5a, 5b) using a respective computer-implemented evaluation (6a, 6b)”.
Claim 15 recites a mathematical concept (i.e., using a self-supervised algorithm) in “using a first measurement parameter (8a) to at least one of verify or adjust an evaluation criterion which is used to generate an evaluation (6b) of a second measurement parameter (8b), via a method of self-supervised learning, in which the first measurement parameter (8a) is taken as a basic truth in order to improve the evaluation of the second measurement parameter (8b)”.
Claim 16 recites a mental process (i.e., an evaluation of the measurement parameters) in “wherein at least one of the measurement parameters (8a, 8b, 8c) is an overall measurement parameter (8) that is influenceable by all elements (14) of the biological system (34)”, and mental processes (i.e., an observation of how the measurement parameters were acquired) in “(a) the overall measurement parameter (8) is acquired without direct measurement of the elements (14) of the biological system (34)” and “(b) at least one of the acquired measurement parameters (8a, 8b, 8c) is a local measurement parameter that is only influenceable by individual ones of the elements (14) of the biological system (34), and the local measurement parameter is acquired by direct measurement of the individual elements (14) of the biological system (34)”.
Claim 17 recites a mathematical concept (see at least Specification Para. [0051]) in “the controller is further configured to learn at least one optimized set value for the at least one action parameter (3) autonomously in a computer-implemented manner”.
Claim 18 recites a mental process (i.e., an evaluation of the use of the apparatus) in “wherein the apparatus is configured to control a biological process (2)”.
Claim 19 recites mental processes (i.e., an observation of the setup/layout of the system) in “(a) the microfluidic device (21) comprises a microfluidically active separating structure (22) with which the elements (14) of the biological system (34) are maintained at a distance from the measuring point (20) at which the process response (4) is acquired via the at least one measuring device (17)” and “(b) the at least one measuring means (17) is at least partially integrated into the microfluidic device (21) and the measuring point (20) is therefore unchangeable with respect to the separating structure (22)”.
Claim 21 recites a mathematical concept in “wherein the learning is based on several evaluations (6), which the apparatus (1) has derived autonomously from a respective measured process response (4), respectively”.
Claim 23 recites a mathematical concept in “wherein the controller (16) is configured to learn the at least one optimized set value based on several evaluations (6), which the apparatus (1) controller (16) has derived autonomously from a respective measured process response (4)”.
These recitations are similar to the concepts of collecting information, and displaying certain results of the collection and analysis is Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)), and organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships.
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, and are determined to be directed to mental processes that in the simplest embodiments are not too complex to practically perform in the human mind. Additionally, the recited limitations that are identified as judicial exceptions from the mathematical concepts grouping of abstract ideas are abstract ideas irrespective of whether or not the limitations are practical to perform in the human mind. The instant claims must therefore be examined further to determine whether they integrate the abstract idea into a practical application (Step 2A, Prong One: YES).
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)). 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 following claims recite limitations that equate to additional elements:
Claim 1 recites “wherein the process (2) is controlled by setting at least one action parameter (3)”, “measuring a process response (4) of the process (2) on the at least one action parameter (3), wherein the process response (4) is returned by the process in reaction to the at least one action parameter”, “adjusting at least one set value of the at least one action parameter (3) in a computer-implemented manner based on the evaluation (6)”, and “applying the at least one optimized set value to the biological, the chemical, or the physical process”.
Claim 2 further recites “and is applied to change a composition of the culture medium”.
Claim 3 further recites “measuring the process response (4) of the process (2) on a medium (13) that surrounds elements (14) of the system (34) on which the process (2) is based”, and “the process is applied to change a composition of the culture medium”.
Claim 4 further recites “measuring at least one measurement parameter (8) of the process response (4) in an immediate environment of the elements (14) of the biological system (34) on which the process (2) is based, without direct measurement of the elements (14) of the biological system (34)”.
Claim 5 further recites “based on the process response (4), the apparatus (1) at least one of consuming or producing at least one material by the process (2), at least indirectly”.
Claim 6 further recites “measuring the at least one environmental factor as at least one measurement parameter (8) of the process response (4)”.
Claim 7 further recites “acquiring at least one measurement parameter (8a) of the process response (4) using a spectrometric measurement”.
Claim 8 further recites “wherein the adjusting of the respective set value of the at least one action parameter (3) is computer-implemented via an artificial intelligence (AI)”.
Claim 11 further recites “measuring a process status, wherein a first measurement parameter (8) is measured by the process response (4) and a second measurement parameter (8) is measured by the process status”.
Claim 12 further recites “measuring at least two measurement parameters (8) and using one of the two measurement parameters (8) in order to verify an evaluation carried out using the other measurement parameter (8)”.
Claim 13 further recites “measuring at least two measurement parameters (8)”.
Claim 14 further recites “adjusting at least one set value of the at least one action parameter (3) in a computer-implemented manner based on the evaluations (6a, 6b)”.
Claim 17 recites “a process chamber (15) for accommodating a biological, chemical or physical system, in which the process (2) takes place”, “a controller (16) configured to set at least one action parameter (3) to control the process (2) using the at least one action parameter (3)”, “at least one measuring device (17) for measuring a process response (4) of the process (2), which is returned by the process (2) in reaction to an adjustment of the at least one action parameter (3)”, and “the controller is further configured to apply the at least one optimized set value to a biological, or a chemical, or a physical process in the process chamber (15)”.
Claim 18 further recites “the at least one of the measuring device (17) is configured to acquire an overall measurement parameter (8) of the process response (4), which is changeable or is changed by all elements (14) of the biological system (34) on which the process (2) is based” and “the at least one of the measuring device (17) is configured to acquire the overall measurement parameter (8) and is arranged such that the measurement of the process response (4) takes place at least partially at a measuring point (20) that is kept free from the elements (14) of the biological system (34)”.
Claim 19 further recites “a microfluidic device (21) for supplying the system (34) with a medium”.
Claim 20 further recites “at least one actuator (23) configured to change the at least one action parameter (3)”, “the at least one actuator (23) is regulatable by the controller (16)”, and “the controller (16) is configured to adjust at least one set value of the at least one action parameter (3) in a computer-implemented manner by an evaluation (6) of the process response (4) in order to align the process response (4) with a preset target specification (5)”.
Claim 22 further recites “wherein the measured process responses (4), from which the evaluations (6) were derived by the apparatus (1) autonomously, were returned by the process in each case in reaction to set values of the at least one action parameter (3), which the apparatus (1) had specified autonomously, respectively”.
Claim 24 further recites “wherein the controller (16) is configured to derive the evaluations (6) autonomously from measured process responses (4) returned by the process in each case in reaction to set values of the at least one action parameter (3), which the controller (16) had specified autonomously, respectively”.
Regarding the above cited limitations in claims 1, 8, 14, 17, and 20 of (i) adjusting at least one set value of the at least one action parameter (3) in a computer-implemented manner based on the evaluation (6), (ii) wherein the adjusting of the respective set value of the at least one action parameter (3) is computer-implemented via an artificial intelligence (AI), (iii) adjusting at least one set value of the at least one action parameter (3) in a computer-implemented manner based on the evaluations (6a, 6b), (iv) a controller (16) configured to set at least one action parameter (3) in order to control the process (2) using the action parameter (3), (v) the at least one actuator (23) is regulatable by the controller (16), and (vi) the controller (16) is configured to adjust at least one set value of the at least one action parameter (3) in a computer-implemented manner by an evaluation (6) of the process response (4) in order to align the process response (4) with a preset target specification (5). These limitations require only a generic computer component, which does not improve computer technology. Therefore, these limitations equate to mere instructions to implement an abstract idea on a generic computer, which the courts have established does not render an abstract idea eligible in Alice Corp. 573 U.S. at 223, 110 USPQ2d at 1983.
Regarding the above cited limitations in claims 1, 3-4, 6-8, 11-14, and 17-20 of (vii) the process (2) is controlled by setting at least one action parameter (3), (viii) measuring a process response (4) of the process (2) on the at least one action parameter (3), wherein the process response (4) is returned by the process in reaction to the at least one action parameter, (ix) measuring the process response (4) of the process (2) on a medium (13) that surrounds elements (14) of the system (34) on which the process (2) is based, (x) measuring at least one measurement parameter (8) of the process response (4) in an immediate environment of the elements (14) of the biological system (34) on which the process (2) is based, without direct measurement of the elements (14) of the biological system (34), (xi) measuring the at least one environmental factor as at least one measurement parameter (8) of the process response (4), (xii) acquiring at least one measurement parameter (8a) of the process response (4) using a spectrometric measurement, (xiii) measuring a process status, and a first measurement parameter (8) is measured by the process response (4) and a second measurement parameter (8) is measured by the process status, (xiv) measuring at least two measurement parameters (8) and using one of the two measurement parameters (8) in order to verify an evaluation carried out using the other measurement parameter (8), (xv) measuring at least two measurement parameters (8), (xvi) a process chamber (15) for accommodating a biological, chemical or physical system, in which the process (2) takes place, (xvii) at least one measuring device (17) for measuring a process response (4) of the process (2), which is returned by the process (2) in reaction to an adjustment of the at least one action parameter (3), (xviii) the at least one of the measuring device (17) is configured to acquire an overall measurement parameter (8) of the process response (4), which is changeable or is changed by all elements (14) of the biological system (34) on which the process (2) is based, (xix) the at least one of the measuring device (17) is configured to acquire the overall measurement parameter (8) and is arranged such that the measurement of the process response (4) takes place at least partially at a measuring point (20) that is kept free from the elements (14) of the biological system (34), (xx) a microfluidic device (21) for supplying the system (34) with a medium, and (xxi) at least one actuator (23) configured to change the at least one action parameter (3). These limitations equate to insignificant, extra-solution activity of mere data gathering because these limitations gather data before or after the recited judicial exceptions of evaluating the process response (4) with a computer-implemented evaluation (6) using a preset target specification (5) (see MPEP § 2106.04(d)).
Regarding the above cited limitations in claims 1-3, 5, and 17 of (xxii) applying the at least one optimized set value to the biological, or the chemical, or the physical process (claim 1); (xxiii) applied to change a composition of the culture medium (claim 2); (xxiv) the process is applied to change a composition of the culture medium (claim 3); (xxv) the apparatus (1) at least one of consuming or producing at least one material by the process (2), at least indirectly (claim 5); and (xxvi) to apply the at least one optimized set value to a biological, or a chemical, or a physical process in the process chamber (15) (claim 17). These limitations equate to extra-solution “apply it” steps because the limitations are recited at a high level of generality to physically change the process or composition without providing any details of how the change is accomplished for any biological process, any chemical process, any physical process, or any cell culture medium (see MPEP § 2106.05(f)). As such, claims 1-24 are directed to an abstract idea (Step 2A, Prong Two: NO).
Step 2B:
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The instant claims recite same additional elements described in Step 2A, Prong Two above.
Regarding the above cited limitations in claims 1, 8, 14, 17, and 20 of (i) adjusting at least one set value of the at least one action parameter (3) in a computer-implemented manner based on the evaluation (6), (ii) wherein the adjusting of the respective set value of the at least one action parameter (3) is computer-implemented via an artificial intelligence (AI), (iii) adjusting at least one set value of the at least one action parameter (3) in a computer-implemented manner based on the evaluations (6a, 6b), (iv) a controller (16) configured to set at least one action parameter (3) in order to control the process (2) using the action parameter (3), (v) the at least one actuator (23) is regulatable by the controller (16), and (vi) the controller (16) is configured to adjust at least one set value of the at least one action parameter (3) in a computer-implemented manner by an evaluation (6) of the process response (4) in order to align the process response (4) with a preset target specification (5). These limitations equate to instructions to implement an abstract idea on a generic computing environment, which the courts have established does not provide an inventive concept (see MPEP § 2106.05(d) and MPEP § 2106.05(f)).
Regarding the above cited limitations in claims 1, 3-4, 6-8, 11-14, and 17-20 of (viii) measuring a process response (4) of the process (2) on the at least one action parameter (3), wherein the process response (4) is returned by the process in reaction to the at least one action parameter, (ix) measuring the process response (4) of the process (2) on a medium (13) that surrounds elements (14) of the system (34) on which the process (2) is based, (x) measuring at least one measurement parameter (8) of the process response (4) in an immediate environment of the elements (14) of the biological system (34) on which the process (2) is based, without direct measurement of the elements (14) of the biological system (34), (xi) measuring the at least one environmental factor as at least one measurement parameter (8) of the process response (4), (xii) acquiring at least one measurement parameter (8a) of the process response (4) using a spectrometric measurement, (xiii) measuring a process status, and a first measurement parameter (8) is measured by the process response (4) and a second measurement parameter (8) is measured by the process status, (xiv) measuring at least two measurement parameters (8) and using one of the two measurement parameters (8) in order to verify an evaluation carried out using the other measurement parameter (8), (xv) measuring at least two measurement parameters (8), (xvii) at least one measuring device (17) for measuring a process response (4) of the process (2), which takes place in reaction to an adjustment of the at least one action parameter (3), (xviii) the at least one of the measuring device (17) is configured to acquire an overall measurement parameter (8) of the process response (4), which is changeable or is changed by all elements (14) of the biological system (34) on which the process (2) is based, and (xix) the at least one of the measuring device (17) is configured to acquire the overall measurement parameter (8) and is arranged such that the measurement of the process response (4) takes place at least partially at a measuring point (20) that is kept free from the elements (14) of the biological system (34). These limitations are considered to be insignificant extra-solution activity of mere data gathering. These steps are incidental to the primary process of evaluating the process response (4) with a computer implemented evaluation using a present target specification (5) and adjusting at least one set value of the at least one action parameter (3) in a computer-implemented manner based on the evaluation (6), wherein the above measured parameters are merely inputs for the evaluation and subsequent adjustment process. These limitations are similar to the following examples of activities that the courts have found to be insignificant extra-solution activity: (i) Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989) and (ii) Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis)(see MPEP § 2106.05(g)).
Regarding the above cited limitations in claims 1-3, 5, 17, and 19-20 of (vii) wherein the process (2) is controlled by setting at least one action parameter (3); (xvi) a process chamber (15) for accommodating a biological, chemical or physical system, in which the process (2) takes place; (xx) a microfluidic device (21) for supplying the system (34) with a medium; (xxi) at least one actuator (23) configured to change the at least one action parameter (3); (xxii) applying the at least one optimized set value to the biological, or the chemical, or the physical process; (xxiii) applied to change a composition of the culture medium; (xxiv) the process is applied to change a composition of the culture medium; (xxv) the apparatus (1) at least one of consuming or producing at least one material by the process (2), at least indirectly; and (xxvi) to apply the at least one optimized set value to a biological, or a chemical, or a physical process in the process chamber (15). These limitations when viewed individually and in combination, are WURC limitations as taught by Beighley et al. (U.S. Patent Application Publication, US 2017/0138924 A1; previously cited) and Jing et al. (U.S. Patent Application Publication US 2019/0352589 A1; newly cited). Beighley et al. discloses methods and systems for automated real time assessment and monitoring of biological cells or their environment, including a step of setting on an environmental control unit to cause the treatment to be applied to the biological cells (limitation (vii)) (Title, Abstract, Para. [0011]). Beighley et al. further discloses a cell chamber comprising an inlet and output (limitation (xvi)) (Para. [0015]). The system also includes a microfluidic pump unit (limitation (xx)) (Para. [0042]) and an actuator for applying pneumatic pressure in sealed containers (limitation (xxi)) (Para. [0115]). Jing et al. discloses an automated cell culture system including a cell culture reactor and a computing device. The computing device is configured to automatically control operation of the cell culture reactor based on one or more detected parameters (Abstract). The parameters could include detecting an amount of cell culture media in the reservoir and the computing system can control the addition of cell culture reagents (limitations (xxii)-(xxvi)) (Para. [0027] and [0088]).
These additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the instant claims do not amount to significantly more than the judicial exception itself (Step 2B: NO). As such, claims 1-24 are not patent eligible.
Response to Arguments under 35 U.S.C. 101
Applicant’s arguments filed 11/26/2025 have been fully considered but they are not persuasive.
1. Applicant argues that, as explained for example in Para [0016]-[0018], a major benefit of the method according to the invention is the ability to automate computer-implemented machine learning, for example, of a growth condition (typically patient specific) for particular cell-types that are to be used in patient data specific cancer treatment. Such immune cells are thus designed for particular needs of a patient and need a delicate balancing of various process parameters ("action parameters (3)") to achieve optimum cell proliferation (which is thus an optimized "process response (4)"), which is needed to provide the patient with a large number of such immune cells. This is done by carrying out the method which not only autonomously learns at least one optimized set value for the at least one action parameter, but also applies the at least one optimized set value to the biological, or the chemical, or the physical process. A further example described in the Specification notes the ability for optimizing a certain mix of drugs to inhibit the growth of cancer cells. Here, the method is applied to machine-learn the best mix of drugs (as "action parameters (3)") for killing the cancer cells rapidly, thereby controlling the decay of those cells as a "process response" of the biological process. (Applicant’s Remarks, Pg. 14).
It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
MPEP 2106.05(a) recites:
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., thereby increasing the bandwidth of the channel"). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim "as a whole," in other words, the claim should be evaluated "as an ordered combination, without ignoring the requirements of the individual steps." When performing this evaluation, examiners should be "careful to avoid oversimplifying the claims" by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.
The alleged improvements indicated by Applicant are not commensurate in scope with the claimed invention. Applicant appears to assert that the claimed features may be used to, for example, automate a growth condition for particular cell-types that are used in patient data specific cancer treatment (see Specification Para. [0017], [0023], and [0033]). However, the claim broadly recites the automation of any biological or chemical process, and is not limited to automating a growth condition (e.g., death) in cells for cancer treatment. The claim does not provide any indication that the autonomous method is used for the treatment of cancer. Therefore, it appears the alleged improvements are not commensurate in scope with the claimed invention. This argument is thus not persuasive.
2. Applicant argues that as claim 1 now applies the evaluated and optimized values to the biological, chemical, or physical process to achieve concrete results, it is directed to more than merely an abstract idea (Applicant’s Remarks, Pg. 14).
It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
MPEP § 2106.05(f) recites:
“(3) The particularity or generality of the application of the judicial exception. A claim having broad applicability across many fields of endeavor may not provide meaningful limitations that integrate a judicial exception into a practical application or amount to significantly more. For instance, a claim that generically recites an effect of the judicial exception or claims every mode of accomplishing that effect, amounts to a claim that is merely adding the words "apply it" to the judicial exception. See Internet Patents Corporation v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1418 (Fed. Cir. 2015) (The recitation of maintaining the state of data in an online form without restriction on how the state is maintained and with no description of the mechanism for maintaining the state describes "the effect or result dissociated from any method by which maintaining the state is accomplished" and does not provide a meaningful limitation because it merely states that the abstract idea should be applied to achieve a desired result). See also O’Reilly v. Morse, 56 U.S. 62 (1854) (finding ineligible a claim for "the use of electromagnetism for transmitting signals at a distance"); The Telephone Cases, 126 U.S. 1, 209 (1888) (finding a method of "transmitting vocal or other sound telegraphically ... by causing electrical undulations, similar in form to the vibrations of the air accompanying the said vocal or other sounds," to be ineligible, because it "monopolize[d] a natural force" and "the right to avail of that law by any means whatever.").”
As described in Step 2A, Prong Two above, the limitation of “applying the at least one optimized set value to the biological, or the chemical, or the physical process” equates to an extra-solution “apply it” step because the limitation is recited at a high level of generality to physically change the process without providing any details of how the change is accomplished for any biological process, any chemical process, or any physical process. Therefore, this limitation is broadly recited and does not confine the judicial exception to a particular, practical application of the judicial exception. This argument is thus not persuasive.
3. Applicant also argues that under step 2B, significantly more is provided than the judicial exception itself since this additional requirement of applying the at least one optimized set value to the biological, chemical, or physical process is also required (Applicant’s Remarks, Pg. 14). It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
As described in Step 2B above, the limitation of “applying the at least one optimized set value to the biological, or the chemical, or the physical process” is a well-understood, routine, and conventional limitation as taught by Jing et al. Jing et al. discloses an automated cell culture system including a cell culture reactor and a computing device, which automatically controls the operation of the cell culture reactor based on one or more parameters (Jing et al., Abstract). Therefore, this limitation does not comprise an inventive concept or amount to significantly more than the judicial exception. This argument is thus not persuasive.
4. Applicant also argues that as specified in claims 2, 3, and 5, the application is specified as changing a composition of the culture medium (claims 2 and 3) as well as causing the apparatus to at least one of consume or produce one material by the process (claim 5). These provide additional concrete steps that are beyond being merely an abstract idea under step 2A, prong 2, and also provides significantly more under step 2B (Applicant’s Remarks, Pg. 15). It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
Similar to the arguments detailed above for the applying step in claim 1, the limitations of “applied to change a composition of the culture medium”, “process is applied to change a composition of the culture medium”, and “the apparatus at least one of consume or produce one material by the process” are extra-solution “apply it” steps as described in Step 2A, Prong Two above, and are well-understood, routine and conventional limitations as taught by Jing et al., as described in Step 2B above. Therefore, since these limitations are broadly recited, they do not provide significantly more than the judicial exception, and this argument is not persuasive.
5. Applicant also argues that with respect to claim 17, this claim has also been amended to require that the controller is further configured to learn at least one optimized set value for the at least one action parameter autonomously in a computer-implemented manner, and to apply the at least one optimized set value to a biological, or a chemical, or physical process in the process chamber. Accordingly, claim 17 now also more than mere data gathering or analysis under step 2A, prong 2, and provides significantly more than the judicial exception in step 2B (Applicant’s Remarks, Pg. 15). It is respectfully submitted that Applicant’s arguments are not persuasive for the following reasons:
Similar to the arguments detailed above for claim 1, the limitation of “apply the at least one optimized set value to a biological, or a chemical, or a physical process in the process chamber (15)” is an extra-solution “apply it” step as described in Step 2A, Prong Two above, and is a well-understood, routine and conventional limitation as taught by Jing et al., as described in Step 2B above. For the same reasons as described for claim 1 in the arguments above, this limitation does not amount to significantly more than the judicial exception, and this argument is thus not persuasive.
Claim Rejections - 35 USC § 102
The rejection of claims 1-7, 11-14, 16-18, and 20 under 35 U.S.C. 102(a)(2) as anticipated by Beighley et al. is withdrawn in view of Applicant’s amendments to the claims filed 11/26/2025 and Applicant’s arguments were found persuasive (Applicant’s Remarks, Pg. 15-20). Specifically, Beighley et al. does not disclose a system for real-time assessment of biological cells where the controlled feedback from the computer is autonomously learned, or applying the learned parameter to control the apparatus.
Claim Rejections - 35 USC § 103
The rejection of claims 8-10 and 15 under 35 U.S.C. 103 as being unpatentable over Beighley et al in view of Tulsyan et al. is withdrawn in view of Applicant’s amendments to the claims filed 11/26/2025 and Applicant’s arguments were found persuasive (Applicant’s Remarks, Pg. 20-21). Specifically, Tulsyan et al. also does not disclose a method or system for real-time control wherein the feedback is autonomously learned to control the system.
The rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Beighley et al. in view of Wu et al. is withdrawn view of Applicant’s amendments to the claims filed 11/26/2025 and Applicant’s arguments were found persuasive (Applicant’s Remarks, Pg. 21). Specifically, Wu et al. also does not disclose a method or system for real-time control wherein the feedback is autonomously learned to control the system.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Claims 1-24 appear to be free from the prior art because the prior art does not fairly suggest or teach a method for controlling an apparatus where the controlled feedback is autonomously learned and the learned parameter is used to control the apparatus. The closest prior art is Beighley et al. (U.S. Patent Application Publication, US 2017/0138924 A1; previously cited). Beighley et al. discloses a method and a system for real-time assessment and monitoring of biological cells or their environment, including steps of controlling the settings on an environmental control unit, measuring perturbations to the cells, evaluating the change in the cells due to the perturbations, and applying a treatment to the cells by controlling a setting on the environmental control unit. However, Beighley et al. does not teach the limitations of wherein at least one optimized set value for the at least one action parameter is learned autonomously by the apparatus in a computer-implemented manner, and applying the at least one optimized set value to the biological, or the chemical, or the physical process, as disclosed in instant claims 1 and 17. Claims 2-16 and 18-24 appear to be free from the prior art due to their dependency on claims 1 and 17.
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/D.P.S./Examiner, Art Unit 1687
/Lori A. Clow/Primary Examiner, Art Unit 1687