DETAILED ACTION
Applicant’s response filed 01/02/2026 has been fully considered. The following rejections and/or objections are either reiterated or newly applied.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/02/2026 has been entered.
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 .
Claim Status
Claims 1-18 are cancelled by Applicant.
Claims 19-39 are currently pending and are herein under examination.
Claims 19-39 are rejected.
Priority
The instant application claims foreign priority to Korean Application No. 10-2021-0037449 filed on 03/23/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The claim to foreign priority for claims 19-39 is acknowledged. As such, the effective filing date of claims 19-39 is 03/23/2021.
Claim Objections
The objection to claim 25 is withdrawn in view of claim amendment.
Claim Rejections - 35 USC § 112
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 19-27 and 39 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 as necessitated by claim amendment.
Claims 19 and 39 recite the following limitation that does not have disclosure in either the instant specification or drawings and thus recites new matter: “performing an anti-cancer therapy on the biological individual using the anti-cancer agent whose treatment response is positive”. There is no disclosure for performing/administering an anti-cancer agent directly to an individual.
Furthermore, claims 20-27 are also rejected because they depend on claim 19, which is rejected.
35 USC 112(b)
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 19-39 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.
This rejection is newly recited as necessitated by claim amendment.
Claim 19, line 16, recites the phrase “the cell experiments” which renders the claim indefinite. It is unclear which cell experiments are being referenced because “cell experiments” is recited in line 4 and line 11. To overcome this rejection, clarify which cell experiments are being referenced.
Claim 19, last two lines, recites the phrase “wherein the anti-cancer agent includes targeted anti-cancer drugs or chemical anti-cancer drugs” which renders the claim indefinite. It’s unclear whether the phrase requires the anti-cancer agent to be more than one targeted or chemical drug, or if the phrase means that the anti-cancer agent is a single drug which can be either one targeted or one chemical drug. To overcome this rejection, clarify how the phrase should be interpreted.
Furthermore, claims 20-27 are also rejected because they depend on claim 19, which is rejected, and because they do not resolve the issue indefiniteness.
Claim 26 recites the phrase “the evaluation results on the sensitivity” which lacks antecedent basis. To overcome this rejection, provide antecedent basis.
Claim 28, line 27, recites the phrase “the cell experiments” which renders the claim indefinite. It is unclear which cell experiments are being referenced because the phrase “cell experiments” appears in lines 3-4 and line 22. To overcome this rejection, clarify which cell experiments are being referenced.
Claim 28, last 5 lines, recites the following limitations that renders the claim indefinite: “wherein, during the cell experiments, the biological specimen is cultured on a culture plate that includes: a containing space for containing a cell culture solution; and a plurality of pillar portions that protrude from a bottom surface of the culture plate by a predetermined height and are configured to accommodate cells.” MPEP 2173.05(p) recites “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In the instant case, the above cited limitations recite method steps in a system claim. For examination purposes, these limitations are being interpreted as product by process limitations. These limitations describe a process previously performed, outside the metes and bounds of the claimed system, to obtain the “cell experiments” recited in lines 3-4. To overcome this rejection, clarify whether these limitations should be interpreted as a product by process.
Furthermore, claims 29-36 are also rejected because they depend on claim 28, which is rejected, and because they do not resolve the issue indefiniteness.
Claim 39, line 15, recites the phrase “the cell growth factor” which lacks antecedent basis. To overcome this rejection, change the phrase to “a cell growth factor”.
Claim 39, line 18, recites the phrase “the Z-score” which renders the claim indefinite. It is unclear which Z-scores are being referenced because there are Z-scores for both the anti-cancer agent response factor and the cell growth factor, as recited in lines 16-17. To overcome this rejection, clarify which Z-scores are being referenced.
Claim 39, last two lines, recites the phrase “wherein the anti-cancer agent includes targeted anti-cancer drugs or chemical anti-cancer drugs” which renders the claim indefinite. It’s unclear whether the phrase requires the anti-cancer agent to be more than one targeted or chemical drug, or if the phrase means that the anti-cancer agent is a single drug which can be either one targeted or one chemical drug. To overcome this rejection, clarify how the phrase should be interpreted.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 19-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Any newly recited portions herein are necessitated by claim amendment.
Step 2A, Prong 1:
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 phenomena (Step 2A, Prong 1). In the instant application, claims 19-27 recite a method, claims 28-36 recite a system, claims 37-38 recite a CRM, and claim 39 recites a method. The instant claims recite the following limitations that equate to one or more categories of judicial exception:
Claims 19 and 37 recite “obtaining a prediction dividing line by performing a curve fitting for the anti-cancer agent response factor and the cell growth factor according to the cell experiments; determining whether treatment response of the biological specimen to the anti-cancer agent is positive or negative with respect to the prediction dividing line;”
Claim 21 recites “… extract a sensitivity characteristic associated with the anti-cancer agent response factor according to cell experiments, wherein the step of determining whether treatment response is positive or negative comprises: extracting the sensitivity characteristic based on the biological test data by using the sensitivity prediction model; and determining the sensitivity of the biological individual to the anti-cancer agent in terms of whether treatment response is positive or negative based on the sensitivity characteristic.”
Claim 22 recites “wherein the sensitivity characteristic is prediction dividing line created by performing a curve fitting for the biological test data including the cell growth factor and the anti-cancer agent”
Claims 23 and 32 recite “wherein the curve fitting is performed by at least one selected from the group consisting of PR (Probit regression), Quadratic classifiers, Kernel estimation, LVQ (Learning vector quantization), ANN (Artificial neural networks), RF (random forest), Bagging (bootstrap aggregating), AdaBoost, Gradient Boosting, XGBoost, SVM (support vector machine), LASSO (least absolute shrinkage and selection operator), and Elastic Net.”
Claim 24 recites “wherein the step of determining whether treatment response is positive or negative further comprises using the sensitivity prediction model to determine the sensitivity of the biological individual to the anti-cancer agent in terms of whether treatment response is positive or negative based on the biological test data and the reference data.”
Claim 25 recites “wherein the step of determining whether treatment response is positive or negative further comprises using the sensitivity prediction model to determine a degree of treatment response to the anti-cancer agent,”
Claim 28 recites “obtain a prediction dividing line by performing a curve fitting for the anti-cancer agent response factor and the cell growth factor according to the cell experiments; determine whether treatment response of the biological individual to the anti-cancer agent is positive or negative with respect to the prediction dividing line; and select the anti-cancer agent whose treatment response is positive”
Claim 30 recites “… extract a sensitivity characteristic associated with the anti-cancer agent response factor and the cell growth factor according to cell experiments, … use the sensitivity prediction model to extract the sensitivity characteristic based on the biological test data and determine the sensitivity of the biological individual to the anti-cancer agent in terms of whether treatment response is positive or negative.”
Claim 31 recites “wherein the sensitivity characteristic is a prediction dividing line created by performing a curve fitting for the biological test data including the cell growth factor and the anti-cancer agent response factor of the cell.”
Claim 33 recites “… use the sensitivity prediction model to determine the sensitivity of the biological individual to the anti-cancer agent in terms of whether treatment response is positive or negative based on the biological test data and the reference data.”
Claim 34 recites “… use the sensitivity prediction model to determine a degree of treatment response to the anti-cancer agent and provide the degree of treatment response to the anti- cancer agent determined by the sensitivity prediction model.”
Claim 39 recites “calculating Z-scores of the anti-cancer agent response factor and Z-scores of the cell growth factor according to the cell experiments; obtaining a prediction dividing line by performing a curve fitting for the Z-scores; determining whether treatment response of the biological specimen to the anti-cancer agent is positive or negative with respect to the prediction dividing line;”
Limitations reciting a mental process.
Claims 19, 21-25, 28, 30-34, 37 and 39 contain limitations recited at such a high level of generality that they equate to a mental process because they are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), which the courts have identified as concepts that can be practically performed in the human mind or by a human using pen and paper. The paragraph below discusses the limitations in these claims that recite a mental process under their broadest reasonable interpretation (BRI):
The BRI of obtaining a prediction dividing line includes performing a curve fitting using a function recited in claims 23/32. The BRI of determining treatment response based on the prediction dividing line includes analyzing data and making a mental determination. The BRI of using a sensitivity prediction model to extract a sensitivity characteristic includes performing the operations of a probit regression, which a human could practically do using pen and paper. The BRI of determining the sensitivity based on the sensitivity characteristic includes evaluating data and making a determination. The BRI of performing a curve fitting using a probit regression includes a human performing the operations of the probit regression. The BRI of selecting an anti-cancer agent includes making a mental determination. The BRI of calculating Z-scores includes performing calculations using pen and paper.
Limitations reciting a mathematical concept.
Claims 19, 22-23, 28, 31-32, 37 and 39 recite limitations that equate to a mathematical concept because they are similar to the concepts of 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)), which the courts have identified as mathematical concepts. The BRI in claims 19, 22, 31, 28, 37 and 39 of performing a curve fitting includes performing calculations using a function recited in claims 23/32. In claim 39, calculating Z-scores recites a mathematical concept.
As such, claims 19-39 recite an abstract idea (Step 2A, Prong 1: Yes).
Step 2A, Prong 2:
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exception is not integrated into a practical application because the claims do not recite additional elements that reflect an improvement to a computer, technology, or technical field (MPEP § 2106.04(d)(1) and 2106.5(a)), require a particular treatment or prophylaxis for a disease or medical condition (MPEP § 2106.04(d)(2)), implement the recited judicial exception with a particular machine that is integral to the claim (MPEP § 2106.05(b)), effect a transformation or reduction of a particular article to a different state or thing (MPEP § 2106.05(c)), nor provide some other meaningful limitation (MPEP § 2106.05(e)). Rather, the claims include limitations that equate to an equivalent of the words “apply it” and/or to instructions to implement an abstract idea on a computer (MPEP § 2106.05(f)) and to insignificant extra-solution activity (MPEP § 2106.05(g)). The instant claims recite the following additional elements:
Claim 19 recites “receiving biological test data according to cell experiments for a biological specimen separated from a biological individual; providing a sensitivity prediction model which comprises a two-dimensional graph that includes a first axis that represents an anti-cancer agent response factor and a second axis that represents a cell growth factor, wherein the cell growth factor is at least one selected from the group consisting of a rate of increase in cell viability, a cell growth rate, a rate of increase in cell size, and a colony generation rate that indicates a cell growth according to cell experiments concerning the cell growth rate; performing an anti-cancer therapy on the biological individual using the anti-cancer agent whose treatment response is positive, and wherein the anti-cancer agent response factor is at least one selected from the group consisting of IC50, %IC50, and an area under the curve (AUC), and wherein the anti-cancer agent includes targeted anti-cancer drugs or chemical anti-cancer drugs .”
Claim 20 recites “wherein the biological test data according to cell experiments are at least one selected from the group consisting of a name of the anti-cancer agent, a concentration of the anti-cancer agent, a dilution ratio of the anti-cancer agent, and the cell viability.”
Claim 21 recites “wherein the sensitivity prediction model is further configured to …”
Claim 24 recites “receiving reference data of clinical trial results for the biological individual prior to the step of determining whether treatment response is positive or negative”
Claim 25 recites “wherein the method further comprises: providing the degree of treatment response to the anti-cancer agent determined by the sensitivity prediction model.”
Claim 26 recites “authenticating a user intending to receive the evaluation results on the sensitivity of the biological individual to the anti-cancer agent, prior to a step of receiving the biological test data.”
Claim 27 recites “wherein the anti-cancer agent is doxorubicin, wherein the biological individual is an entity with ovarian cancer or breast cancer.”
Claim 28 recites “A system for selecting an anti-cancer agent for an anti-cancer therapy, the system comprising: a communication unit configured to receive biological test data according to cell experiments for a biological specimen separated from a biological individual; and a processor operationally connected to the communication unit, wherein the processor is configured to: provide a sensitivity prediction model, which comprises a two-dimensional graph that contains a first axis that represents an anti-cancer agent response factor and a second axis that represents a cell growth factor; wherein the cell growth factor is at least one selected from the group consisting of a rate of increase in cell viability, a cell growth rate, a rate of increase in cell size, and a colony generation rate that indicates a cell growth according to cell experiments concerning the cell growth rate, wherein the anti-cancer agent response factor is at least one selected from the group consisting of IC50, %IC50, and an area under the curve (AUC), and wherein, during the cell experiments, the biological specimen is cultured on a culture plate that includes: a containing space for containing a cell culture solution; and a plurality of pillar portions that protrude from a bottom surface of the culture plate by a predetermined height and are configured to accommodate cells.”
Claim 29 recites “wherein the biological test data according to cell experiments are at least one selected from the group consisting of a name of the anti-cancer agent, a concentration of the anti-cancer agent, a dilution ratio of the anti-cancer agent, and the cell viability.”
Claim 30 recites “wherein the sensitivity prediction model is further configured to … wherein the processor is further configured to …”
Claim 33 recites “a receiver for receiving reference data of clinical trial results for the biological individual, wherein the processor is further configured to . . .”
Claim 34 recites “wherein the processor is further configured to . . .”
Claim 35 recites “wherein the processor is further configured to authenticate a user intending to receive the evaluation results on the sensitivity of the biological individual to the anti-cancer agent.”
Claim 36 recites “wherein the anti-cancer agent is a drug used for anti-cancer therapy, including doxorubicin, wherein the biological individual is an entity with cancer, including ovarian cancer, lung cancer, stomach cancer, or breast cancer.”
Claim 37 recites “A non-transitory computer-readable medium storing a program executing the method according to claim 19.”
Claim 38 recites “The non-transitory computer-readable medium according to claim 37, wherein the biological test data according to cell experiments are at least one selected from the group consisting of the name of the anti-cancer agent, the concentration of the anti-cancer agent, the dilution ratio of the anti-cancer agent, and cell viability.”
Claim 39 recites “receiving biological test data according to cell experiments for a biological specimen separated from a biological individual; providing a sensitivity prediction model which comprises a two-dimensional graph that includes a first axis that represents an anti-cancer agent response factor and a second axis that represents the cell growth factor; performing an anti-cancer therapy on the biological individual using the anti-cancer agent whose treatment response is positive, wherein the anti-cancer agent response factor is at least one selected from the group consisting of IC50, %IC50, and an area under the curve of a cell viability rate or a rate of change of cell viability, wherein the cell growth factor is at least one selected from the group consisting of a rate of increase in cell viability, a cell growth rate, a rate of increase in cell size, and a colony generation rate that indicates a cell growth according to cell experiments concerning the cell growth rate, and wherein the anti-cancer agent includes targeted anti-cancer drugs or chemical anti-cancer drugs.”
Regarding the above cited limitations in claims 28-36 and 37-38 of the system comprising a communication unit, a processor connected to the communication unit, and a receiver nor the non-transitory computer-readable medium storing a program. There are no limitations requiring anything other than generic computer components. As such, these limitations equate to mere instructions to implement the 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. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Regarding the above cited limitations in claims 19, 24-26, 28, 33, 35, 37 and 39 of receiving biological test data, receiving reference data, providing a sensitivity prediction model, providing the degree of treatment response, and authenticating a user. These limitations equate to insignificant, extra-solution activity of mere data gathering and data outputting. These limitations gather data used for the judicial exception and output the results of the judicial exception; both of which do not provide any meaningful limitations.
Regarding the above cited limitations in claims 19-20, 27-29 and 36-39 that further limit the anti-cancer agent response factor, the anti-cancer agent, the cell growth factor, the biological test data, the biological individual, and the sensitivity prediction model also recite insignificant, extra-solution activity of necessary data gathering.
The limitation in claims 19 and 39 of “performing an anti-cancer therapy on the biological individual using the anti-cancer agent whose treatment is responsive” is contingent upon determining positive treatment response. MPEP 2111.04 recites “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” As such, performing an anti-cancer therapy is not required by the claim when a negative treatment response is determined.
The following limitations in claim 28 are being interpreted as product by process limitations: “wherein, during the cell experiments, the biological specimen is cultured on a culture plate that includes: a containing space for containing a cell culture solution; and a plurality of pillar portions that protrude from a bottom surface of the culture plate by a predetermined height and are configured to accommodate cells.” These limitations define a process previously performed for the cell experiments, which are used to receive the biological test data. As such, they are not required to be performed by the claim.
As such, claims 19-39 are directed to an abstract idea (Step 2A, Prong 2: 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). These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because these claims recite additional elements that equate to instructions to apply the recited exception in a generic way and/or in a generic computing environment (MPEP § 2106.05(f)) and to well-understood, routine and conventional (WURC) limitations (MPEP § 2106.05(d)). The instant claims recite the following additional elements:
Claim 19 recites “receiving biological test data according to cell experiments for a biological specimen separated from a biological individual; providing a sensitivity prediction model which comprises a two-dimensional graph that includes a first axis that represents an anti-cancer agent response factor and a second axis that represents a cell growth factor, wherein the cell growth factor is at least one selected from the group consisting of a rate of increase in cell viability, a cell growth rate, a rate of increase in cell size, and a colony generation rate that indicates a cell growth according to cell experiments concerning the cell growth rate; performing an anti-cancer therapy on the biological individual using the anti-cancer agent whose treatment response is positive, and wherein the anti-cancer agent response factor is at least one selected from the group consisting of IC50, %IC50, and an area under the curve (AUC), and wherein the anti-cancer agent includes targeted anti-cancer drugs or chemical anti-cancer drugs .”
Claim 20 recites “wherein the biological test data according to cell experiments are at least one selected from the group consisting of a name of the anti-cancer agent, a concentration of the anti-cancer agent, a dilution ratio of the anti-cancer agent, and the cell viability.”
Claim 21 recites “wherein the sensitivity prediction model is further configured to …”
Claim 24 recites “receiving reference data of clinical trial results for the biological individual prior to the step of determining whether treatment response is positive or negative”
Claim 25 recites “wherein the method further comprises: providing the degree of treatment response to the anti-cancer agent determined by the sensitivity prediction model.”
Claim 26 recites “authenticating a user intending to receive the evaluation results on the sensitivity of the biological individual to the anti-cancer agent, prior to a step of receiving the biological test data.”
Claim 27 recites “wherein the anti-cancer agent is doxorubicin, wherein the biological individual is an entity with ovarian cancer or breast cancer.”
Claim 28 recites “A system for selecting an anti-cancer agent for an anti-cancer therapy, the system comprising: a communication unit configured to receive biological test data according to cell experiments for a biological specimen separated from a biological individual; and a processor operationally connected to the communication unit, wherein the processor is configured to: provide a sensitivity prediction model, which comprises a two-dimensional graph that contains a first axis that represents an anti-cancer agent response factor and a second axis that represents a cell growth factor; wherein the cell growth factor is at least one selected from the group consisting of a rate of increase in cell viability, a cell growth rate, a rate of increase in cell size, and a colony generation rate that indicates a cell growth according to cell experiments concerning the cell growth rate, wherein the anti-cancer agent response factor is at least one selected from the group consisting of IC50, %IC50, and an area under the curve (AUC), and wherein, during the cell experiments, the biological specimen is cultured on a culture plate that includes: a containing space for containing a cell culture solution; and a plurality of pillar portions that protrude from a bottom surface of the culture plate by a predetermined height and are configured to accommodate cells.”
Claim 29 recites “wherein the biological test data according to cell experiments are at least one selected from the group consisting of a name of the anti-cancer agent, a concentration of the anti-cancer agent, a dilution ratio of the anti-cancer agent, and the cell viability.”
Claim 30 recites “wherein the sensitivity prediction model is further configured to … wherein the processor is further configured to …”
Claim 33 recites “a receiver for receiving reference data of clinical trial results for the biological individual, wherein the processor is further configured to . . .”
Claim 34 recites “wherein the processor is further configured to . . .”
Claim 35 recites “wherein the processor is further configured to authenticate a user intending to receive the evaluation results on the sensitivity of the biological individual to the anti-cancer agent.”
Claim 36 recites “wherein the anti-cancer agent is a drug used for anti-cancer therapy, including doxorubicin, wherein the biological individual is an entity with cancer, including ovarian cancer, lung cancer, stomach cancer, or breast cancer.”
Claim 37 recites “A non-transitory computer-readable medium storing a program executing the method according to claim 19.”
Claim 38 recites “The non-transitory computer-readable medium according to claim 37, wherein the biological test data according to cell experiments are at least one selected from the group consisting of the name of the anti-cancer agent, the concentration of the anti-cancer agent, the dilution ratio of the anti-cancer agent, and cell viability.”
Claim 39 recites “receiving biological test data according to cell experiments for a biological specimen separated from a biological individual; providing a sensitivity prediction model which comprises a two-dimensional graph that includes a first axis that represents an anti-cancer agent response factor and a second axis that represents the cell growth factor; performing an anti-cancer therapy on the biological individual using the anti-cancer agent whose treatment response is positive, wherein the anti-cancer agent response factor is at least one selected from the group consisting of IC50, %IC50, and an area under the curve of a cell viability rate or a rate of change of cell viability, wherein the cell growth factor is at least one selected from the group consisting of a rate of increase in cell viability, a cell growth rate, a rate of increase in cell size, and a colony generation rate that indicates a cell growth according to cell experiments concerning the cell growth rate, and wherein the anti-cancer agent includes targeted anti-cancer drugs or chemical anti-cancer drugs.”
Regarding the above cited limitations in claims 28-36 and 37-38 of the system comprising a communication unit, a processor connected to the communication unit, and a receiver nor the non-transitory computer-readable medium storing a program. These limitations equate to instructions to implement an abstract idea on a generic computing system, which the courts have established does not provide an inventive concept in Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). Additionally, in claims 37-38, storing code on a non-transitory computer readable medium equates to storing information in memory, which the courts have established as a WURC function of a generic computer in Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015).
Regarding the above cited limitations in claims 19, 24-26, 28, 33, 35, 37 and 39 of receiving biological test data, receiving reference data, providing a sensitivity prediction model, providing the degree of treatment response, and authenticating a user. The broadest reasonable interpretation of these limitations include that they are computer-implemented. As such, these limitations equate to transmitting/receiving data over a network, which the courts have established as a WURC limitation of a generic computer in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
Regarding the above cited limitations in claims 19-20, 27-29 and 36-39 that further limit the anti-cancer agent, the anti-cancer agent response factor, the cell growth factor, the biological test data, the biological individual, and the sensitivity prediction model. These limitations limit the type of data being transmitted/received but do not change the fact that data is being transmitted/received. Thus, these limitations also equate to a WURC limitation of a generic computer of receiving/transmitting data over a network.
Regarding the above cited limitations in claims 26 and 35 about user authentication in order to receive evaluation results, this is a WURC limitation of a generic computing system as taught by Velasquez et al. (“Velasquez”; Information and Software Technology 94 (2018): 30-37; previously cited on PTO892 mailed 11/01/2023). Velasquez teaches that user authentication is a central component of any security infrastructure and is a common means to verifying a user’s identify before allowing access to resources in a computer system (abstract) (pg. 30, col. 1, para 1).
The limitation in claims 19 and 39 of “performing an anti-cancer therapy on the biological individual using the anti-cancer agent whose treatment is responsive” is contingent upon determining positive treatment response. MPEP 2111.04 recites “The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met.” As such, performing an anti-cancer therapy is not required by the claim when a negative treatment response is determined.
The following limitations in claim 28 are being interpreted as product by process limitations: “wherein, during the cell experiments, the biological specimen is cultured on a culture plate that includes: a containing space for containing a cell culture solution; and a plurality of pillar portions that protrude from a bottom surface of the culture plate by a predetermined height and are configured to accommodate cells.” These limitations define a process previously performed for the cell experiments, which are used to receive the biological test data. As such, they are not required to be performed by the claim.
When these additional elements are considered individually and in combination, they do not provide an inventive concept because they all equate to WURC functions/components of a generic computer and/or generic computing system. Therefore, these additional elements do not transform the claimed judicial exception into a patent-eligible application of the judicial exception and do not amount to significantly more than the judicial exception itself (Step 2B: No).
As such, claims 19-39 are not patent eligible.
Response to Arguments under 35 USC 101
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive.
Applicant argues that claims improve the technical field of administrating anti-cancer agents and cancer treatment. Applicant states that there are problems to predict treatment response to an anti-cancer drug in clinical trials when just using just IC50. This problem is solved by evaluating treatment response using both anti-cancer agent response factors (e.g. IC50) and cell growth factors (e.g. cell growth rate) (pg. 12, para. 1 – pg. 13, para. 1 of Applicant’s remarks). Applicant’s arguments are not persuasive for the following reasons:
It appears that the alleged improvement is a result of the following limitations identified as reciting an abstract idea in claims 19, 28 and 39: “obtaining a prediction dividing line by performing a curve fitting for the anti-cancer agent response factor and the cell growth factor according to the cell experiments; determining whether treatment response of the biological specimen to the anti-cancer agent is positive or negative with respect to the prediction dividing line.” However, MPEP 2106.05(a) recites “the judicial exception alone cannot provide the improvement.” As such, claims 19, 28, and 39 do not improve the technical field of cancer treatment response prediction.
Applicant appears to argue that claims 19 and 39 contain a particular treatment (pg. 13, para. 2-3 of Applicant’s remarks). Applicant’s arguments are not persuasive for the following reasons:
Performing an anti-cancer therapy on the biological individual is contingent upon determining positive treatment response. When treatment response is negative, anti-cancer therapy is not performed. Claims 19 and 39 do not recite a particular treatment because the treatment is not required.
Applicant discusses limitations in claim 28 that are physical things, which makes claim 28 not directed to an abstract idea (pg. 13, last para. – pg. 14, para. 1 of Applicant’s remarks). Applicant’s argument is not persuasive for the following reasons:
MPEP 2106.I recites “It is well-settled that mere recitation of concrete, tangible components is insufficient to confer patent eligibility to an otherwise abstract idea.” The culture plate in claim 28 has been identified as a product by process limitation that is not required by the claim. See discussion above in section Step 2A, Prong 2.
Conclusion
No claims are allowed.
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/N.A.A./Examiner, Art Unit 1687
/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685