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 .
Response to Arguments
Regarding the rejection of claims under Double Patenting, due to the filing of the Terminal Disclaimer, this rejection is withdrawn.
Regarding the arguments against the rejection of claims under 35 USC 101, the Examiner respectfully disagrees. Applicant argues that claim 21 does not recite certain methods of organizing human activity, in that “stochastically introduce at least one error into simulation results of the VCT based on a defined probability” has nothing to do with managing interactions between people. Examiner asserts that, as noted in the Step 2A Prong 2 analysis, the “virtual” nature of the clinical trial is the result of the mere computer implementation of the abstract idea related to the management of a clinical trial. Stochastically introducing an error into the results based on a probability recites an interaction with the clinical trial for the management of its results. Regarding the use of court cases to support the analysis of the claims reciting an abstract idea, it is not necessary to cite a specific case, only the groupings of the judicial exceptions are to be analyzed and applied to the claims, see MPEP 2106.04(a). MPEP 2106.04(a)(2) recites several examples that demonstrate managing interactions or personal behaviors, such as “considering historical usage information while inputting data, BSG Tech. LLC v. Buyseasons, Inc., 899 F.3d 1281, 1286, 127 USPQ2d 1688, 1691 (Fed. Cir. 2018)”. Even though this example is not the same as the instant application, it does demonstrate the consideration of information while inputting data, which is similar to the consideration of the probability when introducing or inputting the error into the results.
Claims 34 and 38, as noted in the rejection below under Step 2A Prong One, recites simulating courses of treatments for individuals by considering events as noted in the analysis, where these steps collectively are for the management of the care of the patients, and therefore recites organizing human activity as analyzed below.
Applicant further argues that Example 38 is analogous to the instant application, in that there is no judicial exception recited. Examiner further asserts that this Example recites the simulation of an analog audio mixer, which recites a technology that is not represented as a judicial exception. The instant application recites the simulation of clinical trials and consideration of factors for the treatment of a patient, which recites certain methods of organizing human activity.
Applicant further argues that the claims do integrate the abstract idea into a practical application, in that the claim’s additional elements integrate the alleged abstract idea into a practical application because the additional elements reflect an improvement in technology or provides a particular treatment or prophylaxis. Examiner asserts that the use of the modules as claims recites generic modules in a computing environment that amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components. There is no indication of the modules or other parts of the computing environment to provide an improved technology or optimize resource allocation in the computing environment itself. Improving clinical trial results by using the generic computing devices recites an improvement to the abstract idea, not necessarily a technology improvement, See MPEP 2106.05(a)II, particularly “Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.” and see MPEP 2106.05(f), specifically” "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”
Applicant further argues that claim 38 integrates the alleged abstract idea into a practical application because it includes a step that applies a judicial exception to affect a particular treatment or prophylaxis. Examiner asserts that the addition of the step of “administering” the treatment as claimed is merely insignificant post solution activity. The action of administering the patient based on the prescription recites impractical application because this activity is incidental to the abstract idea and is merely a nominal or tangential addition to the claim. The generality of the condition of the patient and the generality of the treatment itself is not particular, and thus does not integrate the abstract idea into a practical application, see MEP 2106.04(d)(2).
Applicant further argues that the claims amount to significantly more than the judicial exception. Examiner asserts that GPS, machine learning, and sensors were not analyzed to be a part of the claims. In regards to the other additional elements as noted in the Step 2B analysis below, the elements were analyzed both individually and in combination.
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 21-40 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.).
Patent Subject Matter Eligibility Test: Step 1:
First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I).
Claims 21-33 are related to a system, and claims 34-40 are also related to methods (i.e., a process). Accordingly, these claims are all within at least one of the four statutory categories.
Patent Subject Matter Eligibility Test: Step 2A- Prong One:
Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2).
Independent claim 21 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 21 recites:
An apparatus, comprising:
a memory storing instructions; and
a processing circuit configured to execute the instructions, which when executed, case the processing circuit to:
execute at least one software module implementing at least one clinic module of a virtual clinical trial (VCT), the at least one clinic module configured to stochastically introduce at least one error into simulation results of the VCT based on a defined probability.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, as the abstract limitations of stochastically introducing at least one error into simulation results of the virtual clinical trials based on a defined probability is a process that a person can do when managing results of a clinical trial and recites managing interactions between people.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., processor) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims for claim 21 further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 22 recites further the generation of simulation results by simulating a course of treatment of a health condition for a plurality of patient avatars, where the patient avatars are modeled, abstract representations of patients; the simulation of treatments further describes the abstract idea. Claim 24 recites further abstract limitations describing the error as measurement error, further describing the abstract idea. Claim 25 recites further abstract limitations describing the error as incomplete data, further describing the abstract idea. Claim 26 recites further abstract limitations describing the error as the use of unusable samples, further describing the abstract idea. Claim 27 recites further abstract limitations describing the error as erroneous physician decision, further describing the abstract idea. Claim 28 recites further abstract limitations describing the probability as being based on real world probability of errors associated with real-world clinical data, further describing the abstract idea. Claim 29 recites further the introduced error as being based on real-world operational data of a corresponding entity, further describing the abstract idea. Claim 30 recites further abstract limitations describing the stochastically introduced errors into the simulation results to provide ecologically valid simulation of real-world clinical data associated with the virtual clinical trial, further describing the abstract idea. Claim 31 recites further detail of the simulation and real-world clinical data associated with the virtual clinical trials as a correlation greater than 90%, further describing the abstract idea. Claim 32 recites further abstract limitations describing the patient avatars as physiologically based mathematical models for a health condition, further describing the abstract idea. Claim 33 recites further abstract information describing the patient avatars as being personalized that correspond to a specific patient associated with real data, further describing the abstract idea.
Independent claim 34 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 34 recites:
A method comprising:
executing a virtual clinical trial (VCT) to generate simulation results by simulating a course of treatment of a health condition for a plurality of patient avatars, the VCT generating the simulation results via:
advancing virtual information of each of the plurality of avatars through a series of clinic modules, each of the series of clinic modules configured to model at least one event of an entity of the VCT, wherein a frequency of the event is based on a defined probability for the at least one event, and
generating at least one event result responsive to an occurrence of the event, the at least one event result representing a consequence of the occurrence of the event, wherein the simulation results are generated based, at least in part, on the at least one event result.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing interactions between people as the following abstract limitations recite generating simulation results by simulating a course of treatment of a health condition for a plurality of patient avatars:
Advancing virtual information of each of the plurality of avatars, which recites the analysis and management of information of patients that are represented as abstract models,
Modeling at least one event of an entity of the virtual clinical trial, wherein a frequency of the event is based on a defined probability for at least one event, which is an abstract limitation reciting the management of the data related to an event for the trial,
generating at least one event result responsive to an occurrence of the event, the at least one event result representing a consequence of the occurrence of the event, wherein the simulation results are generated based, at least in part, on the at least one event result, which are abstract limitations of analyzing the data of the event and consideration of results for the management of the trial.
The claim limitations as a whole recite steps for generating simulation results by simulating a course of treatment of a health condition for a plurality of patient avatars and therefore recites managing human activity. The model representation of the avatars, events and clinical trial are abstract, and where the consideration of the data related to the event represents the management of a clinical trial and thus managing interactions between people.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., processor) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims for claim 34 further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 36 describes further abstract limitations of the probability as being based on real-world clinical data, further describing the abstract idea. Claim 37 recites further abstract limitations further describing the stochastic inclusion of error in the simulation results of the virtual clinical trial based on the defined probability, further describing the abstract idea.
Independent claim 38 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 38 recites:
A method of treating a health condition of a patient:
determining a prescription for treating the health condition of the patient based, at least in part, on simulation results of a virtual clinical trial (VCT) simulating a course of treatment of the health condition for a plurality of patient avatars, the VCT generating the simulation results via:
advancing virtual information of each of the plurality of avatars through a series of clinic modules, each of the series of clinic modules configured to model at least one event of an entity of the VCT, wherein a frequency of the event is based on a defined probability for the at least one event, and
generating at least one event result responsive to an occurrence of the event, the at least one event result representing a consequence of the occurrence of the event, wherein the simulation results are generated based, at least in part, on the at least one event result; and
administering the treatment to the patient based on the prescription.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing interactions between people as the following abstract limitations recite treating a health condition of a patient by determining a prescription as claimed:
use of simulation results of a virtual clinical trial that simulates a course of treatment of the health condition for patient avatars, which recites abstract limitations of data analysis by consideration of data of the abstract patient representations to manage the care of the patient,
advancing virtual information of each of the avatar to model an event of an entity of the virtual clinical trial where a frequency of the event is based on a defined probability, which recites abstract limitation of the management of data of an event and consideration of the data from the avatar for the management of the care of the patient,
generating at least one event result responsive to an occurrence of the event, the at least one event result representing a consequence of the occurrence of the event, wherein the simulation results are generated based, at least in part, on the at least one event result, which are abstract limitations of analysis of the consequences of the event, and where the results are used to determine a prescription for the real patient.
The claim limitations as a whole recite steps for treating a health condition of a patient by determining a prescription and therefore recites managing human activity. The modeling of the clinical trial, patient, and events are used as data analysis to be used for the treatment of a patient, thus reciting managing interactions between people.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” (i.e., processor) and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims for claim 38 further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 39 recites further abstract limitations further describing the stochastic inclusion of error in the simulation results of the virtual clinical trial based on the defined probability to provide ecologically valid simulation of real-world clinical data associated with the virtual clinical trial, further describing the abstract idea. Claim 40 recites further detail of the prescription as being based on simulation results of the plurality of patient avatars sharing characteristics with the patient, further describing the abstract idea.
Patent Subject Matter Eligibility Test: Step 2A- Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claims as a whole integrate the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrates the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.).
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Regarding claim 21:
An apparatus, comprising:
a memory storing instructions; and
a processing circuit configured to execute the instructions, which when executed, cause the processing circuit to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)):
execute at least one software module implementing at least one clinic module of a virtual clinical trial (VCT), the at least one clinic module configured to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) stochastically introduce at least one error into simulation results of the VCT based on a defined probability.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of an apparatus comprising memory storing instructions and a processing circuit configured to execute the instructions, which when executed, cause the processing circuit to perform steps, and execute at least one software module implementing at least one clinic module of a virtual clinical trial (VCT), the at least one clinic module configured to perform steps, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0040] of the Applicant’s Specification recites the use of generic computing components for the apparatus using generic memory and processors. [0034, 0040] recites the use of generic modules for the clinical module for the virtual clinical trial, computerizing the clinical trial in a computing environment. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to stochastically introduce at least one error into simulation results, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claims 23, 24, 25, 26, 27 recite the use of generic computing modules as clinical modules to represent the laboratory, physician, or hospital, however these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components.
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Regarding claim 34:
A method comprising (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)):
executing a virtual clinical trial (VCT) to generate simulation results by simulating a course of treatment of a health condition for a plurality of patient avatars, the VCT generating the simulation results via:
advancing virtual information of each of the plurality of avatars through a series of clinic modules, each of the series of clinic modules configured to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) model at least one event of an entity of the VCT, wherein a frequency of the event is based on a defined probability for the at least one event, and
generating at least one event result responsive to an occurrence of the event, the at least one event result representing a consequence of the occurrence of the event, wherein the simulation results are generated based, at least in part, on the at least one event result.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of the overall computer-implemented method, and use of the clinical modules, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0040] of the Applicant’s Specification recites the use of generic computer components, indicating the computer implemented method being used. [0034, 0040] recites the use of generic modules for the clinical module for the virtual clinical trial, computerizing the clinical trial in a computing environment. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to generate simulation results by simulating a course of treatment of a health condition for a plurality of patient avatars, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claim 35 recites the use of generic computing modules as clinical modules to represent the laboratory, physician, or hospital, however these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components.
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Regarding claim 38:
A method of treating a health condition of a patient:
determining a prescription for treating the health condition of the patient based, at least in part, on simulation results of a virtual clinical trial (VCT) simulating a course of treatment of the health condition for a plurality of patient avatars, the VCT generating the simulation results via:
advancing virtual information of each of the plurality of avatars through a series of clinic modules, each of the series of clinic modules configured to (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) model at least one event of an entity of the VCT, wherein a frequency of the event is based on a defined probability for the at least one event, and
generating at least one event result responsive to an occurrence of the event, the at least one event result representing a consequence of the occurrence of the event, wherein the simulation results are generated based, at least in part, on the at least one event result; and
administering the treatment to the patient based on the prescription (merely post solution activity as noted below, see MPEP 2106.05(g) and Versata Dev. Group, Inc. v. SAP Am., Inc.).
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitation of the overall method using a series of clinical modules, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). [0034, 0040] recites the use of generic modules for the clinical module for the virtual clinical trial, computerizing the clinical trial in a computing environment. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer.
Regarding the additional limitation of administering the treatment to the patient based on the prescription, this is merely post-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g)). [0034, 0088] of the Applicant’s Specification recites the administration of the treatment to the patient. The action of administering the patient based on the prescription recites impractical application because this activity is incidental to the abstract idea and is merely a nominal or tangential addition to the claim.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to treat a health condition of a patient, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Patent Subject Matter Eligibility Test: Step 2B:
Regarding Step 2B of the Subject Matter Eligibility Test, the independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application, see MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d).
Regarding claim 21:
Regarding the additional limitation of an apparatus comprising memory storing instructions and a processing circuit configured to execute the instructions, which when executed, cause the processing circuit to perform steps, and execute at least one software module implementing at least one clinic module of a virtual clinical trial (VCT), the at least one clinic module configured to perform steps, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f) and MPEP § 2106.05(d)(II), specifically “storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93”). [0040] of the Applicant’s Specification recites the use of generic computing components for the apparatus using generic memory and processors. [0034, 0040] recites the use of generic modules for the clinical module for the virtual clinical trial, computerizing the clinical trial in a computing environment. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception. The retrieval of the steps of the overall computing system and modules from memory recites well understood, routine, and conventional activity.
Regarding claim 34:
Regarding the additional limitation of the overall computer-implemented method, and use of the clinical modules, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f) and MPEP § 2106.05(d)(II), specifically “storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93”). [0040] of the Applicant’s Specification recites the use of generic computer components, indicating the computer implemented method being used. [0034, 0040] recites the use of generic modules for the clinical module for the virtual clinical trial, computerizing the clinical trial in a computing environment. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception. The retrieval of the steps of the overall computing system and modules from memory recites well understood, routine, and conventional activity.
Regarding claim 38:
Regarding the additional limitation of the overall method using a series of clinical modules, the Examiner submits that these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f) and MPEP § 2106.05(d)(II), specifically “storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93”). [0034, 0040] recites the use of generic modules for the clinical module for the virtual clinical trial, computerizing the clinical trial in a computing environment. The additional elements recite the use of generic computing components with a non-specific implementation to carry out steps of the abstract idea without showing an improvement to technology, computers or other technical fields, and thus recites mere instructions to implement the abstract idea on a computer and does not recite significantly more than the judicial exception. The retrieval of the steps of the overall computing system and modules from memory recites well understood, routine, and conventional activity.
Regarding the additional limitation of administering the treatment to the patient based on the prescription, this is merely post-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of insignificant application to the at least one abstract idea in a manner that does not meaningfully limit the at least on abstract idea (see MPEP § 2106.05(g)). [0034, 0088] of the Applicant’s Specification recites the administration of the treatment to the patient. The action of administering the patient based on the prescription recites impractical application because this activity is incidental to the abstract idea and is merely a nominal or tangential addition to the claim and does not recite significantly more than the judicial exception; see MPEP 2106.05(g), “Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) (non-precedential)”.
The dependent claims for each of the independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exceptions for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
For the reasons stated, the claims fail the Subject Matter Eligibility Test and therefore claims 21-40 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Conclusion
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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/CONSTANTINE SIOZOPOULOS/
Examiner
Art Unit 3686
Prosecution Insights