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 arguments against the rejection of claims under 35 USC 101, the Examiner respectfully disagrees. Applicant argues that the claims reflect specific technical improvements int eh field of digital therapeutics, in that the specification describes improvements to regulatory burdens updates to digital therapeutic software by partitioning a core package from a treatment package. Examiner asserts that there is no indication in the Specification that the partitioning of the software packages is done in a specific, particular way to carry out the abstract idea. As noted in the rejection of this Office Action in Step 2A Prong Two of the rejection, the Specification recites the use of software packages and partitioning the software in a generic manner that is used as a tool to carry out the abstract idea. The “digital” aspect of the digital therapeutics recites mere computer implementation as noted in the Office Action. The method providing the “latest knowledge, research or guidelines” for a given treatment to aid in the regulatory burden and improving the updating frequency does not recite a technology improvement, as the use of the generic software package configuration and generically partitioning the packages is used as tool to carry out the abstract idea related to providing specific information to a user about the treatment for the disease. Providing specific information related to the treatment of the disease may demonstrate an improvement to the abstract idea, however this would not be 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.”
Applicant further argues that the safety module represents a further technical solution to a technical problem in that this module provides a drug database of safe dosage ranges to a known technical problem, namely regulation of dosages below toxic levels. Examiner further asserts that this module and access to a database is used as a generic computer component to provide information of imposing a rule of drug dosages, where actions such as “cross checking” dosages, ensuring dosages are within recommended safety limits are a part of the abstract idea. Again, the use of the software to improve aspects of the abstract idea are not technology improvements, 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.”
Regarding the arguments against the rejection of claims under 35 USC 103, Examiner agrees and therefore this rejection is withdrawn.
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 2-11, 13-15, 17-20, 22, 24-27 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 2-11, 13-15, 17-20, 22, 24-27 are a method (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).
Representative independent claim 26 includes limitations that recite at least one abstract idea. Specifically, independent claim 26 recites:
A method of treatment comprising:
providing a digital treatment system comprising:
one or more treatment specific packages, each treatment specific package for treating a different respective disease or condition, the disease or condition of a first treatment specific package being obesity;
a core package comprising a treatment configurator and a safety module;
wherein the core package is software partitioned from the one or more treatment specific packages;
wherein each treatment specific package of the one or more treatment specific packages comprises a respective treatment configuration including:
a respective one or more interaction directives configured to account for one or more treatment interactions; and
one or more treatment specific safeguards configured to be enforced by the safety module of the core package;
wherein the method further comprises:
receiving, from each treatment specific package of the one or more treatment specific packages, the respective treatment configuration;
for each treatment configuration:
configuring, by the treatment configurator of the core package, a treatment specific therapy based on the respective treatment configuration of the treatment specific package; and
applying by the safety module, one or more treatment-specific safeguards including at least one drug dosage constraint; and
administering a drug to a patient in accordance with the treatment specific therapy, wherein the drug comprises an obesity drug therapy in an amount effective to treat obesity in the patient.
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 are related to configuring a specific treatment for a patient with obesity:
a respective treatment configuration which includes interactions directives configured to account for one or more treatment interactions and where the treatment is for a disease or condition, more specifically for obesity, which is an abstract limitation of analysis for describing directives for treatment interactions,
one or more treatment specific safeguards configured to be enforced, which is an abstract limitation related to further describing the interaction with the other individual taking the treatment by considering safeguards for the treatment,
“receiving” the respective treatment configuration, which is an abstract limitation related to observing and considering an initial treatment configuration,
“configure”, for each treatment configuration, a treatment specific therapy based on the respective treatment configuration for the obesity, which is an abstract limitation related to a judgment by considering the abstract adjusted treatment configuration to further configure the therapies specific for the obesity,
applying one or more treatment-specific safeguards including at least one drug dosage constraint, which is an abstract limitation further describing the abstract safeguards including a drug dosage constraint that needs to be considered for the treatment of the patient with obesity.
The claim limitations as a whole recite steps for configuring a specific treatment for a patient with obesity, and therefore recite managing interactions between people. The steps of observation, analysis and judgments for the configuration of a patient’s treatment is for the management of the care of the other person, and therefore recites certain methods of organizing human activity.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 11 recites receiving patient data and configuring the treatment specific therapies based on the patient data, thus further describing the abstract idea. Claim 13 recites treatment instructions that includes treatment decisions or indications of patient data to configure the treatment specific therapies, thus further describing the abstract idea. Claim 14 recites processing the treatment decisions, thus further describing the abstract idea. Claim 17 recites inherent safeguards for configuring the treatment specific therapies, thus further describing the abstract idea. Claim 18 recites determining inherent drug safeguards based on drug data, thus further describing the abstract idea. Claim 19 recites the configuration of the treatment with specific safeguards, thus further describing the abstract idea. Claim 22 recites the treatment specific therapies as being digital therapies and how it comprises a dosage regimen for a pharma therapy, thus further describing the abstract idea. Claim 25 recites acquiring data and processing treatment decisions based on the data, thus further describing the abstract idea. Claim 27 recites further abstract details describing the non-pharmacological therapy as comprising cognitive behavioral therapy or an exercise regimen, 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 claim as a whole integrates 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 26:
A method of treatment comprising:
providing a digital treatment system 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)):
one or more treatment specific packages, each treatment specific package for treating a different respective disease or condition, the disease or condition of a first treatment specific package (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)) being obesity;
a core package comprising a treatment configurator and a safety module;
wherein the core package is software partitioned from the one or more treatment specific packages (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f));
wherein each treatment specific package of the one or more treatment specific packages comprises a respective treatment configuration including:
a respective one or more interaction directives configured to account for one or more treatment interactions; and
one or more treatment specific safeguards configured to be enforced by the safety module of the core package (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f));
wherein the method further comprises:
receiving, from each treatment specific package of the one or more treatment specific packages, the respective treatment configuration;
for each treatment configuration:
configuring, by the treatment configurator of the core package, a treatment specific therapy based on the respective treatment configuration of the treatment specific package; and
applying by the safety module (amounts to nothing more than an instruction to apply the abstract idea using a generic computer as noted below, see MPEP 2106.05(f)), one or more treatment-specific safeguards including at least one drug dosage constraint; and
administering a drug to a patient in accordance with the treatment specific therapy, wherein the drug comprises an obesity drug therapy in an amount effective to treat obesity in the patient (merely post solution activity as noted below, see MPEP 2106.05(g) and Symantec).
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 digital treatment system, a core package comprising a treatment configurator and a safety module, a specific treatment package, a wherein the core package is software partitioned from the one or more treatment specific packages, wherein the core package is adapted to perform parts of the abstract idea, the use of the safety module of the core package to be used for part of the abstract idea, the use of the treatment specific package to include the treatment configuration, and the use of the treatment configurator to carry out parts of the abstract idea, 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)). [Figure 2] of Applicant’s Specification recites the overall digital treatment system. [Page 19 lines 20-25] of Applicant’s Specification recites details of the core package as comprising a mobile application. [Page 15 lines 5-20] recites the treatment configurator of the system that includes generic computing components recited as engines and [Page 32] for example recites the use of the configurator. [Page 16 lines 30-35, Page 17 lines 1-10, Page 18 lines 4-10] recites generally and generically the safety aspect of the module as being algorithms carrying out part of the abstract idea by generically accessing a database for information specific for the treatment. [Page 20, lines 5-25] recites further detail of the treatment package as being downloaded and integrated with the mobile app. [Pages 6-7] recites how the core package is software partitioned from the treatment package as being separate blocks of code. [Page 21] describes how the core package is used. [Page 15] recites the treatment package including the configuration, for example. [Page 7 lines 25-31] for example recites the specific nature of the treatment packages, however there is no indication that this improves a technology. The configuration of these computing components such as the configurator to perform aspects of the abstract idea are constructed from other generic computing components. These limitations recite the use of generic computing technologies of blocks of software to carry out the abstract idea without a specific implementation or technological improvement, and is thus mere computer implementation.
Regarding the additional limitation of administering a drug to a patient in accordance with the treatment specific therapy, wherein the drug comprises an obesity drug therapy in an amount effective to treat obesity in the patient, 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)). [Page 28 lines 11-15] of Applicant’s specification recites the delivery (or administration) of the treatment (or drug) by instructing a connected device to do so, and where a condition such as obesity is considered as described in [Page 18 lines 17-23]. Merely performing the delivery of the treatment specific therapy after configuring the treatment specific therapy recites impractical application. Additionally, merely claiming the treatment as specific and that it is an administered drug therapy that amounts to effectively treating obesity does not impose a meaningful limit on the judicial exception as it is not an affirmative limitation and is merely a nominal addition to the claim, see MPEP 2106.04(d)(2).
Thus, 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 manage patient treatment therapy, 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).
For these reasons, the independent claims do not recite additional elements that integrate the judicial exception into a practical application.
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claim 2 recites the use of core modules in the core package and treatment modules in the treatment package, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 3 recites a core platform and how the core software is configured to operate the core platform, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 4, 5 recites how the software modules is a separated partition of the software with module performance properties that are further described in claim 5, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 6 recites exported instruments with data that the software module can provide to other parts of the system that is further described in claim 7, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 8 recites providing the instrument requests as described, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 9 recites using a reference interface to communicate the first and second modules and is further described in claim 10, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 15 recites the use of algorithms that are associated with the packages, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 18 recites the use of a drug database to receive data, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 20 recites the use of a contract specification for the software module, however there is no specific configuration of the computing components and therefore recite mere computer implementation. Claim 24 recites the partitions and configuring of software modules with the core platform as described, however there is no specific configuration of the computing components and therefore recite mere computer implementation.
Thus, taken alone, 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 claim does 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 additionally 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 the additional limitation of the overall digital treatment system, a core package comprising a treatment configurator and a safety module, a specific treatment package, a wherein the core package is software partitioned from the one or more treatment specific packages, wherein the core package is adapted to perform parts of the abstract idea, the use of the safety module of the core package to be used for part of the abstract idea, the use of the treatment specific package to include the treatment configuration, and the use of the treatment configurator to carry out parts of the abstract idea, 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)). [Figure 2] of Applicant’s Specification recites the overall digital treatment system. [Page 19 lines 20-25] of Applicant’s Specification recites details of the core package as comprising a mobile application. [Page 15 lines 5-20] recites the treatment configurator of the system that includes generic computing components recited as engines and [Page 32] for example recites the use of the configurator. [Page 16 lines 30-35, Page 17 lines 1-10, Page 18 lines 4-10] recites generally and generically the safety aspect of the module as being algorithms carrying out part of the abstract idea by generically accessing a database for information specific for the treatment. [Page 20, lines 5-25] recites further detail of the treatment package as being downloaded and integrated with the mobile app. [Pages 6-7] recites how the core package is software partitioned from the treatment package as being separate blocks of code. [Page 21] describes how the core package is used. [Page 15] recites the treatment package including the configuration, for example. [Page 7 lines 25-31] for example recites the specific nature of the treatment packages, however there is no indication that this improves a technology. The configuration of these computing components such as the configurator to perform aspects of the abstract idea are constructed from other generic computing components. These limitations recite the use of generic computing technologies of blocks of software to carry out the abstract idea without a specific implementation or technological improvement, and is thus mere computer implementation and does not recite significantly more than the judicial exception.
Regarding the additional limitation of administering a drug to a patient in accordance with the treatment specific therapy, wherein the drug comprises an obesity drug therapy in an amount effective to treat obesity in the patient, 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) and 2106.05(d)(II), specifically “Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information)”). [Page 28 lines 11-15] of Applicant’s specification recites the delivery (or administration) of the treatment (or drug) by instructing a connected device to do so, and where a condition such as obesity is considered as described in [Page 18 lines 17-23]. Merely performing the delivery of the treatment specific therapy after configuring the treatment specific therapy recites impractical application. The specific treatment is merely transmitted to a “connected” device to deliver or administer the treatment without a specific implementation of the device to perform this action as described in [Page 28 lines 11-15]; the transmitting and forwarding of this information to the connected device recites well understood, routine, and conventional activities.
The dependent 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 2-11, 13-15, 17-20, 22, 24-27 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
/JASON B DUNHAM/Supervisory Patent Examiner, Art Unit 3686