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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/22/2026 has been entered.
Status of Claims
In the amendment filed 1/22/2026 the following occurred: Claims 1 and 7 were amended; and Claim 8 was canceled. Claims 1-7 and 9-20 are presented for examination.
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 1-7 and 9-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-20 are drawn to a device, which is/are statutory categories of invention (Step 1: YES).
Independent claim 1 recites acquire a previous medicine intake time and a next scheduled medicine intake time, wherein the previous medicine intake time is a time when a patient previously took a prescription medicine, and the next scheduled medicine intake time is a predetermined time when the patient will take a next dose of the prescription medicine; and a type of the prescription medicine and a measure in response to the patient's failure to take the type of the prescription medicine in correspondence with each other, wherein, if the patient failed to take the prescription medicine, suggest a response method in response to the patient's failure to take the prescription medicine based on the measure stored, the previous medicine intake time, the next scheduled medicine intake time, and a first time when a confirmation operation of failing intake of medicine was detected, estimate a blood concentration of the prescription medicine at the time and a maximum blood concentration of the prescription medicine in a case where taking the prescription medicine on both the first time and the next scheduled medicine intake time based on properties of the prescription medicine; determine whether to set either the first time or the next scheduled medicine intake time as a next recommended medicine intake time, which is a time recommended for the patient to take the next dose of the prescription medicine, based on the blood concentration and the maximum blood concentration that were estimated; determine that the next recommended medicine intake time is the next scheduled medicine intake time in a case where the estimated maximum blood concentration exceeds a threshold that may possibly cause side effects and the estimated blood concentration at the time of the next scheduled medicine intake time does not fall below an effective blood concentration threshold, and determine that the next recommended medicine intake time is the current time in a case where estimated blood concentration at the time of the next scheduled medicine intake time fall below the effective blood concentration threshold; and display a response method suggestion image, which describes patient information representing unique characteristics of the patient, the properties of the prescription medicine, the previous medicine intake time, the next scheduled medicine intake time, the first time, the blood concentration at the first time, the maximum blood concentration in the case of taking the medicine at both the first time and the next scheduled medicine intake time, the next recommended medicine intake time, and the response method against medicine intake failure.
The respective dependent claims 2-7 and 9-20, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the invention is to a medicine intake support device “that allows supporting adequate intake of medicine after the patient's intake status of the prescription medicine deviates from a predetermined intake status” (see: specification paragraph 21). If a claim limitation, under its broadest reasonable interpretation, covers fundamental economic principles or practices and/or managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address a problem where “medicine such as anticancer agents require strict adherence to a medicine intake time. Missing the medicine intake time and compromising the medicine intake time for the next dose is undesirable for ensuring proper therapeutic efficacy” (see: specification paragraph 3). The claims address this problem “by suggesting response methods against the patient's deviation from the predetermined intake status to a healthcare professional or the like” (see: specification paragraph 21). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including “a medicine intake support device, comprising: processing circuitry configured to…a memory that stores…the processing circuitry is further configured to:…in the memory…on an information terminal device of a healthcare professional via a network” (claim 1), “medicine intake support device…the processing circuitry is further configured to…” (claims 2-7, 9-10, 13-16, and 19), “medicine intake support device…the processing circuitry is further configured to…an information terminal device of…” (claim 8), “medicine intake support device…the processing circuitry is further configured to…an information terminal device of…” (claim 11), “medicine intake support device…the memory…the processing circuitry is further configured to…in the memory…” (claim 12), and “medicine intake support device…the processing circuitry is further configured to…an information terminal device of…” (claim 18 and 20), which are additional elements that are recited at a high level of generality (e.g., the “medicine intake support device, comprising: processing circuitry…” performs functions through no more than a statement than that said processor is “configured to” execute said functions; the “memory” is configured though no more than a statement than that said memory “stores” information; the “information terminal device”(s) is/are configured though no more than a statement than that suggestions and alarms are made “to”, and notifications are detected “from”, said information terminal device(s); the “network” is configured though no more than a statement than that to communicate information to an information terminal device performed “via” said network) such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional elements of “detect that the prescription medicine was taken in response to an electric signal generated from a sensor attached to the prescription medicine itself when the prescription medicine was taken” (claim 17), which are nominal or tangential addition to the abstract idea(s) and amount to extra-solution activity concerning mere data gathering. The addition of an insignificant extra-solution activity limitation does not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of the recited abstract idea(s) as outlined in the recitations above. See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components and limitations directed toward extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea(s) into a practical application because they do not impose any meaningful limits on practicing the abstract idea(s). Accordingly, the claims are directed to an abstract idea(s) (Step 2A Prong Two: NO).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea(s) into a practical application, using the additional elements to perform the abstract idea(s) amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea(s). The originally filed specification supports this conclusion:
Paragraph 22, where “As shown in FIG. 1, the medicine intake support device 10 includes a memory circuitry 11, an input interface 12, an output interface 13, a network interface 14, and a processing circuitry 15. The memory circuitry is an example of a memory. The medicine intake support device 10 may be connected to an information terminal device 2 of the healthcare professional and an information terminal device 3 of the patient via a network 4. The information terminal devices 2, 3 may be portable terminal devices such as a mobile phone, a tablet terminal, or a wearable terminal. The information terminal device 3 of the patient may be an information terminal device owned by the patient or an information terminal device owned by someone other than the patient, such as a caregiver of the patient.”
Paragraph 23, where “The memory circuitry 11 is a non-transitory memory device that stores various information and may be a Hard Disk Drive (HDD), a SolidState Drive (SSD), an integrated circuit memory device, or the like. The memory circuitry 11 may store a control program that controls the medicine intake support device 10 and various data used to execute the control program. The memory circuitry 11 also may be a drive device other than the HDD and SSD that reads and writes various information between portable storage media such as a Compact Disc (CD), a Digital Versatile Disk (DVD), and a flash memory, or semiconductor memory elements such as a Random Access Memory (RAM).”
Paragraph 31, where “…A mouse, a keyboard, a trackball, a switch, a button, a joystick, a touchpad, or a touch panel display, etc. may be appropriately used as the input interface 12. The input interface 12 may also include input devices used to detect the patient taking the prescription medicine. The input devices used to detect the intake of medicine may be, for example, a medicine intake storage system that detects and notifies that the prescription medicine has been removed from a storage container with sensors provided in the storage container, a detection system that detects intake behavior using a surveillance camera, or a notification system that detects and notifies that the prescription medicine was taken with a sensor attached to the prescription medicine itself. The input interface 12 may also be configured by an audio input device such as a microphone.”
Paragraph 33, where “The network interface 14 controls communication between the information terminal device 2 of the healthcare professional and the information terminal device 3 of the patient via the network 4 based on a command from the processing circuitry 15. The network interface 14 may send images suggesting response methods against the patient's intake status of the prescription medicine deviating from the predetermined intake status to at least one of the information terminal device 2 of the healthcare professional and the information terminal device 3 of the patient 3. The network interface 14 may be realized by, for instance, a network card, a network adapter, a Network Interface Controller (NIC), or the like.”
Paragraph 34, where “The processing circuitry 15 is a circuit that controls the operation of the medicine intake support device 10…”
Paragraph 35, where “…The processing circuitry 15 may be a processor. The processor configuring the processing circuitry 15 realizes functions corresponding to each program that is read by reading and executing each program from the memory circuitry 11. In other words, the memory circuitry 11 that has read each program includes each function shown in the processing circuitry 15 of FIG. 1.”
Paragraph 36, where “…For instance, the processing circuitry 15 may realize each processing function by combining a plurality of independent processors and letting each processor execute each program. Also, each processing function of the processing circuitry 15 may be realized by adequately distributing or integrating the single circuitry or the plurality of processing circuitry.”
Paragraph 59, where “…For instance, the medicine intake checking function 153 may detect that the patient took the prescription medicine using the medicine intake storage system that detects and notifies that the prescription medicine has been removed from the storage container with sensors provided in the storage container. Or the medicine intake checking function 153 may detect that the patient took the prescription medicine using the detection system that detects intake behavior of medicine with the surveillance camera. Else, the medicine intake checking function 153 may detect that the prescription medicine was taken using the notification system that detects and notifies that the prescription medicine was taken with a sensor attached to the prescription medicine itself. The sensor may be configured to generate electrical signals as the prescription medicine melts inside a stomach. Or the medicine intake checking function 153 may detect that the prescription medicine was taken in response to the patient notifying a completion of taking the medicine (e.g., pushing an intake button on an operating screen) to the medicine intake support device 10 using the information terminal device 3 of the patient…”
Paragraph 129, where “…For instance, the medicine intake checking function 153 may detect the intake with means such as the intake storage, the surveillance camera, or the sensor attached to the prescription medicine itself described above.”
Paragraph 145, where “Note that the word "processor" used in above descriptions means circuits such as, for example, a Central Processing Unit (CPU), a Graphics Processing Unit (GPU), an Application Specific Integrated Circuitry (ASIC), a programmable logic device (for example, a Simple Programmable Logic Apparatus (SPLD), a Complex Programmable Logic Apparatus (CPLD), and a Field Programmable Gate Array (FPGA)). The processor executes functions by reading and executing programs stored in the memory. Note that programs may be configured to be directly integrated in the processor instead of being stored in the memory. In this case, the processor realizes functions by reading and executing programs stored in the circuitry. Note that the processor is not limited to the case arranged as a single processor circuitry, but may be configured as a single processor by combining a plurality of independent circuits to realize functions. Furthermore, a plurality of component elements may be integrated into one processor to realize the functions.”
The claims recite the additional elements directed to pre-solution and post-solution activity, as recited and indicated above, each of which amount to extra-solution activity. The specification (e.g., as excerpted above) does not indicate that the additional element(s) provide anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are presently). See: MPEP 2106.05(g).
Further, the concepts of receiving or transmitting data over a network, such as using the Internet to gather data, and storing and retrieving information in memory have been identified by the courts as well-understood, routine, and conventional activities. See: MPEP 2106.05(d)(II).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea(s) with routine, conventional activity specified at a high level of generality in a particular technological environment. Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea(s) (Step 2B: NO).
Dependent claim(s) 2-7 and 9-20, when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea(s) without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
Applicant’s arguments from the response filed on 01/22/2026 have been fully considered and will be addressed below in the order in which they appeared.
In the remarks, Applicant argues in substance that (1) the 35 U.S.C. 101 rejections should be withdrawn because “the Office Action characterizes the claims as being directed to "certain methods of organizing human activity." Applicant respectfully submits that this characterization does not fully account for the specific technical features recited in amended claim 1. Claim 1 does not merely suggest behavioral guidance, but requires processing circuitry to perform concrete computational operations, including estimating blood concentration of a prescription medicine at a detected confirmation time, estimating a maximum blood concentration in a stacked-dose scenario, and determining a next recommended medicine intake time based on comparisons with defined efficacy and side-effect thresholds.”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
The concrete computational operations argued are representative of the abstract idea. Said features of the claims are argued as “specific technical features”, but which are representative of the abstract idea. The claims were found to cover certain methods of organizing human activity because they address a problem where “medicine such as anticancer agents require strict adherence to a medicine intake time. Missing the medicine intake time and compromising the medicine intake time for the next dose is undesirable for ensuring proper therapeutic efficacy” (see: specification paragraph 3). The claims address this problem “by suggesting response methods against the patient's deviation from the predetermined intake status to a healthcare professional or the like” (see: specification paragraph 21). Hence, it is clear that the invention is to manage the behavior between a patient and healthcare professional or the like.
In the remarks, Applicant argues in substance that (2) the 35 U.S.C. 101 rejections should be withdrawn because “Ex Parte Desjardns confirms that eligibility turns on whether the claims reflect an improvement to computer functionality or to another technology or technical field, and that such improvements may be realized through logical structures and computational processes rather than specialized hardware. The Memorandum further explains that claims should be evaluated as a whole and not at a high level of generality that overlooks meaningful technical limitations. Here, the Specification explains that, through the claimed computational approach, "the next recommended medicine intake time may be calculated conveniently and quickly" See, e.g., Specification paragraph 10109]. This disclosure reflects an improvement in how the medicine intake support device operates when responding to deviations from prescribed intake schedules, namely by enabling efficient determination of a next intake time through a defined sequence of pharmacokinetic estimations and threshold-based decisions. Amended claim 1 reflects this disclosed improvement by reciting specific estimation steps and a constrained determination of the next recommended medicine intake time based on those estimations. Consistent with Ex Parte Desjardins, such improvements need not be described in the specification using explicit performance metrics or conclusory statements of advantage. Rather, where, as here, the Specification explains that the claimed computational structure enables the device to calculate a result conveniently and quickly, and the claim recites the specific operations that achieve that result, the claim reflects a technological improvement that must be credited at Step 2A, Prong Two. The Office Action further asserts that the claimed processing circuitry, memory, and network elements are generic. However, Ex Parte cautions against dismissing claims on that basis without considering whether the claimed logical operations improve how the system operates. In the present case, the claimed processing circuitry is configured to perform a specific sequence of pharmacokinetic estimations and determinations that enables efficient calculation of a next recommended intake time, as disclosed in paragraph [0109], and is therefore not merely a generic implementation of an abstract idea.”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
There is an argued “improvement to computer functionality”, but that this improvement is “through the claimed computational approach”, which is abstract and has been shown to be abstract in the rejection above. It is argued that the invention represents “an improvement in how the medicine intake support device operates when responding to deviations from prescribed intake schedules, namely by enabling efficient determination of a next intake time through a defined sequence of pharmacokinetic estimations and threshold-based decisions”, but this is representative of the abstract idea and does not address the technology or functioning of the computer itself. The additional elements representing the technology of the claimed invention are not particular to the recited acts they perform, but instead, the recited acts may be applied with such devices at a high level. For example, the “medicine intake support device, comprising: processing circuitry…” performs functions through no more than a statement than that said processor is “configured to” execute said functions. The claims here are not directed to a specific improvement to computer functionality that amount to a practical application. Rather, they are directed to the use of conventional or generic technology in a well-known environment, without any claim that the invention reflects an inventive solution to a technical problem presented by combining the two. In the present case, the claims fail to recite any elements that individually or as an ordered combination transform the identified abstract idea(s) in the rejection into a patent-eligible application of that idea.
The Office memorandum on 12/5/2025 concerning Ex Parte Desjardins states that “the Ex Parte Desjardins decision analyzed eligibility in terms of whether the claims were directed to an improvement in the functioning of a computer, or an improvement to other technology or technical field under longstanding Federal Circuit precedent in Enfish, LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) and McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016).” Further, the memorandum quotes the Ex Parte Desjardins decision stating that: “Enfish ranks among the Federal Circuit's leading cases on the eligibility of technological improvements. In particular, Enfish recognized that “[m]uch of the advancement made in computer technology consists of improvements to software that, by their very nature, may not be defined by particular physical features but rather by logical structures and processes.” 822 F.3d at 1339. Moreover, because “[s]oftware can make non-abstract improvements to computer technology, just as hardware improvements can,” the Federal Circuit held that the eligibility determinations should turn on whether “the claims are directed to an improvement to computer functionality versus being directed to an abstract idea.” Id. at 1336. (Desjardins, page 8).”
This provides guidance on what is considered an improvement in computer functionality, and the argued “specific sequence of pharmacokinetic estimations and determinations that enables efficient calculation of a next recommended intake time” does not accord with this guidance. For example, the claims of Enfish were directed to a specific improvement to computer functionality by describing a specific type of data structure designed to improve the way a computer stores and retrieves data in memory, where the specific data structure in question was a self-referential table that functions differently than convention data structures by storing all entity types in a single table defining the table's columns by rows in that same table. The present claims are directed to an abstract idea, as shown above, and do not recite comparable features to that of Enfish. And the basis for the McRO court's decision was that the claims were directed to an improvement in computer-related technology (allowing computers to produce "accurate and realistic lip synchronization and facial expressions in animated characters" that previously could only be produced by human animators), and thus did not recite a concept similar to identified abstract idea. The present claims are directed to an abstract idea, as shown above, and do not recite comparable features to that of McRO. This issue is that the claims are, as argued, to “estimations and determinations”, which are not technical features concerning the way computers function as per Ex Parte Desjardins.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found on the attached PTO-892 form, including:
WO 2004/023245 A2 to Niemiec (see the full paragraph on page 25).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A SOREY whose telephone number is (571)270-3606. The examiner can normally be reached Monday through Friday, 8am to 5pm.
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/ROBERT A SOREY/ Primary Examiner, Art Unit 3682