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 .
This communication is in response to the amendment filed 7/29/26. Claims 1-2, 4-5, 8, and 11-12 are pending.
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 1-2, 4-5, 8, and 11-12 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.
35 USC 101 enumerates four categories of subject matter that Congress deemed to be appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter. As explained by the courts, these “four categories together describe the exclusive reach of patentable subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls outside the plainly expressed scope of Section 101 even if the subject matter is otherwise new and useful.” In re Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007). Step 1 of the eligibility analysis asks: Is the claim to a process, machine, manufacture or composition of matter? Applicant’s claims fall within at least one of the four categories of patent eligible subject matter because claims 1-2, 4-5, and 8 are drawn to a system/apparatus , and claim 11 is drawn to a method. Claims 12 is drawn to a product/article of manufacture
Determining that a claim falls within one of the four enumerated categories of patentable subject matter recited in 35 USC 101 (i.e., process, machine, manufacture, or composition of matter) in Step 1 does not complete the eligibility analysis. Claims drawn only to an abstract idea, a natural phenomenon, and laws of nature are not eligible for patent protection. As described in MPEP 2106, subsection III, Step 2A of the Office’s eligibility analysis is the first part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l,134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. at 77-78, 101 USPQ2d at 1967-68).
In 2019, the United States Patent and Trademark Office (USPTO) prepared revised guidance (2019 Revised Patent Subject Matter Eligibility Guidance) for use by USPTO personnel in evaluating subject matter eligibility. The framework for this revised guidance, which sets forth the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas), is described in MPEP sections 2106.03 and 2106.04.
As explained in MPEP 2106.04(a)(2), the 2019 Revised Patent Subject Matter Eligibility Guidance explains that abstract ideas can be grouped as, e.g., mathematical concepts, certain methods of organizing human activity, and mental processes. Moreover, this guidance explains that a patent claim or patent application claim that recites a judicial exception is not ‘‘directed to’’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception. A claim that recites a judicial exception, but is not integrated into a practical application, is directed to the judicial exception under Step 2A and must then be evaluated under Step 2B (inventive concept) to determine the subject matter eligibility of the claim.
Step 2A asks: Does the claim recite a law of nature, a natural phenomenon (product of nature) or an abstract idea? (Prong One) If so, is the judicial exception integrated into a practical application of the judicial exception? (Prong Two) A claim recites a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is set forth or described in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, while the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.” A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.
In the instant case, claims 1-2, 4-5, 8, and 11-12 recite(s) a method and system for certain methods of organizing human activities, which is subject matter that falls within the enumerated groupings of abstract ideas described in MPEP 2106.04 (2019 Revised Patent Subject Matter Eligibility Guidance) Certain methods of organizing human activities includes fundamental economic practices, like insurance; commercial interactions (i.e. legal obligations, marketing or sales activities or behaviors, and business relations). Organizing human activity also encompasses managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions.) The recited method and system are drawn to monitoring a patient’s condition improvement or change after receiving medication.
In particular, the claims 1 and 11recite a method and system configured to:
accept, an input of administration completion information issued to the patient who has received the administration of the medicine, and
accept an input of medical care information including medical inquiry information related to the patient to receive administration of the medicine, and to transmit the medical care information to the support control apparatus together with the unique identification information of the patient;
execute a consent confirmation procedure, in response to consent inquiry information for inquiring whether there is a consent to respond to a questionnaire, which is sent together with a request for response to the questionnaire from the support control apparatus, to accept an input of consent confirmation information of the patient with respect to a response to the questionnaire, and to transmit the consent confirmation information to the support control apparatus together with the unique identification information of the patient;
transmit, together with the unique identification information, response information that represents a condition of the patient after administration of the medicine and that is input in response to the request for response, after executing the consent confirmation procedure;
receive the administration completion information transmitted from the terminal device and to store the received administration completion information in association with the unique identification information;
extract based on the administration completion information and a preset extraction condition, the patient corresponding to the extraction condition as a research target person and to transmit together with the consent inquiry information the request for response to the terminal device corresponding to the extracted research target person;
receive the response information transmitted from the terminal device and to store the received response information, when confirming consent of the patient in respect to a response to the questionnaire with the consent confirmation information returned from the terminal device, and the consent of the patient is confirmed;
store the received medical care information and the response information as concealed data on which a secret sharing process has been performed that fragments the data without allowing restoration of the fragmented data to the original data;
perform analysis processing on the concealed response information and the concealed medical care information on which the secret sharing process has been performed by using a secret calculation processing without restoring the concealed data to the original data; and
estimate whether or not a harmful reaction has occurred in the patient and whether on-line medical care or face-to-face medical care for the patient is necessary based on the analysis processing performed on the response information and the medical care information
Similarly, claims 4 and 12 recite similar language.
This judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id. An “inventive concept” is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973 (rejecting “the Government’s invitation to substitute Sections 102, 103, and 112 inquiries for the better established inquiry under Section 101”). As made clear by the courts, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the Section 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp.,838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9).
As described in MPEP 2106.05, Step 2B of the Office’s eligibility analysis is the second part of the Alice/Mayo test, i.e., the Supreme Court’s “framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2355, 110 USPQ2d 1976, 1981 (2014) (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961 (2012)). Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception? The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 1, 4, 11, and 12 have been amended to further recite: “transmit the estimation results on whether or not a harmful side reaction has occurred in the patient.” However, the additional perform functions well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
Claims 1, 4, and 11 recite additional limitation(s), including a terminal device, the support control apparatus; a network; the terminal device; Uniform Resource Locator (URL) Claim 12 recites a program storage medium/article of manufacture. The additional components is/are generic components that perform functions well-understood, routine and conventional activities that amount to no more than implementing the abstract idea with a computerized system.
The generic nature of the computer system used to carryout steps of the recited method is underscored by the system description in the instant application, which discloses: “The network NW includes, for example, a wide area network having the Internet as a core and an access network for accessing the wide area network. As the access network, a public wired or wireless communication network, a local wired or wireless area network (LAN), and a cable television (CATV) network are used." (par. 34) The disclosure also states: “The vaccinated person terminal UT is composed of, for example, a general-purpose smartphone including a camera, a browser, and an application for transferring information data using email, a social network system (SNS), a short message service (SMS), or the like. As the vaccinated person terminal UT, a tablet terminal, a wearable terminal, a notebook personal computer, or the like may be used as long as it has a similar function.” (par. 38)
The application explains: “The input/output I/F 5D is connected to an input/output device 6D and a camera 7D. The input/output device 6D is composed of, for example, a display device using liquid crystal or organic electro-luminescence (EL), and an input device using a touch-type input sheet of a pressure-sensitive type or a capacitance type disposed on a display screen of the display device.” (see par. 41) Such language underscores that the applicant's perceived invention/ novelty focuses on the computerized implementation of the abstract idea, not the underlying structure of the additional (generic) components.
Furthermore, the courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). Among these are the following features, which are recited in claims 1, 4,9 and 11-13:
- Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added));
- Performing repetitive calculations, Flook, 437 U.S. at 594, 198 USPQ2d at 199 (recomputing or readjusting alarm limit values); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims.");
- 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;
- Electronically scanning or extracting data from a physical document, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) (optical character recognition); and
Claim 2 is dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claim 2 further define the abstract idea, but fail to recite significantly more than the abstract idea. Therefore, claim(s) 2 is also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 5 and 8 are dependent from Claim 4 and include(s) the limitations of claim(s) 4 and 9 respectively. However, the additional limitations of the claims 5 and 8 and further define the abstract idea, but fail to recite significantly more than the abstract idea. Therefore, claim(s) 5 and 8 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Because Applicant’s claimed invention recites a judicial exception that is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed invention is not patent eligible.
Response to Arguments
Applicant's arguments filed 7/29/2026 have been fully considered.
(A) The rejections under 35 USC 112(a) and 112(b) have been withdrawn.
(B) Applicant argues the claim rejections under 35 USC 101. Applicant argues that the claims are not drawn to an abstract idea.
In response the examiner disagrees. The instant invention recites a method and system for certain methods of organizing human activity. More specifically, the recited method and system are drawn to monitoring a patient’s condition improvement or change after receiving a medication.
The judicial exception is not integrated into a practical application because the claim language does not recite any improvements to the functioning of a computer, or to any other technology or technical field (See MPEP 2106.04(d)(1); see also MPEP 2106.05(a)(I-II)). Moreover, the claims do not integrate the judicial exception into a practical application because the claimed invention does not: apply the judicial exception with, or by use of, a particular machine (see MPEP 2106.05(b)); effect a transformation or reduction of a particular article to a different state or thing (see MPEP 2106.05(c)); or apply or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment see MPEP 2106.05(e). (Considerations for integration into a practical application in Step 2A, prong two and for recitation of significantly more than the judicial exception in Step 2B)
Applicant’s amendment to recite communication/transmission of data via URL is noted, and transmission of results data from the patient terminal is also noted. However, these limitations do not render the claims patent eligible. The courts have recognized certain computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (See MPEP 2106.05 (d) (II)). These functions include receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)).
Additionally, consideration of improvements is relevant to the integration analysis regardless of the technology of the claimed invention. That is, the consideration applies equally whether it is a computer-implemented invention, an invention in the life sciences, or any other technology. See, e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., in which the court noted that a claimed process for preserving hepatocytes could be eligible as an improvement to technology because the claim achieved a new and improved way for preserving hepatocyte cells for later use, even though the claim is based on the discovery of something natural.(See 827 F.3d 1042, 1048 (Fed. Cir. 2016)) Notably, the court did not distinguish between the types of technology when determining that the invention improved technology.
However, it is important to keep in mind that an improvement in the judicial exception itself (e.g., a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG LLC, the court determined that the claim 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. (921 F.3d 1084, 1093-94 (Fed. Cir. 2019).
The features argued by applicant represent an improvement to the abstract idea, not a technological improvement. As explained by applicant, the claimed invention provides a technique that enables the technological environment to provide follow-up research after medication for a wider range of patients who have received the medication. (pg. 13-14)
Applicant suggests that the inclusion of secret sharing process and secret calculation processing provides a technological improvement in the claimed invention. However, as also explained by applicant, “these terms are established in the art and it is believed that when accompanied by their functional description in the claims would be understood to a person of ordinary skill in the art.” (see pg. 11 of the response). As such, they are understood to be well-known, and not inventive or a technological improvement. Moreover, the claims do not actively recite secret sharing or secret processing calculation processing as steps performed during the claimed method or by the claimed system. As drafted, this language is used to describe the “concealed medical care information,” and seems to occur beyond the scope of the claimed invention.
(C) Applicant argues that the prior art does not disclose the claims as amended.
The prior art rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Koide et al (US 20230215524 A1)- discloses a method and system for tracking immunizations including an information system performing secret calculation by using the transmitted information:
([0065] The secret calculation unit 42 performs secret calculation on an immunity certificate of one person or a plurality of immunity certificates of a plurality of person stored in the storage unit 41, and obtains a result of the secret calculation. The result of the secret calculation is, for example, the above-described “information based on an immunity certificate of an individual” and can be effectively used by a person other than the individual.)
Geba et al (US 20200048337 A1) discloses a system and method wherein a patient must provide informed consent to authorize participation as a research target in a sub-study regarding improvement after administration of a drug compound : (par. 38; par. 209)
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachel L Porter whose telephone number is (571)272-6775. The examiner can normally be reached M-F, 10-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rachel L. Porter/Primary Examiner, Art Unit 3684
