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 2/27/26. Claims 1-2, 4-5, 8, and 11-12 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/27/26 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 4-5, 8, and 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 4, and 11 have been amended to recite: “over a network …when the terminal device is at a different location than a site where the medicine was administered.” The examiner was unable to find support in the originally filed disclosure for terminal device location and URL transmission.
Applicant is requested to point out support for the newly added claim language in the originally filed disclosure, or to cancel the unsupported subject matter.
Dependent claims 2, 5, 8, and 11 inherit the deficiencies of their respective independent claims, and are therefore also rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-5, 8, and 11-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 4, and 11 recite “store the medical care information and the response information as concealed data on which a secret sharing process has been performed;” “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.”
The applicant’s disclosure must fully disclose the claimed invention process/method/product for which applicant seeks patent protection. The claim language must clearly and plainly disclose the most comprehensive form of the invention. Insofar as the applicant’s disclosure also uses the terms “a secret sharing process” and “performed by using a secret calculation processing,” the claims are vague and indefinite and fail to point out that which applicant regards as the invention.
Additionally, claim 1 has been amended to further recite: “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, over a network as a Uniform Resource Locator (URL) when the terminal device is at a different location than a site where the medicine was administered, 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.” Claims 4 and 11 have been amended recite similar limitations
It is unclear from this claim language which steps are actively being performed in the method. More specifically, it is unclear which steps/ and elements of the claim method are considered part of the claimed “consent confirmation procedure.”
Additionally it is unclear which elements are “sent together over at network as a…URL. “ The claim recites: consent inquiry information; a questionnaire ; and “a request for response to the questionnaire.” It is unclear which of these elements are sent together. ( which 2 or all 3)
Claims 2, 5, 8, and 12 inherits the deficiencies of claims 1, 4, and 11 respectively, through dependency, and are therefore also rejected.
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 patient compliance and patient 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, 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-5, 8, and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vemireddy et al ( US 20130179178 A1) in view of Jain et al (US 20170246086 A1), and in further view of Lin et al (Lin Y, Zheng J, He Y. “VICO: Ontology-based representation and integrative analysis of Vaccination Informed Consent forms.” J Biomed Semantics. 2016 Apr 19; vol. 7:20. doi: 10.1186/s13326-016-0062-4. PMID: 27099700; PMCID: PMC4837519.)
Claims 1, 4, and 11-12 Vemireddy discloses a patient follow-up research support system for supporting follow-up research on a patient who has received administration of a medicine, the patient follow-up research support system including a terminal device for information registration and a support control apparatus capable of communicating information data with the terminal device via a network, (par. 42, par. 48) the terminal device including processing circuitry configured to:
accept an input of administration completion information issued to the patient who has received the administration of the medicine and to transmit the administration completion information to the support control apparatus together with unique identification information for identifying the patient; (fig. 1; par. 44-patient entered data; par. 83- the next step is to identify the number of these patients who are currently taking a beta blocker. This will provide information to the physicians about which patients are currently not taking a beta blocker and allow review to see if non-compliance may be an issue. After appropriate follow-up with these patients, the clinical measure can be re-calculated to see if there is improvement in the measurement score) ;
accept an input of medical care information including medical inquiry information related to the patient to receive administration of the medicine, (par. 44- the HRA 130 presents the patient 102 with questions that are relevant to his or her medical history and currently presented conditions. The risk assessment logic branches dynamically to relevant and/or critical questions;) and to transmit the medical care information to the support control apparatus together with the unique identification information of the patient, (par. 44-transmitted to and stored with PHR);
transmit, to the support control apparatus 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 a request for response transmitted from the support control apparatus, (par. 4- PHR solicits patient input for tracking: the PHR accepts patient input of family health history, patient's allergies, current over-the-counter medications and herbal supplements, unreported and untreated conditions, as well as input for monitoring items such as blood pressure, cholesterol, and additional pertinent medical information that is likely to be within the realm of patient's knowledge; par. 41-the PHR 108 also solicits the patient's input for entering additional pertinent medical information, tracking of alert follow-up actions and allows the health care organization 100 to track alert outcomes.)
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; (par. 76-79-receiving patient entered data and storing data with previously submitted patient data (used in baselining patient)
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 the request for response to the terminal device corresponding to the extracted research target person; (par. 44-patient data is gathered- The risk assessment logic branches dynamically to relevant and/or critical questions, thereby saving the patient time and providing targeted results. The data entered by the patient 102 into the HRA 130 also populates the corresponding data fields within other areas of PHR 108. The health care organization 100 aggregates the clinical data 114, patient-entered data 128; par. 45-in reviewing patient data, rules trigger inconsistencies or data changes which suggest patient should receive a more targeted interaction; par. 83-review of patient data allows physician to target patients for who medication compliance may be an issue)
receive the response information transmitted from the terminal device in response to the request for response and to store the received response information; and (par. 9- clinical alerts include notifications to contact the health care provider in order to start or stop a specific medication and/or to undergo a specific examination or test procedure associated with one or more conditions and co-morbidities specific to the patient. To ensure prompt patient response, the health care organization sends concurrent email notifications to the patient regarding availability of individualized alerts at the PHR. The clinical alerts notify the patient regarding known drug interactions and suggested medical therapy based on the best evidence-based medical standards of care. In addition to condition specific alerts, the rules engine module notifies the patient regarding relevant preventive health information by issuing personalized wellness alerts, via the PHR.)
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; (par. 55-56)
Vemireddy discloses the system and method substantially as claimed, but does not expressly disclose: “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
Jain discloses a system including an analysis processing section configured to:
perform analysis processing on the concealed response information and the concealed medical care information and estimate a condition change of the patient after the administration of the medicine based on the response information and to output an estimation result. (par. 73- a system as described herein is capable of analyzing a dosing regimen to produce an effect on the body of the user that addresses the circadian patterns of different bodily systems and functions to improve the effects of medication(s) taken by the user; par. 74-75-determining baselines and magnitude of improvement by comparing data; par. 83-85- the system may determine whether the updated state of the biological marker has changed, e.g., improved or worsened, more than a threshold amount compared to the relevant, e.g., same, baseline. In one aspect, the circadian variation in the biological marker may be incorporated into the comparison.) At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system and method of Vemireddy with the teaching of Jain to estimate and output the improvement of a patient taking a medication, with the motivation of accurately assessing whether a therapy is benefiting a patient or whether other therapeutic intervention is necessary.
Claims 1,4 and 11 and 12 further recite:
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;
Vemireddy and Jain in combination disclose teach method/system of patient follow-up research support system, but do not expressly disclose wherein the terminal device is further configured to: 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, over a network as a Uniform Resource Locator (URL) when the terminal device is at a different location than a site where the medicine was administered, 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; and transmit, to the support control apparatus together with the unique identification information via the URL, 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.
Lin discloses a system and method comprising:
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, over a network as a Uniform Resource Locator (URL)( (when the terminal device is at a different location than a site where the medicine was administered: See rejection under 35 USC 112(a); also, location of device does not receive patentable weight) with a request for response to the questionnaire from the support control apparatus, (Methods: par. 1-collection of consent forms and questionnaires at websites; Results section: VICO ontology design- specific VICO terms were generated to represent the vaccination/immunization informed consent forms from different vaccination providers or governments, such as ‘Costco vaccination informed consent form’ (Fig. 1). Another example is ‘vaccination screening questionnaire’, defined as ‘A questionnaire that contains different questions of a vaccination patient’s health history, allergy history, and current condition, in order to assess the contraindication and precaution for administering a vaccine’ in VICO. This term was generated for representing questionnaire embedded in a vaccination informed consent form. The questions for vaccination patients can be answered by the patients themselves, or their legal representatives, prior to a vaccination procedure) to accept an input of consent confirmation information of the patient with respect to a response to the questionnaire, (Methods: par. 1-collection of consent forms and questionnaires at websites); and to transmit the consent confirmation information to the support control apparatus together with the unique identification information of the patient; and transmit, to the support control apparatus together with the unique identification information via the URL, 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 (pg. 12, par. 3-4) At the time of filing, it would have been obvious to one of ordinary skill in the art to modify the system and method of Vemireddy and Jain in combination with the teaching of Lin. One would have been motivated to include these features to facilitate data analysis, data integration, and to aid institutions who perform or monitor the vaccination procedures with more complete information/feedback (Li: pg. 12, par. 3)
Claims 2 and 5 Vemireddy teaches the patient follow-up research support system according to claim 1, wherein the terminal device further includes processing circuitry to: add the medical care information to the administration completion information, extract the patient corresponding to the extraction condition as the research target person, and to transmit questionnaire information corresponding to contents of the administration completion information and the medical care information together with the request for response to the terminal device corresponding to the extracted research target person. (par. 76-77-patient receives and completes questionnaire sent requesting additional information or follow-up information; par. 92-94)
response information.(par. 89-90-recommending patient outreach)
Claim 8. Vemireddy teaches the support control apparatus according to claim 4, further comprising an incentive provision processing section configured to execute consent confirmation processing with respect to use of the response information by the support control apparatus with the terminal device, and to execute processing of providing an incentive to the patient who has received the administration of the medicine and has consented to the use. (par. 51-incentives for patient response)
Response to Arguments
Applicant's arguments filed 2/27/26 have been fully considered but they are not persuasive.
(A) 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 patient compliance and patient condition improvement or change after receiving 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, but does 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 (pg. 12 of the response) represent an improvement to the abstract idea, not a technological improvement.
(B) Applicant argues that Jain does not disclose “using secret data sharing on data.” Applicant further discloses that Vemireddy does not disclose “using secret calculation processing.”
In response, it should be noted that the recitation of a “secret sharing process” and “secret calculation processing” render the claims vague and indefinite. As explained in the claim rejections under 35 USC 112(b), the applicant’s disclosure must fully disclose the claimed invention process/method/product for which applicant seeks patent protection. The claim language must clearly and plainly disclose the most comprehensive form of the invention. Insofar as the applicant’s disclosure also uses the terms “a secret sharing process” and “performed by using a secret calculation processing,” the claims are vague and indefinite and fail to point out that which applicant regards as the invention.
The examiner has given the claim language the broadest reasonable interpretation and applied art according.
(C) Applicant argues that the prior art does not disclose the claims as amended.
In response, the examiner has provided new grounds of rejection to address the amended claim language.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
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)
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.
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RACHEL L. PORTER
Primary Examiner
Art Unit 3684
/Rachel L. Porter/ Primary Examiner, Art Unit 3684
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