DETAILED ACTION
Notice to Applicant
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 application filed on 8/13/25. Claims 1-23 are pending.
The IDS filed on 12/5/25 has been considered.
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 21-22 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.
Claim 21 recite “wherein said selected wearables or other sensors wearables are specifically by the Al engine according to the clinical trial protocol, but the clinical trial protocol does not specify a particular wearable or other sensor.”
The originally filed disclosure teaches that the method includes: “At 816, optionally one or more wearables are selected for the patient to use, in order to obtain actual activity data. “ (par. 69 of US 2026/0074029 A1) However, it is not clear from the specification how the device is selected (i.e. by the AI engine, or by a user). Moreover, while the disclosure states that the AI engine reviews or analyzes data from the information from the wearable, it does not explain “wherein said selected wearables or other sensors wearables are specifically by the Al engine according to the clinical trial protocol, but the clinical trial protocol does not specify a particular wearable or other sensor.”
Claim 22 incorporates the deficiencies of claim 21 through dependency 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 21-22 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.
Claim 21 has been amended to recite “wherein said selected wearables or other sensors wearables are specifically by the Al engine according to the clinical trial protocol, but the clinical trial protocol does not specify a particular wearable or other sensor.”
It is unclear what is/are done “specifically by the Al engine according to the clinical trial protocol…” There appears to be a term missing from the amended claim limitation. For the purpose of applying art, the examiner will interpret the claim to mean “wherein said selected wearables or other sensors wearables are specifically selected by the Al engine according to the clinical trial protocol, but the clinical trial protocol does not specify a particular wearable or other sensor.”
Claim 22 incorporates the deficiencies of claim 21 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 1-23 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 1-17; and 19-22 are drawn to systems; claims 18 and 23
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? If so, is the judicial exception integrated into a practical application of the judicial exception? 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 1-42 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 systems are drawn to developing and updating a clinical trial protocol (for patients) (i.e. managing personal behavior or relationships or interactions between people)
In particular, claims 1, 18 recite:
analyze said real-time data to determine patient compliance with clinical trial protocol requirements;- detect when patient behavior deviates from expected patterns based on said clinical trial parameters;
automatically adjust timing of alarms and prompts sent to said user computational device within said permitted time windows based on analysis of individual patient behavior patterns; and
generate protocol adjustments in response to detected compliance issues or routine disruptions while maintaining scientific rigor of said clinical trial;
wherein said system establishes a dynamic feedback loop between continuous patient monitoring through said wearable devices and adaptive protocol management, enabling real-time adjustment of patient-facing instructions based on actual patient behavior data collected between clinical visits.
Similarly, claims 19 and 23 recite:
constructing, by an AI engine on said server, a patient-facing protocol from clinical trial parameters stored in a database, said patient-facing protocol comprising specific instructions that determine when and how said patient is expected to interact with said wearable devices, when to complete questionnaires, and when to take other prescribed actions during said clinical trial;
implementing said patient-facing protocol as an operational framework that governs all patient interactions with said wearable devices, questionnaire completion schedules, and other trial-related actions;
monitoring, by said AI engine, real-time data from said wearable devices to determine patient compliance with said patient-facing protocol instructions;
detecting, by said AI engine, when patient behavior deviates from expectations defined in said patient-facing protocol;
automatically adjusting, by said AI engine, timing of alarms and prompts sent to said user computational device within permitted time windows specified in said patient-facing protocol based on analysis of individual patient behavior patterns;
dynamically modifying, by said AI engine, said patient-facing protocol instructions in response to detected compliance issues or routine disruptions while maintaining scientific rigor of said clinical trial; and
establishing a dynamic feedback loop between patient behavior monitoring and adaptive modification of said patient-facing protocol instructions
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)
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. 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, and 18 further recite a system configured to “receive real-time data from said wearable devices indicating patient behavior and physiological parameters.” Claim 18 also recites “transmitting said real-time data from said user computational device to said server through said computer network.” The additional steps amount to insignificant extra-solution activity to the judicial exception (see MPEP 2106.05(g)). Examples of insignificant extra-solution activity include mere data gathering, selecting a particular data source or type of data to be manipulated, and insignificant application. In the instant case the additional steps amount to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)
Claims 1, 18-19 and 23 recite additional limitation(s), including a user computational device…; one or more wearable devices comprising sensors; a server for constructing the patient-facing protocol; and a computer network for communication between the user computational device and the server, wherein the server comprises a database for storing clinical trial parameters. The additional components is/are generic components that perform 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: “It is noted that any device featuring a processor (which may be referred to as “data processor”; “pre-processor” may also be referred to as “processor”) and the ability to execute one or more instructions may be described as a computer, a computational device, and a processor (e.g., see above), including but not limited to a personal computer (PC), a server, a cellular telephone, an IP telephone, a smart phone, a PDA (personal digital assistant), a tablet or phablet, including without limitation an iPad, a thin client, a mobile communication device, a smart watch, head mounted display or other wearable that is able to communicate externally, a virtual or cloud based processor, a pager, and/or a similar device. Two or more of such devices in communication with each other may be a “computer network." (par.10) The disclosure also states: “ server gateway 120 preferably comprises processor 130 and memory with machine readable instructions 131 with related or at least similar functions, including without limitation functions of server gateway 120 as described herein. “ (par. 25) The description of system components 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, 18, 19, and 23 (i.e. a database for storing clinical trial parameters; communication between the medical information computational device and the server)
- 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;
Claims 1, 18, 19, and 23 further recite that the systems further comprise an “AI engine.” The recitation of AI in the claims fails to recite significantly more, and amounts to adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, (e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984. (See MPEP 2106.05(A)))
Applicant’s disclosure explains that: ”[v]arious types of NLP (natural language processing) algorithms may be used in place of, or in combination with, any of the AI models as described herein.” (par. 37) The disclosure further describes “exemplary, illustrative, non-limiting AI engines according to at least some embodiments of the present invention.” (par. 35) As drafted, the incorporation of the AI engine is recited with a high level of generality, and it is used merely as a tool to perform an existing process (i.e. analyzing clinical trial data and developing patient instructions and patient tasks for participation in a clinical trial)
Claims 2-17 are dependent from Claim 1 and include(s) all the limitations of claim(s) 1. However, the additional limitations of the claims 2-17 fail to recite significantly more than the abstract idea, and do not render the claims patent eligible. (i.e. recite additional generic system components; recite additional limitations which further define the abstract ideas and/or recite insignificant extra-solution activities.) Therefore, claim(s) 2-17 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claims 20-22 are dependent from Claim 19 and include(s) all the limitations of claim(s)19. However, the additional limitations of the claims 20-22 fail to recite significantly more than the abstract idea. Claims 20-22 recite additional limitations which further define the abstract ideas, recite additional generic system components and/or recite insignificant extra-solution activities Therefore, claim(s) 20-22 are also rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Because Applicant’s claimed inventions recite judicial exceptions that are not integrated into a practical application and do not include additional elements that are sufficient to amount to significantly more than the judicial exception itself, the claimed inventions are not patent eligible.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
-Colley et al (US 20210090694 A1): Colley discloses a system for constructing clinical trial protocols by extracting key information from the medical information, the clinical trial protocol and the clinical trial parameters, using natural language processing and constructing a protocol from extracted key information. (par. 147; par. 202; par. 315; par. 383; par. 1015; par. 2564-2565: Clinical trials may be routinely gathered via any of the collection mediums to identify new clinical trials or modifications to existing clinical trials. A new clinical trial may be added to the clinical trial data storage and any modifications may be updated to be reflected in the clinical trial data storage. Detailed clinical trial information may include inclusion and exclusion criteria corresponding to any of the features stored in the comprehensive patient data store…; par. 2594 )
-Adelson et al (US 20060294108 A1)- Adelson discloses a system and method for customizing times and alarms for patients required to complied with treatment protocols (par. 11- communications interactions include transmission of a personalized message to the end user's communications device(s) to manage compliance with the schedule, and, if suitable, reception of a responsive or end user-initiated message confirming compliance with the schedule and optionally including other related information, such as a description of the end user's experiences resulting from compliance with the schedule and/or pertinent data such as personal medical metrics and other related data, processing the data and sending, in real time, intelligent management data back to the end user.)
Shah et al ( US 20230410959 A1)- Methods and systems for interacting with and/or managing a clinical trial protocol via an electronic clinical trial protocol management system. The electronic clinical trial protocol management system capable of handling one or more treatment cycles within the clinical trial protocol, and having one or more occurrence programmatic elements and one or more treatment cycle programmatic elements
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
Prosecution Insights