DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 23 April 2026.
Claim(s) 2, 3, 5-7, 9, and 11-13 is/are canceled. Claim(s) 1, 4, 8, 10, 14-20 is/are amended.
Claim(s) 1, 4, 8, 10, and 14-20 is/are currently pending and have been examined.
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 .
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 lack a period as required by MPEP 608.01(m).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
Claim 8 is 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.
Amended claim 8 recites the non-original limitation “wherein the clinical trial is concerning heart disease, diabetes, obesity, kidney disease, gastrointestinal disease, or asthma.”
Applicant’s remarks identify [0042], [0047]-[0056], and [0090] of the pre-grant publication as support for the limitations at large. None of these disclosures appear to suggest or support that the clinical trial may concern either kidney disease or gastrointestinal disease. One of ordinary skill in the art would not recognize any support for the identified limitation in Applicant’s identified support for the amendments at large. The remainder of the originally filed disclosure similarly fails to support the identified limitation. For example, the disclosure at [0058] states “In one embodiment, the at least one clinical target disease is heart disease, diabetes, obesity, or asthma.” This disclosure supports several of the claimed diseases, but does not support either kidney disease or gastrointestinal disease..
Because the claims include a non-original limitation that is not supported by the originally filed disclosure, one of ordinary skill in the art would not recognize applicant as possessing the claimed invention. Therefore the claim is rejected based on the written description requirement.
Claim Rejections - 35 USC § 112(b)
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, 4, 8, 10, and 14-20 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 not listed below are rejected for dependency.
Claim 1 recites a “clinical trial provider module … wherein the clinical trial provider module comprises an algorithm for generating a clinical trial eligibility decision for a clinical trial participant at assessment of clinical trial eligibility, wherein the algorithm is based at least in part on inclusion criteria that specify the characteristics required for the clinical trial and exclusion criteria for the clinical trial, wherein the exclusion criteria includes comorbidities and concomitant treatment and wherein the algorithm is further based on clinical trial participant-specific diagnostic guidelines, clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial particular-specific care pathways”, “a clinical trial participant module … wherein the clinical trial participant module is operatively associated with a health monitoring device or mobile electronic device from the clinical trial participant” and “clinical trial data module … wherein the clinical trial data module is adapted for generating the inclusion criteria and exclusion criteria for the clinical trial.” Claim limitations “clinical trial provider module” and “clinical trial data module” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed functions and to clearly link the structure, material, or acts to the function. Per MPEP 2181(II)(B), “[f]or a computer-implemented 35 U.S.C. 112(f) claim limitation, the specification must disclose an algorithm for performing the claimed specific computer function, or else the claim is indefinite under 35 U.S.C. 112(b).” However, the present disclosure does not provide such algorithms for the identified modules. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Claims 4 and 20 are similarly rejected.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4, 8, 10, and 14-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims not listed below are rejected for dependency.
Claim 4 recites a computer system programmed for conducting a clinical trial, comprising a server comprising: … wherein the clinical trial provider module, the clinical trial participant module and the clinical trial data module are implemented as a computer-readable storage medium having computer readable code stored thereon for programming the server to perform the method of claim 1. Based on the reference to another claim, this claim is considered a dependent claim. This claim requires a medium with code that programs the server to perform the acts of claim 1. Because being programmed to do a thing does not actually require the performance of that thing, the claim scope does not actually require the performance of the acts of claim 1. Thus this claim does not include all the limitations of the claim upon which it depends and is an improper dependent claim. Claim 20 is similarly rejected.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4, 8, 10, and 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites a method
decision for a clinical trial participant at assessment of clinical trial eligibility, wherein the algorithm is based at least in part on inclusion criteria that specify the characteristics required for the clinical trial and exclusion criteria for the clinical trial, wherein the exclusion criteria includes comorbidities and concomitant treatment and wherein the algorithm is further based on clinical trial participant-specific diagnostic guidelines, clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways;
performing, by the clinical trial provider, at least one of the steps of:
providing data comprising information from
receiving an alert when a proposed medication or proposed medical dosage conflicts with clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways associated with the clinical trial participant;
performing, by the clinical trial participant, the step of providing health data of the clinical trial participant form the clinical trial participant; and
performing, by the clinical trial investigator, the step of managing or monitoring the clinical trial.
The preceding recitation of the claim has had strikethroughs applied to the additional elements beyond the abstract idea to more clearly demonstrate the limitations setting forth the abstract idea. The remaining limitations describe a concept of implementing a clinical trial with providers, participants, and investigators. This concept is plainly an example of managing behavior and interactions between people. As such, the claims are determined to set forth a method of organizing human activity. Therefore the claims are determined to recite an abstract idea.
MPEP 2106, reflecting the 2019 PEG, directs examiners at Step 2A Prong Two to consider whether the additional elements of the claims integrate a recited abstract idea into a practical application.
Claims 1 recites the additional element of a computer system comprising a server. While dependent claims 4 and 20 are dependent claims, their scope closely parallels claim 1 and thus will be considered with independent claim 1. Claim 4 recites the additional element of a computer system comprising a server. Claim 20 recites the additional element of a non-transitory computer-readable medium. The additional elements are further described as comprising or implementing various modules. However, these limitations remain extremely general and may be interpreted as generic computing devices used to implement the abstract idea. Per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not integrate an abstract idea into a practical application in Step 2A Prong Two, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not integrate the abstract idea into a practical application.
The claim further recites the additional element of accessing the system through a network. The claim further recites the additional element of wherein the module is operatively associated with the monitoring device or mobile electronic device and data from a monitoring device or mobile electronic device, which is interpreted as receiving data from a monitoring device or a mobile electronic device. These additional elements reflect no improvement to technology, no particular machine, no transformation of an article, and no meaningful limitation on the abstract idea. Instead, these additional elements only generally link the abstract idea to a technological environment of networked computing devices. As such, these additional elements do not integrate the abstract idea into a practical application.
The claim further recites the additional element of electronic records. This additional element reflects no improvement to technology, no particular machine, no transformation of an article, and no meaningful limitation on the abstract idea. Instead, this additional element only generally links the abstract idea to a technological environment of a computing device. As such, this additional element does not integrate the abstract idea into a practical application.
There are no further additional elements. When considered as a combination, the additional elements generally link the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore the claims are determined to be directed to an abstract idea.
At Step 2B of the Mayo/Alice analysis, examiners are to consider whether the additional elements amount to significantly more than the abstract idea.
As previously noted, the claims recite additional elements which may be interpreted as generic computing devices used to implement the abstract idea. However, per MPEP 2106.05(f), implementing an abstract idea on a generic computing device does not add significantly more in Step 2B, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea on a generic computer. As such, these additional elements do not amount to significantly more.
As previously noted, the claims recite the additional elements of accessing the system through a network and receiving data from a monitoring device or a mobile electronic device. However, per MPEP 2106.05(d)(II), receiving or transmitting data over a network has been recognized by the courts as a well-understood, routine, and conventional computer functionality. As such, this additional element, both individually and in combination with the prior computing additional element, does not amount to significantly more.
As previously noted, the claims recite the additional element of electronic records. However, per MPEP 2106.05(d)(II), storing and retrieving information in memory has been recognized by the courts as a well-understood, routine, and conventional computer functionality. As such, this additional element, both individually and in combination with the prior computing additional element, does not amount to significantly more.
There are no further additional elements. When considered as a combination, the additional elements generally link the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not amount to significantly more than the abstract idea. Therefore, when considered individually and as an ordered combination, the additional elements of claims 1, 4, and 20 do not amount to significantly more than the judicial exception. Thus claims 1, 4, and 20 are not patent eligible.
Dependent claims 8, 10, and 14-19 continue to recite an abstract idea. Dependent claims 8, 10, and 14-18 recite no further additional elements. The previously identified additional elements, individually and in combination, do not integrate the abstract idea into a practical application for the same reasons articulated above. Therefore claims 8, 10, and 14-18 recite remain directed to an abstract idea. At Step 2B, the previously identified additional elements, individually and in combination, do not amount to significantly more than the abstract idea for the same reasons articulated above. Dependent claim 19 recites the additional element of a graphical user interface. This additional element amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not integrate the abstract idea into a practical application. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. As such, the combination of additional elements does not integrate the abstract idea into a practical application. Therefore claim 19 remains directed to an abstract idea. At Step 2B, the additional element still amounts to instructions to implement the abstract idea with a computing device. As such, this additional element does not amount to significantly more than the abstract idea. When considered in combination with the prior identified additional elements, the combination of additional elements only generally links the abstract idea to a technological environment of networked computing devices. Therefore the combination of additional elements does not amount to significantly more than the abstract idea. Thus as dependent claims 8, 10, and 14-19 remain directed to a judicial exception, and as the additional elements of the claims do not amount to significantly more, dependent claims 8, 10, and 14-19 are not patent eligible.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 8, 10, 14-16, and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boyce (US 2009/0313045 A1).
Regarding Claim 1, 4, and 20: Boyce discloses a method of using a computer system programmed for conducting a clinical trial, comprising the steps of:
accessing the computer system through a network, the computer system comprising a server (A method or a module may be installed on a server connected to the network. See at least [0146]. Also: A connection from a user device to a server that executes or performs instructions for a method may be a direct connection. See at least [0147]) comprising:
a clinical trial provider module adapted for receiving, storing, and providing data in communication with a clinical trial provider, wherein the clinical trial provider module comprises an algorithm for generating a clinical trial eligibility decision for a clinical trial participant at assessment of clinical trial eligibility, wherein the algorithm is based at least in part on inclusion criteria that specify the characteristics required for the clinical trial and exclusion criteria for the clinical trial, wherein the exclusion criteria includes comorbidities and concomitant treatment and wherein the algorithm is further based on clinical trial participant-specific diagnostic guidelines, clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways (FIG. 18 is a diagram of a log-in web page for a provider. See at least [0172]. Also: FIG. 23 is a diagram of a provider web site--qualification form shown in a matrix 2300. Providers or their assigned staff can quickly and easily fill out qualification forms for participants if needed. See at least [0177]. Also: FIG. 24 is a diagram of a provider web site--approved participation completion. Approval may be instantaneous in most cases. Further details may be provided in matrix 2400. It allows a provider to complete qualification for participant if necessary. See at least [0178] and Fig. 24. Also: These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071]. Also: a set of criteria for a candidate to be considered to participate in a project. A project may seek adults in an age group of 25 to 35, with normal blood pressure and cholesterol levels and no symptoms of heart trouble for a new drug for migraine. See at least [0200]. Also: The identifying of a patient as a potential participant in a clinical trial is thus based on a first set of parameters related to the requirements of the clinical trial. For instance, in the above example, a clinical trial is focused on users of two drugs: Drug_A and Drug_B. Clearly the use of Drug_A and Drug_B should be among the parameters for identifying a patient as a potential participant. Other examples of selection parameters for identifying a potential participant may include: an existing illness, an existing complaint, age, weight, gender, blood-pressure, pulse, temperature, use of drugs, one or more symptoms such as a cholesterol level within a certain range, and one or more symptoms such as a cholesterol level outside a certain range. Life style, heritage, type of profession, education, place of birth and many other parameters may be included in a first set of parameters to identify a potential participant. See at least[0119]. Also: For example a project could be the selection of people to try a new migraine medication that is targeted only for men between the ages of 30 and 50 that reside in the US and are currently taking two specific drugs. See at least [0166]).
a clinical trial participant module adapted for receiving, storing, and providing data in communication with the clinical trial participant, wherein the clinical trial participant module is operatively associated with health monitoring device or mobile electronic device from the clinical trial participant (FIG. 25 is a diagram of a log-in web page for a participant. See at least [0179]. Also: FIG. 26 is a diagram of a participant web site--home page. A participant may track her/his participation in projects in one page in a matrix 2600 and quickly and easily update, interact and communicate about information. See at least [0180]. Also: One may use different devices to exchange data. The devices may be provided with a modem to create the appropriate signals and be in compliance with a protocol. For instance one may use a phone 914 to connect to a server. One may also apply a fax 915. One may also use a scanner 916. One may also use any computing device 917 that is enabled to exchange data. A computing device 917 may be a computer; it may be a mobile phone; it may be Personal Digital Assistant or PDA type of device. It may also be a tablet type of device. See at least [0155]); and
a clinical trial data module adapted for receiving, storing, and providing data in communication with a clinical trial investigator, wherein the clinical trial data module is adapted for generating the inclusion criteria and exclusion criteria for the clinical trial (FIG. 10 shows in diagram an illustrative example of a sign-in or log-in web site screen for a network member. See at least [0157]. Also: FIG. 13 is a diagram of a web page that may be used for entering a new project. It demonstrates how easy it is to create rules and setup a research or clinical trial project. Many very flexible rules can be created using a combination of techniques, included but not limited to some of the items shown on the page--like particular "terms" within documentation, participants meeting certain demographic characteristics, certain diagnosis or procedural codes associated with billing to name a few. These rules form the basis of a project which is the selection of participants for inclusion in clinical research, trial or other targeting. For example a project could be the selection of people to try a new migraine medication that is targeted only for men between the ages of 30 and 50 that reside in the US and are currently taking two specific drugs. See at least [0166]. Also: When a project is started a network member may initiate an identifying rule that may provide a set of criteria for a candidate to be considered to participate in a project. A project may seek adults in an age group of 25 to 35, with normal blood pressure and cholesterol levels and no symptoms of heart trouble for a new drug for migraine. See at least [0200])
performing, by the clinical trial provider, at least one of the steps of: providing data comprising information from electronic health records associated with the clinical trial participant, information associated with a treatment compliance program for the clinical trial, and information associated with a clinical target disease of the clinical trial participant; and receiving an alert when a proposed medication or proposed medical dosage conflicts with clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial participant-specific care pathways associated with the clinical trial participant (These methods, particularly the Web Service API and the Scribe platform allow the provider to go about their normal process of patient encounters and encounter documentation in the form for instance of clinical records as entered during or after a patient visit or treatment. As the documentation is created, it is simply passed through the Targeting Module 207 and instantaneous matching and notification occurs in step 208. See at least [0071]. Also: The Scribe Platform creates from patient records including dictations from a physician or practitioner dealing with a patient a database or repository of searchable data that can be parsed and organized for different and specific applications. This allows patient data that is entered in a routinely fashion to be made available and updated in an easy manner for use in for instance a clinical trial. See at least [0128]. Also: While there may be many visits of a particular patient to a doctor, and much paperwork created, only those documents that discuss the migraine condition would be targeted for extraction. In addition, once a document is selected for extraction, then either the entire document or targeted sections of the document will actually be extracted. For example, the extraction may be setup to only pull information on medications and observations sections of the documents related to migraines. See at least [0087]. Also: As clinical documentation and information is created as part of further patient encounters with qualified participants, that information 404 is automatically captured, analyzed and extracted by the extraction module 401 as shown in FIG. 4. The extraction module uses the rules setup by the network members in an earlier step and shown again in FIG. 4 as 402 for each project. These rules can include de-personalizing the information as well as reformatting and extracting just portions of the information. Providers, therefore, do not have to go through efforts to submit information 404 in alternative forms from which it is available, thus greatly streamlining and simplifying the process. See at least [0079]).
performing, by the clinical trial participant, the step of providing health data of the clinical trial participant from a health monitoring device or mobile electronic device from the clinical trial participant (FIG. 30 is a diagram of a participant web site--qualification form. A participant can quickly and easily fill out qualification information requests in matrix 3000 and receive instant answers. See at least [0184]); and
performing, by the clinical trial investigator, the step of managing or monitoring the clinical trial (One may click in FIG. 11 on the cell 1102 with a hyperlinked term Projects. This may bring a user to a web page as shown in FIG. 12. One may call this web page a Project Home Page. The statistics on each project are made available on this page. This may tell a network member in a matrix 1200 how well they are doing on targeting and qualifying participants in their projects. See at least [0164]).
Regarding Claim 8: Boyce discloses the above limitations. The imitation wherein the clinical trial is concerned heart disease, diabetes, obesity, kidney disease, gastrointestinal disease, or asthma is considered intended use and as such may be given limited patentable weight. As such, Boyce continues to disclose the claimed invention.
Regarding Claim 10: Boyce discloses the above limitations. Boyce further discloses wherein the clinical trial provider is a physician, physician assistant, nurse, or nurse practitioner (Healthcare providers may be physicians. See at least [0202]).
Regarding Claim 14: Boyce discloses the above limitations. The limitation wherein the health monitoring device is a heart rate monitor, blood pressure meter, peak flow meter, pulse oximeter, pedometer, weighing scale, or glucometer further limits a claim limitation claimed in the alternative. As the reference discloses the alternative, it continues to disclose the claimed invention.
Regarding Claim 15: Boyce discloses the above limitations. Boyce further discloses wherein data received by the clinical trial participant module comprises at least one social determinant of the clinical target disease of the clinical trial participant (Patient Portal: Scribe's Patient Portal provides HIPAA compliant access to medical records for a patient population and streamlines a registration process by collecting demographic, medical history, and billing information from patients. See at least [0137]. Also: patient demographics like age, sex, race, marital status, etc. See at least [0143]).
Regarding Claim 16: Boyce discloses the above limitations. Boyce further discloses wherein the at least one social determinant comprises at least one of racial, ethnic, religious, behavioral, linguistic, income and geography/location-related associated with the clinical target disease of the at clinical investigation participant (Patient Portal: Scribe's Patient Portal provides HIPAA compliant access to medical records for a patient population and streamlines a registration process by collecting demographic, medical history, and billing information from patients. See at least [0137]. Also: patient demographics like age, sex, race, marital status, etc. See at least [0143]).
Regarding Claim 18: Boyce discloses the above limitations. Boyce further discloses wherein the clinical investigation participant module is further adapted for tracking communication between the clinical investigation participant and the clinical investigation provider (it enables centralizing communications for all parties in one place. See at least [0173]).
Regarding Claim 19: Boyce discloses the above limitations. Boyce further discloses wherein each of the clinical investigation provider module, clinical investigation participant module, and clinical investigation data module is operatively associated with a graphical user interface comprising controls for selectively receiving, storing, and providing data in the computer system in response to an action by the one clinical investigation provider, the clinical investigation participant, and the clinical investigator (See at least Figures 10-31).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boyce (US 2009/0313045 A1) in view of Jain et al. (US 11664099 B1).
Regarding Claim 17: Boyce discloses the above limitations. Boyce does not appear to disclose wherein the clinical investigation participant module is further adapted for tracking use of clinical investigation participant-specific clinical endpoints by the clinical investigation participant. However, Jain teaches wherein the clinical investigation participant module is further adapted for tracking use of clinical investigation participant-specific clinical endpoints by the clinical investigation participant (the application is configured to perform repeated interactions over time to monitor health of the user through (i) sensor measurements performed using sensors of one or more devices, and (ii) survey responses by the user to surveys presented by one or more devices. See at least Column 8, Lines 56-60).
Boyce provides a system which manages part of a clinical trial, upon which the claimed invention’s tracking of endpoint data can be seen as an improvement. However, Jain demonstrates that the prior art already knew of collecting endpoint data from participant facing software. One of ordinary skill could have easily incorporated the functionality of Jain into the system of Boyce. Further, one of ordinary skill in the art would have recognized that such an application of Jain would have resulted in an improved system which would help members collect data regarding their clinical trials. As such, the application of Jain and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosure of Boyce and the teaching of Jain.
Response to Arguments
Applicant’s Argument Regarding 112(b) Rejections of claims 1-20:
Applicant submits that the recitation in Claims 1 and 4, as well as the detailed description in the specification cited above, provide sufficient written description for the algorithm. A person of ordinary skill in the art would be able to generate the decision making algorithm based on the description of the specification.
A person of ordinary skill in the art would understand that the conclusion criteria and exclusion criteria would be clinical trial-specific and no algorithm would be needed to generate the inclusion criteria and exclusion criteria.
Examiner’s Response: Applicant's arguments filed 23 April 2026 have been fully considered but they are not persuasive.
Examiner disagrees. Per MPEP 2181, “In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function.” Here, there is no disclosed algorithm. The portions of the originally filed disclosure do not articulate an algorithm or the implementation of an algorithm, but rather describe the results of the algorithm, which does not satisfy the support necessary for a 112(f) invocation of a computer implemented functionality.
Examiner notes that Applicant’s argument that “no algorithm would be needed” to achieve the recited functionality appears to render the identified limitation disclosed by any computer processor. This seems likely to be applicant’s intended meaning and as such Applicant’s argument is unpersuasive. If applicant considers this limitation to be a general purpose computer function Applicant should expressly advance that position.
Applicant’s Argument Regarding 112(d) Rejections of claim 20: Claim 20 has been amended to address the Examiner’s concerns.
Examiner’s Response: Applicant's arguments filed 23 April 2026 have been fully considered but they are not persuasive. Claim 20 remains an improper dependent claim.
Applicant’s Argument Regarding 101 Rejections of claims 1-20:
The claimed method and system do not simply recite an abstract idea, but physical components of the system.
The claimed method also recites steps that cannot be performed by a mental process.
The claimed features … allow for better decision making by clinical trial providers and the better participation and monitoring of clinical participants.
Examiner’s Response: Applicant's arguments filed 23 April 2026 have been fully considered but they are not persuasive.
The presence of a physical component does not render a claim eligible under the USPTO’s subject matter eligibility guidance.
The presence of steps that cannot be performed by a mental process does not render a claim eligible under the USPTO’s subject matter eligibility guidance. Further, Examiner notes that the current and prior rejections do not identify the claims as setting forth a mental process.
Applicant’s apparent assertion of an improvement is too vague to fully evaluate. It is unclear what specific features are asserted as providing the improvement and what the particular improvement is. Further MPEP 2106.05(a) states “If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification.” Here, there appears to be no technical disclosure supporting the identified improvements.
Applicant’s Argument Regarding 102 Rejections of claims 1-11, 13-16, and 18-20: Boyce does not disclose a “clinical trial provider module comprises an algorithm for generating a clinical trial eligibility decision for the clinical trial participant at assessment of the clinical trial eligibility, wherein the algorithm is based at least in part on inclusion criteria that specify the characteristics require for the clinical trial and exclusion criteria for the clinical trial, wherein the exclusion criteria includes comorbidities and concomitant treatment and wherein the algorithm is further based on clinical trial participant-specific diagnostic guidelines, clinical trial participant-specific treatment guidelines, clinical trial participant-specific medication plans, and clinical trial particular-specific care pathways as recited in claim 1 and claim 4. Boyce also does not disclose a clinical trial participant module that is “operatively associated with a health monitoring device or mobile electronic device from the clinical participant” as recited in claim 1 and 4.
Examiner’s Response: Applicant's arguments filed 23 April 2026 have been fully considered but they are not persuasive. As indicated in the rejection above, Boyce teaches both the identified features.
Request for Information Under 37 CFR § 1.105
The following is a quotation of 37 CF § 1.105(a):
In the course of examining or treating a matter in a pending or abandoned application, in a patent, or in a reexamination proceeding, including a reexamination proceeding ordered as a result of a supplemental examination proceeding, the examiner or other Office employee may require the submission, from individuals identified under § 1.56(c), or any assignee, of such information as may be reasonably necessary to properly examine or treat the matter, for example: …
(iii) Related information: A copy of any non-patent literature, published application, or patent (U.S. or foreign), by any of the inventors, that relates to the claimed invention.
(vii) In Use: Identification of any use of the claimed invention known to any of the inventors at the time the application was filed notwithstanding the date of the use
Applicant and the assignee of this application are required under 37 CFR § 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application.
This is a request that applicants:
provide a copy of any documentation regarding the implementation of the platform referenced by the disclosure at [0106] (“The present clinical investigation/trial platform application has been implemented in a number of clinical studies in the African American, Hispanic and Rural White patient populations. Thousands of patients enrolled through over thirty community based practices, which would not be possible without the present clinical investigation/trial platform application.).
provide the following information known to applicant:
whether the platform referenced by the disclosure at [0106] was accessible to the public, and if yes, the earliest date the platform was accessible to the public.
whether the platform referenced by the disclosure at [0106] was being commercially exploited, and if yes, the earliest date the platform was being commercially exploited.
If applicants have this information, then applicants are required, under 37 CFR 1.56, to disclose the information to the Office.
Applicants are not required or being asked to conduct a search for information beyond applicant's own immediate files. If applicant does not have immediate knowledge of the information requested, then a statement that the information sought is unknown or not readily available to the applicants will be accepted by the Office as a complete reply.
Why the Request for Information is reasonably necessary: Applicant’s originally filed disclosure ([0106]) indicates that a clinical investigation/trial platform incorporating disclosed techniques was in use at the time of filing. Applicant’s most recent remarks (Page 13, 2026-04-23) rely on actual use of that platform to purportedly demonstrate a technical improvement of the current claims for subject matter eligibility purposes. Applicant’s argument therefore indicates that there is a significant correspondence between the then in-use platform and the currently claimed invention. Because there now appears to be a significant correspondence between the then in-use platform and the claimed invention, it is necessary to evaluate the then in-use platform’s impact on the patentability of the claimed invention. Applicant’s filing does not provide any other disclosure of the in-use platform and Examiner’s search has not produced documentation of the then in-use platform. As such, the submission of the above identified information is necessary to properly examine the claimed invention and determine the impact of the platform in use of [0106] on the patentability of the claimed invention.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office action dated 11 February 2026.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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, Kambiz Abdi can be reached at (571) 272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bion A Shelden/Primary Examiner, Art Unit 3685 2026-07-22
Prosecution Insights