DETAILED ACTION
Status of Claims
This action is in reply to the Request for Continue Examination filed on 11/20/2025.
Claims 1, 4 and 10 have been amended.
Claims 1-19 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/2025 has been entered.
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 1-19 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-19 are directed to a method (i.e., a process). Accordingly, claims 1-19 are all within at least one of the four statutory categories.
Step 2A - Prong One:
An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Representative independent claim 1 includes limitations that recite an abstract idea.
Specifically, independent claim 1 recites:
A method of creating a remote clinical trial to recruit one or more patients to an existing clinical trial comprising:
a) identifying one or more patients;
b) identifying one or more local physicians having a clinic local to the one or more patients, wherein either the one or more patients or the one or more local physicians is located remote from a clinical trial site;
c) preparing the one or more local physicians and the respective clinic for research qualification, wherein the preparing comprises providing electronic Investigator Site Files (elSF); and
d) facilitating conduct of the clinical trial for the one or more local physicians, wherein the facilitating conduct of the clinical trial further comprises enabling communication, data collection, regulatory feedback prompting, and patient monitoring via one or more software programs.
The Examiner submits that the foregoing underlined limitations constitute: (a) “certain methods of organizing human activity” because creating a remote clinical trial by recruiting identified patients, identifying physicians having a clinic the identified patients, preparing the physicians and the clinic using research qualification and conducting the clinical trial for the physicians all are a part of conducting a clinical trial and a medical workflow for managing human behavior/interactions between people. Furthermore, these limitations constitute (b) “a mental process” because qualifying a clinical trial and patients for the clinical trial are observations, evaluations and analysis that can be performed in the human mind or with a pen and paper. The foregoing underlined limitations also relate to claim 1. Accordingly, the claim describes at least one abstract idea.
In relation to claims 8-11, 13 and 19, these claims merely recite specific kinds of input data, such as: claim 8 - wherein the contract for the Principal Investigator comprises a trial budget comprising an amount of payment to the local physician and a budget for support services for the local physician, claim 9 - wherein the contract for the sub-Investigator comprises a trial budget comprising an amount of payment to the local physician, services a Principal Investigator will provide to the local physician, services the local physician will provide, and a budget for support services for the local physician, claim 10 - wherein preparing the clinic for research qualification comprises complying with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6) and comprises: a) obtaining regulatory approvals; b) providing training to staff; c) creating standard operating procedures for the clinic to maintain research qualification; d) providing an electronic Investigator Site File; e) obtaining equipment; or f) obtaining technology to enable a remote clinical trial, claim 11 – wherein the regulatory approvals comprise collecting and maintaining regulatory documents, claim 13 - wherein staff may be on site at the clinic or may work remotely and claim 19 - wherein completion or discontinuation of the trial, comprises one or more of facilitating closure of the clinic and return of equipment or technology.
In relation to claims 2-7 and 15-18, these claims merely recite determining steps such as: claim 2 - wherein identifying one or more patients comprises matching each patient’s diagnosis and treatment requirements to a clinical trial, claim 3 - further comprising qualifying each patient for a clinical trial, claim 4 - wherein identifying one or more local physicians comprises: a) selecting each patient’s personal physician to become the local physician; b) providing each patient with technology and resources to identify the local physician who is not the patient’s personal physician; or c) providing each patient’s personal physician with technology and resources to identify the local physician, wherein step c) comprises use of any one of telemedicine, cloud computing, video conferencing, electronic learning management systems, electronic signature software, and data privacy or security software claim 5 - wherein identifying one or more local physicians further comprises approving and qualifying at least one local physician to serve as an Investigator of the clinical trial by a Sponsor of the clinical trial, claim 6 - wherein approving and qualifying the at least one local physician comprises complying with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6 (R2)). 121 CFR §312 is herein incorporated by reference with regard to procedures governing the use of investigational new products including the submission to, and review by, the US FDA; and the ICH (E6) is herein incorporated by reference with regard to Good Clinical Practice procedures, guidelines and standards for clinical trials, claim 7 - wherein preparing the at least one local physician comprises executing a contract with each local physician to serve as a Principal Investigator or a sub-Investigator for the remote clinical trial, claim 15 - wherein facilitating conduct of the clinical trial for the local physician comprises preparing subject level specific training for the site and visit-by-visit walk-through guides for the purposes of ensuring just-in-time training for the local physician and local clinic personnel, as well as for ensuring appropriate documentation of procedures conducted for the purposes of ensuring ongoing compliance with ICH E6 (R2) Sections 4.1.2 and 4.1.5, claim 16 - wherein facilitating conduct of the clinical trial for the local physician further comprises providing ongoing remote support for the local physician, claim 17 - wherein facilitating conduct of the clinical trial for the local physician further comprises one or more of facilitating data entry, answering study- related questions, regulatory document management, and trial management to ensure continued compliance with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6) and claim 18 - wherein facilitating conduct of the clinical trial for the local physician comprises one or more of ongoing facilitation of clinical site activities conducting the trial until the patient completes the trial or trial follow-up, or discontinues the trial. 3421 CFR §312 is herein incorporated by reference with regard to procedures governing the use of investigational new products including the submission to, and review by, the US FDA; and the ICH (E6) is herein incorporated by reference with regard to Good Clinical Practice procedures, guidelines and standards for clinical trials.
In relation to claim 12, these claims merely recite collecting steps such as - wherein the regulatory documents are transmitted or delivered to the regulatory authority.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claim 14, as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a cloud computing, video conferencing, electronic learning management systems, electronic signature software, data privacy and security software to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation within a health care environment in the mind but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” and “Mental Process” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the cloud computing, video conferencing, electronic learning management systems, electronic signature software, data privacy and security software are recited at high levels of generality (i.e., as generic computer components performing generic computer functions of receiving data/inputs, determining and providing data) such that it amounts no more than mere instructions to apply the exception using the generic computer components.
Regarding claim 4, the additional limitations ““cloud computing”, “video conferencing”, “electronic learning management systems”, “electronic signature software,” and “data privacy” or “security software”, the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvements in the functioning of a computer or an improvement to another technology or technical field, apply or us the above-noted implement/use to above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP §2106.05). Their collective functions merely provide conventional computer implementation.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to the integration of the abstract idea into practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer component provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, in representative independent claim 8, regarding the additional limitations of the cloud computing, video conferencing, electronic learning management systems, electronic signature software, data privacy and security software, the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The dependent claims no not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason discussed above with respect to determining that the dependent claims do not integrate the at least abstract idea into a practical application.
Therefore, claims 1-19 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Goldner (US 2014/0310015 A1) in view of Ford (US 2015/0310188 A1).
Claim 1:
Goldner discloses a method of creating a remote clinical trial to recruit one or more patients to an existing clinical trial (See Fig. 4, P041-P0042 clinical trial sponsors, investigators, patients and healthcare providers have terminals to access remote servers and communicate with other terminals via network 216.) comprising:
a) identifying one or more patients (Besides asking patients seeking to join clinical trials a series of question (Fig. 2A-2D, Fig. 5, P0049), see P0051 user registration records to identify patients according to user name, user ID number, login name, password, customized user preferences, mail accounts, links to patient profile.);
b) identifying one or more local physicians having a clinic local to the one or more patients (See P0125-P0126 where geographic information is used for a patient to locate the closest clinical trial. Also, see Fig. 3 where physicians recruiting for clinical trials are listed according to city, state and zip code.), wherein either the one or more patients or the one or more local physicians is located remote from a clinical trial site (See Fig. 3-4, appropriate clinical trial sites, hospitals, medical clinics and pharmacies in P0030-P0031, P0041-P0042 where patients and healthcare professional accessing the server 202 via network 216 are geographically located in a particular state or country using the internet construe physicians and patients remotely located from a clinical trial site.);
c) preparing the one or more local physicians and the respective clinic for research qualification (See Fig. 5, P0077 by forwarding the qualified patient’s application/profile to the host trial site online, allows for local physicians and the respective clinic to prepare.); and
d) facilitating conduct of the clinical trial for the one or more local physicians (See P0086 where provided instructions for taking a drug or using a medical device and accessing a drug or device are ways of facilitating the clinical trial.).
Although Goldner discloses the method of creating a remote clinical trial to recruit patients to an existing clinical trial mentioned above, Goldner does not explicitly teach providing an electronic Investigator Site Files (eISF) for enabling communication, data collection, regulatory feedback prompting, and patient monitoring via one or more software programs. Ford teaches:
wherein the preparing comprises providing electronic Investigator Site Files (elSF) (See P0294, P0303-P0305 where the elSF is essential for clinical trial management.); and
wherein the facilitating conduct of the clinical trial further comprises enabling communication, data collection, regulatory feedback prompting, and patient monitoring via one or more software programs (See P0307-P0308 where the elSF is provided for secure clinical document access, mobile interface and web interface.).
Therefore, it would have been obvious to one of ordinary skill in the art of treating Covid-19 before the effective filing date of the claimed invention to modify the method of Goldner for providing an electronic Investigator Site Files (eISF) for enabling communication, data collection, regulatory feedback prompting, and patient monitoring via one or more software programs as taught by Ford for sharing, viewing, collaborating of networked secure content between entities and maintaining overall synchronization with sponsors mentioned in Ford’s P0002, P0308.
Regarding claim 2, Goldner discloses the method of claim 1, wherein identifying one or more patients comprises matching each patient’s diagnosis and treatment requirements to a clinical trial (See category of questions based on diagnosis in P0022, P0063 and disease specific health assessment in P0039.
Regarding claim 3, Goldner discloses the method of claim 2, further comprising qualifying each patient for a clinical trial (See qualifying patients in P0075, Fig. 5, steps 308, 310 and 312.).
Regarding claim 4, Goldner discloses the method of claim 1, wherein identifying one or more local physicians comprises: a) selecting each patient’s personal physician to become the local physician; b) providing each patient with technology and resources to identify the local physician who is not the patient’s personal physician; or c) providing each patient’s personal physician with technology and resources to identify the local physician (Besides clinical trial website and emails to technically contact physicians who are recruiting patients (Fig. 3), see protecting patient privacy in P0083 and P0081 where professionals can educate themselves about a disease, standard or experimental treatments.), wherein step c) comprises use of any one of telemedicine, cloud computing, video conferencing, electronic learning management systems, electronic signature software, and data privacy or security software (See P0073, P0077-P0078 where access privileges and patient’s privacy serve as data privacy or security software.).
Regarding claim 5, Goldner discloses the method of claim 4, wherein identifying one or more local physicians further comprises approving and qualifying at least one local physician to serve as an Investigator of the clinical trial by a Sponsor of the clinical trial (See P0084 trial sponsor to investigator matching involves matching investigators with trial sites that are looking for investigators with particular qualifications.).
Regarding claim 18, Goldner discloses the method of claim 1, wherein facilitating conduct of the clinical trial for the local physician comprises one or more of ongoing facilitation of clinical site activities conducting the trial until the patient completes the trial or trial follow-up, or discontinues the trial (See P0064 follow-up question, pre-qualifying P0067, P0075 and rejecting patient in P0080 that can dis-qualify completing the trial.).
Claims 6, 10, 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Goldner (US 2014/0310015 A1) in view of Ford (US 2015/0310188 A1) further in view of Fishbein (US 2022/0395488 A1).
Regarding claim 6, although Goldner and Ford teach the method of claim 5 as mentioned above with emphasis on obtaining FDA approval (P0003, P0047), Goldner and Ford do not explicitly teach complying with specific Code of Federal Regulations (CFR). Fishbein teaches wherein approving and qualifying the at least one local physician comprises complying with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6 (R2)).' 121 CFR §312 is herein incorporated by reference with regard to procedures governing the use of investigational new products including the submission to, and review by, the US FDA; and the ICH (E6) is herein incorporated by reference with regard to Good Clinical Practice procedures, guidelines and standards for clinical trials (See Reporting Requirements for the submission to, and review by, the US FDA in P0373-P0376, 21 CFR Part 312.64 in P0389, Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH), and FDA regulations mentioned in P0457, P0517 and P0981.).
Therefore, it would have been obvious to one of ordinary skill in the art of treating Covid-19 before the effective filing date of the claimed invention to modify the method of Goldner and Ford to include complying with specific Code of Federal Regulations (CFR) as taught by Fishbein in order to treat patients infected with SARS-CoV-2 with an effective amount of compounds that directly or indirectly inhibit pathways of the inflammasome/caspase1/pyroptosis axis interest mentioned in Fishbein’s P0022, P0044.
Regarding claim 10, although Goldner and Ford teach the method of claim 1, and comprises: a) obtaining regulatory approvals; b) providing training to staff; c) creating standard operating procedures for the clinic to maintain research qualification; d) providing an electronic Investigator Site File (eISF); e) obtaining equipment; or f) obtaining technology to enable a remote clinical trial (See clinical trial website and emails to technically contact physicians who are recruiting patients (Fig. 3), and HIPAA regulations (P0030), protecting patient privacy in P0083 and P0081 where professionals can educate themselves about a disease, standard or experimental treatments.), Goldner and Ford do not explicitly teach complying with specific Code of Federal Regulations (CFR). Fishbein teaches wherein preparing the clinic for research qualification comprises complying with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6) (See Reporting Requirements for the submission to, and review by, the US FDA in P0373-P0376, 21 CFR Part 312.64 in P0389, Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH), and FDA regulations mentioned in P0457, P0517 and P0981.).
Therefore, it would have been obvious to one of ordinary skill in the art of treating Covid-19 before the effective filing date of the claimed invention to modify the method of Goldner and Ford to include complying with specific Code of Federal Regulations (CFR) as taught by Fishbein in order to treat patients infected with SARS-CoV-2 with an effective amount of compounds that directly or indirectly inhibit pathways of the inflammasome/caspase1/pyroptosis axis interest mentioned in Fishbein’s P0022, P0044.
Regarding claim 14, Goldner discloses the method of claim 10, wherein the technology comprises one or more of telemedicine, cloud computing, video conferencing, electronic learning management systems, electronic signature software, data privacy and security software (See P0053 where the patient's medical privacy, anonymity and identity are maintained when submitted to the trial site online (P0077-P0078).
Regarding claim 16, although Goldner discloses the method of claim 14 as mentioned above, Goldner does not explicitly teach facilitating conduct of the clinical trial by providing ongoing remote support for the local physician. Fishbein teaches wherein facilitating conduct of the clinical trial for the local physician further comprises providing ongoing remote support for the local physician (With investigators as physicians, see provided support mentioned in P0451-P0453, P0972-P0975.).
Therefore, it would have been obvious to one of ordinary skill in the art of treating Covid-19 before the effective filing date of the claimed invention to modify the method of Goldner to include facilitating conduct of the clinical trial by providing ongoing remote support for the local physician as taught by Fishbein in order to treat patients infected with SARS-CoV-2 with an effective amount of compounds that directly or indirectly inhibit pathways of the inflammasome/caspase1/pyroptosis axis interest mentioned in Fishbein’s P0022, P0044.
Regarding claim 17, although Goldner discloses the method of claim 14, wherein facilitating conduct of the clinical trial for the local physician further comprises one or more of facilitating data entry, answering study- related questions (See Fig. 4 Healthcare Professional 212, Question Records 236 and multiple questions mentioned in Abstract, P0021, P0042.), Goldner does not explicitly teach regulatory document management, and trial management to ensure continued compliance with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6). (See observations, measurements and questions. Fishbein teaches regulatory document management, and trial management to ensure continued compliance with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6) (See Reporting Requirements for the submission to, and review by, the US FDA in P0373-P0376, 21 CFR Part 312.64 in P0389, Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH), and FDA regulations mentioned in P0457, P0517 and P0981.).
Therefore, it would have been obvious to one of ordinary skill in the art of treating Covid-19 before the effective filing date of the claimed invention to modify the method of Goldner to include regulatory document management, and trial management to ensure continued compliance with 21 CFR §312 and the International Council for Harmonization for Better Health/Good Clinical Practices (ICH E6) as taught by Fishbein in order to treat patients infected with SARS-CoV-2 with an effective amount of compounds that directly or indirectly inhibit pathways of the inflammasome/caspase1/pyroptosis axis interest mentioned in Fishbein’s P0022, P0044.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Goldner (US 2014/0310015 A1) in view of Ford (US 2015/0310188 A1) further in view of Blumenfeld (US 2016/0239910 A1).
Regarding claim 7, although Goldner discloses the method of claim 1 as mentioned above, Goldner does not explicitly teach executing a contract with each local physician to serve as a Principal Investigator or a sub-Investigator for the remote clinical trial. Blumenfeld teaches wherein preparing the at least one local physician comprises executing a contract with each local physician to serve as a Principal Investigator or a sub-Investigator for the remote clinical trial (See Abstract, P0059 (Table 1), lines 16-18 with awarded contract details. Fig. 5B screen for prompting user about roles as Principal Investigator or a sub-Investigator mentioned in P0038-P0039.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical trial budgeting before the effective filing date of the claimed invention to modify the method of Goldner to include executing a contract with each local physician to serve as a Principal Investigator or a sub-Investigator for the remote clinical trial as taught by Blumenfeld for the specific research opportunity and forwards qualified and matched researchers to the sponsor mentioned in Blumenfeld’s P0013.
Claims 8-9, 11 and 13 rejected under 35 U.S.C. 103 as being unpatentable over Goldner (US 2014/0310015 A1) in view of Ford (US 2015/0310188 A1) further in view of Fishbein (US 2022/0395488 A1) and Blumenfeld (US 2016/0239910 A1).
Regarding claim 8, although Goldner, Ford and Fishbein teach the method of claim 6 as mentioned above, Goldner, Ford and Fishbein do not explicitly teach a trial budget comprising an amount of payment to the local physician and a budget for support services for the local physician. Blumenfeld teaches wherein the contract for the Principal Investigator comprises a trial budget comprising an amount of payment to the local physician and a budget for support services for the local physician (See Fig. 12, P0049, P0052 per-patient budget, Abstract, P0059 (Table 1), lines 16-18 with awarded contract details. Fig. 5B screen for prompting user about roles as Principal Investigator or a sub-Investigator mentioned in P0038-P0039. See [P0061] either the Web server or the database server can incorporate the ability to handle payments from one participant to another, as well as from participants to the company operating the servers.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical trial budgeting before the effective filing date of the claimed invention to modify the method of Goldner, Ford and Fishbein to include a trial budget comprising an amount of payment to the local physician and a budget for support services for the local physician as taught by Blumenfeld to see how researcher, site and or organization performance results for the study compares with other researcher, site and/or organization performance results for efficiency and room for improvement mentioned in Blumenfeld’s P0015.
Regarding claim 9, although Goldner, Ford and Fishbein teach the method of claim 6 as mentioned above, Goldner, Ford and Fishbein do not explicitly teach the contract for the sub-Investigator, clinical trial budget comprising an amount of payment to the local physician, services a Principal Investigator will provide to the local physician, services the local physician will provide, and a budget for support services for the local physician. Blumenfeld teaches wherein the contract for the sub-Investigator comprises a trial budget comprising an amount of payment to the local physician, services a Principal Investigator will provide to the local physician, services the local physician will provide, and a budget for support services for the local physician (See Fig. 12, P0049, P0052 per-patient budget, Abstract, P0059 (Table 1), lines 16-18 with awarded contract details. See per-patient budget in Fig. 8, budget template in Fig. 14, P0045, P0058, completing screen (Fig. 5B) before prompting user about roles as Principal Investigator or a sub-Investigator mentioned in P0038-P0039.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical trial budgeting before the effective filing date of the claimed invention to modify the method of Goldner, Ford and Fishbein to include the contract for the sub-Investigator, clinical trial budget comprising an amount of payment to the local physician, services a Principal Investigator will provide to the local physician, services the local physician will provide, and a budget for support services for the local physician as taught by Blumenfeld to see how researcher, site and or organization performance results for the study compares with other researcher, site and/or organization performance results for efficiency and room for improvement mentioned in Blumenfeld’s P0015.
Regarding claim 11, although Goldner, Ford and Fishbein teach the method of claim 10 as mentioned above, Goldner, Ford and Fishbein do not explicitly teach regulatory approvals comprise collecting and maintaining regulatory documents. Blumenfeld teaches wherein the regulatory approvals comprise collecting and maintaining regulatory documents (See P0039-P0040 site pages solicited for any FDA or sponsor audit. Also, see P0044 physician records and P0045-P0046 checking for duplicate records such as synopsis specific questionnaires.).
Therefore, it would have been obvious to one of ordinary skill in the art of clinical trial budgeting before the effective filing date of the claimed invention to modify the method of Goldner, Ford and Fishbein to include regulatory approvals comprise collecting and maintaining regulatory documents as taught by Blumenfeld to collect data concerning the progress of research and to provide an evaluation based on the collected data mentioned in Blumenfeld’s P0006.
Regarding claim 13, Goldner discloses the method of claim 10, wherein staff may be on site at the clinic or may work remotely (See Fig. 4, P041-P0042 clinical trial sponsors, investigators, patients and healthcare providers have terminals to access remote servers and communicate with other terminals via network 216.).
Claims 12 are rejected under 35 U.S.C. 103 as being unpatentable over Goldner (US 2014/0310015 A1) in view of Ford (US 2015/0310188 A1) further in view of Fishbein (US 2022/0395488 A1), Blumenfeld (US 2016/0239910 A1) and Syed (US 2015/0332022 A1).
Regarding claim 12, although Goldner, Ford, Fishbein and Blumenfeld teach the method of claim 11 as mentioned above, Goldner, Ford, Fishbein and Blumenfeld do not explicitly teach transmitting or delivering documents to the regulatory authority. Syed teaches wherein the regulatory documents are transmitted or delivered to the regulatory authority (See exemplary Regulatory Agreement site file listed on page 6 (Table 2), lines 8-10. Also, see P0074, Fig. 3, Fig. 6 Clinical Document Exchange and P0077-P0078, Fig. 6, Fig. 7 Clinical Research Protocol document shared for review. See [P0088-P0089] The Parent Content Type, Authoring Template and Folder Path are looked up in the Document Inventory List for the selected Artifact. The property information for the Parent Content Type is looked up in the Document Property List.).
Therefore, it would have been obvious to one of ordinary skill in the art of administering clinical trials before the effective filing date of the claimed invention to modify the method of Goldner, Ford, Fishbein and Blumenfeld to include transmitting or delivering documents to the regulatory authority as taught by Syed to improve the communications amongst the trial sponsors, investigational sites, and clinical investigators desired to minimize the overhead associated with conducting clinical trials mentioned in Syed’s P0002.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Goldner (US 2014/0310015 A1) in view of Ford (US 2015/0310188 A1) further in view of E6 (R2) Good Clinical Practice: Integrated Addendum to ICH E6 (R1) Guidance for Industry by the U.S. Department of Health and Human Services Food and Drug Administration (March 2018 Procedural).
Regarding claim 15, although Goldner and Ford teach the method of claim 1, wherein facilitating conduct of the clinical trial for the local physician as mentioned above, Goldner and Ford do not explicitly teach preparing subject level specific training for the site and visit-by-visit walk-through guides for the purposes of ensuring just-in-time training for the local physician and local clinic personnel, as well as for ensuring appropriate documentation of procedures conducted for the purposes of ensuring ongoing compliance with ICH E6 (R2) Sections 4.1.2 and 4.1.5. E6 (R2) Good Clinical Practice teaches:
comprises preparing subject level specific training for the site and visit-by-visit walk-through guides for the purposes of ensuring just-in-time training for the local physician and local clinic personnel, as well as for ensuring appropriate documentation of procedures conducted for the purposes of ensuring ongoing compliance with ICH E6 (R2) Sections 4.1.2 and 4.1.5 (See training on Page 11, lines 1-2 and 20-21 (Step 2.8), Page 15, lines 11-18. See documented site visits on Page 36, lines 23-25, Page 36, line 35 to Page 37, line 3 and compliance sections mentioned on Page 29, lines 1-6 and Page 27, lines 27-33.).
Therefore, it would have been obvious to one of ordinary skill in the art of guidance for the clinical trials industry before the effective filing date of the claimed invention to modify the method of Goldner and Ford to include preparing subject level specific training for the site and visit-by-visit walk-through guides for the purposes of ensuring just-in-time training for the local physician and local clinic personnel, as well as for ensuring appropriate documentation of procedures conducted for the purposes of ensuring ongoing compliance with ICH E6 (R2) Sections 4.1.2 and 4.1.5as taught by E6 (R2) Good Clinical Practice to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions mentioned on Page 1, lines 16-18 of the E6 (R2) Good Clinical Practice.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Goldner (US 2014/0310015 A1) in view of Syed (US 2015/0332022 A1).
Regarding claim 19, although Goldner and Ford teach the method of claim 18 as mentioned above, Goldner and Ford do not explicitly teach completion or discontinuation of the trial. Syed teaches wherein completion or discontinuation of the trial, comprises one or more of facilitating closure of the clinic and return of equipment or technology (See Clinical Trial Site Statuses listed as Discontinued on page 9 (Table 5, Col. I), lines 24-25, 35-36, 39, 40, 66-67 and 71. Also, see Start Date and End Date on page 9 (Table 5, Col. II), lines 64-67.).
Therefore, it would have been obvious to one of ordinary skill in the art of administering clinical trials before the effective filing date of the claimed invention to modify the method of Goldner and Ford to include completion or discontinuation of the trial as taught by Syed to improve the communications amongst the trial sponsors, investigational sites, and clinical investigators desired to minimize the overhead associated with conducting clinical trials mentioned in Syed’s P0002.
Response to Arguments
Applicant alleges that the method of creating a remote clinical trial integrates a judicial exception into a practical application. See pgs. 7-8 of Remarks – Examiner disagrees.
In Applicant’s claim 1, the recited “c) preparing the one or more local physicians and the respective clinic for research qualification, wherein the preparing comprises providing electronic Investigator Site Files (elSF); and d) facilitating conduct of the clinical trial for the one or more local physicians, wherein the facilitating conduct of the clinical trial further comprises enabling communication, data collection, regulatory feedback prompting, and patient monitoring via one or more software programs”, is insignificant extrasolution activity and not significantly more than an abstract idea. The preceding steps of claim 1, can be done in the human mind, where a user would apply one’s knowledge of a clinical trial investigator and merely match already identified patients and physicians. Also, whatever computer automation of this workflow process is accomplished using basic data processing and is not significantly more than an abstract idea.
Applicant next alleges that the method of creating a remote clinical trial is not a mental process that cannot be performed in the human mind. See pgs. 8-9 of Remarks – Examiner disagrees.
The method steps in the instant case, relies on persons to access a website like TrialJectory (See Applicant’s Fig. 1A) for searching healthcare providers offering nearby treatment. Doing an internet search is what the persons should be expected to do. Furthermore, once these healthcare providers offering nearby treatment are identified, they further conduct the clinical trial administratively, without automation.
Applicant also alleges that the method of creating a remote clinical trial improves the field of clinical trial management, and clinical trial conduct. See pgs. 8-9 of Remarks – Examiner disagrees.
Technology is neither claimed nor explained. Applicant is essentially claiming an administrative workflow process according to Good Clinical Practice’s, for a user to insert undetermined qualifications, provide electronic Investigator Site Files (eISF), and communication means for conducting clinical trials, with no technological criteria for performing tasks, which is an abstract idea. Also, it doesn’t appear computer operations are more efficient or improved upon based on the claimed functions of creating a remote clinical trial to recruit patients, having steps of engaging a user in a computer system.
Applicant’s arguments have been fully considered, but are now moot in view of the new grounds of rejection. The Examiner has entered a new rejection under 35 USC § 103 and applied new art and art already of record.
Conclusion
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/T.S.W./Examiner, Art Unit 3687 03/28/2026
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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