DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
In the amendment filed on December 18, 2025, the following has occurred: claim(s) 169, 172, 174-176, 185, 188-189, 191-194 have been amended, claim(s) 173, 177, 182, 184, 187, 190 have been cancelled, and claim(s) 195-202 have been added. Now, claim(s) 169, 172, 174-176, 185, 188-189, 191-202 are pending.
Claim Objections
Claim 169 objected to because of the following informalities: “…the baseline data…” in p. 2, ll. 20-21, “…follow-up data;” in p. 2, ll. 21-23, “…the metric…” in p. 2, ll. 26, “…via the access-controlled interface,…” in p. 3, ll. 13-14, “…the instruction…” in p. 3, ll. 15, “…the pre-specified time point…” in p. 3, ll. 16, “…the criterion…” in p. 3, ll. 18, “…the corresponding time point…” in p. 3, ll.18 , “…the corresponding time point…” in p. 3, ll. 21, “…the instruction…” in p. 3, ll. 23-24, “…the corresponding time point,…” in p. 4, ll. 7-8, “…the secure provision and the execution outcome,” in p. 4, ll. 12-13. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “..the baseline disease-activity data…”, “…follow-up therapeutic outcome data and theragnostic data;”, “…the therapeutic effectiveness metric…”, “…an access-controlled interface…”, “…the machine-executable selected administration instruction…”, “…the pre-specified post-initiation time point…”, “…the pre-specified therapeutic effectiveness criterion…”, “…the corresponding pre-specified post-initiation time point…”, “…the corresponding pre-specified post-initiation time point…”, “…the machine-executable selected alternative therapy instruction…”, “…the corresponding pre-specified post-initiation time point…”, “…a secure provision and an execution outcome,”.
Claim 172 objected to because of the following informalities: “providing the efficacy assurance…” in p. 5, ll. 3, “...via the interface,…” in p. 5, ll. 6-9, “…the selected instruction…” in p. 5, ll. 14, “…the selected instruction…” in p. 5, ll. 15. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “providing an efficacy assurance…”, “…via the access-controlled interface,…”, “…the selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction…”, “…the selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction…”.
Claim 174 objected to because of the following informalities: “…the selected instruction…” in p. 5, ll. 30, “…the selected instruction…” in p. 5, ll. 30. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “…the selected electronic payment or denial instruction…”, “…the selected electronic payment or denial instruction…”.
Claim 176 objected to because of the following informalities: “…the baseline and follow-up data…” in p. 6, ll. 30, “…the baseline and follow-up data…” in p. 7, ll. 1. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “…the baseline disease-activity data and follow-up therapeutic outcome data and theragnostic data…”, “…the baseline disease-activity data and follow-up therapeutic outcome data and theragnostic data…”.
Claim 185 objected to because of the following informalities: “…the access-controlled data interface of element (c),…” in p. 8, ll. 31, “…the instruction…” in p. 8, ll. 33, “…the pre-specified time point…” in p. 8, ll. 33, p. 9, ll. 1, “…criterion…” in p. 9, ll. 3, “…the corresponding time point…” in p. 9, ll. 3-4, “…the corresponding time point…” in p. 9, ll. 7, “…the access-controlled data interface of element (c),…” in p. 9, ll. 8-9, “…the selected alternative therapy instruction…” in p. 9, ll. 10-11, “…the corresponding time point…” in p. 9, ll. 18, “…the secure provision and the execution outcome;” in p. 9, ll. 22-23, “c) an access-controlled data interface configured to…” in p. 10, ll. 9. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…an access-controlled data interface,…”, “…the machine-executable selected administration…”, “…the pre-specified post-initiation time point…”, “…the pre-specified therapeutic-effectiveness criterion…”, “…the corresponding pre-specified post-initiation time point…”, “…an access-controlled data interface,…”, “…the machine-executable selected alternative therapy instruction…”, “…the corresponding pre-specified post-initiation time point…”, “…the corresponding pre-specified post-initiation time point…”, “…a secure provision and an execution outcome;”, “c) the access-controlled data interface configured to…”.
Claim 189 objected to because of the following informalities: “…the selected instruction…” in p. 11, ll. 10, “…the selected instruction…” in p. 11, ll. 14, “…the selected instruction…” in p. 11, ll. 15. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…the machine-executable selected administration instruction…”, “…the machine-executable selected alternative therapy instruction…”, “…the machine-executable selected alternative therapy instruction…”.
Claim 192 objected to because of the following informalities: “…the selected instruction…” in p. 12, ll. 20. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “…the machine-executable selected administration instruction…”.
Claim 193 objected to because of the following informalities: “…the selected instruction…” in p. 13, ll. 4, “…the selected administration instruction…” in p. 13, ll. 5. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…the machine-executable selected administration instruction…”, “…the machine-executable selected administration instruction…”.
Claim 194 objected to because of the following informalities: “…the selected instruction…” in p. 13, ll. 21, “…the selected instruction…” in p. 13, ll. 26. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…the machine-executable selected administration instruction…”, “…the machine-executable selected administration instruction…”.
Claim 196 objected to because of the following informalities: “…the selected instruction…” in p. 14, ll. 16, “…the selected instruction…” in p. 14, ll. 17. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…the selected electronic instruction…”, “…the selected electronic instruction…”.
Claim 197 objected to because of the following informalities: “…the selected instruction…” in p. 15, ll. 1-2, “…the selected instruction…” in p. 15, ll. 3. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…the selected electronic instruction…”, “…the selected electronic instruction…”.
Claim 199 objected to because of the following informalities: “…the drug…” in p. 15, ll. 20-21, “…the baseline data…” in p. 15, ll. 29, “…the follow-up data…” in p. 15, ll. 29, “the metric” in p. 16, ll. 1, “…the selected instruction…” in p. 16, ll. 18, “…the pre-specified time point…” in p. 16, ll. 19, “…the criterion…” in p. 16, ll. 21, “…the corresponding time point…” in p. 16, ll. 21, “…the selected alternative therapy instruction…” in p. 16, ll. 26, “…the pre-specified time point,…” in p. 16, ll. 29, “…the corresponding time point…” in p. 16, ll. 31-32, “…the secure provision and the execution outcome”. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…a drug…”, “…the baseline disease-activity data…”, “…the follow-up therapeutic-outcome data…”, “…the therapeutic-effectiveness metric…”, “…the machine-executable selected administration…”, “…the pre-specified post-initiation time point…”, “…the pre-specified therapeutic-effectiveness criterion…”, “…the corresponding pre-specified post-initiation time point…”, “…the machine-executable selected alternative therapy instruction…”, “…the pre-specified post-initiation time point…”, “…the corresponding pre-specified post-initiation time point…”, “…a secure provision and an execution outcome”.
Claim 200 objected to because of the following informalities: “…the selected instruction…” in p. 17, ll. 16-17. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “…the machine-executable selected instruction…”.
Claim 201 objected to because of the following informalities: “…the selected instruction…” in p. 18, ll. 1-2, “…the selected instruction…” in p. 18, ll. 2, “…the selected instruction…” in p. 18, ll. 2-3. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…the machine-executable selected instruction…”, “…the machine-executable selected instruction…” “…the machine-executable selected instruction…”.
Claim 202 objected to because of the following informalities: “…the submission…” in p. 18, ll. 10-11, “…the submission…” in p. 18, ll. 12-13. These appear to be typographical errors. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portions as “…the machine-executable selected instruction…”, “…the machine-executable selected instruction…”.
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.
Claims 169, 172, 174-176, 185, 188-189, 191-202 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. The terms are listed below:.
Claim 169: "baseline disease-activity data" first recited in p. 2, ll. 14, the Applicant’s Specification from August 20, 2020 only describes “The diagnostic may be to evaluate baseline, to determine standards, to measure control levels, to evaluate rates of change, and other such measures.” in Paragraph [0217], the Specification lacks description of “baseline disease-activity data”. “one or more pre-specified post-initiation time points” first recited in p. 2, ll. 18, the Applicant’s Specification from August 20, 2020 does not describe “one or more pre-specified post-initiation time points”. “an encrypted, access-controlled repository comprising one or more databases or a data warehouse” first recited in p. 2, ll. 24-25, the Applicant’s Specification from August 20, 2020 does not describe “an encrypted, access-controlled repository comprising one or more databases or a data warehouse”. “a stratification flag” first recited in p. 2, ll. 27-28, the Applicant’s Specification from August 20, 2020 the Specification lacks description of a “flag” or a specific “stratification flag”. “a feedback-controlled theragnostic evaluation” in p. 3, ll. 1, the Applicant’s Specification from August 20, 2020 only describes “Communication and feedback may be provided at all stages from recruitment, informed consent, patient counseling, through to answering clinically and therapeutically relevant questions and measuring clinical endpoints and adverse reactions and explaining participant outcomes.” in Paragraph [0077]. “a therapeutic guidance signal” first recited in p. 3, ll. 9, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], but the Specification lacks description of “a therapeutic guidance signal”. “a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both,” first recited in p. 3, ll. 10-11, the Applicant’s Specification from August 20, 2020 in Paragraph [0010]: “a different dosing schedule”, Paragraph [0096]: “first patient dosing, completion of Phase-I,”, Paragraph [0223]: “(b) therapeutic guidance, which provides details of therapy, including aspects of specific drug dosing and schedule details during a treatment cycle;”, Paragraph [0343]: “Diagnostic evaluations are performed on the patients to determine whether there are any toxicity or adverse side effects from dosing, and to document any side effects on clinical indication being tested.”, the Applicant’s Specification does not describe the claimed portion “a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both,”. “the access-controlled interface” first recited in p. 3, ll. 13-14, the Applicant’s Specification from August 20, 2020 mentions “an interface” in Paragraph [0328], but does not disclose that the “interface” is “access-controlled”. “a machine-executable selected administration instruction” first recited in p. 3, ll. 14-15, the Applicant’s Specification from August 20, 2020 does not describe “a machine-executable selected administration instruction”, the Specification lacks a recitation of “instruction”, “machine” is mentioned in Paragraphs [0002]-[0006], [0112], [0123], [0261], [0389], however the Specification lacks the description of “a machine-executable selected administration instruction”. “an alternative therapy signal” first recited in p. 3, ll. 20, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], the Specification lacks description of “an alternative therapy signal”. “a machine-executable selected alternative therapy instruction” first recited in p. 3, ll. 21-22, the Applicant’s Specification from August 20, 2020 does not describe “a machine-executable selected alternative therapy instruction”, the Specification lacks a recitation of “instruction”, “machine” is mentioned in Paragraphs [0002]-[0006], [0112], [0123], [0261], [0389], the Specification lacks the description of “a machine-executable selected alternative therapy instruction”. “a pre-specified switching rule” first recited in p. 3, ll. 25-26, the Applicant’s Specification from August 20, 2020 does not describe “a pre-specified switching rule”.
Claim 172 recites “the encrypted, access-controlled repository comprising one or more databases or a data warehouse” in p. 5, ll. 4, “the access-controlled interface” in p. 5, ll. 6-9 and are similarly rejected as described in the rejection to claim 169. Claim 172 also recites “processor-executable assurance logic” in p. 5, ll. 11, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “assurance logic”. “a selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction” first recited in p. 5, ll. 12-13, the Applicant’s Specification does not describe “instruction” and does not specifically describe “a selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction”.
Claim 174 recites “one or more pre-specified post-initiation time points” in p. 5, ll. 19-20, “via the access-controlled interface” in p. 5, ll. 29-30, “the encrypted, access-controlled repository” in p. 6, ll. 1, and are similarly rejected as described in the rejection to claim 169. Claim 174 also recites “processor-executable reimbursement logic” first recited in p. 5, ll. 27-28, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “reimbursement logic”. “a selected electronic payment or denial instruction” first recited in p. 5, ll. 28, the Applicant’s Specification does not describe “instruction”.
Claim 175 recites “the encrypted, access-controlled repository” in p. 6, ll. 19, and are similarly rejected as described in the rejection to claim 169.
Claim 176 recites “an access-controlled interface” in p. 6, ll. 24-25, “the baseline disease-activity data and follow-up therapeutic outcome data and theragnostic data against the pre-specified post-initiation time points” in p. 6, ll. 30-31, “the baseline disease-activity data and follow-up therapeutic outcome data and theragnostic data” in p. 7, ll. 1, and are similarly rejected as described in the rejection to claim 169. Claim 176 recites “processor-executable verification logic” first recited in p. 6, ll. 28-29, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “verification logic”.
Claim 185: “one or more encrypted, access-controlled databases, or an encrypted, access-controlled data warehouse,” first recited in p. 7, ll. 15-16, the Applicant’s Specification from August 20, 2020 describes “encrypted” in Paragraph [0016], “encryption” in Paragraph [0334], the Specification does not specifically describe “one or more encrypted, access-controlled databases, or an encrypted, access-controlled data warehouse,”. "baseline disease-activity data" recited in p. 7, ll. 18, the Applicant’s Specification from August 20, 2020 only describes “The diagnostic may be to evaluate baseline, to determine standards, to measure control levels, to evaluate rates of change, and other such measures.” in Paragraph [0217], the Specification lacks description of “baseline disease-activity data”. “pre-specified post-initiation time points” in p. 8, ll. 1-2, the Applicant’s Specification from August 20, 2020 does not describe “pre-specified post-initiation time points”. “a stratification flag” first recited in p. 8, ll. 11, the Applicant’s Specification from August 20, 2020 makes no mention of a “flag” or a specific “stratification flag”. “a feedback-controlled theragnostic evaluation” in p. 8, ll. 14, the Applicant’s Specification from August 20, 2020 only describes “Communication and feedback may be provided at all stages from recruitment, informed consent, patient counseling, through to answering clinically and therapeutically relevant questions and measuring clinical endpoints and adverse reactions and explaining participant outcomes.” in Paragraph [0077]. “a therapeutic guidance signal” first recited in p. 8, ll. 25, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], but the Specification lacks description of “a therapeutic guidance signal”. “a machine-executable selected administration instruction” first recited in p. 8, ll. 31-32, the Applicant’s Specification from August 20, 2020 does not describe “a machine-executable selected administration instruction”, the Specification lacks a recitation of “instruction”, “machine” is mentioned in Paragraphs [0002]-[0006], [0112], [0123], [0261], [0389], however the Specification lacks the description of “a machine-executable selected administration instruction”. “an alternative therapy signal” first recited in p. 9, ll. 7-8, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], but the Specification lacks description of “an alternative therapy signal”. “a machine-executable selected alternative therapy instruction” first recited in p. 9, ll. 9-10, the Applicant’s Specification from August 20, 2020 does not describe “a machine-executable selected alternative therapy instruction”, the Specification lacks a recitation of “instruction”, “machine” is mentioned in Paragraphs [0002]-[0006], [0112], [0123], [0261], [0389], the Specification lacks the description of “a machine-executable selected alternative therapy instruction”. “an access-controlled interface” first recited in p. 10, ll. 9, the Applicant’s Specification from August 20, 2020 mentions “an interface” in Paragraph [0328], but does not disclose that the “interface” is “access-controlled”.
Claim 188 recites “access-controlled interface” in p. 10, ll. 19 and is similarly rejected as described in the rejection to claim 185.
Claim 189 recites “pre-specified post-initiation time points” in p. 11, ll. 4, “the access-controlled interface” in p. 11, ll. 8, p. 11, ll. 13, “machine-executable selected administration instruction” in p. 11, ll. 9, “machine-executable selected alternative therapy instruction” in p. 11, ll. 12-13 and are similarly rejected as described in the rejection to claim 185. Additionally claim 189 recites “a database layer” first recited in p. 11, ll. 2, the Applicant’s Specification from August 20, 2020 does not describe “a database layer”, “layer” is mentioned in Paragraphs [0197], [0199], [0211], [0218], however the “layers” described are not related to “a database layer”.
Claim 191 recites “the access-controlled interface” in p. 11, ll. 27, “the encrypted access-controlled repository” in p. 11, ll. 28, and are similarly rejected as described in the rejection to claim 169. Additionally, claim 191 recites “processor-executable regulatory submission logic” recited in p. 11, ll. 23, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “regulatory submission logic”.
Claim 192 recites “baseline disease-activity data” in p. 12, ll. 6-7, “the access-controlled interface” in p. 12, ll. 13, “…machine-executable selected administration instruction…” in p. 12, ll. 15-16, p. 12, ll. 20, and are similarly rejected as described in the rejection to claim 169. Additionally, claim 192 recites “a priori therapeutic appropriateness signal” first recited in p. 12, ll. 3, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], but the Specification lacks description of “a priori therapeutic appropriateness signal”. “a pre-specified baseline rule” first recited in p. 12, ll. 4-6, the Applicant’s Specification from August 20, 2020 mentions “baseline” in Paragraph [0217], however the Specification does not mention “a pre-specified baseline rule”.
Claim 193 recites “the pre-specified baseline rule” in p. 12, ll. 24-25, “a priori therapeutic appropriateness signal” in p. 12, ll. 26, “the encrypted access-controlled repository” in p. 12, ll. 28, “the stratification flag” in p. 12, ll. 29-30, p. 12, ll. 31-32, p. 13, ll. 1, “a machine-executable selected administration instruction” in p. 13, ll. 1-2, p. 13, ll. 4, p. 13, ll. 5, and these terms are similarly rejected as described above in the rejections to claims 169 and 192. Additionally, claim 193 recites “processor-executable assignment logic” in p. 12, ll. 22, the Applicant’s Specification from August 20, 2020 describes only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “assignment logic”.
Claim 194 recites “the feedback-controlled theragnostic evaluation” in p. 13, ll. 7-8, “the stratification flag” in p. 13, ll. 9-10, “respective pre-specified post-initiation time points” in p. 13, 10-11, “a therapeutic guidance signal” in p. 13, ll. 13, “the stratification flag” in p. 13, ll. 14, “the encrypted, access-controlled repository” in p. 13, ll. 16-17, “the access-controlled interface,” in p. 13, ll. 19, “a machine-executable selected administration instruction” in p. 13, ll. 19-20, “a subsequent pre-specified post-initiation time point of the machine-executable selected administration instruction” in p. 13, ll. 21-22, “the pre-specified post-initiation time point” in p. 13, ll. 23-24, “the machine-executable selected administration instruction” in p. 13, ll. 26 and these terms are similarly rejected as described above in the rejections to claim 169. Additionally, claim 194 recites “processor-executable dosing-update logic” in p. 13, ll. 12-13, the Applicant’s Specification from August 20, 2020 describes only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “dosing-update logic”. “a pre-specified dosing rule” in p. 13, ll. 13-14 and “a pre-specified stopping rule” in p. 13, ll. 27-28, the Applicant’s Specification from August 20, 2020 does not describe “a pre-specified dosing rule” or “a pre-specified stopping rule”.
Claim 195 is rejected under 35 U.S.C. 112(a) based on the claim’s dependency on claim 169.
Claim 196 recites “the encrypted access-controlled repository” in p. 14, ll. 19 and this term is similarly rejected as described above in the rejections to claim 169. Additionally, claim 196 recites “processor-executable reimbursement logic or assurance logic” in p. 14, ll. 10, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “reimbursement logic or assurance logic”. Additionally, claim 196 recites “selected electronic instruction” in p. 14, ll. 11, p. 14, ll. 16-17, “an electronic payment or denial instruction” in p. 14, ll. 12, “an electronic efficacy assurance, partial assurance issuance, or assurance denial instruction” in p. 14, ll. 14-15, and the Applicant’s Specification does not describe “electronic instruction”.
Claim 197 recites “the access-controlled data interface” in p. 14, ll. 23, p. 15, ll. 1 and these terms are similarly rejected as described above in the rejections to claim 185. Additionally, claim 197 recites “processor-executable reimbursement logic or assurance logic” in p. 14, ll. 25 the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “reimbursement logic or assurance logic”. Additionally, claim 197 recites “selected electronic instruction” in p. 14, ll. 24, p. 15, ll. 1-2, p. 15, ll. 3, “an electronic payment or denial instruction” in p. 14, ll. 25, “an electronic efficacy assurance, partial assurance issuance, or assurance denial instruction” in p. 14, ll. 26-27, and the Applicant’s Specification does not describe “electronic instruction”.
Claim 198 recites “the access-controlled data interface” in p. 15, ll. 11 and this term is similarly rejected as described above in the rejections to claim 185.
Claim 199: “one or more encrypted, access-controlled databases or an encrypted, access-controlled data warehouse;” first recited in p. 15, ll. 17-18, the Applicant’s Specification from August 20, 2020 does not describe “one or more encrypted, access-controlled databases or an encrypted, access-controlled data warehouse;”. “an access-controlled data interface” in p. 15, ll. 18-19, p. 15, ll. 22, the Applicant’s Specification from August 20, 2020 mentions “an interface” in Paragraph [0328], but does not disclose that the “interface” is “access-controlled”. “baseline disease-activity data” in p. 15, ll. 24 p. 15, ll. 29, the Applicant’s Specification from August 20, 2020 only describes “The diagnostic may be to evaluate baseline, to determine standards, to measure control levels, to evaluate rates of change, and other such measures.” in Paragraph [0217], with no mention of “baseline disease-activity data”. “one or more pre-specified post-initiation time points” first recited in p. 15, ll. 26-27, the Applicant’s Specification from August 20, 2020 does not describe “one or more pre-specified post-initiation time points”. “an encrypted, access-controlled repository” in p. 15, ll. 30, the Applicant’s Specification from August 20, 2020 does not describe “an encrypted, access-controlled repository”. “a stratification flag” in p. 16, ll. 4, the Applicant’s Specification from August 20, 2020 makes no mention of a “flag” or a specific “stratification flag”. “a feedback-controlled theragnostic evaluation” in p. 16, ll. 7, the Applicant’s Specification from August 20, 2020 only describes “Communication and feedback may be provided at all stages from recruitment, informed consent, patient counseling, through to answering clinically and therapeutically relevant questions and measuring clinical endpoints and adverse reactions and explaining participant outcomes.” in Paragraph [0077]. “a therapeutic guidance signal” first recited in p. 16, ll. 13, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], but the Specification lacks description of “a therapeutic guidance signal”. “a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both,” first recited in p. 16, ll. 13-14, the Applicant’s Specification from August 20, 2020 in Paragraph [0010]: “a different dosing schedule”, Paragraph [0096]: “first patient dosing, completion of Phase-I,”, Paragraph [0223]: “(b) therapeutic guidance, which provides details of therapy, including aspects of specific drug dosing and schedule details during a treatment cycle;”, Paragraph [0343]: “Diagnostic evaluations are performed on the patients to determine whether there are any toxicity or adverse side effects from dosing, and to document any side effects on clinical indication being tested.”, the Applicant’s Specification does not describe the claimed portion “a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both,”. “a machine-executable selected administration instruction” first recited in p. 16, ll. 17-18, the Applicant’s Specification from August 20, 2020 does not describe “a machine-executable selected administration instruction”, the Specification lacks a recitation of “instruction”, “machine” is mentioned in Paragraphs [0002]-[0006], [0112], [0123], [0261], [0389], however the Specification lacks the description of “a machine-executable selected administration instruction”. “an alternative therapy signal” first recited in p. 16, ll. 23, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], but no mention of “an alternative therapy signal”. “a machine-executable selected alternative therapy instruction” first recited in p. 16, ll. 24-25, the Applicant’s Specification from August 20, 2020 does not describe “a machine-executable selected alternative therapy instruction”, the Specification lacks a recitation of “instruction”, “machine” is mentioned in Paragraphs [0002]-[0006], [0112], [0123], [0261], [0389], the Specification lacks the description of “a machine-executable selected alternative therapy instruction”. “a pre-specified switching rule” first recited in p. 16, ll. 27, the Applicant’s Specification from August 20, 2020 does not describe “a pre-specified switching rule”.
Claim 200 recites “the access-controlled data interface” in p. 17, ll. 6-7, “a post-initiation pre-specified time point” in p. 17, ll. 18-19, “the encrypted, access-controlled repository” in p. 17, ll. 20, and are similarly rejected as described in the rejection to claim 199. Additionally, claim 200 recites “processor-executable reimbursement logic or assurance logic” in p. 17, ll. 9-10, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “reimbursement logic or assurance logic”. “a machine-executable selected instruction” in p. 17, ll. 10, the Applicant’s Specification from August 20, 2020 does not describe a machine-executable selected instruction”, the Specification lacks a recitation of “instruction”, “machine” is mentioned in Paragraphs [0002]-[0006], [0112], [0123], [0261], [0389], however the Specification lacks the description of “a machine-executable selected instruction”. “an electronic payment or denial instruction” in p. 17, ll. 12, the Applicant’s Specification does not describe “instruction”. “an electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction” in p. 17, ll. 14-15, the Applicant’s Specification does not describe “instruction”.
Claim 201 recites “pre-specified post-initiation time point” in p. 17, ll. 24, “the encrypted, access-controlled repository” in p. 17, ll. 25, “the access-controlled data interface” in p. 17, ll. 27, p. 18, ll. 1-2, “the machine-executable selected administration instruction” in p. 17, ll. 28, p. 18, ll. 1-4, and are similarly rejected as described in the rejection to claim 199. Additionally, claim 201 recites “a database layer” in p. 17, ll. 23, the Applicant’s Specification from August 20, 2020 does not describe “a database layer”, “layer” is mentioned in Paragraphs [0197], [0199], [0211], [0218], however the “layers” described are not related to “a database layer”. “processor-executable reimbursement or assurance logic” in p. 18, ll. 1, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “reimbursement or assurance logic”.
Claim 202 recites “the access-controlled data interface” in p. 18, ll. 10, “the encrypted, access-controlled repository,” in p. 18, ll. 12, and are similarly rejected as described in the rejection to claim 199. Additionally, claim 202 recites “processor-executable regulatory submission logic” in p. 18, ll. 7, the Applicant’s Specification from August 20, 2020 mentions only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “regulatory submission logic”.
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.
Claim(s) 169, 172, 174-176, 185, 188-189, 191-202 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 169, 172, 174-176, 191-196: Step 2A Prong One
Claim 169 recite(s):
a) administering the drug to one or more enrolled subjects;
b) receiving, for each subject:
i) baseline disease-activity data and at least one drug—or disease-specific theragnostic data point acquired before clinical trial initiation; and
ii) follow-up therapeutic outcome data and theragnostic data acquired at one or more pre-specified post-initiation time points;
c) determining, by theragnostic evaluation, a therapeutic effectiveness metric for each subject by comparing the baseline disease-activity data with the follow-up therapeutic outcome data;
d) developing and storing, one or more therapeutic effectiveness datasets, one or more clinical trial datasets, or both, derived from the therapeutic effectiveness metric of step (c), each dataset corresponding to one or more of: (i) a single subject, (ii) at least one stratified subset of subjects, or (iii) an entire clinical trial population, each dataset being indexed by subject and by a stratification flag determined from any of (i) mechanism of action of the drug, (ii) disease subtype, (iii) disease stage, or (iv) disease severity; and
e) operating a feedback-controlled theragnostic evaluation that, at each pre-specified post-initiation time point, and using at least one of: (i) the therapeutic effectiveness metric in step (c); and (ii) one or more datasets developed in step (d), causes the electronic clinical trial system, for each subject or for at least one stratified subset of subjects identified by the stratification flag of step (d), to:
i) generate a therapeutic guidance signal that, under a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both, a machine- executable selected administration instruction, and causes execution of the machine- executable selected administration instruction for a next administration event at the pre- specified post initiation time point to achieve or maintain a pre-specified therapeutic effectiveness criterion; and upon failure to achieve or maintain the pre-specified therapeutic effectiveness criterion at the corresponding pre-specified post-initiation time point, perform sub-clause (e)(ii);
ii) upon failure to achieve or maintain the pre-specified therapeutic effectiveness criterion at the corresponding pre-specified post-initiation time point, generate an alternative therapy signal that securely provides, a machine-executable selected alternative therapy instruction and causes execution of the machine-executable selected alternative therapy instruction to initiate an alternative therapy according to a pre- specified switching rule;
iii) verify execution using a verification mechanism configured to confirm execution at the pre-specified post-initiation time point, including at least one of: telehealth remote monitoring; order-fulfillment confirmation; or device telemetry; and
iv) update the datasets developed in step (d) to record, for the corresponding pre- specified post-initiation time point, each signal, and each machine-executable selected instruction, generated under sub-clauses (e)(i)-(e)(ii), the update to the stored dosage or dosing schedule, and the verification of execution;
wherein the through (e) by conditioning clinical trial participation or funding on performance of the recited steps by one or more entities acting individually or collectively
These limitations, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people, including following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. That is other than reciting, “an electronic clinical trial system comprising at least one processor”, “in an encrypted, access-controlled repository comprising one or more databases or a data warehouse,”, “updates a subject-specific drug dosage or dosing schedule stored in the access-controlled repository, securely provides,”, “store, in the encrypted, access-controlled repository, a time-pointed record of a secure provision and an execution outcome,”, “via an access-controlled interface,” “via the access-controlled interface,” the claim recites a Certain Method of Organizing Human Activity. For example, the claim encompasses a user following instructions to administer a drug to one or more enrolled subjects, a user following instructions to obtain baseline disease-activity data and at least one drug—or disease-specific theragnostic data point acquired before clinical trial initiation, and follow-up therapeutic outcome data and theragnostic data acquired at one or more pre-specified post-initiation time points, a user following instructions to determine a therapeutic effectiveness metric for each subject by comparing the baseline disease-activity data with the follow-up therapeutic outcome data, a user following instructions to develop and store one or more therapeutic effectiveness datasets, one or more clinical trial datasets, or both, derived from the therapeutic effectiveness metric, a user following instructions to operate a feedback-controlled theragnostic evaluation, and a user following instructions to exercise direction or control over steps (a)-through (e). These steps could be accomplished by a user following rules or instructions to conduct a clinical trial, such as scientific researchers or medical professionals.
Claims 172, 174-176, 191-196 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claim 172 incorporates the abstract idea and describes determining an efficacy assurance and providing said efficacy assurance to a healthcare payer or a subject. Similarly, claim 174 incorporates the abstract idea and further describes how the payment is made. Similarly, claims 175-176 incorporate the abstract idea and further describe the clinical trial. Similarly, claim 191 incorporates the abstract idea and describes an electronic regulatory submission. Similarly, claim 192 incorporates the abstract idea and further describe rules or instructions when utilizing the generic computer components or perform the method steps. Similarly, claim 193 incorporates the abstract idea and describes assigning each subject or at least one baseline-stratified subset of subjects identified by the pre-specified baseline rule to a clinical trial arm or dosing regimen, and storing the assignments. Similarly, claim 194 incorporates the abstract idea and further describes the feedback-controlled theragnostic evaluation. Similarly, claim 195 incorporates the abstract idea and further describes the entity that participates in the clinical trial funding. Similarly, claim 196 incorporates the abstract idea and describes generating an output record. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 169, 172, 174-176, 191-196: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining element amounts to no more than general purpose computer components programmed to perform the abstract idea, and insignificant extra-solution activity.
Claims 169, 172, 174-176, 191-196, directly or indirectly, recite the following generic computer components, “an electronic clinical trial system comprising at least one processor”, “in an encrypted, access-controlled repository comprising one or more databases or a data warehouse,”, “via an access-controlled interface,” “via the access-controlled interface”. As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “updates a subject-specific drug dosage or dosing schedule stored in the access-controlled repository, securely provides,” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “store, in the encrypted, access-controlled repository, a time-pointed record of a secure provision and an execution outcome,” do not integrate the judicial exception into a practical application because they merely recite insignificant, extra-solution activity of data gathering of the abstract idea.
Claims 169, 172, 174-176, 191-196: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.”)
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Insignificant, extra solution, data gathering activity has been found to not amount to
significantly more than an abstract idea (See MPEP 2106.05(g)). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claims 185, 188-189, 197-198: Step 2A Prong One
Claim 185 recite(s):
a) receive and store, for each subject to whom the drug is administered:
i) baseline disease-activity data and at least one drug- or disease-specific theragnostic data point acquired before clinical trial initiation; and
ii) follow-up therapeutic-outcome data and theragnostic data acquired at one or more pre-specified post-initiation time points;
b)
i) determine, at the pre-specified post-initiation time points, a therapeutic effectiveness metric for each subject by comparing the baseline disease-activity data and the baseline theragnostic data with the follow-up therapeutic outcome data and the follow-up theragnostic data;
ii) develop and store, one or more therapeutic effectiveness datasets, one or more clinical trial datasets, or both, for (i) a single subject, (ii) at least one stratified subset of subjects, or (iii) an entire clinical trial population, each dataset being indexed by subject and by a stratification flag determined from any of (i) mechanism of action of the drug, (ii) disease subtype, (iii) disease stage, or (iv) disease severity; and
iii) operate a feedback-controlled theragnostic evaluation that, at each pre- specified post-initiation time point, and using at least one of:
(1) the therapeutic-effectiveness metric determined in element (b)(i); and
(2) one or more of the datasets developed in element (b)(ii), by causes the electronic clinical trial system, for each subject or for at least one stratified subset of subjects identified by the stratification flag of element (b)(ii), to:
(a) generate a therapeutic guidance signal that, under a pre- specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both, automatically updates a subject-specific drug dosage or dosing schedule, a machine-executable selected administration instruction, and causes execution of the machine-executable selected administration instruction for a next administration event at the pre- specified post-initiation time point to achieve or maintain a pre-specified therapeutic-effectiveness criterion; and, upon failure to achieve or maintain the therapeutic-effectiveness criterion at the corresponding pre- specified post-initiation time point, perform sub-clause (b)(iii)(b);
(b) upon failure to achieve or maintain the pre-specified therapeutic effectiveness criterion at the corresponding pre-specified post- initiation time point, generate an alternative therapy signal that securely provides, a machine-executable selected alternative therapy instruction and causes execution of the machine-executable selected alternative therapy instruction to initiate an alternative therapy according to a pre- specified switching rule;
(c) verify execution using a verification mechanism configured to confirm execution at the pre-specified time point, including at least one of:
telehealth remote monitoring; order-fulfillment confirmation; or device
telemetry; and
(c) enable one or more entities, acting individually or collectively, under the direction or control of the third-party clinical trial sponsor by conditioning clinical trial participation or funding, to access, analyze, or otherwise process data stored in element (a) or developed in element (b)
These limitations, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people, including following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. That is other than reciting, “one or more encrypted, access-controlled databases, or an encrypted, access-controlled data warehouse, configured to…”, “one or more processors operatively coupled to the clinical trial database system, the processors being configured to execute processor-executable instructions to:”, “in the databases or data warehouse recited in element (a),”, “stored in the clinical trial database system,”, “via an access-controlled data interface,”, “via the access-controlled data interface”, the access-controlled data interface”, “(d) update the datasets developed in element (b)(ii) to record, for the corresponding time point, each signal and each machine-executable selected instruction generated under sub-clauses (b)(iii)(a)-(b), the update to the stored dosage or dosing schedule, and the verification of execution; and store, in the databases or data warehouse recited in element (a), a time-pointed record of a secure provision and an execution outcome;” the claim recites a Certain Method of Organizing Human Activity. For example, the claim encompasses a user following instructions to obtain baseline disease-activity data and at least one drug- or disease-specific theragnostic data point acquired before clinical trial initiation and follow-up therapeutic-outcome data and theragnostic data acquired at one or more pre-specified post-initiation time points, a user following instructions to determine, at the pre-specified post-initiation time points, a therapeutic effectiveness metric for each subject, a user following instructions to develop and store, one or more therapeutic effectiveness datasets, one or more clinical trial datasets, or both, a user following instructions to operate a feedback-controlled theragnostic evaluation, and a user following instructions to enable one or more entities, acting individually or collectively, under the direction or control of the third-party clinical trial sponsor by conditioning clinical trial participation or funding, to access, analyze, or otherwise process data. These steps could be accomplished by a user following rules or instructions to conduct a clinical trial, such as scientific researchers or medical professionals.
Claims 188-189, 197-198 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claim 188 incorporates the abstract idea and further describes the generic computer components. Similarly, claims 189 and 197 incorporate the abstract idea and further describe performing the abstract idea with the use of generic computer components. Finally, claim 198 incorporates the abstract idea and describes determining and communicating electronic regulatory submission. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 185, 188-189, 197-198: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining element amounts to no more than general purpose computer components programmed to perform the abstract idea, and insignificant extra-solution activity.
Claims 185, 188-189, 197-198, directly or indirectly, recite the following generic computer components, “one or more encrypted, access-controlled databases, or an encrypted, access-controlled data warehouse, configured to…”, “one or more processors operatively coupled to the clinical trial database system, the processors being configured to execute processor-executable instructions to:”, “in the databases or data warehouse recited in element (a),”, “stored in the clinical trial database system,” “via an access-controlled data interface,”, “via the access-controlled data interface”, the access-controlled data interface”,. As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “(d) update the datasets developed in element (b)(ii) to record, for the corresponding time point, each signal and each machine-executable selected instruction generated under sub-clauses (b)(iii)(a)-(b), the update to the stored dosage or dosing schedule, and the verification of execution;” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “store, in the databases or data warehouse recited in element (a), a time-pointed record of a secure provision and an execution outcome;” do not integrate the judicial exception into a practical application because they merely recite insignificant, extra-solution activity of data gathering of the abstract idea.
Claims 185, 188-189, 197-198: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.”)
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Insignificant, extra solution, data gathering activity has been found to not amount to
significantly more than an abstract idea (See MPEP 2106.05(g)). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Claims 199-202: Step 2A Prong One
Claim 199 recite(s):
a) receiving, for each subject to whom the drug is administered:
i) baseline disease-activity data and at least one drug- or disease-specific theragnostic data point acquired before clinical trial initiation; and
ii) follow-up therapeutic-outcome data and theragnostic data acquired at one or more pre-specified post-initiation time points;
b) determining, by theragnostic evaluation, a therapeutic-effectiveness metric for each subject by comparing the baseline disease-activity data with the follow-up therapeutic-outcome data;
c) developing and storing, in an encrypted, access-controlled repository comprising one or more databases or a data warehouse, one or more therapeutic-effectiveness datasets, one or more clinical-trial datasets, or both, derived from the therapeutic-effectiveness metric of operation (b), each dataset corresponding to one or more of: (i) a single subject, (ii) at least one stratified subset of subjects, or (iii) an entire clinical trial population, each dataset being indexed by subject and by a stratification flag determined from any of (i) mechanism of action of the drug, (ii) disease subtype, (iii) disease stage, or (iv) disease severity; and
d) operating a feedback-controlled theragnostic evaluation that, at each pre-specified post-initiation time point, and using at least one of: (i) the therapeutic-effectiveness metric determined in operation (b); and (ii) one or more of the datasets developed in operation (c), causes the electronic clinical trial system, for each subject or for at least one stratified subset of subjects identified by the stratification flag of operation (c), to:
i) generate a therapeutic guidance signal that, under a pre-specified dosing rule keyed to the therapeutic-effectiveness metric, the stratification flag, or both, automatically updates a subject-specific drug dosage or dosing schedule stored in the access-controlled repository, securely provides, a machine-executable selected administration instruction, and causes execution of the selected instruction for a next administration event at the pre-specified post-initiation time point to achieve or maintain a pre-specified therapeutic-effectiveness criterion; and, upon failure to achieve or maintain the pre-specified therapeutic-effectiveness criterion at the corresponding time point, perform sub-clause (d)(ii);
ii) upon failure to achieve or maintain the pre-specified therapeutic-effectiveness criterion at the corresponding pre-specified post-initiation time point, generate an alternative therapy signal that securely provides, a machine-executable selected alternative therapy instruction, and causes execution of the machine-executable selected alternative therapy instruction to initiate an alternative therapy according to a pre- specified switching rule;
iii) verify execution using a verification mechanism configured to confirm execution at the pre-specified post-initiation time point, including at least one of: telehealth remote monitoring; order-fulfillment confirmation; or device telemetry; and
iv) update the datasets developed in operation (c) to record, for the corresponding time point, each signal and each machine-executable selected instruction generated under sub-clauses (d)(i)-(d)(ii), the update to the stored dosage or dosing schedule, and the verification of execution; and store, in the encrypted, access-controlled repository, a time-pointed record of the secure provision and the execution outcome
These limitations, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people, including following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. That is other than reciting, “(a) one or more encrypted, access-controlled databases or an encrypted, access-controlled data warehouse; (b) one or more processors; and (c) an access-controlled data interface, the clinical trial being conducted by a third-party clinical trial sponsor other than a pharmaceutical company that developed or commercialized a drug, cause the electronic clinical trial system to perform operations comprising:”, “via an access-controlled interface,”, “via the access-controlled data interface of element (c),”, “via the access-controlled data interface of element (c),”, “iv) update the datasets developed in operation (c) to record, for the corresponding time point, each signal and each machine-executable selected instruction generated under sub-clauses (d)(i)-(d)(ii), the update to the stored dosage or dosing schedule, and the verification of execution;”, “store, in the encrypted, access-controlled repository, a time-pointed record of a secure provision and an execution outcome” the claim recites a Certain Method of Organizing Human Activity. For example, the claim encompasses a user following instructions to obtain baseline disease-activity data and at least one drug- or disease-specific theragnostic data point acquired before clinical trial initiation and follow-up therapeutic-outcome data and theragnostic data acquired at one or more pre-specified post-initiation time points, a user following instructions to determine a therapeutic effectiveness metric for each subject, a user following instructions to develop and store, one or more therapeutic effectiveness datasets, one or more clinical trial datasets, or both, and a user following instructions to operate a feedback-controlled theragnostic evaluation. These steps could be accomplished by a user following rules or instructions to conduct a clinical trial, such as scientific researchers or medical professionals.
Claims 199-202 incorporate the abstract idea identified above and recite additional limitations that expand on the abstract idea. For example, claim 200 incorporates the abstract idea and describes a payment and assurance issuance steps. Similarly, claim 201 incorporates the abstract idea and further describes performing the abstract idea with the use of generic computer components. Finally, claim 202 incorporates the abstract idea and further describes determining and communicating electronic regulatory submission. Such steps encompass Certain Methods of Organizing Human Activity.
Claims 199-202: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining element amounts to no more than general purpose computer components programmed to perform the abstract idea, and insignificant extra-solution activity.
Claims 199-202, directly or indirectly, recite the following generic computer components, “(a) one or more encrypted, access-controlled databases or an encrypted, access-controlled data warehouse; (b) one or more processors; and (c) an access-controlled data interface, the clinical trial being conducted by a third-party clinical trial sponsor other than a pharmaceutical company that developed or commercialized a drug, cause the electronic clinical trial system to perform operations comprising:”, “via an access-controlled interface,”, “via the access-controlled data interface of element (c),”, “via the access-controlled data interface of element (c),”. As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 “merely include[ing] instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “iv) update the datasets developed in operation (c) to record, for the corresponding time point, each signal and each machine-executable selected instruction generated under sub-clauses (d)(i)-(d)(ii), the update to the stored dosage or dosing schedule, and the verification of execution;” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Additionally, the claims recite “store, in the encrypted, access-controlled repository, a time-pointed record of a secure provision and an execution outcome” do not integrate the judicial exception into a practical application because they merely recite insignificant, extra-solution activity of data gathering of the abstract idea.
Claims 199-202: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.”)
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Insignificant, extra solution, data gathering activity has been found to not amount to
significantly more than an abstract idea (See MPEP 2106.05(g)). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
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 (i.e., changing from AIA to pre-AIA ) 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 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 169, 172, 174-176, 185, 188-189, 191-202 are rejected under 35 U.S.C. 103 as being unpatentable over Elton et al. (U.S. Patent Pre-Grant Publication No. 2012/0231959) in view of Bockelman et al. (U.S. Patent Pre-Grant Publication No. 2014/0330572).
As per claim 169, Elton discloses a method of conducting a clinical trial of a drug, implemented in and coordinated by an electronic clinical trial system comprising at least one processor (See [0058], [0101]: The system comprises an operational data store, the operational data store integrates the information using module configured to integrate the patient data and the information into a data set having normalized semantics, which the Examiner is interpreting the system to encompass an electronic clinical trial system, and the module to encompass at least one processor), the clinical trial being conducted by a third-party clinical trial sponsor other than a pharmaceutical company that developed or commercialized the drug (See [0066]-[0067]: The modules are configured to evaluate a specific patient or member, evaluate a population, evaluate a specific provider or provider network, evaluate prevalence or treatment of a specific condition, evaluate an episode of care with respect to Cost quality and efficacy, evaluate clinical trials, and extract hypotheses to lead to the formation of clinical trials, which the Examiner is interpreting evaluate prevalence or treatment of a specific condition to encompass conducting a clinical trial investigating a drug), the method comprising:
b) receiving, for each subject:
i) baseline disease-activity data and at least one drug- or disease-specific theragnostic data point acquired before clinical trial initiation (See [0056]-[0058]: The operational data store integrates the information using module configured to integrate the patient data and the information into a data set having normalized semantics, which the Examiner is interpreting the patient data to encompass baseline disease activity data and at least one drug- or disease-specific theragnostic data point acquired before trial initiation as the patient data includes electronic medical records, patient health records, personal medical history, and family history of the patient ([0056]), and the patient data collection can occur before clinical trial initiation ([0063])); and
ii) follow-up therapeutic outcome data and theragnostic data acquired at one or more pre-specified post-initiation time points (See [0106]-[0107]: The progress of the therapeutic pathway is monitored, as well as the outcome, and such information is stored in the system, which the Examiner is interpreting the therapeutic pathway outcome to encompass follow-up therapeutic outcome data and theragnostic data as new diagnostic information is collected by the physician practice, central molecular diagnostic laboratory, and other sources eligibility (See Paragraph [0085]), interpreting the monitoring is based on new information that is compiled into the database and determinations of outcomes during treatment of the patient to encompass at one or more pre-specified post-initiation time points (See Paragraph [0107]));
c) determining, by theragnostic evaluation, a therapeutic effectiveness metric for each subject by comparing the baseline disease-activity data with the follow-up therapeutic outcome data and theragnostic data (See Paragraphs [0066]-[0067], [0084], [0106]-[0107]: The system and specialists than determine whether a particular variation is pathological or benign, the comparison of the patient's profile to other information in the database allows for the system to identify a pattern in the publicly available information and associate the pattern with the genetic profile of the patient, such an association is used to determine the outcome of particular courses of treatment and to calculate a therapeutic pathway, which the Examiner is interpreting associating the pattern with the genetic profile of the patient and calculating a therapeutic pathway to encompass determining, by theragnostic evaluation, therapeutic effectiveness metric as the Applicant’s Specification ion Paragraph [0002] that a diagnostic test can be a theragnostic test (Paragraph [0054]: A “therapeutic pathway” is a clinical treatment plan that includes diagnosis of disease, molecular characterization of the disease, and/or therapeutic regimens including drug selection, dosing, and/or schedules);
d) developing and storing, in an encrypted, access-controlled repository comprising one or more databases or a data warehouse, one or more therapeutic effectiveness datasets, one or more clinical trial datasets, or both (See [0075]-[0076]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting information relating to clinical trials is stored in the one or more databases of the system to encompass one or more clinical trial datasets, and interpreting allows for the access to information in the one or more databases to encompass access-controlled repository), derived from the therapeutic-effectiveness metric of step (c) (See [0072]: The system can also provide alerts or updates to members of the network of new information that is stored in the database relating to therapeutic pathways provided to the practitioners at the member healthcare providers, which the Examiner is interpreting the therapeutic pathways to encompass the therapeutic-effectiveness metric), each dataset corresponding to one or more of: (i) a single subject, (ii) at least one stratified subset of subjects, or (iii) an entire clinical trial population (See [0075]: Patient data can be collected by the system), each dataset being indexed by subject and by a stratification flag (See [0067]: The therapeutic pathway is a decision tree that takes into account both the genotype and phenotype of the patient, as well as data in the database associated with the particular disease of the patient, which the Examiner is interpreting the outcome of the decision tree to encompass a stratification flag as the Applicant’s Specification in Paragraph [0221] describes “A theragnostic methods can be mechanistic: (a) based on the mechanism of action of the drug itself and understanding why a patient or subset(s) of patients respond well given their particular genetic makeup (e.g., the primary therapeutic mechanism of rituximab monotherapy in B-NHL can be ADCC); and (b) based on the pathophysiology of the disease itself as stratified, e.g., according to immunologically defined subtypes of disease (e.g., fibrinogen induced arthritis), disease severity, pharmacology, disease states, and physiology.”) determined from any of (i) mechanism of action of the drug, (ii) disease subtype, (iii) disease stage, or (iv) disease severity (See [0066]-[0067]: The modules are configured to evaluate a specific patient or member, evaluate a population, evaluate a specific provider or provider network, evaluate prevalence or treatment of a specific condition, evaluate an episode of care with respect to Cost quality and efficacy, evaluate clinical trials, and extract hypotheses to lead to the formation of clinical trials, which the Examiner is interpreting evaluate a specific patient or member to encompass each dataset being indexed by subject and by a stratification flag determined from any of (i) mechanism of action of the drug); and
e) operating a feedback-controlled theragnostic evaluation that, at each pre-specified post-initiation time point (See [0066]-[0067], [0086]-[0087]: The responsible physician and patient make a decision as to whether treatment will be according to the evidence-based treatment pathway or by a clinical trial for which the patient meets the eligibility criteria, which the Examiner is interpreting the responsible physician and patient make a decision as to whether treatment will be according to the evidence-based treatment pathway to encompass operating a feedback-controlled theragnostic evaluation that, at each pre-specified post-initiation time point as the Applicant’s Specification from August 20, 2020 only mentions “feedback” in Paragraph [0077]: “Communication and feedback may be provided at all stages from recruitment, informed consent, patient counseling, through to answering clinically and therapeutically relevant questions and measuring clinical endpoints and adverse reactions and explaining participant outcomes.”), and using at least one of: (i) the therapeutic effectiveness metric in step (c); and (ii) one or more datasets developed in step (d), causes the electronic clinical trial system, for each subject or for at least one stratified subset of subjects identified by the stratification flag of step (d) (See [0067]-[0068]: The therapeutic pathway is a decision tree that takes into account both the genotype and phenotype of the patient, as well as data in the database associated with the particular disease of the patient, which the Examiner is interpreting a patient to encompass a subject, interpreting data in the database to encompass one or more datasets developed in step (d)), to:
i) generate a therapeutic guidance signal that, under a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both (See [0073]-[0074]: The system utilizes available information to create new hypothesis or validate an existing hypothesis, which the Examiner is interpreting new hypothesis to encompass a therapeutic guidance signal as Applicant’s Specification describes “signal” relating to transmitted data in Paragraph [0311]: “Examples or wireless communication means can include a Wi-Fi receiver, a means for accessing a mobile data standard such as a 3G or 4G LTE data signal, or a Bluetooth receiver. In some cases, data can be transmitted by an email.” and Paragraph [0316]: “These devices and methods can utilize labeled probes in various sandwiches, competitive or non-competitive assay formats, to generate a signal that can be related to the presence or amount of an analyte of interest.”), updates a subject-specific drug dosage or dosing schedule stored in the access-controlled repository, securely provides, via an access-controlled interface, a machine-executable selected administration instruction (See [0074]-[0077]: Algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture, and each recommendation includes drug form and dosage, which the Examiner is interpreting recommendation includes drug form and dosage to encompass a updates a subject-specific drug dosage or dosing schedule, ), and causes execution of the machine-executable selected administration instruction for a next administration event at the pre-specified post-initiation time point to achieve or maintain a pre-specified therapeutic effectiveness criterion (See [0073]-[0075]: Each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored by the rules-based engine, which the Examiner is interpreting each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored to encompass the claimed portion); and, upon failure to achieve or maintain the pre-specified therapeutic effectiveness criterion at the corresponding pre-specified post-initiation time point, perform sub-clause (e)(ii) (See [0073]-[0075]: Each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored by the rules-based engine, which the Examiner is interpreting each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored to encompass the claimed portion);
ii) upon failure to achieve or maintain the pre-specified therapeutic effectiveness criterion at the corresponding pre-specified post-initiation time point, generate an alternative therapy signal that securely provides, via the access-controlled interface, a machine-executable selected alternative therapy instruction (See [0073]-[0075]: Each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored by the rules-based engine, which the Examiner is interpreting each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored to encompass the claimed portion) and causes execution of the machine-executable selected administration instruction to initiate an alternative therapy according to a pre-specified switching rule (See [0072]-[0073]: The system can also provide alerts or updates to members of the network of new information that is stored in the database relating to therapeutic pathways provided to the practitioners at the member healthcare providers, which the Examiner is interpreting the new information to encompass the claimed portion as the Applicant’s Specification does not describe an alternative therapy signal);
iii) verify execution using a verification mechanism configured to confirm execution at the pre-specified time point, including at least one of: telehealth remote monitoring; order-fulfillment confirmation; or device telemetry (See [0075]-[0076]: The system also monitors the progress of the clinical trials, provides safety review and data review, and allows for the access to information in the one or more databases, which the Examiner is interpreting safety review and data review to encompass a verification mechanism configured to confirm execution at the pre-specified time point, including at least one of: telehealth remote monitoring as the system can be connected to remote clinical practices ([0101])); and
iv) update the datasets developed in step (d) to record, for the corresponding time point, each signal and each machine-executable selected instruction generated under sub-clauses (e)(i)-(e)(ii) (See [0014]: Additional aspects are disclosed that further comprise updating the one or more databases with the therapeutic outcome associated with the therapeutic pathway, recalculating the therapeutic pathway based on the therapeutic outcome and providing the recalculated pathway to the members, and/or compiling financial data from the user), the update to the stored dosage or dosing schedule, and the verification of execution (See [0070]-[0073]: The system can also provide alerts or updates to members of the network of new information that is stored in the database relating to therapeutic pathways provided to the practitioners at the member healthcare providers, which the Examiner is interpreting the new information to encompass update to the stored dosage or dosing schedule, and positive verification to encompass the verification of execution); and store, in the encrypted, access-controlled repository, a time-pointed record of a secure provision and an execution outcome (See [0075]-[0076]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting information relating to clinical trials is stored in the one or more databases of the system to encompass the claimed portion),
wherein the third-party clinical trial sponsor exercises direction or control over steps (a)- through (e) by conditioning clinical trial participation or funding on performance of the recited steps by one or more entities acting individually or collectively (See [0069]-[0070]: Upon positive verification, the submitted claim is transmitted to the appropriate payer (private insurance company, authorized third party administrator, government entity, or party handling claims processing on behalf of the government entity), which the Examiner is interpreting the appropriate payer to encompass the third-party sponsor, and interpreting P4P program management to encompass conditioning clinical trial participation or funding on performance of the recited steps by one or more entities acting individually or collectively.)
While Elton discloses the method as described above, Elton may not explicitly teach a) administering the drug to one or more enrolled subjects.
Bockelman teaches a method for a) administering the drug to one or more enrolled subjects (See Fig. 3 and Paragraphs [0043]-[0044]: Treatment entity includes a number of operational parameters, such as test product, treatment length, number of subject visits, daily or weekly visit model, and number of case report form (CRF) pages, test product is a medicinal drug or medical device being tested during a test treatment, where test product is administered to (or used with) a number of subjects during the test treatment, which the Examiner is interpreting test product is administered to (or used with) a number of subjects during the test treatment to encompass administering the drug to one or more enrolled subjects.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Elton to include administering the drug to one or more enrolled subjects as taught by Bockelman. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Elton with Bockelman with the motivation of provide a physician's access to treatment options for faster, more efficient and/or improved patient treatment (See Background of Bockelman in Paragraph [0005]).
Claim(s) 185 and 199 mirror claim 169 only within different statutory categories, and are rejected for the same reason as claim 169.
Claims 185 and 199 does not include the step of “a) administering the drug to one or more enrolled subjects”.
As per claim 172, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches further comprising:
a) determining, on subject-by-subject basis, at least one efficacy assurance outcome, selected from therapeutic efficacy assurance (TEA) and financial assurance (FA) (See [0070]-[0071]: This information is utilized to compute financial transaction data relating to the costs of treatment, and the information is provided to an archive in the one or more databases of the system, which the Examiner is interpreting cost of treatment to encompass financial assurance, on a subject-by-subject basis), by comparing the subject-specific therapeutic effectiveness metric of step (c) against at least one of:
i) one or more pre-specified therapeutic criteria, including a disease-specific therapeutic reference index, to generate a TEA outcome of full, partial, or none (See [0082]-[0084]: The inclusion and exclusion criteria for each trial will be aligned with fields captured in the electronic health records, such that if all fields have favorable values, the clinical trial will be presented to the provider, which the Examiner is interpreting inclusion and exclusion criteria to encompass one or more pre-specified therapeutic criteria, and interpreting the system looks for criteria whereby the patient may have higher therapeutic benefit for being considered for a clinical trial versus the current best evidence-based treatment approach to encompass higher therapeutic benefit to encompass a TEA outcome of full, partial, or none);
ii) one or more pre-specified financial or contractual criteria to generate an FA outcome of full, partial, or none (See [0070]-[0073]: Based on the most appropriate pathway selected actual clinical activities performance and planned are evaluated for consistency with the criteria established in the evidence-based treatment pathway, and each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored by the rules-based engine, which the Examiner is interpreting the criteria established in the evidence-based treatment pathway to encompass one or more pre-specified contractual criteria, and cost of treatment to encompass FA outcome of full);
wherein the criteria in sub-clauses (i) and (ii) provide thresholds for determining the TEA and FA outcomes, respectively (See [0084]: Higher therapeutic benefit can be calculated on the basis of current general patient response to the best evidence-based treatment versus the presence of a highly specific genetic mutation in the patient's cancer, or cancers, for which there may be an available clinical trial therapy, which the Examiner is interpreting higher therapeutic benefit to encompass provide the thresholds for determining the TEA outcomes, and the information is utilized to compute financial transaction data relating to the costs of treatment to encompass thresholds for determining the FA outcomes ([0071]); and
providing an efficacy assurance by performing at least one of:
i) storing, in the encrypted, access-controlled repository, the TEA outcome, the FA outcome, or both (See [0075]-[0076]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting information relating to clinical trials is stored in the one or more databases of the system to encompass the TEA outcome, the FA outcome, or both); or
ii) securely providing the outcome, via the access-controlled interface, to one or more entities selected from: each subject; at least one stratified subset of subjects; or an entire clinical trial population
wherein the electronic clinical trial system executes processor-executable assurance logic to: (a) generate a selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction (See [0069]-[0070]: Upon positive verification, the submitted claim is transmitted to the appropriate payer (private insurance company, authorized third party administrator, government entity, or party handling claims processing on behalf of the government entity), which the Examiner is interpreting the submitted claim is transmitted to the appropriate payer to encompass a selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction); (b) securely provide, via the access-controlled interface, the selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction (See [0069]-[0070], [0102]: Upon positive verification, the submitted claim is transmitted to the appropriate payer (private insurance company, authorized third party administrator, government entity, or party handling claims processing on behalf of the government entity), and data can be entered in any user interface and such information can be stored in the system and accessed as well, which the Examiner is interpreting securely provide, via the access-controlled interface); and (c) cause execution of the selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction (See [0069]-[0070]: Upon positive verification, the submitted claim is transmitted to the appropriate payer (private insurance company, authorized third party administrator, government entity, or party handling claims processing on behalf of the government entity), which the Examiner is interpreting the submitted claim is transmitted to the appropriate payer to encompass cause execution of the selected electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction.)
As per claim 174, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches wherein payment of at least a portion of the drug cost or clinical trial cost is contingent upon whether, at one or more pre-specified post-initiation time points during or after the clinical trial, a pre-specified therapeutic effectiveness criterion is achieved or maintained (See [0088]: Patient clinical trial care is authorized through a claims validation procedure in the system and is transmitted to appropriate payer for reimbursement, and other direct trial expense, e.g., therapeutics costs, and validated and then directed to the trial sponsor or their designed clinical research entity for payment, which the Examiner is interpreting directed to the trial sponsor or their designed clinical research entity for payment to encompass the claimed portion as Elton does not require the payer must pay), the payment to the third-party clinical trial sponsor being made according to one or both of:
a) a scope of payment selected from: each subject; at least one stratified subset of subjects; or an entire clinical trial population (See [0088]: Patient clinical trial care is authorized through a claims validation procedure in the system and is transmitted to appropriate payer for reimbursement, which the Examiner is interpreting patient clinical trial care is authorized through a claims validation procedure to encompass scope of payment selected from each subject; at least one stratified subset of subjects; or an entire clinical trial population); and
b) a schedule of payment selected from: pay-as-you-go; or multiple installments contingent upon the drug remaining therapeutically effective;
wherein the electronic clinical trial system executes processor-executable reimbursement logic to: (i) generate a selected electronic payment or denial instruction (See [0009]: The system allows for payments to be disbursed from the system after a claim is validated); (ii) securely provide, via the access-controlled interface, the selected electronic payment or denial instruction (See [0102]: Data can be entered in any user interface and such information can be stored in the system and accessed as well, which the Examiner is interpreting the user interface to encompass the access-controlled interface as the “access-controlled interface” is not described in the Specification); (iii) cause execution of the selected electronic payment or denial instruction (See [0009]: The system allows for payments to be disbursed from the system after a claim is validated); and (iv) store, in the encrypted, access-controlled repository, a time-pointed record of the secure provision and the execution outcome (See [0102]: Data can be entered in any user interface and such information can be stored in the system and accessed as well, which the Examiner is interpreting the information to be stored to encompass a time-pointed record of the secure provision and the execution outcome.)
As per claim 175, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches wherein the clinical trial comprises at least one of the following characteristics:
a) investigates one or more medicaments selected from:
i) a licensed drug approved for at least one indication, investigated for that approved indication or a different, unapproved indication (See Paragraph [0073]: The recalculated pathway can be used to revise treatment or to refine treatment, new information relating to the dosage of a drug when prescribed in combination with another drug can lead to a reduction or increase in the dosage of the drug, which the Examiner is interpreting new information to encompass a different, unapproved indication);
ii) an unapproved, unlicensed drug candidate undergoing a Phase-2, Phase-3, or Phase-4 clinical trial; or
iii) a licensed or unlicensed biosimilar, or a generic small molecule drug;
b) is conducted as (i) a single-site trial; or (ii) a site-less virtual trial via the electronic clinical trial system or a telehealth platform, including remote monitoring of a subject (See [0075]-[0076]: The system also monitors the progress of the clinical trials, provides safety review and data review, and allows for the access to information in the one or more databases, patient data can be collected by the system via phone, device, or the Web, which the Examiner is interpreting monitors the progress of the clinical trials to encompass a site-less virtual trial via the electronic clinical trial system or a telehealth platform);
c) is a retrospective clinical trial analysis; or
d) is not substantially funded by a pharmaceutical company that developed or
commercialized the drug;
and further comprising, by the electronic clinical trial system, performing at least one of:
(i) writing the datasets developed in step (d) to non-volatile, machine-readable storage; or
(ii) archiving the datasets in the encrypted, access-controlled repository (See [0102]: Data can be entered in any user interface and such information can be stored in the system and accessed as well, which the Examiner is interpreting the information to be stored to encompass archiving the datasets in the encrypted, access-controlled repository.)
As per claim 176, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches wherein:
a) the clinical trial is a treatment-cum-trial protocol, with enrolled subjects receiving therapeutic care and the electronic clinical trial system concurrently receiving data (See [0074]-[0076], [0083]: Inclusion and exclusion criteria are defined for each clinical trial, the system stores such criteria directly from enrollment sites that are part of the network and/or from clinicaltrials.gov (registration on this website is currently required for all clinical trials in the US) or other sources, which the Examiner is interpreting to encompass the claimed portion as the system also monitors the progress of the clinical trials, provides safety review and data review, and allows for the access to information in the one or more databases); or
b) the data received in step (b) comprise real-world data (RWD) captured, via an
access-controlled interface, from one or both of: (i) a telehealth electronic clinical trial
platform; and (ii) an electronic health record (EHR) feed; and
further comprising prior to performing the theragnostic evaluation of step (c), verifying, by the electronic clinical trial system executing processor-executable verification logic, at least one of: (i) data quality; (ii) data completeness (See [0075]-[0076], [0101]: The system also monitors the progress of the clinical trials, provides safety review and data review, and allows for the access to information in the one or more databases, which the Examiner is interpreting safety review and data review to encompass verifying, by the electronic clinical trial system executing processor-executable verification logic, at least one of: data completeness); or (iii) time-point alignment of the baseline disease-activity data and follow-up therapeutic outcome data and theragnostic data against the pre-specified post-initiation time points using at least one drug-or disease-specific theragnostic criterion, to qualify the baseline disease-activity data and follow-up therapeutic outcome data and theragnostic data for use in developing one or more regulatory-grade clinical trial datasets (See [0057]: In addition to patient data being received by the system, the system receives and stores publicly-available information from regulatory agencies 120 such as the FDA and NIH, which the Examiner is interpreting to encompass qualify the baseline disease-activity data and follow-up therapeutic outcome data and theragnostic data for use in developing one or more regulatory-grade clinical trial datasets when utilized with the outcomes of Elton in [0098], [0106].)
As per claim 188, Elton/Bockelman discloses the system of claim 185 as described above. Elton further teaches further configured, via the access-controlled data interface of element (c), to:
a) interface with one or more external data sources, including at least one of: (i) a clinical trial database; (ii) a diagnostic database; (iii) a theragnostic database; (iv) a real-world evidence database; (v) a healthcare payer database, a healthcare provider database, or an integrated healthcare payer-provider database; (vi) a disease registry (See [0058], [0098]: The system compares any changes with information from public databases that catalog human genetic variation (dbSNP, COSMIC), published literature, and other sources of information, which the Examiner is interpreting public databases and disparate information sources to encompass one or more external data sources including at least one of: clinical trial, diagnostic, theragnostic, real-world evidence, payer, provider, or payer-provider databases); or (vii) a patient registry; and
b) for each received record: (i) map the record to a subject identifier and a pre-specified post-initiation time point (See [0073]: The system utilizes a rules-based engine that assesses and identifies the most appropriate evidence-based treatment pathway for each individual patient based on data extracted from the electronic medical records and available from the diagnostic image repository or laboratory information system of a centralized molecular diagnostics lab, which the Examiner is interpreting identifies the most appropriate evidence-based treatment pathway for each individual patient to encompass map the record to a subject identifier and a pre-specified post-initiation time point); (ii) update one or more of the datasets developed in element (b)(ii) (See [0072]-[0073]” The system can also provide alerts or updates to members of the network of new information that is stored in the database relating to therapeutic pathways provided to the practitioners at the member healthcare providers, which the Examiner is interpreting updates to members of the network of new information that is stored in the database to encompass the claimed portion); and (iii) store a time-pointed record of the update in the databases or data warehouse recited in element (a) (See [0072]-[0073]” The system can also provide alerts or updates to members of the network of new information that is stored in the database relating to therapeutic pathways provided to the practitioners at the member healthcare providers, which the Examiner is interpreting updates to members of the network of new information that is stored in the database to encompass the claimed portion.)
As per claim 189, Elton/Bockelman discloses the system of claim 185 as described above. Elton further teaches wherein the operations of element (b) are implemented in a database layer by database-engine-executable routines that, at each pre-specified post-initiation time point, perform one or both of:
a) writing, in the databases or data warehouse recited in element (a), an updated drug dosage or dosing schedule record and causing the electronic clinical trial system to securely provide, via the access-controlled data interface of element (c), the machine-executable selected administration instruction recited in sub-clause (b)(iii)(a) and to cause execution of the machine-executable selected administration instruction; and
b) causing generation of the machine-executable selected alternative therapy instruction recited in sub-clause (b)(iii)(b), securely providing, via the access- controlled data interface of element (c), the selected instruction and causing execution of the machine-executable selected administration instruction (See [0066], [0070], [0087]-[0089]: Trial participation termination and trial course of therapy conclusion are all integrated into the trial data management system or collected for formatting into SAS format file for secure transmittal to the trial sponsor or their designee (e.g., external clinical research organization), and a compliance threshold can be used to enhance quality criteria and goals, and interpreting the real-time analytics to encompass at each pre-specified time point),
wherein each machine-executable selected instruction is securely provided, via the access-controlled data interface of element (c), to an entity designated by the third-party clinical trial sponsor, and the clinical trial database system is updated to store, for each pre-specified post-initiation time point, a time-pointed record of the secure provision and the execution outcome (See [0102]: Data can be entered in any user interface and such information can be stored in the system and accessed as well, which the Examiner is interpreting the information to be stored to encompass the clinical trial database system is updated to store, for each pre-specified post-initiation time point, a time-pointed record of the secure provision and the execution outcome.)
Claim(s) 201 mirrors claim 189 only within a different statutory category, and is rejected for the same reason as claim 189.
As per claim 191, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches further comprising, by the electronic clinical trial system executing processor-executable regulatory submission logic:
a) generating an electronic regulatory submission comprising at least one of: (i)a therapeutic effectiveness dataset; or (ii) a clinical trial dataset (See [0057], [0065]: The system receives and stores publicly-available information from regulatory agencies such as the FDA and NIH, and a module configured to identify a pattern from a comparison of the patient data and patient-centric information to the other information (e.g., publicly available information) stored in the operational data store, which the Examiner is interpreting identify a pattern from a comparison of the patient data and patient-centric information to the other information (e.g., publicly available information) stored in the operational data store to encompass generating an electronic regulatory submission comprising at least one of: (ii) a clinical trial data as the Examiner is interpreting the regulatory agencies such as the FDA and NIH to encompass a drug regulatory agency);
b) securely transmitting, via the access-controlled interface, the submission to a drug regulatory agency as a required filing activity (See [0057], [0065]: The system receives and stores publicly-available information from regulatory agencies such as the FDA and NIH, and a module configured to identify a pattern from a comparison of the patient data and patient-centric information to the other information (e.g., publicly available information) stored in the operational data store, which the Examiner is interpreting identify a pattern from a comparison of the patient data and patient-centric information to the other information (e.g., publicly available information) stored in the operational data store to encompass required filing activity as the Examiner is interpreting the regulatory agencies such as the FDA and NIH to encompass a drug regulatory agency); and
c) storing, in the encrypted access-controlled repository, a time-pointed record of the submission (See [0075]-[0076]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting information relating to clinical trials is stored in the one or more databases of the system to encompass storing, in the encrypted access-controlled repository, a time-pointed record of the submission.)
Claim(s) 198 mirrors claim 191 only within a different statutory category, and is rejected for the same reason as claim 191.
Claim 198 recites step (c) as “update the databases or data warehouse recited in element (a) to store a time- pointed record of the electronic regulatory submission”, claim 191 recites step (c) storing, in the encrypted access-controlled repository, a time-pointed record of the submission, the subject matter is similar.
Claim(s) 202 mirrors claim 191 only within a different statutory category, and is rejected for the same reason as claim 191.
As per claim 192, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches further comprising, prior to step (a):
generating, by the electronic clinical trial system executing processor-executable logic, an a priori therapeutic appropriateness signal for each subject or for at least one baseline-stratified subset of subjects identified by a pre-specified baseline rule, using baseline disease-activity data and at least one drug- or disease-specific theragnostic criterion (See [0066]-[0067], [0082]-[0087]: The modules are configured to evaluate a specific patient or member, evaluate a population, evaluate a specific provider or provider network, evaluate prevalence or treatment of a specific condition, evaluate an episode of care with respect to Cost quality and efficacy, evaluate clinical trials, and extract hypotheses to lead to the formation of clinical trials, which the Examiner is interpreting evaluate prevalence or treatment of a specific condition to encompass generating, by the electronic clinical trial system, an a priori therapeutic appropriateness signal for each subject or for at least one baseline-stratified subset of subjects identified by a pre-specified baseline rule, and the real-time analytics to encompass at each pre-specified post-initiation time point, and interpreting the inclusion and exclusion criteria to encompass or for at least one baseline-stratified subset of subjects identified by a pre-specified baseline rule); and
b) securely providing, via the access-controlled interface, a machine-executable selected administration instruction for a first administration event only to:
i) each subject determined, based on the a priori therapeutic appropriateness signal, to be therapeutically appropriate (See [0075]-[0076], [0083]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting the inclusion and exclusion criteria for each trial will be aligned with fields captured in the electronic health records to encompass each subject determined, based on the a priori therapeutic appropriateness signal, to be therapeutically appropriate); or
ii) subjects in at least one baseline-stratified subset identified by the pre-specified baseline rule and determined, based on the a priori therapeutic appropriateness signal, to be therapeutically appropriate,
wherein step (a) of claim 169 causes execution of the selected machine-executable administration instruction ((See [0066]-[0067], [0082]-[0087]: The modules are configured to evaluate a specific patient or member, evaluate a population, evaluate a specific provider or provider network, evaluate prevalence or treatment of a specific condition, evaluate an episode of care with respect to Cost quality and efficacy, evaluate clinical trials, and extract hypotheses to lead to the formation of clinical trials, which the Examiner is interpreting to encompass the claimed portion.)
As per claim 193, Elton/Bockelman discloses the method of claims 169 and 192 as described above. Elton further teaches further comprising, by the electronic clinical trial system executing processor-executable assignment logic:
a) automatically assigning, each subject, or at least one baseline-stratified subset of subjects identified by the pre-specified baseline rule, to a clinical trial arm or dosing regimen determined to be therapeutically appropriate on the a priori therapeutic appropriateness signal (See [0075]-[0076], [0083]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting the inclusion and exclusion criteria for each trial will be aligned with fields captured in the electronic health records to encompass the claimed portion); and
b) (i) storing, in the encrypted, access-controlled repository of step (d) of claim 169, a time-pointed record of the assignment mapped to a subject identifier and to the stratification flag of step (d) when generated (See [0075]-[0076], [0083]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting the inclusion and exclusion criteria for each trial will be aligned with fields captured in the electronic health records, and the data repository to encompass the claimed portion);
(ii) securely providing, via the access-controlled interface, a machine-executable selected administration instruction for the first administration event according to the assigned arm or regimen (See [0075]-[0076], [0083]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting the inclusion and exclusion criteria for each trial will be aligned with fields captured in the electronic health records, and the data repository to encompass the claimed portion); and
(iii) causing execution of the machine-executable selected administration (See [0075]-[0076], [0083]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting the inclusion and exclusion criteria for each trial will be aligned with fields captured in the electronic health records, and the data repository to encompass the claimed portion.),
wherein step (a) of claim 169 causes execution of the machine-executable selected administration instruction according to the assignment of sub-clause (a) (See [0075]-[0076], [0083]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting the inclusion and exclusion criteria for each trial will be aligned with fields captured in the electronic health records, and the data repository to encompass the claimed portion.)
As per claim 194, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches wherein the feedback-controlled theragnostic evaluation of step (e) comprises for each subject or for at least one stratified subset of subjects identified by the stratification flag of step (d), at least two automated update cycles executed at respective pre-specified post-initiation time points (See [0073]: Based on the most appropriate pathway selected actual clinical activities performance and planned are evaluated for consistency with the criteria established in the evidence-based treatment pathway, which the Examiner is interpreting to encompass the claimed portion as real-time analytics can be utilized by the system ([0066])), each cycle comprising:
a) generating, by the electronic clinical trial system executing processor-executable dosing-update logic, a therapeutic guidance signal that, under a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both (See [0072]-[0073]: The system can also provide alerts or updates to members of the network of new information that is stored in the database relating to therapeutic pathways provided to the practitioners at the member healthcare providers, which the Examiner is interpreting the new information to encompass a therapeutic guidance signal that, under a pre-specified dosing rule keyed to the therapeutic effectiveness metric, the stratification flag, or both), causes the electronic clinical trial system to:
i) write, in the encrypted, access-controlled repository of step (d), an updated subject-specific drug dosage or dosing schedule record (See [0072]-[0073]: The system can also provide alerts or updates to members of the network of new information that is stored in the database relating to therapeutic pathways provided to the practitioners at the member healthcare providers, which the Examiner is interpreting the new information to encompass an updated subject-specific drug dosage or dosing schedule record);
ii) securely provide, via the access-controlled interface, a machine-executable selected administration instruction for a next administration event (See [0073]-[0075]: Each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored by the rules-based engine, which the Examiner is interpreting each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored to encompass the claimed portion); and
iii) cause execution, at a subsequent pre-specified post-initiation time point, of the selected instruction (See [0073]-[0075]: Each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored by the rules-based engine, which the Examiner is interpreting each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored to encompass the claimed portion); and
b) re-evaluating at the next pre-specified post-initiation time point, the subject-specific therapeutic effectiveness metric using follow-up therapeutic outcome data and theragnostic data acquired following execution of the selected instruction in sub-clause (a)(iii) and repeating the update cycle until a pre-specified therapeutic effectiveness criterion is achieved or a pre- specified stopping rule is met (See [0073]-[0075]: Each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored by the rules-based engine, which the Examiner is interpreting each decision and action taken in a patient's care for compliance with evidence-based treatment pathways is monitored to encompass the claimed portion as the pathways can be recalculated ([0105]).)
As per claim 195, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches wherein an entity participates in the clinical trial by funding, at least in part, a drug cost or a clinical trial cost, wherein payment is made, through the electronic clinical trial system, to the third-party clinical trial sponsor (See [0088], [0093]: Claim reimbursement takes into account compliance to an evidence-based treatment protocol, quality of care associated with the therapy, and payment for the particular therapies used, which the Examiner is interpreting the payer to encompass an entity, and payment for the particular therapies used to encompass the clinical trial by funding, at least in part, a drug cost, and interpreting payment made through system to encompass wherein payment is made, through the electronic clinical trial system, to the third-party clinical trial sponsor as the system is connected to payers), and wherein:
a) the entity is at least one of: (i) a private or government healthcare payer (See Paragraph [0070]: The submitted claim is transmitted to the appropriate payer (private insurance company, authorized third party administrator, government entity, or party handling claims processing on behalf of the government entity), or (ii) a subject; and
b) the entity and the third-party clinical trial sponsor are either distinct legal entities or part of an integrated healthcare payer-provider system (See [0093]: The validated claim is forwarded to the payer, who either instructs the system to pay the claim for a designated account or pays the claim directly to the network member practice, which the Examiner is interpreting to encompass the payer and the third-party sponsor are part of an integrated payer-provider system.)
As per claim 196, Elton/Bockelman discloses the method of claim 169 as described above. Elton further teaches further comprising generating, by the electronic clinical trial system, an output record and securely providing the output record to a healthcare payer or another entity designated by the third-party clinical trial sponsor (See [0070]: The requests for payment (claim) by the healthcare provider are sent through the one or more databases for verification of consistency with evidence-based therapeutic pathways), the output record triggering processor-executable reimbursement logic or assurance logic to:
a) generate a selected electronic instruction comprising at least one of:
i) an electronic payment or denial instruction to pay, partially pay, or withhold payment to the third-party clinical trial sponsor (See [0070]: The requests for payment (claim) by the healthcare provider are sent through the one or more databases for verification of consistency with evidence-based therapeutic pathways, which the Examiner is interpreting the requests for payment to encompass an electronic payment to pay); or
ii) an electronic efficacy assurance issuance, partial assurance issuance, or assurance denial instruction;
b) securely provide the selected electronic instruction (See [0088] Trial participation termination and trial course of therapy conclusion are all integrated into the trial data management system or collected for formatting into SAS format file for secure transmittal to the trial sponsor or their designee (e.g., external clinical research organization), which the Examiner is interpreting secure transmittal to encompass securely provide the selected electronic instruction);
c) cause execution of the selected electronic instruction, contingent on whether a pre-specified therapeutic effectiveness criterion is achieved at a pre-specified time point (See [0067]: The therapeutic pathway is a decision tree that takes into account both the genotype and phenotype of the patient, as well as data in the database associated with the particular disease of the patient, which the Examiner is interpreting the branches in the decision tree to encompass execution of the selected electronic instruction, contingent on whether a pre-specified therapeutic effectiveness criterion is achieved at a pre-specified time point); and
d) store, in the encrypted access-controlled repository of step (d), a time-pointed record of the secure provision and the execution outcome (See [0075]-[0076]: The system can act as a data repository, information relating to clinical trials is stored in the one or more databases of the system, and the algorithms and services from hosted or licensed software are utilized clinical trial monitoring and data capture include software and algorithms that utilize encryption, which the Examiner is interpreting information relating to clinical trials is stored in the one or more databases of the system to encompass the claimed portion.)
Claim(s) 197 mirrors claim 196 only within a different statutory category, and is rejected for the same reason as claim 196.
Claim 197 recites step (d) as “d) update the databases or data warehouse recited in element (a) to store a time- pointed record of the secure provision and the execution outcome”, and claim 196 recites step (d) as “d) store, in the encrypted access-controlled repository of step (d), a time-pointed record of the secure provision and the execution outcome” the subject matter is similar.
Claim 200 mirrors claim 196 only within a different statutory category, and is rejected for the same reason as claim 196.
Response to Arguments
In the Remarks filed on December 18, 2025, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s), 35 U.S.C. 101 rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the previous Claim Objection(s) and the 35 U.S.C. 101 rejection(s) directed to non-statutory subject matter. However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the newly added Claim Objection(s), the newly added 35 U.S.C. 112(a) rejection(s), 35 U.S.C. 101 rejection(s), and the 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) independent claims recite a method, a system, and a non-transitory computer-readable medium storing processor-executable instructions. "Signals" in the claims are machine-generated data/control outputs that are time-pointed into encrypted, access-controlled repositories; no claim recites a propagating/transitory signal per se. The claims are directed to a specific machine-implemented controller, not an abstract idea or transitory media;
(2) no feedback-controlled theragnostic evaluation loop, time-pointed controller in Elton/Bockelman. Elton and Bockelman disclose advisory analytics, classical (conventional) inclusion and exclusion criteria, and EDC/CTMS/claims workflows, but do not teach or suggest the claimed feedback loop sequence at pre-specified post-initiation time points: update stored dose/schedule under a dosing rule [Wingdings font/0xE0] securely provide machine-executable selected instructions via the access-controlled interface/data interface [Wingdings font/0xE0] cause execution at the next administration event [Wingdings font/0xE0] verify execution [Wingdings font/0xE0] write time-pointed records of secure provision and execution outcome into hierarchical datasets at subject, stratified subset, or entire clinical trial population scopes;
(3) payer/assurance and regulatory-submission code paths are absent. The cited art does not disclose the claimed outcome-contingent payer/assurance logic and electronic regulatory submission paths implemented as machine-executed code paths (including secure provision, transmission, and time-pointed archival), tied to the same stratification-flag-keyed datasets and time-pointed controller described above.
(4) a priori gating and automated arm assignment (claims 192-193) are not classical eligibility rules. The "a priori therapeutic appropriateness signal" and automated assignment logic of claims 192 and 193 are baseline-only, theragnostic, per-subject/baseline-subset controls that gate who even receives a first-dose instruction and determine trial arm/dosing regimen, with time-pointed assignment records and machine-executed first-dose instructions. Elton's inclusion and exclusion criteria and trial eligibility filtering and Bockelman's enrollment features for conducting classical (or conventional) clinical trials do not teach or suggest this a priori gating + arm-assignment + first-dose controller layered on top of claim 169's feedback-controlled theragnostic evaluation architecture.
In response to argument (1), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the Applicant’s claims, as drafted given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people, including following rules or instructions, which is a subgrouping of Certain Methods of Organizing Human Activity. The Examiner maintains that the Applicant’s claims encompass instructions for a user to follow. This judicial exception is not integrated into a practical application because the remaining element amounts to no more than general purpose computer components programmed to perform the abstract idea, and insignificant extra-solution activity. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention.”) Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2106.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)). Insignificant, extra solution, data gathering activity has been found to not amount to significantly more than an abstract idea (See MPEP 2106.05(g)). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea. The 35 U.S.C. 101 rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Elton/Bockelman when combined encompass the claims as newly amended. The Applicant’s claimed limitation “pre-specified post-initiation time points” is not supported by the Specification as described above in the 35 U.S.C. 112(a) rejection(s), and the Examiner maintains that Elton in [0066]-[0067], [0086]-[0087] discloses that the responsible physician and patient make a decision as to whether treatment will be according to the evidence-based treatment pathway or by a clinical trial for which the patient meets the eligibility criteria, which the Examiner is interpreting the responsible physician and patient make a decision as to whether treatment will be according to the evidence-based treatment pathway to encompass operating a feedback-controlled theragnostic evaluation that, at each pre-specified post-initiation time point as the Applicant’s Specification from August 20, 2020 only mentions “feedback” in Paragraph [0077]: “Communication and feedback may be provided at all stages from recruitment, informed consent, patient counseling, through to answering clinically and therapeutically relevant questions and measuring clinical endpoints and adverse reactions and explaining participant outcomes.” The Examiner maintains that the claimed feedback loop sequence at pre-specified post-initiation time points is encompassed by Elton/Bockelman as described above in the 35 U.S.C. 103 rejection(s). The 35 U.S.C. 103 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that Elton/Bockelman encompasses payer/assurance and regulatory-submission code paths. Elton discloses in Paragraphs [0069]-[0070] that upon positive verification, the submitted claim is transmitted to the appropriate payer (private insurance company, authorized third party administrator, government entity, or party handling claims processing on behalf of the government entity, and disclosure of the P4P program management to encompass outcome-contingent payer/assurance logic and electronic regulatory submission paths implemented as machine-executed code paths (including secure provision, transmission, and time-pointed archival), tied to the same stratification-flag-keyed datasets and time-pointed controller as rejected above in the 35 U.S.C. 103 rejection(s) above. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (4), the Examiner does not find the Applicant’s argument(s) persuasive. The “a priori therapeutic appropriateness signal”, the Applicant’s Specification from August 20, 2020 only describes “signal” in Paragraphs [0205], [0311], [0316], but the Specification lacks description of “a priori therapeutic appropriateness signal”, and the Applicant’s Specification from August 20, 2020 describes only “A "computer processor" can include a microcontroller and/or a microprocessor, and can contain an integrated CPU processor core, an arithmetic and logic unit, a register, an internal clock, an internal bus, a logic gate, a transistor, a ceramic cover, computer memory, program memory, and/or a programmable input/output peripheral.”, the Applicant’s Specification does not describe “assignment logic”. The Examiner maintains that the combination of Elton and Bockelman encompasses the newly amended claims as presented. The Examiner maintains that the claims 185 and 199 mirror claim 169, except for rewording of the databases and repository, and the claims are in different statutory categories than claim 169. The 35 U.S.C. 103 rejection(s) stand.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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/Bennett Stephen Erickson/ Primary Examiner, Art Unit 3683