DETAILED ACTION
Notices to Applicant
This communication is a Final Office Action on the merits. Claims 1, 3, 6, 8, 10, 12, and 15-28 as filed 07/13/2026, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application claims the benefit of U.S. Provisional Patent Application No. 63/444,875, filed February 10, 2023, and U.S. Provisional Patent Application No. 63/444,869, filed February 10, 2023, each of which is incorporated by reference herein in its entirety.
The present application is also a continuation-in-part application of U.S. Patent Application No. 17/502,005, filed October 14, 2021, which is a continuation-in-part of U.S. Patent Application No. 17/402,256, filed August 13, 2021, both naming Dimitar V. Baronov, Robert Hammond-Oakley, and Evan J. Butler as inventors, which claims priority to U.S. Provisional Patent Application No. 63/091,493, filed October 14, 2020, U.S. Provisional Patent Application No. 63/091,427, filed October 14, 2020, U.S. Provisional Patent Application No. 63/180,881, filed April 28, 2021, U.S. Provisional Patent Application No. 63/183,979, filed May 4, 2021, and U.S. Provisional Patent Application No. 63/190,070, filed May 18, 2021.
Claim Interpretation
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are: “a reporting module,” in claim 18, “a concordance module,” and “a protocol trigger module,” in claim 21 and “an eligibility module,” in claim 28.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18, 21, and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitations “a reporting module,” in claim 18, “a concordance module,” and “a protocol trigger module,” in claim 21 and “an eligibility module,” in claim 28.invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The present Application Specification is silent as to linking the corresponding structure of each of the concordance module, the protocol trigger module, and the eligibility module for performing the claimed function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 6, 8, 10, 12, and 15-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1, 3, 6, 22, and 25 are drawn to a method for back testing a medical protocol, which is within the four statutory categories (i.e. method).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites:
1. A method of back testing a medical protocol comprising: receiving an eligibility rule and a compliance rule for a medical protocol, the compliance rule being different from the eligibility rule, and each of the rules having one or more conditions;
receiving collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time from one or more sensors and/or medical devices;
determining when a patient was eligible for the protocol as a function of the eligibility rule and the collected patient data; and
determining, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the longitudinal patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during which the successive values satisfied the compliance rule.
The above claim limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting “one or more sensors and/or medical devices,” nothing in the claim precludes the limitations from being rules or instructions for managing personal behavior or interactions between people. For example, but for the above bolded language, receiving an eligibility rule and compliance rule for a medical protocol, the compliance rule being different from the eligibility rule, and each of the rules having one or more conditions; receiving collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time; determining when a patient was eligible for the protocol as a function of the eligibility rule and the collected patient data; and determining, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the longitudinal patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during which the successive values satisfied the compliance rule in the context of this claim encompasses the managing of personal behaviors for back testing a medical protocol. If a claim limitation, under its broadest reasonable interpretation, covers performance of managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the “determining …” as currently recited covers concepts performable in the mind, which falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using “one or more sensors and/or medical devices,” to perform the claim limitations. The additional elements are recited at a high-level of generality utilizing the claimed machinery of one or more sensors and/or medical devices in its ordinary capacity (i.e., the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others (Application Specification [0063], [0064])). As such, the limitations amount to no more than mere instructions to implement an abstract idea invoking machinery as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Further, this additional element of using “one or more sensors and/or medical devices,” amounts to are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 “one or more sensors and/or medical devices,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using machinery in its ordinary capacity (i.e., the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others (Application Specification [0063], [0064])). Mere instructions to apply an exception using machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). Further, this additional element of using “one or more sensors and/or medical devices,” amounts to are mere data gathering and output receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. The claim is not patent eligible.
Dependent claims 3, 6, 22, and 25 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behaviors for back testing a medical protocol. claims 6 recites a “graphic compiler,” however, both of these limitations are recited at a high level of generality as a tool for performing the abstract idea. See Application Specification at [0058], [0063], [0064], [0127], [0136]; MPEP 2106.05(f). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 8, 10, 12, 23, and 26 are drawn to a computer program product for back testing a medical protocol on a computer system, which is within the four statutory categories (i.e. manufacture).
Independent Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 8 recites:
8. A computer program product for back testing a medical protocol on a computer system, the computer program product comprising a non-transitory computer-readable storage medium having computer-readable program code thereon, the computer-readable program code comprising:
program code for receiving an eligibility rule and a compliance rule for a medical protocol, the compliance rules being different from the eligibility rule;;
program code for receiving collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time from one or more sensors and/or medical devices;
program code for determining when a patient was eligible for the protocol as a function of the eligibility rule and the collected patient data; and
program code for determining, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during successive values satisfied the compliance rule.
The above claim limitations, as drafted, is a manufacture that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting “a tangible, non-transient computer usable medium having computer readable program code thereon,” and “one or more sensors and/or medical devices,” nothing in the claim precludes the limitations from being rules or instructions for managing personal behavior or interactions between people. For example, but for the above bolded language, receiving an eligibility rule and compliance rule for a medical protocol, each of the rules having one or more conditions; receiving collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time; determining that a patient was eligible for the protocol as a function of the eligibility rule and the collected patient data; and determining a historic dynamic concordance rate for the protocol, the historic dynamic concordance rate for the protocol indicating the rate at which the patient data was consistent with the compliance rule for the protocol over the period of time in the context of this claim encompasses the managing of personal behaviors for back testing a medical protocol. If a claim limitation, under its broadest reasonable interpretation, covers performance of managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the limitations of “determining …” falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using “a tangible, non-transient computer usable medium having computer readable program code thereon,” and “one or more sensors and/or medical devices,” to perform the claim limitations. The additional elements are recited at a high-level of generality (i.e., a computer program product for use with a computer system that may include a series of computer instructions fixed either on a tangible, non-transitory medium, such as a computer readable medium (e.g., a diskette, CD-ROM, ROM, or fixed disk); and the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others (Application Specification [0063], [0064], [0248])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or machinery in its ordinary capacity, or merely uses a computer/machinery as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, this additional element of using “one or more sensors and/or medical devices,” amounts to are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 tangible, non-transient computer usable medium having computer readable program code thereon,” and “one or more sensors and/or medical devices,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using generic computing components and machinery used its ordinary capacity (i.e., a computer program product for use with a computer system that may include a series of computer instructions fixed either on a tangible, non-transitory medium, such as a computer readable medium (e.g., a diskette, CD-ROM, ROM, or fixed disk); and the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others (Application Specification [0063], [0064], [0248])). Mere instructions to apply an exception using a generic computer component or machinery used in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f). Further, this additional element of using “one or more sensors and/or medical devices,” amounts to are mere data gathering and output receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. The claim is not patent eligible.
Dependent claims 10, 12, 23, and 28 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behaviors for back testing a medical protocol. Claims 12 recites a “graphic compiler,” however, limitations this additional element is recited at a high level of generality as a tool for performing the abstract idea. See Application Specification at [0058], [0063], [0064], [0127], [0136]; MPEP 2106.05(f). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 15-20, 24, and 27 are drawn to a system for simulating a medical protocol, which is within the four statutory categories (i.e. machine).
Independent Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 15 recites:
15. A system for simulating a medical protocol, the system comprising: an application simulator comprising: one or more processors; and a memory storing instructions that, when executed by the one or more processors cause the one or more processors to:
receive an eligibility rule and a compliance rule for a medical protocol, the compliance rule being different from the eligibility rule;
receive collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time from one or more sensors and/or medical devices,
compare the collected patient data with the eligibility rule to determine when a patient was eligible for the protocol, and
determine, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the longitudinal patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during which the successive values satisfied the compliance rule.
The above claim limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting “an application simulator comprising: one or more processors; and a memory storing instructions that, when executed by the one or more processors cause the one or more processors,” and “one or more sensors and/or medical devices,” nothing in the claim precludes the limitations from being rules or instructions for managing personal behavior or interactions between people. For example, but for the above bolded language, receive an eligibility rule and a compliance rule for a medical protocol, the compliance rule being different from the eligibility rule; receive collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time, compare the collected patient data with the eligibility rule to determine when a patient was eligible for the protocol, and determine, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the longitudinal patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during which the successive values satisfied the compliance rule in the context of this claim encompasses the managing of personal behaviors for back testing a medical protocol. If a claim limitation, under its broadest reasonable interpretation, covers performance of managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the limitations of “compare …” and “determine …” falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using “an application simulator comprising: one or more processors; and a memory storing instructions that, when executed by the one or more processors cause the one or more processors,” and “one or more sensors and/or medical devices,” to perform the claim limitations. The additional elements are recited at a high-level of generality (i.e., a computer program product for use with a computer system that may include a series of computer instructions fixed either on a tangible, non-transitory medium, such as a computer readable medium (e.g., a diskette, CD-ROM, ROM, or fixed disk); and the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others (Application Specification [0063], [0064], [0136])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer or machinery in its ordinary capacity, or merely uses a computer/machinery as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, this additional element of using “one or more sensors and/or medical devices,” amounts to are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 “an application simulator comprising: one or more processors; and a memory storing instructions that, when executed by the one or more processors cause the one or more processors,” and “one or more sensors and/or medical devices,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using generic computing components and machinery used in its ordinary capacity (i.e., a computer program product for use with a computer system that may include a series of computer instructions fixed either on a tangible, non-transitory medium, such as a computer readable medium (e.g., a diskette, CD-ROM, ROM, or fixed disk); and the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others (Application Specification [0063], [0064], [0248])). Mere instructions to apply an exception using a generic computer component or machinery used in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f). Further, the additional element of using “one or more sensors and/or medical devices,” amounts to are mere data gathering and output receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. The claim is not patent eligible.
Dependent claims 16-20, 24, and 27 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behaviors for back testing a medical protocol. Claims 19-20 recite a “graphic compiler,” however, both of these limitations are recited at a high level of generality as a tool for performing the abstract idea. See Application Specification at [0058], [0063], [0064], [0127], [0136]; MPEP 2106.05(f). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the dependent claims are rejected under 35 U.S.C. § 101.
Claims 21 and 28 are drawn to a system for controlling a treatment device according to a medical protocol, which is within the four statutory categories (i.e. machine).
Independent Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 21 recites:
21. A system for controlling a treatment device according to a medical protocol, the system comprising: an interface configured to receive real-time patient data from one or more sensors and/or medical devices;
a concordance module configured to determine, and update as new real-time patient data is received, a current dynamic concordance rate indicating a rate at which the real-time patient data is consistent with a compliance rule of the protocol over time; and
a protocol trigger module configured to: determine that a protocol trigger condition including a threshold for the current dynamic concordance rate is satisfied; and
in response to determining that the protocol trigger condition is satisfied, transmit a control instruction to a treatment device that causes the treatment device to begin a course of action defined by the protocol.
The above claim limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded language, nothing in the claim precludes the limitations from being rules or instructions for managing personal behavior or interactions between people. For example, but for the above bolded language, determine, and update as new real-time patient data is received, a current dynamic concordance rate indicating a rate at which the real-time patient data is consistent with a compliance rule of the protocol over time; determine that a protocol trigger condition including a threshold for the current dynamic concordance rate is satisfied; and in response to determining that the protocol trigger condition is satisfied, begin a course of action defined by the protocol in the context of this claim encompasses the managing of personal behaviors for back testing a medical protocol. If a claim limitation, under its broadest reasonable interpretation, covers performance of managing personal behavior or interactions between people through following rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Further, the “determine …” as currently recited covers concepts performable in the mind, which falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites the above bolded additional elements of using, “an interface,” “one or more sensors and/or medical devices,” and the concordance rate module and protocol trigger module to perform the claim limitations. The additional elements are recited at a high-level of generality utilizing the claimed machinery of one or more sensors and/or medical devices in its ordinary capacity (i.e., the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others including a device interface to receive patient data and modules as they relate to conventional software (Application Specification [0063], [0064], [0073], [0136])). As such, the limitations amount to no more than mere instructions to implement an abstract idea invoking machinery as a tool to perform an abstract idea. See MPEP 2106.05(f)(2). Further, this additional element of using “one or more sensors and/or medical devices,” and “transmit a control instruction to a treatment device,” amounts to are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does 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 “one or more sensors and/or medical devices,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using machinery in its ordinary capacity (i.e., the sensors may include, but are not limited to, a blood oximeter, a blood pressure measurement device, a pulse measurement device, a glucose measuring device, one or more analyte measuring devices, an electrocardiogram recording device, amongst others including a device interface to receive patient data and modules as they relate to conventional software (Application Specification [0063], [0064], [0073], [0136])). Mere instructions to apply an exception using machinery in its ordinary capacity cannot provide an inventive concept. See MPEP 2106.05(f)(2). Further, this additional element of using “one or more sensors and/or medical devices,” and “transmit a control instruction to a treatment device,” amounts to are mere data gathering and output receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. The claim is not patent eligible.
Dependent claim 28 includes limitations of the independent claim and is directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behaviors for back testing a medical protocol. claims 6 recites a “graphic compiler,” however, both of these limitations are recited at a high level of generality as a tool for performing the abstract idea. See Application Specification at [0058], [0063], [0064], [0127], [0136]; MPEP 2106.05(f). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6, 8, 12, 15-16, 18-19 and 22-27 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2009/0313048 A1 (hereinafter “Kahn et al.”) in view of U.S. 2019/0328338 A1 (hereinafter “Hu et al.”) and U.S. 2016/0246932 A1 (hereinafter “Allen et al.”).
RE: Claim 1 (Currently Amended) Kahn et al. teaches the claimed:
1. A method of back testing a medical protocol comprising: receiving an eligibility rule and a compliance rule for a medical protocol, the compliance rule being different from the eligibility rule, and each of the rules having one or more conditions ((Kahn et al., [0127], [0149], Fig 18) (establish initial patient eligibility criteria, this could involve selecting values for the attributes in the previously selected patient eligibility attribute list, or establishing further eligibility criteria, or both; The fact of enrollment is recorded in the patient information database; the workflow management tool, governed by the iCP database, directs all of the workflow task required at each patient visit in order to ensure compliance with the protocol; Example protocol consists of treatment administered intravenously every three weeks as long as the patient has stable or responding disease i.e. compliance rule e.g. granucolocyte count must be >= 1500/ul and platelet count must be >= 10000/ul on day 1 of each cycle));
receiving collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time from one or more sensors and/or medical devices ((Kahn et al., [0063], [0082], [0148]) (Once a patient is enrolled into a study, the protocol database indicates to the clinician exactly what tasks are to be performed at each patient visit. These tasks can include both patient management tasks, such as administering a drug or taking a measurement, and also data management tasks, such as completing and submitting a particular CRF; patient measurement data e.g. blood pressure i.e. requiring use of a sensor and/or medical device; The iCP may direct certain patient assessment tasks which are relevant to the further eligibility criteria of the particular study. It also directs the data management tasks which are appropriate so that clinical site personnel enter the patient assessment results into the system for comparison against the further eligibility criteria));
Kahn et al. fails to explicitly teach, but Hu et al. teaches the claimed:
determining, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the longitudinal patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during which the successive values satisfied the compliance rule ((Hu et al., Tables1-3, [0006], [0031], [0037], [0041], [0043], [0047]-[0050]) (tables showing the rate over an interval of time when patient data e.g. oxygen saturation, heart rate satisfies a threshold rule for whether or not a treatment e.g. blood transfusion is required)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
Kahn et al. and Hu et al. fails to explicitly teach, but Allen et al. teaches the claimed:
determining when a patient was eligible for the protocol as a function of the eligibility rule and the collected patient data ((Allen et al., [0023]) (the attribute values identified in the patient's medical record are compared against the criteria for eligibility. The patient's eligibility for the clinical trial being evaluated is then scored based on the required attribute values met and the weights of those attributes; Scoring may comprise an aggregation score where scores are aggregated and when the patient's eligibility score reaches a particular threshold, the patient may be determined to be eligible for the trial)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. with the motivation of providing techniques for weighing manageable patient attributes during criteria evaluations for treatment (Allen et al. at [0002]).
RE: Claim 6 (Currently Amended) Kahn et al., Hu et al., and Allen et al. teach the claimed:
6. The method as defined by claim 1, wherein the protocol eligibility rule and compliance rule are generated using a graphic compiler ((Kahn et al., [0102]) (In addition to being kept in the form of Visit objects, management task objects and VisitTo VisitTransition objects, the protocol meta-model also allows an iCP to keep the protocol schema in a graphical or diagrammatic form as well. In fact, it is the graphical form that protocol authors typically use, with intuitive drag-and-drop and drill-down behaviors, to encode clinical trial protocols using Protege 2000)).
RE: Claim 8 (Currently Amended) Kahn et al. teaches the claimed:
8. A computer program product for back testing a medical protocol on a computer system, the computer program product comprising a non-transitory computer-readable storage medium having computer-readable program code thereon, the computer-readable program code comprising: program code for receiving an eligibility rule and a compliance rule for a medical protocol, the compliance rule being different from the eligibility rule ((Kahn et al., [0127], [0149], Fig 18, claim 19) (a computer readable medium for storing the intelligent clinical protocol; establish initial patient eligibility criteria, this could involve selecting values for the attributes in the previously selected patient eligibility attribute list, or establishing further eligibility criteria, or both; The fact of enrollment is recorded in the patient information database; the workflow management tool, governed by the iCP database, directs all of the workflow task required at each patient visit in order to ensure compliance with the protocol; Example protocol consists of treatment administered intravenously every three weeks as long as the patient has stable or responding disease i.e. compliance rule e.g. granucolocyte count must be >= 1500/ul and platelet count must be >= 10000/ul on day 1 of each cycle));
program code for receiving collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time from one or more sensors and/or medical devices ((Kahn et al., [0063], [0082], [0148]) (Once a patient is enrolled into a study, the protocol database indicates to the clinician exactly what tasks are to be performed at each patient visit. These tasks can include both patient management tasks, such as administering a drug or taking a measurement, and also data management tasks, such as completing and submitting a particular CRF; patient measurement data e.g. blood pressure i.e. requiring use of a sensor and/or medical device; The iCP may direct certain patient assessment tasks which are relevant to the further eligibility criteria of the particular study. It also directs the data management tasks which are appropriate so that clinical site personnel enter the patient assessment results into the system for comparison against the further eligibility criteria)).
Kahn et al. fails to explicitly teach, but Hu et al. teaches the claimed:
program code for determining, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during which the successive values satisfied the compliance threshold ((Hu et al., Tables1-3, [0006], [0031], [0037], [0041], [0043], [0047]-[0050]) (tables showing the rate over an interval of time when patient data e/g/ oxygen saturation, hear rate satisfies a threshold rule for whether or not a treatment e.g. blood transfusion is required)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
Kahn et al. and Hu et al. fails to explicitly teach, but Allen et al. teaches the claimed:
program code for determining when a patient was eligible for the protocol as a function of the eligibility rule and the collected patient data ((Allen et al., [0023]) (the attribute values identified in the patient's medical record are compared against the criteria for eligibility. The patient's eligibility for the clinical trial being evaluated is then scored based on the required attribute values met and the weights of those attributes; Scoring may comprise an aggregation score where scores are aggregated and when the patient's eligibility score reaches a particular threshold, the patient may be determined to be eligible for the trial)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. with the motivation of providing techniques for weighing manageable patient attributes during criteria evaluations for treatment (Allen et al. at [0002]).
RE: Claim 12 (Currently Amended) Kahn et al., Hu et al., and Allen et al. teach the claimed:
12. The computer program product of claim 8, wherein the protocol eligibility rule and compliance rule are generated using a graphic compiler ((Kahn et al., [0102]) (In addition to being kept in the form of Visit objects, management task objects and VisitTo VisitTransition objects, the protocol meta-model also allows an iCP to keep the protocol schema in a graphical or diagrammatic form as well. In fact, it is the graphical form that protocol authors typically use, with intuitive drag-and-drop and drill-down behaviors, to encode clinical trial protocols using Protege 2000)).
RE: Claim 15 (Currently Amended) Kahn et al. teaches the claimed:
15. A system for simulating a medical protocol, the system comprising: an application simulator comprising: one or more processors; and a memory storing instructions that, when executed by the one or more processors cause the one or more processors to ((Kahn et al., [0137], Claims 27, 32) (the central authority maintains the iCP databases only on the central server and makes them available using a central application service provider (ASP) and thin-client model that supports multiple user devices including work stations, laptop computers and hand held devices; a processor and memory for storing instructions));
receive an eligibility rule and a compliance rule for a medical protocol, the compliance rule being different from the eligibility rule ((Kahn et al., [0086], [0126], [0127], [0149], Fig 18) (The iCP database is used by most software modules in the overall system to ensure that all protocol parameters, treatment decisions, and testing procedures are followed; an accrual simulation method for establishing patient eligibility criteria, substantially solves the problem mentioned above in which after finalizing a clinical trial protocol, engaging study sites and beginning the enrollment process, it is finally found that the eligibility criteria for the study are too restrictive and that with such criteria it is not possible to enroll sufficient patients in the trial; establish initial patient eligibility criteria, this could involve selecting values for the attributes in the previously selected patient eligibility attribute list, or establishing further eligibility criteria, or both; The fact of enrollment is recorded in the patient information database; the workflow management tool, governed by the iCP database, directs all of the workflow task required at each patient visit in order to ensure compliance with the protocol; Example protocol consists of treatment administered intravenously every three weeks as long as the patient has stable or responding disease i.e. compliance rule e.g. granucolocyte count must be >= 1500/ul and platelet count must be >= 10000/ul on day 1 of each cycle));
receive collected patient data from a plurality of patients, the collected patient data including longitudinal patient data relating to a specific parameter collected over a period of time from one or more sensors and/or medical devices ((Kahn et al., [0063], [0082], [0148]) (Once a patient is enrolled into a study, the protocol database indicates to the clinician exactly what tasks are to be performed at each patient visit. These tasks can include both patient management tasks, such as administering a drug or taking a measurement, and also data management tasks, such as completing and submitting a particular CRF; patient measurement data e.g. blood pressure i.e. requiring use of a sensor and/or medical device; The iCP may direct certain patient assessment tasks which are relevant to the further eligibility criteria of the particular study. It also directs the data management tasks which are appropriate so that clinical site personnel enter the patient assessment results into the system for comparison against the further eligibility criteria)).
Kahn et al. fails to explicitly teach, but Hu et al. teaches the claimed:
determine, for the patient, a historic dynamic concordance rate for the protocol by applying the compliance rule to successive values of the longitudinal patient data over the period of time, the historic dynamic concordance rate indicating a percentage of the period of time during which the successive values satisfied the compliance rule ((Hu et al., Tables1-3, [0006], [0031], [0037], [0041], [0043], [0047]-[0050]) (tables showing the rate over an interval of time when patient data e/g/ oxygen saturation, hear rate satisfies a threshold rule for whether or not a treatment e.g. blood transfusion is required)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
Kahn et al. and Hu et al. fail to explicitly teach, but Allen et al. teaches the claimed:
compare the collected patient data with the eligibility rule to determine when a patient was eligible for the protocol ((Allen et al., [0023]) (the attribute values identified in the patient's medical record are compared against the criteria for eligibility. The patient's eligibility for the clinical trial being evaluated is then scored based on the required attribute values met and the weights of those attributes; Scoring may comprise an aggregation score where scores are aggregated and when the patient's eligibility score reaches a particular threshold, the patient may be determined to be eligible for the trial)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. with the motivation of providing techniques for weighing manageable patient attributes during criteria evaluations for treatment (Allen et al. at [0002]).
RE: Claim 16 Kahn et al., Hu et al., and Allen et al. teach the claimed:
16. The system as defined by claim 15, further comprising a database including the eligibility rule and the compliance rule ((Kahn et al., [0062]) (The protocol designer chooses the meta-model and preliminary eligibility list appropriate for the relevant disease category, and encodes the clinical trial protocol, including eligibility and patient workflow, within the selected meta-model. The resulting protocol database is stored together with databases of other protocols in the same and different disease categories)).
RE: Claim 18 (Currently Amended) Kahn et al. and Hu et al. teach the claimed:
18. The system as defined by claim 16, further comprising a reporting module configured to provide a report about the protocol, wherein the report includes clicks by medical staff in a user interface, interactions with the user interface by medical staff, average patient compliance, time from eligibility to protocol start, ICU length of stay, ventilation time, extubation failure rate, readmission rate, and/or patient outcomes relative to dynamic concordance of the patient, wherein the reporting module is configured to generate the report based at least in part on an output of the application simulator, and wherein the report associates the historic dynamic concordance rate with at least one patient outcome ((Kahn et al., [0064], [0147]) (The system keeps track of the progress of the patient and the clinician through the workflow graph of a particular protocol. The system reports this information to study sponsors, who can then monitor the progress of an overall clinical trial in near-real-time, and to the central authority which can then generate performance metrics; involves manual entry of newly obtained patient data, then preferably such data is added to the patient information database i.e. interactions with the interface by the medical staff)).
RE: Claim 19 Kahn et al., Hu et al., and Allen et al. teach the claimed:
19. The system as defined by claim 18, further comprising a graphic compiler configured to graphically generate the eligibility rule and/or the compliance rule ((Kahn et al., [0102]) (In addition to being kept in the form of Visit objects, management task objects and VisitTo VisitTransition objects, the protocol meta-model also allows an iCP to keep the protocol schema in a graphical or diagrammatic form as well. In fact, it is the graphical form that protocol authors typically use, with intuitive drag-and-drop and drill-down behaviors, to encode clinical trial protocols using Protege 2000)).
RE: Claim 22 Kahn et al., Hu et al., and Allen et al. teach the claimed:
22. (New) The method of claim 1, wherein the longitudinal patient data comprises values of the specific parameter corresponding to respective times within the period of time; wherein determining when the patient was eligible comprises applying the eligibility rule to the values and their corresponding times to determine when, during the period of time, the patient was eligible ((Allen et al., [0014]) (The pipeline may also analyze the attributes of a patient and determine which attributes may change. While certain patient attributes are not variable and cannot change, other patient attributes can change over time. For example, the fact that a patient once broke their arm cannot change, but that patient's weight or blood pressure can change over time. That is, a patient's weight is manageable as the patient can control their weight such as through diet and exercise. Other patient attributes may be mutable as they may be changed through medical interventions. For example, a patient's blood pressure may be mutable through medication. Further, certain attributes may change over time, but this change may or may not matter depending on the required attribute value)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the variably changing patient data for a patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. with the motivation of providing techniques for weighing manageable patient attributes during criteria evaluations for treatment (Allen et al. at [0002]).
wherein determining the historic dynamic concordance rate comprises applying the compliance rule to the values and their corresponding times within the period of time to identify portions of the period of time during which the values satisfied the compliance rule and deriving the historic dynamic concordance rate from the identified portions ((Hu et al., [0053]) (The secondary coefficient ranges of the parameters listed in Table 4 are based on the first data collection over a fixed time interval of about 15 minutes. Table 5 is also provided, which lists the range of secondary coefficient values and the recommended secondary coefficient values for each parameter, based on the first data being collection over a fixed time interval of about 30 minutes)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over corresponding periods of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
RE: Claim 23 Kahn et al., Hu et al., and Allen et al. teach the claimed:
23. (New) The computer program product of claim 8, wherein the longitudinal patient data comprises values of the specific parameter corresponding to respective times within the period of time; wherein the program code for determining when the patient was eligible comprises program code for applying the eligibility rule to the values and their corresponding times to determine when, during the period of time, the patient was eligible ((Allen et al., [0014]) (The pipeline may also analyze the attributes of a patient and determine which attributes may change. While certain patient attributes are not variable and cannot change, other patient attributes can change over time. For example, the fact that a patient once broke their arm cannot change, but that patient's weight or blood pressure can change over time. That is, a patient's weight is manageable as the patient can control their weight such as through diet and exercise. Other patient attributes may be mutable as they may be changed through medical interventions. For example, a patient's blood pressure may be mutable through medication. Further, certain attributes may change over time, but this change may or may not matter depending on the required attribute value)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the variably changing patient data for a patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. with the motivation of providing techniques for weighing manageable patient attributes during criteria evaluations for treatment (Allen et al. at [0002]).
wherein the program code for determining the historic dynamic concordance rate comprises program code for applying the compliance rule to the values and their corresponding times within the period of time to identify portions of the period of time during which the values satisfied the compliance rule and deriving the historic dynamic concordance rate from the identified portions ((Hu et al., [0053]) (The secondary coefficient ranges of the parameters listed in Table 4 are based on the first data collection over a fixed time interval of about 15 minutes. Table 5 is also provided, which lists the range of secondary coefficient values and the recommended secondary coefficient values for each parameter, based on the first data being collection over a fixed time interval of about 30 minutes)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over corresponding periods of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
RE: Claim 24 Kahn et al., Hu et al., and Allen et al. teach the claimed:
24. (New) The system of claim 15, wherein the longitudinal patient data comprises values of the specific parameter corresponding to respective times within the period of time, and wherein the application simulator is further configured to: apply the eligibility rule to the values and their corresponding times to determine when, during the period of time, the patient was eligible ((Allen et al., [0014]) (The pipeline may also analyze the attributes of a patient and determine which attributes may change. While certain patient attributes are not variable and cannot change, other patient attributes can change over time. For example, the fact that a patient once broke their arm cannot change, but that patient's weight or blood pressure can change over time. That is, a patient's weight is manageable as the patient can control their weight such as through diet and exercise. Other patient attributes may be mutable as they may be changed through medical interventions. For example, a patient's blood pressure may be mutable through medication. Further, certain attributes may change over time, but this change may or may not matter depending on the required attribute value)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the variably changing patient data for a patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. with the motivation of providing techniques for weighing manageable
apply the compliance rule to the values and their corresponding times within the period of time to identify portions of the period of time during which the values satisfied the compliance rule; and derive the historic dynamic concordance rate from the identified portions ((Hu et al., [0053]) (The secondary coefficient ranges of the parameters listed in Table 4 are based on the first data collection over a fixed time interval of about 15 minutes. Table 5 is also provided, which lists the range of secondary coefficient values and the recommended secondary coefficient values for each parameter, based on the first data being collection over a fixed time interval of about 30 minutes)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over corresponding periods of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
RE: Claim 25 Kahn et al., Hu et al., and Allen et al. teach the claimed:
25. (New) The method of claim 1, wherein the period of time over which the historic dynamic concordance rate is determined begins when a course of action defined by the protocol was initiated for the patient ((Hu et al., [0057]) (One hour of continuous VS data and PPG waveform data was collected for analysis, beginning at the time of arrival of the patient at the trauma unit of the hospital)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over corresponding periods of time a patient measurement satisfied a threshold condition for a treatment initiating at the beginning of treatment protocol as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
RE: Claim 26 Kahn et al., Hu et al., and Allen et al. teach the claimed:
26. (New) The computer program product of claim 8, wherein the period of time over which the historic dynamic concordance rate is determined begins when a course of action defined by the protocol was initiated for the patient ((Hu et al., [0057]) (One hour of continuous VS data and PPG waveform data was collected for analysis, beginning at the time of arrival of the patient at the trauma unit of the hospital)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over corresponding periods of time a patient measurement satisfied a threshold condition for a treatment initiating at the beginning of treatment protocol as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
RE: Claim 27 Kahn et al., Hu et al., and Allen et al. teach the claimed:
27. (New) The system of claim 15, wherein the period of time over which the historic dynamic concordance rate is determined begins when a course of action defined by the protocol was initiated for the patient ((Hu et al., [0057]) (One hour of continuous VS data and PPG waveform data was collected for analysis, beginning at the time of arrival of the patient at the trauma unit of the hospital)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over corresponding periods of time a patient measurement satisfied a threshold condition for a treatment initiating at the beginning of treatment protocol as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2009/0313048 A1 (hereinafter “Kahn et al.”) in view of U.S. 2019/0328338 A1 (hereinafter “Hu et al.”) and U.S. 2016/0246932 A1 (hereinafter “Allen et al.”). and further in view of U.S. 2017/0132383 A1 (hereinafter “Myers et al.”).
RE: Claim 17 Kahn et al., Hu et al., and Allen et al. teach the claimed:
17. The system as defined by claim 16,
Kahn et al., Hu et al., and Allen et al. fail to explicitly teach, but Myers et al. teaches the claimed:
wherein the application simulator is configured to receive notification rule associated with the protocol, and to determine the number of notifications as a function of the protocol and the patient data ((Myers et al., [0031], [0043]) (The system can be configured to allow for customizable alarms or notifications to be set that are triggered when significant health state changes or measurement data drifts are observed. Triggering of an alarm, event or notification will solicit a response, which in tum will either ignore the detected change or drift and continue to look for further change or drift, modify some of the algorithm or detection parameters, or reset the baseline, i.e. the historical rate, with a subset of the data or begin acquiring new data to form a new baseline i.e. the adjusted notification rule. The notification can result in a custom labelling of patient state, such as the reporting of a graded risk category. Multiple tests can be performed and an alert triggered if one or more tests agree to a drift or trend detection)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the setting and adjusting of patient state detection notification rules as taught by Myers et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. and the patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. with the motivation improving patient state detection and alarm accuracy considering feedback of target events or health-state changes (Myers et al. at [0004]).
RE: Claim 20 (Currently Amended) Kahn et al., Hu et al., Allen et al., and Myers et al. teach the claimed:
20. The system as defined by claim 17, wherein a rule of the protocol is modified using a graphical compiler after generating the report ((Kahn et al., [0102]) (In addition to being kept in the form of Visit objects, management task objects and VisitTo VisitTransition objects, the protocol meta-model also allows an iCP to keep the protocol schema in a graphical or diagrammatic form as well. In fact, it is the graphical form that protocol authors typically use, with intuitive drag-and-drop and drill-down behaviors, to encode clinical trial protocols using Protege 2000)).
Claims 21 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2009/0313048 A1 (hereinafter “Kahn et al.”) in view of U.S. 2019/0328338 A1 (hereinafter “Hu et al.”) and in view of U.S. 2020/0170510 A1 (hereinafter “Ferdows et al.”).
RE: Claim 21 Kahn et al. teaches the claimed:
21. (New) A system for controlling a treatment device according to a medical protocol, the system comprising: an interface configured to receive real-time patient data from one or more sensors and/or medical devices ((Kahn et al., [0062], [0063], [0082], [0148]) (Once a patient is enrolled into a study, the protocol database indicates to the clinician exactly what tasks are to be performed at each patient visit. These tasks can include both patient management tasks, such as administering a drug or taking a measurement, and also data management tasks, such as completing and submitting a particular CRF; patient measurement data e.g. blood pressure i.e. requiring use of a sensor and/or medical device; The iCP may direct certain patient assessment tasks which are relevant to the further eligibility criteria of the particular study. It also directs the data management tasks which are appropriate so that clinical site personnel enter the patient assessment results into the system for comparison against the further eligibility criteria; near-real-time monitoring)).
Kahn et al. fails to explicitly teach, but Hu et al. teaches the claimed:
a concordance module configured to determine, and update as new real-time patient data is received, a current dynamic concordance rate indicating a rate at which the real-time patient data is consistent with a compliance rule of the protocol over time; a protocol trigger module configured to: determine that a protocol trigger condition including a threshold for the current dynamic concordance rate is satisfied ((Hu et al., Tables1-3, [0006], [0008], [0031], [0037], [0041], [0043], [0047]-[0050], [0051]) (The apparatus includes a pulse oximeter configured to measure first data that indicates values for one or more parameters of a characteristic of a PPG waveform collected during a treatment of a patient; tables showing the rate over an interval of time when patient data e/g/ oxygen saturation, hear rate satisfies a threshold rule for whether or not a treatment e.g. blood transfusion is required; if the calculated prediction (P) is above 0.5, the patient is likely in need of a transfusion within the time range. If the calculated prediction is between 0.2 and 0.5, then further investigation, such as further collection of the first data, may be necessary. If the calculated prediction is below 0.2, then the patient is likely not in need of a transfusion within the time range after the collection of the first data.)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the rate over a period of time a patient measurement collected during treatment of a patient satisfied a threshold condition for a treatment as taught by Hu et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. with the motivation of determining whether a patient requires intervention at an earlier stage of the treatment process (Hu et al. at [0003]).
Kahn et al. and Hu et al. fail to explicitly teach, but Ferdows et al. teaches the claimed:
and in response to determining that the protocol trigger condition is satisfied, transmit a control instruction to a treatment device that causes the treatment device to begin a course of action defined by the protocol ((Ferdows et al., [0036]) (The frequency of the tests may be determined in advance by a supervising physician and thereafter conducted in an automated manner by the mobile device to modify the timing and dosage of medication to be delivered within predetermined parameters set by the physician. Thereafter in step 540 the smart pill may release medication to the patient's body at a particular dosage level and at a particular time based on the signal received from the mobile device)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine real time medication release under predetermined parameters as taught by Ferdows et al. within the method and system for intelligent clinical protocol management and evaluation as taught by Kahn et al. and the method and system for determining the rate over a period of time a patient measurement satisfied a threshold condition for a treatment as taught by Hu et al. and the patient determined to be eligible for the trial when the patient’s eligibility score reaches a particular threshold as taught by Allen et al. with the motivation for delivering medications to patients that helps patients by delivering medication on time in personalized doses (Ferdows et al. at [0003]).
RE: Claim 28 Kahn et al., Hu et al., and Ferdows et al. teach the claimed:
28. (New) The system of claim 21, further comprising an eligibility module configured to determine that the patient was eligible for the protocol as a function of an eligibility rule and the real-time patient data, the eligibility rule being different from the compliance rule, wherein the protocol trigger module transmits the control instruction in response to determining both that the patient was eligible for the protocol and that the protocol trigger condition including the threshold for the current dynamic concordance rate is satisfied ((Kahn et al., [0086], [0126], [0127], [0149], Fig 18) (The iCP database is used by most software modules in the overall system to ensure that all protocol parameters, treatment decisions, and testing procedures are followed; an accrual simulation method for establishing patient eligibility criteria, substantially solves the problem mentioned above in which after finalizing a clinical trial protocol, engaging study sites and beginning the enrollment process, it is finally found that the eligibility criteria for the study are too restrictive and that with such criteria it is not possible to enroll sufficient patients in the trial; establish initial patient eligibility criteria, this could involve selecting values for the attributes in the previously selected patient eligibility attribute list, or establishing further eligibility criteria, or both; The fact of enrollment is recorded in the patient information database; the workflow management tool, governed by the iCP database, directs all of the workflow task required at each patient visit in order to ensure compliance with the protocol; Example protocol consists of treatment administered intravenously every three weeks as long as the patient has stable or responding disease i.e. compliance rule e.g. granucolocyte count must be >= 1500/ul and platelet count must be >= 10000/ul on day 1 of each cycle)).
Response to Arguments
Applicant's arguments filed 07/13/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed on 07/13/2026.
In the remarks, Applicant argues in substance that:
Regarding the 112(f) interpretation of claim 15, Applicant argues the amendments to the claim no longer warrant 112(f) interpretation;
Regarding the 112(b) rejection of claims 2-4, 6-7, 12-14, and 20, Applicant argues the rejection of claims 2, 7, 9, and 13 are moot in view of the cancelled claims, claims 6, 12, and 18 are amended to provide proper antecedent basis;
Regarding the 101 rejection of claims 1, 3, 6, 8, 10, 12, and 15-28, Applicant argues the claims do not recite an abstract idea, the additional elements integrate the claim into a practical application, and does not recite well-understood, routine and conventional activity; and
Regarding the 103 rejection of claims 1, 3, 6, 8, 10, 12, and 15-28, Applicant argues the prior cited references fail to teach each limitation of the currently amened claims.
In response to Applicant’s argument that (a) regarding the 112(f) interpretation of claim 15, Examiner is persuaded; however, Examiner notes the 112(f) interpretation of limitations in new claim 21.
In response to Applicant’s argument that (b) regarding the 112(b), Examiner is persuaded and has withdrawn the prior 112(b) rejections, however, Examiner notes new 112(b) rejections of claims 21 and 28.
In response to Applicant’s argument that (c) regarding the 101 rejection of claims 1, 3, 6, 8, 10, 12, and 15-28, Examiner respectfully disagrees.
First, each of the independent claims recite an abstract idea of at least organizing human activity and/or a mental process. Applicant argues that the claims “evaluate whether physiological or medical device data satisfies protocol conditions.” Examiner respectfully submits that this is an abstract idea. For example, receiving eligibility rules and a compliance rules for a medical protocol is a rule or instruction for managing the personal behavior or interaction between people to evaluate whether physiological or medical device data satisfies protocol conditions. Further, the determining when a patient is eligible for the protocol as a function of the eligibility rule and determining, for the patient, a historic dynamic concordance rate each recite an abstract idea as a rule or instruction for managing the personal behavior or interaction between people for deciding based on a function of patient data compared to an eligibility rule or a mental process of making such an evaluation. AS a result, the claims recite an abstract idea but for the recitation of generic computer components.
Second, the additional elements of the claim do not integrate the abstract idea into a practical application. Applicant argues that the limitations define a specific, protocol-dependent process for reconstructing protocol conformity from time series sensor data such that it reflects an improvement to technology. Examiner respectfully disagrees and submits that the claims recite an alleged improvement to the abstract idea itself i.e. evaluate whether physiological or medical device data satisfies protocol conditions, and do not recite an improvement to the functioning of a computer or other technology i.e. sensors and/or medical devices. The claims, in contrast, are directed to the data analysis transmitted from the sensors/devices as it relates to a medical protocol, but do not improve the functioning of the sensors and devices themselves. New claims 22-24 and similarly claims 3, 10, and 20 further recite what the data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond the managing of personal behaviors for back testing a medical protocol. New claim 21 recites the additional element “transmit a control instruction to a treatment device,” which amounts to are mere data gathering and output recited at a high level of generality, and thus are insignificant extra-solution activity. See MPEP 2106.05(g) (“whether the limitation is significant”). And is mere data gathering and output receiving or transmitting data over a network and is well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. This additional element does not improve the functioning of the treatment device itself, nor does it provide a particular treatment for a particular disease.
Lastly, Examiner respectfully submits the additional elements of the claim do not recite significantly more than the abstract idea. Examiner respectfully submits that the additional elements of using “one or more sensors and/or medical devices,” and “transmit a control instruction to a treatment device,” amounts to are mere data gathering and output receiving or transmitting data over a network and are well-understood, routine, conventional activity. See MPEP 2106.05(d), subsection II. Examiner respectfully submits that the data analysis limitations, for example, determining the concordance rate, is a recitation of an abstract idea, not an additional element under Step 2A Prong Two or Step 2B.
Accordingly, Examiner maintains the 101 rejection of claims 1, 3, 6, 8, 10, 12, and 15-28.
In response to Applicant’s argument that (d) regarding the 103 rejections, Examiner respectfully disagrees.
First, regarding the independent claims, Examiner respectfully disagrees and submits Kahn et al. teaches two functionally distinct rules of an eligibility rule and a compliance rule through teaching establishing initial patient eligibility criteria, this could involve selecting values for the attributes in the previously selected patient eligibility attribute list, or establishing further eligibility criteria, or both i.e. eligibility rules; and example protocol consists of treatment administered intravenously every three weeks as long as the patient has stable or responding disease i.e. compliance rules e.g. granucolocyte count must be >= 1500/ul and platelet count must be >= 10000/ul on day 1 of each cycle. See Kahn et al., [0127], [0149], Fig 18.
Examiner respectfully submits that newly cited reference Allen et al. is cited as teaching determining when a when a patient becomes eligible.
Examiner respectfully submits that Hu et al. fills the gaps of Kahn et al. by teaching the determining a historic dynamic concordance rate as claimed through disclosing tables showing the rate over an interval of time i.e. a percentage, when patient data e.g. oxygen saturation, hear rate satisfies a threshold rule i.e. a compliance rule for successive values, for whether or not a treatment e.g. blood transfusion is required i.e. a medical protocol. See Hu et al. at Tables1-3, [0006], [0031], [0037], [0041], [0043], [0047]-[0050]. Examiner respectfully submits that Kahn et al., Hu et al., and Allen et al. teach each limitation under broadest reasonable interpretation as currently recited i.e. the claimed two-rule, successive-value measurement. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to dependent claims 3 and 10, Examiner is persuaded and has withdrawn the prior 103 rejection in view of the current amendments in the particular ordered combination as currently claimed.
In response to dependent claims 6, 12, and 19-20, Examiner respectfully disagrees and submits that Khan et al. teaches protocol authoring through a graphical form to encode the clinical trial protocols. See Khan et al. at [0102].
In response to dependent claim 8, while Kahn et al. does not disclose a report comprising the concordance rate, it does disclose reports comprising performance metrics. Hu et al. fills the gap by teaching the concordance rate metric, such that the obvious combination reads on the claim. In response to claim 17, Examiner submits that Kahn et al., Hu et al., Allen et al., and Myers et al. teach each limitation of the dependent claim as applicant argues in view of dependency on the independent claim as addressed above.
Accordingly Examiner respectfully maintains the 103 rejection of Claims 1, 6, 8, 12, and 15-28 as applied in the above Office Action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
W.O. 2011038173 A1 teaches selection of the hygiene protocols to be applied by a cleaning event detector and/or within any particular patient zone may be based on a variety of one or more different factors as described herein, e.g., patient-based criteria, environmental criteria, historical hygiene protocol compliance rate, etc. (
U.S. 2019/0224434 A1 teaches a medical system for intubation procedure for a patient comprising airflow sensors (abstract); and
U.S. 2015/0213221 A1 teaches a decision support system for management of extubation in tensive care unit patients (abstract).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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