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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 02/17/2026, the following occurred: Claims 1, 3-5, 7, 12, 13 and 17 have been amended.
Claims 1-20 are currently pending.
Drawings
The drawings are further objected to as failing to comply with 37 CFR 1.84(I) because the following figure(s) is/are unreadable and/or are unsatisfactory for reproduction:
Fig. 7B and 7C
The drawings are further objected to as failing to comply with 37 CFR 1.84(g) because following figure(s) do not conform to the margin requirements (note that the margin requirement includes text):
One inch (1”) left margin - Fig. 1, 2, 3A, 7C, 7D;
Five eighths inch (5/8”) right margin – Fig. 1, 2, 3A, 7C, 7D, 7F, 8;
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 4 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a clinical trial platform, which is within a statutory category.
Regarding claims 1, 4 and 12, the limitation of (claim 1 being representative) displays a list of source fields associated with a first third-party clinical trial tool, a list of target fields associated with a second third-party clinical data tool, and a list of transformational rules for transforming the source fields into the target fields; extract source data from the first third-party clinical trial tool; transmit transformed target data to the second third-party clinical data tool; execute the transformational rules on the source data extracted to generate the transformed target data formatted according to the target field ingestion by the second third-party clinical data tool; and store, as a versioned configuration record, identifiers and the transformational rules executed; wherein automatically suggests the source fields, target fields and transformational rules; includes an editor that allows a user to overwrite one or more of the source fields, target fields or transformational rules, and automatically augmented in response to fields overwritten using the editor; and automatically generates documentation in human readable form for validation based on at least an actual system configuration or mapping rules defined, the documentation including a validation package comprising at least one executable validation script or test case derived from the versioned configuration record and configured to validate the transformed target data against the target fields as drafted, is a process that, under the broadest reasonable interpretation, covers a method organizing human activity but for the recitation of generic computer components. That is other than reciting (in claim 4) a plurality of bus connectors and (in claim 12) a processor and memory, the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). The Examiner notes that Claim 1 is not tied to any particular technological environment. For example, but for the clinical trial platform, mapper, plurality of bus connectors, processor and memory, the claims encompass displaying lists and rules, extracting source data, transmitting transformed target data, executing rules, storing identifiers, suggesting fields and rules, overwriting fields and rules, augmenting in response to fields overwritten and generating documentation in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 is not tied to any particular technological environment. Claim 4 recites the additional element of a plurality of bus connectors. Claim 12 recites the additional element of a processor and memory. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server for enabling access to medical information or generic computer components for performing generic computer functions. See Spec. at para. [0017], [0023]. [0030]) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including 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. Accordingly, even in combination, 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.
Claim 1 further recite the additional element of a user interface, a knowledge base, a mapper, a first connector, a second connector, a transformation engine and a configuration repository. Claim 4 recite the additional elements of a user interface, a mapper, a knowledge base, an API gateway, a configuration repository and a bus connector. Claim 12 recite the additional elements of a user interface, a knowledge base, a first connector, a second connector and a configuration repository. These additional element are recited at a high level of generality (i.e. a general means to display/receive/store/transmit/extract/execute data) and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the plurality of bus connectors, processor and memory to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary 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”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional elements of a user interface, a knowledge base, an API gateway, a mapper, a first connector, a second connector, a transformation engine, a configuration repository and a bus connector were considered extra-solution activity (or alternatively generally linking the abstract idea to a practical technological environment). This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional in the field of healthcare. Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-3, 5-11 and 13-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 and 14 further merely describe(s) the documentation. Claim(s) 3, 5, 6, 13 and 16 further merely describe(s) the user interface. Claim(s) 7 and 17 further merely describe(s) the data connectors. Claim(s) 8 and 18 further merely describe(s) the source and target fields. Claim(s) 9-11 and 19 further merely describe(s) the platform. Claim(s) 15 further merely describe(s) instructions the processor executes. Claim(s) 20 further merely describe(s) the user interface comprises a self-service interface. Claim(s) 20 also include the additional element of “a self-service interface” which is interpreted the same as the user interface and does not provide practical application or significantly more. Claims 2-3, 5-11 and 13-20 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1, 4 and 12.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations are:
A first connector in claims 1 and 12.
A second connector in claims 1 and 12.
A transformation engine in claim 1.
A configuration repository in claims 1, 4 and 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
The examiner has reviewed the specification and found no structure associated with the first connector, the second connector, the transformation engine and the configuration repository.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/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 limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/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 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 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Claims 1, 4 and 12 recite functional steps for which the Applicant has not adequately described the steps in sufficient detail for one of the ordinary skill in the art to conclude that the Applicant has possession of the invention at the time of filling.
Specifically, the claim 1 recites “… a first connector configured to extract source data from the first third-party clinical trial tool; a second connector configured to transmit transformed target data to the second third-party clinical data tool; a transformation engine configured to execute the transformational rules on the source data extracted by the first connector to generate the transformed target data formatted according to the target fields for ingestion by the second third-party clinical data tool; and a configuration repository configured to store…” Claim 4 recites “… a configuration repository configured to store…” Claim 12 recites “…extracting source data from the first third-party clinical trial tool via a first connector; executing the transformational rules on the extracted source data to generate transformed target data formatted according to the target fields for ingestion by the second third-party clinical data tool; storing, in a configuration repository, a versioned configuration record identifying at least the first connector, a second connector for transmitting the transformed target data …” The Applicant has provided no disclosure of structure associated the first connector, the second connector, the transformation engine and the configuration repository.
The specification at para. 0003 states: “… An artificial intelligence (Al) engine automatically suggests the source fields, target fields and transformational rules from a knowledge base of representative source and target systems. In one embodiment, this Al engine uses machine learning and pattern recognition techniques to automatically suggest the source fields, target fields, and transformational rules, derived from a knowledge base of representative source and target systems. The user interface includes an editor that allows a user to overwrite one or more of the source fields, target fields, transformational rules and validation rules, and subsequently, any alterations are ingested by the Al engine to augment the knowledge base, promoting a continuous learning environment in response to fields overwritten using the editor. In one example, the platform automatically generates documentation in human readable form for validation based on at least an actual system configuration or mapping rules…”, at para. 0026 States: “when a suggested validation rule is overridden by the user, the result is automatically added to the Al knowledge base. Once the entries in columns 601, 603, 605 and 606 are finalized and saved, several output screens (shown in Figures 7A-7H) are in automatically generated in human readable form in compliance with regulatory requirements. In the example shown, these output screens provide an FDA compliant functional requirements specification on the actual system configuration, as well as the defined mapping rules and data stream configuration.”, at para. 0024 States: “Once a stream is defined, it can be stored in the stream library 800 (shown in Figure 8) for reuse whereupon revised run-time parameters are specified according to that particular instance of the data stream.” and at para. 0023 states: “ a connector library 400 is shown for mapping data between the third-party tools. Connector library 400 includes multiple connector types, including a processor type 401, source type 402, and a sink type 403. Each source type connector 402 corresponds to a specific version of a 3rd party tool (example: Argus Medical System) that is providing data into the data stream using its preferred method such as public/ private, standards based or proprietary means of reading data from same. Each processor type connector 401 corresponds to modules that run the instructions generated using the mapping wizard as well as other manually entered instruction sets. There can be many processor types in any given data stream as needed as they are components that do the majority of the work. Each sink type connector 403 corresponds to a specific version of a 3rd party tool that is receiving data from the data stream using its public/ private, standards based or proprietary means of reading data from same. The connectors are adapted to interface with the third-party tools shown on Figure 1. For example, connector 404 may be adapted to interface with the Bioclinica Clinical Trial tool, and connector 405 is adapted to interface with the Medrio Clinical Trial tool . The user can select various connectors from the library”.
As can be see, there is no clear link to the first connector, the second connector, the configuration repository and the transformation engine having any structure evidencing that the Applicant was not in possession of the invention at the time of filing. As such the claimed invention lacks adequate written description.
Dependent claims are rejected by virtue of dependency.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 1 and 12, the limitation “the first connector” invokes 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 as-filed disclosure is devoid of any structure associated with the first connector. 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.
In claims 1 and 12, the limitation “the second connector” invokes 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 as-filed disclosure is devoid of any structure associated with the second connector. 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.
In claim 1, the limitation “the transformation engine” invokes 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 as-filed disclosure is devoid of any structure associated with the transformation engine. 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.
In claims 1, 4 and 12, the limitation “the configuration repository” invokes 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 as-filed disclosure is devoid of any structure associated with the configuration repository. 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.
Dependent claims are rejected by virtue of dependency.
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.
Response to Arguments
drawing Objections
Regarding the specification objection(s), the Applicant has amended the drawings but does not overcome all the basis/bases of objection.
Rejection under 35 U.S.C. § 112(b)
Regarding the indefinite rejection of claims 3, 5 and 13, the Applicant has amended the claims
to overcome the bases of rejection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-20, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
As amended, claim 1 is expressly drafted to foreground the technical effect and the technical mechanism that achieves it. The preamble now recites: "A clinical trial platform for technically integrating heterogeneous third-party clinical systems by executing transformation rules to generate target-formatted clinical data and automatically generating a configuration-derived validation package ....".
Regarding 1, The Examiner respectfully submits that the preamble holds no wait.
… These limitations define a concrete interoperability pipeline and validation artifact generation process that produces machine-usable outputs (target-formatted transformed data and executable validation scripts/test cases) tethered to an identified integration configuration.
Regarding 2, The Examiner respectfully submits that producing outputs is an abstract idea.
In view of these amendments, the Office Action's characterization that the claims are directed to "generating diagnosis" is inapposite. (Office Action, p. 3). The amended claims are directed to technical interoperability and validation between heterogeneous clinical systems through connector-based extraction/transmission, rule execution producing ingestion-ready target-formatted data, and configuration- derived executable validation artifacts.
Regarding 3, The Examiner made an error and has corrected the characterization.
The amended claim language, however, makes clear that the claims are directed to a technical integration and validation mechanism implemented by specific platform components and operations, including connectors/bus connectors; execution of transformation rules to generate ingestion-ready target-formatted data; storage of a versioned configuration record identifying the connectors and executed rules; and automatic generation of a validation package including executable validation scripts/test cases derived from that configuration record.
Regarding 4, The Examiner respectfully submits that generating ingestion-ready target-formatted data, i.e., data, storing versioned configuration records and generating validation package is an abstract idea. Claim 1 is not tied to any particular technological environment.
… The amended claims do not merely claim the result of "mapping" in the abstract; they recite the particularized mechanism by which the platform executes transformation rules on extracted source data to generate target-formatted transformed data for ingestion by a different third-party system, and then derives executable validation artifacts from a stored versioned configuration record. That is a technical, rule-based automation that meaningfully limits the claim scope and is not a generic instruction to apply "rules" using a computer. Accordingly, properly characterized, the claims are directed to a technical improvement in computerized interoperability/validation across heterogeneous clinical systems, not to managing personal behavior or interactions between people.
Regarding 5, The Examiner respectfully disagrees. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to displaying lists and rules, extracting source data, transmitting transformed target data, executing rules, storing identifiers, suggesting fields and rules, overwriting fields and rules, augmenting in response to fields overwritten and generating documentation in the manner described in the identified bolded abstract idea in the 101 rejection. Other than reciting generic computer components, i.e., (in claim 4) a plurality of bus connectors and (in claim 12) a processor and memory, the claimed invention amounts to managing personal behavior or interaction between people. The Examiner notes that Claim 1 is not tied to any particular technological environment. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
… Applying that standard here, the "additional elements" are significant because they are not peripheral display/reporting features; they are the mechanism by which the platform actually performs interoperability and validation. For example, claim 1 requires connector-based extraction and transmission; requires a transformation engine to execute transformation rules on extracted source data to generate transformed target data formatted for ingestion by the target tool; requires a configuration repository storing a versioned configuration record identifying connectors and executed rules; and requires that the validation documentation include an executable validation script/test case derived from that configuration record and configured to validate the transformed target data. This ordered combination integrates any purported "rules" concept into a concrete technical operation that transforms data into a target-compatible format and automatically generates configuration-derived executable validation artifacts… the amended claims apply those rules in a specific, computer-implemented way that improves a technological process by producing ingestion-ready, target-formatted transformed clinical data and configuration- derived executable validation scripts/test cases tied to a versioned configuration record.
Regarding 6, The Examiner respectfully disagrees. This judicial exception is not integrated into a practical application. In particular, claim 1 is not tied to any particular technological environment. The additional element of a plurality of bus connectors, a processor and memory are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server for enabling access to medical information or generic computer components for performing generic computer functions. See Spec. at para. [0017], [0023]. [0030]) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including 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. Accordingly, even in combination, 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. Moreover, the additional element of a user interface, a knowledge base, a mapper, a first connector, a second connector, a transformation engine, a configuration repository, an API gateway and a bus connector are recited at a high level of generality (i.e. a general means to display/receive/store/transmit/extract/execute data) and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The Office Action concludes that the claims do not include additional elements sufficient to amount to "significantly more," and that "mere instructions to apply an exception using a generic computer component" cannot provide an inventive concept; it further cites Alice, buySAFE, and Flook for the proposition that generic computing and routine networking/calculation functions are well-understood, routine, and conventional. (Office Action, p. 5-6). That conclusion does not address the amended claims' ordered combination and the technical coupling among elements that produces the technical effect stated in the preambles… This is consistent with Amdocs (Isr.) Ltd. v. Openet Telecom, Inc., 841 F.3d 1288 (Fed. Cir. 2016), which recognizes that eligibility may be supported by an ordered combination that yields a specific technological solution, even where individual components may be known in isolation. Here, even if connectors, repositories, gateways, or scripts are broadly known categories, the claims' ordered combination requires a specific interoperability/validation pipeline tied to a versioned configuration record and automatically producing configuration-derived executable validation artifacts, which constitutes "significantly more" than any alleged abstract idea.
Regarding 7, The Examiner respectfully disagrees. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of the plurality of bus connectors, processor and memory to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary 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”). Moreover, the additional elements of a user interface, a knowledge base, an API gateway, a mapper, a first connector, a second connector, a transformation engine, a configuration repository and a bus connector were considered extra-solution activity (or alternatively generally linking the abstract idea to a practical technological environment). This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional in the field of healthcare. Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
As such the claim is not patent eligible.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. 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.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Burns (US 2013/0238351) teaches clinical data management system. Ford (US 2015/0310188) teaches system and methods of secure data exchange. Vergetis (US 2020/0321083) teaches system and interfaces for processing and interacting with clinical data.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683