DETAILED ACTION
This action is in response to new application filled 6/5/2024 titled “METHODS, SYSTEMS AND COMPUTER PROGRAM PRODUCTS FOR RETROSPECTIVE DATA MINING”. Claims 1 are under consideration.
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/5/2024 and 11/15/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,080,404. Although the claims at issue are not identical, they are not patentably distinct from each other because each and every element of the above independent claim 1 of the present application is broader and therefore anticipated by the corresponding independent claim 1 of U.S. Patent No. 12,080,404.
18/734179 Claim 1
US 12,080,404, Claim 1
An integrated system for collecting, storing, and distribution of images acquired of subjects in a research or clinical environment, the integrated system comprising:
An integrated system for collecting, storing, and distribution of images acquired of subjects in a research or clinical environment, the integrated system comprising:
an image and data repository including a plurality of images originating from one or more image-generating devices, data associated with the images, and data associated with imaged subjects;
an image and data repository comprising a plurality of interoperable databases for management of structured and unstructured data;
where the structured and unstructured data includes a plurality of images originating from one or more image-generating devices, data associated with the images, and data associated with imaged subjects;
a workflow management module in direct communication with the image and data repository and with the one or more image-generating devices and/or storage devices that store the images of the imaged subjects, the workflow management module being configured to transport the images directly from the one or more image-generating devices and/or storage devices to the image and data repository and to manage the collation and distribution of images, data associated with the raw images and the data associated with the imaged subjects in the image and data repository
a workflow management module in direct communication with the image and data repository and with the one or more image-generating devices and/or storage devices that store the images of the imaged subjects, the workflow management module being configured to transport the images directly from the one or more image-generating devices and/or storage devices to the image and data repository and to manage the collation and distribution of images, data associated with the raw images and the data associated with the imaged subjects in the image and data repository;
wherein the workflow management module comprises a data integration module, a data management module, a pre-processing engine and a data utilization module;
wherein the workflow management module comprises a data integration module, a data management module, a pre-processing engine and a data utilization module;
wherein the data integration module receives data from one or more user-selected electronic data sources in connection with the workflow management module; the data management module parses the data received through the data integration module into records within the image and data repository; the pre-processing engine is configured to run one or more automated algorithms on images and data prior to storing images or data in the repository; and the data utilization module distributes images and data from the repository to authorized users for analysis according to automation rules defined within the workflow management module;
wherein the data integration module receives data from one or more user-selected electronic data sources in connection with the workflow management module; the data management module parses the data received through the data integration module into records within the image and data repository; the pre-processing engine is configured to run one or more automated algorithms on images and data prior to storing images or data in the repository; and the data utilization module distributes images and data from the repository to authorized users for analysis according to automation rules defined within the workflow management module;
wherein the automation rules include rules for masking of data for human annotation, labelling and grading and rules for parsing data into grading sets, algorithm training sets, algorithm testing sets, and algorithm validation sets;
wherein the automation rules include rules for masking of data for human annotation, labelling and grading and rules for parsing data into grading sets, algorithm training sets, algorithm testing sets, and algorithm validation sets;
wherein the masking and parsing of data retains traceability to the source images and data in the repository;
wherein the workflow management module further comprises automated logging to record and trace activities associated with automated processing routines applied to images and data within the framework of the workflow management module in communication with the image and data repository and automated logging to user access records for all images and data within the framework of the workflow management module in communication with the image and data repository; and
wherein the workflow management module further comprises automated logging to record and trace activities associated with automated processing routines applied to images and data within the framework of the workflow management module in communication with the image and data repository and automated logging to user access records for all images and data within the framework of the workflow management module in communication with the image and data repository; and
wherein the ordered combination of processes and automations that comprise a specific workflow are configured by the user using a library of available operations
wherein the ordered combination of processes and automations that comprise a specific workflow are configured by the user using a library of available operations.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walker et al (US 2004/0122790).
With respect to claim 1 Walker teaches an integrated system for collecting, storing, and distribution of images acquired of subjects in a research or clinical environment, the integrated system comprising:
an image and data repository including a plurality of images originating from one or more image-generating devices, data associated with the images, and data associated with imaged subjects (see Walker paragraphs 0012, 0048-0049 and 0074);
a workflow management module in direct communication with the image and data repository and with the one or more image-generating devices and/or storage devices that store the images of the imaged subjects, the workflow management module being configured to transport the images directly from the one or more image-generating devices and/or storage devices to the image and data repository and to manage the collation and distribution of images, data associated with the raw images and the data associated with the imaged subjects in the image and data repository (see Walker paragraphs 0048-0049 i.e. “The federated database 14 may be software-based, and includes data access tools for drawing information from the various resources as described below, or coordinating or translating the access of such information. In general, the federated database will unify raw data into a useable form. Any suitable form may be employed, and multiple forms may be employed, where desired, including hypertext markup language (HTML) extended markup language (XML), Digital Imaging and Communications in Medicine (DICOM), Health Level Seven.RTM. (HL7), and so forth... In general, data within the resources and knowledge base are digitized and stored to make the data available for extraction and analysis by the federated database and the data processing system. In the present context, the integrated knowledge base 12 is considered to include any and all types of available medical data which can be processed by the data processing system and made available to the clinicians for providing the desired medical care” Paragraph 0049 goes on to state “the term "integrated knowledge base" is intended to include one or more repositories of medical- related data in a broad sense, as well as interfaces and translators between the repositories, and processing capabilities for carrying out desired operations on the data, including analysis, diagnosis, reporting, display and other functions” also see paragraph 0053 and 0075-0077);
wherein the workflow management module comprises a data integration module, a data management module, a pre-processing engine and a data utilization module;
wherein the data integration module receives data from one or more user-selected electronic data sources in connection with the workflow management module (see Walker paragraphs 0076);
the data management module parses the data received through the data integration module into records within the image and data repository (see Walker paragraph 0053-0054 and 0061);
the pre-processing engine is configured to run one or more automated algorithms on images and data prior to storing images or data in the repository (see Walker paragraph 0049, 0072 and 0075); and the data utilization module distributes images and data from the repository to authorized users for analysis according to automation rules defined within the workflow management module (see Walker paragraph 0350-0351 and 0354);
wherein the automation rules include rules for masking of data for human annotation, labelling and grading and rules for parsing data into grading sets, algorithm training sets, algorithm testing sets, and algorithm validation sets (see Walker paragraph 0299 i.e. “However, the classification process may then be automated based on the attributes provided by domain experts and adjunct methods. In one embodiment, any clinical data may be automatically categorized and indexed so that it can be retrieved on demand for various intended purposes” and paragraph 0392-0393 i.e. “Based upon the identified relationships, rule identification is carried out as indicated at block 384. Such rules may include comparisons, Boolean relationships, regression equations, and so forth used to link the various items of data or input in the identified relationships. Input refinement steps are carried out as indicated at block 386 in which the relationships are linked to various data inputs which are available from the resources or database or knowledge base. As noted in FIG. 25, such inputs 388 may be non-parametric, that is, relate to raw or processed data which is not specifically influenced by settings or parameters of the CAX process. Other input identification, as indicated at block 390, is targeted to parametric inputs which can be impacted by alteration of the CAX process. Based upon the input identification, the rule identification and the relationship identification, reconciliation and refinement of the model is possible as indicated at block 392. Again, such reconciliation and refinement may include addition or deletion of certain inputs, placement of certain conditions on inclusion of inputs, weighting of some inputs, and so forth. Such reconciliation and refinement may be carried out by the system or with input from an expert as indicated at reference numeral 6 in FIG. 25. The entire process, then, may be somewhat iterative as indicated by the return arrows in FIG. 25, such that the reconciliation and refinement process may further impact identification of relationships, rules and inputs. This clearly teaches algorithm training sets, algorithm testing sets, and algorithm validation sets are used for analysis also see paragraph 0397, 0423 and 0439-0440);
wherein the workflow management module further comprises automated logging to record and trace activities associated with automated processing routines applied to images and data within the framework of the workflow management module in communication with the image and data repository and automated logging to user access records for all images and data within the framework of the workflow management module in communication with the image and data repository (see Walker paragraph 0049, 0056 and 0406); and
wherein the ordered combination of processes and automations that comprise a specific workflow are configured by the user using a library of available operations (see Walker paragraph 0354, 0408 and 0427).
Prior Art
Zhao et al (US 2013/0208955) titled “CLOUD-BASED MEDICAL IMAGE PROCESSING SYSTEM WITH ACCESS CONTROL”
Zhao et al (US 2013/0208966) titled “CLOUD-BASED MEDICAL IMAGE PROCESSING SYSTEM WITH ANONYMOUS DATA UPLOAD AND DOWNLOAD”
Yu (US 2012/0041786) titled “METHODS, SYSTEMS, AND DEVICES FOR MANAGING MEDICAL IMAGES AND RECORDS”
Backhaus et al (US 20110010192) titled “MEDICAL IMAGE METADATA PROCESSING”
Maresh et al (US 2009/0112882) titled “METHODS, SYSTEMS, AND DEVICES FOR MANAGING MEDICAL IMAGES AND RECORDS”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN E ALMEIDA whose telephone number is (571)270-1018. The examiner can normally be reached on Monday-Thursday from 7:30 A.M. to 5:00 P.M. The examiner can also be reached on alternate Fridays from 7:30 A.M. to 4:00 P.M.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Saleh Najjar, can be reached on 571-272-4006. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN E ALMEIDA/Examiner, Art Unit 2492
/SALEH NAJJAR/Supervisory Patent Examiner, Art Unit 2492