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
Claims 1-7, 10-17 and 20 are presented for examination.
Claims 1 and 11 were amended.
Claims 8-9 and 18-19 were cancelled.
This is a Final Action.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7, 10-17 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Furthermore, applicant makes the following arguments:
1. Applicant argues, Kobozev does not teach querying a record and verify system, retrieving MRN/UID, using DICOM transactions, or exporting treatment data.
Examiner respectfully agrees with the applicant. However, the rejection does not rely on Kobozev for those limitations. Ballard expressly teaches DICOM-based querying and retrieval of medical records using patient identifiers and procedure identifiers. Kobozev is relied upon solely for secured storage and disaster recovery. The combination properly distributes teachings across the references.
2. Applicant argues, Kobozev is enterprise-level backup; Ballard is federated search. No teaching, suggestion or motivation to combine. Combination would require redesign and hindsight.
Examiner respectfully disagrees with the applicant. Both references operate in the field of electronic medical data management. Ballard retrieves medical records over a network and address provider/database unavailability. Kobozev teaches protecting electronic data via secondary storage for disaster recovery. Improving reliability and recoverability of retrieved medical records would have been an obvious design consideration. The combination merely applies known backup techniques to a known medical data retrieval system, yielding predictable improvements in data availability. No redesign of core functionality is required, only addition of secondary storage.
3. Applicant argues, Examiner’s combination requires hindsight knowledge of applicant’s oncology continuity workflow.
Examiner respectfully disagrees with the applicant. The combination does not change Ballard’s principle of operation. Ballard retrieves medical data; Kobozev stores protected secondary copies. Adding secure backup storage to retrieved data is a routine system reliability enhancement and does not require redesign of query mechanisms. This is a predictable use of prior art elements according to their established functions (KSR).
4. Applicant argues, with regards to dependent claims allowable if base claim is allowable.
Examiner respectfully maintains his arguments and has further added new prior art in view of amended claim therefore the dependent claims are also maintained as rejected.
With respect to 101, examiner respectfully agrees, therefore 101 has been removed.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claims 1-20 rejected under 35 U.S.C. 103 as being unpatentable over Kobozev et al. (US 2020/387535 – IDS) in view of Ballard et al. (US 2021/0057064 – IDS) further in view of Walsh (US 6,497,358)
1. Kobozev teaches, A method for continuity and disaster recovery in an oncology treatment system (Paragraph 163 - teaches system 100 may also make and retain disaster recovery copies, at disaster recovery locations using auxiliary copy or replication operations, such as continuous data replication technologies – describes disaster recovery systems for clinical/medical data, Kobozev), comprising:
storing the exported patient and associated treatment data on a secured file storage (Paragraphs 77 and 78 teaches secondary copies 116 may be stored in relatively slow and/or lower cost storage (e.g. magnetic tape), secondary storage computing device 106 may index secondary copies enabling user to browse and restore at a later time, Kobozev).
Kobozev does not explicitly teach,
querying a record and verify system for a list of medical record numbers (MRN);
for each retrieved MRN, retrieving a plan unique ID (UID);
using the MRN and UID to query the record and verify system using DICOM transactions; and
exporting patient and associate treatment data using the DICOM transactions; and
creating a treatment record document that is used to reconcile data electronic data stored in the secured file storage.
However, Ballard teaches,
querying a record and verify system for a list of medical record numbers (MRN) (Paragraph 66 - teaches in step 214, the virtual machine 113 transmits a prior medical record query to the virtual machines, the C-FIND request can include various identifiers such as, patient identifiers, medical record numbers – describes querying remote systems using MRNs as identifiers, Ballard);
for each retrieved MRN, retrieving a plan unique ID (UID) (paragraphs 8 & 67 - teaches generated, by a server, a query for prior imaging studies, wherein the query includes the patient identifier and the procedure identifier – describes the “procedure identifier” serves as a unique identifier associated with the MRN (analogous to UID for treatment plan), Ballard);
using the MRN and UID to query the record and verify system using DICOM transactions (Paragraph 66 - teaches the virtual machine utilizes a C-FIND request which conforms to the DICOM standards. The C-FIND service is an operation by which relavant patient information and medical records can be queried across disparate databases, Ballard); and
exporting patient and associate treatment data using the DICOM transactions (Paragraph 77 - teaches the virtual machine 114 utilizes a C-MOVE request which copies composite instances of the prior medical record to the virtual machine 114, Ballard);
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which said subject matter pertains to allow to incorporate Kobozev’s secondary storage and disaster recovery techniques into Ballard’s DICOM-based medical record retrieval system to ensure recoverability and continued availability of retrieved medical records in the event of database failure or corruption. Ballard contemplates database unavailability, and Kobozev teaches storing secondary copies of electronic data for restoration following deletion or disaster. The combination merely applies known backup storage techniques to a known medical data retrieval system to yield predictable improvements in data integrity and continuity.
Walsh teaches,
creating a treatment record document (Col 5: (h) – teaches using ahigh speed printer to print prescribed treatment data on a paper verification sheet, Walsh) that is used to reconcile data electronic data (Col 5: (n) – teaches checking the core treatment data on the printed hard copy against the actual treatment data entered into the patient’s chart, Walsh) stored in the secured file storage (Col 14: lines 24-25 – teaches saves the values to the VEEBAT fileserver 30, Walsh).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which said subject matter pertains to incorporate Walsh’s known paper-based reconciliation technique into the secure electronic storage system of Kobozev and Ballard to prevent mismatches between stored electronic treatment data and treatment documentation, and to improve treatment accuracy and audit reliability in radiation therapy systems.
2. The combination of Kobozev, Ballard and Walsh teach, The method of claim 1, further comprising retrieving UIDs created within a predetermined period of time ( Paragraph 9 – teaches calculating a query date by the server based on the appointment date and a pre-determined time offset; generating by the server, a query for prior imaging studies, Ballard).
3. The combination of Kobozev, Ballard and Walsh teach, The method of claim 1, further comprising accepting only DICOM transactions from a DICOM daemon in a predetermined environment (Paragraph 66 – teaches the virtual machine 114 utilizes a C-FIND request which conforms to the DICOM standards, the C-FIND service is an operation by which relevant patent information and medical records can be queried across disparate databases, Ballard).
4. The combination of Kobozev, Ballard and Walsh teach, The method of claim 1, wherein the secured file storage is locally attached to a workstation (Paragraph 118 – teaches the local database 500 can reside within the virtual machine 114, or can locate remotely, in another embedment the database 112 is utilized instead of the local database 500, Ballard).
5. The combination of Kobozev, Ballard and Walsh teach, The method of claim 4, further comprising periodically executing a script to delete data older than a predetermined period of time (Paragraph 92, & 101 – storage manage 140 provide… tracking age information related to secondary copies 116, secondary storage 108, comparing the age information against retention guidelines, and initiating data pruning when appropriate – teaches retention policies ma specify data aging, older data may be pruned, deleted or migrated according to automated schedules, Kobozev).
6. The combination of Kobozev, Ballard and Walsh teach, The method of claim 1, further comprising executing a script to capture documents to the secured file storage by using a list of MRNs to query a Documents API exposed by a web server and transfer each document for each patient (Paragraphs 23 and 45-49 – teaches the virtual machine 114 configured to transmit a message, the virtual machine 114 includes a parsing engine to analyze text; in another embodiment, information related to the patient appointment can be transmitted directly… via a data exchange interface such as an API, Ballard).
7. The combination of Kobozev, Ballard and Walsh teach, The method of claim 6, further comprising capturing associated treatment data that is newer than a predetermined date (Claim 13 – teaches monitoring the data feed by the server to determine if the appointment date has been modified; Paragraph 9 – teaches calculating a query date based on a predetermined time offset , Ballard).
10. The combination of Kobozev, Ballard and Walsh teach, The method of claim 1, further comprising providing the secured file storage to a radiotherapy delivery system (Paragraph 29 – teaches that the secured/local storage (database/PACS) is directly provided to treatment delivery systems such as radiotherapy, Ballard).
Claim11-20 are similar to claims 1-10 hence rejected similarly.
Claim 11 recites additional limitation of “providing contextual event notifications” (Paragraphs 70-72 – teaches generating notification and alters to providers when contextual events occur (e.g., provider offline, failed queries, missing medical records), Ballard).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMRESH SINGH whose telephone number is (571)270-3560. The examiner can normally be reached Monday-Friday 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ann J. Lo can be reached at (571) 272-9767. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMRESH SINGH/Primary Examiner, Art Unit 2159