DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6 and 8-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0179039 to Pelissier et al. “Pelissier” in view of U.S. Patent No. 6,689,055 to Mullen et al. “Mullen” and U.S. Publication No. 2020/0315572 to Salgaonkar.
As for Claims 1, 4, 11, 13, 15 and 20, Pelissier discloses an ultrasound system and method for producing a record of a use of the ultrasound system (Abstract). Pelissier discloses wherein the system includes an ultrasound probe configured to acquire echo signals responsive to ultrasound pulses transmitted toward a subject during the exam (Paragraphs [0024] and [0027) an input of pre-defined inputs associated with a particular exam protocol (e.g. modes) (Paragraphs [0025]-[0026], [0028]]). Pelissier explains that the record of use of the ultrasound system can help facilitate maintaining of medical records, supervising ultrasound operators, auditing job performance and/or training of ultrasound operators (Paragraph [0127]-[0130]).
However, while Pelissier video of the use of the ultrasound system tracks manipulations of the probe during the exam via tracking system (Paragraph [0073]) and would image user interactions with the system, it does not expressly disclose tracking the probe manipulations based on the image data and generating log files documenting the manipulators and user inputs as claimed.
Mullen teaches from within a similar field of endeavor with respect to analyzing data of a use of an ultrasound system where keystroke data is logged and stored for performance analysis (Abstract; Column 2, Lines 15-22; Column 6, Lines 1-30). Mullen explains wherein keystroke data may set up the system according to a selected exam category (e.g. protocol) (Column 5, Lines 45-65).
Accordingly, one skilled in the art would have been motivated to have modified the system and method described by Pelissier to record and log keystroke information of the ultrasound operator as described by Mullen in order to enhance the oversight/training of ultrasound operators by providing a complete record of the use of the system and requires nothing more than combining prior art elements according to known techniques to yield predictable results (MPEP 2143). Examiner notes the recorded keystroke information relating to a protocol would read on the step of identifying meaningful user inputs received during the scan indicative of adherence to an exam protocol in its broadest reasonable interpretation.
As for determining ultrasound probe position from images, Salgaonkar teaches from within a similar field of endeavor with respect to ultrasound imaging systems and methods where an acquired images is analyzed to determine the position of the probe relative to landmarks (Paragraphs [0033]-[0036]).
Accordingly, one skilled in the art would have been motivated to have modified the ultrasound system and method described by Pelissier with Salgaonkar’s processing means to detect probe position by analyzing acquired images in order to enhance the accuracy of probe location during an ultrasound exam and improve operator training/auditing.
As for Claims 2 and 14, Examiner notes that the protocol operating parameters would include the claimed conventional settings such as frequency, depth gain, focus (Pelissier-Paragraph [0025]).
Regarding Claim 3, Pelissier’s system allows a measurement in a current frame (Paragraphs [0029] and [0031]).
With respect to Claims 5-6, 12 and 16-17 , Salgaonkar explains that machine learning is used to identify landmarks (e.g. anatomical feature) in current images and compare them with training data to determine the probe’s position (Paragraphs [0033]-[0038]).
Regarding Claims 8-9 and 18-19 Pelissier discloses synchronizing discrete data into a single multi-medica container for convenient storage and playback with timestamps (Abstract; Paragraphs [0041], [0043] and [0113]). Accordingly, one skilled in the art would have been motivated to have combined the keystroke log files with the detected probe positions into the multi-media container in order to efficiently store the aforementioned data.
With respect to Claim 10, Pelissier explains the container file may include a user input narration text signal (Paragraph [0113]; Claim 3).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pelissier, Mullen and Salgaonkar as applied to claim 1 above, and further in view of U.S. Patent No. 6,468,212 to Scott et al. “Scott”.
As for Claim 7, Pelissier, Mullen and Salgaonkar disclose an ultrasound system and method for recording an operator’s actions with respect to an imaging protocol as described above. However, the art of record does not compare the user’s actions (e.g. keystrokes, positions, image acquisitions) with a protocol checklist.
Scott teaches from within a similar field of endeavor with respect to ultrasound imaging systems and methods where the system provides a checklist for the medical protocol (Abstract) on a user interface to ensure the ultrasound techniques comply with a predetermined protocol (Column 2, Lines 1-10).
Accordingly, one skilled in the art would have been motivated to have included a protocol checklist described by Scott into the multi-media container file described by Pelissier, Mullen and Salgaonkar in order to compare the user’s system interaction with a predetermined protocol and improve operator training/auditing. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
Response to Arguments
Applicant's arguments filed 04/29/2026 have been fully considered but they are not persuasive. With respect to the 35 U.S.C. 103 rejection, Applicant argues “Claim 1 requires that the processor ‘identify meaningful user inputs received during the ultrasound examination of adherence to the exam protocol’ and then generates log files documenting those meaningful inputs. By contrast, Mullen et al. explicitly records every keystroke after the set up phase” (REMARKS, page 7). Examiner notes Mullen’s keystroke data may be sorted, filtered and reported in a spreadsheet, chart or other formats to determine “productivity measurements” such as, for example, but not limited to, number of exams performed by type, day operator, referring physician, etc; length of time of exams, individually collectively or by specific type conformance to departmental processes and procedures (Column 2, Lines 30-57). Examiner notes such recorded and filtered keystrokes are considered to read on the claimed step of identifying meaningful user inputs received during the ultrasound exam indicative of adherence to the exam protocol in its broadest reasonable interpretation. In addition, Examiner respectfully notes the claims fail to preclude every keystroke from the ultrasound exam from being considered “meaningful” and “adhering to the exam protocol”. In other words, Applicant’s arguments are not commensurate with the scope of the claim and Applicant should consider clarifying what “meaningful inputs” are in the claim and limiting them to only a subset of user inputs that do not include all user inputs during an ultrasound examination. Regarding Claim 7, Applicant argues Scott does not remedy deficiencies of Pelissier, Mullen and Salgaonkar and Scott does not contemplate use of meaningful inputs that are indicative of adherence to an exam protocol (REMARKS, Page 8). Examiner respectfully notes Scott is relied upon to teach a list of expected inputs associated with the exam protocol. In the modified system, the recorded and filtered keystrokes are compared with Scott’s list in order to compare the user’s system interaction with a predetermined protocol and improve operator training/auditing.
Thus, the rejections have been maintained.
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 CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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