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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/22/2026 has been entered.
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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2023/0342922 to Ayinde et al. “Ayinde” in view of U.S. Publication No. 2023/0329674 to Ghani et al. “Ghani” and U.S. Publication No. 2019/0336110 to Kustra et al “Kustra”.
As for Claims 1 and 4-8, Ayinde discloses an ultrasound diagnostic apparatus and method (Abstract; Fig. 1 and corresponding descriptions) comprising a probe configured to transmit ultrasound signals toward a target and receive echo signals (Paragraph [0027]) and a processor (Fig. 2 and corresponding descriptions) configured to generate a first, initial image with initial settings (511, 512 in Fig. 5 and corresponding descriptions), evaluate the image to identify changes in settings that would further “optimize” the settings and then reimages the subject using the “improved settings” (Paragraphs [0045]-[0046]; 520, 521, 540 and 541 in Fig. 5 and corresponding descriptions). Ayinde explains in some embodiments one or more additional setting improvement cycles are performed on subsequently generated images (Paragraph [0046]). Ayinde discloses wherein image settings include, for example, gain and depth (Paragraphs [0047]-[0049]). Examiner notes the depth of the image depend on a frequency setting in its broadest reasonable interpretation. Such disclosures are considered to read on the claimed steps of generating a first ultrasound image from a reception signal acquired by transmitting and reception of ultrasound waves according to an image quality parameter for generating an ultrasound image, calculate a first evaluation value indicating the evaluation of an image quality of the first image, changing the image quality parameter, performing transmission/reception of the ultrasound waves again to generate a second image according to the changed parameter, calculating a second evaluation value indicating an evaluation of the second image’s quality and changing the image settings again if necessary in its broadest reasonable interpretation.
While Ayinde’s processing system would quantify (e.g. provide a value of) the quality of the image in order to suggest a change in parameters, it is not clear if the quality value is compared with a threshold as claimed. In addition, Examiner notes that continuing to suggest parameter changes for a third, fourth, etc. improvement cycle would notify the user the quality is not sufficient even though initial parameters were changed, it is not clear how the user is notified.
Ghani teaches from within a similar field of endeavor with respect to ultrasound imaging systems and methods (Abstract) where a “score” is associated with an image and if the score does not satisfy a threshold, new parameters are suggested (e.g. change gain, depth, etc.) (Paragraphs [0010]-[0012], [0055]-[0057], [0073]-[0075] and [0093]-[0095]).
Accordingly, one skilled in the art would have been motivated to have modified each setting improvement cycle described by Ayinde, particularly the quality determination processing means to calculate quality scores to be compared with quality thresholds as described by Ghani in order to easily convey the image quality and proper adjustments to the user. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
As for the notification, Examiner notes the displayed score may also represent a notification to the user that the image quality score for each setting improvement cycle exceeds or does not exceed the threshold in its broadest reasonable interpretation. Nonetheless, Kustra teaches from within a similar field of endeavor with respect to ultrasound imaging systems and methods to assess image quality (Abstract; Paragraph [0040]) where an alarm unit provides an optical, audible or haptic alarm if the image quality is below a threshold (Paragraph [0040]).
Accordingly, one skilled in the art would have been motivated to have incorporated Kustra’s alarm unit and processing means into the modified ultrasound setting improvement cycle described by Ayinde and Ghani in order to alert the user to poor image quality for all acquisitions (e.g. first and every subsequent image). Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143).
With respect to Claim 2, Ayinde explains initial settings may be automatically determined based on inputs about the user (e.g. body type; Paragraphs [0020]-[0022]) and machine learning models used to assess image quality are trained with respect to “particular groups” (Paragraphs [0043]). Thus, one skilled in the art would have been motivated to have used different threshold values for different groups in order to optimize image settings across groups of people.
As for Claim 3, Ayinde discloses where an optimized image is evaluated based on a region of interest in the ultrasound images (e.g. heart, lungs, etc.; Paragraph [0049]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are not persuasive. Regarding the 35 U.S.C. 103 rejection of Claim 1, Applicant argues amended claim 1 recites a step to notify the user that the second evaluation value does not exceed the predetermined threshold despite the image quality parameter having been changed to generate the second ultrasound image and the cited references fail to disclose or suggest the features recited in the amended claims (REMARKS, Page 5). Applicant asserts Ayinde fails to disclose a notification to a user, Kustra only notifies the user that the evaluation value of the quality of an ultrasound image is below the threshold value (REMARKS, Page 6) and concludes “…the information to be notified completely differs between the amended claims and Kustra” (REMARKS, Page 6). Examiner respectfully disagrees and in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains the combination of references disclose all features in the amended claims. As set forth above, Ayinde’s discloses an ultrasound diagnostic system and processing means to generate a first image, evaluate the quality of the image, change settings, reimage using the changed settings. Importantly, Ayinde makes it clear that one or more additional setting improvement cycles are performed on subsequently generated images (Paragraph [0046]). Thus, Ayinde evaluates the quality of every image in the optimization loop in its broadest reasonable interpretation. The proposed modification is to insert Ghani’s quality threshold score and Kustra’s notification into each setting improvement cycle in order to alert the user of poor image quality for every imaging cycle. Such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143). Claim 6 follows the same fact pattern.
Thus, the rejections have been maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Publication No. 2021/0192720 to Annangi et al. “Annangi” which discloses determining if an ultrasound image meets a quality threshold (Paragraphs [0050]-[0051]; Also Fig. 4-5).
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All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797
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