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 .
Election/Restrictions
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 26 Jun 2026.
Applicant argues, see pg. 2, filed 26 Jun 2026, with respect to the Restriction Requirement of 22 Apr 2026, that “The (non-elected) method claims do not recite a materially different way of practicing the invention; rather they recite the training and use of the neural network model that enables the (elected) system of Group I to perform the claimed identification and setup functions”. However, the Examiner respectfully disagrees. As previously explained in the Restriction Requirement of 22 Apr 2026, the non-elected method claims at least require training a neural network model, which is classified in G06N3/08 and is not required by the elected system claims. Additionally, the non-elected method claims do not require identifying an anatomy in live images through a deep learning: a deep learning is a specific subset of neural network. Also, “installing a neural network model in a computer-based system” as recited in the non-elected method claims requires at least unpacking files associated with the neural network model, which is not required for a model that is stored in a storage. Therefore, the elected system claims and the non-elected methods are indeed materially different. Furthermore, there indeed is a serious search and examination burden when the system claims and the method claims require at least a different field of search based on different classifications; different prior arts need to be applied to the system claims vs. the method claims; and the system claims and the method claims are likely to raise different non-prior art issue under 35 U.S.C. 101 and 35 U.S.C. 112. See the Restriction Requirement of 22 Apr 2026. The Restriction Requirement of 22 Apr 2026 is hereby being maintained.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with all conditions for receiving the benefit of an earlier filing date of 19 Oct 2016 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 22 Jul 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
Status of Claims
Claims 1-9 and 16 are currently under examination. See the Election/Restrictions above regarding the withdrawn claims 10-15.
Claim Objections
Claims 1 and 7 are objected to because of the following informality:
“identify(ing) anatomy” should read “identify(ing) an anatomy” (claim 1);
“displays control made active” should read “displays a control made active” (claim 7).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-9 and 16 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.
Claim 1 recites the limitation “an image processor, coupled to the probe, which is configured to produce ultrasound images”. It is unclear whether “ultrasound images” recited in the limitation is the same or different from “ultrasound images” recited in the preamble of the claim. Claims 2-9 and 16 inherit the deficiency by the nature of their dependency on claim 1. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “an image processor, coupled to the probe, which is configured to produce the ultrasound images”.
Claim 1 recites in the preamble “identifying anatomy in ultrasound images using deep learning” and the limitation “identify anatomy in the ultrasound images through a deep learning technique” in the body of the claim. It is unclear whether the anatomy identified in the preamble is the same as that in the body of the claim. Also, it is unclear whether “a deep learning technique” recited in the body of the claim is the same or different from “deep learning” recited in the preamble. Claims 2-9 and 16 inherit the deficiency by the nature of their dependency on claim 1. For the purposes of the examination, the limitation in the body of the claim is being given a broadest reasonable interpretation as “identify the anatomy in the ultrasound images through the deep learning”.
Claim 1 recites the limitation “a settings controller configured to obtain imaging system settings and activate user controls/or an exam of the identified anatomy in response to the identification of the anatomy by the neural network model”. It is unclear what “/or” means. Claims 2-9 and 16 inherit the deficiency by the nature of their dependency on claim 1. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “a settings controller configured to obtain imaging system settings and activate user controls for an exam of the identified anatomy in response to the identification of the anatomy by the neural network model”.
Claim 2 recites the limitation “wherein the neural network model is further configured to identify the view of anatomy of an ultrasound image”. The antecedent basis for “the view” is unclear. Claim 3 inherits the deficiency by the nature of its dependency on claim 2. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the neural network model is further configured to identify a view of anatomy of an ultrasound image”.
Claim 4 recites the limitation “wherein the ultrasound system further comprises a plurality of user controls, wherein the setting of one or more of the controls is done in response to identification of the anatomy in an ultrasound image”. First, it is unclear whether “a plurality of user controls” in the limitation is the same or different from “user controls” already recited in claim 1, to which claim 4 depends. Second, the antecedent bases for “the setting” and “the controls” are unclear. In particular, it is unclear whether “the controls” is referring to “user controls” recited in claim 1 or “a plurality of user controls” recited in claim 4. Claims 5-7 inherit the deficiency by the nature of their dependency on claim 4. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the ultrasound system further comprises the user controls, wherein setting of one or more of the user controls is done in response to identification of the anatomy in an ultrasound image”.
Claim 5 recites the limitation “wherein the setting of one or more of the controls is done in response to identification of the view of the anatomy in an ultrasound image”. The antecedent basis for “the view” in the limitation is unclear. In particular, claim 2 recites “the view of anatomy”, but claim 5 does not depend on claim 2 and rather depends on claim 4. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the setting of one or more of the controls is done in response to identification of a view of the anatomy in an ultrasound image”.
Claim 7 recites the limitation “wherein the user control display further displays control made active in response to identification of the anatomy in an ultrasound image”. First, the limitation recites a method within the apparatus claim 7, mixing statutory categories. Second, it is unclear whether “control made active” is the same or different from “user controls” that are activated in claim 1, to which claim 7 depends. For the purposes of the examination, the limitation is being given a broadest reasonable interpretation as “wherein the user control display is further configured to display the user controls made active in response to identification of the anatomy in an ultrasound image”.
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.
Claims 1-3, 7-9, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 respectively of U.S. Patent No. 12383236 – hereinafter referred to as ‘236. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the instant application are anticipated by the patented claims.
Patented claim 1 of ‘236 recites “An ultrasonic diagnostic imaging system for identifying anatomy in ultrasound images using deep learning comprising: an ultrasound probe adapted to acquire live ultrasound image signals; an image processor, coupled to the probe, which is adapted to produce ultrasound images; a neural network model stored in a non-transitory computer-readable memory and adapted to receive the ultrasound images and to identify anatomy in the ultrasound images through a deep learning technique; a user control settings controller coupled to the neural network model, the settings controller configured to obtain imaging system settings and activate user controls for an exam of the identified anatomy in response to the identification of the anatomy by the neural network model; and a display adapted to display the ultrasound images, … and the identified anatomy.” Therefore, patented claim 1 of ‘236 anticipates the invention of claim 1 of the instant application.
The following is a mapping between the claims of the instant application under examination and the patented claims of ‘236:
Claims of Instant Application
Patented Claims of ‘236
1
1
2
2
3
3
4
-
5
-
6
-
7
4
8
5
9
6
16
7
.
Allowable Subject Matter
Claims 1-9 and 16 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and Double Patenting set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
When the claims are considered as a whole, prior arts do not disclose, neither individually nor in combination, at least a neural network model configured to identify an anatomy in ultrasound images using a deep learning and a user control settings controller coupled to the neural network model, the settings controller configured to obtain imaging system settings and activate user controls for an exam of the identified anatomy in response to the identification of the anatomy by the neural network model; and a display adapted to display the ultrasound images and the identified anatomy. In particular, Pagoulatos et al. (US PG Pub No. 2017/0262982) discloses at least a neural network model configured to identify anatomy in ultrasound images through a deep learning ([0048]-[0050]), but does not disclose at least a user control settings controller configured to obtain image system settings and activated user controls for an exam of identified anatomy in response to the identification of the anatomy by the neural network model. While Rothberg et al. (US PG Pub No. 2017/0360412) discloses activating user controls following the operator identification of an anatomy (Fig. 7E-H and [0217]-[0219]), Rothberg et al. does not disclose activating controls in response to, or based on, the anatomy identified by the neural network model (see pg. 8-9 of PTAB Decision of 26 Feb 2025 for parent application 15/782,923 (now US Patent No. 12383236): “there is no disclosure in Rothberg that such user controls are activated in any way by the system recognizing imaged anatomy. What the Rothberg system activates based on recognized imaged anatomy are user guide instructions, as noted above”).
The technical advantage of the claimed invention is to provide “automation of setting up an ultrasound system for a particular exam … (by) an ultrasound system to identify anatomy in an image through processing by a neural network model … (and) The identification of the anatomy is used to annotate the image, or set up the user controls on the ultrasound system for the conduct of an exam of the identified anatomy (pg. 2, line 15 – pg. 4, line 2 of the specification of the instant application).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hedlund et al. (US Patent Pub No. 2017/0143312) discloses obtaining imaging system settings for an exam of identified anatomy in response to an identification of the anatomy (see at least Fig. 3 and [0055]-[0058]);
Chen et al. (Chen et al. (02 Oct 2016). Iterative Multi-domain Regularized Deep Learning for Anatomical Structure and Detection and Segmentation from Ultrasound Images. MICCAI 2016, Part II, LNCS 9901, pp. 487-495. Doi: 10.1007/978-3-319-46723-8_56. A copy attached to this Office action) discloses displaying ultrasound images annotated with identified anatomy in response to the identification of the anatomy by a neural network model (Fig. 3: detection and segmentation results from different neural network architectures (circles) and 3.4 Evaluation and Comparison); and
Sharma et al. (US PG Pub No. 2018/0071452) discloses at least automatically determining imaging parameters for a region of interest (see at least Fig. 2) and identifying the region of interest in an ultrasound image using deep learning ([0087]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Younhee Choi whose telephone number is (571)272-7013. The examiner can normally be reached M-F 9AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Y.C./Examiner, Art Unit 3797
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
09/08/2026
Prosecution Insights