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 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 5/06/2026 has been entered.
Response to Amendment
The rejection under 35 U.S.C. 103 has been withdrawn in light of the Decision on Appeal of 12 March 2026.
The rejection under 35 U.S.C. 112(a) has been withdrawn in light of the claim amendments of 5 May 2026.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-16, & 18-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In particular, Claim 1 now recites “automatically detecting a plurality of anatomical landmarks of the fetal heart within an ultrasound image of the group of ultrasound images”; however, the instant specification fails to show possession of automatic detection of anatomical landmarks within an ultrasound image of the group of ultrasound images because the instant specification does not describe “the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention” as laid out in MPEP § 2163.02. More specifically, the instant specification discloses in ¶ [0115-0116] that:
In step 140, an anatomical landmark of the fetal heart is detected within an ultrasound image of the group of ultrasound images.
For example, anatomical landmark may be identified based on a model of pose points (also referred to as key points in a 2D image) of the view of the fetal heart. The desired point in the cardiac cycle for a given clinical view may be selected from the group of ultrasound images by tracking the pose points in real time. The anatomical landmarks associated with the pose points may include, for example, aortic and ductal arches, inferior and superior vena cava, trachea and the like. Further, a plurality of anatomical landmarks may be taken into account and detected within the ultrasound image.”
However, the instant specification is completely silent to the pose point tracking method being automatic. It should be appreciated that the previously mentioned PTAB decision establishes the “dynamic model” method of automatically detecting anatomical landmark as disclosed in ¶ [0118] is performed across a group of ultrasound images. The dynamic model method cannot provide written description support for a method performed “within an ultrasound image of the group of ultrasound images.” Therefore, one of ordinary skill in the art would not recognize that the automatic nature of the dynamic model method would apply to the poise point tracking method. Accordingly, the instant specification does not convey with reasonable clarity how one of ordinary skill in the art, as of the filing date sought, can show the inventor was in possession of automatically detecting a plurality of anatomical landmarks of the fetal heart within an ultrasound image of the group of ultrasound images. Accordingly, Claim 1 fails to meet the written description requirement of 35 U.S.C. 112(a).
Moreover, the instant specification fails to fails to explain the steps/procedure for performing the “automatic detect[ion],” i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. More specifically, with respect to the poise point tracking method of ¶ [0116], the instant specification only disclosed that the poise points are associated with anatomical landmarks and that the “plurality of anatomical landmarks may be taken into account and detected within the ultrasound image.” The instant specification is completely silent as to how the anatomical landmark are detected, let alone automatically detected, within the poise point tracking method. Accordingly, the instant specification fails to provide a finite sequence of steps for performing the step of “automatically detecting a plurality of anatomical landmarks of the fetal heart within an ultrasound image of the group of ultrasound images,” thus, the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Claim 1 also recites “building a model of the fetal heart based on the detected or tracked plurality of anatomical landmarks across the group of ultrasound images”; however, the instant specification fails to explain the steps/procedure for building the model, i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. More specifically, in ¶ [0122] the instant specification discloses that:
“The method provides a means of generating a fingerprint of the fetal heart during the live scan. The fingerprint may be built from key anatomical landmarks detected in real time on the structure of the fetal heart from live ultrasound data. In this way, a model of the fetal heart may be built, from which several parameters such as biometrics, structural and functional anomalies can be detected. The model can be used to detect optimal scan planes and fetal screening views during routine ultrasound scanning of the fetal heart.”
However, the instant specification fails to provide any details regarding the “means” for generating the fingerprint. While the instant specification discloses that the “[T]he fingerprint may be built from key anatomical landmarks detected in real time on the structure of the fetal heart from live ultrasound data,” the instant specification fails to disclose how the means builds the fingerprint in sufficient manner such that one of ordinary skill in the art understands the inventors’ intended functionality. Accordingly, the instant specification fails to provide a finite sequence of steps for performing the step of “building a model of the fetal heart based on the detected or tracked plurality of anatomical landmarks across the group of ultrasound images,” thus, the aforementioned claim fails to meet the written description requirement under 35 U.S.C. 112(a).
Claim 15 recites similar limitations and are rejected under the same rationale as claim 1. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
With regards to Claim 2, the claim now recites “detecting and tracking the plurality of landmarks across the group of ultrasound image. However, as noted above, the poise point tracking method is only disclosed to performed “within an ultrasound image of the group of ultrasound images,” whereas the dynamic model method is performed “across the group of ultrasound images.” It appears that Applicant is combining two distinct methods for detecting anatomical landmarks; however, such a combination neither explicitly disclosed or inherently disclosed. Accordingly, Claim 2 fails to meet the written description requirement of 35 U.S.C. 112(a).
Claim 16 recites similar limitations and are rejected under the same rationale as claim 2. Dependent claims are rejected by virtue of their dependency to abovementioned claims.
Allowable Subject Matter
Claims 1-2, 5-16, & 18-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: as determined by the PTAB in the decision of 12 March 2026, neither Jin, Yeo, or Raju, alone or in combination teaches of comparing the plurality of ultrasound images to a predefined clinical view.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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