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 § 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, 5-15, 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.
An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicants may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted). This can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015), see MPEP § 2161(I).
With regards to Claim 1, the claim now recites “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 explain the steps/procedure for performing the “detecting a plurality of anatomical landmarks,” 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, the instant specification fails to describe what a dynamic motion model of the fetal heart is and fails to disclose how the said motion model detects the plurality of landmarks. One of ordinary skill in the art would not deem the instant specification having sufficient detail so that they could understand how the inventor intended the function to be performed.
Similarly, the instant specification fails to provide written description support “building a model of the fetal heart based on the detected or tracked plurality of anatomical landmarks across the group of ultrasound images.” As detailed in the previous Action, the instant specification fails to provide any details regarding the “means” for generating the fingerprint associated with the fetal heart model. 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.
Since the instant specification fails to provide a finite sequence of steps for performing the “detecting a plurality of anatomical landmarks of the fetal heart within an ultrasound image of the group of ultrasound images” & “building a model of the fetal heart based on the detected or tracked plurality of anatomical landmarks across the group of ultrasound images” 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.
Allowable Subject Matter
Claims 1, 5-15, & 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.
Response to Arguments
Applicants’ arguments filed 8 September 2026 have been fully considered but they are not persuasive.
In particular, Applicant contends that the claims meet the written description requirement under 35 U.S.C. 112(a). In support Applicant argues that “tracking across a group of ultrasound images is performed together with detecting within an ultrasound image, and this is thoroughly described in the application and drawings as filed.” Applicant purports that ¶ [0052, 0056, 0063, 0078, 0115-0120, 0138] along with Claim 1 & 12 as originally filed provides the requisite written description support. The Office agrees in part. However, while instant specification provides support for the results of the said algorithm, i.e. genus, the instant specification fails to provide written description support because it fails to support the scope of the genus: generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed” (MPEP § 2161.01(I)).
In that vein, Applicant also argues that “The written-description inquiry is therefore whether the application reasonably conveys possession of landmark detection, landmark tracking, and model generation from tracked landmarks, not whether a particular implementation algorithm is disclosed. The automatic detection within an ultrasound image is taught as a sequence of steps at, for example, paragraph [0116].” The Office disagrees. MPEP § 2161.01(I) is clear regarding computer implemented functional language: “The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” The sequence of steps Applicant mentions are results of algorithms which are executed in succession. The algorithmic steps to achieve each of said results must be described such that one of ordinary skill in the art would understand how the inventor achieves their intended result. One of ordinary skill in the art would recognize that some description requiring a particular implementation is required to meet this standard. In other words, one of ordinary skill in the art would expect a 1:1 correspondence between the inputs of the algorithm and the outputs. For example, one of ordinary skill in the art would have to achieve the exact results as Applicant utilizing ANY landmark detection, landmark tracking, model generation from track landmarks, and fingerprinting algorithm regardless of how they are implemented. However, these algorithmic steps are not trivial steps and require a specific implementation to achieve the intended results of detecting anatomical landmarks in fetal hearts, tracking said landmarks, generating a model therefrom, and fingerprint generation. Applicant is reminded that the MPEP § 2161.01(I) states that “It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement,” i.e. a particular implementation in which the scope of the genus is adequately supported. For at least this reason, Applicant’s argument is not persuasive.
It should be appreciated that the PTAB decision of 12 March 2026 also agreed that the “This is an insufficient description of how to "automatically detect an anatomical landmark of the fetal heart within an ultrasound image of the group of ultrasound images with a dynamic motion model of the fetal heart," as recited in claim 1 and substantially recited in claim 15.” Regardless of whether the detection is automatic or not, the instant specification fails to provide sufficient description of how the detection is achieved.
Conclusion
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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 extension fee 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 date of this final action.
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 8:00 am - 4:00 pm (CST).
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, Keith M. Raymond can be reached on (571) 270-1790. 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.
/ASHISH S. JASANI/Examiner, Art Unit 3798
/JOEL LAMPRECHT/ Primary Examiner, Art Unit 3798
Prosecution Insights