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 .
Drawings
The drawings were received on 1/3/2025. These drawings are accepted for examination.
Claim Rejections - 35 USC § 112
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 1-13 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). Applicant 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 Claims 1, 9, and 11-12, the claim recites “…generate an estimated three-dimensional ultrasound image of the anatomical structure at the first time frame by processing at least the first set of two-dimensional ultrasound images and the three-dimensional ultrasound image of the anatomical structure using a machine-learning algorithm.”; however, the instant specification fails to explain the steps/procedure for performing the generation, i.e. computer function, in sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function/algo to be performed. More specifically, Page 2 Line 10-15, Page 3 Line 10-18, 22-28, 36-Page 4 Line 15, and page 4 Line 17-26 describe possible embodiments which could be utilized by the instant invention. Turning to the description of those embodiments, the instant specification describes that the “suitable machine-learning algorithms for being employed in the present invention will be apparent to the skilled person and cites SVMs, Naïve Bayesian modes, and logistic regressions as examples, describes that training algorithms is well-known (page 9 Line 1-21) and describes that methods of generating simulated 2d images from a 3d image are also known to one of ordinary skill in the art, without providing specific input data, output data, and ground truthing/training which is utilized for the instant reduction to practice. While it is appreciated that Applicant cites how well-known each step of the claimed method is to one of ordinary skill in the art, the type of training that is expressly employed by the preferred embodiment, what data is input, and what is output is lacking from the instant recitation and claims.
While the instant claim language appears to lack the sufficient detail to perform the functions as recited, it is believed that the generator/generation steps in the network, in combination with the specific disclosure of the training and input/output in the instant specification could overcome this rejection and provide sufficient basis for the instant invention, but a proper recitation of a combination of instant claims 1, 5, as well as elements of the training recitation would be required to provide the complete picture of the instant invention.
Since the instant specification fails to provide a finite sequence of steps for performing the “…generate an estimated three-dimensional ultrasound image of the anatomical structure at the first time frame by processing at least the first set of two-dimensional ultrasound images and the three-dimensional ultrasound image of the anatomical structure using a machine-learning algorithm.”; the aforementioned claim(s) fails to meet the written description requirement under 35 U.S.C. 112(a).
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 1-13 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. As mentioned above in the 112(a) rejection, the instant recitation is indefinite with respect to the recited processing and generation steps for providing a 3d ultrasound image by processing a first set of 2d images and the 3d image of the anatomical structure.
While the instant claim language appears to lack the sufficient detail to perform the functions as recited, it is believed that the generator/generation steps in the network, in combination with the specific disclosure of the training and input/output in the instant specification could overcome this rejection and provide sufficient basis for the instant invention, but a proper recitation of a combination of instant claims 1, 5, as well as elements of the training recitation would be required to provide the complete picture of the instant invention (including the temporal relationships between elements which allow for the generation(s)).
Allowable Subject Matter
Claims 1-13 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, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance: While cited US 12,541,893 discloses and teaches multi-plane ultrasound image generation for roadmap images via registration and motion derivation, the reference, alone or in combination with Applicant’s cited relevant art fail to disclose the generation of a 3d ultrasound image for a first time frame on the basis of a 2d image at first time frame and 3d ultrasound image at another, third time frame (and from at least two different oriented planes). The 3d scout images in a feed-forward processing enable later processing (or the 2d=>3d processing in the case of cited Yoo, cited Gogna (‘618), or Funka-Lea) but the generation of a 3d ultrasound image for a first time frame on the basis of a 2d image at first time frame and 3d ultrasound image at another, third time frame are not covered by the disclosures.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798
