CTNF 18/858,836 CTNF 87849 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority Acknowledgement is made of Applicant’s claim of this application being a National Stage of the International Application No. PCT/EP2023/060717, filed on April 25, 2023, and claim of priority and benefit of European Patent Application No. EP22177525.7, filed on June 7, 2022 and Chinese Patent Application No. PCT/CN2022/089501, filed on April 27, 2022. Information Disclosure Statement The information disclosure statement (“IDS”) filed on October 22, 2024 was reviewed and the listed references were noted. Drawings The 6-page drawings have been considered and placed on record in the file. 12-151 AIA 26-51 12-51 Status of Claims Claims 1-15 are pending. Claim Objections 07-29-01 AIA Claim s 2-6, 10, and 12 are objected to because of the following informalities: placing a comma (“,”) is required before the term “wherein” in these claims . Appropriate correction is required. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter as follows. Claim 15 is directed to a "computer program product comprising a computer readable medium ...". The specification is silent with respect to the definition of a "computer readable medium." The broadest reasonable interpretation of a claim drawn to a computer readable medium typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See Subject Matter Eligibility of Computer Readable Media, 1351 OG 212 (26 Jan 2010). See MPEP 2111.01. Signals are nothing but the physical characteristics of a form of energy, and as such is nonstatutory natural phenomena. See, e.g., In re Nuitjen, 500 F. 3d 1346, 1357 (Fed. Cir. 2007)(slip. op. at 18)("A transitory, propagating signal like Nuitjen's is not a process, machine, manufacture, or composition of matter.' ... Thus, such a signal cannot be patentable subject matter."). Thus, Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. In order to overcome this rejection, Applicant may insert the term “non-transitory” before the computer readable medium. Therefore, the claim may be amended as: “A computer program product comprising a non-transitory computer readable medium, …”. Claim Rejections - 35 USC § 101 07-04-01 AIA 07-04 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite a method, an apparatus, and a program directed to analysis of an ultrasound image feed, detecting a target tissue, and highlighting the target tissue on the display in each consecutive ultrasound images. With respect to method Claim 1: Step 1: With regard to Step 1, the instant claim is directed to a method; and therefore, the claim is directed to one of the statutory categories of invention. Step 2A, Prong One: With regard to 2A, Prong One, the limitation “detecting a target tissue in a first image of the US image feed”; “sending a message to a display to cause the display to highlight the target tissue in the first image on the display, if the target tissue has a visibility above a first visibility threshold”, “and causing the display to highlight the target tissue in each consecutive US image subsequent to the first image in which the target tissue is visible in the US image feed” as drafted, recite an abstract idea, such as a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind of a person or by using a pen and paper (a copy of a medical image of a patient), i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). That is, a medical technician/practician may review an initial ultrasound image of a target tissue, i.e., a lesion, mark/highlight the target on the display of the ultrasound system, and follow the highlighted target as it appears in the consecutive ultrasound image frames. This is the concept that falls under the grouping of abstract ideas mental processes for the detection/decision (evaluation, judgement, and/or opinion of an analyst). Step 2A, Prong Two: The 2019 PEG defines the phrase “ evaluate whether the claim recites additional elements that integrate the exception into a practical application of the exception ”. Therefore, additional elements, or a combination of additional elements in the claim, are required to apply, rely on, or use the judicial exception. In the instant claim, there are no additional limitations apply, rely on, or use the judicial exception as an indication of integration of the judicial exception into a practical application. Accordingly, the claim recites an abstract idea. Step 2B: Because the claim fails under Step 2A, the claim is further evaluated under Step 2B. The claim herein does not include additional elements that are sufficient to amount to significantly more than the judicial exception, because as discussed above with respect to integration of the abstract idea into practical application, no additional limitations are recited. Accordingly, the claim fails under Step 2B, as well. Therefore, Claim 1 is not patent eligible. In addition, the elements of independent Claims 13 and 15 are analyzed in the same manner as Claim 1. The additional elements recited in these claims, i.e., “a processor”, “a memory”, and “a computer program product” are all regarded as mere generic computer components, and may not provide an inventive concept or significantly more than the identified abstract idea. Therefore, independent Claims of the instant application are not patent eligible. Finally, dependent Claims 2-12 and 14 recite additional elements that are not considered significantly more that the identified abstract idea, and therefore, rejected under this section of the rules. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 1-3, 5-7, 9, and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Millioni De Carvalho et al. (US 2021/0259649 – IDS – hereinafter referred to “Millioni”) in view of Shawn St. Pierre (US 2021/0015447) . Consider Claim 1, Millioni discloses “A computer implemented method of analysing an ultrasound, US , image feed as part of an ultrasound examination, the method comprising: detecting a target tissue in a first image of the US image feed” (Millioni, Paragraph [0002], where the location of the target tissue (lesion) is identified. Also, Paragraph [0016] discloses the method utilized to enhance visualization of the target tissue) ; “sending a message to a display to cause the display to highlight the target tissue in the first image on the display, if the target tissue has a visibility above a first visibility threshold” (Millioni, Paragraph [0016] discloses a digital subtraction process to enhance visibility of the target tissue. Paragraph [0018] discloses a user’s defined marker, i.e., highlight, of the target tissue in the reference (first) image where the contrast is still present; i.e., visibility of the target region is above acceptable threshold ) ; “and causing the display to highlight the target tissue in each consecutive US image subsequent to the first image in which the target tissue is visible in the US image feed” (Millioni, Paragraph [0018] discloses: “The registered biopsy target position, or a previously calculated biopsy target contour, are therefore highlighted on all subsequent morphological images, allowing the procedure to continue with increased confidence. Also Millioni Fig. 8, demonstrates that the marker (highlight) will be shown on any subsequent images: PNG media_image1.png 242 356 media_image1.png Greyscale ) . Millioni relies on imaging techniques, using digital mammography (see for example, Millioni, Paragraph [0011]) to disclose the features recited and mapped above in limitations of Claim 1 of the instant application. Millioni has not been relied on to disclose use of an ultrasound imaging device. However, in an analogous field of endeavor, St. Pierre discloses The interventional procedure may require the use of an ultrasound device to visualize and locate the detected lesion” (St. Pierre, Paragraph [0002]) . Accordingly, it would have been obvious to a person of ordinary skill, before the effective filing date of the instant application, to combine Millioni with the teachings of St. Pierre to generate medical images using an ultrasound system instead of x-ray mammography. One of ordinary skill in the art would have been motivated to substitute the x-ray device of Millioni with the ultrasound of St. PIerre to obtain medical images of a target tissue and to automatically detect the lesion, and the results would have been predictable. Accordingly, the combination of Millioni and St. Pierre discloses the invention of Claim 1. Consider Claim 2, the combination of Millioni and St. Pierre discloses “A method as in claim 1 wherein the step of causing the display to highlight the target tissue in each consecutive US image subsequent to the first image in which the target tissue is visible in the US image feed, is performed even if in one or more consecutive US image the target tissue is visible with a visibility below the first visibility threshold” (Millioni, Fig. 5 shows the curve for threshold visibility and Fig. 8 shows that regardless of the visibility, the target tissue is highlighted in all subsequent images) . Consider Claim 3, the combination of Millioni and St. Pierre discloses “A method as in claim 1 wherein the step of detecting (302) a target tissue in a first image of the US image feed is performed using a machine learning model trained to detect target tissues in US images” (St. Pierre, Paragraph [0076] discloses: the ultrasound workflow tool may use image analysis or machine-learning techniques to automatically identify the lesion) . The proposed combination as well as the motivation for combining the Millioni and St. Pierre references presented in the rejection of Claim 1, apply to Claim 3 and are incorporated herein by reference. Thus, the method recited in Claim 3 is met by Millioni and St. Pierre. Consider Claim 5, the combination of Millioni and St. Pierre discloses “A method as in claim 1 wherein the step of causing the display to highlight the target tissue in each consecutive US image, subsequent to the first image, in which the target tissue is visible in the US image feed comprises: tracking the target tissue in US images subsequent to the first image in the ultrasound image feed” (Millioni, Fig. 3 and Paragraph [0019] disclose: a method for track ing a biopsy target across one or more images) . Consider Claim 6, the combination of Millioni and St. Pierre discloses “A method as in claim 1 wherein the method further comprises: grouping the first image and the consecutive US images subsequent to the first image in which the target tissue is visible, as a first group of images” (Millioni, the grouping of the target tissues in Fig. 6) . Consider Claim 7, the combination of Millioni and St. Pierre discloses “A method as in claim 6 wherein the first group of US images further comprises consecutive US images directly preceding the first image in which the target tissue is visible below the first visibility threshold” (Millioni, Fig. 6, wherein some of the images have visibility of the target tissue, which is below the threshold) . Consider Claim 9, the combination of Millioni and St. Pierre discloses “A method as in claim 1, wherein the method is performed in real-time on a live ultrasound image feed” (St. Pierre, Paragraph [0023]) . The proposed combination as well as the motivation for combining the Millioni and St. Pierre references presented in the rejection of Claim 1, apply to Claim 3 and are incorporated herein by reference. Thus, the method recited in Claim 3 is met by Millioni and St. Pierre. Consider Claim 12, the combination of Millioni and St. Pierre discloses “A method as in claim 1 wherein the US image feed comprises images of breast tissue obtained as part of a breast lesion examination” (both Millioni and St. Pierre disclose use of image data to analyze breast lesion, see for example, Millioni, Fig. 6 and Paragraph [0002], and St. Pierre, Paragraph [0021]) . Claim 13 recites an apparatus with elements corresponding to the steps of the method recited in Claims 1. Therefore, the recited elements of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Millioni and St. Pierre references, presented in rejection of Claim 1, apply to this claim. In addition, the combination of Millioni and St. Pierre discloses a memory and a processor to act on the instructions stored in the memory (see for example, Millioni, Paragraphs [0024] and [0026]) . Consider Claim 14, the combination of Millioni and St. Pierre discloses “An ultrasound, US, imaging system comprising the apparatus of claim 13 and a display to display the ultrasound image feed; and wherein the message and the further messages cause the display to highlight the target tissue in the first image on the display and in the consecutive US images” (Millioni, Fig. 8:802, 806, and 808) . Claim 15 recites a computer program product comprising a computer readable medium storing instruction corresponding to the steps of the method recited in Claims 1. Therefore, the recited instructions of this claim are mapped to the proposed combination in the same manner as the corresponding steps in its corresponding method claim. Additionally, the rationale and motivation to combine the Millioni and St. Pierre references, presented in rejection of Claim 1, apply to this claim. In addition, the combination of Millioni and St. Pierre discloses a computer readable medium (see for example, Millioni, Paragraph [0033]) . 07-21-aia AIA Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Millioni De Carvalho et al. (US 2021/0259649 – IDS – hereinafter referred to “Millioni”) in view of Shawn St. Pierre (US 2021/0015447), and in further view of Kenta Inoue (US 2022/0378403, w/ EFD of May 25, 2021) . Consider Claim 4, although the combination of Millioni and St. Pierre discloses tracking the target above certain visibility threshold in the first image and highlighting it in the subsequent images (as shown in analysis of Claim 1), this combination is not relied on to disclose “highlight the target tissue in the first image on the display, is performed in response to the machine learning model detecting the target tissue with a confidence above the threshold confidence level.” However, in an analogous field of endeavor, Inoue discloses “In response to detection of a lesion site, lesion site information is output from the image analyzer unit 28. The lesion site information includes a lesion site detection flag, a confidence level of the lesion site, position information (position data) of the lesion site, and size information (size data) of the lesion site. For each set of display frame data, lesion site information is transmitted from the image analyzer unit 28 to the mark generator unit 30” (Inoue, Paragraph [0044]) . Accordingly, it would have been obvious to a person of ordinary skill, before the effective filing date of the instant application, to combine the combination of Millioni and St. Pierre with the teachings of Inoue to add a confidence level of the identified lesion site to the machine learned target detection of St. Pierre. One of ordinary skill in the art would have been motivated to combine the Millioni, St. Pierre, and Inoue to establish a method of target detection in a medical image with high confidence. Accordingly, the combination of Millioni, St. Pierre, and Inoue discloses the invention of Claim 4 . 07-21-aia AIA Claim s 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Millioni De Carvalho et al. (US 2021/0259649 – IDS – hereinafter referred to “Millioni”) in view of Shawn St. Pierre (US 2021/0015447), and in further view of Chang et al. (US 2013/0310690) . Consider Claim 8, the combination of Millioni and St. Pierre is not relied on to disclose “A method as in claim 6 or 7 further comprising: buffering the US image feed; and upon receiving a request from a user, causing the display to replay a portion of the buffered US image feed and highlight a time period in the portion of the buffered US image feed on a time bar that corresponds to the first group of images.” However, in an analogous field of endeavor, Chag discloses “ stor age module for recording all the breast ultrasound images as well as scanning positions and scanning angles thereof; and a tumor image positioning and stor age module for recording at least one suspicious tumor ultrasound image as well as a scanning position and a scanning angles thereof “ (Chang, Paragraphs [0014] and [0042], the doctor may access the information regarding the tumor in the future) . Accordingly, it would have been obvious to a person of ordinary skill, before the effective filing date of the instant application, to combine the combination of Millioni and St. Pierre with the teachings of Chang to store the information regarding the target tissue for future access. One of ordinary skill in the art would have been motivated to combine the Millioni, St. Pierre, and Chang to create an target detection and storage method for future analysis of the ultrasound images. Accordingly, the combination of Millioni, St. Pierre, and Change discloses the invention of Claim 8. Consider Claim 10, the combination of Millioni and St. Pierre is not relied on to disclose “A method as in claim 9 wherein the step of: sending a message to a display, causes the display to display an alert that a live detection has occurred.” However, in an analogous field of endeavor, Chag discloses “the suspicious tumor alert module 17 issues a suspicious tumor alert 171 to remind the doctor of the suspicious tumor after identifying the suspicious tumor ultrasound image 123” (Chang, Paragraph [0046]) . Accordingly, it would have been obvious to a person of ordinary skill, before the effective filing date of the instant application, to combine the combination of Millioni and St. Pierre with the teachings of Chang to issue an alert when a live detection has occurred. One of ordinary skill in the art would have been motivated to combine the Millioni, St. Pierre, and Chang to create an automated target detection using an ultrasound system, which notifies a technician of a successful detection of a suspicious lesion (Change, Paragraph [0017]) . Accordingly, the combination of Millioni, St. Pierre, and Change discloses the invention of Claim 10 . 07-21-aia AIA Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Millioni De Carvalho et al. (US 2021/0259649 – IDS – hereinafter referred to “Millioni”) in view of Shawn St. Pierre (US 2021/0015447), and in further view of Menachem Halmann (US 2012/0157844) . Consider Claim 11, the combination of Millioni and St. Pierre discloses the step of highlighting the target tissue on a display as showed in analysis of Claim 1. Although including multiple displays to show the results of a medical examination is a simple design choice, the combination of Millioni and St. Pierre is not relied on to disclose use of two displays for the method using ultrasound images. However, in an analogous field of endeavor, Halmann discloses a method to illustrate ultrasound data at independent displays (Halmann, Paragraph [0021]) . Accordingly, it would have been obvious to a person of ordinary skill, before the effective filing date of the instant application, to combine the combination of Millioni and St. Pierre with the teachings of Halmann to use two displays to show different images of the same examination results. One of ordinary skill in the art would have been motivated to combine the Millioni, St. Pierre, and Halmann to create an ultrasound method of a patient’s examination having ultrasound data illustrated in a different manner depending on specific needs (Halmann, Paragraph [0021]) . Accordingly, the combination of Millioni, St. Pierre, and Halmann discloses the invention of Claim 11. Conclusion and Contact Information 07-96 AIA The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure : St. Pierre et al. (US 2023/0103969) . Any inquiry concerning this communication or earlier communications from the examiner should be directed to Siamak HARANDI whose telephone number is (571)270-1832. The examiner can normally be reached Monday - Friday 9:30 - 6:00 ET. 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, Amandeep Saini can be reached on (571)272-3382. 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. /Siamak Harandi/Primary Examiner, Art Unit 2662 Application/Control Number: 18/858,836 Page 2 Art Unit: 2662 Application/Control Number: 18/858,836 Page 3 Art Unit: 2662 Application/Control Number: 18/858,836 Page 4 Art Unit: 2662 Application/Control Number: 18/858,836 Page 5 Art Unit: 2662 Application/Control Number: 18/858,836 Page 6 Art Unit: 2662 Application/Control Number: 18/858,836 Page 7 Art Unit: 2662 Application/Control Number: 18/858,836 Page 9 Art Unit: 2662 Application/Control Number: 18/858,836 Page 10 Art Unit: 2662 Application/Control Number: 18/858,836 Page 11 Art Unit: 2662 Application/Control Number: 18/858,836 Page 12 Art Unit: 2662 Application/Control Number: 18/858,836 Page 13 Art Unit: 2662 Application/Control Number: 18/858,836 Page 14 Art Unit: 2662 Application/Control Number: 18/858,836 Page 15 Art Unit: 2662 Application/Control Number: 18/858,836 Page 16 Art Unit: 2662 Application/Control Number: 18/858,836 Page 17 Art Unit: 2662
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