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
Applicant's election with traverse of Invention II species V in the reply filed on 11/18/2025 is acknowledged. The traversal is on the ground(s) that “the restriction has not been properly established under MPEP 806.05(d)” because “Inventions I-II substantially overlap in scope”. This is not found persuasive because the claims are to different scopes. Invention I is to displaying a contrast enhanced breast image and adjusted BPE image whereas Invention II is to outputting an adjusted contrast enhanced breast image to a display whereas Invention III is to outputting a recombined image based on low energy x-ray image and high energy x-ray image to a display. Furthermore, these different scopes require a serious search burden by requiring searching different main-groups/sub-groups and employing different search strategies and search queries. Therefore the restriction of between Inventions I-III is deemed proper.
Applicant further argues that the restriction between Species V-VIII of elected Invention I has not been properly established under the MPEP. Applicant argues that the overlap between species is not addressed. However, Species V is defined respectively as increase or decrease a contrast of the ROI or highlight the ROI, whereas Species VI is defined respectively as adjust the ROI to a first and second level, whereas Species VII is defined respectively as wherein the BPE and suspicious area algorithms are machine learning algorithms, whereas Species VIII is defined respectively as wherein the BPE and suspicious area algorithms are included in a combined BPE and suspicious area algorithm.
The requirement is still deemed proper and is therefore made FINAL, with the understanding that rejoinder is possible upon allowance. For purposed of examination claims 1-9, 13-16, and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Inventions I and III and nonelected species VI-VIII.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/24/2023 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) has/have been considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Contrast Enhanced Breast Imaging With An Adjusted Background Parenchymal Enhancement Region of Interest.
Claim Objections
Claim 17 objected to because of the following informalities: “an output of suspicious area algorithm” should be “an output of the suspicious area algorithm”. 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.
Claim 12 recites the limitation "a corresponding contrast enhanced breast image without enhanced contrast" in lines 2-3. This wording is unclear. For purposes of examination examiner interprets the claim to mean that the original contrast enhanced image is output with the adjusted image as in Figs. 6 and 7 of the instant application.
Claim Rejections - 35 USC § 101
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 10-12 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed
to an abstract idea (a mental process) without significantly more. The flow chart in MPEP 2106,
Subject Matter Eligibility Test For Products and Processes, will be referred to establish ineligible
subject matter.
Regarding claim 10, Step 1: The claim(s) recite(s) “an image processing system” which would be categorized as a product under the 4 statutory categories. See MPEP 2106.03. Step 2A Prong One: However, the claim is further directed to an abstract idea (a mental process) of distinguish a region of interest (ROI) of a contrast enhanced breast image corresponding to background parenchymal enhancement (BPE) using a BPE algorithm that has been trained using image pairs including a ground truth BPE segmented image and a suspicious area algorithm that has been trained using image pairs including a ground truth suspicious area segmented image, which can be done mentally. For example, a clinician that reads contrast enhanced images would be trained over time with examples of suspicious areas and BPE areas. See MPEP 2106.04 subsection II and 2106.04(a)(2) subsection III. Further, “adjust, using an adjustment algorithm, the ROI of the contrast enhanced breast image corresponding to BPE” is considered a mental process. The BRI of this claim limitation includes windowing the full image. This is common practice of clinicians with the use of a generic viewer of medical images on a computer and is therefore considered a mental process with the use of a generic computer aid. See MPEP 2106.04 subsection II and 2106.04(a)(2) subsection III. Step 2A Prong Two: Additional elements include computer elements (a processor, a memory, and a display), and output the adjusted contrast enhanced breast image to the display device. With regards to the computer elements MPEP 2106.04 (A2) III. Metal Process establishes that the addition of a generic computer-implemented steps does not integrate the judicial exception into a practical application. With regards to output the adjusted contrast enhanced breast image to the display device this is considered is insignificant post-solution activity. See MPEP 2106.04(d) Step 2B: The additional claim elements do not amount to significantly more than the judicial exception. With regards to the computer elements MPEP 2106.04 (A2) III. Metal Process establishes that the addition of a generic computer- implemented steps does not integrate the judicial exception into significantly more. With regards to output the adjusted contrast enhanced breast image to the display device this is considered is insignificant post-solution activity. See MPEP 2106.05(g). Therefore, the claim is not eligible subject matter.
Regarding claim 11, additional limitations are to how the ROI is adjusted, but are generically recited and are therefore not considered significantly more than the judicial exception and are therefore not considered eligible subject matter.
Regarding claims 12 and 17, the additional limitations generically recited and are therefore not considered significantly more than the judicial exception and are therefore not considered eligible subject matter.
Claim Rejections - 35 USC § 103
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.
Claim(s) 10-12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over You (Pub. No. CN114066911A see attached translation for paragraph numbers) in view of Ha (Pub. No. US20200372637A1).
Regarding claim 10, You discloses An image processing system, comprising: a display device; (You ¶69; displaying results is disclosed, see Figs 3-7.) an image processing device communicatively coupled to the display device and including a processor and non-transitory memory storing instructions executable by the processor to: (You ¶66; training of method is disclosed as being performed on a 32GB NVIDIA TESLA 39C GPU.) distinguish a region of interest (ROI) of a contrast enhanced breast image corresponding to background parenchymal enhancement (BPE) using a BPE algorithm (You ¶26-31; BPE extraction is performed using a first segmentation module that segments the breast region then a second segmentation module that segments tumors in the breast region, then a candidate region extraction module and BPE area extraction module.) and a suspicious area algorithm that has been trained using image pairs including a ground truth suspicious area segmented image; (You ¶26-31, ¶59 and 63-65; tumor segmentation is learned using images that are segmented by radiologists.) adjust, using an adjustment algorithm, the ROI of the contrast enhanced breast image corresponding to BPE; and (You Figs. 4 and 5 and ¶46-47; an overlay of the segmentation within the breast tissue can be seen for various thresholds of the segmentation in (g-j) of Fig. 4 and (g-k) of Fig. 5.) output the adjusted contrast enhanced breast image to the display device. (You Fig. 4 and 5; show displayed outputs of the segmentation.)
You does not explicitly disclose BPE algorithm that has been trained using image pairs including a ground truth BPE segmented image.
Ha, however discloses BPE algorithm that has been trained using image pairs including a ground truth BPE segmented image.(Ha ¶56 and ¶49-50, ¶64-65; Ground truth data was created by manual segmentation. The u-net (se Fig. 4) was then trained using 80% of the available images.)
It would have been obvious, before the effective filing date of the claimed invention, to one of ordinary skill in the art to modify the device of You with the teachings of Ha by replacing the segmentation of BPE by thresholding with the u-net of Ha order to segment the BPE in a fast and precise way (Ha ¶70). This would be a simple substitute known in the art that would yield predictable results of BPE segmentation.
Regarding claim 11, the combination of You and Ha disclose the claim limitations with regards to claim 10, as described above. They further disclose The image processing system of claim 10, wherein the instructions to adjust the ROI of the contrast enhanced breast image corresponding to BPE further include to increase a contrast of the ROI of the contrast enhanced breast image corresponding to BPE, decrease the contrast of the ROI of the contrast enhanced breast image corresponding to BPE, or highlight the ROI of the contrast enhanced breast image corresponding to BPE. (You Figs. 4 and 5 and ¶46-47; an overlay of the segmentation within the breast tissue (i.e. the BPE is highlighted) can be seen for various thresholds of the segmentation in (g-j) of Fig. 4 and (g-k) of Fig. 5.)
Regarding claim 12, the combination of You and Ha disclose the claim limitations with regards to claim 10, as described above. They further disclose wherein the instructions further include to output an unadjusted contrast enhanced breast image and a corresponding contrast enhanced breast image without enhanced contrast. (You Fig. 4 and 5; contrast enhanced images can be seen in (a) of Fig. 4 and (a) in Fig. 5 as well as the segmentation overlayed images in (g-j) and (g-k) respectively. Examiner assumes the original contrast enhanced image output with the adjusted image as in Figs. 6 and 7 is meant see 112(b) rejection above.)
Regarding claim 17, the combination of You and Ha disclose the claim limitations with regards to claim 10, as described above. They further disclose wherein an output of the BPE algorithm and an output of suspicious area algorithm are sequential or simultaneous inputs of an adjustment algorithm. (You ¶26-31; tumor regions are extracted and then not utilized in the BPE extraction module to segment the BPE area, which is then overlayed onto the contrast enhanced image (see Fig. 4 g-j and Fig. 5 g-k).)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEREDITH TAYLOR whose telephone number is (571)270-5805. The examiner can normally be reached M-Th 7:30-5. Examiner’s email is Meredith.taylor@uspto.gov.
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/MEREDITH TAYLOR/ Examiner, Art Unit 2671
/VINCENT RUDOLPH/ Supervisory Patent Examiner, Art Unit 2671
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