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, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/13/2026 has been entered.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8, 9, 11-15, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jung (KR 20230011044 A, Jan. 20, 2023) (hereinafter “Jung”).
Regarding claims 1, 19, and 20: Jung discloses an image processing device with corresponding method and CRM, comprising: at least one processor, wherein the processor specifies a target bone, which is a target of state evaluation of a bone, from a radiation image of a subject ([0033]-[0037] - the units are implicitly "at least one processor" because this is a computer-implemented method; [0045]), the state evaluation of the bone being an evaluation for deriving an evaluation value indicating a likelihood of osteoporosis or a determination result of whether or not osteoporosis is present ([0004] - the entire purpose of the invention disclosed by Jung is to improve osteoporosis diagnosis, [0038] - “body part subject to osteoporosis testing”, [0039] - bone density value or T- and Z-score, [0047]-[0048] - “…can accurately determine whether the examination target image has osteoporosis”, [0061] - “…and diagnose osteoporosis”), determines whether or not the state evaluation of the bone is possible based on the specification result of the target bone ([0048], [0051]-[0053] - determines whether an "error part" is in the image, where an “error part” causes inaccurate osteoporosis results; [0058]; [0061] - the evaluation is performed only on regions not including an error part which, when combined with the disclosure that an error part causes inaccurate results, is a clear indication that the decision to exclude the error part is a determination that evaluation is not possible for the bone having the error part), derives an evaluation result by performing the state evaluation of the bone using the target bone in a case in which it is determined that the state evaluation of the bone is possible ([0061] - the evaluation is performed on normal vertebrae L1, L2, and L4), and performs the state evaluation of the bone by changing an evaluation method in a case in which it is determined that the state evaluation of the bone is not possible ([0061] - excluding L3).
Regarding claim 2: Jung discloses the image processing device according to claim 1, wherein the processor specifies the target bone by excluding a fracture and an artificial object in the radiation image ([0005], [0053]).
Regarding claim 3: Jung discloses the image processing device according to claim 2, wherein the processor determines whether or not the state evaluation of the bone is possible based on whether or not the target bone that does not include the fracture and the artificial object is included in the radiation image at a predetermined standard or higher ([0054]-[0055]).
Regarding claim 8: Jung discloses the image processing device according to claim 1, wherein the radiation image is a bone part image in which a bone part of the subject is emphasized ([0038], [0045]).
Regarding claim 9: Jung discloses the image processing device according to claim 2, wherein the radiation image is a bone part image in which a bone part of the subject is emphasized ([0038], [0045]).
Regarding claim 11: Jung discloses the image processing device according to claim 1, wherein the processor derives an evaluation value indicating a likelihood of osteoporosis or a determination result of whether or not osteoporosis is present, as the evaluation result, based on image information of a region of the target bone in the radiation image ([0004], [0047]-[0048]).
Regarding claim 12: Jung discloses the image processing device according to claim 2, wherein the processor derives an evaluation value indicating a likelihood of osteoporosis or a determination result of whether or not osteoporosis is present, as the evaluation result, based on image information of a region of the target bone in the radiation image ([0004], [0047]-[0048]).
Regarding claim 13: Jung discloses The image processing device according to claim 1, wherein the processor derives at least one of a bone density of the target bone, information on a microstructure of the target bone, or a relationship with a bone adjacent to the target bone, as an indicator indicating a state of the bone, and derives the evaluation result based on the indicator ([0047]-[0048]).
Regarding claim 14: Jung discloses the image processing device according to claim 2, wherein the processor derives at least one of a bone density of the target bone, information on a microstructure of the target bone, or a relationship with a bone adjacent to the target bone, as an indicator indicating a state of the bone, and derives the evaluation result based on the indicator ([0047]-[0048]).
Regarding claim 15: Jung discloses the image processing device according to claim 13, wherein the processor derives a representative value of the bone density in the target bone as the indicator ([0047]-[0048]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claim(s) 4-7, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Choplin, Robert H., Leon Lenchik, and Scott Wuertzer. "A practical approach to interpretation of dual-energy X-ray absorptiometry (DXA) for assessment of bone density." Current Radiology Reports 2.6 (2014): 48 (hereinafter “Choplin”).
Regarding claim 4: Jung discloses the image processing device according to claim 1, but is silent on wherein the processor changes the evaluation method such that the state evaluation of the bone using an additional target bone of a type different from the target bone is performed, in a case in which it is determined that the state evaluation of the bone is not possible.
Choplin, in the same field of endeavor, discloses that a typical osteoporosis screening includes both hip and lumbar spine scanning (The Test Components; Exclusion of Vertebrae).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to proceed with scanning at least one additional site (i.e. the hip or spine) when one bone location (i.e. either the hip or spine) is determined to be unsuitable for scanning as taught by Choplin in order to provide an accurate screening result to the patient using sufficient data.
Regarding claim 5: Jung discloses the image processing device according to claim 2, but is silent on wherein the processor changes the evaluation method such that the state evaluation of the bone using an additional target bone of a type different from the target bone is performed, in a case in which it is determined that the state evaluation of the bone is not possible.
Choplin, in the same field of endeavor, discloses that a typical osteoporosis screening includes both hip and lumbar spine scanning (The Test Components; Exclusion of Vertebrae).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to proceed with scanning at least one additional site (i.e. the hip or spine) when one bone location (i.e. either the hip or spine) is determined to be unsuitable for scanning as taught by Choplin in order to provide an accurate screening result to the patient using sufficient data.
Regarding claim 6: Jung and Choplin disclose the image processing device according to claim 4. Choplin further discloses that when one scan site is determined to be unsuitable, a forearm scan should be added (The Test Components; Exclusion of Vertebrae).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to proceed with scanning at least two additional sites (i.e. the hip or spine, and forearm) when one bone location (i.e. either the hip or spine) is determined to be unsuitable for scanning as taught by Choplin in order to provide an accurate screening result to the patient using sufficient data.
With respect to “adding different types of target bones in a predetermined order,” it is noted that the technician performing the exam would necessarily have to select an order in which to add the additional scan sites prior to actually operating the workstation to update the scan protocol, which is “predetermined.”
Regarding claim 7: Jung and Choplin disclose the image processing device according to claim 6, wherein the processor performs notification indicating that the state evaluation of the bone is not possible, in a case in which it is determined that the state evaluation of the bone is not possible for all of the plurality of types of additional target bones (Jung outputs information indicating that each tested bone site has an error if an error is detected – [0059], [0062], where the identification of an error in the bone indicates that it is not suitable for examination, i.e. as described in [0060]-[0061]).
Regarding claim 17: Jung discloses the image processing device according to claim 1. Jung further provides an example of a radiation image along with the evaluation result (fig. 2). However, Jung does not explicitly describe that this information is displayed to the user.
Choplin, in the same field of endeavor, discloses that a typical DXA scan result report includes displays the radiation image in which the target bone is emphasized, and the evaluation result (DXA Output, figs. 9 and 11-13).
It would have been prima facie obvious for one having ordinary skill in the art to modify the device of Jung to include providing a display of a conventional scan report as taught by Choplin in order to allow the patient and physician to review the results and any relevant diagnostic information.
Regarding claim 18: Jung discloses the image processing device according to claim 2. Jung further provides an example of a radiation image along with the evaluation result (fig. 2). However, Jung does not explicitly describe that this information is displayed to the user.
Choplin, in the same field of endeavor, discloses that a typical DXA scan result report includes displays the radiation image in which the target bone is emphasized, and the evaluation result (DXA Output, figs. 9 and 11-13).
It would have been prima facie obvious for one having ordinary skill in the art to modify the device of Jung to include providing a display of a conventional scan report as taught by Choplin in order to allow the patient and physician to review the results and any relevant diagnostic information.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Hussain, Dildar, et al. "Femur segmentation in DXA imaging using a machine learning decision tree." Journal of X-ray Science and Technology 26.5 (2018): 727-746 (hereinafter “Hussain”).
Regarding claim 10: Jung discloses the image processing device according to claim 8, where the bone part image is a DXA image ([0038], [0045]) which inherently has two different energy level components (“are acquired by imaging the subject with radiation having different energy distributions”; the ‘D’ in DXA stands for “dual-energy”).
However, Jung does not explicitly state whether the high energy and low energy portions of the DXA scan data are provided to the processor as two separate images.
Hussain, in the same field of endeavor, discloses a method for processing DXA scan images for bone density evaluation, including providing the high energy and low energy (HE and LE, respectively) as two separate images in order to facilitate image processing, including separately de-noising the HE and LE data in order to provide a better quality result (2. Methods).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Jung to include deriving the bone part image from a first radiation image and a second radiation image, which are acquired by imaging the subject with radiation having different energy distributions as taught by Hussain in order to facilitate image processing, including improved denoising.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of Truscott, John G., Joseph Devlin, and Paul Emery. "DXA scanning." Baillière's clinical rheumatology 10.4 (1996): 679-698 (hereinafter “Truscott”).
Regarding claim 16: Jung discloses the image processing device according to claim 15, but is silent on wherein the processor derives the representative value of the bone density for each of a plurality of lines in a predetermined direction in the target bone, and derives a representative value of the representative values of the respective lines as the indicator.
Truscott, in the same field of endeavor, discloses that the conventional manner of obtaining a bone density value from a DXA scan is to derive a representative value of the bone density for each of a plurality of lines (i.e. scan lines) in a predetermined direction in the target bone (the direction of scanning), and derive a representative value of the representative values of the respective lines as the indicator (see entire document).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to obtain the bone density value in the conventional manner as taught by Truscott in order to obtain a conventional result because the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results (KSR, 550 U.S. at 416, 82 USPQ2d at 1395).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung in view of El Maghraoui, A., and C. Roux. "DXA scanning in clinical practice." QJM: An International Journal of Medicine 101.8 (2008): 605-617. (hereinafter “El Maghraoui”)
Regarding claim 21: Jung discloses the image processing device according to claim 3, but is silent on determining whether or not the state evaluation of the bone is possible based on whether or not a number of the specified target bone is included in the radiation image at a predetermined standard or higher, or whether or not an area of a region of the target bone in the radiation image is equal to or larger than a threshold value.
El Maghraoui, in the same field of osteoporosis testing and DXA scanning, discloses that two vertebrae is considered the minimum for performing an evaluation for osteoporosis and that a single vertebrae is not recommended, while an image where all vertebrae are affected artifacts or structural changes should be reported as “invalid” and no evaluation performed (DXA scan analysis, paragraph 2).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Jung to include determining if the state evaluation is possible based on whether or not a number of the specified target bone is included in the radiation image at a predetermined standard or higher in view of the teachings of El Maghraoui that an image where all the target bones are affected is invalid (where ‘more than none’ would reasonably be considered a threshold value) and that two vertebrae is considered to be the minimum number for a successful evaluation, in order to provide accurate osteoporosis testing results.
Response to Arguments
Applicant’s arguments regarding prior art rejections of all pending claims, filed 05/13/2026, have been fully considered but are not persuasive.
Applicant argues that “it is believed that Jung fails to teach determining whether or not a final evaluation of a patient is possible, using the information of a target bone.” No evidence is provided to support this assertion.
Examiner respectfully disagrees. As a preliminary matter, Examiner notes that it’s not entirely clear what a “final evaluation” is since this term is not used anywhere in the instant disclosure or claims. Examiner interprets “final evaluation” to refer to the “state evaluation” corresponding to evaluation for osteoporosis, as defined in claim 1. Jung discloses that the presence of an “error part” causes inaccurate evaluation results ([0053]), identifies the presence of an “error part” and segments the bone corresponding to the “error part” ([0051], [0058]-[0060]), and excludes the bone corresponding to the “error part” from the osteoporosis evaluation ([0061]). The exclusion of the bone having the “error part” is at least an implicit disclosure that a determination is made regarding whether a state evaluation is possible on the target bone.
The rejections are maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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, Chris Koharski can be reached at (571) 272-7230. 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.
/CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799
Prosecution Insights