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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Japan on 09/20/2023. It is noted, however, that applicant has not filed a certified copy of the priority application as required by 37 CFR 1.55.
Applicant should note the failure status report dated 02/20/2025.
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]) a specification result being indicative of the target bone being affected by a fracture or by presence of an artificial object ([0051]-[0053], [0055] – “error part” which might be a surgical instrument, where a surgical instrument is an artificial object), determines whether or not the state evaluation of the bone is possible based on a specification result of the target bone ([0051]-[0053] - determines whether an "error part" is in the image, [0058]), 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).
Response to Arguments
Applicant’s arguments regarding prior art rejections of all pending claims, filed 12/03/2025, have been fully considered but are not persuasive.
Applicant argues that “it is believed that Jung fails to disclose the presently claimed steps following the target bone specification.” Applicant argues that in paragraph [0061] of Jung, it is not a processor but rather a user that diagnosis osteoporosis.
Examiner respectfully disagrees. First, Applicant has provided no evidence to support this assertion. There is nothing in Jung that indicates a user manually, without the aid of the processor, derives the evaluation result by performing the state evaluation of the bone as claimed. To the contrary, all evidence in Jung points to the use of a processor to perform this function. See at least paragraphs [0044] – “…an artificial neural network model to accurately identify whether the examination region image is an osteoporosis state examination region image or a normal state examination region image by using the examination region image including human information” and [0048] – “…the determination unit 140, which will be described later, can accurately determine whether the examination target image has osteoporosis”; as well as figure 2 which shows a computer generated table of bone density values as well as diagnostic information (T- and Z-scores). Moreover, Chopin provides evidence that a calculator (processor) is typically included in DEXA scanners and is used to generate the bone density and diagnostic values. Nothing in the claims precludes a user operating the processor to obtain the evaluation result.
The rejections are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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