DETAILED ACTION
Examiner’s Comments
Claim 13 fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim only recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor.
Accordingly, the disclosure is not commensurate with the scope of the claim.
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 1-28 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. Claims 1, 13, 14, 15, 16 and 28 use the term “a predetermined region” twice in the claims, apparently to refer to the same region. The second use of the term should read “the predetermined region” to remove antecedent basis ambiguity.
Claim Rejections – 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture and 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 1-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of determining two body part misalignments in an x-ray image. This idea could constitute a mental process, i.e., concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Under the 2019 Revised Patent Subject Matter Eligibility Guidance a multi-step analysis is used in order to evaluate eligibility.
Step 1: Examiner notes that the claim is directed to one of the statutory categories, ‘a process, machine, manufacture, or composition of matter’.
Step 2a – Prong One: Examiner notes that the claim does recite an abstract idea, in particular ‘determining two body part misalignments in an x-ray image’. This idea could constitute a mental process, i.e., concepts performed in the human mind (including an observation, evaluation, judgment, opinion).
Step 2a – Prong Two: Prong two is concerned with whether the claim recites additional elements that integrate the exception into a practical application, such that the claim is ‘more than a drafting effort designed to monopolize the exception’.
In the case of independent claims 1, 13, 14, 15, 16 and 28 additional elements include a processor and a radiographic image obtainer. In context of performing the identified abstract idea these elements represent insignificant extra-solution activity such that the abstract idea can be ‘applied’ on a generic computer as the tool to perform the abstract idea. Their application to the abstract idea does not represent an improvement to the functioning of a computer or to any other technology or technical field. That is, the claims do not recite a technological solution to a technological problem.
In the case of the dependent claims, they involve basic implementation details such as looking for misalignment in two directions, identifying misalignment amounts, basic steps related to re-imaging and the concept of using training data and a learned model. This amounts to insignificant extra-solution activity such that the abstract idea can be ‘applied’ on a generic computer as the tool to perform the abstract idea.
Step 2b: Similarly to the analysis under step 2a – Prong Two the above claims are found ineligible as they are directed to a judicial exception that is not integrated into a practical application because generically recited computer elements do not add a meaningful limitation since they amount to simply implementing the abstract idea on a computer. These elements are recited at a high level of generality as performing generic computer functions routinely used in computer applications. The following were recognized by the courts as well-understood, routine or conventional computer functions: Performing computational steps on a computer, Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012), electronically extracting data from a sensor, Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1348, 113 USPQ2d 1354, 1358 (Fed. Cir. 2014) and Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
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.
Claim(s) 1-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugahara ‘075 (US PGPub 2022/0028075) in view of Sugahara ‘573 (US PGPub 2022/0151573)
Regarding claim 1, Sugahara ‘075 teaches a re-imaging determination support device comprising a hardware processor that: (Sugahara ‘075 teaches a system for radiation image joint position evaluation to determine whether re-imaging is required and to provide instruction for joint re-positioning. Processor at ¶ 0124)
judges a first misalignment of a predetermined region in a radiographic image; (¶ 0082 teaches detecting from the radiographic image that the articular surfaces of the medial and lateral condyles of the femur are not matched with each other.)
outputs re-imaging determination support information that supports determining whether or not to perform re-imaging for the radiographic image, based on at least a judgement of the first misalignment. (Fig. 10 and ¶ 0078 and 0087 teaches re-imaging determination and outputting a reason for imaging failure based on the misalignment.)
In the field of joint re-positioning for radiation imaging Sugahara ‘573 judges a second misalignment of a predetermined region in the radiographic image and outputs imaging determination based on a judgement of the second misalignment. (Sugahara ‘573 teaches a system for radiation image joint position evaluation to determine whether re-positioning is required and to provide instructions. A camera is used in conjunction with the radiation imaging. ¶ 0062-0063 and Figs. 8-9 teach imaging the upper and lower leg on either side of the knee joint in 3 angular alignment directions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined Sugahara ‘075’s joint re-positioning for radiation imaging with Sugahara ‘573’s joint re-positioning for radiation imaging. Both references teach systems for radiation image joint position evaluation to determine whether re-positioning is required and to provide instructions prior to radiation re-imaging. Sugahara ‘573 teaches imaging the upper and lower leg on either side of the knee joint in 3 angular alignment directions. Simply measuring alignment deviation in two adjacent parts of the leg and in two directions cannot be considered a non-obvious improvement in view of the relevant prior art here which is already doing so. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 2, the above combination teaches the re-imaging determination support device according to claim 1, wherein the hardware processor judges a misalignment in a first direction of the predetermined region in the radiographic image as the judgement of the first misalignment, judges a misalignment in a second direction of the predetermined region in the radiographic image as the judgement of the second misalignment, and outputs the re-imaging determination support information based on a judgement of the misalignment in the first direction and a judgement of the misalignment in the second direction. (As above, Sugahara ‘573 teaches a system for radiation image joint position evaluation to determine whether re-positioning is required and to provide instructions. A camera is used in conjunction with the radiation imaging. ¶ 0062-0063 and Figs. 8-9 teach imaging the upper and lower leg on either side of the knee joint in 3 angular alignment directions).
Regarding claim 3, the above combination teaches the re-imaging determination support device according to claim 1, wherein the hardware processor judges a misalignment amount in a first direction of the predetermined region in the radiographic image as the judgement of the first misalignment, judges a misalignment amount in a second direction of the predetermined region in the radiographic image as the judgement of the second misalignment, and outputs the re-imaging determination support information based on a judgement of the misalignment amount in the first direction and a judgement of the misalignment amount in the second direction. (See rejection of claim 2, the misalignment amounts are measured in first and second directions.)
Regarding claim 4, the above combination teaches the re-imaging determination support device according to claim 1, wherein the hardware processor outputs information about the first misalignment and information about the second misalignment as the re-imaging determination support information. (See outputting at Sugahara ‘573 ¶ 0064-0066.)
Regarding claim 5, the above combination teaches the re-imaging determination support device according to claim 1, wherein the hardware processor outputs information for changing a position of a first part related to the first misalignment and information for changing a position of a second part related to the second misalignment, as the re-imaging determination support information. (As above, see outputting at Sugahara ‘573 ¶ 0064-0066. ¶ 0062-0063 and Figs. 8-9 teach imaging the upper and lower leg parts on either side of the knee joint in 3 angular alignment directions)
Regarding claim 6, the above combination teaches the re-imaging determination support device according to claim 3, wherein the hardware processor outputs information for changing a position of a first part related to the first misalignment based on the misalignment amount in the first direction and outputs information for changing a position of a second part related to the second misalignment based on the misalignment amount in the second direction, as the re-imaging determination support information. (As above, see outputting at Sugahara ‘573 ¶ 0064-0066, ¶ 0062-0063 and Figs. 8-9 teach imaging the upper and lower leg on either side of the knee joint in 3 angular alignment directions.)
Regarding claim 7, the above combination teaches the re-imaging determination support device according to claim 5, wherein the hardware processor outputs a movement distance of the first part as the information for changing the position of the first part and outputs a movement distance of the second part as the information for changing the position of the second part. (Sugahara ‘075 ¶ 0087 teaches outputting a movement distance that the medial and lateral condyles of the femur need to shift.)
Regarding claim 8, the above combination teaches the re-imaging determination support device according to claim 5, wherein the hardware processor outputs a movement direction of the first part as the information for changing the position of the first part and outputs a movement direction of the second part as the information for changing the position of the second part. (As above, Sugahara ‘075 ¶ 0087 teaches outputting a movement distance that the medial and lateral condyles of the femur need to shift.)
Regarding claim 9, the above combination teaches the re-imaging determination support device according to claim 1, wherein the hardware processor outputs the re-imaging determination support information along with information indicating that re-imaging is necessary. (Sugahara ‘075 Fig. 10 and ¶ 0078 and 0087 teaches re-imaging determination and outputting a reason for imaging failure based on the misalignment.)
Regarding claim 10, the above combination teaches the re-imaging determination support device according to claim 1, wherein the predetermined region for which the first misalignment is judged and the predetermined region for which the second misalignment is judged is in a same joint region. (Sugahara ‘075 and Sugahara ‘573 both teach that the misalignments are in the same joint region.)
Regarding claim 11, the above combination teaches the re-imaging determination support device according to claim 1, wherein the hardware processor decides the predetermined region based on imaging part information. (See Sugahara ‘075 ¶ 0076-0077.)
Regarding claim 12, the above combination teaches the re-imaging determination support device according to claim 1, wherein the predetermined region for which the first misalignment is judged and the predetermined region for which the second misalignment is judged include a range bounded by a humeral trochlea outer edge and a humeral capitulum edge, or by the humeral capitulum edge and a humeral trochlea inner edge, in a side of an elbow joint. (See Sugahara ‘075 ¶ 0076-0077 teach a similar region of interest range determination for the knee joint. The prior art does not expressly disclose doing so for the elbow joint, however ¶ 0056 teaches that the joint of interest can be the elbow. Examiner notes that both the concept and advantage of applying this region determination to the elbow joint when it is being imaged would have been obvious to incorporate with predictable result and without undue experimentation. One of ordinary skill in the art could have combined the elements in the manner explained above using known engineering design without changing a “fundamental” operating principle of the above combination. The proposed combination would have constituted a mere arrangement of old elements with each performing their known function, the combination yielding no more than one would expect from such an arrangement.)
Regarding claim 13, the above combination teaches a learning device that learns with at least a radiographic image, information about a first misalignment of a predetermined region in the radiographic image, and information about a second misalignment of a predetermined region in the radiographic image, as teacher data. (See rejection of claim 1 and Sugahara ‘075 ¶ 0069-0072 and 0075-0079 which teach a learning model.)
Claim 14 is the device corresponding to the device of claim 1, with a requirement for using a learned model in which the misalignment data are learned as teacher data, an obtainer for radiographic information, and that the re-imaging determination support is based on the learned model. See rejection of claim 1 and Sugahara ‘075 ¶ 0069-0072 and 0075-0079 which teach using a learning model for the determination. Fig. 7 teaches an image obtainer. Remaining limitations are rejected similarly. See detailed analysis above.
Claim 15 is the device corresponding to the device of claim 1, without express requirement that the re-imaging support information is re-imaging determination support information. Remaining limitations are rejected similarly. See detailed analysis above.
Claims 16-27 are the non-transitory recording medium corresponding to the device of claims 1-12. Sugahara ‘075 teaches a recording medium. Remaining limitations are rejected similarly. See detailed analysis above.
Claim 28 is the method corresponding to the device of claim 1. The device necessitates method steps. Remaining limitations are rejected similarly. See detailed analysis above.
Conclusion
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/RAPHAEL SCHWARTZ/ Examiner, Art Unit 2671