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 .
Claim Rejections - 35 USC § 112 six
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Claims 1-18 the limitation as in the phrase “determination unit”, “alignment unit”, “evaluation unit”, “obtaining unit”, are (non-structural term) has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “device, unit, module” coupled with functional language” without reciting sufficient structure to achieve the function.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
DETAILED ACTION
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-5, 7-9, 14 and 17-20, are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Tajima (U.S. Pub No: 2018/0333118 A1).
Regarding claim 1, Tajima discloses an information processing apparatus comprising: a determination unit configured to determine, for each of a first radiation image corresponding to a first radiation energy and a second radiation image corresponding to a second radiation energy different from the first radiation energy, a first bone area indicating a predetermined bone portion (see abstract, a control unit acquires first radiographic image data and second radiographic image data and derives bone density from an image of a derivation region of a DXA image which is a difference image between a first radiographic image and a second radiographic image. Then, the control unit derives an evaluation value of the accuracy of derivation of the bone density, on the basis of at least one of the first radiographic image, the second radiographic image, and a bone part ES image, a soft part ES image, and a DXA image which are generated using the first radiographic image and the second radiographic image.
Also, page 1, paragraphs, [0004] and [0007], in some cases, bone density and bone mineral content are derived using image data (for example, dual-energy X-ray absorptiometry (DXA) image data) which is generated on the basis of image data of two radiographic images generated by irradiation with (absorption of) radiations having different energy levels. In order to achieve the object, the present disclosure provides an image processing apparatus comprising: an acquisition unit that acquires a first radiographic image generated by a first radiation detector irradiated with radiation with a first energy level and a second radiographic image generated by a second radiation detector irradiated with radiation with a second energy level different from the first energy level from a radiography apparatus including the first and second radiation detectors in which a plurality of pixels, each of which includes a conversion element that generates a larger amount of charge as it is irradiated with a larger amount of radiation, are arranged and which are arranged in a direction in which the radiation is emitted; a first derivation unit that derives at least one of bone density or bone mineral content from an image of a predetermined derivation region of a difference image between the first radiographic image and the second radiographic image; and a second derivation unit that derives an evaluation value of an accuracy of derivation of the at least one of the bone density or the bone mineral content derived by the first derivation unit, on the basis of a third radiographic image generated using the first radiographic image and the second radiographic image);
an alignment unit configured to perform an alignment between a first partial area including the first bone area in the first radiation image and a second partial area including the first bone area in the second radiation image (see page 13, paragraph [0170] in a case in which the amount of deviation of the calibration position is large, the first radiographic image and the second radiographic image are not appropriately corrected as described above, which results in a reduction in the accuracy of derivation of the bone density. For this reason, it is preferable to capture the image of the subject W again or to perform calibration based on the calibration position aligned with the imaging position. Therefore, the guidance information for guiding the execution of re-imaging is associated with the evaluation of the calibration position in the guidance correspondence information stored in the storage unit in this embodiment.
Also, page 14, paragraphs, [0178-0179] then, in Step S94, the control unit 80 determines whether the imaging position and the calibration position “imaging conditions are aligned with each other”, on the basis of the imaging position information (imaging condition information) acquired in Step S90 and the calibration position information 97 acquired in Step S92. In a case in which the amount of deviation between the imaging position and the calibration position is equal to or less than the amount of deviation in which the accuracy of derivation of the bone density is evaluated to satisfy the desired accuracy, the control unit 80 considers that the calibration position and the imaging position are aligned with each other. The determination result in Step S94 is “Yes” and the process proceeds to Step S102 of the image processing (see FIG. 8) according to the first embodiment. On the other hand, in a case in which the determination result in Step S94 is “No”, the process proceeds to Step S96. In Step S96, the control unit 80 controls the display unit 92 such that a predetermined warning is displayed on the display unit 92 and proceeds to Step S120. FIG. 23 is a diagram illustrating an example of a state in which a warning is displayed on the display unit 92. FIG. 23 illustrates a state in which warning information 130 indicating that the accuracy of derivation is likely to be reduced since the calibration position deviates and a confirmation button 132 are displayed on the display unit 92. The user can see the display of the warning information 130 and rapidly perform a re-imaging operation for the subject W or perform calibration based on the calibration position aligned with the imaging position);
and an obtaining unit configured to obtain a bone mineral density of the first bone area based on a difference image including the first bone area, the difference image being obtained based on a result of the alignment (see above, also page 8, paragraph, [0099] in some cases, in the derivation of the bone density, for example, the accuracy of derivation of the bone density is reduced in a case in which noise is superimposed on the image of the derivation region R1 or a case in which gas generated in the body of the subject W is included in the image of the derivation region R1 (which will be described in detail below). As a result, the desired accuracy is not obtained. In this embodiment, “a state in which noise is superimposed on an image” includes, for example, a state in which noise is superimposed on image data indicating a radiographic image, such as the first radiographic image data or the second radiographic image data, by the influence of disturbance and the influence of noise appears in the image indicated by the image data and a state in which a sufficiently high signal/noise (S/N) ratio is not obtained since the amount of radiation R is small.
Also, page 14, paragraphs, [0178-0179] then, in Step S94, the control unit 80 determines whether the imaging position and the calibration position (imaging conditions) are aligned with each other, on the basis of the imaging position information (imaging condition information) acquired in Step S90 and the calibration position information 97 acquired in Step S92. In a case in which the amount of deviation between the imaging position and the calibration position is equal to or less than the amount of deviation in which the accuracy of derivation of the bone density is evaluated to satisfy the desired accuracy, the control unit 80 considers that the calibration position and the imaging position are aligned with each other. The determination “result” in Step S94 is “Yes” and the process proceeds to Step S102 of the image processing (see FIG. 8) according to the first embodiment. On the other hand, in a case in which the “determination result” in Step S94 is “No”, the process proceeds to Step S96. In Step S96, the control unit 80 controls the display unit 92 such that a predetermined warning is displayed on the display unit 92 and proceeds to Step S120. FIG. 23 is a diagram illustrating an example of a state in which a warning is displayed on the display unit 92. FIG. 23 illustrates a state in which warning information 130 indicating that the accuracy of derivation is likely to be reduced since the calibration position deviates and a confirmation button 132 are displayed on the display unit 92. The user can see the display of the warning information 130 and rapidly perform a re-imaging operation for the subject W or perform calibration based on the calibration position aligned with the imaging position).
Regarding claim 3, Tajima discloses the information processing apparatus according to claim 1, 2first radiation image and an area corresponding to the first partial area in the second radiation image (see claim 1, also page 11, paragraph, [0138] FIG. 16 illustrates a state in which the DXA image 100 is displayed in an image display region 110. As illustrated in FIG. 16, an image indicating the derivation region R1 used to derive the bone density is displayed so as to be superimposed on the DXA image 100. In addition, in the example illustrated in FIG. 16, a DXA profile used to derive the bone density is displayed in a profile display region 112. Also, page 13, paragraphs, [0170] and [0178], in a case in which the amount of deviation of the calibration position is large, the first radiographic image and the second radiographic image are not appropriately corrected as described above, which results in a reduction in the accuracy of derivation of the bone density. For this reason, it is preferable to capture the image of the subject W again or to perform calibration (hereinafter, generically referred to as “re-imaging”) based on the calibration position aligned with the imaging position. Therefore, the guidance information 125 for guiding the execution of re-imaging is associated with the evaluation of the calibration position in the guidance correspondence information 89 stored in the storage unit 88 in this embodiment. Then, in Step S94, the control unit 80 determines whether the imaging position and the calibration position (imaging conditions) are aligned with each other, on the basis of the imaging position information (imaging condition information) acquired in Step S90 and the calibration position information 97 acquired in Step S92. In a case in which the amount of deviation between the imaging position and the calibration position is equal to or less than the amount of deviation in which the accuracy of derivation of the bone density is evaluated to satisfy the desired accuracy, the control unit 80 considers that the calibration position and the imaging position are aligned with each other. The determination result in Step S94 is “Yes” and the process proceeds to Step S102 of the image processing (see FIG. 8) according to the first embodiment).
Regarding claim 4, Tajima discloses the information processing apparatus according to claim 1, wherein the first partial area is a rectangle in which the first bone area determined in the first radiation image is circumscribed, and the second partial area is an area that includes the first bone area determined in the first radiation image and is larger than the rectangle (see claim 1, also page 7, paragraph, [0096] FIG. 7 illustrates the value of each pixel in a derivation region R1 of the DXA image illustrated in FIG. 6. In FIG. 7, the horizontal axis indicates a pixel position in the horizontal direction of FIG. 6. In addition, in FIG. 7, the vertical axis indicates an average value of the values of a plurality of pixels in the vertical direction of FIG. 6 at each pixel position in the horizontal direction of FIG. 6. Hereinafter, a data group of the pixel values at each pixel position along the horizontal direction of FIG. 6 which is illustrated in FIG. 7 is referred to as a “DXA profile”).
Regarding claim 5, Tajima discloses the information processing apparatus according to claim 1, wherein in each of the first radiation image and the second radiation image, the determination unit determines a second bone area including the first bone area and determines the first bone area based on an image of the second bone area (see page 10, paragraph, [0132] it is easy to determine the bone region, regardless of whether or not the image of gas is included in the bone part ES image since the bone part ES image has a smaller pixel value than the image of gas included in the DXA image. For example, the control unit 80 subtracts image data obtained by multiplying the first radiographic image data by a predetermined coefficient for the bone from image data obtained by multiplying the second radiographic image data by the predetermined coefficient for the bone for each corresponding pixel to remove the soft tissues and generates bone part ES image data indicating the bone part ES image in which the bone tissues have been highlighted. Here, it is possible to remove the image of gas from the bone part ES image or to sufficiently suppress the image of gas by adjusting the predetermined coefficient, that is, by using a coefficient (the predetermined coefficient for the bone) corresponding to the influence of gas. Since the soft part ES image is an image in which the image of gas is easily seen, it is easy to avoid the gas region G. Therefore, the bone region is derived on the basis of the bone part ES image and a region other than the bone region derived on the basis of the bone part ES image and the gas region G is specified as the soft region. However, as the width of the gas region G increases and as the number of gas regions G increases, the region that can be used as the soft region is narrowed. Therefore, the accuracy of derivation of the reference line K is reduced).
Regarding claim 7, Tajima discloses the information processing apparatus according to claim 5, further comprising: a designation unit configured to accept a designation of a measurement range of a bone mineral density by a user, wherein the determination unit determines, as the first bone area, an area corresponding to the measurement range in the second bone area (see pages 11-12, paragraphs, [0141-0145] As illustrated in FIG. 16, a change button 126 and an end button 128 are displayed on the display unit 92. The end button 128 is designated by the user through the operation unit 94 in a case in which the display of the bone density information 122 or the DXA image 100 ends. [0142] The change button 126 is designated by the user through the operation unit 94 in a case in which the derivation region R1 is changed and bone density is derived again. In the example illustrated in FIG. 16, bone density is derived from the derivation region R1 corresponding to the second lumbar vertebra L2 and the accuracy of derivation of the bone density is low since a large amount of gas is generated in the derivation region R1 or in the vicinity of the derivation region R1. For example, in a case in which no gas generated in the fourth lumbar vertebra L4, the accuracy of derivation of the bone density in the fourth lumbar vertebra L4 is likely to satisfy the desired accuracy. In this case, according to the console 18 of this embodiment, the user who has performed determination on the basis of, for example, the DXA image 100 can designate the change button 126 to change the position (the bone whose density is to be derived) of the derivation region R1. Then, in Step S116, the control unit 80 determines whether to change the derivation region R1. In a case in which the end button 128 displayed on the display unit 92 is designated by the user, the determination result in Step S116 is “No” and the image processing ends. On the other hand, in a case in which the change button 126 displayed on the display unit 92 is designated by the user, the determination result in Step S116 is “Yes” and the process proceeds to Step S118. In Step S118, the control unit 80 detects a region which has been designated as the derivation region R1 by the user through the operation unit 94 and returns to Step S104. How the user designates a region as the derivation region R1 and a method for detecting the region designated by the user are not particularly limited. [0145] For example, in a case in which the display unit 92 and the operation unit 94 are integrated into a touch panel display, the user may trace the image displayed in the image display region 110 with a finger to designate a region as the derivation region R1. In this case, for example, the control unit 80 may detect the position of the image traced by the finger of the user and may detect an image (pixel) region in a predetermined range from the detected position as the derivation region R1).
Regarding claim 14, Tajima discloses the information processing apparatus according to claim 1, wherein the first bone area is a group of vertebral bodies selected from five vertebral bodies constituting a lumbar spine, and a size of the second partial area in a direction of an arrangement of the lumbar spine is a size, obtained by adding a size corresponding to one vertebral body to a rectangle in which the first bone area is circumscribed, or smaller (see claim 1, also page 12, paragraphs, [0154-0155] in this embodiment, as illustrated in FIG. 18, in a case in which the determination result in Step S108 is “No”, the process proceeds to Step S113. In Step S113, the control unit 80 determines whether to change the derivation region R1 on the basis of the DXA image. For example, in a case in which the bone density of the second lumbar vertebra L2 is derived from the derivation region R1 corresponding to the second lumbar vertebra L2, the control unit 80 determines whether the derivation region can be changed to the derivation region R1 corresponding to each of other lumbar vertebrae, such as the first lumbar vertebra L1, the third lumbar vertebra L3, and the fourth lumbar vertebra L4. In this embodiment, for example, in a case in which there is a lumbar vertebra whose bone density has not been derived, the determination result in Step S113 is “Yes” and the process proceeds to Step S115. In Step S115, the control unit 80 selects one lumbar vertebra whose bone density has not been derived, changes the derivation region to the derivation region R1 corresponding to the selected lumbar vertebra, and returns to Step S104. Then, the control unit 80 derives bone density again, using the changed derivation region R1, and evaluates the accuracy of derivation of the bone density).
Regarding claim 17, Tajima discloses a radiation imaging system comprising: the information processing apparatus according to claim 1; a radiation generation apparatus; and a radiation imaging apparatus configured to capture the first radiation image and the second radiation image by using radiation irradiated from the radiation generation apparatus (see claim 1, also page 6, paragraph, [0085] with the above-mentioned configuration, the radiography apparatus 16 according to this embodiment captures radiographic images using the first radiation detector 20A and the second radiation detector 20B. Hereinafter, the radiographic image “captured” by the first radiation detector 20A is referred to as a “first radiographic image” and image data indicating the first radiographic image is referred to as “first radiographic image data”. In addition, hereinafter, the radiographic “image captured” by the second radiation detector 20B is referred to as a “second radiographic image” and image data indicating the second radiographic image is referred to as “second radiographic image data”.
Regarding claim 20, Tajima discloses a non-transitory computer-readable storage medium storing a program for causing a computer to execute the method according to claim 19 (see page 2, paragraph, [0023] in order to achieve the object, the present disclosure provides a non-transitory recording medium recording an image processing program that causes a computer to perform: acquiring a first radiographic image generated by a first radiation detector irradiated with radiation with a first energy level and a second radiographic image generated by a second radiation detector irradiated with radiation with a second energy level different from the first energy level from a radiography apparatus including the first and second radiation detectors in which a plurality of pixels, each of which includes a conversion element that generates a larger amount of charge as it is irradiated with a larger amount of radiation, are arranged and which are arranged in a direction in which the radiation is emitted; deriving at least one of bone density or bone mineral content from an image of a predetermined derivation region of a difference image between the first radiographic image and the second radiographic image; and deriving an evaluation value of an accuracy of derivation of the at least one of the bone density or the bone mineral content, on the basis of a third radiographic image generated using the first radiographic image and the second radiographic image).
With regard to claims 8, 9 and 18-19, the arguments analogous to those presented above for claims 1, 3, 4, 5, 7, 14, 17 and 20 are respectively applicable to claims 8, 9 and 18-19.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) 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.
Claims 2 and 16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tajima (U.S. Pub No: 2018/0333118 A1) in view of Kawamura (U.S. Pub No: 2024/0260891 A1).
Regarding claim 2, Tajima discloses the information processing apparatus according to claim 1, wherein the alignment unit performs the alignment by template matching in which the first partial area determined in the first radiation image is set as a template and the second partial area determined in the second radiation image is set as a search area (see claim 1, also page 9, paragraph, [0109], and page 13, paragraph, [0178], a second evaluation item is evaluation based on the “outline” of the image of the bone tissue (hereinafter, referred to as a “bone part image”). Then in step S94, the control unit 80 determines whether the imaging position and the calibration position “imaging conditions are aligned” with each other, on the basis of the imaging position information (imaging condition information) acquired in Step S90 and the calibration position information 97 acquired in Step S92. In a case in which the amount of deviation between the imaging position and the calibration position is equal to or less than the amount of deviation in which the accuracy of derivation of the bone density is evaluated to satisfy the desired accuracy, the control unit 80 considers that the calibration position and the imaging position are “aligned” with each other. The determination result in Step S94 is “Yes” and the process proceeds to Step S102 of the image processing (see FIG. 8) according to the first embodiment.
But does not explicitly state “an alignment unit perform template matching”.
On the other hand, “Kawamura”, in the same field of “bone disease prediction device by using a radiation image”, teaches (see page 5, paragraph, [0077] the segmentation unit 33 segments the bone part image Gb into a femoral region, a pelvis region, and a vertebral region. The segmentation may be performed by using an extraction model in which machine learning is performed to respectively extract the femur, the pelvis, and the vertebra from the bone part image Gb. Further, templates respectively representing the femur, the pelvis, and the vertebra may be stored in the storage 13, and template matching between these templates and the bone part image Gb may be performed to perform the segmentation).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the Tajima invention according to the teaching of Kawamura because to combine “determining the bone part outline indicating the bone and determining the imaging position and the calibration position are aligned with each other, that is taught by the Tajima invention according to the teaching taught by Kawamura, using template matching between these templates and the bone part image to be performed, provides an improved and accurate method of measuring and comparing a bone mineral density of two different images in diagnostic and treatment of bone disease.
With regard to claim 16, the arguments analogous to those presented above for claims 1 and 2 are respectively applicable to claim 16.
Allowable Subject Matter
Claims 6 and 10-13 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seyed Azarian whose telephone number is (571) 272-7443. The examiner can normally be reached on Monday through Thursday from 6:00 a.m. to 7:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Matthew Bella, can be reached at (571) 272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEYED H AZARIAN/Primary Examiner, Art Unit 2667
September 25, 2025