Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/16/2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the details as described in the specification. Specifically, Figs 1-4, and Fig. 7 are without any written descriptions except the numbers. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-30, and 32-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “and both the larger region and the smaller region are distinct from a contour of the portion of the subject”.
A review of the originally filed specification shows that this limitation is not disclosed, described, or reasonably conveyed to a person of ordinary skill in the art at the time of filling.
The originally filled specification does not contain the phrase “distinct from contour”; any statement that a region must not coincide with, must be independent of, or must be different from an anatomical contour; or any teaching that excludes regions derived from, bounded by, or aligned with a contour of the subject.
Accordingly, the limitation introduces new matter and lacks written description support under 35 USC § 112(a).
Response to Arguments
Applicant's arguments filed on Sep 16, 2025 have been fully considered but they are not persuasive.
Applicant on page 3 of the “Remark” applicant asserts “Applicant submits that the regions 63 and 65 in Goto are regions in the actual object being imaged, which in this case is the femoral region having muscle, bone, and fat. Thus, the contours of the regions 63 and 65, associated by the Examiner with the claimed larger region and smaller region, respectively, are contours of the femoral region. The contours of the regions 63 and 65 are not "distinct from a contour" of the femoral region. Applicant submits that Goto clearly teaches distinguishing various regions (fat region, intramuscular fat, etc.) of the femoral region, and that the various regions including regions 63 and 65 are contours of the femoral region, as clearly illustrated in FIGS. 8-11. There is no teaching in Goto of any larger regions and smaller regions that are distinct from a contour of the femoral region. Accordingly, Applicant submits that Goto fails to disclose or suggest that "the placing the plurality of regions comprises automatically placing a larger region of the image and a smaller region of the image, the smaller region of the image disposed within the larger region of the image, and both the larger region and the smaller region are distinct from a contour of the portion of the subject," as recited in independent claim 29.”
Response: Examiner respectfully disagree with applicant’s argument. Goto’s contour curve (e.g., curve 61) is a one-dimensional boundary, whereas region 63 and 65 are two-dimensional areas bounded by that curve. A region bounded by a contour is necessarily distinct from the contour itself. The claim does not require that the region be independent of or unrelated to contour, only that they be distinct from it. Accordingly, Goto’s disclosure satisfies this limitation.
Regarding Goto fails to disclose or suggest that “automatically placing a larger region of the image and a smaller region of the image, the smaller region of the image disposed within the larger region of the image” Goto on para [0099] expressly teaches that the medical image processing device divides a region into an outer and an inner region by setting a contour as a border and that anatomical region can be automatically distinguished (see para [0031]). Thus, Goto teaches automatically identifying nested regions.
Further, the reference Ruth (US 20050094859 A1, cited on the final action for dependent claim 50), independently teaches automatically placing a larger global region and smaller sub-regions disposed within the larger region, satisfying this limitation even if Goto were deemed insufficient.
Even assuming arguendo that Goto’s regions were considered contour-based, Ruth explicitly teaches rectangular, grid-based regions of interest defined by rows and columns, which are distinct from anatomical contours. Thus, the combination of Goto and Ruth teaches the claimed limitation.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 29-30, 32-33, 36-38, 40-41, 48 and 50 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goto et al. (US 20110002522 A1) in view of Thorner (US 20070219226 A1), and further in view of Ruth et al. (US 20050094859 A1).
Regarding claim 29, Goto et al. teach placing a plurality of regions on the image (see Fig. 11 disclose placing various regions para [0079]; “On the basis of the result displayed by distinguishing subcutaneous fat region 47 and intramuscular fat, the operator evaluates effect of training or treatment by executing area measurement, etc. of the fat region (step 1003)”), combining the plurality of regions to determine an estimate of intramuscular adipose tissue (see Fig. 11, para [0079]; “Since it is desirable that the amount of fat decreases in the muscle, the operator can determine the effect of training with high accuracy by, for example, measuring the amount of intramuscular fat over time”); comparing the determined estimate of intramuscular adipose tissue over a period of time for the subject (see para [0079]; “Since it is desirable that the amount of fat decreases in the muscle, the operator can determine the effect of training with high accuracy by, for example, measuring the amount of intramuscular fat over time”, see also para [0080]; “The "comparative process of the muscle region" is, for example, a process that variation of the muscle region over time is to be compared with respect to plural sets of medical image information having different imaged times”), wherein the placing the plurality of regions comprises automatically placing a larger region of the image and a smaller region of the image, the smaller region of the image disposed within the larger region of the image (see para [0031]; “since the medical image information of the femoral region and the lower leg region can be automatically distinguished, effectiveness in diagnosis can be improved. Also, the medical image processing device can be applied not only to diagnosis of image information of the lower leg region but also to diagnosis of evaluation regions (fat region, muscle region, etc.) of an abdominal region or chest region”, see also para [0099]; “Next, medical image processing device 1 divides region B (the region wherein air region 51 and bone region 53 are eliminated from image information 301) into outer region 63 and inner region 65 by setting curve 61 which indicates the extracted contour of muscle region 57 as the border, and obtains image information 304 (step 2006: FIG. 9)… FIG. 9 shows image information 304. Image information 304 indicates outer region 63 of curve 61 (between femoral skin 55 and curve 61) and inner region 65 (the closed region enveloped by curve 61)”, and para [0199]; “S2006 DIVIDE REGION B INTO OUTER REGION 63 AND INNER REGION 65 SETTING THE EXTRACTED CURVE 61 AS A BORDER (FIG. 9)”), and both the larger region and the smaller region are distinct from a contour of the portion of the subject (see para [0100]; “FIG. 9 shows image information 304. Image information 304 indicates outer region 63 of curve 61 (between femoral skin 55 and curve 61) and inner region 65 (the closed region enveloped by curve 61)”, Note: the contour is curve 61, while regions 63 and 65 are areas bounded by the curve, not the curve itself, i.e., regions 63 and 65 are distinct from the contour itself, even though bounded by it).
However, Goto et al. does not explicitly teach a method of diagnosing sarcopenia in a subject, the method comprising; acquiring dual-energy x-ray measurements for respective pixel positions of a two-dimensional projection image of a portion of the subject, diagnosing sarcopenia in the subject based on the comparison; and wherein the acquiring dual-energy x-ray measurements comprises acquiring dual-energy x-ray measurements for pixel positions related to the larger and smaller regions.
In the same field of endeavor, Ruth et al. teach the method comprising: acquiring dual-energy x-ray measurements for respective pixel positions of a two-dimensional projection image of a portion of the subject (see para [0057]; “a typical DEXA bone densitometer includes a scanner 10 where a patient is scanned with x-rays that impinge on a detector subsystem after passage through the patient to thereby produce x-ray measurements related to respective pixel positions”), and both the larger region and the smaller region are distinct from a contour of the portion of the subject (see para [0024]; “The Global region is a rectangular region defined by two rows and two columns”, see also para [0014]; “a region(s) of interest (ROI) that include a global region and subregions within the global region”, and para [0012]; “Let the long axis of the spine be vertical or at least extending generally in the up-down direction, and the separator lines be horizontal or at least transverse to the long axis of the spine” Note: with vertical left/right boundaries and horizontal upper/lower boundaries, which are not anatomical contours), and wherein the acquiring dual-energy x-ray measurements comprises acquiring dual-energy x-ray measurements for pixel positions related to the larger and smaller regions (see para [0014]; “a system automatically identifies region(s) of interest for DEXA hip images. The input comprises the pixel values of a greyscale anterior-posterior (AP) projective image of the left or right hip. The output comprises a region(s) of interest (ROI) that include a global region and subregions within the global region”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. in view of the use of automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in order to follow the progress of the patient to determine if treatment is slowing, preventing, or reversing muscle mass decline (see para [0057]).
However, the combination of Goto et al. and Ruth et al. as a whole does not teach a method of diagnosing sarcopenia in a subject, and diagnosing sarcopenia in the subject based on the comparison
In the same field of endeavor, Throner teaches a method of diagnosing sarcopenia in a subject (see para [0029]; “Sarcopenia, as defined by Baumgartner, is the appendicular skeletal muscle mass (kg/height.sup.2 (m.sup.2)) being less than two standard deviations below the mean of a young reference group (i.e., the t-score). A t-score is determined by measuring the axial skeletal muscle mass of a patient, typically by dxa (i.e., dual energy xray absorptiometry)”, see also para [0125]; “a t-score was computed for each individual, relating the TASM/ht.sup.2 to those of gender-specific young adults (12)”), and diagnosing sarcopenia in the subject based on the comparison (see para [0026]; “Total ASM is the sum of lean mass in all 4 limbs derived from the DXA whole body scan at each time point”, see also para [0149]; “Total ASM was also significantly increased from baseline at 6 and 12 months”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. in view of the use of automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. and DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner in order to follow the progress of the patient to determine if treatment is slowing, preventing, or reversing muscle mass decline (see para [0029]).
Regarding claim 30, the rejection of claim 29 incorporated herein.
Thorner in the combination further teach wherein sarcopenia is diagnosed when the determined estimate of intramuscular adipose tissue increases over the period of time (see para [0023] “Total ASM was also significantly increased from baseline at 6 and 12 months (P.ltoreq.0.001) and vs. placebo (P<0.001). Leg ASM was significantly increased from baseline and vs. placebo (P=0.001)”).
Regarding claim 32, the rejection of claim 29 incorporated herein.
Ruth et al. in the combination further teach wherein combining the plurality of regions comprises combining the dual-energy x-ray measurements acquired for the pixel positions related to the larger and smaller regions (see para [0014]; “a system automatically identifies region(s) of interest for DEXA hip images. The input comprises the pixel values of a greyscale anterior-posterior (AP) projective image of the left or right hip. The output comprises a region(s) of interest (ROI) that include a global region and subregions within the global region”).
Regarding claim 33, the rejection of claim 29 incorporated herein.
Goto et al. in the combination further teach wherein each of the larger region and the smaller region has left and right boundaries and wherein placing the plurality of regions comprise placing the left and right boundaries of the smaller region based on percent fat profile data corresponding to pixel positions from inside the left and right boundaries of the larger region moving toward a center of the larger region (see para [0131]; “On screen 502, image information 404 (FIG. 16), e.g. image information created by superposing muscle region 71-1 in image information 401 (FIG. 13) and muscle region 71-2 in image information 402 (FIG. 14) to match the position of femur 73 is displayed. Also, the muscle areas of muscle region 71-1 and muscle region 71-2 are calculated, and displayed as "muscle area S1 cm2" 85-1 and "muscle area S2 cm2" 85-2 respectively. Each of muscle region 71-1 and muscle region 71-2 may be displayed by different colors or patterns” Note; various regions and boundaries identified on the image”).
Regarding claim 36, the rejection of claim 29 incorporated herein.
Goto in the combination further teach wherein the larger region of the image extends from a first side of a limb to a second side of the limb and wherein the smaller region extends across a muscle area from a first side to a second side between outermost extents of muscle wall (see Fig. 11; several regions identified on image; cross from sides of limbs and muscle walls).
Regarding claim 37, the rejection of claim 29 incorporated herein.
Goto et al. in the combination further teach wherein the larger region of the image extends from a first side of a limb to a second side of the limb and wherein the smaller region extends across a muscle area from a first side to a second side between outermost extents of muscle wall but is exclusive of a third region which is identified where bone is present and percent fat cannot be directly measured (see Fig. 11; several regions identified on image; cross from sides of limbs and muscle walls but bone region is excluded).
Regarding claim 38, the rejection of claim 29 incorporated herein.
Ruth et al. in the combination further teach wherein placing the plurality of regions of the image comprises using at least some of the dual-energy x-ray measurements for placing at least one region of the images (see Abstract ; “In DEXA (dual energy x-ray absorptiometry), a system for automatically or nearly so identifying a region of interest in an AP (anterior/posterior) spinal image by processing the pixel values within a global region to find the lateral extent of the vertebra and the spaces between vertebra, and further processing the pixel values within the region of interest to derive estimates of bone parameters. In addition, also in DEXA, a system for automatically locating regions of interest in the hip”).
Regarding claim 40, the rejection of claim 29 incorporated herein.
Ruth et al. in the combination further teach wherein placing the plurality of regions of the image comprises using at least some of the dual-energy x-ray measurements for placing the smaller region of the image (see para [0006]; “The ROI comprises a set of subregions, each of which surrounds a given vertebra”).
Regarding claim 41, the rejection of claim 36 incorporated herein.
Goto et al. in the combination further teach further comprising identifying a left muscle wall and a right muscle wall by identifying inflection of adipose tissue values for identifying the smaller region of the image (see para [0025]; “specify a bone region and a muscle region from the extracted evaluation regions, extract the reference region to be the reference for positioning with respect to each of the specifies bone region”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. The motivation to modify Goto et al. in view of Throner and Bertin et al. would have been use to approximately diagnose the direction of the increased muscle with respect to the reference point, as taught by Gota et al. (see para [0025]).
Regarding claim 48, the rejection of claim 29 incorporated herein.
Goto et al. in the combination further teach wherein: each of the larger region and the smaller region has upper and lower boundaries; and the method further comprises superimposing the upper and lower boundaries of the smaller region over the upper and lower boundaries of the larger region (see para [0131]; On screen 502, image information 404 (FIG. 16), e.g. image information created by superposing muscle region 71-1 in image information 401 (FIG. 13) and muscle region 71-2 in image information 402 (FIG. 14) to match the position of femur 73 is displayed. Also, the muscle areas of muscle region 71-1 and muscle region 71-2 are calculated, and displayed as "muscle area S1 cm2" 85-1 and "muscle area S2 cm2" 85-2 respectively. Each of muscle region 71-1 and muscle region 71-2 may be displayed by different colors or patterns”).
Regarding claim 50, the rejection of claim 29 incorporated herein.
Ruth et al. in the combination further teach wherein: each of the larger region and the smaller region has left and right boundaries and upper and lower boundaries (see para [0014]; “The output comprises a region(s) of interest (ROI) that include a global region and subregions within the global region”, see also para [0024]; “The Global region is a rectangular region defined by two rows and two columns. The superior boundary (rowgsup) is a specified number of rows relative to rowsh. The inferior boundary (rowginf) is defined as a specified number of rows below rowlt. …. The lateral boundary (colglat) is defined as a specified number of columns relative to colgt. The medial boundary (colgmed)”); the left and right boundaries are vertical; and the upper and lower boundaries are horizontal (see para [0012]; “Let the long axis of the spine be vertical or at least extending generally in the up-down direction, and the separator lines be horizontal or at least transverse to the long axis of the spin” Note: left and right boundaries are defined by column indices (vertical) and upper and lower boundaries are defined by row indices (horizontal), rectangular boxes (global region and sub-regions).
Claims 34, 39, and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goto et al and Ruth et al. in view of Thorner et al. as applied in claim 29 above, and further in view of Bertin et al. NPL “Measurement of Visceral Adipose tissue by DXA combined with anthropometry in Obese Humans”: Cited by Applicant.
Regarding claim 34, the rejection of claim 29 incorporated herein. The combination Goto et al., Ruth et al., Thorner and Bertin et al. as a whole does not teach further comprising combining the acquired dual-energy x-ray measurements in a linear equation using constants that provide correlation between dual-energy x-ray measured intramuscular adipose tissue and intramuscular adipose tissue measured by computed tomography.
In the same field of endeavor, Bertin teaches further comprising combining the acquired dual-energy x-ray measurements in a linear equation (see page 267, left col., 2nd para; “Linear regression analysis of simple DXA data alone or combined between themselves to VAT, demonstrated that TID was the best predictor of VAT (r 0.90 in women and 0.79 in men, P < 0.0001), whereas TED was poorly contributive”), using constants that provide correlation between dual-energy x-ray measured intramuscular adipose tissue and intramuscular adipose tissue measured by computed tomography (see page 265, right col., 3rd para; “Pearson product ± moment correlation coefficients were used to analyse the relationships of DXA data alone or combined between themselves or with anthropometric measurements, to CT scan data”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. and automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and further in view of performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. in order to assess fat mass distribution (WC, WHR, SD), SD showed the best correlation (page 267, left col., 3rd para).
Regarding claim 39, the rejection of claim 29 incorporated herein.
Bertin et al. in the combination further teach wherein placing the plurality of regions of the image comprises using an anatomical landmark and a preselected region of interest line to place the larger region of the image (see page 264, right col., 4th para; “7 Furthermore, we analysed fat mass distribution at a higher precision level, by de®ning manually many other regions from skeletal landmarks. We thus selected the more discriminating ones in term of fat mass distribution: the abdominal region delineated by an upper horizontal border located at half of the distance between acromions and external end of iliac crests, a lower border determined by the external end of iliac crests and laterally to any trunk soft tissue; the thigh region between the upper part of the greater trochanters and the lower horizontal border de®ned at a distance equal to the height of the abdominal region and laterally to any leg soft tissue (Figure 1)”, see also page 264, right col., 2nd para; “Various regions of interest can also be considered, depending on the pixels selected). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. and automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and further in view of performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. in order to assess fat mass distribution (WC, WHR, SD), SD showed the best correlation (page 264, right col., 4th para).
Regarding claim 42, the rejection of claim 29 incorporated herein.
Goto et al. in the combination further teach further comprising providing an estimate of intramuscular adipose tissue by processing the larger and smaller regions (see para [0108]; “medical image processing device 1 is capable of acquiring an imaginary fascia, and automatically divides the fat region into the subcutaneous fat region and the intramuscular fat region while setting the fascia as a border, which makes it possible to quantitatively obtain the amount of intramuscular fat.
Bertin et al. in the combination further teach wherein processing the larger and smaller regions comprises correlating the acquired dual-energy x-ray measurements combined in a linear equation with intramuscular adipose tissue measured by quantitative computed tomography (see page 265, right col., 4th para; “Accuracy analysis was performed using CT data as the independent variable and DXA=anthropometric data as the dependent variables in a linear regression model”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. and automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and further in view of performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. in order to assess fat mass distribution (WC, WHR, SD), SD showed the best correlation (page 265, right col., 4th para).
Claim 35 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goto et al., Ruth et al. and Thorner et al. in view of Bertin et al. as applied to claims 29, and 34 above, and further in view of Charles (US 6816564 B2) cited on IDS.
Regarding claim 35, the rejection of claim 34 incorporated herein.
The combination Goto et al., Ruth et al., Thorner and Bertin et al. as a whole does not teach combining the x-ray measurements using polynomial expansion.
In the same field of endeavor, Charles teaches wherein combining the acquired dual-energy x-ray measurements (see Abstract: “Techniques for deriving bone properties from images generated by a dual-energy x-ray absorptiometry apparatus”) comprises combining the x-ray measurements using polynomial expansion (see col.13, line 40-45; “The coefficients of the polynomial are determined by measurements on the phantoms. The polynomial functions are inverted to yield the thickness of each calibration material as a polynomial function of the attenuations at the two photon-energies”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. and automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and further in view of performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. and techniques for deriving bone properties from images generated by a dual-energy x-ray absorptiometry apparatus of Charles in order to use the thicknesses of calibration materials (see col.13, line 40-45).
Claims 43-47, and 49 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Goto et al., Ruth et al. and Thorner et al. in view of Bertin et al. as applied to claims 29, 34, and 42 above, and further in view of Shepherd (US 6233473 B1).
Regarding claim 43, the rejection of claim 42 incorporated herein.
The combination Goto et al., Ruth et al., Thorner and Bertin et al. as a whole teach all the limitations of the claimed invention except for explicitly teaching that calculating the intramuscular adipose tissue as: J * muscle region adipose mass -K * (limb adipose mass - muscle region adipose mass) + b.
Shepherd teaches comprising calculating the intramuscular adipose tissue as: J * muscle region adipose mass -K * (limb adipose mass - muscle region adipose mass) + b (see col.6, line 35-45; “The next two numbers (0 and 1.192) are a linear slope and a projected mass for the first pass with the narrower-angle x-ray distribution, where the slope (0) indicates the linear slope showing how the projected mass (1.192 in this case) varies as a function of pixel position number as one moves from one pixel position to another toward the beginning of the line”. This is mathematically equivalent as claimed). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. and automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and further in view of performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. and body composition analysis in DXA systems using a fan-shaped distribution of x-rays of Sheperd et al. in order to progressively higher true mass values for indicative of thicker mass elements (see col.6, line 35-45).
Regarding claim 44, the rejection of claim 43 incorporated herein.
Shepherd in the combination further teach wherein constants J and K provide a correlation between dual-energy x-ray absorptiometry (DXA) intramuscular adipose tissue and intramuscular adipose tissue measured by computed tomography, and wherein b is an intercept (see col.5, line 15-25; “where A (E.sub.H) is the high energy x-ray attenuation (dimensionless) measured for the respective pixel position, and k(E.sub.H, .rho.) is the linear attenuation coefficient (in units of (1/length) of the column of material traversed by the ray path giving rise to the measurement for the respective pixel position”, see also col.1, line 33-37; “Other types of systems have been used for BMD measurement to a lesser extent, such as quantitative computer-aided tomography (QCT) and single photon absorptiometry (SPA) using isotopes as radiation sources”).
Regarding claim 45, the rejection of claim 43 incorporated herein.
Shepherd in the combination further teach further comprising selecting a value for at least one of J, K and b for the subject (see col.6, line 35-45; “The first two numbers (1.192 and 1.183) are the projected and the true mass, respectively. The next two numbers (0 and 1.192) are a linear slope and a projected mass for the first pass with the narrower-angle x-ray distribution, where the slope (0) indicates the linear slope showing how the projected mass (1.192 in this case) varies as a function of pixel position number as one moves from one pixel position to another toward the beginning of the line”).
Regarding claim 46, the rejection of claim 45 incorporated herein.
Shepherd in the combination further teach wherein selecting the value for at least one of J, K and b is based on at least one of age, gender, ethnicity, weight, height, body mass index, waist circumference, and other anthropomorphic variables of the subject (see col.4, line 41-47; “The maximum value of r can be correspondingly defined as: r.sub.max =T sec.theta.+t(.theta., z) where t(.theta., z) is the thickness of body 26 along the length of r at angle .theta. within x-ray distribution 24”, see also col. 7, lines 40-45; “in the form of numeric results and graphs such as BMD estimates obtained from estimates from populations matched by age and/or other characteristics, and units 52 and 54 communicate interactively with a user input unit 56”).
Regarding claim 47, the rejection of claim 29 incorporated herein.
Shepherd in the combination further teach wherein placing the smaller region comprises automatically placing the smaller region using % fat inflection (see col.5, line 21-29; “where the % Fat is estimated from the ratio of high and low x-ray energy measurements for the respective pixel positions as is known in the art… by directly solving the mathematical expressions set forth above”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. and automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and further in view of performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. and body composition analysis in DXA systems using a fan-shaped distribution of x-rays of Sheperd et al. in order to progressively higher true mass values for indicative of thicker mass elements (see col.5, line 21-29).
Regarding claim 49, the rejection of claim 33 incorporated herein.
Shepherd in the combination further teach further comprising setting each of the left and right boundaries of the smaller region at an inflection point by identifying % fat values of two consecutive pixels lower than a preceding pixel (see col.5, line 21-25; “The density.rho. can be estimated for the individual pixel positions using the patient's % Fat estimates for the respective pixel positions, where the % Fat is estimated from the ratio of high and low x-ray energy measurements for the respective pixel positions as is known in the art”). Accordingly, it would have been obvious to one of ordinary skill in the art at the time of invention of the claimed invention to modify the general medical image processing device that generates images for making diagnosis of effect in training or treatment of Goto et al. and automatically identifies the area occupied by individual vertebra in an AP spine image in DEXA of Ruth et al. in view of the use of DXA for measuring the axial skeletal muscle mass (Sarcopenia) of a patient of Throner and further in view of performing DXA at the abdomen or along the length of the body of visceral adipose tissue (VAT) of Bertin et al. and body composition analysis in DXA systems using a fan-shaped distribution of x-rays of Shepherd et al. in order to establish thickness values for the respective pixel positions (see col.6, line 35-45).
Conclusion
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/WINTA GEBRESLASSIE/Examiner, Art Unit 2677
/ANDREW W BEE/Supervisory Patent Examiner, Art Unit 2677