DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
2. Claims 1-14 have been examined in this application. This communication is the first action on the merits.
Foreign Priority
3. The Examiner has noted the Applicants claiming Foreign Priority from Application DE102023204237.1 filed on 05/08/2023. Receipt is acknowledged of papers submitted under 35 U.S.C. § 119(a)-(d), which papers have been placed of record in the file.
IDS Statements
4. The 1 Information Disclosure Statement (IDS) filed on 05/06/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 and is considered by the Examiner.
35 U.S.C. § 112 (f) Claim Interpretation
5. 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.
6. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
These claim limitation(s) are shown below and reflected for Independent Claim 13.
7. (A). The 1st limitation of Independent Claim 13 recites the following:
“an X-ray unit configured to acquire an X-ray recording of an object.”
Step (A): The term “X-ray unit” is considered to be structural and therefore is not considered to be a generic placeholder. Therefore, the term “X-ray unit” appears to not invoke 35 U.S.C. § 112 (f).
(B). The 2nd limitation of Independent Claim 13 recites the following:
“a reconstruction unit configured to create a first reconstruction from the X-ray recording.”
Step (A): The term “Reconstruction unit” is considered to be structural and therefore is not considered to be a generic placeholder. Therefore, the term “Reconstruction unit” appears to not invoke 35 U.S.C. § 112 (f).
See from Applicant’s Specification ¶[0028]: “The aforementioned object is also achieved by way of: an X-ray apparatus for creating an X-ray reconstruction with an X-ray unit configured for acquiring an X-ray recording of an object; a reconstruction unit (image processing, processor, memory store) configured for creating a first reconstruction from the X-ray recording; a determining unit configured for (automatically or manually) determining a geometry or a structure of an uncertainty region within the first reconstruction; an ultrasound unit configured for acquiring an ultrasound recording restricted to a part of the object corresponding to the uncertainty region; and a data processing unit configured for combining data of the first reconstruction with data of the ultrasound recording to create a second reconstruction.”
See from Applicant’s Specification ¶ [0029]: “The X-ray unit may include a C-arm device or a CT scanner. The reconstruction unit may be an image processing unit with a processor and a memory store”. Thus, the “reconstruction unit” is an image processing unit with a processor and memory store.
(C). The 3rd limitation of Independent Claim 13 recites the following:
“a determining unit configured to determine a geometry or a structure of an uncertainty region within the first reconstruction.”
Step (A): The term “Determining unit” is considered to be structural and therefore is not considered to be a generic placeholder. Therefore, the term “Determining unit” appears to not invoke 35 U.S.C. § 112 (f).
See from Applicant’s Specification ¶ [0029]: “The X-ray unit may include a C-arm device or a CT scanner. The reconstruction unit may be an image processing unit with a processor and a memory store. The determining unit for determining the geometry or the structure of the uncertainty region may include an image processing unit for automatic determination of the uncertainty region. Alternatively, the determining unit may also have an input interface with which an uncertainty region may be input manually, for example, drawn in. The ultrasound unit may be based upon different technologies such as shear wave technology, Doppler technology, etc. Furthermore, the ultrasound unit may be moved and/or controlled, if appropriate, by way of a control facility of the X-ray apparatus, in order to record the uncertainty region as precisely as possible within its limits. The data processing unit for combining and/or integrating the data of the first reconstruction and of the ultrasound recording may also possess image processing functionality and may be constructed with a processor and possible storage elements”.
Thus the “determining unit” is a imaging unit which may have a input interface.
Also, in the paragraph 0029, the “data processing unit” is defined a processor (see underlined section).
(D). The 4th limitation of Independent Claim 13 recites the following:
“an ultrasound unit configured to acquire an ultrasound recording restricted to a part of the object that corresponds to the uncertainty region.”
Step (A): The term “ultrasound unit” is considered to be structural and therefore is not considered to be a generic placeholder. Therefore, the term “ultrasound unit” appears to not invoke 35 U.S.C. § 112 (f).
(E). The 5th limitation of Independent Claim 13 recites the following:
“a data processing unit configured to combine data of the first reconstruction with data of the ultrasound recording to create a second reconstruction.”
Step (A): The term “Data processing unit” is considered to be structural and therefore is not considered to be a generic placeholder. Therefore, the term “Data processing unit” appears to not invoke 35 U.S.C. § 112 (f).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In conclusion, Examiner interprets that Independent Claim 13 does not invoke 35 U.S.C. § 112 (f).
Claim Rejections - 35 USC § 101
8. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
9. Step 1: Claims 1-13 are each focused to a statutory category namely a “method” or a “process” (Claims 1-12), a “system” or an “apparatus” (Claim 13) and “signal per se” or “non-statutory category / non-statutory subject matter” (Claim 14).
Examiner Note: The claimed invention is directed to non-statutory subject matter. Independent Claim 14 does not fall within at least one of the four categories of patent eligible subject matter because it is directed to a “computer program” or “computer readable media” as described in the preamble. Applicant’s Original Specification ¶ [0030-0031] recites tangible features of the computer storage media. See for example Applicant’s Specification ¶ [0030]: “A computer program is also provided that may be loaded directly into a memory store of a control facility of the X-ray apparatus that is described above. The computer program has program means in order to carry out the acts of the aforementioned method when the program is executed in the control facility.” See for example Applicant’s Specification ¶ [0031]: “In a similar manner, an electronically readable data carrier with electronically readable control information stored thereon is also provided, wherein the control information includes at least the computer program as described above and being configured such that, on use of the data carrier in the control facility, it causes the X-ray apparatus to carry out a method as described above”. Independent Claim 14 is therefore a “computer-readable medium.” It is within the scope of the disclosure that the “computer-readable medium” is a transitory form of signal transmission. Thus, Independent Claim 14 as they currently stand are directed to merely a “signal per se”, which is non-statutory (see in re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007)). Signal per se is not patentable under § 101; therefore, the claimed invention does not fall within a statutory class of subject matter.
Step 2A Prong One: Independent Claims 1 and 13-14 describes a method/ apparatus / and medium of "acquiring," "reconstructing," "determining," and "combining" imaging data. The method involves using physical X-ray machines and ultrasound devices. The steps of acquiring data, reconstructing it, and combining it to improve imaging resolution or certainty are not directed to an abstract idea, but rather to a specific technological improvement in image processing and diagnostic capability. The focus is on the improvement of the imaging, not just the mathematical calculation. While reconstruction algorithms are mathematical, their specific application to combining multi-modal imaging data to reduce uncertainty constitutes a concrete technical solution. These steps of acquiring X-ray/ultrasound data are physical, tangible acts. Determining uncertainty regions and combining data are data processing, but in the context of creating a superior image, they constitute a technological improvement to imaging systems rather than a mathematical algorithm or abstract idea.
Independent Claims 1 and 13-14 are not directed to an abstract idea, natural phenomenon, or law of nature under 35 U.S.C. § 101 step 2a prong 1. It is a technical process for improved imaging.
Step 2A Prong Two: Assuming arguendo that Independent Claims 1 and 13-14 are directed to a mathematical algorithm (e.g., reconstruction algorithm), the "inventive concept" lies in the ordered combination of steps: (1) Initial X-ray, (2) Identifying an "uncertainty region" (a specific area of ambiguity), (3) Targeted ultrasound of only that region, and (4) Combining the data. This specific, iterative, multi-modal, targeted approach is not conventional, well-understood, or routine in the field of imaging. It improves the accuracy of the imaging process beyond simple, single-modality methods. Even if the "determining" or "combining" steps were considered abstract mathematical analysis, the combination of X-ray and ultrasound in this specific, iterative manner (using X-ray to define the uncertainty region for a subsequent, targeted ultrasound) constitutes a concrete, specific improvement in technical accuracy (see MPEP § 2106.05 (a)). It is not just "using a computer to look at data". Alternatively, these steps also provide additional elements that demonstrate a particular transformation under MPEP § 2106.05 (c) for integrate of the additional elements into a practical application.
The combination of steps for Independent Claims 1 and 13-14 provides an inventive concept that provides additional elements that integrate the judicial exception into a practical application under 35 U.S.C. § 101 step 2a prong 2.
Step 2B: For Independent Claims 1 and 13-14, the steps (1-5) are not merely routine, conventional acts. Specifically, the steps of (3) "determining a geometry or a structure of an uncertainty region within the first reconstruction" and (4) "acquiring an ultrasound recording restricted to a part of the object corresponding to the uncertainty region" constitute a non-routine, specific, and inventive combination of techniques.
Independent Claims 1 and 13-14 provides significantly more than the abstract concept itself under 35 U.S.C. § 101 step 2B.
Claims 1-13 are patent eligible over 35 U.S.C. § 101. Claim 14 is not patent eligible over 35 U.S.C. § 101 due to the 35 U.S.C. § 101 step 1 issue. Examiner Note: Please amend Independent Claim 14 to correct the 35 U.S.C. § 101 step 2a prong 1 issue for “signal per se”.
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
12. Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over US PG Pub (US 2016/0086329 A1) hereinafter Dennerlein, et. al., in view of US PG Pub (US 2021/0350526 A1) hereinafter Reinhart, et. al., in view of Foreign Patent Application (DE 102016203809 A1) hereinafter Lerch, et. al., and in further view of Foreign Patent Application (KR20150099381 A) hereinafter Ra, et. al.
Regarding Independent Claim 1, Dennerlein method for creating an X-ray reconstruction teaches the following limitations:
- acquiring an X-ray recording on an object (see at least Dennerlein: (Claim 1 of Dennerlein) & ¶ [0003] & ¶ [0009]. Dennerlein notes that 3D data may be made from a plurality of x-ray recordings during a circular arc shaped trajectory about any object or a patient (e.g., during cone beam computed tomography). The scanned region during x-ray image acquisition may be restricted due to external conditions (e.g., caused by a possible collision with the patient or an instrument unit). See also Dennerlein at ¶ [0009]: “A meaningful data record consisting of voxels is available if each voxel, as measured to the isocenter of the recording x-ray system, is acquired over at least a circular segment of 180 degrees plus 2 times half of the respective fan angle of the x-ray source of the x-ray system. The x-ray recordings are taken at intervals of approximately 1° or 2°, or there is at least one x-ray recording in an angle range of 1° to 2°. In practice, the scanned region is approximately a circular segment of 200° through which x-ray recordings of the object are made from the x-ray source in order to provide a 3D data field that is sufficient for reconstructing a 2D/3D x-ray image.” See also Claim 1 of Dennerlein noting “apparatus for assessing reconstructed x-ray images from a three-dimensional (3D) data field formed from a plurality of x-ray images recorded of an object from different predeterminable directions.”).
- creating a first reconstruction from the X-ray recording (see at least Dennerlein: ¶ [0008-0009] & ¶ [0019]. Dennerlein teaches receive a plurality of x-ray recordings showing an examination object from different directions, from which a 2D or 3D data field representing the examination object is generated. The computing apparatus RE is configured to establish one confidence level for a plurality of elements of the 2D/3D data field The confidence level specifies a reliability or an imaging accuracy of an imaged part of the reconstructed x-ray image from a plurality of x-ray recordings. The scanned region is approximately a circular segment of 200° through which x-ray recordings of the object are made from the x-ray source in order to provide a 3D data field that is sufficient for reconstructing a 2D/3D x-ray image. As a result of restricting the scanned region, it is no longer the case that all required data is available for a region to be reconstructed (e.g., information for a complete 2D/3D reconstruction with respect to the reconstruction or formation of a 2D/3D x-ray image is missing for some of the voxels). See also Dennerlein at ¶ [0019]: The dividend of the confidence level k for an image point r(x, y, z) of a reconstructed 2D/3D x-ray image emerges from a first number of x-ray recordings made of an object in different angle ranges. This first number is divided by a second number of x-ray recordings of the object (O) for complete imaging of an image point r(x, y, z) in a 2D/3D x-ray image to be reconstructed.)
Moreover, Dennerlein method for creating an X-ray reconstruction does not explicitly disclose, but Reinhart in the analogous art for creating an X-ray reconstruction does disclose the following:
- determining a geometry (see at least Reinhart: ¶ [0012-0013] & ¶ [0021] & ¶ [0029]. Reinhart notes that the radiographic measurement is carried out using a device that ascertains measurement data from a radiographic geometry around the object. The object is irradiated here from different radiographic directions. A radiographic geometry describes the direction in which radiation is passing through the object, and also the position of the irradiated region and the magnification. Generally speaking the radiographic geometry can be described by the position of the x-ray source and of the detector as seen from the point of view of the measurement object. This can, for example, refer to a reconstruction, a segmentation and/or a surface determination of the measurement data. For example here a dimensional analysis, in particular with reference to dimensions, shape, position, waviness, roughness, wall thicknesses, a target/actual comparison of defined geometries or in defined regions, a defect analysis, in particular for pores, blowholes, inclusions, cracks, porosities or structural loosening, and/or a material analysis, in particular a fibre composite analysis or a foam structure analysis, can be carried out.) or a structure of an uncertainty region within the first reconstruction (see at least Reinhart: ¶ [0021] & ¶ [0024-0025] & ¶ [0035-0037]. Reinhart teaches that the radiographic geometries can be identified using a provisional surface or a forward projection on the basis of the reconstruction. The provisional digital partial representation can, for example, be volume data from a provisional reconstruction, or a surface ascertained therefrom. Regions which so far have been acquired with an inadequate data quality are analyzed with reference to a provisional reconstruction. Those radiographic geometries that cover these regions are identified and preferably used. See also Reinhart at ¶ [0021]: From this it is possible to deduce whether details of a certain size, for example small structures, defects or fibres, can be recognized with a particular reliability or uncertainty with the present quality of measurement data. See also Reinhart at ¶ [0024-0025]: A certain quality of the measurement data, or uncertainty in the measurement data, can be expected for this purpose in a specific region if this region is acquired from a certain number of radiographic images. This can, for example, be deduced from the specification of the CT system in use. In a two-dimensional measurement or analysis, an uncertainty can be, for example, derived from recording parameters such as the size of the x-ray spot or the resolution of the detector. Alternatively, or in addition, parameters such as the noise or the contrast in the radiographic images can be analyzed.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein method for creating an X-ray reconstruction with the aforementioned teachings of: determining a geometry or a structure of an uncertainty region within the first reconstruction, and in view of Reinhart, whereby at least one radiographic geometry is ascertained for the radiographic measurement of the object. For the at least one region of the at least one portion of the provisional digital representation of the object, in which the measurement data have a data quality that lies below the quality threshold value, a radiographic measurement is carried out using the at least one radiographic geometry. In this way additional measurement data that either have a better data quality and/or that improve the data quality in combination with the measurement data ascertained so far can be ascertained for regions in which the data quality of the measurement data ascertained so far is not sufficient to carry out accurate analyses (see at least Reinhart: ¶ [0065]).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Reinhart, the results of the combination were predictable.
Moreover, Dennerlein / Reinhart method for creating an X-ray reconstruction does not explicitly disclose, but Lerch in the analogous art for creating an X-ray reconstruction does disclose the following:
- acquiring an ultrasound recording restricted to a part of the object corresponding to the uncertainty region (see at least Lerch: 3rd ¶ of Page 4 & 1st ¶ - 3rd ¶ of Page 13. Lerch teaches that with the control commands, for example, an operating mode of the ultrasound probe can be set and / or adjusted. The operating mode of the ultrasonic probe may, for example, be selected from the operating mode group, which consists of a B-mode operating mode, an Mmode operating mode, a 1D operating mode, a 2D operating mode, a 3D operating mode, a 4D operating mode, a Doppler mode of operation, a color Doppler mode of operation, a spectral Doppler mode of operation, a contrast agent mode of operation, and combinations thereof. See also Lerch 1st ¶ - 3rd ¶ of Page 13: It is provided that the ultrasound data set has Doppler ultrasound measurement data. In the context of this application, the term color Doppler is understood to mean a color-coded Doppler ultrasound (FKDS). With color Doppler ultrasound probes, blood flow can also be measured in relatively small vessels. Due to the high dynamics of the heart muscle, however, this is often not possible, or only possible to a limited extent, in the relatively small coronary vessels. “The partial region can be, for example, an anomaly, in particular a constriction (stenosis) of the vessel. The section of the vessel may, in particular, be a section of the vessel which is located behind and / or in front of the constriction of the vessel with respect to a direction of fluid flow. In particular, a volume within which the flow parameter is determined can be automatically restricted to the automatically recognized subregion.” See also Lerch 1st ¶ - 3rd ¶ of Page 14: “Acquisition of first imaging data of the region to be imaged by means of a medical imaging device based on electromagnetic radiation, Reconstruction of the medical image data set based on the first imaging data. The provision of the medical image data record can include, for example, reconstructing the medical image data record based on the first imaging data and / or acquisition of the first imaging data by means of the medical imaging device. Acquisition of second imaging data by means of an ultrasound probe, generating the ultrasound data set based on the second imaging data.” Examiner note: Please note Lerch reference includes for a computed tomography, the first imaging data may be projection data, the imaging data acquisition unit may be a projection data acquisition unit, the radiation source may be an X-ray source, and the radiation detector may be an X-ray detector.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart method for creating an X-ray reconstruction with the aforementioned teachings of: acquiring an ultrasound recording restricted to a part of the object corresponding to the uncertainty region, and in further view of Lerch, to perform an automatic evaluation of the temporal course of the movement of the anatomical structure and / or the spatial distribution of the ultrasound contrast agent in the anatomical structure based on the ultrasound data set. Alternatively, and / or in addition to the temporal course of the movement of the anatomical structure, in the case of automatic evaluation, a variable derived from the time profile or a further course derived from the time profile can be taken into account (see at least Lerch: last ¶ of Page 7 and 1st ¶ of Page 8).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Lerch, the results of the combination were predictable.
Moreover, Dennerlein / Reinhart / Lerch method for creating an X-ray reconstruction does not explicitly disclose, but Ra, et. al. in the analogous art for creating an X-ray reconstruction does disclose the following:
- combining data of the first reconstruction with data of the ultrasound recording to create a second reconstruction (see at least Ra: Page 4, Lns. 8-17 & Page 6, Lns 1-4 and Lns. 30-33 & Page 30, 2nd thru 3rd ¶’s. Ra teaches that wherein the target image is reconstructed using a plurality of projection data corresponding to a plurality of views that are RO data obtained by performing tomographic imaging while rotating at less than one rotation. Ra also notes that wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A moving image of a moving object is obtained by using the data obtained in each of the first angular section corresponding to the first viewpoint and the second angular section corresponding to the second viewpoint and facing the first angular section, And acquiring a second image; Acquiring first information indicating a motion amount of the object at a time point using the first image and the second image and reconstructing a target image representing the target object at a target point based on the first information. See also Ra at Page 6, Lns 1-4 and Lns. 30-33: Ra teaches wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A first partial image and a second partial image, which are partial images, are obtained by using tomographic images of a moving object and data obtained in each of a start angle section and an end angle section opposed to the start angle section. Obtaining first information indicating a motion of the object using the first image and the second image and reconstructing the target image using the first information. See also Ra at Page 30, 2nd thru 3rd ¶’s: Filtered Back Projection, Iterative method, and the like can be used as a method of reconstructing a tomographic image in the tomography apparatuses 600 and 700 have. The back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality. See also Ra at Page 51, Lns. 9-11: “The pixel 2254 along with the rectangular image grating 2241 and 2251 including the partial area 2261 and the partial area 2262 is further provided with a signal value '1' of the partial area 2261 and a signal value ' And '1.5' which is a signal value obtained by adding the value '0.5'.”).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch method for creating an X-ray reconstruction with the aforementioned teachings of: combining data of the first reconstruction with data of the ultrasound recording to create a second reconstruction, and in further view of Ra, et. al., whereby the back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality. (see at least Ra: 3rd ¶ of Page 30).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Ra, et. al., the results of the combination were predictable.
Regarding Independent Claim 13, Dennerlein apparatus for creating an X-ray reconstruction teaches the following limitations:
- an X-ray unit (see at least Dennerlein: Fig. 1 & Fig. 3 & ¶ [0017]. Examiner interprets that the X-rays with an associated computing unit in Fig. 1 along with a C-arm shown in Fig. 3.) configured to acquire an X-ray recording on an object (see at least Dennerlein: (Claim 1 of Dennerlein) & ¶ [0003] & ¶ [0009]. Dennerlein notes that 3D data may be made from a plurality of x-ray recordings during a circular arc shaped trajectory about any object or a patient (e.g., during cone beam computed tomography). The scanned region during x-ray image acquisition may be restricted due to external conditions (e.g., caused by a possible collision with the patient or an instrument unit). See also Dennerlein at ¶ [0009]: “A meaningful data record consisting of voxels is available if each voxel, as measured to the isocenter of the recording x-ray system, is acquired over at least a circular segment of 180 degrees plus 2 times half of the respective fan angle of the x-ray source of the x-ray system. The x-ray recordings are taken at intervals of approximately 1° or 2°, or there is at least one x-ray recording in an angle range of 1° to 2°. In practice, the scanned region is approximately a circular segment of 200° through which x-ray recordings of the object are made from the x-ray source in order to provide a 3D data field that is sufficient for reconstructing a 2D/3D x-ray image.” See also Claim 1 of Dennerlein noting “apparatus for assessing reconstructed x-ray images from a three-dimensional (3D) data field formed from a plurality of x-ray images recorded of an object from different predeterminable directions.”).
- a reconstruction unit (see at least Dennerlein: Figs. 1-3.) create a first reconstruction from the X-ray recording (see at least Dennerlein: ¶ [0008-0009] & ¶ [0019]. Dennerlein teaches receive a plurality of x-ray recordings showing an examination object from different directions, from which a 2D or 3D data field representing the examination object is generated. The computing apparatus RE is configured to establish one confidence level for a plurality of elements of the 2D/3D data field The confidence level specifies a reliability or an imaging accuracy of an imaged part of the reconstructed x-ray image from a plurality of x-ray recordings. The scanned region is approximately a circular segment of 200° through which x-ray recordings of the object are made from the x-ray source in order to provide a 3D data field that is sufficient for reconstructing a 2D/3D x-ray image. As a result of restricting the scanned region, it is no longer the case that all required data is available for a region to be reconstructed (e.g., information for a complete 2D/3D reconstruction with respect to the reconstruction or formation of a 2D/3D x-ray image is missing for some of the voxels). See also Dennerlein at ¶ [0019]: The dividend of the confidence level k for an image point r(x, y, z) of a reconstructed 2D/3D x-ray image emerges from a first number of x-ray recordings made of an object in different angle ranges. This first number is divided by a second number of x-ray recordings of the object (O) for complete imaging of an image point r(x, y, z) in a 2D/3D x-ray image to be reconstructed.)
Moreover, Dennerlein apparatus for creating an X-ray reconstruction does not explicitly disclose, but Reinhart in the analogous art for creating an X-ray reconstruction does disclose the following:
- a determining unit (see at least Reinhart: Fig. 1.) configured to determine a geometry (see at least Reinhart: ¶ [0012-0013] & ¶ [0021] & ¶ [0029]. Reinhart notes that the radiographic measurement is carried out using a device that ascertains measurement data from a radiographic geometry around the object. The object is irradiated here from different radiographic directions. A radiographic geometry describes the direction in which radiation is passing through the object, and also the position of the irradiated region and the magnification. Generally speaking the radiographic geometry can be described by the position of the x-ray source and of the detector as seen from the point of view of the measurement object. This can, for example, refer to a reconstruction, a segmentation and/or a surface determination of the measurement data. For example here a dimensional analysis, in particular with reference to dimensions, shape, position, waviness, roughness, wall thicknesses, a target/actual comparison of defined geometries or in defined regions, a defect analysis, in particular for pores, blowholes, inclusions, cracks, porosities or structural loosening, and/or a material analysis, in particular a fibre composite analysis or a foam structure analysis, can be carried out.) or a structure of an uncertainty region within the first reconstruction (see at least Reinhart: ¶ [0021] & ¶ [0024-0025] & ¶ [0035-0037]. Reinhart teaches that the radiographic geometries can be identified using a provisional surface or a forward projection on the basis of the reconstruction. The provisional digital partial representation can, for example, be volume data from a provisional reconstruction, or a surface ascertained therefrom. Regions which so far have been acquired with an inadequate data quality are analyzed with reference to a provisional reconstruction. Those radiographic geometries that cover these regions are identified and preferably used. See also Reinhart at ¶ [0021]: From this it is possible to deduce whether details of a certain size, for example small structures, defects or fibres, can be recognized with a particular reliability or uncertainty with the present quality of measurement data. See also Reinhart at ¶ [0024-0025]: A certain quality of the measurement data, or uncertainty in the measurement data, can be expected for this purpose in a specific region if this region is acquired from a certain number of radiographic images. This can, for example, be deduced from the specification of the CT system in use. In a two-dimensional measurement or analysis, an uncertainty can be, for example, derived from recording parameters such as the size of the x-ray spot or the resolution of the detector. Alternatively, or in addition, parameters such as the noise or the contrast in the radiographic images can be analyzed.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein apparatus for creating an X-ray reconstruction with the aforementioned teachings of: a determining unit configured to determine a geometry or a structure of an uncertainty region within the first reconstruction, and in view of Reinhart, whereby at least one radiographic geometry is ascertained for the radiographic measurement of the object. For the at least one region of the at least one portion of the provisional digital representation of the object, in which the measurement data have a data quality that lies below the quality threshold value, a radiographic measurement is carried out using the at least one radiographic geometry. In this way additional measurement data that either have a better data quality and/or that improve the data quality in combination with the measurement data ascertained so far can be ascertained for regions in which the data quality of the measurement data ascertained so far is not sufficient to carry out accurate analyses (see at least Reinhart: ¶ [0065]).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Reinhart, the results of the combination were predictable.
Moreover, Dennerlein / Reinhart apparatus for creating an X-ray reconstruction does not explicitly disclose, but Lerch in the analogous art for creating an X-ray reconstruction does disclose the following:
- an ultrasound unit (see at least Lerch: 4th ¶ of Page 2 under description section. Lerch notes that when ultrasound imaging is used in addition to a CT, an independent ultrasound device is often provided to the computed tomography device.) acquiring an ultrasound recording restricted to a part of the object corresponding to the uncertainty region (see at least Lerch: 3rd ¶ of Page 4 & 1st ¶ - 3rd ¶ of Page 13. Lerch teaches that with the control commands, for example, an operating mode of the ultrasound probe can be set and / or adjusted. The operating mode of the ultrasonic probe may, for example, be selected from the operating mode group, which consists of a B-mode operating mode, an Mmode operating mode, a 1D operating mode, a 2D operating mode, a 3D operating mode, a 4D operating mode, a Doppler mode of operation, a color Doppler mode of operation, a spectral Doppler mode of operation, a contrast agent mode of operation, and combinations thereof. See also Lerch 1st ¶ - 3rd ¶ of Page 13: It is provided that the ultrasound data set has Doppler ultrasound measurement data. In the context of this application, the term color Doppler is understood to mean a color-coded Doppler ultrasound (FKDS). With color Doppler ultrasound probes, blood flow can also be measured in relatively small vessels. Due to the high dynamics of the heart muscle, however, this is often not possible, or only possible to a limited extent, in the relatively small coronary vessels. “The partial region can be, for example, an anomaly, in particular a constriction (stenosis) of the vessel. The section of the vessel may, in particular, be a section of the vessel which is located behind and / or in front of the constriction of the vessel with respect to a direction of fluid flow. In particular, a volume within which the flow parameter is determined can be automatically restricted to the automatically recognized subregion.” See also Lerch 1st ¶ - 3rd ¶ of Page 14: “Acquisition of first imaging data of the region to be imaged by means of a medical imaging device based on electromagnetic radiation, Reconstruction of the medical image data set based on the first imaging data. The provision of the medical image data record can include, for example, reconstructing the medical image data record based on the first imaging data and / or acquisition of the first imaging data by means of the medical imaging device. Acquisition of second imaging data by means of an ultrasound probe, generating the ultrasound data set based on the second imaging data.” Examiner note: Please note Lerch reference includes for a computed tomography, the first imaging data may be projection data, the imaging data acquisition unit may be a projection data acquisition unit, the radiation source may be an X-ray source, and the radiation detector may be an X-ray detector.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart apparatus for creating an X-ray reconstruction with the aforementioned teachings of: an ultrasound unit configured to acquire an ultrasound recording restricted to a part of the object corresponding to the uncertainty region, and in further view of Lerch, to perform an automatic evaluation of the temporal course of the movement of the anatomical structure and / or the spatial distribution of the ultrasound contrast agent in the anatomical structure based on the ultrasound data set. Alternatively, and / or in addition to the temporal course of the movement of the anatomical structure, in the case of automatic evaluation, a variable derived from the time profile or a further course derived from the time profile can be taken into account (see at least Lerch: last ¶ of Page 7 and 1st ¶ of Page 8).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Lerch, the results of the combination were predictable.
Moreover, Dennerlein / Reinhart / Lerch apparatus for creating an X-ray reconstruction does not explicitly disclose, but Ra, et. al. in the analogous art for creating an X-ray reconstruction does disclose the following:
- a data processing unit configured to (see at least Ra: Figs. 6-7 & 2nd ¶ - 3rd ¶ of Page 22. Li notes image reconstruction unit 720 correspond to the data acquisition unit 610 and the image reconstruction unit 620 of FIG. 6. Referring to FIG. 7, the tomographic apparatus 700 includes a data obtaining unit 710 and an image restoring unit 720.) combine data of the first reconstruction with data of the ultrasound recording to create a second reconstruction (see at least Ra: Page 4, Lns. 8-17 & Page 6, Lns 1-4 and Lns. 30-33 & Page 30, 2nd thru 3rd ¶’s. Ra teaches that wherein the target image is reconstructed using a plurality of projection data corresponding to a plurality of views that are RO data obtained by performing tomographic imaging while rotating at less than one rotation. Ra also notes that wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A moving image of a moving object is obtained by using the data obtained in each of the first angular section corresponding to the first viewpoint and the second angular section corresponding to the second viewpoint and facing the first angular section, And acquiring a second image; Acquiring first information indicating a motion amount of the object at a time point using the first image and the second image and reconstructing a target image representing the target object at a target point based on the first information. See also Ra at Page 6, Lns 1-4 and Lns. 30-33: Ra teaches wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A first partial image and a second partial image, which are partial images, are obtained by using tomographic images of a moving object and data obtained in each of a start angle section and an end angle section opposed to the start angle section. Obtaining first information indicating a motion of the object using the first image and the second image and reconstructing the target image using the first information. See also Ra at Page 30, 2nd thru 3rd ¶’s: Filtered Back Projection, Iterative method, and the like can be used as a method of reconstructing a tomographic image in the tomography apparatuses 600 and 700 have. The back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality. See also Ra at Page 51, Lns. 9-11: “The pixel 2254 along with the rectangular image grating 2241 and 2251 including the partial area 2261 and the partial area 2262 is further provided with a signal value '1' of the partial area 2261 and a signal value ' And '1.5' which is a signal value obtained by adding the value '0.5'.”).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch apparatus for creating an X-ray reconstruction with the aforementioned teachings of: a data processing unit configured to combine data of the first reconstruction with data of the ultrasound recording to create a second reconstruction, and in further view of Ra, et. al., whereby the back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality. (see at least Ra: 3rd ¶ of Page 30).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Ra, et. al., the results of the combination were predictable.
Regarding Independent Claim 14, Dennerlein electronically readable data carrier for creating an X-ray reconstruction teaches the following limitations:
- acquire an X-ray recording on an object (see at least Dennerlein: (Claim 1 of Dennerlein) & ¶ [0003] & ¶ [0009]. Dennerlein notes that 3D data may be made from a plurality of x-ray recordings during a circular arc shaped trajectory about any object or a patient (e.g., during cone beam computed tomography). The scanned region during x-ray image acquisition may be restricted due to external conditions (e.g., caused by a possible collision with the patient or an instrument unit). See also Dennerlein at ¶ [0009]: “A meaningful data record consisting of voxels is available if each voxel, as measured to the isocenter of the recording x-ray system, is acquired over at least a circular segment of 180 degrees plus 2 times half of the respective fan angle of the x-ray source of the x-ray system. The x-ray recordings are taken at intervals of approximately 1° or 2°, or there is at least one x-ray recording in an angle range of 1° to 2°. In practice, the scanned region is approximately a circular segment of 200° through which x-ray recordings of the object are made from the x-ray source in order to provide a 3D data field that is sufficient for reconstructing a 2D/3D x-ray image.” See also Claim 1 of Dennerlein noting “apparatus for assessing reconstructed x-ray images from a three-dimensional (3D) data field formed from a plurality of x-ray images recorded of an object from different predeterminable directions.”).
- create a first reconstruction from the X-ray recording (see at least Dennerlein: ¶ [0008-0009] & ¶ [0019]. Dennerlein teaches receive a plurality of x-ray recordings showing an examination object from different directions, from which a 2D or 3D data field representing the examination object is generated. The computing apparatus RE is configured to establish one confidence level for a plurality of elements of the 2D/3D data field The confidence level specifies a reliability or an imaging accuracy of an imaged part of the reconstructed x-ray image from a plurality of x-ray recordings. The scanned region is approximately a circular segment of 200° through which x-ray recordings of the object are made from the x-ray source in order to provide a 3D data field that is sufficient for reconstructing a 2D/3D x-ray image. As a result of restricting the scanned region, it is no longer the case that all required data is available for a region to be reconstructed (e.g., information for a complete 2D/3D reconstruction with respect to the reconstruction or formation of a 2D/3D x-ray image is missing for some of the voxels). See also Dennerlein at ¶ [0019]: The dividend of the confidence level k for an image point r(x, y, z) of a reconstructed 2D/3D x-ray image emerges from a first number of x-ray recordings made of an object in different angle ranges. This first number is divided by a second number of x-ray recordings of the object (O) for complete imaging of an image point r(x, y, z) in a 2D/3D x-ray image to be reconstructed.)
Moreover, Dennerlein electronically readable data carrier for creating an X-ray reconstruction does not explicitly disclose, but Reinhart in the analogous art for creating an X-ray reconstruction does disclose the following:
- determine a geometry (see at least Reinhart: ¶ [0012-0013] & ¶ [0021] & ¶ [0029]. Reinhart notes that the radiographic measurement is carried out using a device that ascertains measurement data from a radiographic geometry around the object. The object is irradiated here from different radiographic directions. A radiographic geometry describes the direction in which radiation is passing through the object, and also the position of the irradiated region and the magnification. Generally speaking the radiographic geometry can be described by the position of the x-ray source and of the detector as seen from the point of view of the measurement object. This can, for example, refer to a reconstruction, a segmentation and/or a surface determination of the measurement data. For example here a dimensional analysis, in particular with reference to dimensions, shape, position, waviness, roughness, wall thicknesses, a target/actual comparison of defined geometries or in defined regions, a defect analysis, in particular for pores, blowholes, inclusions, cracks, porosities or structural loosening, and/or a material analysis, in particular a fibre composite analysis or a foam structure analysis, can be carried out.) or a structure of an uncertainty region within the first reconstruction (see at least Reinhart: ¶ [0021] & ¶ [0024-0025] & ¶ [0035-0037]. Reinhart teaches that the radiographic geometries can be identified using a provisional surface or a forward projection on the basis of the reconstruction. The provisional digital partial representation can, for example, be volume data from a provisional reconstruction, or a surface ascertained therefrom. Regions which so far have been acquired with an inadequate data quality are analyzed with reference to a provisional reconstruction. Those radiographic geometries that cover these regions are identified and preferably used. See also Reinhart at ¶ [0021]: From this it is possible to deduce whether details of a certain size, for example small structures, defects or fibres, can be recognized with a particular reliability or uncertainty with the present quality of measurement data. See also Reinhart at ¶ [0024-0025]: A certain quality of the measurement data, or uncertainty in the measurement data, can be expected for this purpose in a specific region if this region is acquired from a certain number of radiographic images. This can, for example, be deduced from the specification of the CT system in use. In a two-dimensional measurement or analysis, an uncertainty can be, for example, derived from recording parameters such as the size of the x-ray spot or the resolution of the detector. Alternatively, or in addition, parameters such as the noise or the contrast in the radiographic images can be analyzed.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein method for creating an X-ray reconstruction with the aforementioned teachings of: determining a geometry or a structure of an uncertainty region within the first reconstruction, and in view of Reinhart, whereby at least one radiographic geometry is ascertained for the radiographic measurement of the object. For the at least one region of the at least one portion of the provisional digital representation of the object, in which the measurement data have a data quality that lies below the quality threshold value, a radiographic measurement is carried out using the at least one radiographic geometry. In this way additional measurement data that either have a better data quality and/or that improve the data quality in combination with the measurement data ascertained so far can be ascertained for regions in which the data quality of the measurement data ascertained so far is not sufficient to carry out accurate analyses (see at least Reinhart: ¶ [0065]).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Reinhart, the results of the combination were predictable.
Moreover, Dennerlein / Reinhart electronically readable data carrier for creating an X-ray reconstruction does not explicitly disclose, but Lerch in the analogous art for creating an X-ray reconstruction does disclose the following:
- acquire an ultrasound recording restricted to a part of the object corresponding to the uncertainty region (see at least Lerch: 3rd ¶ of Page 4 & 1st ¶ - 3rd ¶ of Page 13. Lerch teaches that with the control commands, for example, an operating mode of the ultrasound probe can be set and / or adjusted. The operating mode of the ultrasonic probe may, for example, be selected from the operating mode group, which consists of a B-mode operating mode, an Mmode operating mode, a 1D operating mode, a 2D operating mode, a 3D operating mode, a 4D operating mode, a Doppler mode of operation, a color Doppler mode of operation, a spectral Doppler mode of operation, a contrast agent mode of operation, and combinations thereof. See also Lerch 1st ¶ - 3rd ¶ of Page 13: It is provided that the ultrasound data set has Doppler ultrasound measurement data. In the context of this application, the term color Doppler is understood to mean a color-coded Doppler ultrasound (FKDS). With color Doppler ultrasound probes, blood flow can also be measured in relatively small vessels. Due to the high dynamics of the heart muscle, however, this is often not possible, or only possible to a limited extent, in the relatively small coronary vessels. “The partial region can be, for example, an anomaly, in particular a constriction (stenosis) of the vessel. The section of the vessel may, in particular, be a section of the vessel which is located behind and / or in front of the constriction of the vessel with respect to a direction of fluid flow. In particular, a volume within which the flow parameter is determined can be automatically restricted to the automatically recognized subregion.” See also Lerch 1st ¶ - 3rd ¶ of Page 14: “Acquisition of first imaging data of the region to be imaged by means of a medical imaging device based on electromagnetic radiation, Reconstruction of the medical image data set based on the first imaging data. The provision of the medical image data record can include, for example, reconstructing the medical image data record based on the first imaging data and / or acquisition of the first imaging data by means of the medical imaging device. Acquisition of second imaging data by means of an ultrasound probe, generating the ultrasound data set based on the second imaging data.” Examiner note: Please note Lerch reference includes for a computed tomography, the first imaging data may be projection data, the imaging data acquisition unit may be a projection data acquisition unit, the radiation source may be an X-ray source, and the radiation detector may be an X-ray detector.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart electronically readable data carrier for creating an X-ray reconstruction with the aforementioned teachings of: acquire an ultrasound recording restricted to a part of the object corresponding to the uncertainty region, and in further view of Lerch, to perform an automatic evaluation of the temporal course of the movement of the anatomical structure and / or the spatial distribution of the ultrasound contrast agent in the anatomical structure based on the ultrasound data set. Alternatively, and / or in addition to the temporal course of the movement of the anatomical structure, in the case of automatic evaluation, a variable derived from the time profile or a further course derived from the time profile can be taken into account (see at least Lerch: last ¶ of Page 7 and 1st ¶ of Page 8).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Lerch, the results of the combination were predictable.
Moreover, Dennerlein / Reinhart / Lerch electronically readable data carrier for creating an X-ray reconstruction does not explicitly disclose, but Ra, et. al. in the analogous art for creating an X-ray reconstruction does disclose the following:
- combine data of the first reconstruction with data of the ultrasound recording to create a second reconstruction (see at least Ra: Page 4, Lns. 8-17 & Page 6, Lns 1-4 and Lns. 30-33 & Page 30, 2nd thru 3rd ¶’s. Ra teaches that wherein the target image is reconstructed using a plurality of projection data corresponding to a plurality of views that are RO data obtained by performing tomographic imaging while rotating at less than one rotation. Ra also notes that wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A moving image of a moving object is obtained by using the data obtained in each of the first angular section corresponding to the first viewpoint and the second angular section corresponding to the second viewpoint and facing the first angular section, And acquiring a second image; Acquiring first information indicating a motion amount of the object at a time point using the first image and the second image and reconstructing a target image representing the target object at a target point based on the first information. See also Ra at Page 6, Lns 1-4 and Lns. 30-33: Ra teaches wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A first partial image and a second partial image, which are partial images, are obtained by using tomographic images of a moving object and data obtained in each of a start angle section and an end angle section opposed to the start angle section. Obtaining first information indicating a motion of the object using the first image and the second image and reconstructing the target image using the first information. See also Ra at Page 30, 2nd thru 3rd ¶’s: Filtered Back Projection, Iterative method, and the like can be used as a method of reconstructing a tomographic image in the tomography apparatuses 600 and 700 have. The back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality. See also Ra at Page 51, Lns. 9-11: “The pixel 2254 along with the rectangular image grating 2241 and 2251 including the partial area 2261 and the partial area 2262 is further provided with a signal value '1' of the partial area 2261 and a signal value ' And '1.5' which is a signal value obtained by adding the value '0.5'.”).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch electronically readable data carrier for creating an X-ray reconstruction with the aforementioned teachings of: combine data of the first reconstruction with data of the ultrasound recording to create a second reconstruction, and in further view of Ra, et. al., whereby the back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality (see at least Ra: 3rd ¶ of Page 30).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Ra, et. al., the results of the combination were predictable.
Regarding Dependent Claim 2, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Dennerlein further teaches the method for creating an X-ray reconstruction comprising:
- wherein the X-ray recording is a Cone-Beam Computed Tomography (CBCT) recording (see at least Dennerlein: ¶ [0003]. Dennerlein teaches that using the produced two-dimensional (2D) x-ray recordings, it is possible to generate a three-dimensional (3D) data field and, depending on the problem, reconstruct arbitrary views of an object in order to contribute to planning and/or performing surgical and/or therapeutic measures. For example, 3D data may be made from a plurality of x-ray recordings during a circular arc shaped trajectory about any object or a patient (e.g., during cone beam computed tomography).)
Regarding Dependent Claim 3, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Reinhart further teaches the method for creating an X-ray reconstruction comprising:
- wherein the geometry (see at least Reinhart: ¶ [0012-0013] & ¶ [0021] & ¶ [0029]. Reinhart notes that the radiographic measurement is carried out using a device that ascertains measurement data from a radiographic geometry around the object. The object is irradiated here from different radiographic directions. A radiographic geometry describes the direction in which radiation is passing through the object, and also the position of the irradiated region and the magnification. Generally speaking the radiographic geometry can be described by the position of the x-ray source and of the detector as seen from the point of view of the measurement object. This can, for example, refer to a reconstruction, a segmentation and/or a surface determination of the measurement data. For example here a dimensional analysis, in particular with reference to dimensions, shape, position, waviness, roughness, wall thicknesses, a target/actual comparison of defined geometries or in defined regions, a defect analysis, in particular for pores, blowholes, inclusions, cracks, porosities or structural loosening, and/or a material analysis, in particular a fibre composite analysis or a foam structure analysis, can be carried out.) of the uncertainty region relates to a location and/or an extent within the first reconstruction (see at least Reinhart: ¶ [0017] & ¶ [0024-0025] & ¶ [0035-0037]. Reinhart teaches that the radiographic geometries can be identified using a provisional surface or a forward projection on the basis of the reconstruction. The provisional digital partial representation can, for example, be volume data from a provisional reconstruction, or a surface ascertained therefrom. Regions which so far have been acquired with an inadequate data quality are analyzed with reference to a provisional reconstruction. Those radiographic geometries that cover these regions are identified and preferably used. See also Reinhart at ¶ [0017]: This can be a global minimum quality of the measurement data specified for the entire measurement volume, or a local minimum quality of the measurement data defined depending on the location or on a property that is to be measured. See also Reinhart at ¶ [0021]: From this it is possible to deduce whether details of a certain size, for example small structures, defects or fibres, can be recognized with a particular reliability or uncertainty with the present quality of measurement data. See also Reinhart at ¶ [0024-0025]: A certain quality of the measurement data, or uncertainty in the measurement data, can be expected for this purpose in a specific region if this region is acquired from a certain number of radiographic images. This can, for example, be deduced from the specification of the CT system in use. In a two-dimensional measurement or analysis, an uncertainty can be, for example, derived from recording parameters such as the size of the x-ray spot or the resolution of the detector. Alternatively, or in addition, parameters such as the noise or the contrast in the radiographic images can be analyzed.)
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein the geometry of the uncertainty region relates to a location and/or an extent within the first reconstruction, and in further view of Reinhart, whereby at least one radiographic geometry is ascertained for the radiographic measurement of the object. For the at least one region of the at least one portion of the provisional digital representation of the object, in which the measurement data have a data quality that lies below the quality threshold value, a radiographic measurement is carried out using the at least one radiographic geometry. In this way additional measurement data that either have a better data quality and/or that improve the data quality in combination with the measurement data ascertained so far can be ascertained for regions in which the data quality of the measurement data ascertained so far is not sufficient to carry out accurate analyses (see at least Reinhart: ¶ [0065]).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Reinhart, the results of the combination were predictable.
Regarding Dependent Claim 4, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Lerch further teaches the method for creating an X-ray reconstruction comprising:
- wherein the ultrasound recording (see at least Lerch on last ¶ of Page 10: Lerch teaches “determining a transformation for image registration of an ultrasound dataset and a medical image dataset recorded with electromagnetic radiation relative to one another”. See also 2nd ¶ of Page 8: The medical image data set can be displayed superimposed on the patient together with the ultrasound data record during an ultrasound-guided intervention in the form of extended real-time information.) is acquired by way of a technique based on shear waves, Doppler ultrasound, or image capture by higher harmonics (see at least Lerch: 3rd ¶ of Page 4 & 1st ¶ - 3rd ¶ of Page 13. Lerch teaches that with the control commands, for example, an operating mode of the ultrasound probe can be set and / or adjusted. The operating mode of the ultrasonic probe may, for example, be selected from the operating mode group, which consists of a B-mode operating mode, an Mmode operating mode, a 1D operating mode, a 2D operating mode, a 3D operating mode, a 4D operating mode, a Doppler mode of operation, a color Doppler mode of operation, a spectral Doppler mode of operation, a contrast agent mode of operation, and combinations thereof. See also Lerch 1st ¶ - 3rd ¶ of Page 13: It is provided that the ultrasound data set has Doppler ultrasound measurement data. In the context of this application, the term color Doppler is understood to mean a color-coded Doppler ultrasound (FKDS). With color Doppler ultrasound probes, blood flow can also be measured in relatively small vessels. Due to the high dynamics of the heart muscle, however, this is often not possible, or only possible to a limited extent, in the relatively small coronary vessels.)
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein the ultrasound recording is acquired by way of a technique based on shear waves, Doppler ultrasound, or image capture by higher harmonics, and in further view of Lerch, to perform an automatic evaluation of the temporal course of the movement of the anatomical structure and / or the spatial distribution of the ultrasound contrast agent in the anatomical structure based on the ultrasound data set. Alternatively, and / or in addition to the temporal course of the movement of the anatomical structure, in the case of automatic evaluation, a variable derived from the time profile or a further course derived from the time profile can be taken into account (see at least Lerch: last ¶ of Page 7 and 1st ¶ of Page 8).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Lerch, the results of the combination were predictable.
Regarding Dependent Claim 5, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Reinhart further teaches the method for creating an X-ray reconstruction comprising:
- where both the first reconstruction and the ultrasound recording are three-dimensional (3D) recordings (see at least Reinhart: ¶ [0009-0010] & ¶ [0014] & ¶ [0057]. Reinhart teaches that the measurement is a radiographic measurement, for example with x-rays, neutrons or ultrasound. In a radiographic measurement, the analysis can be carried out on the basis of 2D radiographic images, a reconstructed 3D volume, or a combination of both. Recording parameters of a projection can be the radiographic geometry of the projection and/or setting options that can be set during the radiographic examination of an object. See also Reinhart at ¶ [0014]: For example the evaluation of three-dimensional measurement data that is ascertained from radiographic measurements of an object. See also Reinhart at ¶ [0057]: This can, for example, be a two-dimensional representation of the object or a three-dimensional representation of the object. The digital representation of the object can equally be derived from measurement data, for example, in the case of radiographic measurements, through a tomographic reconstruction.)
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: where both the first reconstruction and the ultrasound recording are three-dimensional (3D) recordings, and in further view of Reinhart, whereby at least one radiographic geometry is ascertained for the radiographic measurement of the object. For the at least one region of the at least one portion of the provisional digital representation of the object, in which the measurement data have a data quality that lies below the quality threshold value, a radiographic measurement is carried out using the at least one radiographic geometry. In this way additional measurement data that either have a better data quality and/or that improve the data quality in combination with the measurement data ascertained so far can be ascertained for regions in which the data quality of the measurement data ascertained so far is not sufficient to carry out accurate analyses (see at least Reinhart: ¶ [0065]).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Reinhart, the results of the combination were predictable.
Regarding Dependent Claim 6, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Lerch further teaches the method for creating an X-ray reconstruction comprising:
- wherein the data of the ultrasound recording (see at least Lerch: last ¶ of Page 3 & 1st ¶ of Page 4. Lerch teaches that it is provided that the control device has an ultrasound data record generation module which is designed to generate an ultrasound dataset based on the second imaging data. The ultrasound data record can have, for example, spatially resolved ultrasound image data and / or spatially resolved ultrasound measurement data. See also Lerch at 1st ¶ of Page 4: The ultrasound data record can have, for example, an ultrasound image with a plurality of image points, wherein each image point of the plurality of image points are assigned an image value and / or a measured value. For example, the ultrasound data set may include an ultrasound image dataset having multiple ultrasound images.) comprises material information, tissue information, or structural information (see at least Lerch: 6th ¶ of Page 4: it is provided that the ultrasound probe is designed to acquire second imaging data. The second imaging data may, for example, relate to an area to be imaged, in particular a region of a patient to be imaged, an anatomical structure being located in the region to be imaged. Examiner Note: Examiner interprets that Lerch discloses the data of the ultrasound record which comprises structural information.)
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein the data of the ultrasound recording comprises material information, tissue information, or structural information, and in further view of Lerch, to perform an automatic evaluation of the temporal course of the movement of the anatomical structure and / or the spatial distribution of the ultrasound contrast agent in the anatomical structure based on the ultrasound data set. Alternatively, and / or in addition to the temporal course of the movement of the anatomical structure, in the case of automatic evaluation, a variable derived from the time profile or a further course derived from the time profile can be taken into account (see at least Lerch: last ¶ of Page 7 and 1st ¶ of Page 8).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Lerch, the results of the combination were predictable.
Regarding Dependent Claim 7, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Lerch further teaches the method for creating an X-ray reconstruction comprising:
- wherein an ultrasound unit (see at least Lerch: 4th ¶ of Page 2: When ultrasound imaging is used in addition to CT, an independent ultrasound device is often provided to the computed tomography device. For many applications, such a configuration is not optimal with respect to the interaction of components of the ultrasound device and components of the computed tomography device.) is controlled for acquiring the ultrasound recording in dependence upon the geometry of the uncertainty region (see at least Lerch: 3rd ¶ of Page 4 & 1st ¶ - 3rd ¶ of Page 13. Lerch teaches that with the control commands, for example, an operating mode of the ultrasound probe can be set and / or adjusted. The operating mode of the ultrasonic probe may, for example, be selected from the operating mode group, which consists of a B-mode operating mode, an Mmode operating mode, a 1D operating mode, a 2D operating mode, a 3D operating mode, a 4D operating mode, a Doppler mode of operation, a color Doppler mode of operation, a spectral Doppler mode of operation, a contrast agent mode of operation, and combinations thereof. See also Lerch 1st ¶ - 3rd ¶ of Page 13: It is provided that the ultrasound data set has Doppler ultrasound measurement data. In the context of this application, the term color Doppler is understood to mean a color-coded Doppler ultrasound (FKDS). With color Doppler ultrasound probes, blood flow can also be measured in relatively small vessels. Due to the high dynamics of the heart muscle, however, this is often not possible, or only possible to a limited extent, in the relatively small coronary vessels. “The partial region can be, for example, an anomaly, in particular a constriction (stenosis) of the vessel. The section of the vessel may, in particular, be a section of the vessel which is located behind and / or in front of the constriction of the vessel with respect to a direction of fluid flow. In particular, a volume within which the flow parameter is determined can be automatically restricted to the automatically recognized subregion.” See also Lerch 1st ¶ - 3rd ¶ of Page 14: “Acquisition of first imaging data of the region to be imaged by means of a medical imaging device based on electromagnetic radiation, Reconstruction of the medical image data set based on the first imaging data. The provision of the medical image data record can include, for example, reconstructing the medical image data record based on the first imaging data and / or acquisition of the first imaging data by means of the medical imaging device. Acquisition of second imaging data by means of an ultrasound probe, generating the ultrasound data set based on the second imaging data.” Examiner note: Please note Lerch reference includes for a computed tomography, the first imaging data may be projection data, the imaging data acquisition unit may be a projection data acquisition unit, the radiation source may be an X-ray source, and the radiation detector may be an X-ray detector.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein an ultrasound unit is controlled for acquiring the ultrasound recording in dependence upon the geometry of the uncertainty region, and in further view of Lerch, to perform an automatic evaluation of the temporal course of the movement of the anatomical structure and / or the spatial distribution of the ultrasound contrast agent in the anatomical structure based on the ultrasound data set. Alternatively, and / or in addition to the temporal course of the movement of the anatomical structure, in the case of automatic evaluation, a variable derived from the time profile or a further course derived from the time profile can be taken into account (see at least Lerch: last ¶ of Page 7 and 1st ¶ of Page 8).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Lerch, the results of the combination were predictable.
Regarding Dependent Claim 8, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Reinhart further teaches the method for creating an X-ray reconstruction comprising:
- wherein the uncertainty region (see at least Reinhart: ¶ [0017] & ¶ [0024-0025] & ¶ [0047]. Reinhart notes that in addition, an estimate of the measurement uncertainty is taken into consideration, for example on the basis of the current quality of the measurement data, although also on the basis of empirical values, it is possible to ascertain whether the value is safely inside or outside the tolerance interval. See also Reinhart at ¶ [0024]: “A certain quality of the measurement data, or uncertainty in the measurement data, can be expected for this purpose in a specific region if this region is acquired from a certain number of radiographic images.”) is situated at least partially outside a target recording region of an X-ray device used for the X-ray recording (see at least Reinhart: Fig. 1 & ¶ [0024-0025] & ¶ [0034-0035]. Reinhart notes that in a two-dimensional measurement or analysis, an uncertainty can be, for example, derived from recording parameters such as the size of the x-ray spot or the resolution of the detector. See also Reinhart at ¶ [0035]: The provisional digital partial representation can, for example, be volume data from a provisional reconstruction, or a surface ascertained therefrom. See also Claim 9 of Reinhart noting “Ascertainment of at least one accuracy value interval for a surface in the digital partial representation; ascertainment of an estimated value for the accuracy of the surface; and definition of a region around the surface, wherein the region comprises the surface, as a region with a data quality value below the quality threshold value if the estimated value lies outside the accuracy value interval.”).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein the uncertainty region is situated at least partially outside a target recording region of an X-ray device used for the X-ray recording, and in further view of Reinhart, whereby the measurement is a radiographic measurement, for example with x-rays, neutrons or ultrasound. In a radiographic measurement, the analysis can be carried out on the basis of 2D radiographic images, a reconstructed 3D volume, or a combination of both (see at least Reinhart: ¶ [0009]). Empirical values can furthermore be used for different analyses, in order to estimate the local quality of the measurement data and/or the uncertainty. A certain quality of the measurement data, or uncertainty in the measurement data, can be expected for this purpose in a specific region if this region is acquired from a certain number of radiographic images. In a two-dimensional measurement or analysis, an uncertainty can be, for example, derived from recording parameters such as the size of the x-ray spot or the resolution of the detector (see at least Reinhart: ¶ [0024-0025).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Reinhart, the results of the combination were predictable.
Regarding Dependent Claim 9, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Reinhart further teaches the method for creating an X-ray reconstruction comprising:
- wherein the determining of the geometry of the uncertainty region (see at least Reinhart: ¶ [0021] & ¶ [0024-0025] & ¶ [0047]. Reinhart teaches that a determination of the—possibly local—quality of the measurement data is necessary. In addition, a determination of the local uncertainty resulting from the quality of the measurement data can be performed, and this can be set in relation with the ascertained measurement result and tolerance, as well as the position of the ascertained measurement result within this tolerance. In the case of dimensional metrology, the local volume data can be analyzed in order to estimate a local uncertainty of the measurement, for example the position of the surface or of geometric elements adapted to the surface.) takes place based on an image contrast of the first reconstruction (see at least Reinhart: ¶ [0021] & ¶ [0025] & ¶ [0041]. Reinhart teaches that it is possible to deduce whether details of a certain size, for example small structures, defects or fibres, can be recognized with a particular reliability or uncertainty with the present quality of measurement data. What is known as a “contrast detail detectability” can be derived from this. See also Reinhart at ¶ [0025]: “Alternatively or in addition, parameters such as the noise or the contrast in the radiographic images can be analyzed.” See also Reinhart at ¶ [0035]: The radiographic geometries can be identified using a provisional surface or a forward projection on the basis of the reconstruction. The provisional digital partial representation can, for example, be volume data from a provisional reconstruction, or a surface ascertained therefrom. See also Reinhart at ¶ [0041].), an image sharpness of the first reconstruction, or a convergence rate of an algorithm used for the first reconstruction
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein the determining of the geometry of the uncertainty region takes place based on an image contrast of the first reconstruction, an image sharpness of the first reconstruction, or a convergence rate of an algorithm used for the first reconstruction, and in further view of Reinhart, whereby the measurement is a radiographic measurement, for example with x-rays, neutrons or ultrasound. In a radiographic measurement, the analysis can be carried out on the basis of 2D radiographic images, a reconstructed 3D volume, or a combination of both (see at least Reinhart: ¶ [0009]). Empirical values can furthermore be used for different analyses, in order to estimate the local quality of the measurement data and/or the uncertainty. A certain quality of the measurement data, or uncertainty in the measurement data, can be expected for this purpose in a specific region if this region is acquired from a certain number of radiographic images. In a two-dimensional measurement or analysis, an uncertainty can be, for example, derived from recording parameters such as the size of the x-ray spot or the resolution of the detector (see at least Reinhart: ¶ [0024-0025).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Reinhart, the results of the combination were predictable.
Regarding Dependent Claim 10, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Ra further teaches the method for creating an X-ray reconstruction comprising:
- wherein a movement correction of at least a part of the first reconstruction is carried out with the ultrasound data to acquire the second reconstruction (see at least Ra: Figs. 31-32 & 8th ¶ of Page 45. Ra teaches that the image reconstructing unit 720 reconstructs the target image by using the projection data obtained at the target point of time Ttarget except for the surface portion of the object or the region of the object, The surface region of the object or the region of the object imaged by the projection data can perform motion correction using the first information. See also Li at 2nd ¶ of Page 57: Ra notes that the medical image may be a medical image such as a scout image, a tomographic image, an MRI image, an X-ray image, or an ultrasound image. See also Ra at 1st ¶ of Page 58: Movement of the person's front direction 3330, a lot of movement occurs in the front direction 3330 of the person, (E. G., 3171) extending in a direction adjacent to the < / RTI > That is, if a lot of movement in the front direction 3330 occurs, the surface 3171 must be clearly imaged in the first and second images used to obtain the first information. The amount of motion of the object in the front direction 3330 can be accurately grasped by comparing the surface 3171 imaged in the first image with the surface 3171 imaged in the second image to obtain the first information to be.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein a movement correction of at least a part of the first reconstruction is carried out with the ultrasound data to acquire the second reconstruction, and in further view of Ra, et. al., whereby the back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality (see at least Ra: 3rd ¶ of Page 30).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Ra, et. al., the results of the combination were predictable.
Regarding Dependent Claim 11, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Independent Claim 1 above, and Ra further teaches the method for creating an X-ray reconstruction comprising:
- wherein the combining of the data of the first reconstruction with data of the ultrasound recording (see at least Ra: Page 4, Lns. 8-17 & Page 6, Lns 1-4 and Lns. 30-33 & Page 30, 2nd thru 3rd ¶’s. Ra teaches that wherein the target image is reconstructed using a plurality of projection data corresponding to a plurality of views that are RO data obtained by performing tomographic imaging while rotating at less than one rotation. Ra also notes that wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A moving image of a moving object is obtained by using the data obtained in each of the first angular section corresponding to the first viewpoint and the second angular section corresponding to the second viewpoint and facing the first angular section, And acquiring a second image; Acquiring first information indicating a motion amount of the object at a time point using the first image and the second image and reconstructing a target image representing the target object at a target point based on the first information. See also Ra at Page 6, Lns 1-4 and Lns. 30-33: Ra teaches wherein the information indicating the amount of movement of the surface of the object during the first time point to the second time point. A first partial image and a second partial image, which are partial images, are obtained by using tomographic images of a moving object and data obtained in each of a start angle section and an end angle section opposed to the start angle section. Obtaining first information indicating a motion of the object using the first image and the second image and reconstructing the target image using the first information. See also Ra at Page 30, 2nd thru 3rd ¶’s: Filtered Back Projection, Iterative method, and the like can be used as a method of reconstructing a tomographic image in the tomography apparatuses 600 and 700 have. The back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality. See also Ra at Page 51, Lns. 9-11: “The pixel 2254 along with the rectangular image grating 2241 and 2251 including the partial area 2261 and the partial area 2262 is further provided with a signal value '1' of the partial area 2261 and a signal value ' And '1.5' which is a signal value obtained by adding the value '0.5'.”) comprises registration of the ultrasound recording to the first reconstruction (see at least Ra: 6th ¶ of Page 33. Li notes that the motion vector field is information obtained for motion extraction of the object, and it is possible to measure the amount of motion of the object using non-rigid registration. See also Li at Page 4: Wherein the motion vector information is information corresponding to a motion vector field between the first image and the second image and is information indicating a motion amount of a surface forming the object corresponding to each time point.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein the combining of the data of the first reconstruction with data of the ultrasound recording comprises a registration of the ultrasound recording to the first reconstruction, and in further view of Ra, et. al., whereby the back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality (see at least Ra: 3rd ¶ of Page 30).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Ra, et. al., the results of the combination were predictable.
Regarding Dependent Claim 12, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Claims 1 and 11 above, and Lerch further teaches the method for creating an X-ray reconstruction comprising:
- wherein a specifiable high contrast object is determined as the structure, wherein a position of the high contrast object (see at least Lerch: ¶ [abstract] & 4th ¶ of Page 8. Lerch notes determining position information with which the section of the vessel is locatable in the ultrasound data set, based on the medical image data set, - determining the flow parameter, which determines the fluid flow in the section of the vessel based on the ultrasound data set and based on the position information. See also Lerch at 4th ¶ of Page 8: Providing an ultrasound dataset which relates to a temporal course of a movement of the anatomical structure and / or a spatial distribution of an ultrasound contrast agent in the anatomical structure, and determining a trigger time based on the ultrasound data set.) is acquired by way of triangulation (see at least Lerch: 4th ¶ of Page 6. Lerch teaches that the ultrasound probe can be detected, for example, directly by means of the optical sensor system. Infrared reflectors may be arranged on the ultrasound probe, which are detected by means of the optical sensor system. The radio-tracking system may for example be based on a triangulation of radio signals. The control device can be designed, for example, for controlling the locating system.).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein a specifiable high contrast object is determined as the structure, wherein a position of the high contrast object is acquired by way of triangulation, and in further view of Lerch, to perform an automatic evaluation of the temporal course of the movement of the anatomical structure and / or the spatial distribution of the ultrasound contrast agent in the anatomical structure based on the ultrasound data set. Alternatively, and / or in addition to the temporal course of the movement of the anatomical structure, in the case of automatic evaluation, a variable derived from the time profile or a further course derived from the time profile can be taken into account (see at least Lerch: last ¶ of Page 7 and 1st ¶ of Page 8).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Lerch, the results of the combination were predictable.
Moreover, however regarding Dependent Claim 12, Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction teaches the limitations of Claims 1 and 11 above, and Ra further teaches the method for creating an X-ray reconstruction comprising:
- wherein the registration of the ultrasound recording to the first reconstruction takes place in dependence upon the position of the high contrast object (see at least Ra: 2nd ¶ of Page 57 & 4th-5th ¶’s of Page 58. Ra teaches the medical image may be a medical image such as a scout image, a tomographic image, an MRI image, an X-ray image, or an ultrasound image. See also Ra at Page 2 noting “Wherein the measurement is performed using non-rigid registration.” and Ra at 6th ¶ of Page 33 noting “the motion vector field is information obtained for motion extraction of the object, and it is possible to measure the amount of motion of the object using non-rigid registration. In addition, the amount of motion of the object can be measured using various motion measurement techniques such as rigid registration, optical flow, and feature matching.” See also Ra at 4th-5th ¶’s of Page 58: Specifically, the data obtaining unit 710 obtains the first image corresponding to the first viewpoint through the partial angle reconstruction and obtains the second image corresponding to the second viewpoint. Then, based on the amount of motion between the first image and the second image, the first information indicating the relationship between the amount of motion and the time of the object can be obtained. The data obtaining unit 710 reconstructs at least one or more reference images for estimating the motion of the object by rotating and rotating at angular intervals less than one rotation about the object and acquires first information indicating the amount of motion of the object do. Here, the 'angular section of less than one rotation' may correspond to the same one-angular section. Also, at least one reference image may be a partial angle image obtained in a partial angle section included in one-week angular interval. Specifically, the reference image may be at least one of the first image 1310 and the second image 1320 described.)
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have combined / modified the teachings of Dennerlein / Reinhart / Lerch / Ra method for creating an X-ray reconstruction with the aforementioned teachings of: wherein the registration of the ultrasound recording to the first reconstruction takes place in dependence upon the position of the high contrast object, and in further view of Ra, whereby the back projection method is a method in which projection data obtained in a plurality of directions (view) is added back to the pixel surface and added together to restore the image. Specifically, the back projection method can obtain an image similar to an actual image by using projection data in a plurality of directions. In addition, filtering may be additionally performed to remove artifacts existing in the reconstructed image and to improve image quality (see at least Ra: 3rd ¶ of Page 30).
Further, the claimed invention is merely a combination of old elements in a similar field for creating an X-ray reconstruction and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that, given the existing technical ability to combine the elements as evidenced by Ra, et. al., the results of the combination were predictable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US Patents and/or US PG Pub Documents
-> US PG Pub (US 2018/0211420 A1) – “Tomographic Device and Tomographic Image Processing Method according to the same”, hereinafter Yoo, et. al.
-> US PG Pub (US 2015/0243070 A1) – “Tomography Apparatus and Method of Reconstructing a Tomography Image by the Tomography Apparatus”, hereinafter Ra, et. al.
-> US PG Pub (US 2017/0209112 A1) – “Tomography Apparatus and Method of Reconstructing Tomography Image”, hereinafter Yi, et. al.
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/DERICK J HOLZMACHER/ Patent Examiner, Art Unit 3625
/VINCENT RUDOLPH/ Supervisory Patent Examiner, Art Unit 2671