DETAILED ACTION
Summary
Claims 1-14, and 16-21 are pending in the application. Claims 1-7, 9-14, and 16-21 are rejected under 35 USC 103.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 10 objected to because of the following informalities:
Claim 10 recites “the additional recordings of image data” in line 7. It should recite “the additional recordings of additional image data”.
Appropriate correction is required.
Claim Interpretation
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.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an application unit” in claim 11, “a number of X-ray device components” in claim 11, “a reconstruction unit” in claim 11, and “an output unit” in claim 11.
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.
The limitations will be interpreted as follows:
“an application unit” will be interpreted as an automatically controlled injector, consistent with [0049] of the specification.
“a number of X-ray device components” will be interpreted as a radiation source and radiation detector, consistent with [0063] of the specification.
“a reconstruction unit” will be interpreted as software running on computer hardware, consistent with [0069]+[0095] of the specification.
“an output unit” will be interpreted as a display, consistent with Fig. 1, 11 and [0068]+[0091] of the specification.
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.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 6, 13, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Javor et al. (Javor, D., et al. "Endoleak detection using single-acquisition split-bolus dual-energy computer tomography (DECT)." European Radiology 27.4 (2017): 1622-1630.) in view of Proksa et al. (U.S PGPub 2019/0239842 A1) and Breeuwer et al. (U.S PGPub 2016/0235330 A1).
Regarding Claim 1, Javor teaches a method of operating an X-ray device for creating reconstructed images of a body region (Pg. 1622, Abstract), the method comprising:
triggering administration of a first contrast medium application for presaturation of the body region with contrast medium (Pg. 1623, Col 2, CT acquisition protocol (split bolus)) (Table 2);
triggering administration of a second contrast medium application, the second contrast medium application having a bolus larger than in the first contrast medium application (Pg. 1623, Col 2, CT acquisition protocol (split bolus)) (Table 2);
recording spectral image data at at least two different beam energies (Pg. 1624, Col 1, ¶1-2) (DECT obtains spectral image data);
reconstructing images from the spectral image data (Pg. 1624, Col 1, ¶3 “Data processing and evaluation of the split-bolus scan”); and
outputting the images (Pg. 1624, Col 1, ¶3) (Pg. 1624, Col 1-2, ¶6-1) (Fig. 1 shows the outputted images).
Javor fails to explicitly teach triggering administration of the second contrast medium application in response to the first contrast medium application reaching a first equilibrium concentration.
Proksa teaches a system for detecting endoleaks using multiple contrast agents (Abstract). This system triggers administration of the second contrast medium administration in response to the first contrast medium application reaching a first equilibrium concentration (Fig. 3, T2) [0041]-[0042] (the second administration occurs a time after the peak TP of the first contrast is achieved. As detailed in the Applicant’s specification at [0013], the equilibrium concentration of a contrast occurs after the contrast reaches the peak or decreases again. As Proksa has the second administration occur after the first concentration reaches its peak, then starts to decline, the second administration is triggered in response to the first contrast medium reaching a first equilibrium concentration).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Javor so the second bolus is administered in response to the first contrast medium reaching an equilibrium concentration, as taught by Proksa, because this allows for improved detection of an endoleak, thereby increasing the quality of imaging, as recognized by Proksa [0005].
Alternatively, assuming Proksa were silent regarding the first contrast medium application achieving first equilibrium concentration, the combination would be still be obvious further combined with Breeuwer.
Breeuwer teaches a method of imaging the heart (Abstract). This system administers contrast medium in such a way that it achieves an equilibrium (steady-state) concentration [0024].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of administering the first contrast medium so that it achieves a desired equilibrium concentration, as taught by Breeuwer, as the substitution for one known method of administering contrast with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the contrast being administered to achieve a desired equilibrium concentration are reasonably predictable.
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Javor further teaches wherein the contrast medium is administered at more than 4 ml/s in the bolus of the second contrast medium application (Pg. 1624, Table 2, 25-30 BMI and >30 BMI).
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Javor further teaches determining a point in time of the second contrast medium application using the first contrast medium application (Pg. 1623, CT acquisition protocol (split bolus)) (The second contrast medium application occurs 35 second after the first contrast medium application (the time of the first contrast medium application is used to decide on the second contrast medium application)).
Regarding Claim 13, Javor further teaches a control device configured to control a computed tomography system (Pg. 1623-1624, CT acquisition protocol (split bolus)), the computed tomography system configured to operate according to the method as claimed in claim 1 (See rejection of claim 1 above).
Javor is silent regarding a control device.
Breeuwer teaches a method of imaging the heart (Abstract). The system controls the imaging modality with a control device [0041].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of controlling the CT scanner, as taught by the combination, with a control device, as taught by Breeuwer, as the substitution for one known method of controlling an imaging modality with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the control occurring with a control device are reasonably predictable.
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. The combination further teaches operate according to the method as claimed in claim 1 (See rejection of claim 1 above).
Javor fails to explicitly teach a non-transitory computer-readable medium storing computer-executable instructions that, when executed by a computer at a system, cause the system to operate.
Breeuwer teaches a method of imaging the heart (Abstract). The system contains a non-transitory computer program product comprising commands that, when executed by a computer at a system, trigger the system to operate [0041].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of controlling the CT scanner, as taught by the combination, with a control device, as taught by Breeuwer, as the substitution for one known method of controlling an imaging modality with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the control occurring with a control device are reasonably predictable.
Regarding Claim 19, the combination of references teaches the invention substantially as claimed. Javor further teaches wherein the contrast medium is administered at more than 5 ml/s in the second contrast medium application (Pg. 1624, Table 2); and the second contrast medium application is adapted based on at least one of cardiac output, anatomy to be analyzed, or pathology (Table 2) (Pg. 1623-1624, CT acquisition protocol (split bolus)) (the second contrast medium is adapted based on BMI, which is indicative of a pathology (i.e. obese patient obtained more contrast medium)).
Claims 3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa and Breeuwer as applied to claim 1 above, and further in view of Flohr et al. (U.S PGPub 2013/0077845 A1) and Ohishi (U.S PGPub 2016/0015279 A1).
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the reconstructing of the images comprises: segmenting different base materials to obtain a plurality of segments; and selectively highlighting, attenuating, or masking the plurality of segments in at least one of the images depending on at least one contrast medium concentration, wherein at least one of areas having increased contrast medium concentrations are selectively enhanced, contrast medium concentrations lying outside a value range are visualized on virtual native images, or contrast having concentrations that are below a first threshold value are selectively enhanced, wherein a detection of fresh versus organized thrombi is included for the selective enhancement, areas with contrast medium concentrations above a second threshold value are masked, not further amplified, or linearly co-amplified, arterial and venous phases in the brain or bronchus are separated, or a distinction is made between an arterial and portal venous phase of an accumulation of contrast medium in the liver.
Flohr teaches a system for determining perfusion defects (Abstract). This system reconstructs images by segmenting different base materials to obtain a plurality of segments [0098]-[0099].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to segment base materials, as taught by Flohr, as this provides a better method for detecting perfusion defects, as recognized by Flohr [0008].
The combined system fails to explicitly teach selectively highlighting, attenuating, or masking segments in an image depending on at least one contrast medium concentration, wherein at least one of areas having increased contrast medium concentrations are selectively enhanced.
Ohishi teaches a system for imaging blood vessels (Abstract). This system selectively highlights an image depending on the contrast agent concentration, where areas having increased contrast medium concentrations are selectively enhanced [0190].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to selectively enhances areas with increased concentration, as taught by Ohishi, because this better allows the user to determine the shape of a blood vessel, as recognized by Ohishi [0007].
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the reconstructing of the images comprises: segmenting different base materials to obtain a plurality of segments; and selectively highlighting, attenuating or masking the plurality of segments in at least one of the images depending on the at least one contrast medium concentration.
Flohr teaches a system for determining perfusion defects (Abstract). This system reconstructs images by segmenting different base materials to obtain a plurality of segments [0098]-[0099].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to segment base materials, as taught by Flohr, as this provides a better method for detecting perfusion defects, as recognized by Flohr [0008].
The combined system fails to explicitly teach selectively highlighting, attenuating, or masking segments in at least one of the images depending on at least one contrast medium concentration.
Ohishi teaches a system for imaging blood vessels (Abstract). This system selectively highlights an image depending on the contrast medium concentration, where areas having increased contrast medium concentrations are selectively enhanced [0190].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to selectively enhances areas with increased concentration, as taught by Ohishi, because this better allows the user to determine the shape of a blood vessel, as recognized by Ohishi [0007].
Claims 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa and Breeuwer as applied to claim 1 above, and further in view of Carmi (U.S PGPub 2018/0276853 A1).
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Javor further teaches reconstructing a virtual non-contrast (VNC) image (Fig. 1, VNC image) and a material image (Fig. 1, iodine contrast image), wherein the VNC image simulates an image recording without the contrast medium (Fig. 1, VNC Image) (Pg. 1624, Data processing and evaluation of the split bolus scan) (a virtual non-contrast image simulates an image recording without contrast media), and the material image represents information of local concentrations of the contrast medium (Fig. 1, iodine contrast image) (Pg. 1624, Data processing and evaluation of the split bolus scan) (Fig. 1 shows the iodine image represents the local concentrations of the contrast media).
Javor fails to explicitly teach creating a result image from the VNC image and the material image by at least one of image superimposition or masking image information that lies outside a threshold value range, the image superimposition including subtraction methods.
Carmi teaches a method for generating contrast maps (Abstract). This system creates a result image (Fig. 5, subtraction image contrast agent concentration map) from a VNC image (Fig. 5, VNC image) and a material image (Fig. 5, contrast enhanced image volume) [0053]. This technique uses image superimposition including subtraction methods (Fig. 5, the step of subtracting the two volumes is considered image superimposition using subtracting methods) [0053].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to create a result image, as taught by Carmi, because the result image improves diagnosis accuracy, as recognized by Carmi [0002]+[0010].
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. Javor further teaches reconstructing a virtual non-contrast (VNC) image (Fig. 1, VNC image) and a material image (Fig. 1, iodine contrast image), wherein the VNC image simulates an image recording without the contrast medium (Fig. 1, VNC Image) (Pg. 1624, Data processing and evaluation of the split bolus scan) (a virtual non-contrast image simulates an image recording without contrast media), and the material image represents information of local concentrations of the contrast medium (Fig. 1, iodine contrast image) (Pg. 1624, Data processing and evaluation of the split bolus scan) (Fig. 1 shows the iodine image represents the local concentrations of the contrast media).
Javor fails to explicitly teach creating a result image from the VNC image and the material image by at least one of image superimposition or masking image information that lies outside a threshold value range.
Carmi teaches a method for generating contrast maps (Abstract). This system creates a result image (Fig. 5, subtraction image contrast agent concentration map) from a VNC image (Fig. 5, VNC image) and a material image (Fig. 5, contrast enhanced image volume) [0053]. This technique uses image superimposition including subtraction methods (Fig. 5, the step of subtracting the two volumes is considered image superimposition using subtracting methods) [0053].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to create a result image, as taught by Carmi, because the result image improves diagnosis accuracy, as recognized by Carmi [0002]+[0010].
Claims 5 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa and Breeuwer as applied to claim 1 above, and further in view of Hempel et al. (U.S PGPub 2008/0027309 A1) and Kalafut et al. (U.S PGPub 2010/0113887 A1).
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Javor is silent regarding wherein at least the first contrast medium application is performed by an automatically controlled application unit.
Hempel teaches a method for setting an injection pump (Abstract). This system performs a first contrast medium application by an automatically controlled application unit [0012].
It would have been obvious to one of ordinary skill in the art to modify the combined system to administer the contrast medium with an automatically controlled application unit, as taught by Hempel, because this improves the application of the contrast agent, thereby shortening the examination and improving the quality of the resulting images, as recognized by Hempel [0008]-[0009].
The combination is silent regarding the method further comprising selecting a contrast medium concentration for the second contrast medium application and diluting the contrast medium concentration for the first contrast medium application.
Kalafut teaches protocols for applying a contrast agent (Abstract). This system uses a diluted test bolus (i.e. first contrast medium application) [0024]+[0153]. The system then uses a selected contrast medium concentration for the main (i.e. second) bolus [0172] (Tables 2A+2B).
It would have been obvious to one of ordinary skill in the art to modify the combined system to use a dilute first contrast and a second contrast concentration, as taught by Kalafut, because this allows for better, more flexible, control of the contrast injection, as recognized by Kalafut [0010]+[0013].
Regarding Claim 9, the combination of references teaches the invention substantially as claimed. Javor fails to explicitly teach wherein the method further comprises selecting at least one of limits of value ranges, threshold values, applied contrast medium quantities, contrast medium concentrations, or kernels for the reconstructing of the images based on at least one of a tumor biology, a selected examination type or a body region to be examined.
Kalafut teaches protocols for applying a contrast agent (Abstract). This system applies contrast medium quantities based on a selected examination type, or the body region [0115].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the amount of contrasty medium based on the selected examination type/body region to be examined, as taught by Kalafut, as the substitution for one known method of choosing a contrast medium amount with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of choosing an amount of contrast medium based on an examination type are reasonably predictable.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa and Breeuwer as applied to claim 1 above, and further in view of Kalafut et al. (U.S PGPub 2007/0255135 A1) (Kalafut’135).
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Javor further teaches the second contrast medium application is adapted based on at least one of cardiac output, anatomy to be analyzed, or pathology (Pg. 1623-1624, CT acquisition protocol (split bolus)) (the second contrast medium is adapted based on BMI, which is indicative of a pathology (i.e. obese patient obtained more contrast medium)).
Javor fails to explicitly teach wherein the contrast medium is administered at more than 6 ml/s in the second contrast medium application.
Kalafut’135 teaches methods for delivering contrast to a patient (Abstract). This system can deliver contrast medium at more than 6 ml/s [0131].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to deliver contrast at more than 6 ml/s, as taught by Kalafut’135, because it makes it easier to detect extravasation at higher flow rates, as recognized by Kalafut’135 [0132].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa and Breeuwer as applied to claim 1 above, and further in view of Carmi and Flohr.
Regarding Claim 10, the combination of references teaches the invention substantially as claimed. Javor fails to explicitly teach performing additional recordings of additional image data at least one of between the first contrast medium application and the second contrast medium application or at different recording points in time after the second contrast medium application, the additional recordings of image data being performed at at least two different beam energies; and creating a result image for different recording points in time from respective recorded images by at least one of image superimposition or by masking image information that lies outside a threshold value range, the image superimposition including subtraction methods, and the respective recorded images being based on the additional image data.
Carmi teaches a method for generating contrast maps (Abstract). This system performs the additional recordings of image data being performed at at least two different beam energies [0043]; and creating a result image for different recording points in time from respective recorded images by at least one of image superimposition or by masking image information that lies outside a threshold value range, the image superimposition including subtraction methods (Fig. 5, the step of subtracting the two volumes is considered image superimposition using subtracting methods), and the respective recorded images are based on the additional image data [0053].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to create a result image, as taught by Carmi, because the result image improves diagnosis accuracy, as recognized by Carmi [0002]+[0010].
Carmi fails to explicitly teach additional recordings of image data at least one of between the first contrast medium application and the second contrast medium application or at different recording points in time after the second contrast medium application.
Flohr teaches a method of determining perfusion defects (Abstract). This system obtains the images after contrast is applied [0053], and can obtain a time-series of images at different recording points after the contrast application [0047]+[0053]+[0070].
It would have been obvious to obtain a series of high and low energy images, as taught by Flohr, because this provides a better method for detecting perfusion defects, as recognized by Flohr [0008].
Claims 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa, Breeuwer, Hempel, and Ohishi.
Regarding Claim 11, Javor teaches a method of operating an X-ray device for creating reconstructed images of a body region (Pg. 1622, Abstract), the method comprising:
trigger administration of a first contrast medium application for presaturation of the body region with contrast medium (Pg. 1623, Col 2, CT acquisition protocol (split bolus)) (Table 2);
trigger administration of a second contrast medium application, the second contrast medium application having a bolus larger than a bolus the first contrast medium application (Pg. 1623, Col 2, CT acquisition protocol (split bolus)) (Table 2);
wherein in the bolus of the contrast medium is administered at more than 4 ml/s (Pg. 1624, Table 2, 25-30 BMI and >30 BMI).
recording spectral image data at at least two different beam energies (Pg. 1624, Col 1, ¶1-2) (DECT obtains spectral image data);
a number of X-ray device components configured to record spectral image data at at least two different beam energies (Pg. 1624, Col 1, ¶1-2)
reconstruct images from the spectral image data (Pg. 1624, Col 1, ¶3 “Data processing and evaluation of the split-bolus scan”); and
output the images (Pg. 1624, Col 1, ¶3) (Pg. 1624, Col 1-2, ¶6-1) (Fig. 1 shows the outputted images).
Javor fails to explicitly teach triggering administration of the second contrast medium application in response to the first contrast medium application reaching a first equilibrium concentration.
Proksa teaches a system for detecting endoleaks using multiple contrast agents (Abstract). This system triggers administration of the second contrast medium administration in response to the first contrast medium application reaching a first equilibrium concentration (Fig. 3, T2) [0041]-[0042] (the second administration occurs a time after the peak TP of the first contrast is achieved. As detailed in the Applicant’s specification at [0013], the equilibrium concentration of a contrast occurs after the contrast reaches the peak or decreases again. As Proksa has the second administration occur after the first concentration reaches its peak, then starts to decline, the second administration is triggered in response to the first contrast medium reaching a first equilibrium concentration).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Javor so the second bolus is administered in response to the first contrast medium reaching an equilibrium concentration, as taught by Proksa, because this allows for improved detection of an endoleak, thereby increasing the quality of imaging, as recognized by Proksa [0005].
Alternatively, assuming the combination were silent regarding the first contrast medium application achieving first equilibrium concentration, the combination would be still be obvious further combined with Breeuwer. The combination fails to explicitly teach a reconstruction unit.
Breeuwer teaches a method of imaging the heart (Abstract). This system administers contrast medium in such a way that it achieves an equilibrium (steady-state) concentration [0024]. This system reconstructs the images in reconstruction unit, and outputs the images to an output unit [0054]. This system can be a CT system [0012].
It would have been obvious to one of ordinary skill in the art before the effective filing date to substitute the method of administering the first contrast medium so that it achieves a desired equilibrium concentration, as taught by Breeuwer, as the substitution for one known method of administering contrast with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of the contrast being administered to achieve a desired equilibrium concentration are reasonably predictable.
The combination fails to explicitly teach an application unit.
Hempel teaches a method for setting an injection pump (Abstract). This system performs a first contrast medium application by an automatically controlled application unit [0012].
It would have been obvious to one of ordinary skill in the art to modify the combined system to administer the contrast medium with an automatically controlled application unit, as taught by Hempel, because this improves the application of the contrast agent, thereby shortening the examination and improving the quality of the resulting images, as recognized by Hempel [0008]-[0009].
The combination fails to explicitly teach reconstruction including selectively enhancing, attenuating, or masking concentration dependent portions in the images.
Ohishi teaches a system for imaging blood vessels (Abstract). This system selectively highlights an image depending on the concentration, where areas having increased contrast medium concentrations are selectively enhanced [0190].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to selectively enhances areas with increased concentration, as taught by Ohishi, because this better allows the user to determine the shape of a blood vessel, as recognized by Ohishi [0007].
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Javor further teaches a computed tomography system (Pg. 1623, CT acquisition protocol (split bolus)) comprising the system as claimed in claim 11 (See rejection of claim 11 above).
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa, Breeuwer, Hempel, and Ohishi as applied to claim 11 above, and further in view of Kalafut.
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the application unit is configured to automatically dilute the contrast medium for the first contrast medium application to, or by, a defined first value, apply the contrast medium for the first contrast medium application in a first diluted manner, automatically dilute the contrast medium for the second contrast medium application to, or by, a defined second value, and apply the contrast medium for the second contrast medium application in a second diluted manner.
Kalafut teaches protocols for applying a contrast agent (Abstract). This system uses a diluted test bolus (i.e. first contrast medium application) and applies the diluted bolus [0024]+[0153]. The system then automatically dilutes a second contrast medium, and applies the second contrast medium in a diluted manner [0172] (Tables 2A+2B) (The contrast concentration get lower (i.e. are diluted) based on the weight and desired HU). The system can automatically dilute the contrast before application [0128].
It would have been obvious to one of ordinary skill in the art to modify the combined system to use a dilute first contrast and a second contrast concentration, as taught by Kalafut, because this allows for better, more flexible, control of the contrast injection, as recognized by Kalafut [0010]+[0013].
Regarding Claim 20, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the application unit is configured to automatically dilute the contrast medium for the first contrast medium application to, or by, a defined first value, apply the contrast medium for the first contrast medium application in a first diluted manner, and apply the contrast medium for the second contrast medium application in an undiluted manner.
Kalafut teaches protocols for applying a contrast agent (Abstract). This system uses a diluted test bolus (i.e. first contrast medium application) and applies the diluted bolus [0024]+[0153]. The system then uses a selected contrast medium concentration for the main (i.e. second) bolus [0172] (Tables 2A+2B). The selected contrast can be undiluted [0130] (the main bolus is not diluted compared to the diluted phase). The system can automatically dilute the contrast before application [0128].
It would have been obvious to one of ordinary skill in the art to modify the combined system to use a dilute first contrast and a second contrast concentration, as taught by Kalafut, because this allows for better, more flexible, control of the contrast injection, as recognized by Kalafut [0010]+[0013].
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Javor in view of Proksa and Breeuwer as applied to claim 1 above, and further in view of Flohr, Ohishi, and Juergens (U.S PGPub 2022/0225954 A1).
Regarding Claim 21, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach wherein the reconstructing of the images comprises: segmenting different base materials to obtain a plurality of segments; and selectively highlighting, attenuating, or masking the plurality of segments in at least one of the images depending on at least one contrast medium concentration, wherein at least one of contrast medium concentrations lying outside a value range are visualized on virtual native images, or contrast having concentrations that are below a first threshold value are selectively enhanced, wherein a detection of fresh versus organized thrombi is included for the selective enhancement, areas with contrast medium concentrations above a second threshold value are masked, not further amplified, or linearly co-amplified, arterial and venous phases in the brain or bronchus are separated, or a distinction is made between an arterial and portal venous phase of an accumulation of contrast medium in the liver.
Flohr teaches a system for determining perfusion defects (Abstract). This system reconstructs images by segmenting different base materials to obtain a plurality of segments [0098]-[0099].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to segment base materials, as taught by Flohr, as this provides a better method for detecting perfusion defects, as recognized by Flohr [0008].
The combined system fails to explicitly teach selectively highlighting, attenuating, or masking segments in an image depending on at least one contrast medium concentration, wherein at least one of areas having increased contrast medium concentrations are selectively enhanced.
Ohishi teaches a system for imaging blood vessels (Abstract). This system selectively highlights an image depending on the contrast agent concentration [0190].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to selectively enhances areas with increased concentration, as taught by Ohishi, because this better allows the user to determine the shape of a blood vessel, as recognized by Ohishi [0007].
The combination fails to explicitly teach wherein at least one of contrast medium concentrations lying outside a value range are visualized on virtual native images.
Juergens teaches a system for x-ray imaging (Abstract). This system displays virtual native images which visualize contrast medium concentrations (it visualizes contrast medium which lies outside a value range of zero contrast to below an average contrast value) [0098].
It would have been obvious to one of ordinary skill in the art to modify the combined system to visualize the contrast outside a range on virtual native images, as taught by Flohr’227, because this reduces artifacts in the resulting image, thereby increasing the image quality, as recognized by Flohr’227 [0055].
Allowable Subject Matter
Claim 8 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 8 would be allowable for substantially the same reasons set forth in the non-final rejection mailed 8/8/2025.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Proksa has been brought in to teach the newly added limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798