DETAILED ACTION
This office action is in response to the communication received on 09/05/2025 concerning application no. 17/779,614 filed on 05/25/2022.
Claims 5-15, 18-25, and 27-29 are pending (Claims 9-11 and 20 are withdrawn from consideration).
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 .
Response to Arguments
Applicant's arguments filed 09/05/2025 have been fully considered but they are not persuasive.
Regarding the rejection of claim 5 under Wu, Applicant argues “at best, Wu describes selecting these energies such that energies higher and lower than the K-edge are selected with respect to each of the K- edge materials. Wu is silent, however, regarding "selecting at least two different X-ray photon energies based on a first amount of change in the second X-ray absorption [of the second X-ray contrast agent] between the at least two different X-ray photon energies being less than half of a second amount of change in the first X-ray absorption [of the first X-ray contrast agent] between the at least two different X-ray photon energies," [emphasis added], as recited by amended claim 5.”
Examiner disagrees. MPEP 716.01(c) establishes “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).” Applicant provides no explanation or support as to the allegation “at best, Wu describes selecting these energies such that energies higher and lower than the K-edge are selected with respect to each of the K- edge materials.” Furthermore, it is counter the fundamental operability of any x-rays system. As discussed in the prior action, filed 05/05/2025, “As discussed in the interview, held on 03/27/2025, the K-edge is an atomic property of the element. That is, “The K-absorption edge (K-edge) refers to the abrupt increase in the photoelectric absorption of x-ray photons observed at an energy level just beyond the binding energy of the k-shell electrons of the absorbing atom. K-shell binding energies are specific to each element. As the atomic number (Z) of an element increases, so does its corresponding k-shell binding energy, and therefore the greater the photon energy at which the K-edge occurs. Binding energies are expressed in kiloelectronvolts (keV).”1 Such properties are associated to the atomic properties of the element itself and are defined such that Bremsstrahlung radiation is generated. So, the use of gadolinium and tungsten will have the defined k-edge values and the Fig. 3 shows that from the ranges of ~51keV to 70 keV, the change in the absorption is as claimed. Furthermore, this atomic property of the elements is why paragraph 0029 discusses the range in which the kVp system is able to operate for the acquisition of the element. Paragraph 0031 teaches the use of various kVps such that the distinct incident spectra are acquired. Such a selection is needed to actually capture the used contrast agents. Paragraph 0045 teaches that the system “employs the K-edge knowledge of the N K-edge material contrast agents to select at least N+2 kVps scan”.” Applicant acknowledges in their very remarks “Wu describes medical CT images enhanced using contrast agents by taking images above and below a K-edge absorption energy of each respective contrast agent (para. 0008-0010, 0025 and 0029). A system using two K-edge materials is resolved using four different spectra (para. 0031, 0034-0035, 0040-0043 and 0057). K-edge knowledge of N K-edge material contrast agents is used to select N+2 kVps scans (para. 0045).” (See pages 12 of remarks, filed 09/05/2025). The use of the K-edge is the fundamental assessment in the operability of an x-ray system. It is extremely well-known that “The K-absorption edge (K-edge) refers to the abrupt increase in the photoelectric absorption of x-ray photons observed at an energy level just beyond the binding energy of the k-shell electrons of the absorbing atom.”2 This is the basis upon which the system operates as “Elements with larger K-edge values, that are within the useful portion of the x-ray spectrum, are of greater interest in radiology. The k-edge properties of certain materials can be specifically chosen for their use in contrast media, intensifying screens and beam filters.”3 Additionally, the attenuation coefficient is due to absorption. Again, this is a commonly known fact and is the basis for radiation based imaging. “When a photon passes through a matter, it can either penetrate the matter without any interactions (penetration), be completely absorbed by matter (absorption), or deposit its energy and deflected from its original path (scatter). The three main mechanisms of photon interactions in body tissue are: photoelectric effect, Compton effect, [and] coherent scattering.” 4 In addition to the commonly understood meaning and operability of K-edges, Wu teaches that the “materials may be resolved with a four-energy bin ED system, for example, where the x-ray spectrum is divided into four energy bins and the integrated x-ray photon counts in each energy bin are separately recorded by the ED detectors as the detectors 20.” (Paragraph 0034) (emphasis added). In paragraph 0035, Wu further explains the operability, “a multiple energy bin system using the ED detector as the detector 20 comprises enhanced, improved, and/or superior sensitivity. An exemplary approach chooses, selects, and/or determines the energy bins and the K-edge materials with exemplary roles such as one, multiple, and/or all of the following. All K-edges in an example are well within the x-ray spectrum. Certain separation of the K-edges in energy for different K-edge materials in an example is accepted, sought, and/or needed for desirable and/or good sensitivity.” (emphasis added).
Examiner maintains the rejection.
Applicant's arguments filed 09/05/2025 have been fully considered but they are not persuasive.
Regarding the rejection of claim 5 under Wu, Applicant “Wu is silent, regarding "the first amount of change in the second X-ray absorption" of one among gadolinium or tungsten (each alleged by the Examiner to correspond to the claimed "second X-ray contrast agent") "between the at least two different X-ray photon energies being zero," as is the case with the claimed "second X-ray contrast agent." Instead, Wu merely describes energies at which a difference in mass attenuation coefficient between gadolinium and tungsten is zero. Accordingly, Wu does not disclose or suggest at least, "selecting ... the at least two different X-ray photon energies based on the first amount of change in the second X-ray absorption [of the second X-ray contrast agent] between the at least two different X-ray photon energies being zero," as recited by amended claim 27.”
Examiner disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the use of gadolinium or tungsun) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Paragraph 0034 teaches a four bin system. Fig. 3 shows absorption coefficient of 6 occurring at both around 40 and 80 keV. Furthermore, the curves in Fig. 3 shows zero change across the energy spectra.
Examiner maintains the rejection.
Applicant’s arguments with respect to claim 5 rejection under Soesbe 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5-8, 12-15, 18-19, 21-25, and 27-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “selecting at least two different X-ray photon energies based on a first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being less than half of a second amount of change in the first X-ray absorption between the at least two different X-ray photon energies”. While paragraph 0017 of the specification discloses “‘Significantly’ should be understood in this context to mean that the change in the absorption of the second X-ray contrast agent amounts to less than half the change in the first X-ray contrast agent at the selected different X-ray photon energies” and paragraph 0036 discloses “‘Not significantly different’ should be understood in this context to mean that the change in the absorption of the second X-ray contrast agent amounts to less than half the change in the absorption of the first X-ray contrast agent at the selected different X-ray photon energies”, the specification does not disclose the selection based on amounts of change. The specification does not disclose the determination of the amounts, the manner of determination, what those amounts are, or what the amount values are in relation to the contrast agents’ absorption. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 27 recites “wherein the selecting the at least two different X-ray photon energies selects the at least two different X-ray photon energies based on the first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being zero”. As discussed above, the specification does not disclose the selection based on amounts of change. The specification does not disclose the determination of the amounts, the manner of determination, what those amounts are, or what the amount values are in relation to the contrast agents’ absorption. Additionally, the specification does not disclose the amount being zero. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 28 recites “determining a first subset of the X-ray raw data representing the first X-ray contrast agent based on the first subset of the X-ray raw data corresponding to the second amount of change in X-ray absorption between the at least two different X-ray photon energies; and determining a second subset of the X-ray raw data representing the second X-ray contrast agent based on the second subset of the X-ray raw data corresponding to the first amount of change in X-ray absorption between the at least two different X-ray photon energies”. The specification does not disclose the determination of subsets of raw data according to amounts of change in the absorption. In addition to the above discussed absence of specification disclose of selection based on amounts of change, the specification does not provide support for the determination of subsets of raw data broadly and the determination being based in on the amount of change in particular. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claim 29 recites “determining the second subset of the X-ray raw data based on the second subset of the X-ray raw data corresponding to the same X-ray absorption between the at least two different X-ray photon energies”. The specification does not disclose the determination of subsets of raw data according to amounts of change in the absorption. In addition to the above discussed absence of specification disclose of selection based on amounts of change, the specification does not provide support for the determination of subsets of raw data broadly and the determination being based in on the amount of change in particular. Furthermore, the specification does not disclose the determination being based on an amount being zero. Therefore, the claim contains subject matter which is not described in the specification in such a way as to reasonably convey to one with ordinary skill in the art that the inventor had possession of the claim invention at the time of filing.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the deficiencies of the claims they respectively depend upon.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-8, 12-15, 18-19, 21-25, and 27-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 is indefinite for the following reasons:
Recites “second amount of change in the first X-ray absorption between the at least two different X-ray photon energies”. There is insufficient antecedent basis for this limitation in the claim.
Applicant is encouraged to provide consistent and clear language.
Recites “second amount of change in the first X-ray absorption between the at least two different X-ray photon energies”. This claim element is indefinite. The claim fails to establish a first amount of change for the first X-ray absorption.
Applicant is encouraged to provide consistent and clear language.
Claim 27 is indefinite for the following reasons:
Recites “wherein the selecting the at least two different X-ray photon energies selects the at least two different X-ray photon energies based on the first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being zero”. This claim element is indefinite. Claim 5 establishes “selecting at least two different X-ray photon energies based on a first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being less than half of a second amount of change in the first X-ray absorption between the at least two different X-ray photon energies”. It would be unclear to one with ordinary skill in the art if the second X-ray absorption undergoes a change or not. A change of zero is not a change. Change means “to become different”, “to replace with another”, or “to make different in some particular way or aspect”5. If the value is zero, there is no change and therefore contradicts the claim 5 establishing a change of the second absorption.
Applicant is encouraged to provide consistent and clear language.
Claim 29 is indefinite for the following reasons:
Recites “determining the second subset of the X-ray raw data based on the second subset of the X-ray raw data corresponding to the same X-ray absorption between the at least two different X-ray photon energies”. This claim element is indefinite. It would be unclear to one with ordinary skill in the art if the absorption is changing or not. Claim 5 establishes “selecting at least two different X-ray photon energies based on a first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being less than half of a second amount of change in the first X-ray absorption between the at least two different X-ray photon energies”. Additionally claim 28 establishes “determining a second subset of the X-ray raw data representing the second X-ray contrast agent based on the second subset of the X-ray raw data corresponding to the first amount of change in X-ray absorption between the at least two different X-ray photon energies”. It would be unclear to one with ordinary skill in the art if the second X-ray absorption undergoes a change or not. A change of zero is not a change. Change means “to become different”, “to replace with another”, or “to make different in some particular way or aspect”6. If the value is zero, there is no change and therefore contradicts the claim 5 and 28 establishing a change of the second absorption.
Applicant is encouraged to provide consistent and clear language.
Recites “the same X-ray absorption”. There is insufficient antecedent basis for this limitation in the claim.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 5-6, 12-15, 21-24, and 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (PGPUB No. US 2008/0137803).
Regarding claim 5, Wu teaches an X-ray imaging method, comprising:
selecting an ensemble of X-ray contrast agents, the ensemble including a first X- ray contrast agent having a first X-ray absorption and a second X-ray contrast agent having a second X-ray absorption (Abstract teaches the utilization of N K-edge contrast agents, where N is an integer greater than or equal to 1. Paragraph 0009 teaches that K-edge is indicative of the increase in the attenuation coefficient of photons and it is due to photelectric absorption of photons. Paragraph 0035 teaches an instance where gadolinium and tungsten are used. See Fig. 3),
capturing X-ray raw data from a first region of an examination object and a second region of the examination object using a multi-energy recording method, the first region being flooded by the first X-ray contrast agent, the second region being flooded by the second X-ray contrast agent, and the multi-energy recording method including selecting at least two different X-ray photon energies based on a-a first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being less than half of a second amount of change in the first X-ray absorption between the at least two different X-ray photon energies (Paragraph 0057 teaches that the K-edge contrast agents can be simultaneously resolved. Fig. 6 shows the acquisition of target object 22 that has the gadolinium and tungsten in different portions. Abstract teaches the utilization of N K-edge contrast agents, where N is an integer greater than or equal to 1. Paragraph 0009 teaches that K-edge is indicative of the increase in the attenuation coefficient of photons and it is due to photelectric absorption of photons. Paragraph 0035 teaches an instance where gadolinium and tungsten are used. See Fig. 3 that shows the assessment of the mass attenuation coefficient spectra with respect the photon energies from 0-150 keV. The gadolinium and tungsten K-edges are at differing peaks and ranges. In the instance of ~51 keV, the k-edge of the gadolinium is at ~18.5 of the mass attenuation coefficient spectra and drops to 8 at ~ 70 keV resulting in a change of ~10.5. In the similar range of ~51keV to 70 keV range, the change of the tungsten mass attenuation coefficient spectra is from 6 to 2.5 and results in 3.5. 3.5 is less than half of 10.5. Paragraph 0025 teaches the use of a multi energy imaging system);
carrying out a material decomposition based on the X-ray raw data in relation to the first X-ray contrast agent and the second X-ray contrast agent (Paragraph 0052 teaches the decomposition of the object with the contrast agents. The materials are separated as seen in Fig. 6. Paragraph 0031 teaches that the application of the BMD can be extended to complex objects with K-edge materials. Fig. 4 teaches the material decomposition that comprises K-edge materials and contrast materials); and
reconstructing at least two image datasets based on the material decomposition (Paragraph 0061 teaches that the contrast agents can be reconstructed. Paragraph 0052 teaches the decomposition of the object with the contrast agents. The materials are separated as seen in Fig. 6. Paragraph 0031 teaches that the application of the BMD can be extended to complex objects with K-edge materials.), the at least two image datasets including
a first image dataset representing a first image region affected by the first X-ray contrast agent (Paragraphs 0052-53 teach the imaging and decomposition of the contrast agent materials. The regions with gadolinium and tungsten are determined. See Fig. 6), and
a second image dataset representing a second image region affected by the second X-ray contrast agent (Paragraphs 0052-53 teach the imaging and decomposition of the contrast agent materials. The regions with gadolinium and tungsten are determined. See Fig. 6).
Regarding claim 6, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches an X-ray imaging method, further comprising:
the multi-energy recording method comprises specifying at least two different X-ray tube voltages based on the first X-ray contrast agent and the second X-ray contrast agent (Paragraph 0005 teaches the operation of the x-ray tube at 80 and 160 kVp. Paragraph 0031 teaches multiple kVps can be performed for multiple distinct incident spectra that use differing kVps. Paragraph 0034 teaches that with four materials, two of which are K-edge materials, four different kVp scans be used. See Fig. 3);
the capturing captures at least two raw datasets of X-ray image recordings with the at least two different X-ray tube voltages, the X-ray raw data including the at least two raw datasets, and the at least two raw datasets including a first raw dataset and at least one second raw dataset (Paragraph 0034 teaches that with four materials, two of which are K-edge materials, four different kVp scans be used. See Fig. 3); and
the carrying out carries out the material decomposition based on the first raw dataset and the at least one second raw dataset (Paragraph 0061 teaches that the contrast agents can be reconstructed. Paragraph 0052 teaches the decomposition of the object with the contrast agents. The materials are separated as seen in Fig. 6. Paragraph 0031 teaches that the application of the BMD can be extended to complex objects with K-edge materials. Paragraphs 0052-53 teach the imaging and decomposition of the contrast agent materials. The regions with gadolinium and tungsten are determined. See Fig. 6. Fig. 5 shows the reconstruction of the material specific projections. Paragraphs 0040-45 teach the application of the four kVps).
Regarding claim 12, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches a non-transitory computer program product including a computer program directly loadable into a storage facility of an X-ray imaging system, the non-transitory computer program product having program portions configured to cause the X-ray imaging system to carry out the method of claim 5 when the computer program is executed in the X-ray imaging system (Paragraph 0065 teaches that the computer readable material can contain the implementation of the system according to the disclosed method. See Figs. 1-2 which show the memory and computer working in conjunction with the x-ray scanner).
Regarding claim 13, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches a non-transitory computer-readable medium storing program portions that, when executed by a computer unit, cause the computer unit to carry out the method as claimed in claim 5 (Paragraph 0065 teaches that the computer readable material can contain the implementation of the system according to the disclosed method. See Figs. 1-2 which show the memory and computer working in conjunction with the x-ray scanner).
Regarding claim 14, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches an X-ray imaging method, wherein
the multi-energy recording method is a dual-energy recording method (Abstract teaches the utilization of N K-edge contrast agents, where N is an integer greater than or equal to 1. Paragraph 0057 teaches that the K-edge contrast agents can be simultaneously resolved. Fig. 6 shows the acquisition of target object 22 that has the gadolinium and tungsten); and
the at least two different X-ray photon energies include two different X-ray photon energies (Abstract teaches the utilization of N K-edge contrast agents, where N is an integer greater than or equal to 1. Paragraph 0057 teaches that the K-edge contrast agents can be simultaneously resolved. Fig. 6 shows the acquisition of target object 22 that has the gadolinium and tungsten. Fig. 3 shows k-edges at 51 keV and 70 keV. Paragraph 0005 teaches the operation of the x-ray tube at 80 and 160 kVp).
Regarding claim 15, Wu teaches the X-ray imaging method in claim 6, as discussed above.
Wu further teaches an X-ray imaging method, wherein the multi-energy recording method is a dual-energy recording method (Abstract teaches the utilization of N K-edge contrast agents, where N is an integer greater than or equal to 1. Paragraph 0057 teaches that the K-edge contrast agents can be simultaneously resolved. Fig. 6 shows the acquisition of target object 22 that has the gadolinium and tungsten).
Regarding claim 21, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches an X-ray imaging method, further comprising: visualizing the first image dataset and the second image dataset as at least one image on a screen (Paragraph 0027 teaches the display allows for the observation of the reconstructed image. Fig. 6 shows the resulting image. Paragraph 0052 teaches the resulting image comprises the information of the K-edge contrast agents).
Regarding claim 22, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches an X-ray imaging method, further comprising: visualizing both the first image dataset and the second image dataset in a single image (Paragraph 0027 teaches the display allows for the observation of the reconstructed image. Fig. 6 shows the resulting image. Paragraph 0052 teaches the resulting image comprises the information of the K-edge contrast agents).
Regarding claim 24, Wu teaches the X-ray imaging method in claim 6, as discussed above.
Wu further teaches an X-ray imaging method, further comprising: visualizing both the first image dataset and the second image dataset in a single image (Paragraph 0027 teaches the display allows for the observation of the reconstructed image. Fig. 6 shows the resulting image. Paragraph 0052 teaches the resulting image comprises the information of the K-edge contrast agents).
Regarding claim 27, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches an X-ray imaging method, wherein the selecting the at least two different X-ray photon energies selects the at least two different X-ray photon energies based on the first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being zero (Paragraph 0034 teaches a four bin system. Fig. 3 shows absorption coefficient of 6 occurring at both around 40 and 80 keV).
Regarding claim 28, Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches an X-ray imaging method, wherein the carrying out the material decomposition comprises:
determining a first subset of the X-ray raw data representing the first X-ray contrast agent based on the first subset of the X-ray raw data corresponding to the second amount of change in X-ray absorption between the at least two different X-ray photon energies (Paragraph 0061 teaches that each of the plurality of K-edge contrast agents is targeted to different tissues and/or organs in a single CT scans. Paragraph 0061 teaches that the contrast agents can be reconstructed. Paragraph 0052 teaches the decomposition of the object with the contrast agents. The materials are separated as seen in Fig. 6. Paragraph 0031 teaches that the application of the BMD can be extended to complex objects with K-edge materials. Paragraph 0057 teaches that the K-edge contrast agents can be simultaneously resolved. Fig. 6 shows the acquisition of target object 22 that has the gadolinium and tungsten in different portions. Abstract teaches the utilization of N K-edge contrast agents, where N is an integer greater than or equal to 1. Paragraph 0009 teaches that K-edge is indicative of the increase in the attenuation coefficient of photons and it is due to photelectric absorption of photons. Paragraph 0035 teaches an instance where gadolinium and tungsten are used. See Fig. 3); and
determining a second subset of the X-ray raw data representing the second X-ray contrast agent based on the second subset of the X-ray raw data corresponding to the first amount of change in X-ray absorption between the at least two different X-ray photon energies (Paragraph 0061 teaches that each of the plurality of K-edge contrast agents is targeted to different tissues and/or organs in a single CT scans. Paragraph 0061 teaches that the contrast agents can be reconstructed. Paragraph 0052 teaches the decomposition of the object with the contrast agents. The materials are separated as seen in Fig. 6. Paragraph 0031 teaches that the application of the BMD can be extended to complex objects with K-edge materials. Paragraph 0057 teaches that the K-edge contrast agents can be simultaneously resolved. Fig. 6 shows the acquisition of target object 22 that has the gadolinium and tungsten in different portions. Abstract teaches the utilization of N K-edge contrast agents, where N is an integer greater than or equal to 1. Paragraph 0009 teaches that K-edge is indicative of the increase in the attenuation coefficient of photons and it is due to photelectric absorption of photons. Paragraph 0035 teaches an instance where gadolinium and tungsten are used. See Fig. 3).
Regarding claim 29, Wu teaches the X-ray imaging method in claim 28, as discussed above.
Wu further teaches an X-ray imaging method, wherein the carrying out the material decomposition comprises:
determining the second subset of the X-ray raw data based on the second subset of the X-ray raw data corresponding to the same X-ray absorption between the at least two different X-ray photon energies (Paragraph 0034 teaches a four bin system. Fig. 3 shows absorption coefficient of 6 occurring at both around 40 and 80 keV).
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 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.
Claims 7 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (PGPUB No. US 2008/0137803) in view of Forthmann et al. (PGPUB No. US 2011/0096892).
Regarding claim 7, modified Wu teaches the X-ray imaging method in claim 5, as discussed above.
Wu further teaches an X-ray imaging method, the material decomposition is based on energy-resolved raw data (Paragraph 0061 teaches that the contrast agents can be reconstructed. Paragraph 0052 teaches the decomposition of the object with the contrast agents. The materials are separated as seen in Fig. 6. Paragraph 0031 teaches that the application of the BMD can be extended to complex objects with K-edge materials. Paragraphs 0052-53 teach the imaging and decomposition of the contrast agent materials. The regions with gadolinium and tungsten are determined. See Fig. 6. Fig. 5 shows the reconstruction of the material specific projections. Paragraphs 0040-45 teach the application of the four kVps).
However, Wu is silent regarding an X-ray imaging method, the capturing captures the X-ray raw data based on an energy-resolved capture of the X-ray raw data using photon-counting detector, energy thresholds of the photon-counting detector being set such that the change in the first X-ray absorption differs from the change in the second X-ray absorption.
In an analogous imaging field of endeavor, regarding x-ray imaging of multiple contrast agents, Forthmann teaches an X-ray imaging method, the capturing captures the X-ray raw data based on an energy-resolved capture of the X-ray raw data using photon-counting detector, energy thresholds of the photon-counting detector being set such that the change in the first X-ray absorption differs from the change in the second X-ray absorption; and the material decomposition is based on energy-resolved raw data (Paragraph 0030 teaches that a photon counting detector is used for the detection of the radiation. The array is sensitive to photon energy and is able to perform 4 independent energy resolved measurements. Paragraph 0065 teaches that the binning is defined based on the energy range with respect to the thresholds where the photon count is determined. Paragraph 0077 teaches that the thresholding can be set in accordance to the K-edge of the contrast material, where the contrast agent has two or more materials. Paragraph 0037 teaches that the decomposition algorithm performs an analysis that includes reconstruction of energy-resolved data to obtain meaningful clinical information).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wu with Forthmann’s teaching of energy resolving via a photon counting detector and thresholding for material decomposition. This modified method would allow the user to differentiate between contrast agents and anatomical features (Paragraph 0039 of Forthmann). Furthermore, the modification provides an new and improved spectral CT technique that addresses the issue of complexity, noise, and difficulty in distinguishing between materials (Paragraphs 0005-06 of Forthmann).
Regarding claim 25, modified Wu teaches the X-ray imaging method in claim 7, as discussed above.
Wu further teaches an X-ray imaging method, further comprising: visualizing both the first image dataset and the second image dataset in a single image (Paragraph 0027 teaches the display allows for the observation of the reconstructed image. Fig. 6 shows the resulting image. Paragraph 0052 teaches the resulting image comprises the information of the K-edge contrast agents).
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (PGPUB No. US 2008/0137803) in view of Sabol et al. (PGPUB No. US 2004/0101088).
Regarding claim 8, modified Wu teaches the X-ray imaging method in claim 5, as discussed above.
While Wu teaches simultaneous imaging of multiple contrast agents (Paragraph 0057 and Fig. 6), Wu is silent regarding an X-ray imaging method, wherein the X-ray imaging method is one of the following CT imaging methods:
a simultaneous representation of an embolic agent and a local blood flow during a chemoembolization;
a simultaneous representation of a venous or portal venous phase and an arterial phase of a liver; or
a simultaneous representation of a local blood flow of a lung parenchyma and a lung ventilation.
In an analogous imaging field of endeavor, regarding x-ray imaging of multiple contrast agents, Sabol teaches an X-ray imaging method, wherein the X-ray imaging method is one of the following CT imaging methods:
a simultaneous representation of an embolic agent and a local blood flow during a chemoembolization;
a simultaneous representation of a venous or portal venous phase and an arterial phase of a liver (Paragraph 0041 teaches that the hepatic circulation system that includes the liver can be imaged. The arterial and venous circulation and portal circulation are imaged and liver perfusion is discriminated. Paragraph 0042 teaches that multiple contrast agents can be used where each can be introduced to arterial or venous vessels. Paragraph 0020 teaches that the imaging can be simultaneous); or
a simultaneous representation of a local blood flow of a lung parenchyma and a lung ventilation.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wu with Sabol’s teaching of simultaneous imaging of multiple contrast agents that show venous and arterial phases of a liver. This modified method would allow the user to visualize collateral blood flow, simultaneous imaging of lymphatic and vascular vessels, visualization of catheter tips or stents in a relatively radiopaque contrast filled vessel, and differentiation of multiple stents in a single image or projection (Paragraph 0021 of Sabol). Furthermore, the modification allows for accurate liver function assessment (Paragraph 0041 of Sabol).
Regarding claim 18, modified Wu teaches the X-ray imaging method in claim 6, as discussed above.
While Wu teaches simultaneous imaging of multiple contrast agents (Paragraph 0057 and Fig. 6), Wu is silent regarding an X-ray imaging method, wherein the X-ray imaging method is one of the following CT imaging methods:
a simultaneous representation of an embolic agent and a local blood flow during a chemoembolization;
a simultaneous representation of a venous or portal venous phase and an arterial phase of a liver; or
a simultaneous representation of a local blood flow of a lung parenchyma and a lung ventilation.
In an analogous imaging field of endeavor, regarding x-ray imaging of multiple contrast agents, Sabol teaches an X-ray imaging method, wherein the X-ray imaging method is one of the following CT imaging methods:
a simultaneous representation of an embolic agent and a local blood flow during a chemoembolization;
a simultaneous representation of a venous or portal venous phase and an arterial phase of a liver (Paragraph 0041 teaches that the hepatic circulation system that includes the liver can be imaged. The arterial and venous circulation and portal circulation are imaged and liver perfusion is discriminated. Paragraph 0042 teaches that multiple contrast agents can be used where each can be introduced to arterial or venous vessels. Paragraph 0020 teaches that the imaging can be simultaneous); or
a simultaneous representation of a local blood flow of a lung parenchyma and a lung ventilation.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wu with Sabol’s teaching of simultaneous imaging of multiple contrast agents that show venous and arterial phases of a liver. This modified method would allow the user to visualize collateral blood flow, simultaneous imaging of lymphatic and vascular vessels, visualization of catheter tips or stents in a relatively radiopaque contrast filled vessel, and differentiation of multiple stents in a single image or projection (Paragraph 0021 of Sabol). Furthermore, the modification allows for accurate liver function assessment (Paragraph 0041 of Sabol).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (PGPUB No. US 2008/0137803) in view of Forthmann et al. (PGPUB No. US 2011/0096892) further in view of Sabol et al. (PGPUB No. US 2004/0101088).
Regarding claim 19, modified Wu teaches the X-ray imaging method in claim 7, as discussed above.
While Wu teaches simultaneous imaging of multiple contrast agents (Paragraph 0057 and Fig. 6), the combination of Wu and Forthmann is silent regarding an X-ray imaging method, wherein the X-ray imaging method is one of the following CT imaging methods:
a simultaneous representation of an embolic agent and a local blood flow during a chemoembolization;
a simultaneous representation of a venous or portal venous phase and an arterial phase of a liver; or
a simultaneous representation of a local blood flow of a lung parenchyma and a lung ventilation.
In an analogous imaging field of endeavor, regarding x-ray imaging of multiple contrast agents, Sabol teaches an X-ray imaging method, wherein the X-ray imaging method is one of the following CT imaging methods:
a simultaneous representation of an embolic agent and a local blood flow during a chemoembolization;
a simultaneous representation of a venous or portal venous phase and an arterial phase of a liver (Paragraph 0041 teaches that the hepatic circulation system that includes the liver can be imaged. The arterial and venous circulation and portal circulation are imaged and liver perfusion is discriminated. Paragraph 0042 teaches that multiple contrast agents can be used where each can be introduced to arterial or venous vessels. Paragraph 0020 teaches that the imaging can be simultaneous); or
a simultaneous representation of a local blood flow of a lung parenchyma and a lung ventilation.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the combination of Wu and Forthmann with Sabol’s teaching of simultaneous imaging of multiple contrast agents that show venous and arterial phases of a liver. This modified method would allow the user to visualize collateral blood flow, simultaneous imaging of lymphatic and vascular vessels, visualization of catheter tips or stents in a relatively radiopaque contrast filled vessel, and differentiation of multiple stents in a single image or projection (Paragraph 0021 of Sabol). Furthermore, the modification allows for accurate liver function assessment (Paragraph 0041 of Sabol).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wu et al. (PGPUB No. US 2008/0137803) in view of Eusemann et al. (PGPUB No. US 2017/0020472).
Regarding claim 23, modified Wu teaches the X-ray imaging method in claim 5, as discussed above.
However, Wu is silent regarding an X-ray imaging method, further comprising: visualizing the first image dataset in a first image and the second image dataset in a second image.
In an analogous imaging field of endeavor, regarding x-ray imaging of multiple contrast agents, Eusemann teaches an X-ray imaging method, further comprising: visualizing the first image dataset in a first image and the second image dataset in a second image (Claim 7 teaches the simultaneous display of a first and second image associated to their own respective image sets).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wu with Eusemann’s teaching of simultaneous display. This modified method would allow the user to facilitate the simultaneous acquisition and visualization of anatomy including vasculature and macrophage-based hotspots (Paragraph 0002 of Eusemann). Furthermore, the modification will enhance various aspects of the subject's anatomy simultaneously during imaging (Paragraph 0028 of Eusemann).
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soesbe et al. ("Separating High-Z Oral Contrast From Intravascular Iodine Contrast in an Animal Model Using Dual-Layer Spectral CT", 2018) in view of Salb et al. (PGPUB No. US 2001/0031035).
Regarding claim 5, Soesbe teaches an X-ray imaging method, comprising:
selecting an ensemble of X-ray contrast agents, the ensemble including a first X-ray contrast agent having a first X-ray absorption and a second X-ray contrast agent having a second X-ray absorption (Abstract teaches the use of iodine and tungsten contrast agents. Fig. 6 shows the iodine and tungsten spectra according to photon energies and the absorption);
capturing X-ray raw data from a first region of an examination object and a second region of the examination object using a multi-energy recording method, the first region being flooded by the first X-ray contrast agent, the second region being flooded by the second X-ray contrast agent, and the multi-energy recording method including at least two different X-ray photon energies based on a-a first amount of change in the second X-ray absorption between the at least two different X-ray photon energies being less than half of a second amount of change in the first X-ray absorption between the at least two different X-ray photon energies (Abstract teaches the use of dual-layer dual-energy spectral X-ray computed tomography for the acquisition of the images according to the tungsten and iodine contrast agents. Fig. 5 shows in the reconstructed images that the iodine is accumulated in the kidneys and the tungsten in the stomach and bowel lumen. Fig. 6 shows the change between 57 keV to 83 keV of the iodine is less than the half change of tungsten);
carrying out a material decomposition based on the X-ray raw data in relation to the first X-ray contrast agent and the second X-ray contrast agent (Abstract teaches the implementation of material decomposition to separate the iodine contrast agent from the tungsten contrast agent); and
reconstructing at least two image datasets based on the material decomposition (Abstract teaches the implementation of material decomposition to separate the iodine contrast agent from the tungsten contrast agent. See Fig. 5), the at least two image datasets including
a first image dataset representing a first image region affected by the first X-ray contrast agent (Fig. 5 shows in the reconstructed images that the iodine is accumulated in the kidneys and the tungsten in the stomach and bowel lumen), and
a second image dataset representing a second image region affected by the second X-ray contrast agent (Fig. 5 shows in the reconstructed images that the iodine is accumulated in the kidneys and the tungsten in the stomach and bowel lumen).
While Soesbe teaches the utilization of the photon energies that have absorptions of two contrast agents that change and has one agent’s change less than half of the other, Soesbe does not mention the selection.
In an analogous imaging field of endeavor, regarding selection of contrast agents, Salb teaches a method of selection of selected photon energy according to the K-absorption edges (Paragraph 0280 teaches that the selected photon energy is according to the substance with the K-edges for the generation of a beam. Paragraph 0281 establishes that the K-edge is “a characteristic photon energy at which X-ray attenuation sharply increases.” This is “for each element in the periodic table.” Such a K-edge is a natural phenomenon of the element that results in the attenuation spike at the associated selected photon energy. It is extremely well known that “K-shell binding energies are specific to each element.”7 This is the basis of x-ray imaging as “Elements with larger K-edge values, that are within the useful portion of the x-ray spectrum, are of greater interest in radiology. The k-edge properties of certain materials can be specifically chosen for their use in contrast media, intensifying screens and beam filters.”8 (emphasis added). Such a feature is the basis on which x-ray is performed as it is what results in the “abrupt increase in the photoelectric absorption of x-ray photons observed at an energy level just beyond the binding energy of the k-shell electrons of the absorbing atom” 9 and thereby provides the ability to detect the material via the x-ray detector).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Soesbe with Salb’s teaching of selection of photon energy according to the material used. This modified method would allow the user to generate a beam with the desired energy spectrum (Paragraph 0280 of Salb). Furthermore, the modification provides for an improvement for visualization of small malignant tumors on mammograms would enable their earlier detection, enhance the effectiveness of therapy, and prolong patient survival time (Paragraph 0013 of Salb).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Wang (PGPUB No. US 2005/0080019): Teaches selection of photon energy according to absorption.
Bourke (PGPUB No. US 2009/0104212): Teaches selection of photon energy according to absorption.
Wen (PGPUB No. US 2021/0077045): Teaches selection of photon energy according to absorption.
Leng et al. (PGPUB No. US 2013/0108013): Teaches selection of photon energy according to absorption.
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 extension fee 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 date of this final action.
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/ADIL PARTAP S VIRK/Primary Examiner, Art Unit 3798
1 https://radiopaedia.org/articles/k-absorption-edge?lang=us
2 https://radiopaedia.org/articles/k-absorption-edge?lang=us
3 https://radiopaedia.org/articles/k-absorption-edge?lang=us
4 https://radiopaedia.org/articles/attenuation-coefficient?lang=us
5 https://www.merriam-webster.com/dictionary/change
6 https://www.merriam-webster.com/dictionary/change
7 https://radiopaedia.org/articles/k-absorption-edge?lang=us
8 https://radiopaedia.org/articles/k-absorption-edge?lang=us
9 https://radiopaedia.org/articles/k-absorption-edge?lang=us