DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Response to Amendment
Applicant’s response to the last Office Action, filed on 11/21/2025 has been entered and made of record.
Existing rejection under 35 USC 112 first paragraph for new matter has been removed in view amendments. A new rejection under 35 USC 112 first paragraph for new matter has been added in view amendments
Rejections under 35 USC 112 second paragraph have been withdrawn in view of amendments.
Certain rejections under 35 USC 112 second paragraph have been withdrawn in view of amendments while others remain.
Double patenting rejection is maintained.
Response to Arguments
Applicant's arguments filed on 11/21/2025 have been fully considered but they are not persuasive.
The claim rejections have been updated to fully reflect the newly amended claim language. See detailed analysis below.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 2, 4-8, 10-13, and 16-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 9,769,912. Although the claims at issue are not identical, they are not patentably distinct from each other:
Regarding claim 16, U.S. Patent No. 9,769,912 discloses the imaging system to acquire image data, comprising: (claims 1, 6 and 13)
a source system including, (claims 1, 6 and 13)
a single x-ray source tube, (claims 1, 6 and 13)
a first power system having a first power characteristic to power the single x-ray source tube to emit x-rays relating to the first power characteristic operable to have a first voltage and amperage, wherein the first power characteristic is selected to be at least one of a first voltage of about 40 kV to about 180 kV or a first amperage of about 10 mA to about 500 mA; (claims 1, 6 and 13)
a second power system having a second power characteristic to power the single x-ray source tube to emit x-rays relating to the second power characteristic operable to have a second voltage and amperage, wherein the second power characteristic is selected to be at least one of a second voltage that is about 40 kV to about 60 kV different than the first voltage or a second amperage that is about 20 mA to about 150 mA different than the first amperage; (claims 1, 6 and 13)
a switch assembly connected to the first power system and the second power system to allow switching between the first power system and the second power system based on a known time when the first power system is used to generate the x-rays relating to the first power characteristic as opposed to the second power system to generate the x-rays relating to the second power characteristic such that the source system is configured to be switched between the first power system and the second power system by operation of the switch to power the single x-ray source tube to emit the x-rays relating to the first power characteristic or emit the x-rays relating to the second power characteristic; (switch and power gating limitations at claims 1, 6, 12 and 13)
a detector system positioned to detect the x-rays relating to the first power characteristic to acquire a first image data at a first time and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to acquire a second image data at a second time different than the first time; (claim 13)
a gating system configured to gate acquisition of the first image data of the subject and the second image data of the subject, wherein the first image data and the second image data are operable to include at least one of a first phase and a second phase of the subject; (claims 1, 6 and 13)
a processor to execute instructions to reconstruct a single three-dimensional model of at least a portion including at least a vasculature of the subject separate from a surrounding tissue of the subject based on the detected x-rays relating to the first power characteristic and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to discriminate the vasculature from the surrounding tissue of the subject, wherein the reconstruction of the single three-dimensional model is based on the discrimination and a segregation of the first image data and the second image data based on the first time and the second time due to the gating system that gates the acquisition of the first image data and the second image data; (claims 3 and 13)
wherein the source system and the detector system are configured to be positioned along a path in concert at a plurality of selected positions relative to at least the portion of the subject including such that the detector is configured to start, stop, rewind or combinations thereof relative to the path. (claim 13)
Regarding claim 17 the instant application is similar to the reference application's claim 13.
Regarding claim 18 the instant application is similar to the reference application's claims 1, 6 and 20.
Regarding claim 19 the instant application is similar to the reference application's claim 14.
Regarding claim 20 the instant application is similar to the reference application's claim 19.
Regarding claim 21 the instant application is similar to the reference application's claims 1, 6 and 13.
Regarding claim 22 the instant application is similar to the reference application's claim 16.
Regarding claim 24 the instant application is similar to the reference application's claims 19 and 21.
Claims 1, 2, 4-8, 10-13, and 16-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,807,860. Although the claims at issue are not identical, they are not patentably distinct from each other:
Regarding claim 16, U.S. Patent No. 9,807,860 discloses the imaging system to acquire image data, comprising: (claims 1, 7 and 21)
a source system including, (claims 1, 7 and 21)
a single x-ray source tube, (claims 1, 7 and 21)
a first power system having a first power characteristic to power the single x-ray source tube to emit x-rays relating to the first power characteristic operable to have a first voltage and amperage, wherein the first power characteristic is selected to be at least one of a first voltage of about 40 kV to about 180 kV or a first amperage of about 10 mA to about 500 mA; (claims 1, 7 and 21)
a second power system having a second power characteristic to power the single x-ray source tube to emit x-rays relating to the second power characteristic operable to have a second voltage and amperage, wherein the second power characteristic is selected to be at least one of a second voltage that is about 40 kV to about 60 kV different than the first voltage or a second amperage that is about 20 mA to about 150 mA different than the first amperage; (claims 1, 7 and 21)
a switch assembly connected to the first power system and the second power system to allow switching between the first power system and the second power system based on a known time when the first power system is used to generate the x-rays relating to the first power characteristic as opposed to the second power system to generate the x-rays relating to the second power characteristic such that the source system is configured to be switched between the first power system and the second power system by operation of the switch to power the single x-ray source tube to emit the x-rays relating to the first power characteristic or emit the x-rays relating to the second power characteristic; (claims 3 and 23)
a detector system positioned to detect the x-rays relating to the first power characteristic to acquire a first image data at a first time and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to acquire a second image data at a second time different than the first time; (detector and image acquisition at claims 1, 7 and 21)
a gating system configured to gate acquisition of the first image data of the subject and the second image data of the subject, wherein the first image data and the second image data are operable to include at least one of a first phase and a second phase of the subject; (gating and alternating power source at claims 1, 7, 16 and 21)
a processor to execute instructions to reconstruct a single three-dimensional model of at least a portion including at least a vasculature of the subject separate from a surrounding tissue of the subject based on the detected x-rays relating to the first power characteristic and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to discriminate the vasculature from the surrounding tissue of the subject, wherein the reconstruction of the single three-dimensional model is based on the discrimination and a segregation of the first image data and the second image data based on the first time and the second time due to the gating system that gates the acquisition of the first image data and the second image data; (venous, arterial and vasculature discrimination along with three-dimensional model at claims 1, 4, 7, 16, 24 and 25)
wherein the source system and the detector system are configured to be positioned along a path in concert at a plurality of selected positions relative to at least the portion of the subject including such that the detector is configured to start, stop, rewind or combinations thereof relative to the path. (moving source assembly at claims 1, 7 and 21.)
Regarding claim 17 the instant application is similar to the reference application's claims 1, 7 and 21.
Claims 1, 2, 4-8, 10-13, and 16-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. claims 1-20 of 15/823,031. Although the claims at issue are not identical, they are not patentably distinct from each other:
Regarding claim 16, application 15/823,031 discloses the imaging system to acquire image data, comprising: (claims 1, 9 and 15)
a source system including, (claims 1, 9 and 15)
a single x-ray source tube, (claims 1, 9 and 15)
a first power system having a first power characteristic to power the single x-ray source tube to emit x-rays relating to the first power characteristic operable to have a first voltage and amperage, wherein the first power characteristic is selected to be at least one of a first voltage of about 40 kV to about 180 kV or a first amperage of about 10 mA to about 500 mA; (claims 1, 9, 11 and 15)
a second power system having a second power characteristic to power the single x-ray source tube to emit x-rays relating to the second power characteristic operable to have a second voltage and amperage, wherein the second power characteristic is selected to be at least one of a second voltage that is about 40 kV to about 60 kV different than the first voltage or a second amperage that is about 20 mA to about 150 mA different than the first amperage; (claims 1, 9, 11 and 15)
a switch assembly connected to the first power system and the second power system to allow switching between the first power system and the second power system based on a known time when the first power system is used to generate the x-rays relating to the first power characteristic as opposed to the second power system to generate the x-rays relating to the second power characteristic such that the source system is configured to be switched between the first power system and the second power system by operation of the switch to power the single x-ray source tube to emit the x-rays relating to the first power characteristic or emit the x-rays relating to the second power characteristic; (claims 1, 9 and 15)
a detector system positioned to detect the x-rays relating to the first power characteristic to acquire a first image data at a first time and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to acquire a second image data at a second time different than the first time; (claims 1, 12, and 15)
a gating system configured to gate acquisition of the first image data of the subject and the second image data of the subject, wherein the first image data and the second image data are operable to include at least one of a first phase and a second phase of the subject; (phase-based acquisition at claims 1, 9 and 15)
a processor to execute instructions to reconstruct a single three-dimensional model of at least a portion including at least a vasculature of the subject separate from a surrounding tissue of the subject based on the detected x-rays relating to the first power characteristic and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to discriminate the vasculature from the surrounding tissue of the subject, wherein the reconstruction of the single three-dimensional model is based on the discrimination and a segregation of the first image data and the second image data based on the first time and the second time due to the gating system that gates the acquisition of the first image data and the second image data; (venous, arterial and vasculature discrimination along with three-dimensional model at claims 1, 9 14, 15 and 20)
wherein the source system and the detector system are configured to be positioned along a path in concert at a plurality of selected positions relative to at least the portion of the subject including such that the detector is configured to start, stop, rewind or combinations thereof relative to the path. (moving source assembly at claims 1, 9 and 15.)
Regarding claim 17 the instant application is similar to the reference application's claims 1, 9 and 15.
Regarding claim 18 the instant application is similar to the reference application's claims 9 and 12.
Regarding claim 19 the instant application is similar to the reference application's claim 15.
Regarding claim 21 the instant application is similar to the reference application's claim 1, 9 and 15.
Regarding claim 22 the instant application is similar to the reference application's claim 1, 14 and 19.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 4-8, 10-13, and 16-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. claims 1-20 of 15/797,429. Although the claims at issue are not identical, they are not patentably distinct from each other:
Regarding claim 16, application 15/797,429 discloses the imaging system to acquire image data, comprising: (claims 1, 12 and 19)
a source system including, (claims 1, 12 and 19)
a single x-ray source tube, (claims 1, 12 and 19)
a first power system having a first power characteristic to power the single x-ray source tube to emit x-rays relating to the first power characteristic operable to have a first voltage and amperage, wherein the first power characteristic is selected to be at least one of a first voltage of about 40 kV to about 180 kV or a first amperage of about 10 mA to about 500 mA; (claim 9)
a second power system having a second power characteristic to power the single x-ray source tube to emit x-rays relating to the second power characteristic operable to have a second voltage and amperage, wherein the second power characteristic is selected to be at least one of a second voltage that is about 40 kV to about 60 kV different than the first voltage or a second amperage that is about 20 mA to about 150 mA different than the first amperage; (claim 9)
a switch assembly connected to the first power system and the second power system to allow switching between the first power system and the second power system based on a known time when the first power system is used to generate the x-rays relating to the first power characteristic as opposed to the second power system to generate the x-rays relating to the second power characteristic such that the source system is configured to be switched between the first power system and the second power system by operation of the switch to power the single x-ray source tube to emit the x-rays relating to the first power characteristic or emit the x-rays relating to the second power characteristic; (claim 6)
a detector system positioned to detect the x-rays relating to the first power characteristic to acquire a first image data at a first time and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to acquire a second image data at a second time different than the first time; (claims 1, 12 and 19)
a gating system configured to gate acquisition of the first image data of the subject and the second image data of the subject, wherein the first image data and the second image data are operable to include at least one of a first phase and a second phase of the subject; (phase-based acquisition at claims 1, 12 and 19)
a processor to execute instructions to reconstruct a single three-dimensional model of at least a portion including at least a vasculature of the subject separate from a surrounding tissue of the subject based on the detected x-rays relating to the first power characteristic and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to discriminate the vasculature from the surrounding tissue of the subject, wherein the reconstruction of the single three-dimensional model is based on the discrimination and a segregation of the first image data and the second image data based on the first time and the second time due to the gating system that gates the acquisition of the first image data and the second image data; (venous vasculature discrimination along with three-dimensional model at claims 1, 4, 12 and 19)
wherein the source system and the detector system are configured to be positioned along a path in concert at a plurality of selected positions relative to at least the portion of the subject including such that the detector is configured to start, stop, rewind or combinations thereof relative to the path. (moving source assembly at claims 1, 12 and 19.)
Regarding claim 17 the instant application is similar to the reference application's claim 8.
Regarding claim 18 the instant application is similar to the reference application's claims 7.
Regarding claim 19 the instant application is similar to the reference application's claim 1.
Regarding claim 20 the instant application is similar to the reference application's claim 1.
Regarding claim 21 the instant application is similar to the reference application's claim 1, 12 and 19.
Regarding claim 22 the instant application is similar to the reference application's claim 1.
Regarding claim 23 the instant application is similar to the reference application's claim 2.
Regarding claim 24 the instant application is similar to the reference application's claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1, 2, 4-8, 10-13, and 16-26 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1, 16 and 21 recite, “interpolate the first image data and the second image data based on a movement of the single x-ray source tube or detector between acquisition of the first image data and the second image data, wherein the interpolation aligns the first image data and the second image data during reconstruction of the single three-dimensional model”. The underlined section of the claim language above does not appear to have support in the originally filed disclosure. Examiner notes that the ‘interpolation based on movement’ (for which there is disclosure) need not align the two image data sets to one another.
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 21-24 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 21 requires, “controlling an assembly of the first power source, second power source, and at least moving of the single x-ray source tube with a detector, and a gantry” It is not clear from the claim language what is includes in the assembly, and what is meant the language, “and at least moving of the single x-ray source tube with a detector, and a gantry”. It is not clear what is required to be moved, in particular, for example, whether the gantry is part of the assembly or whether the claim is requiring that the gantry is moved. Prior to the amendment the assembly was a list of components, but with the recent amendment “at least moving of the…” it is no longer clear what the metes and bounds are.
Claims 21-24 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 21 requires, “gantry is configured to move relative to the subject during the acquisition of the first image data and the second image data to assist in defining the path” It is not clear from the claim language what the metes and bounds are of the language, “to assist in defining the path”. Similarly, the claim requires, “configured to start, stop, rewind or combinations thereof relative to assist in defining the path.” Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 2 and 4-6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant).
Regarding claim 1, Seppi discloses a method of acquiring image data with an imaging system (¶ 0026 teaches CT acquisition), comprising:
providing a first power source to power a single x-ray source tube with a first power characteristic to emit x-rays to acquire a first image data relative to a first selected position for acquisition of a first image data of a subject; (Pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels.” Tube is taught at ¶ 0043.)
providing a second power source separate from the provided first power source to power the single x-ray source tube with a second power characteristic different from the first power characteristic to emit x-rays to acquire a second image data relative to the first selected position of the subject; (As above, Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to acquire respective images.)
providing a switch separate form, the provided first power source and the provided second power source to switch between the provided first power source and provided second power source to power the single x-ray source tube; (Seppi ¶ 0030 teaches that the x-ray source device is a switch which switches the two power sources in quick succession to capture the radiation at both power levels.)
providing a moving system to move the single x-ray source tube relative to the subject during the acquisition of the first image data and the second image data, wherein at least one of the first image data or the second image data include a vasculature of the subject, and wherein the acquisition of the first image data and the second image data is performed in the presence of a contrast agent injected into the subject; and (As above, pg. 3, ¶ 0030 teaches that the assembly rotates about the subject, ¶ 0043 teaches that this includes the tube. Seppi ¶ 0035 illustrates surrounding tissue in one of the two volumetric images and the contrast agent plus vasculature in the other image.)
providing a processor configured to execute instructions to (i) reconstruct a single three-dimensional model that represents at least a portion of the subject based on the acquired first image data and the second image data; (¶ 0068 and 0069 teach volumetric reconstruction. ¶ 0035 teaches how reconstruction is accomplished via the first and second image data (dual energy imaging). See Seppi ¶ 0082 regarding a processor.)
(ii) discriminate a first selected portion of the subject from a second selected portion of the subject within the single three-dimensional model due at least to the first image data acquired with the first power characteristic and the second image data acquired with the second power characteristic, wherein the discrimination includes at least the vasculature of the subject separate from a surrounding tissue of the subject;; (Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to exploit a difference in absorption between the two energy levels. ¶ 0035 further describes how this difference is used in discriminate selected portions of the subject. Seppi ¶ 0035 illustrates discriminating surrounding tissue in one of the two volumetric images and the contrast agent plus vasculature in the other image.)
(iii) interpolate based on an amount of movement of the single x-ray source tube between when the first image data was acquired with the first power source and the second image data was acquired with the second power source, wherein the interpolation aligns the acquired first image data and the acquired second image data during reconstruction of the single three-dimensional anatomical model; (See interpolation at Seppi ¶ 0034.)
wherein the single three-dimensional model is reconstructed based on a difference of the first image data at the first power characteristic and the second image data at the second power characteristic: wherein the first image data at the first power includes x-rays having a first attenuation with the first selected portion of the subject and the second image data at the second power includes x-rays having a second attenuation with the second selected portion of the subject wherein the first attenuation is different than the second attenuation. (As above Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to exploit a difference in attenuation between the two power levels. ¶ 0035 further describes how this attenuation difference is used in imaging. As above, ¶ 0068 and 0069 teach volumetric reconstruction. ¶ 0035 teaches how reconstruction is accomplished via the first and second image data (dual energy imaging).
Seppi does not expressly teach the remaining limitations.
In the field of dual energy medical imaging Rappoport teaches the first power characteristic is selected to be at least one of a first voltage of about 40 kV to about 180 kV and a first amperage of about 10 mA to about 500 mA and wherein the second power characteristic is selected to be at least one of a second voltage that is about 40 kV to about 60 kV different than the first voltage and a second amperage that is about 20 mA to about 150 mA different than the first amperage. (Rappoport Pg. 3, ¶ 0040, “For the dual-energy measurements, technique factors of about 60 mA at 130 kVp (i.e., the first power source) and about 30 mA at 80 kVp (i.e., the second power source) were chosen.”)
It would have been obvious at the time the invention was made to one of ordinary skill in the art to modify the above combination to include a power source according to the claimed specifications. One skilled in the art would have been motivated to include these previously chosen power specifications in order for the imaging to be compatible with the selected contrast agent. Further, Rappoport Pg. 3, ¶ 0036, “Some of the determining factors concerning what specific parameters to use may comprise radiation exposure, noise, type of contrast agent used, size of area to be scanned, and size of patient and so on.” The prior art collectively includes each element claimed, and one of ordinary skill in the art could have combined the elements in the manner explained above using known engineering design without changing a “fundamental” operating principle of above combination.
Regarding claim 2, the above combination discloses the method of claim 1, further comprising: positioning the movable single x-ray source tube in a housing. (Seppi pg. 2, ¶ 0024, teaches a gantry which houses the x-ray source assembly)
Regarding claim 4, the above combination discloses the method of claim 1, further comprising: providing controls to move at least one of the movable single x-ray source tube or the housing during acquiring the first image data and the second image data. (Seppi ¶ 0026 teaches a control 40 to control the gantry rotation.)
Regarding claim 5, the above combination discloses the method of claim 1, further comprising: acquiring the first image data and the second image data based on and of a selected physiological event of the subject, wherein the first image data and the second image data are used separately to generate different models of the subject. (Seppi ¶ 0027 teaches synchronizing gating based on physiological event “motion signal representative of a physiological movement of the patient 16 can be used to predictively gate an operation of the x-ray source assembly 20 such that image data can be generated at prescribed phase(s) or prescribed amplitude range(s) of a physiological cycle.” See ¶ 0035 regarding the separated first and second data separated to generate different models.)
Regarding claim 6, the above combination discloses the method of claim 5, further comprising: gating the acquisition of the first image data and the second image data relative to the first selected position at both the first power characteristic and the second power characteristic to acquire the first image data and the second image data at the selected physiological event of the subject. (As above, Seppi ¶ 0027 teaches synchronizing gating for a first and second image acquisition based on physiological event.)
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant) and Montagnat (“Globally constrained deformable models for 3D object reconstruction”; provided by Applicant).
Regarding claim 7, the above combination discloses the method of claim 1 wherein the first image data is two-dimensional image data and the second image data is two-dimensional (As above, Seppi ¶ 0030 teaches emitting x-rays at first and second power levels (first and second image data) to exploit a difference in absorption between the two energy levels. ¶ 0030 and 0035 teach that these are two-dimensional image data.), including the processor to execute instructions for reconstructing the single three-dimensional model of at least the portion of the subject based on the acquired first image data and the second image data to illustrate one of a first phase or a second phase of the subject (see rejection of claim 1), but does not expressly disclose the remaining limitations.
In the field of CT image reconstruction Montagnat teaches performing an algebraic iterative technique to alter a theoretical formed model of the subject. (Both the deformable model framework described as free-form deformation (abstract and pg. 174, section 1.1) and the non-rigid registration framework (abstract and pg. 175, section 1.2) as well as Montagnat’s own model (pg. 175, section 2) all meet the above limitations of the iterative reconstruction model.)
It would have been obvious at the time the invention was made to one of ordinary skill in the art to use a reconstruction model which iteratively alters a theoretical template. The prior art collectively includes each element claimed, and one of ordinary skill in the art could have combined the elements in the manner explained above using known engineering design without changing a “fundamental” operating principle of above combination, while the teaching of Montagnat continues to perform the same function as originally taught prior to being combined, in order to produce the repeatable and predictable result of including the functionality from a well-known and widely performed reconstruction technique in CT imaging. Although Seppi and the above combination do not expressly disclose this reconstruction method, iterative CT reconstruction as described is a widely-practiced technique and substituting it with Seppi’s reconstruction would not produce an unexpected result.
Claim 8 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant), Montagnat (“Globally constrained deformable models for 3D object reconstruction”; provided by Applicant) and Licato (U.S. PG Pub. 2010/0128942).
Regarding claim 8, the above combination discloses the method of claim 7, further comprising gating the acquisition to the first image data and the second image data relative to the first selected position at both the first power characteristic and the second power characteristic to acquire the first image data and the second image data at selected time intervals, but does not expressly teach the remaining limitations (Pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels.”)
In the field of dual-energy CT systems Licato teaches what the above combination does not expressly disclose, namely, selecting the first phase and the second phase based on the selected time intervals wherein the first phase corresponds to an arterial structure and the second phase to be a venous structure. (Licato teaches a dual-energy CT system which teaches separate arterial and venous imaging based on the contrast agent peak in the vasculature. ¶ 0031, “CTA [CT angiography] data is also extracted from the CT perfusion image data by locating the dynamic acquisition phase associated with a peak arterial concentration of contrast. Similarly, the CT venography ("CTV") data is also extracted from the dynamic acquisition data using the peak venous phase.”)
It would have been obvious at the time the invention was made to one of ordinary skill in the art to modify Seppi’s system to include reconstructing separate venous and arterial models in separate phases of contrast agent propagation. Seppi already teaches reconstructing based on separate physiological phases. Licato explicitly teaches doing so for venous and arterial phases. One skilled in the art would have been motivated to modify Seppi to include this well-known technique of separate reconstruction of arteries and veins in order that the user does not have to differentiate between the two, if such an image is desired (this increases system flexibility). Furthermore, the prior art collectively includes each element claimed (though not all in the same reference), and one of ordinary skill in the art could have combined the elements in the manner explained above using known engineering design without changing a “fundamental” operating principle.
Claim 12 and 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant), and Licato (U.S. PG Pub. 2010/0128942).
Regarding claim 12, the above combination discloses the method of claim 1, wherein providing the processor configured to execute instructions to reconstruct the single three-dimensional model of at least the portion of the subject includes illustrating both a first vascular phase and a second vascular phase as separate anatomical portions of the subject. (see rejection of claim 8 for combination in view of Licato teaching separate venous and arterial structures.)
Regarding claim 26, the above combination discloses the method of Claim 12, further comprising: causing the reconstructed single three-dimensional model to display either the first vascular phase or the second vascular phase on a display device. (Seppi ¶ 0026 and Licato ¶ 0041.)
Claims 16-17 and 19-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant).
Regarding claim 16, Seppi discloses the imaging system to acquire image data (¶ 0026 teaches CT acquisition), comprising:
a source system including, (Pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels.”)
a single x-ray source tube, (Tube is taught at ¶ 0043.)
a first power system having a first power characteristic to power the single x-ray source tube to emit x-rays relating to the first power characteristic (As above, Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to acquire respective images.)
a second power system having a second power characteristic to power the single x-ray source tube to emit x-rays relating to the second power characteristic (As above, Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to acquire respective images.)
a switch assembly connected to the first power system and the second power system to allow switching between the first power system and the second power system based on a known time when the first power system is used to generate the x-rays relating to the first power characteristic and to the second power system is used to generate the x-rays relating to the second power characteristic wherein operation of the switch powers the single x-ray source tube to emit the x-rays relating to either the first power characteristic or the second power characteristic; (Seppi ¶ 0030 teaches that the x-ray source device is a switch which switches the two power sources in quick succession to capture the radiation at both power levels.)
a detector system positioned to detect the x-rays relating to the first power characteristic to acquire a first image data at a first time and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to acquire a second image data at a second time different than the first time; (See detector at Seppi ¶ 0024. Seppi ¶ 0030 teaches that the two images of different energy levels are acquired at separate times in succession of one another.)
a gating system configured to gate acquisition of the first image data of the subject and the second image data of the subject, wherein the first image data and the second image data are operable to include at least one of a first phase and a second phase of the subject; (Seppi ¶ 0027 teaches synchronizing gating based on physiological event “motion signal representative of a physiological movement of the patient 16 can be used to predictively gate an operation of the x-ray source assembly 20 such that image data can be generated at prescribed phase(s) or prescribed amplitude range(s) of a physiological cycle.” That is, gating the source is taught to image multiple physiological phases. See further detail at ¶ 0091. Also see ¶ 0035 regarding the separate first and second data separated to generate different models.)
a processor to execute instructions to reconstruct a single three-dimensional model of at least a portion including at least a vasculature of the subject separate from a surrounding tissue of the subject based on the detected x-rays relating to the first power characteristic and the x-rays relating to the second power characteristic emitted from the single x-ray source tube to discriminate the vasculature from the surrounding tissue of the subject, wherein the reconstruction of the single three-dimensional model is based on the discrimination and a segregation of the first image data and the second image data based on the first time and the second time due to the gating system that gates the acquisition of the first image data and the second image data, wherein the discrimination is based at least in part on the presence of a contrast agent injected into the subject as depicted in the first image data and the second image data acquired at different power characteristics; (¶ 0068 and 0069 teach volumetric reconstruction/a single 3D model. ¶ 0035 teaches how reconstruction is accomplished via the first and second image data (dual energy imaging). Pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels” acquiring plurality of image data at both energy levels based on a segregation of time. That is, ¶ 0030 and 0035 teach acquiring first and second image data at a first and second power levels at first and second phases, based on a segregation of time. See Seppi ¶ 0035 regarding differentiating vasculature from surrounding tissue. See ¶ 0082 regarding a processor.)
interpolate the first image data and the second image data based on a movement of the single x-ray source tube or detector system between acquisition of the first image data and the second image data, wherein the interpolation aligns the first image data and the second image data during reconstruction of the single three-dimensional model (Seppi ¶ 0034)
wherein the source system and the detector system are configured to be positioned along a path in concert at a plurality of selected positions relative to at least the portion of the subject wherein the path includes the detector configured to start, stop, rewind, or combinations thereof relative to the path. (¶ 0026 teaches rotating the gantry assembly with the attached detector and source that rotates around the patient in order to position at a plurality of selected positions relative to the subject. Also see Fig. 1B with source 20 and detector 24. See ¶ 0030-0033 regarding the detector being configured start, stop, or rewind)
In the field of dual energy medical imaging Rappoport teaches what Seppi does not expressly disclose, namely, that said first power system is operable to have a first voltage and amperage, wherein the first power characteristic is selected to be at least one of a first voltage of about 40 kV to about 180 kV or a first amperage of about 10 mA to about 500 mA and that said second power system is operable to have a second voltage and amperage, wherein the second power characteristic is selected to be at least one of a second voltage that is about 40 kV to about 60 kV different than the first voltage or a second amperage that is about 20 mA to about 150 mA different than the first amperage; and (Rappoport Pg. 3, ¶ 0040, “For the dual-energy measurements, technique factors of about 60 mA at 130 kVp (i.e., the first power source) and about 30 mA at 80 kVp (i.e., the second power source) were chosen.” This meets the range of the claimed first power characteristics and the required difference between first and second power characteristics.)
It would have been obvious at the time the invention was made to one of ordinary skill in the art to modify the above combination to include a power source according to the claimed specifications. Seppi already discloses dual energy CT imaging but does not expressly mention the particular claimed kV and mA ranges. Rappoport, also in the field of dual energy CT imaging does disclose the claimed ranges. One skilled in the art would have been motivated to include Rappoport’s power specifications in order to provide a difference between the two power levels for dual energy imaging and for the imaging to be compatible with the selected contrast agent. Further, Rappoport Pg. 3, ¶ 0036, “Some of the determining factors concerning what specific parameters to use may comprise radiation exposure, noise, type of contrast agent used, size of area to be scanned, and size of patient and so on.” Simply using already-known kV and mA ranges for the dual energy imaging cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 17, the above combination discloses the system of claim 16, further comprising:
a control system configured to control movement of the detector system and the source system; (Seppi ¶ 0026 teaches a control 40 to control the gantry rotation which contains the source and detector.)
wherein the detected x-rays relating to the first power characteristic are a first image data; (see rejection of claim 16)
wherein the detected x-rays relating to the second power characteristic are a second image data; (see rejection of claim 16)
wherein the control system is configured to move the detector system and the source system to the plurality of selected positions relative to at least the portion of the subject to acquire a plurality of first image data and a plurality of second image data. (As above, Seppi pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels” acquiring plurality of image data at both energy levels from a plurality of rotational positions. Also as above, Seppi ¶ 0026 teaches the gantry rotation which contains the source and detector.)
wherein the switch assembly is configured to have a switching rate of about 1 millisecond to about 1 second (Seppi, ¶ 0030, “the two sets of image data are generated in quick succession (e.g., within 5 to 20 milliseconds) using radiation at different levels”)
Regarding claim 19, the above combination discloses the system of claim 16, further comprising: a pump operable to inject the contrast agent into the at least the portion of the subject, wherein the image data is gated relative to an operation of the pump. (Seppi pgs. 2-3, ¶ 0028, “The contrast agent can be administered with a mechanical power injector.” Also see Seppi, ¶ 0030, “After a prescribed time (e.g., 150 seconds) measured from the point of contrast injection has lapsed, the gantry 12 then rotates about the breast 18 to generate two sets of image data (Step 204).”)
Regarding claim 20, the above combination discloses the system of claim 16, wherein the control system is operable to gate an image data acquisition and the movement of the detector system along the selected path based on an injection time of a contrast agent into the subject. (As above, Seppi, ¶ 0030, “After a prescribed time (e.g., 150 seconds) measured from the point of contrast injection has lapsed, the gantry 12 then rotates about the breast 18 to generate two sets of image data (Step 204).”)
wherein the selected path of the detector system is configured so that the detector system need never travel a full 360o around the subject due at least in part to controlled movement of the gantry and the detector system to acquire the image data. (Seppi pg. 2, ¶ 0027, “if a full cone detector is used, the system 10 may acquire data while the gantry 12 rotates 180o plus the angle of the beam pattern.”)
Claims 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant), Feuerlein (U.S. PG Pub. 2008/0306381) and Bertolina (U.S. Pat. Appl. Pub. 2008/0285722; provided by Applicant).
Regarding claim 18, the above combination discloses the system of claim 17, further comprising:
a gantry configured to contain the detector system and the source system and wherein the gantry is configured to encircle at least a portion of the subject, wherein at least a portion of the path is movement of the detector system within the gantry; (See Seppi Fig. 1A and Seppi pg. 2, ¶ 0024, teaches a gantry which houses the x-ray source assembly and detector. Seppi’s gantry rotates surrounding the subject.);
wherein the gantry is movable relative to the subject and the gantry stand (Figs. 1A, 1B and Seppi pg. 2, ¶ 0024 teach a gantry which rotates relative to the subject and gantry stand.)
wherein the detector system and the source system are operable to move around at least the portion of the subject within the gantry to acquire first image data and second image data. (As above, Seppi Fig. 1A and Seppi pg. 2, ¶ 0024, teaches a gantry which houses the x-ray source assembly and detector rotating around the subject within the gantry.)
wherein the control system is further configured to control movement of the gantry, the source system, and the detector system to move at least the detector system in a selected path. (Seppi pg. 3, ¶ 0030 teaches that the gantry assembly which includes the source and detector rotates about the subject, ¶ 0043. Seppi ¶ 0026 teaches a control 40 to control the gantry rotation.)
In the field of imaging devices with attached gantries, Bertolina teaches what the above combination does not expressly disclose, namely, a mobile cart configured to move from a first location to a second location and relative to the subject. (Fig. 1 discloses an imaging apparatus with attached gantries on wheels/casters.)
It would have been obvious at the time the invention was made to one of ordinary skill in the art to modify the above combination to a cart with wheels for allowing increased mobility of the imaging apparatus. One skilled in the art would have been motivated to modify the system with Bertolina’s previously-performed step of attaching wheels onto the imaging apparatus for the purpose of moving the housing. Simply attaching wheels to a medical imaging appliance cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
In the field of CT systems Feuerlein teaches what the above combination does not expressly disclose, namely, that said gantry is configured to enclose the detector system and the source system within a single volume defined by the gantry and the detector system and the source system are operable to move around at least the portion of the subject within and while enclosed by the gantry to acquire image data, and wherein the switch assembly, the first power system and the second power system are housed within the gantry. (See Fig. 3 and ¶ 0073)
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the above combination's CT system with Feuerlein’s CT system (which teaches using a gantry which encloses the detector system and the source system within a single volume). Seppi teaches a gantry which houses a source and detector, but not in such a way that they are both enclosed within a single volume. Feuerlein teaches the well-known and widely-used annular ring CT design in which the detector system and the source system are enclosed within a single ring-shaped enclosure, for the purpose of imaging larger body portions than Seppi which is primarily set up for breast imaging. The combination constitutes the repeatable and predictable result of simply applying Feuerlein’s teaching here for using a ring gantry shape. This cannot be considered a non-obvious improvement in view of the relevant prior art. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Claims 21, 22 and 24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant), and Feuerlein (U.S. PG Pub. 2008/0306381)
Regarding claim 21, Seppi discloses a method of acquiring image data with an imaging system (Seppi ¶ 0026 teaches CT acquisition), comprising:
acquiring a first image data by powering a single x-ray source tube with a first power source at a first power characteristic wherein the single x-ray source tube is configured to emit first x-rays based on the first power characteristic to acquire the first image data; (Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to acquire respective images. Tube is taught at ¶ 0043.)
acquiring a second image data by powering the single x-ray source tube with a second power source at a second power characteristic wherein the single x-ray source tube is configured to emit second x-rays based on the second power characteristic that is different from the first power characteristic to acquire the second image data; (As above, Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to acquire respective images. Single tube is taught at ¶ 0043.)
controlling an assembly of the first power source, second power source, and at least moving of the single x-ray source tube with a detector and a gantry, at least the single x-way source tube and the detector moving relative to the subject in a path while contained within the gantry, the gantry encircles the subject, and the gantry is configured to move relative to the subject during the acquisition of the first image data and the second image data to assist in defining the path, wherein controlling the assembly includes at least control of a motion of the detector gated relative to the subject along a path the detector being configured to start, stop, rewind or combinations thereof to assist in defining the path; (Seppi Fig. 1A and Seppi pg. 2, ¶ 0024, teaches a gantry which houses the x-ray source assembly and detector rotating around the subject within the gantry. Seppi ¶ 0026 teaches that the control controls a motion of the gantry assembly with the attached detector that rotates around the patient. Also see Fig. 1B with detector 24. See ¶ 0030-0033 regarding the detector being configured start, stop, or rewind.)
controlling an injection of a contrast agent into the subject at least prior to the acquisition of the first image data with the first power source at the first power characteristic and the second image data with the second power source at the second power characteristic and wherein the acquisition of the first image data and the second image data is performed in the presence of the contrast agent injected into the subject; (Seppi pgs. 2-3, ¶ 0028, “The contrast agent can be administered with a mechanical power injector.” Also see Seppi, ¶ 0030, “After a prescribed time (e.g., 150 seconds) measured from the point of contrast injection has lapsed, the gantry 12 then rotates about the breast 18 to generate two sets of image data (Step 204).”)
and operating a processor to; (¶ 0068 and 0069 teach volumetric reconstruction/a single 3D model. ¶ 0035 teaches how reconstruction is accomplished via the first and second image data (dual energy imaging). See ¶ 0082 regarding a processor.)
(1) index the acquired first image data and the acquired second image data are indexed after the acquisition of the first image data and the second image data based on knowing a first time when the first power source is used to acquire the first image data and a second time when the second power source is used to acquire the second image data, wherein the first time and the second time are different and control of the motion of the detector is configured to ensure a selected separation of the first image data from the second image data; (Seppi pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels” acquiring plurality of image data at both energy levels, each at a different time. ¶ 0030 specifies that the two image data are captured at different times in quick succession. As noted above, the motion of the gantry including its source and detector is controlled by rotating around the patient during imaging.)
(2) based on the indexed first image data and the second image data identity or segregate different features being imaged based on a differentiation of x-ray attenuation by the features of the first x-rays that are used to generate the first image data and the second x-rays that are used to generate the second image data in the subject, and (As above, Seppi pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels” acquiring plurality of image data at both energy levels, each at a different time. Seppi ¶ 0030 teaches emitting x-rays at first and second power levels to exploit a difference in attenuation between the two power levels. ¶ 0035 further describes how this attenuation difference is used in imaging.)
(3) interpolate the first image data and the second image data based on a movement of the single x-ray source tube or detector between acquisition of the first image data and the second image data, wherein the interpolation aligns the first image data and the second image data during reconstruction of the single three-dimensional model (Seppi ¶ 0034.)
(4) reconstruct a single three-dimensional model of at least a portion of a subject based on the indexed acquired first image data and acquired second image data. (As above, Seppi ¶ 0068 and 0069 teach volumetric reconstruction/a single 3D model. ¶ 0035 teaches how reconstruction is accomplished via the first and second image data (dual energy imaging).)
In the field of dual energy medical imaging Rappoport teaches what Seppi does not expressly disclose, namely, that the first power characteristic is selected to be of a first voltage of about 40 kV to about 180 kV or a first amperage of about 10 mA to about 500 mA and that said second power characteristic is selected to be of a second voltage that is about 40 kV to about 60 kV different than the first voltage or a second amperage that is about 20 mA to about 150 mA different than the first amperage; and (Rappoport Pg. 3, ¶ 0040, “For the dual-energy measurements, technique factors of about 60 mA at 130 kVp (i.e., the first power source) and about 30 mA at 80 kVp (i.e., the second power source) were chosen.” This meets the range of the claimed first power characteristics and the required difference between first and second power characteristics. Also see Rappaport ¶ 0031 regarding the moving gantry assembly.)
It would have been obvious at the time the invention was made to one of ordinary skill in the art to modify the above combination to include a power source according to the claimed specifications. Seppi already discloses dual energy CT imaging but does not expressly mention the particular claimed kV and mA ranges. Rappoport, also in the field of dual energy CT imaging does disclose the claimed ranges. One skilled in the art would have been motivated to include Rappoport’s power specifications in order to provide a difference between the two power levels for dual energy imaging and for the imaging to be compatible with the selected contrast agent. Further, Rappoport Pg. 3, ¶ 0036, “Some of the determining factors concerning what specific parameters to use may comprise radiation exposure, noise, type of contrast agent used, size of area to be scanned, and size of patient and so on.” Simply using already-known kV and mA ranges for the dual energy imaging cannot be considered a non-obvious improvement in view of the relevant prior art here. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
In the field of CT systems Feuerlein teaches what the above combination does not expressly disclose, namely, that said gantry is configured to enclose the assembly of the source and detector (See Fig. 3 and ¶ 0073. ¶ 0073 also teaches a moving gantry assembly.)
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the above combination's CT system with Feuerlein’s CT system (which teaches using a gantry which encloses the detector system and the source system within a single volume). Seppi teaches a gantry which houses a source and detector, but in a way in which they are partially exposed and not enclosed (See Fig. 1). Feuerlein teaches the well-known and widely-used annular ring CT design in which the detector system and the source system are enclosed within a single ring-shaped enclosure, for the purpose of imaging larger body portions than Seppi which is primarily set up for breast imaging. The combination constitutes the repeatable and predictable result of simply applying Feuerlein’s teaching here for using an enclosed ring gantry shape. This cannot be considered a non-obvious improvement in view of the relevant prior art. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Regarding claim 22, the above combination discloses the method of claim 21, further comprising: displaying the single three-dimensional model with a display device. (Seppi ¶ 0026)
Regarding claim 24, the above combination discloses the method of claim 23, further comprising:
moving the assembly enclosed within a volume of the gantry that encircles at least the portion of the subject; (see rejection of claim 21 and in particular Feuerlein as above for the teaching of the detector and sources housed so as to move within a volume of an enclosed gantry.)
wherein moving the assembly of the first power source, second power source, single x-ray source tube, and the detector within the gantry includes moving the assembly around the subject in a selected path that need is less than a full 360 degrees around the subject. (As above, pg. 3, ¶ 0030, “As the gantry 12 rotates about the breast 18, the x-ray source assembly 20 alternately emits radiation at a first and a second energy levels.” Seppi pg. 2, ¶ 0027, “if a full cone detector is used, the system 10 may acquire data while the gantry 12 rotates 180o plus the angle of the beam pattern.”)
Claims 23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant), Feuerlein (U.S. PG Pub. 2008/0306381) and Koenig (US PGPub 20030152519)
Regarding claim 23, the above combination discloses the method of claim 21, further comprising: acquiring a plurality of the first image data and a plurality of the second image data; (see rejection of claim 21)
wherein operating the processor to execute instructions to reconstruct the single three-dimensional model of at least the portion of the subject is based on the acquired plurality of the first image data and the plurality of the second image data, wherein the first image data or the second image data is operable to illustrate a surrounding tissue relative to a vasculature of the subject. (See rejection of claim 21 and Seppi ¶ 0035 which illustrates surrounding tissue in one of the two volumetric images and the contrast agent plus vasculature in the other image.)
In the field of CT systems Koenig teaches what the above combination does not expressly disclose, namely, acquiring image data for about 13 seconds (¶ 0064 and 0065 teach a number of ranges of image data acquisition which include 13 seconds.)
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the above combination's CT system with Koenig’s CT system. Seppi teaches acquiring dual phase CT video data for a number of seconds, but does not explicitly mention the number of seconds. Koenig teaches a system for vascular CT imaging that does disclose this range. The combination constitutes the repeatable and predictable result of simply applying Koenig’s teaching here, for the purpose of acquiring CT data for a certain period of time. Operating the CT for around 13 seconds cannot be considered a non-obvious improvement in view of the relevant prior art. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Claims 25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Seppi (U.S. PG Pub. 2005/0084060; provided by Applicant) in view of Rappoport (U.S. PG Pub. 2007/0238968; provided by Applicant) and Johnson (“Material differentiation by dual energy CT: initial experience”).
Regarding claim 25, the above combination discloses the method of Claim 1, wherein the first power characteristic is a voltage of about 75 kV and an amperage of about 50 mA and the second power characteristic is a voltage of 125 kV and an amperage of about 20 mA. (Rappoport Pg. 3, ¶ 0040, “For the dual-energy measurements, technique factors of about 60 mA at 130 kVp (i.e., the first power source) and about 30 mA at 80 kVp (i.e., the second power source) were chosen.” Examiner notes that as per MPEP § 2144.05 (I) a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). Additionally there is no evidence indicating that the example voltage and amperage parameters given in ¶ 0027 of the specification and claim 25 are critical to the invention. See MPEP MPEP § 2144.05 (II) (A).)
In the field of dual energy CT systems Johnson teaches using a lower tube current for the higher tube voltage (pg. 1512, right column, ¶ 2, “Tube voltages were set to 80 and 140 kV and the current was adjusted to 3-fold for the 80 kV over the 140-kV tube, i.e., 65 and 190 mA, to compensate for the lower photon output at the lower voltage.”)
It would have been obvious to one of ordinary skill in the art to have combined the above combination's dual energy CT system with Johnson's dual energy CT system (which teaches using a lower tube current for the higher tube voltage). Rappoport teaches a similar range of voltages and amperages as the claims in a dual energy CT system. A prima facie case for obviousness exists when claimed amounts are similar to prior art amounts, see MPEP § 2144.05 (I) as described above. Johnson adds the teaching of using a higher tube current for the lower tube voltage to compensate for the lower photon output and to stay within CT dosage requirements (teaching a 3:1 amperage ratio, similar to the prior art's 2.5:1 ratio). The combination constitutes the repeatable and predictable result of simply using Johnson's dual energy CT teachings here. This is not considered a non-obvious improvement in view of the relevant prior art. Using known engineering design, no “fundamental” operating principle of the teachings are changed; they continue to perform the same functions as originally taught prior to being combined.
Conclusion
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/RAPHAEL SCHWARTZ/ Examiner, Art Unit 2671