Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 16 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to “derive feature amounts,” “analyze a time phase delay,” and “comparing the feature amounts” encompass mathematical concepts and data analysis operations under the 2019 PEG. Dependent claims 3–9 and 13 further expressly recite mathematical concepts such as deriving ratios, comparing ratios to thresholds, comparing blood vessel presence ratios across time phases, and analyzing an amount of change over time. without significantly more. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements of “processing circuitry,” “computer,” and “computer-readable non-transitory storage medium” appear generic and may be well-understood, routine, and conventional for acquiring medical images and performing calculations, absent evidence that the broad claimed implementation itself is unconventional.
Claims 10, 11, 12, 14 and 15 are not rejected under 101 for being an abstract idea because they are integration into a practical application because they add MIP processing, projection processing range identification, vascular image generation, superimposition, and display, which tie the calculations to specific medical image processing operations and output images used for evaluating collateral circulation.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 10, 11, and 14-17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by D1 [Johanna M et al: "Utility of Time-Variant Multiphase CTA Color Maps in Outcome Prediction for Acute ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion"], from IDS.
Claim 1. A medical image processing device comprising processing circuitry configured to:
acquire original medical images of a plurality of time phases of a brain of a subject, D1 discloses of “temporal transverse maximum intensity projection (MIPs) images with slice thickness of 20 mm, which provides time-resolved images of the arterial, parenchymal and venous phases” (D1, 4th page);
having one of left and right sides of the brain as an affected side and the other as a healthy side, D1 discloses of stroke patients having an affected hemisphere and a contralateral healthy hemisphere (D1, 7th page: “intermediate and poor to stroke patients”);
derive feature amounts related to collateral circulation in the brain of the subject based on the acquired original medical images, D1 discloses of deriving a “numerical computed collateral score” from the acquired images (D1, 6th page);
analyze a time phase delay in the affected side relative to the healthy side, D1 discloses that “extent and velocity of the collateral filling can be evaluated with dynamic-CTA” (D1, 4th page), wherein velocity inherently represents a time phase delay because speed indicates the difference in arrival time between the affected and healthy sides, as demonstrated in the temporal plots shown in Figures 2 and 5;
based on a result of comparing the feature amounts of the affected side and the healthy side, D1 discloses of “MIPs of each of the 3D CTA volumes over time (right) the mean intensity plot of right (green) versus left (blue) hemisphere and the computed and radiologist score. The sinus which is more visible on the left, the stroke affected side, (circled in orange) slightly affects the score” (D1, 7th page); and
for each of the plurality of time phases, D1 discloses, as mentioned above, the temporal plots over time in Figures 2 and 5, which demonstrate that plural phases at different points in time are evaluated throughout the analysis.
Claims 16 and 17 are rejected for similar reasons as to those described in claim 1 wherein they are the similar method and crm claims.
Claim 2. The medical image processing device according to claim 1, wherein the processing circuitry is further configured to cause a display to display delay information regarding the determined time phase delay. D1 teaches that “Vessels with maximum enhancement in the prevenous phase are displayed in red, those with maximum enhancement in the peak venous phase and late venous phase are displayed in green and blue, respectively.”; “Most collaterals are opacified on the first mCTA phase and appear red … consistent with a zero-phase delay.”;“Most collaterals are opacified on the second mCTA phase and appear green … consistent with a one-phase delay.”; “The few visible collaterals are mostly opacified on the third mCTA phase and appear blue … consistent with a two-phase delay”. D1 teaches causing display of delay information regarding time phase delay by using color-coded mCTA maps in which colors indicate whether vessels enhance in the first, second, or third phase. (D1, Page 2 and Figure 1)
Claim 10. The medical image processing device according to claim 1, wherein the processing circuitry is further configured to perform maximum intensity projection processing on the original medical images to generate a maximum intensity projection image, and to derive the feature amounts based on the maximum intensity projection image. D1 “Axial images with 1 mm overlap and multiplanar axial, coronal and sagittal reconstructions with 3 mm thickness, 1 mm intervals and 1 mm overlap for the first phase were then generated as well as axial maximum intensity projections MIPs for all three phases.” ; “Time variant mCTA color maps were generated with the FastStroke research prototype … and displayed as axial, coronal, sagittal, and oblique MIP reformations.” ; “Collateral extent and filling dynamics were then graded on a three-point scale using time-variant mCTA color-maps.” ; “Both delay and extent of collateral filling were graded on a trichotomized scale on axial color-coded maximum intensity projections MIPs.” ; Therefore, D1 teaches generating MIP images from original multiphase CTA images and deriving collateral-circulation feature information based on the MIP images. (D1, Abstract and Page 2-3)
Claim 11. The medical image processing device according to claim 10, wherein the processing circuitry is further configured to identify a projection processing range that is a target of the maximum intensity projection processing. D1 teaches generating maximum intensity projection MIP images from multiphase CTA image data and displaying time-variant mCTA color maps as MIP reformations. (D1, Page 2)
Claim 14. The medical image processing device according to claim 10, wherein the processing circuitry is configured to generate vascular images based on the maximum intensity projection image, and the vascular images in different time phases are superimposed and displayed on a display. D1 teaches “Axial maximum intensity projections MIPs for all three phases” were generated. ; “Time variant mCTA color maps were generated … and displayed as axial, coronal, sagittal, and oblique MIP reformations.” ; “We have recently described a new color-coded mCTA display format, in which all 3 mCTA series are consolidated in a single color-coded map, thereby potentially facilitating and improving mCTA interpretation.” ; “Vessels with maximum enhancement in the prevenous phase are displayed in red, those with maximum enhancement in the peak venous phase and late venous phase are displayed in green and blue, respectively.” ; D1 teaches that vascular images or vascular information from different time phases are superimposed and displayed together, because all three mCTA series are consolidated into one color-coded map and the vessels are color-coded according to the phase in which maximum enhancement occurs. (D1, Page 2)
Claim 15. The medical image processing device according to claim 10, wherein the maximum intensity projection image is an image including at least one of an entire region, an anterior cerebral artery region, a middle cerebral artery region, and a posterior cerebral artery region in the brain. D1 teaches “The mCTA scans consisted of three phases, with arch to vertex coverage in the first arterial and skull base to vertex coverage the second peak venous and third late venous phases.” ; “Axial maximum intensity projections MIPs for all three phases” were generated.; “We included patients with anterior circulation LVO internal carotid artery, M1orproximal M2 occlusions in this study.” ; “Occlusion site was determined on axial mCTA MIP images and was reported as either terminal internal carotid artery, M1 segment or proximal M2 segment”.
Claim(s) 3, 5, 6, and 8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by D1 [Johanna M et al: "Utility of Time-Variant Multiphase CTA Color Maps in Outcome Prediction for Acute ischemic Stroke Due to Anterior Circulation Large Vessel Occlusion"] in view of D2 [US 2005/0065432 A1].
Claim 3. The medical image processing device according to claim 1, wherein the processing circuitry is configured to derive a ratio between inflow amounts of fluid flowing into blood vessels on the affected side and the healthy side for each of the plurality of time phases, and to analyze the time phase delay based on the ratio between the inflow amounts. D1 teaches multiphase CTA collateral filling-delay assessment in an affected/occluded vascular territory relative to the contralateral hemisphere. D2 teaches analyzing time-series medical images obtained using a tracer to determine blood-flow dynamics and comparing diseased and healthy regions using ratios to a healthy/reference region. See D2, [0002], [0007], [0087]–[0089]. D2 further teaches an inflow-related parameter, namely the rising maximum gradient or up slope US, and teaches calculating a healthy-part blood-flow ratio. See D2, [0035]–[0036], [0151]–[0160]. It would have been obvious, before the effective filing date, to use D2’s healthy-part inflow/flow ratio analysis in D1’s affected/contralateral multiphase CTA collateral assessment to quantitatively analyze affected-side delay relative to the healthy side.
Claim 5. The medical image processing device according to claim 1, wherein the processing circuitry is configured to derive a ratio between outflow amounts of fluid flowing out of blood vessels on the affected side and the healthy side for each of the plurality of time phases, and to analyze the time phase delay based on the ratio between the outflow amounts. D2 teaches time-series tracer image analysis and diseased/healthy-region ratio comparison. See D2, [0002], [0007], [0087]–[0089]. D2 further teaches outflow/washout-related TIC parameters including disappearance time DT, down slope DS, and output vein TIC Cv\(t). See D2, [0031]–[0038], [0043]–[0048].
Claim 6. The medical image processing device according to claim 3, wherein the processing circuitry is configured to determine that there is a time phase delay when the ratio between the inflow amounts is less than a first threshold value. D2 teaches calculating an inflow/flow-related healthy-part ratio using the rising maximum gradient US. See D2, [0035]–[0036], [0151]–[0160]. D2 further teaches displaying and using clinically dangerous threshold values for blood-flow parameter ratios. See D2, ¶ [0184].
Claim 8. The medical image processing device according to claim 5, wherein the processing circuitry is configured to determine that there is a time phase delay when the ratio between the outflow amounts is equal to or greater than a third threshold value. D2 teaches outflow/washout-related blood-flow parameters, including disappearance time DT, down slope DS, output vein TIC Cv\(t), and transit/MTT-related behavior. See D2, [0031]–[0038], [0043]–[0048], [0055]–[0064]. D2 further teaches threshold-based evaluation of blood-flow parameter ratios. See D2, [0184], [0186]–[0188].
Allowable Subject Matter
Claims 12, 14, and 15 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/AMANDEEP SAINI/Supervisory Patent Examiner, Art Unit 2662
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