DETAILED ACTION
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 .
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-11 and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12, 13 of U.S. Patent No. 11,963,814 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because every feature or element of the instant claims are recited in claims of the patent. Since the word “comprising” does not preclude further limitations of the claims of the patent, the claims of the instant Application would be obvious in view of the claims of the patent.
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.
35 U.S.C. 101 requires that a claimed invention must fall within one of the four eligible categories of invention (i.e. process, machine, manufacture, or composition of matter) and must not be directed to subject matter encompassing a judicially recognized exception as interpreted by the courts. MPEP 2106. Three categories of subject matter are found to be judicially recognized exceptions to 35 U.S.C. § 101 (i.e. patent ineligible) (1) laws of nature, (2) physical phenomena, and (3) abstract ideas. MPEP 2106(II). To be patent-eligible, a claim directed to a judicial exception must as whole be directed to significantly more than the exception itself. See 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74618, 74624 (Dec. 16, 2014). Hence, the claim must describe a process or product that applies the exception in a meaningful way, such that it is more than a drafting effort designed to monopolize the exception. Id
Claims 1-9, 12 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more. Claim 1 is directed to obtaining a scanning region corresponding to the ROI and obtaining a plurality of images of the scanning region by performing a pre-scan on the scanning region; and determining, based on the plurality of images of the scanning region, a target scanning phase of the ROI for performing the target scan, without additional elements that are sufficient to amount to significantly more than the judicial exception. Specifically, obtaining a scanning region corresponding to the ROI and obtaining a plurality of images of the scanning region by performing a pre-scan on the scanning region, is referring to gathering data under insignificant Extra-solution activity e.g. pre-solution activity (MPEP 2106.05(g)) and determining, based on the plurality of images of the scanning region, a target scanning phase of the ROI for performing the target scan, referring to mental process of abstract idea, by visually observing the gathered data, the concepts are performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III). Therefore, claim 1, meets the requirement of the step 2A, prong one of the guidelines for including an abstract idea.
The claim is then considered under step 2A, prong two, for integrating the judicial exception into a practical application. Limitations that the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
Based on the above conditions, Examiner does not believe that the language of claim 1 includes any of the qualifying conditions above. In fact, the limitations of claim 1 tend to lean more toward conditions that are not qualified i.e. “Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h)”. Therefore claim 1 fails step 2A, prong two.
Additionally, claim 1 is considered under step 2B to include additional elements that amount to significantly more than the judicial exception. Limitations that the courts have found to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Improvements to the functioning of a computer, e.g., a modification of conventional Internet hyperlink protocol to dynamically produce a dual-source hybrid webpage, as discussed in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014) (see MPEP § 2106.05(a));
ii. Improvements to any other technology or technical field, e.g., a modification of conventional rubber-molding processes to utilize a thermocouple inside the mold to constantly monitor the temperature and thus reduce under- and over-curing problems common in the art, as discussed in Diamond v. Diehr, 450 U.S. 175, 191-92, 209 USPQ 1, 10 (1981) (see MPEP § 2106.05(a));
iii. Applying the judicial exception with, or by use of, a particular machine, e.g., a Fourdrinier machine (which is understood in the art to have a specific structure comprising a headbox, a paper-making wire, and a series of rolls) that is arranged in a particular way to optimize the speed of the machine while maintaining quality of the formed paper web, as discussed in Eibel Process Co. v. Minn. & Ont. Paper Co., 261 U.S. 45, 64-65 (1923) (see MPEP § 2106.05(b));
iv. Effecting a transformation or reduction of a particular article to a different state or thing, e.g., a process that transforms raw, uncured synthetic rubber into precision-molded synthetic rubber products, as discussed in Diehr, 450 U.S. at 184, 209 USPQ at 21 (see MPEP § 2106.05(c));
v. Adding a specific limitation other than what is well-understood, routine, conventional activity in the field, or adding unconventional steps that confine the claim to a particular useful application, e.g., a non-conventional and non-generic arrangement of various computer components for filtering Internet content, as discussed in BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350-51, 119 USPQ2d 1236, 1243 (Fed. Cir. 2016) (see MPEP § 2106.05(d)); or
vi. Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment, e.g., an immunization step that integrates an abstract idea of data comparison into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases, as discussed in Classen Immunotherapies Inc. v. Biogen IDEC, 659 F.3d 1057, 1066-68, 100 USPQ2d 1492, 1499-1502 (Fed. Cir. 2011) (see MPEP § 2106.05(e)).
Limitations that the courts have found not to be enough to qualify as "significantly more" when recited in a claim with a judicial exception include:
i. Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
iii. Adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)); or
iv. Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010) or a claim limiting the use of a mathematical formula to the petrochemical and oil-refining fields, as discussed in Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (MPEP § 2106.05(h)).
Based on the above conditions, Examiner is unable to identify one or more claimed elements that amount to significantly more than the judicial exception. The claim language leaning over to non-qualifying condition i.e. “ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception”. Therefore claim 1 also fails step 2B as well. Also, the courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. Nor the courts distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2)(III)). Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures "can be carried out in existing computers long in use, no new machinery being necessary." 409 U.S at 67, 175 USPQ at 675, (MPEP 2106.04(a)(2)(III)(C)). The claim is therefore not eligible under 101.
Regarding claim 2, it recites, wherein the plurality of images are sequentially acquired during the pre-scan with the subject being located at a fixed position relative to a radiation source of an imaging device, as further referring to gathering data under insignificant Extra solution activity, and therefor does not remedy the deficiencies of the claim. Therefore, the claim is ineligible under 101.
Regarding claim 3, it recites, wherein the determining, based on the plurality of images of the scanning region, a target scanning phase of the ROI includes: obtaining physiological motion data indicating the physiological motion of the ROI during the pre-scan; for each of the plurality of images, determining a feature element from the image; and determining, based on the feature element of each image and the physiological motion data, the target scanning phase of the ROI, as referring to gathering data under insignificant Extra-solution activity and determining, by mental process of visually observing the image and further determining the target scanning phase by mental process of analyzing and judging the data. Therefore, the claim is ineligible under 101.
Regarding claim 4, it recites, determining the target scanning phase of the ROI includes: determining an initial time interval during which the ROI is in a steady status, as mental process of observation of data and judgment, and determining, from the initial time interval, the target scanning phase of the ROI based on the feature element of each image, again as mental process of observation of data and judgment. Therefore, the claim is ineligible under 101.
Regarding claim 5, it recites, wherein determining a target coordinate, as referring to mental process of observing and identifying the coordinate, and for each of the plurality of images, determining, from the image, an element having the target coordinate as the feature element of the image, as further referring to mental process of observing and analyzing and judging the feature element. Therefore, the claim is ineligible under 101.
Regarding claim 6, it recites, wherein for each of the plurality of images, determining a projection value of the feature element of the image, as referring to mental process of determining a value in view of gathered data, determining a first variation of the projection values of the feature elements of the plurality of images over time, as mental process of comparing observed data and judging the change, and determining, from the initial time interval, the target scanning phase based on the first variation, as referring to mental process observing the gathered time data and judging the scanning phase, may be using a pen an paper as well. Therefore, the claim is ineligible under 101.
Regarding claim 7, it recites, for each of the plurality of images, determining, based on the image, a target projection value, as referring to mental process of determining by observing, and determining, from the image, an element having the target projection value as the feature element of the image, as referring to mental process of observing, analyzing and judging. Therefore, the claim is ineligible under 101.
Regarding claim 8, it recites, determining a plurality of projection values of a plurality of elements in the image; determining, among the plurality of projection values, a maximum projection value; and determining the target projection value based on the maximum projection value, as all referring to mental process of determining by observation, analysis and judgement. Therefore, the claim is ineligible under 101.
Regarding claim 9, it recites, for each of the plurality of images, determining a coordinate of the feature element of the image; determining a second variation of the coordinates of the feature elements of the plurality of images over time; and determining the target scanning phase based on the second variation, as further referring to mental process of determining by observation, analysis and judgement. Therefore, the claim is ineligible under 101.
Regarding claim 12, it recites, wherein the target motion status is a steady status or a static status, as referring to mental process of observation, analysis of data and judging the status. Therefore, the claim is ineligible under 101.
Regarding claim 13, it recites, wherein the target motion status is designated by a user, as mental process of observing and judging by the user. Therefore, the claim is ineligible under 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 7, 12, 14-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,736,594 B2 to De Man et al (hereinafter ‘De Man’).
Regarding claim 1, De Man discloses a method for scanning a region of interest (ROI) of a subject, the ROI being to be scanned by a target scan and undergoing a physiological motion (column 2, lines 20-24, wherein an object motion phase of the non-static object is estimated as the monitoring scan is being performed based on the unreconstructed scan data. A diagnostic scan trigger is determined as the monitoring scan is being performed based on at least the object motion phase), wherein the method is implemented on a computing device having at least one processor and at least one storage device, and the method comprises: obtaining a scanning region corresponding to the ROI (column 12, lines 40-42, wherein in one embodiment the projection data may be pre-processed, e.g., to identify anatomical regions of interest); obtaining a plurality of images of the scanning region by performing a pre-scan on the scanning region (column 11, line 65 through column 12, line 1, and Fig. 3, wherein the monitoring scan 190 may be performed by pulsing the X-ray tube, resulting in a sparse-view dataset (sinogram) 194, corresponding to lower radiation dose, as pre-scan of the region); and determining, based on the plurality of images of the scanning region, a target scanning phase of the ROI for performing the target scan (column 12, lines 57-60, wherein estimating the cardiac phase comprises directly estimating the timing of a quiescent cardiac phase, which is then used for triggering the acquisition of the diagnostic scan data.), the target scanning phase of the ROI being a target time point or a target time period when the ROI is in a target motion status in a motion cycle of the ROI (column 12, lines 61-66, wherein cardiac phase can be estimated using a motion based approach. In a motion-based approach, the heart motion level is directly estimated from the raw data. A scan time or a range of view angles are then identified that are expected to contain the least motion during a future heart-beat.). As much as Applicant may disagree with Examiner’s assessment of De Man obtaining the scanning region corresponding to ROI from the low-dose images prior to supplying of the processing, as discussed above, De Man also discloses obtaining the scanning region corresponding to the ROI in another alternative embodiment at or after ROI identification (Column 4, lines 29-39, wherein there are two ways to predict contrast arrival time: ‘timing bolus’ and ‘smart prep’. With a timing bolus, a small amount of contrast is injected to a patient in a pre-session and the patient is scanned repeatedly (with low dose) to find the time delay from injection to opacification of the region of interest (ROI), as obtaining of the ROI to before scanning. In ‘smart prep’, there is no separate session. The contrast agent is injected only once, in a monitoring phase repeated scanning (with low dose) of a specific region of interest is performed, as scanning the obtained region of interest, and the contrast agent in a small region is monitored until it reaches a certain threshold). Therefore, it would have been obvious to one of ordinary skill in the art to combine injecting small amount of contrast to the patient in a pre-session and scan repeatedly (with low dose) in order to find the time delay from injection to opacification of the region of interest (ROI).
Regarding claim 2, De Man discloses wherein the plurality of images are sequentially acquired during the pre-scan with the subject being located at a fixed position relative to a radiation source of an imaging device (column 9, lines 3-7, wherein the linear positioning subsystem 134 may enable the patient/object 118, or more specifically a table supporting the patient, to be displaced within the bore of the CT system 110, such as in the z-direction relative to rotation of the gantry, as plurality of fixed positions).
Regarding claim 3, De Man discloses wherein the determining, based on the plurality of images of the scanning region, a target scanning phase of the ROI includes: obtaining physiological motion data indicating the physiological motion of the ROI during the pre-scan (column 12, lines 46-48, wherein the cardiac phase estimation 200 determines the quiescent phase of the heart cycle); for each of the plurality of images, determining a feature element from the image (column 12, lines 29-32, wherein the sinogram analysis 198 is performed to estimate one or more of a cardiac phase, a bolus parameter, as feature element); and determining, based on the feature element of each image and the physiological motion data, the target scanning phase of the ROI (column 13, lines 29-40, wherein the estimated results 196 of the various estimators may be numeric values and may be separate numeric estimations for each motion-related parameter (e.g., cardiac phase, respiratory phase, bolus parameter(s)) being evaluated or may be a combined or aggregate motion indicator or number generally indicative of motion from the various monitored sources e.g., a generic motion number or indicator for the region of interest. In the depicted example, the estimates 196 may be inputs to a timing estimator 206 that is configured to output a trigger 210 or other timing signal that can cause the diagnostic scan 192 to be performed).
Regarding claim 4, De Man discloses wherein the determining, based on the feature element of each image and the physiological motion data, the target scanning phase of the ROI includes: determining, based on the physiological motion data, an initial time interval during which the ROI is in a steady status (column 12, lines 61-66, wherein cardiac phase can be estimated using a motion based approach. In a motion based approach, the heart motion level is directly estimated from the raw data. A scan time or a range of view angles are then identified that are expected to contain the least motion, as the steady state, during a future heart-beat.); and determining, from the initial time interval, the target scanning phase of the ROI based on the feature element of each image (column 4, lines 46-53, wherein in both the timing bolus and smart prep cases, the contrast agent opacification is evaluated in the reconstructed image domain, i.e., not in the raw acquisition data. The target slices are reconstructed repeatedly, then the voxel value of target ROI or vessel (or suitable nearby anatomy region), as the feature element of the image, is evaluated (e.g., plotted) vs. time. From the time profile (i.e., the reconstructed voxel intensity in the ROI as a function of time), the time of predicted peak opacification is estimated.).
Regarding claim 7, De Man discloses wherein for each of the plurality of images, the determining a feature element from the image includes: for each of the plurality of images, determining, based on the image, a target projection value (column 4, lines 46-48, wherein in both the timing bolus and smart prep cases, the contrast agent opacification is evaluated in the reconstructed image domain, i.e., not in the raw acquisition data, as including target projection value); and determining, from the image, an element having the target projection value as the feature element of the image (Column 4, lines 48-53, wherein he target slices are reconstructed repeatedly, then the voxel value, as the feature element, of target ROI or vessel (or suitable nearby anatomy region) is evaluated (e.g., plotted) vs. time. From the time profile (i.e., the reconstructed voxel intensity in the ROI as a function of time), the time of predicted peak opacification is estimated, as the target projection value).
Regarding claim 12, De Man discloses wherein the target motion status is a steady status or a static status (column 12, lines 54-60, wherein It is generally accepted that the least cardiac motion occurs, inherently as steady or static state, during the diastole stage (50%-60%), therefore this interval can be used to predict the optimal acquisition timing in a future heartbeat. In one embodiment estimating the cardiac phase comprises directly estimating the timing of a quiescent cardiac phase, which is then used for triggering the acquisition of the diagnostic scan data.).
Regarding claim 14, De Man discloses a method for scanning a region of interest (ROI) of a subject, the ROI being to be scanned by a target scan and undergoing a physiological motion (column 2, lines 20-24, wherein an object motion phase of the non-static object is estimated as the monitoring scan is being performed based on the unreconstructed scan data. A diagnostic scan trigger is determined as the monitoring scan is being performed based on at least the object motion phase.), wherein the method is implemented by a computing device including at least one processor and at least one storage device, and the method comprises: obtaining a scanning region corresponding to the ROI (column 12, lines 40-42, wherein in one embodiment the projection data may be pre-processed, e.g., to identify anatomical regions of interest), the scanning region including multiple sub-regions ; obtaining a plurality of images of the scanning region by performing a pre-scan on the scanning region (column 11, line 65 through column 12, line 1, and Fig. 3, wherein the monitoring scan 190 may be performed by pulsing the X-ray tube, resulting in a sparse-view dataset (sinogram) 194, corresponding to lower radiation dose, as pre-scan of the region); determining, based on the plurality of images of the scanning region, a target scanning phase of each of the multiple sub-regions for performing the target scan (column 12, lines 57-60, wherein estimating the cardiac phase comprises directly estimating the timing of a quiescent cardiac phase, which is then used for triggering the acquisition of the diagnostic scan data.); and for each of the multiple target scanning phases, obtaining a target image of the ROI corresponding to the target scanning phase by directing an imaging device to perform the target scan on the ROI according to the target scanning phases corresponding to the multiple sub-regions (column 12, lines 11-21, wherein Projection data 194, as used herein, may consist of one or more projection images. In one embodiment, projection data consists of projection data acquired in the AP (anterior-posterior) position. i.e., the X-ray source and detector are in an angular position such as to acquire an AP view of the patient. In one embodiment, one or more AP views (or sets of projections in small angular intervals around the AP position) are acquired. In another embodiment, AP views are collected as well as views at other angular directions, as multiple sub-regions). As much as Applicant may disagree with Examiner’s assessment of De Man obtaining the scanning region corresponding to ROI from the low-dose images prior to supplying of the processing, as discussed above, De Man also discloses obtaining the scanning region corresponding to the ROI in another alternative embodiment at or after ROI identification (Column 4, lines 29-39, wherein there are two ways to predict contrast arrival time: ‘timing bolus’ and ‘smart prep’. With a timing bolus, a small amount of contrast is injected to a patient in a pre-session and the patient is scanned repeatedly (with low dose) to find the time delay from injection to opacification of the region of interest (ROI), as obtaining of the ROI to before scanning. In ‘smart prep’, there is no separate session. The contrast agent is injected only once, in a monitoring phase repeated scanning (with low dose) of a specific region of interest is performed, as scanning the obtained region of interest, and the contrast agent in a small region is monitored until it reaches a certain threshold). Therefore, it would have been obvious to one of ordinary skill in the art to combine injecting small amount of contrast to the patient in a pre-session and scan repeatedly (with low dose) in order to find the time delay from injection to opacification of the region of interest (ROI).
Regarding claim 15, De Man discloses wherein determining, based on the plurality of images of the scanning region, a target scanning phase of each of the multiple sub-regions for performing the target scan comprises: for each of the multiple sub-regions, obtaining physiological motion data indicating the physiological motion of the sub-region during the pre-scan (column 12, lines 46-48, wherein the cardiac phase estimation 200 determines the quiescent phase of the heart cycle); for each of the plurality of images, determining a feature element corresponding to the sub-region from the image (column 12, lines 29-32, wherein the sinogram analysis 198 is performed to estimate one or more of a cardiac phase, a bolus parameter, as feature element); and determining, based on the feature element of each image and the physiological motion data, the target scanning phase corresponding to the sub-region (column 13, lines 29-40, wherein the estimated results 196 of the various estimators may be numeric values and may be separate numeric estimations for each motion-related parameter (e.g., cardiac phase, respiratory phase, bolus parameter(s)) being evaluated or may be a combined or aggregate motion indicator or number generally indicative of motion from the various monitored sources e.g., a generic motion number or indicator for the region of interest. In the depicted example, the estimates 196 may be inputs to a timing estimator 206 that is configured to output a trigger 210 or other timing signal that can cause the diagnostic scan 192 to be performed).
Regarding claim 16, Please refer to the corresponding method claim 4 above for further teachings.
Regarding claim 20, Please refer to the corresponding method claim 12 above for further teachings.
Claims 5, 6, 9, 10, 11, 13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over De Man in view of US 2008/0253505 A1 to Imai.
Regarding claims 5 and 17, De Man does not specifically disclose wherein for each of the plurality of images, the determining a feature element from the image includes: determining, based on at least one of the plurality of images, a target coordinate; and for each of the plurality of images, determining, from the image, an element having the target coordinate as the feature element of the image. Imai discloses for each of the plurality of images, the determining a feature element from the image includes: determining, based on at least one of the plurality of images, a target coordinate; and for each of the plurality of images, determining, from the image, an element having the target coordinate as the feature element of the image (Para [0088], wherein for an imaging start position zs, an imaging end position ze, a target position Pm, etc., numeric value representing coordinates and symbols are displayed in synchronization with an input operation via GUI.). De Man and Imai are combinable because they both disclose scanning objects with motion consideration. Therefore, before the effective filing data of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine the determining target coordinate; and determining an element having the target coordinate as the feature element of the image, of Imai’s method with De Man’s so that to indicate the start and end positions of the imaging cycle on the display (Para [0088]).
Regarding claims 6 and 18, in the combination of De Man and Imai, Imai further discloses wherein the determining, from the initial time interval, the target scanning phase of the ROI based on the feature element of each image (Para [0090], wherein it should be noted that the optimal cardiac phase Tgph may be set as, instead of a phase itself, a cardiac phase represented by an elapsed time, as initial time interval, from an R peak in the electrocardiographic waveform, for example.) includes: for each of the plurality of images, determining a projection value of the feature element of the image (para [0092], wherein FIG. 7 is a pictorial view roughly showing an exemplary position of a right coronary artery #2 K2, as the feature element, that is a coronary artery K of a heart 6a, as the image); determining a first variation of the projection values of the feature elements of the plurality of images over time (Para [0092], wherein the coronary arteries are in an area that exhibits relatively great variation due to cardiac motion and is one of the positions suitable as target position Pm); and determining, from the initial time interval, the target scanning phase based on the first variation (Para [0104], wherein therefore, imaging can be made on a region to be imaged in the subject 6 at a high speed and with a low X-ray dose such that a desired portion in the subject 6, as target, for example, a portion having significant variation due to heartbeats, can be scanned at a desired cardiac phase, for example, at a phase at which the variation due to heartbeats is slowest).
Regarding claim 9, De Man does not specifically disclose wherein the determining, from the initial time interval, the target scanning phase of the ROI based on the feature element of each image includes: for each of the plurality of images, determining a coordinate of the feature element of the image; determining a second variation of the coordinates of the feature elements of the plurality of images over time; and determining, from the initial time interval, the target scanning phase based on the second variation. Imai discloses wherein the determining, from the initial time interval, the target scanning phase of the ROI based on the feature element of each image includes: for each of the plurality of images, determining a coordinate of the feature element of the image (Para [0088], wherein for an imaging start position zs, an imaging end position ze, a target position Pm, etc., numeric value representing coordinates and symbols are displayed in synchronization with an input operation via GUI.); determining a second variation of the coordinates of the feature elements of the plurality of images over time (Para [0100], wherein during the helical scan, when the cardiac phase of the subject 6 is at the optimal cardiac phase Tgph, the center of the scan width of the rotating section 27 in the z-direction passes through the target position Pm in the subject 6 as calculated if no anomaly such as arrhythmia or the like occurs in the cardiac cycle, as second variation determination); and determining, from the initial time interval, the target scanning phase based on the second variation (Para [0100], wherein collection of projection data (S113). In the helical scan, the imaging range from the imaging start position zs to the imaging end position ze is scanned over a period of time Ts to collect projection data, as plurality of images). De Man and Imai are combinable because they both disclose scanning objects with motion consideration. Therefore, before the effective filing data of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine the determining a coordinate of the feature element of the image and a second variation of the coordinates of the feature elements of the plurality of images over time, and determining the target scanning phase based on the second variation, of Imai’s method with De Man’s so that in the event an anomaly is being observed in a cardiac cycle, the scanning is kept from starting an approach run, and is left to wait (Para [0099]).
Regarding claims 10 and 19, De Man does not specifically disclose wherein the scanning region includes multiple sub-regions, and the determining, based on the plurality of images of the scanning region, a target scanning phase of the ROI for performing the target scan further includes: determining, based on the plurality of images of the scanning region, a target scanning phase for each of the multiple sub-regions, and wherein the operations further include: directing an imaging device to perform the target scan on the ROI according to the target scanning phases corresponding to the multiple sub-regions; and for each of the multiple target scanning phases, generating a target image of the ROI based on target scan data of the ROI acquired during a target time period corresponding to the target scanning phase. Imai discloses wherein the scanning region includes multiple sub-regions, and the determining, based on the plurality of images of the scanning region, a target scanning phase of the ROI for performing the target scan further includes: determining, based on the plurality of images of the scanning region (Para [0088], wherein the scan condition specifying window 13 displays various specification items 13a included in the scan conditions such as, for example, the number of images to be captured, image interval, slice thickness, tube voltage, tube current, optimal cardiac phase, and helical pitch), a target scanning phase for each of the multiple sub-regions, and wherein the operations further include: directing an imaging device to perform the target scan on the ROI according to the target scanning phases corresponding to the multiple sub-regions (Para [0091], wherein on the scout image 13b via GUI, a certain position desired to be defined as target position Pm in the z-direction of the subject 6 that is to be scanned when the cardiac phase of the subject 6 is at the set optimal cardiac phase Tgph. The target position defining section 30c defines the input position as target position Pm (S104).); and for each of the multiple target scanning phases, generating a target image of the ROI based on target scan data of the ROI acquired during a target time period corresponding to the target scanning phase (Para [0100], wherein the imaging range from the imaging start position zs to the imaging end position ze is scanned over a period of time Ts to collect projection data. During the helical scan, when the cardiac phase of the subject 6 is at the optimal cardiac phase Tgph, the center of the scan width of the rotating section 27 in the z-direction passes through the target position Pm in the subject 6 as calculated if no anomaly such as arrhythmia or the like occurs in the cardiac cycle). De Man and Imai are combinable because they both disclose scanning objects with motion consideration. Therefore, before the effective filing data of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine the determining a target scanning phase for each of the multiple sub-regions, and directing an imaging device to perform the target scan on the ROI according to the target scanning phases corresponding to the multiple sub-regions; and for each of the multiple target scanning phases, generating a target image of the ROI based on target scan data of the ROI acquired during a target time period corresponding to the target scanning phase, of Imai’s method with De Man’s so that in the event an anomaly is being observed in a cardiac cycle, the scanning is kept from starting an approach run, and is left to wait (Para [0099]).
Regarding claim 11, De Man does not specifically disclose wherein the performing the pre-scan on the scanning region includes: obtaining morphological information of the ROI based on a 3D image of the ROI; determining, based on the morphological information of the ROI, a scanning angle for the pre-scan; and performing the pre-scan on the scanning region at the scanning angle. Imai discloses wherein the performing the pre-scan on the scanning region includes: obtaining morphological information of the ROI based on a 3D image of the ROI (Para [0091], wherein the target position defining section 30c defines the input position as target position Pm (S104). Here, a position of a coronary artery in a heart that is referred to as right coronary artery #2, inherently as morphological information e.g. shape, is defined as target position Pm, for example); determining, based on the morphological information of the ROI, a scanning angle for the pre-scan (Para [0091], wherein the operator inputs, on the scout image 13b via GUI, a certain position desired to be defined as target position Pm in the z-direction, inherently as a given angle, of the subject 6 that is to be scanned when the cardiac phase of the subject 6 is at the set optimal cardiac phase Tgph. The target position defining section 30c defines the input position as target position Pm (S104)); and performing the pre-scan on the scanning region at the scanning angle (Para [0093], wherein with a low X-ray dose and at a high speed at a position of the rotating section 27 fixed at the scan start position Ps in the z-direction, that is, in a positional relationship such that one end of the scan width of the rotating section 27 coincides with the imaging start position zs). De Man and Imai are combinable because they both disclose scanning objects with motion consideration. Therefore, before the effective filing data of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine the obtaining morphological information of the ROI, determining a scanning angle for the pre-scan, and performing the pre-scan on the scanning region at the scanning angle, of Imai’s method with De Man’s so that contrast delivery time is measured (Para [0093]).
Regarding claim 13, De Man does not specifically disclose wherein the target motion status is designated by a user. Imai discloses the target motion status is designated by a user (Para [0090], wherein the operator also inputs a certain cardiac phase desired to be set as optimal cardiac phase Tgph on the scan condition specifying window 13). De Man and Imai are combinable because they both disclose scanning objects with motion consideration. Therefore, before the effective filing data of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine the target motion status is designated by a user, of Imai’s method with De Man’s so that to input cardiac phase as optimal cardiac phase (para [0090]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over De Man in view of US 2007/0238951 A1 to Ferenczi et al (hereinafter’ Ferenczi’).
Regarding claim 8, De Man does not specifically disclose wherein the determining, based on the image, a target projection value corresponding to a feature point of the ROI includes: determining a plurality of projection values of a plurality of elements in the image; determining, among the plurality of projection values, a maximum projection value; and determining the target projection value based on the maximum projection value. Ferenczi discloses the determining, based on the image, a target projection value corresponding to a feature point of the ROI includes: determining a plurality of projection values of a plurality of elements in the image (Para [0066], wherein some embodiments of method 400 includes generating 406 a plurality of cross-sectional digital image groups, each group comprising at least two digital images of the plurality of cross-sectional digital images wherein each of the two digital images indicate the internal anatomy at a substantially similar respiratory state.); determining, among the plurality of projection values, a maximum projection value (Para [0066], wherein each digital image of the plurality of 3-D digital images is determined from a corresponding one of the plurality of cross-sectional digital image groups performing a maximum intensity projection of the plurality of 3-D digital images to obtain a first 3-D digital image); and determining the target projection value based on the maximum projection value (Para [0066], wherein some embodiments of method 400 includes generating 410 a boundary, as the target projection value, within the first 3-D digital image around a predetermined portion of the internal anatomy of the person). De Man and Ferenczi are combinable because they both disclose scanning objects with motion consideration. Therefore, before the effective filing data of the claimed invention, It would have been obvious to one of ordinary skill in the art to combine determining a plurality of projection values of a plurality of elements in the image; determining, a maximum projection value; and determining the target projection value based on the maximum projection value, of Ferenczi’s method with De Man’s so that provide for reduced risk of radiation injuries to the surrounding healthy organs (para [0065]).
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/SHERVIN K NAKHJAVAN/ Primary Examiner, Art Unit 2672