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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mistretta et al. (US 2011/0037761 A1, Feb. 17, 2011) (hereinafter “Mistretta”) in view of Grass et al. (WO 2010/046839 A1, Apr. 29, 2010) (hereinafter “Grass”).
Regarding claim 1: Mistretta discloses a method performed via digital subtraction angiography, comprising obtaining target imaging data of a target object including a contrast agent (figs. 1-2, [0031]-[0032] – “The 2D images and 3D image produced at process blocks 102 and 104, respectively, can be produced using DSA techniques.”); and generating a vascular angiographic image based on the imaging data (fig. 3, [0033]). Mistretta further teaches that the 3D images are acquired using either a rotational fluoroscopy system or a CT system ([0036]).
Mistretta does not disclose that the target imaging data comprising the 3D images is obtained through a spiral scanning manner.
Vaz, in the same problem solving are of angiography, teaches a spiral scanning manner (helical scan) for acquiring 3D images and that a spiral scanning manner (helical scan) reduces total scan time ([0039]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Mistretta to obtain the target imaging data (the 3D data) through the spiral scanning manner taught by Vaz in order to reduce total scan time.
Regarding claim 2: Mistretta and Vaz disclose the vascular imaging method of claim 1. Vaz further discloses wherein the target imaging data is obtained through the spiral scanning manner by: obtaining the target imaging data by receiving, through a radiation detector, radiations emitted by a radiation emitter when the radiation emitter moves along a first direction and rotates around the first direction at the same time ([0039] – this is merely the definition of a helical CT scan).
Regarding claim 12: Mistretta and Vaz disclose the vascular imaging method of claim 2 wherein the injection of the contrast agent into a blood vessel of the target object is performed simultaneously or alternately with the spiral scanning manner of the radiation emitter and the radiation detector (Mistretta – [0031] - images are acquired “alternately” – i.e. before and after – contrast injection; [0057]-[0058], [0061]-[0062], [0121], [0145] – in various embodiments, the bolus injection is performed before and/or during a scan).
Regarding claim 13: Mistretta and Vaz disclose the vascular imaging method of claim 12. Vaz further discloses wherein the injection of the contrast agent into the blood vessel of the target object being performed alternately includes: the spiral scanning time period of the spiral scanning partially overlapping with the injection time period of the contrast agent ([0057]-[0058], [0061]-[0062], [0121], [0145] – in various embodiments, the bolus injection is performed before and/or during a scan).
Regarding claim 14: Mistretta and Vaz disclose the vascular imaging method of claim 12. Vaz further discloses wherein the spiral scanning manner includes at least a first sub-scanning and a second sub-scanning, and injection of the contrast agent includes at least a first injection and a second injection ([0061] - first injection and first sub-scanning refers to the injection and monitoring of the timing bolus; [0121]); wherein a start time of the first sub-scanning is later than a start time of the first injection, and an end time of the first sub-scanning is later than an end time of the first injection ([0061] - first injection and first sub-scanning refers to the injection and monitoring of the timing bolus; [0121]); and a start time of the second sub-scanning is later than a start time of the second injection, and an end time of the second sub-scanning is later than an end time of the second injection ([0121], [0135], fig. 11; figs. 3-4 show the imaging phases where the scans persist beyond the signal peak or "later than an end time" of the second injection).
Regarding claim 15: Mistretta and Vaz disclose the vascular imaging method of claim 1. Mistretta further discloses wherein the generating the vascular angiographic image based on the imaging data includes: obtaining a reconstructed image by performing reconstruction based on the imaging data (fig. 2, [0029]); and generating the vascular angiographic image by performing a vascular segmentation on the reconstructed image ([0034], [0037] – the multiplication process resulting in “zeroing out” undesired signal is a type of segmentation).
Regarding claim 16: Mistretta and Vaz disclose the vascular imaging method of claim 1. Mistretta further discloses wherein the generating the vascular angiographic image based on the imaging data includes: obtaining auxiliary imaging data ([0031], [0036] – pre-contrast mask images); generating an image sequence based on the imaging data and the auxiliary imaging data ([0029]-[0031] – the acquired images, including mask images, are time series or “sequence”); and generating the vascular angiographic image based on the image sequence (figs. 2 and 3).
Claim(s) 3-5, 8-11, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mistretta and Vaz as applied to claim 1 above and further in view of Grass et al. (WO 2010/046839 A1, Apr. 29, 2010) (hereinafter “Grass”).
Regarding claim 3: Mistretta and Vaz discloses the method of claim 1, including that the method may be performed using a device including an arm, a radiation emitter, and a radiation detector respectively disposed at two ends of the arm (C-arm system) (Mistretta - [0022]; Vaz - [0033]), including a DSA device (Mistretta – abstract, [0031]; it is noted that the performing a DSA method on a C-arm device renders that C-arm device “a DSA device.” The C-arm of Mistretta is a DSA device); but are silent on the details including controlling the arm to move along a first direction and the radiation emitter to rotate around the first direction at the same time, and obtaining the imaging data by receiving radiations emitted by the radiation emitter through the radiation detector.
Grass, in the same field of endeavor, discloses a method of obtaining imaging data of a target object (pg. 3, lines 5-13), the imaging data being obtained through a spiral scanning manner (pg. 6, lines 29-34); and generating an image based on the imaging data (pg. 12, lines 6-10), “applied to” an imaging device including an arm, a radiation emitter, and a radiation detector respectively disposed at two ends of the arm (pg. 3, lines 16-29; fig. 1), the imaging method further comprising: controlling the arm to move along a first direction and the radiation emitter to rotate around the first direction at the same time, and obtaining the imaging data by receiving radiations emitted by the radiation emitter through the radiation detector (pg. 2, lines 22-28; pg. 4, lines 3-18; pg. 12, lines 16-22).
Grass further teaches that the disclosed method using a C-arm is preferrable to a conventional method using a gantry CT device because during a medical intervention, it is not appropriate to change the patient's position because the patient is connected to several tubes and cables that can disconnect easily when the patient's position is changed. Moreover the CT devices are very large-sized which significantly interferes the freedom of movement inside the intervention room (pg. 1, lines 20-30).
It would have been prima facie obvious prior to the effective filing date of the claimed invention to acquire the 3D imaging data of Mistretta and Vaz on the C-arm device as taught by Grass in order to achieve the benefits of using a C-arm as opposed to a CT device further taught by Grass, and in view of the teaching of Vaz that a C-arm would be an acceptable substitution.
Regarding claim 4: Mistretta, Vaz and Grass disclose the vascular imaging method of claim 3. Grass further discloses wherein the obtaining the target imaging data includes: controlling the arm to move along the first direction and the radiation emitter to perform a first rotation around the first direction at the same time (pg. 7, lines 24-28); controlling the radiation emitter to emit first radiations (pg. 7, lines 24-28); obtaining first imaging data by receiving the first radiations through the radiation detector (pg. 7, lines 24-28); in response to determining that an angle of the first rotation is greater than a preset angle, stopping the first rotation (pg. 10, lines 4-6; pg. 12, line 23 - pg. 13, line 2; pg. 13, lines 3-11); controlling the arm to move along the first direction and the radiation emitter to perform a second rotation around the first direction at the same time (fig. 3; pg. 7, lines 24-28 – the basic acquisition process is the same for both portions of the helical path); controlling the radiation emitter to emit second radiations (pg. 7, lines 24-28 – the basic acquisition process is the same for both portions of the helical path); obtaining second imaging data by receiving the second radiations through the radiation detector, wherein a rotation direction of the second rotation is opposite to a rotation direction of the first rotation (pg. 12, line 23 - pg. 13, line 2; pg. 13, lines 3-11; fig. 3); and determining the target imaging data based on the first imaging data and the second imaging data (pg. 6, lines 29-34; pg. 12, lines 6-10 – all of the acquired image data is used in the reconstruction).
Regarding claim 5: Mistretta, Vaz and Grass disclose the method of claim 4. Grass further discloses wherein an ending point position of the first rotation is a starting point position of the second rotation (fig. 3).
Regarding claim 8: Mistretta, Vaz and Grass disclose the method of claim 3. Grass further discloses wherein the arm is connected to a frame, and the frame drives the arm to move; a rotation of the arm is achieved through at least one of: the arm rotating at a connection relative to the frame; or the connection between the frame and the arm remaining stationary relative to the arm, and the frame driving the arm to rotate (pg. 10, lines 7-12; fig. 1).
Regarding claim 9: Mistretta, Vaz and Grass disclose the method of claim 8. Grass further discloses wherein the arm rotating at the connection relative to the frame includes: a bearing being disposed at the connection, and the arm rotating relative to the frame through the bearing; or the connection between the frame and the arm being equipped with a slide rail, and the arm sliding relative to the frame along the slide rail (fig. 1, first holder element 30 is a “slide rail”; pg. 9, lines 25-29).
Regarding claim 10: Mistretta, Vaz and Grass disclose the method of claim 8. Grass further discloses the method of claim 8, wherein the connection between the arm and the frame is at a center position of the arm; or the connection between the arm and the frame is offset from the center position of the arm, and the radiation emitter and the radiation detector rotate relative to the arm (pg. 10, lines 7-12; it is further noted that at the center or not at the center are the only two possible options).
Regarding claim 11: Mistretta, Grass and Vaz discloses the method of claim 2. Grass further discloses wherein the movement of the radiation emitter is achieved through at least one of: drive the frame to move the arm; or the arm being equipped with a slide rail, and the slide rail moving relative to the arm (pg. 10, lines 7-12).
Regarding claim 21: Mistretta and Vaz disclose the vascular imaging method of claim 1 but are silent on the axial scanning range of the spiral scanning manner.
Grass, in the same field of endeavor, discloses a spiral scanning method that provides a larger axial scanning range (“large coverage along the patient’s axis”) as compared to a conventional C-arm but without the drawbacks CT techniques (pg. 1, line 14 – pg. 2, line 8; pg. 2, line 29 – pg. 3, line 2).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to perform the method of Mistretta and Vaz using the scanning pattern of Grass in order to achieve a large axial scanning range without the drawbacks of a conventional CT system.
Additionally, while it is noted that Grass does not give a specific size for the large axial scanning range in cm, the instant disclosure defines a large axial scanning range as “e.g., greater than 38 cm, 39 cm, 40 cm, 41 cm, 42 cm” and a small scanning range as “e.g., smaller than 38 cm, 39 cm, 40 cm, 41 cm, 42 cm.” Since the ranges overlap so significantly (e.g. a “small” range can be smaller than 42 cm while a “large” range can be greater than 38 cm, there is no criticality or unexpected result with respect to the specific size of the scanning range. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide a scanning range larger than 42 cm, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device (i.e. the scanning range of the device is a dimension of the device), and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984),
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grass et al. (WO 2010/046839 A1, Apr. 29, 2010) (hereinafter “Grass”) in view of Mistretta et al. (US 2011/0037761 A1, Feb. 17, 2011) (hereinafter “Mistretta”).
Regarding claim 19: Grass discloses a vascular imaging system comprising an arm, a radiation emitter, and a radiation detector respectively disposed at two ends of the arm (figure 1: c-shaped element 2, x-ray tube 3, x-ray detector 4), and at least one processor configured to perform operations (pg. 11, line 25 – pg. 12, line 5) including: controlling the arm to move along the first direction and the radiation emitter to perform a first rotation around the first direction at the same time (pg. 7, lines 24-28); controlling the radiation emitter to emit first radiations (pg. 7, lines 24-28); obtaining first imaging data by receiving the first radiations through the radiation detector (pg. 7, lines 24-28); in response to determining that an angle of the first rotation is greater than a preset angle, stopping the first rotation (pg. 10, lines 4-6; pg. 12, line 23 - pg. 13, line 2; pg. 13, lines 3-11); controlling the arm to move along the first direction and the radiation emitter to perform a second rotation around the first direction at the same time (fig. 3; pg. 7, lines 24-28 – the basic acquisition process is the same for both portions of the helical path); controlling the radiation emitter to emit second radiations (pg. 7, lines 24-28 – the basic acquisition process is the same for both portions of the helical path); obtaining second imaging data by receiving the second radiations through the radiation detector, wherein a rotation direction of the second rotation is opposite to a rotation direction of the first rotation (pg. 12, line 23 - pg. 13, line 2; pg. 13, lines 3-11; fig. 3); and determining the target imaging data based on the first imaging data and the second imaging data (pg. 6, lines 29-34; pg. 12, lines 6-10 – all of the acquired image data is used in the reconstruction).
While Grass discloses that the acquired data can be used for a variety of applications requiring 3D image data, including of the head and neck (pg. 3, lines 3 – 13), Grass is silent on performing digital subtraction angiography (DSA) operations.
Mistretta, in the same field of endeavor, discloses a digital subtraction angiography (DSA) method and system comprising generating DSA data using 3D imaging data (abstract, fig. 2, [0029] – [0031]). Mistretta further discloses that 3D-DSA is an important component in the diagnosis and management of people with a large variety of central nervous system vascular diseases ([0003]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the vascular imaging system of Grass to perform digital subtraction angiography (DSA) as taught by Mistretta in order to provide important 3D diagnostic data for people with central nervous system vascular diseases.
Allowable Subject Matter
Claims 6 and 17 are 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. Claim 7 is also objected to based on its dependency from claim 6.
Claim 20 is allowable over the prior art by virtue of containing the same allowable subject matter as that present in claim 6.
Response to Arguments
Applicant’s arguments with respect to prior art rejection of all pending claims, filed 12/30/2025, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799