Ex Parte Martin et alDownload PDFPatent Trial and Appeal BoardOct 26, 201612943572 (P.T.A.B. Oct. 26, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/943,572 11/10/2010 45436 7590 10/28/2016 DEAN D, SMALL THE SMALL PA TENT LAW GROUP LLC 225 S. MERAMEC, STE. 725T ST. LOUIS, MO 63105 FIRST NAMED INVENTOR Jennifer Martin UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 245107 (553-1617) 3941 EXAMINER LAMPRECHT, JOEL ART UNIT PAPER NUMBER 3737 NOTIFICATION DATE DELIVERY MODE 10/28/2016 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): Docket@splglaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JENNIFER MARTIN and GARY CHENG HOW NG 1 Appeal2014-008064 Application 12/943,572 Technology Center 3700 Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and JACQUELINE T. HARLOW, Administrative Patent Judges. PER CURIAM DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method and a system for displaying ultrasound data. The claims are rejected as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellants, the Real Party in Interest is General Electric Company (Br. 3). Appeal2014-008064 Application 12/943,572 STATEMENT OF THE CASE The Specification describes "methods and systems for displaying ultrasound data, and more particularly [for] displaying quantitative ultrasound data correlated with physiological monitoring data" (Spec. i-f 1 ). Claims 1-21 are on appeal. Claim 1 is illustrative and reads as follows (emphasis added): 1. A method for displaying ultrasound data, the method compnsmg: acqmnng ultrasound image data and physiological monitoring data during an ultrasound imaging scan; generating quantitative ultrasound data from the acquired ultrasound image data; correlating the quantitative ultrasound data with the physiological monitoring data; and displaying the correlated quantitative ultrasound data and physiological monitoring data time aligned on a display. The claims stand rejected as follows: I. Claims 1---6 and 8-21 stand rejected under 35 U.S.C. § 102(e) as being anticipated by Mehi.2 II. Claim 7 stands rejected under 35 U.S.C. § 103(a) as being obvious based on Mehi and Skyba. 3 2 Mehi et al., US 2011/0144494 Al, published June 16, 2011. 3 Skyba et al., US 2004/0066389 Al, published Apr. 8, 2004. 2 Appeal2014-008064 Application 12/943,572 I. We have considered Appellants' arguments, but are not persuaded that the Examiner erred in rejecting claims 1---6 and 8-21 under 3 5 U.S. C. § 102( e) as being anticipated by Mehi. Findings of Fact We adopt the Examiner's findings of fact and reasoning regarding the scope and content of the prior art (Final Act. 2-5; Ans. 2-9). For clarity, we highlight the following. FF 1. Mehi discloses "methods for displaying ultrasound images using a persistence algorithm, gating ultrasound acquisition based on subject respiration, triggering ultrasound acquisition based on subject ECG, ... " (Mehi Abstract; see also Final Act. 2). FF 2. Mehi discloses a method for frame persistence implemented by an ultrasound imaging system by obtaining a plurality of frames of ultrasound at a baseline frame rate (FRo); processing a portion of the plurality of frames of ultrasound at a processing rate (PR), wherein the portion includes a first frame having a first plurality of data points; applying a persistence routine to at least one of the first plurality of data points, wherein the persistence routine combines the at least one of the first plurality of data points with a corresponding stored data point based on a user defined persistence setting, FRo, and PR, to produce at least one persistence processed data point; storing the at least one persistence processed data point to replace the previously stored data point; and generating a persistence processed output frame from the at least one persistence processed data point. (Mehi i-f 4; see also Final Act. 3.) FF 3. Mehi discloses that "[t]he plurality of frames may include B- Mode data, Color Flow image data, or Power Doppler image data. The 3 Appeal2014-008064 Application 12/943,572 method may fhrther include displaying the persistence processed output frame on a display" (Mehi i-f 4; see also Final Act. 3). FF 4. Mehi discloses "scanning a region of interest in the subject with ultrasound" (Mehi i-f 5; see also Final Act. 2, Ans. 9). FF 5. Mehi discloses a method for respiration gating during ultrasound imaging by acquiring a respiration signal from a subject; determining a start of a respiration cycle in the respiration signal; setting a valid zone based on the start of the respiration cycle and user defined offset and/or duration; acquiring a plurality of frames of ultrasound, e.g., at an acquisition rate of at least 200 frames per second; discarding one or more frames of the plurality of frames acquired outside the valid zone; and outputting remaining frames of the plurality of frames acquired inside the valid zone. The acquired plurality of frames may also be time-stamped to indicate when each frame is acquired. (Mehi i-f 6; see also Final Act. 2-3; Ans. 3, 5, 9.) FF 6. Mehi discloses a method for ECG triggered acquisition during ultrasound imaging by acquiring, at a host computer, an ECG signal from a subject; determining, at the host computer, an R-wave point in the ECG signal; determining, at the host computer, a trigger point threshold and a trigger slope based on the R-wave point; transferring the trigger point threshold and the trigger slope to a programmable logic device; and triggering, by the programmable logic device, the acquisition of ultrasound based on the trigger point threshold and the trigger slope, e.g., at a rate of at least 200 frames per second. The method may be employed to acquire a cineloop that starts at a specified point in a cardiac cycle and runs for a specified number of cardiac cycles. The method may be used to acquire one or more of B-Mode data, Color Doppler Mode data, Power Doppler Mode data, Contrast Mode data, and 3D Mode data. (Mehi i-f 7; see also Final Act. 2-3.) 4 Appeal2014-008064 Application 12/943,572 FF 7. Mehi depicts in Figure 1 an exemplary waveform (Mehi i-f 10). Figure 1 is reproduced below. FIG. l 4204 Time(m~cl 4200 (Id. at Fig. 1.) Figure 1 shows "an exemplary respiration waveform 4200 from a subject where the x-axis represents time in milliseconds (ms) and the y-axis represents voltage in millivolts (m V)" (id. i-f 10) in which "a reference line 4204 can be inserted on the waveform 4202" (id. i-f 26). FF 8. Mehi depicts in Figure 2 a valid acquisition zone (id. i-f 11 ). Figure 2 is reproduced below. FIG, 2 (Id. at Fig. 2.) Figure 2 shows "a valid acquisition zone where the start of the respiration cycle combined with the user's specifications denotes the valid acquisition zone" (id. i-f 11 ). 5 Appeal2014-008064 Application 12/943,572 FF 9. Mehi depicts in Figure 6C an exemplary single pulse of ECG data (id. i-f 17). Figure 6C is reproduced below. c. '· :,'l.,,l li ""*' :· ·. ~~';·,f:': r·,.:-:~.-.:: :f'n,~'w'r••'>~•,..,,,..,...,,....._.,'.>,",,,...__,,._,._ • ..._,-.~ • '-''-~'• • .._,v •• '"''-:•:• "'•'.•-·_ ... .,.,., .. ~ (Id. at Fig. 6C.) Figure 6C "illustrates an exemplary single pulse of ECG data showing a threshold trigger point and a blank period" (id. i-f 17; see also Final Act. 3). FF 10. Mehi discloses that persistence processing combines information from previous frames of B-Mode detected data with the most recent frame of B-Mode detected data to produce an output frame. Persistence can also be applied to other data sets such as Color Flow or Power Doppler overlays or image data processed with harmonic imaging methods (Mehi i-f 19; see also Final Act. 3). FF 11. Mehi discloses a method for gating retention of ultrasound based on the respiration cycle. For example, a threshold value can be selected, and a time position can be recorded when the respiration signal exceeds the threshold. . . . The user can specify additional information such as a custom offset from the start of the cycle. The user can also specify a duration during which to allow acquisition. As shown in FIG. 2, the start of the respiration cycle combined with the user's specifications denotes a valid 6 Appeal2014-008064 Application 12/943,572 acquisition zone, e.g., when frames can be acquired without motion artifact. (Mehi iT 27.) FF 12. Mehi discloses Small animals can be anesthetized during imaging and vital physiological parameters such as heart rate and temperature can be monitored. Thus, an embodiment of the system may include means for acquiring ECG and temperature signals for processing and display. An embodiment of the system may also display physiological waveforms such as an electro-cardiogram (ECG), respiration or blood pressure waveform. (Id. iT 57; see also Final Act. 2-3, 5-7.) FF 13. Mehi discloses The systems can also be used in M-Mode, with simultaneous B- Mode, for cardiology or other applications where such techniques are desired. The system can optionally be used in Duplex and Triplex modes, in which M-Mode and PW Doppler and/or Color Flow modes run simultaneously with B-Mode in real-time. A 3-D mode in which B-Mode or Color Flow mode information is acquired over a 3-dimensional region and presented in a 3-D surface rendered display can also be used. A line based image reconstruction or "EKV" mode, can be used for cardiology or other applications, in which image information is acquired over several cardiac cycles and recombined to provide a very high frame rate display. (Mehi iT 68; see also Final Act. 3; Ans. 3-7, 9.) FF 14. Mehi discloses [a] method for ECG triggered acquisition during ultrasound imaging, comprising: (a) acquiring, at a host computer, an ECG signal from a subject; (b) determining, at the host computer, an R-wave point in the ECG signal; 7 Appeal2014-008064 Application 12/943,572 ( c) determining, at the host computer, a trigger point threshold and a trigger slope based on the R-wave point; ( d) transferring the trigger point threshold and the trigger slope to a programmable logic device; and ( e) triggering, by the programmable logic device, the acquisition of ultrasound based on the trigger point threshold and the trigger slope. (Mehi Claim 19; see also Ans. 3, 5-9.) FF 15. Mehi discloses "triggering based on the trigger point threshold and the trigger slope is used to acquire a cineloop that starts at a specified point in a cardiac cycle and runs for a specified number of cardiac cycles" (Mehi Claim 20; see also Ans. 3, 5-9). FF 16. Mehi discloses "triggering based on the trigger point threshold and the trigger slope is used to acquire one or more of B-Mode data, Color Doppler Mode data, Power Doppler Mode data, Contrast Mode data, and 3D Mode data" (Mehi Claim 21 ). FF 17. Mehi discloses (i) acquiring a respiration signal from a subject; (ii) determining a start of a respiration cycle m the respiration signal; (iii) setting a valid zone based on the start of the respiration cycle and user defined offset and/ or duration; (iv) discarding ultrasound acquired outside the valid zone during step ( e ); and ( v) outputting ultrasound acquired inside the valid zone during step ( e ). (Id. at Claim 22.) FF 18. Mehi discloses "ultrasound frames are time-stamped to indicate when each frame is acquired" (id. at Claim 24; see also Ans. 8-9). FF 19. The Specification discloses that "quantitative ultrasound data refers to any quantifiable, plottable, measurable, determinable or other 8 Appeal2014-008064 Application 12/943,572 numerical data acquired, determined and/ or generated from ultrasound data, which may be obtained using different types of ultrasound data acquisition" (Spec. ii 21 ). FF20. The Specification discloses Various embodiments may include a method 50 as illustrated in Figure 2 to acquire and display correlated quantitative ultrasound data and monitoring data, such as patient monitoring data. It should be noted that although the method 50 is described in connection with generating color flow ultrasound data and correlating the data with particular physiological data, the method 50 is not limited to particular quantitative ultrasound data or physiological data. (Id. ii 26.) FF 21. The Specification discloses In general, color flow ultrasound data includes data that may be used to produce a color-coded map of Doppler shifts superimposed onto a B-mode ultrasound image (color flow maps). In operation, color flow imaging uses pulses along each of a plurality of color scan lines of the image to obtain a mean frequency shift and a variance at each area of measurement. This frequency shift is displayed as a color pixel. (Id. ii 27.) FF22. The Specification discloses For example, the quantitative data may include color blood flow data wherein a determination is made as to an amount or ratio of blood flow through an ROI based on a number of color flow pixels in the ultrasound image data indicating varying levels of blood flow. For example a blood flow ratio for one or more RO Is may be determined as follows: (number of color flow pixels I total number of pixels) in the RO Is. (Id. ii 30.) 9 Appeal2014-008064 Application 12/943,572 FF 23. The Specification discloses It should be noted that the quantitative data may be any type of quantitative data or parameter. For example, although color flow and power Doppler quantitative data may be displayed, other types of quantitative data may be displayed, such as grayscale or volume data (namely three-dimensional data instead of two-dimensional data). (Id. ii 35.) FF24. The Specification discloses that "[i]t also should be noted that correlation as used herein refers to any type of association of data and is not limited, for example, to a mathematical correlation" (id. ii 23). Analysis We begin with claim interpretation, because until a claim is properly interpreted, its scope cannot be compared to the prior art. Each of independent claims 1, 13, and 18 recites the term "quantitative ultrasound data." Specifically, claim 1 recites "displaying the correlated quantitative ultrasound data and physiological monitoring data time aligned on a display" (emphasis added), claim 13 recites "at least one plot of quantitative ultrasound data on the time aligned graph" (emphasis added), and claim 18 recites "a display configured to display quantitative ultrasound data based on the ultrasound image data and the physiological monitoring data time aligned" (emphasis added). The Specification discloses that "quantitative ultrasound data refers to any quantifiable, plottable, measurable, determinable or other numerical data acquired, determined and/or generated from ultrasound data, which may be obtained using different types of ultrasound data acquisition" (FF 19 (emphasis added)). The Specification also discloses "a method 50 as 10 Appeal2014-008064 Application 12/943,572 illustrated in Figure 2 to acquire and display correlated quantitative ultrasound data" and that "the method 50 is described in connection with generating color flow ultrasound data ... , the method 50 is not limited to particular quantitative ultrasound data" (FF 20 (emphasis added)). The Specification further explains that "color flow ultrasound data includes data that may be used to produce a color-coded map of Doppler shifts superimposed onto a B-mode ultrasound image (color flow maps)," "color flow imaging uses pulses along each of a plurality of color scan lines of the image to obtain a mean frequency shift and a variance at each area of measurement," and "[t ]his frequency shift is displayed as a color pixel" (FF 21 ). The Specification discloses "the quantitative data may include color blood flow data ... based on a number of color flow pixels in the ultrasound image data" (FF 22; see also Appellants' claims 5 and 11), and "quantitative data may be any type of quantitative data or parameter. For example, although color flow and power Doppler quantitative data may be displayed, other types of quantitative data may be displayed, such as grayscale or volume data (namely three-dimensional data instead of two- dimensional data)" (FF 23). Therefore, we conclude that the broadest reasonable interpretation of the phrase "quantitative ultrasound data," as used in claims 1, 13, and 18, encompasses any quantifiable or numerical data or parameter that can be obtained from ultrasound data acquisition, and can include color flow ultrasound data, color flow maps, such as a color-coded map of Doppler shifts superimposed onto a B-mode ultrasound image, color flow pixels in the ultrasound image data, power Doppler data, and grayscale or volume data that can be two-dimensional or three-dimensional data. See In re 11 Appeal2014-008064 Application 12/943,572 Sneed, 710 F.2d 1544, 1548 (Fed. Cir. 1983) ("[C]laims in an application are to be given their broadest reasonable interpretation consistent with the specification, and that claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art." (internal citation omitted)). We next address Appellants' contention that Mehi does not teach quantitative ultrasound data because the image in Mehi is "merely a display of a plurality of pixels showing an imaged region" and that "[a] user is not able, for example, to ascertain quantitative values from the displayed image of Mehi" (Br. 12-13). This argument is not persuasive because, as discussed above, we conclude that the broadest reasonable interpretation of the phrase "quantitative ultrasound data" includes any quantifiable or numerical data or parameter that can be obtained from ultrasound data acquisition, which can be color pixels. Moreover, Appellants' argument is unavailing because it is contrary to the Specification's disclosure of pixels as one example of "quantitative ultrasound data." We further note that, as discussed above regarding the exemplary "quantitative ultrasound data" disclosed in the Specification, many of the same examples of "quantitative ultrasound data" are disclosed by Mehi (FF 3 ("Color Flow image data, or Power Doppler image data"); FF 6 ("Color Doppler Mode data, Power Doppler Mode data, Contrast Mode data, and 3D Mode data"); FF 10 ("Color Flow or Power Doppler overlays")). We also observe that Mehi discloses frames of ultrasound data such as "a first frame having a first plurality of data points" (FF 2) which certainly is quantifiable or numerical data or parameter that is 12 Appeal2014-008064 Application 12/943,572 obtained from ultrasound data acquisition, and therefore, are "quantitative ultrasound data." Appellants contend that Mehi does not describe "aligning of the physiological waveforms with any of the other displayed information, for example, an ultrasound image, much less quantitative ultrasound data, such as on a time aligned graph" (Br. 15). We are not persuaded. Mehi discloses "methods for displaying ultrasound images using a persistence algorithm, gating ultrasound acquisition based on subject respiration, triggering ultrasound acquisition based on subject ECG, ... " (FF 1 (emphasis added); see also FF 14). Mehi discloses "a method for respiration gating during ultrasound imaging by acquiring a respiration signal from a subject" and "acquiring a plurality of frames of ultrasound, e.g., at an acquisition rate of at least 200 frames per second'' (FF 5 (emphasis added); see also FF 15). Mehi discloses that "[ s ]mall animals can be anesthetized during imaging and vital physiological parameters such as heart rate and temperature can be monitored" and that "the system may include means for acquiring ECG and temperature signals for processing and display" (FF 12). Therefore, we agree with the Examiner that because Mehi discloses "the gating of the imaging is aligned to the cardiovascular cycle," Mehi "provides teaching of time-aligned physiological data with ultrasound data" (Ans. 5). Appellants argue that Mehi does not teach "displaying an ultrasound image, at least one plot, and at least one physiological monitoring trace concurrently" (Br. 15-16). We do not find this argument persuasive. Further to the discussion above, Mehi discloses that "[t]he systems can also be used in M-Mode, with 13 Appeal2014-008064 Application 12/943,572 simultaneous R-Mode, for cardiology or other applications where such techniques are desired. The system can optionally be used in Duplex and Triplex modes, in which M-Mode and PW Doppler and/or Color Flow modes run simultaneously with B-Mode in real-time" (FF 13 (emphasis added)). Because such data are displayed simultaneously, and are known in the art to comprise data in graphical representation, we agree with the Examiner that "as such, both inherently and necessarily, the images produced and displayed include physiological data as they are from those specific points in the cardiac cycle (specifically noted, the R-wave point)" (Ans. 3), and that "the display of both PW/Color Flow datasets is at least a quantitative display of ultrasonic data, and is indeed also a plot" (id. at 4). As the Examiner explains "the B-Mode and M-Mode data can be viewed as a typical ultrasound 'image', and the output from the PW Doppler or Color Flow analysis are displayed as a plot of datapoints" (id. at 3). Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. . . . Whether the rejection is based on "inherency" under 3 5 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Appellants argue that the Examiner "fails to consider the recited 'time aligned on a display' language in claim 1" and that Mehi does not disclose this claimed limitation (Br. 17). We do not agree. As discussed above, because Mehi discloses "gating ultrasound acquisition based on subject 14 Appeal2014-008064 Application 12/943,572 respiration, triggering ultrasound acquisition based on subject ECG, ... " (FF 1 (emphasis added)), "acquiring a plurality of frames of ultrasound, e.g., at an acquisition rate of at least 200 frames per second'' (FF 5 (emphasis added)), and "[t]he systems can also be used in M-Mode, with simultaneous B-Mode, for cardiology or other applications where such techniques are desired. The system can optionally be used in Duplex and Triplex modes, in which M-Mode and PW Doppler and/or Color Flow modes run simultaneously with B-Mode in real-time" (FF 13 (emphasis added)), we agree with the Examiner that Mehi inherently and necessarily teaches the "time aligned on a display" limitation (see Ans. 5---6). See In re Best, 562 F.2d at 1255. To the extent that Appellants argue that Mehi does not teach "correlating the quantitative ultrasound data with the physiological monitoring data" as claimed (see Br. 17), we are not persuaded. We note that the Specification discloses that "[i]t also should be noted that correlation as used herein refers to any type of association of data and is not limited, for example, to a mathematical correlation" (FF 24). Because Mehi teaches the acquisition of ultrasound data is triggered by physiological data such as ECG signals, the data are associated, and therefore, there is correlation. In regard to Appellants' arguments concerning claims 2-5, 10, 14, 15, and 17 that Mehi does not disclose displaying an ultrasound image frame, a plot, or a graph (see Br. 19-21 ), we are not persuaded for the reasons discussed above. With respect to the claim 3 requirement of "receiving a user input defining at least one region of interest (ROI) in the displayed ultrasound image," we note that Mehi discloses "scanning a region of interest in the subject with ultrasound" (FF 4). We, therefore, agree with the 15 Appeal2014-008064 Application 12/943,572 Examiner that Mehi teaches the limitations of claims 2-5, 10, 14, 15, and 17 as explained and reiterated by the Examiner (see Ans. 6-9). In regard to claim 14, we do not find persuasive Appellants' contention that Mehi does not disclose a frame line indicator (Br. 20-21 ). Mehi depicts in Figure 1 an exemplary waveform in which in which "a reference line 4204 can be inserted on the waveform 4202" (FF 7). Mehi depicts in Figure 2 a valid acquisition zone having a line indicator showing "the start of the respiration cycle combined with the user's specifications denotes the valid acquisition zone" (FF 8). Mehi also depicts in Figure 6C an exemplary single pulse of ECG data with a line indicator and "illustrates an exemplary single pulse of ECG data showing a threshold trigger point and a blank period" (FF 9). Mehi discloses [a] method for ECG triggered acquisition during ultrasound imaging, comprising: (a) acquiring, at a host computer, an ECG signal from a subject; (b) determining, at the host computer, an R-wave point in the ECG signal; ( c) determining, at the host computer, a trigger point threshold and a trigger slope based on the R-wave point. (FF 14.) Mehi discloses "triggering based on the trigger point threshold and the trigger slope is used to acquire one or more of B-Mode data, Color Doppler Mode data, Power Doppler Mode data, Contrast Mode data, and 3D Mode data" (FF 17; see also FF 15-16) and "ultrasound frames are time- stamped to indicate when each frame is acquired" (FF 18). Because these multitude of data are displayed in combination and simultaneously as discussed above, we agree with the Examiner that Mehi inherently and necessarily discloses the limitation "a frame indicator line on the graph 16 Appeal2014-008064 Application 12/943,572 identifying a time at which the ultrasound image frame was acquired corresponding to a time along the physiological monitoring trace" (see Ans. 8-9). See In re Best, 562 F.2d at 1255. II. The Examiner has rejected claim 7 under 35 U.S.C. § 103(a) as being obvious based on Mehi and Skyba. Appellants present no additional argument based on the teachings of Skyba, and rely on the same arguments addressed above with regard to Mehi (see Br. 21 ). For the reasons discussed above, therefore, we affirm the rejection of claim 7. SUMMARY We affirm the rejection of claims 1, 13, and 18 under 35 U.S.C. § 102( e) based on Mehi. Claims 2---6, 8-12, and 21 fall with claim 1, claims 14--17 fall with claim 13, and claims 19 and 20 fall with claim 18. We affirm the rejection of claim 7 under 35 U.S.C. § 103(a) based on Mehi and Skyba. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 17 Copy with citationCopy as parenthetical citation