Ex Parte Kouchi et alDownload PDFBoard of Patent Appeals and InterferencesJun 20, 201210525749 (B.P.A.I. Jun. 20, 2012) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte KENJI KOUCHI, RYUJI NAGAI, and SHINYA NAGATA __________ Appeal 2011-000476 Application 10/525,749 Technology Center 1600 __________ Before TONI R. SCHEINER, LORA M. GREEN, and MELANIE L. McCOLLUM, Administrative Patent Judges. SCHEINER, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 1-3, 5-15, and 17-20, directed to a biological information trend display device. The claims have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part. Appeal 2011-000476 Application 10/525,749 2 STATEMENT OF THE CASE The Specification discloses a biological information trend display device “capable of facilitating check of the biological information trend and identification of [an] abnormal value” (Spec. 2: 6-8). Figure 5 of the Specification is reproduced immediately below: Figure 5 of the Specification is a schematic view illustrating an embodiment of Appellants‟ biological information trend display device that meets the limitations of claim 1, as well as several narrower dependent claims. In the embodiment shown in Figure 5, the device displays ST level trend curves from 12 ECG leads in an overlapping manner (i.e., all 12 curves are plotted on the same graph, such that curves with similar values overlap each other). The dotted lines at 0.1 mV and -0.1 mV represent predetermined upper and lower limits of the normal range of values. The Appeal 2011-000476 Application 10/525,749 3 area from left to right of the display screen represents a time period, in this case, 30 minutes. Icons representing ECG leads I, II, III, aVL, aVR, aVF, V1, V2, V3, V4, V5, and V6 are displayed in both the upper and lower parts of the display screen 14. (Spec. 18: 13 – 19: 3.) In Figure 5, “[t]he parts of the curves within the normal range are displayed in the normal value color „a‟ (blue, for example)” (id. at 19: 9-11), while “ST levels of the waveforms derived from the 12 leads [which] show abnormal values” (id. at 19: 13-14) are displayed as follows: A curve 70 showing the ST level of the lead waveform derived from the lead III is above the upper limit and displayed (plotted) in an abnormal value color X (graph display style). To indicate that the ST level derived from the lead III is higher than the upper limit, a lead icon 60 (for the lead III) in the upper part of the display screen is displayed in the same abnormal value color X as the curve 70 in the drawing (the type of data is displayed in the same style as the curve of the data). A curve 72 showing the ST level of the waveform derived from the lead V5 has become lower than the lower limit, and the part of the curve below the lower limit is displayed in an abnormal value color Y. To indicate that the ST level derived from the lead V5 has become lower than the lower limit, a lead icon 62 (for the lead V5) in the lower part of the display screen is displayed in the same abnormal value color Y as the curve 72 in the drawing. (Id. at 19: 17 - 20: 1.) According to the Specification, “[t]he user . . . can easily understand the trend of determined abnormal biological information and the source for obtaining the biological information” (id. at 3: 19-21). Appeal 2011-000476 Application 10/525,749 4 Claims 1-3, 5-15, and 17-20 are pending and on appeal. Claim 1 is representative: 1. A biological information trend display device for displaying a time series trend of biological information, comprising: means for obtaining a plurality of biological information; means for determining whether the obtained biological information is abnormal biological information or not; and means for displaying a time-series trend for each of the plurality of biological information, wherein the displaying means changes trend display style for biological information that is determined as the abnormal biological information, and wherein the displaying means further displays biological information determined as the abnormal biological information in association with information relating to the source of the biological information, wherein a graph displaying area and a data type displaying area are provided; the time-series trends for the plurality of biological information are overlapped and displayed on the same graph displaying area and the biological information determined as the abnormal biological information is displayed in association with information related to the source of the biological information; and text indicating the source of the biological information is displayed on the data type displaying area in the same displaying style as the time-series trend for biological information which is determined as the abnormal biological information. The Examiner relies on the following evidence: Sakaguchi et al. US 5,807,246 Sep. 15, 1998 Schradi et al. US 5,860,918 Jan. 19, 1999 Manuel et al. US 6,806,891 B1 Oct. 19, 2004 Dia Medical Systems JP 51-787 Jan. 6, 1976 S. Nelwan, et al., Implementing a continuous 12 lead ST Monitoring system, 18 TH ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY 1355-1356 (1996). Appeal 2011-000476 Application 10/525,749 5 I. Claims 1, 3, 5-8, 10-14, and 17-20 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Schradi, Sakaguchi, and Dia Medical Systems. II. Claim 9 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Schradi, Sakaguchi, Dia Medical Systems, and Manuel. III. Claims 2 and 15 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Schradi, Sakaguchi, Dia Medical Systems, and Nelwan. FINDINGS OF FACT 1. Schradi discloses a medical monitoring device comprising means for: monitoring and recording physiological parameters of a patient; comparing the monitored physiological parameters with predetermined threshold values; determining whether a physiological parameter exceeds the associated threshold; and producing a representation of the event in relation to time (Schradi, col. 1, l. 62 - col. 2, l. 16). 2. Figure 2 of Schradi is reproduced below: Appeal 2011-000476 Application 10/525,749 6 Figure 2 depicts the display of Schradi‟s medical monitoring device 110. The review window graphically displays abnormal events associated with multiple channels, “one for each physiological parameter monitored” (Schradi, col. 6, ll. 63-64), in this case: bradycardia (channel 200); desaturation (channel 202), and apnea (channel 204) (id. at col. 6, l. 64-67). 3. An event occurs when “one parameter or a plurality of parameters exceed a threshold or an alarm limit associated therewith . . . [and] the expression exceed can mean that the detected value is larger than . . . [an upper] threshold” or “smaller than . . . [a lower] threshold” (id. at col. 5, l. 67 - col. 6, l. 6). “[E]vents are shown in the respective channel by vertical bars, cf. e.g., 210. The length of these bars depends on the extent to which the respective parameter, which caused an event, exceeded the threshold associated therewith” (id. at col. 7, ll. 4-8). 4. According to Schradi, “a user who looks at the review window is able to see immediately to what extent a parameter related to a respective event exceeded the threshold or alarm limit associated therewith” (Schradi, col. 7, ll. 33-36). Moreover, “[e]vent string boxes 222, 224, and 226 in the right margin of the review window . . . contain items of information . . . indicating the active threshold or alarm limit of the parameter in question” (id. at col. 8, ll. 3-10) and “the trigger event is always shown [in] „invers[e] video‟” (id. at col. 8, ll. 14-15). 5. Sakaguchi discloses a medical “multicolor display unit” which displays numbers, letters, symbols, and messages in two or more colors and illumination modes to distinguish between normal and abnormal conditions Appeal 2011-000476 Application 10/525,749 7 (Sakaguchi, col. 1, ll. 32-33; col. 3, l. 5 - col. 4, l. 18). According to Sakaguchi, [M]ultiple types of data can be displayed in accordance with the type of color used in a continuous illumination mode, and by adding flashing to this the amount of data which can be displayed is doubled, so that various types of data can be displayed in respectively differing modes. For example, when the multicolor display unit consists of colors, by the combination of display color and steady illumination or flashing display can be performed in 4 modes, so that the 3 statuses of normal and abnormal diagnostic and therapeutic data and setting adjustment values can be easily displayed in differing display modes. (Id. at 1, ll. 40-50.) 6. Dia Medical Systems discloses a “trend monitor” which shows “several pieces of biological information [for a given patient] for a certain period of time at once in different colors” (Dia Medical Systems 2-3). “When any piece of the information exceeds its specific limit preset for each patient, the system indicates the applicable part in another color such that it stands out from the rest to focus attention” (id. at 3). That is, When the information data . . . falls within the range between a minimum and maximum limit, [a] color code decoder . . . decodes color codes to indicate pieces of biological information in different basic colors by type of information. For example, a waveform representing pulse rate is indicated in blue while a waveform representing body temperature [is indicated] in yellow . . . . In contrast, when the information data fails to fall within the range between a minimum and maximum limit, the color code decoder . . . decodes color codes to indicate the applicable part of the waveform in another color such that it stands out from the rest of the waveform to focus attention. For example, part of the waveform representing pulse rate, which exceeds the maximum limit of 90 or drops below the minimum limit of 50, is indicated in red . . . . Also, part of the waveform Appeal 2011-000476 Application 10/525,749 8 representing body temperature, which exceeds the maximum level of 38° C or drops below the minimum limit of 35° C, is indicated in vermillion. (Id. at 5-6.) 7. Figure 2 of Dia Medical Systems is reproduced below: Figure 2 depicts the display section 12 of the Dia Medical Systems trend monitor, in this case displaying a trend line for the patient‟s pulse rate, and another trend line for the patient‟s body temperature. 8. According to Dia Medical Systems, “each waveform on the graph representing a piece of information can be accurately identified by a color even when the waveforms are too close to each other or cross each other” (Dia Medical Systems 7). Thus, the reference discloses a trend monitor which displays a plurality of biological information trend lines in an overlapping manner on the same graph. Appeal 2011-000476 Application 10/525,749 9 PRINCIPLES OF LAW “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). The obviousness “analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418. See also id. at 421 (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”). The “suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.” DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006). DISCUSSION I. Claims 1, 3, 5-8, 10-14, and 17-20 stand rejected as unpatentable over the combined disclosures of Schradi, Sakaguchi, and Dia Medical Systems. Claim 1: Schradi discloses a system that displays time series trends for a plurality of physiological parameters (i.e., a plurality of biological information) in a graphical display area. Each physiological parameter is visually aligned, i.e., associated, with a specific channel, (elements 200, 202, 204, comprising text identifying the physiological parameter, i.e., indicating the source of the biological information) (FFs 2, 3). An abnormal event associated with a given parameter is depicted as a vertical bar (210) on the trend line associated with the channel for that particular parameter. In addition, an event string box (222, 224, 226) displays specific information Appeal 2011-000476 Application 10/525,749 10 associated with the event in the form of numbers and symbols, highlighted in inverse video, to make it easy to identify which parameter has exceeded its threshold (FF4). Dia Medical Systems discloses another conventional strategy for easy visualization of abnormal events associated with multiple physiological parameters, using color to differentiate between normal and abnormal parts of overlapping curves (FFs 7, 8). Similarly, Sakaguchi discloses a display system which differentiates between normal and abnormal conditions using different colors and/or different illumination modes (FF5). We agree with the Examiner‟s conclusion that it would have been obvious to one of ordinary skill “to link the style of display of the data trend line for a specific data source with text describing the data source . . . to easily confirm the significance and contents of the display by simple observation, and enhance the ease of use of the medical diagnosis and treatment system” (Ans. 14), given the teachings of Schradi, Sakaguchi, and Dia Medical systems. The claimed display device relies on a combination of familiar, predictable visualization strategies - i.e., using color or other visual phenomena to highlight abnormal events and differentiate between different sources of information, and to instantly identify the significance of the information. While the claimed invention is esthetically and functionally elegant, it is nevertheless the product of the inferences and creative steps that would be employed by a person of ordinary skill in the art of organizing and displaying data for easy visualization (see KSR, 550 U.S. at 421). We are not persuaded otherwise by Appellants‟ arguments. Appeal 2011-000476 Application 10/525,749 11 Specifically, Appellants contend that Schradi neither “teaches, suggests nor discloses that the displaying means displays a source for abnormal biological information as claimed” (App. Br. 15). However, as discussed above, and as noted by the Examiner, “the vertical bars in [Schradi‟s] figures show information determined to be abnormal that is displayed with information related to the source of the information, the terms BRADY[bpm], DESAT[%], and APNEA DURAT‟N[sec]” (FFs 2, 3; Ans. 12). In addition, Appellants contend that “the relied upon references [neither] teach, suggest nor disclose that the time-series trends for the plurality of biological information are overlapped and displayed on the same graph displaying area as recited . . . in independent claim 1” (App. Br. 15). Again, however, Dia Medical Systems explicitly states that “each waveform on the graph representing a piece of information can be accurately identified by a color even when the waveforms are too close to each other or cross each other” (Dia Medical Systems 7; FF8), and Figure 2 plainly shows overlapping curves for pulse rate and body temperature (FF7). Finally, Appellants contend that “[t]he references are also absent any teaching that correlates the style of the text indicating the source of the biological information and the time series trend as claimed” (App. Br. 16), and “simply changing the display for abnormal information does not anticipate nor render obvious the claimed features” (id. at 17). It is true that none of the references discloses using the same style, e.g., color, for both the depiction of the abnormal event and the depiction of the source of the biological information. However, Schradi uses inverse video to highlight data associated with a graphically displayed abnormal Appeal 2011-000476 Application 10/525,749 12 event, and Sakaguchi and Dia Medical Systems both show that color is conventionally used to graphically organize and highlight important aspects of a multicomponent display. Highlighting abnormal biological information on a trend line with a distinctive color, and displaying information related to the source of the biological information in the same color is merely the sort of creative step that would be employed by one skilled in the art of visually organizing and displaying complex data. Claim 5: Appellants contend that claim 5 requires that “the time-series trends for biological information judged as normal are displayed in the same style with each other” (App. Br. 20), but none of the cited references discloses this feature. This argument is not persuasive. First, Schradi‟s channels and trend lines appear to be in the same format, except for abnormal events, which are indicated by vertical bars associated with data highlighted in inverse video style. Second, if the aim is to make abnormal information conspicuous and easily identifiable, then it would have been an obvious creative step for one of ordinary skill in this art to display normal, less important information in a less conspicuous manner than abnormal information, e.g., all in the same color. Claim 6: Appellants contend that claim 6 requires a feature not disclosed by any of the cited references, specifically: [T]he displaying means further displays a source for obtaining biological information at an upper portion of the time-series trend when the biological information exceeds certain level, and displays a source for obtaining biological information at a lower Appeal 2011-000476 Application 10/525,749 13 portion of the time-series trend when the biological information falls below certain level. (App. Br. 21.) The Examiner essentially disregards this feature, reasoning that Appellants are “arguing limitations of a method” (Ans. 15), rather than limitations to the system (id.). The limitations, however, are limitations as to how the system is programed and data is displayed, and not merely method limitations. Thus, we agree with Appellants that the Examiner has not established that this particular feature (illustrated, e.g., in Figure 5 of the Specification) would have been obvious over the cited prior art, and are compelled to reverse the rejection with respect to claim 6. Claim 7: Appellants contend that claim 7 requires “when subsequent biological information is no longer determined to be abnormal biological information the displaying means further displays the trend of the subsequent biological information in the original style, and maintains the indication of the information relating to the source of the biological information” (App. Br. 21), and none of the references “teaches, suggests or discloses the above feature” (id.). This argument is not persuasive. We note (as did the Examiner) that Dia Medical Systems discloses a curve that reverts to the normal color when the parameter returns to normal after an abnormal event (Ans. 16; FFs 6, 7). Claim 8: Appellants contend that none of the references “teaches, suggests or discloses the ability to discriminate” between abnormal current information; Appeal 2011-000476 Application 10/525,749 14 abnormal past and current information; past abnormal and current normal information (App. Br. 22). This argument is not persuasive. As noted by the Examiner, Schradi allows this type of discrimination (Ans. 16; FF4), and we note that Dia Medical Systems does as well (FFs 6, 7). Claim 10: Appellants contend that claim 10 requires that “the displaying means further displays a time-series trend of biological information with information relating to the source of the biological information” (App. Br. 22), and is therefore allowable. This argument is not persuasive, as it is not clear how this claim further limits claim 1, from which it depends, and we have already determined that claim 1 would have been obvious over the cited art. Claim 11: Appellants contend that claim 11 requires that “the displaying means displays different biological information in the same trend display style, which are derived from different sources for the biological information that is not determined as the abnormal biological information” (App. Br. 23), but none of the cited references discloses this feature. This argument is not persuasive. As discussed above in connection with claim 5, Schradi‟s trend lines (which are derived from different sources) appear to be in the same format, except for abnormal events, which are indicated by vertical bars associated with data highlighted in inverse video style (FF2). Appeal 2011-000476 Application 10/525,749 15 Claim 12: Appellants contend that claim 12 requires that “the change of trend display style comprises changing the trend display color” (App. Br. 23), which is neither taught nor suggested by the cited art. Again, we are not persuaded that using color to highlight and organize information in the manner claimed would have been unobvious for the reasons discussed above in connection with claim 1. Claim 13: Appellants contend that claim 13 requires that “the displaying means further conforms the trend display color of biological information that is determined as the abnormal biological information to display color of information relating to the source of the biological information” (App. Br. 24), which is neither taught nor suggested by the cited art. Again, we are not persuaded that using color to highlight and organize information in the manner claimed would have been unobvious for the reasons discussed above in connection with claim 1. Claim 14: Appellants contend that claim 14 requires that “the biological information comprises information that shows different behaviors depending on the sources” (App. Br. 24), which is neither taught nor suggested by the cited art. This argument is not persuasive. As noted by the Examiner, Schradi “shows that the different sources have distinct behaviors” (Ans. 17), for example, Figure 2 of Schradi displays bradycardia as bpm; desaturation as a percentage; and apnea by duration (FF2). Appeal 2011-000476 Application 10/525,749 16 II. Claim 9 stands rejected as unpatentable over the combined disclosures of Schradi, Sakaguchi, Dia Medical Systems, and Manuel. Claim 9 recites that “the device further comprises display area for displaying the information related to the source of biological information related to the source of biological information, wherein the display area includes an inner indication area and an outer indication area” and differentiates between current and past abnormal biological information. The Examiner cites Manuel for its disclosure of “a graphical display for conveying status information . . . [using] an indicator having an inner and outer area” wherein “the inner area changes color when a request has been processed . . . [and the] outer area changes color when a request is made” (Ans. 9). The Examiner finds that Manuel‟s indicator temporally “indicates a changed status in a past event” (id.). Appellants contend that “Manuel has nothing to do with biological information” (App. Br. 30). This argument is not persuasive. Manuel is concerned with visual organization and display of temporal data - the same concern addressed by Schradi, Sakaguchi, and Dia Medical Systems. The mere fact that the types of data to be displayed are different does not mean that Manuel is irrelevant to displaying medical data. III. Claims 2 and 15 stand rejected as unpatentable over the combined disclosures of Schradi, Sakaguchi, Dia Medical Systems, and Nelwan. Appellants contend that claim 2 “is directed toward comparable features of claim 1, [and] the above arguments are equally applicable” (App. Appeal 2011-000476 Application 10/525,749 17 Br. 19). Similarly, with respect to claim 15, Appellants contend that the Examiner “has failed to provide any reference that teaches, suggests or discloses the time-series trends and text as recited in independent claim 1” (id. at 25). These arguments are not persuasive for the same reasons discussed above in connection with the rejection of claim 1. SUMMARY I. The rejection of claims 1, 3, 5-8, 10-14, and 17-20 as unpatentable over Schradi, Sakaguchi, and Dia Medical Systems is reversed with respect to claim 6, and affirmed with respect to claims 1, 3, 5, 7, 8, 10-14, and 17- 20. II. The rejection of claim 9 as unpatentable over Schradi, Sakaguchi, Dia Medical Systems, and Manuel is affirmed. III. The rejection of claims 2 and 15 as unpatentable over Schradi, Sakaguchi, Dia Medical Systems, and Nelwan is affirmed. 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). 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