13913324 (P.T.A.B. Dec. 26, 2018)

Ex Parte Joglekar et al

Patent Trial and Appeal BoardDec 26, 2018

13913324 (P.T.A.B. Dec. 26, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/913,324 06/07/2013 71996 7590 12/28/2018 SHUMAKER & SIEFFERT, P.A 1625 RADIO DRIVE, SUITE 100 WOODBURY, MN 55125 FIRST NAMED INVENTOR Ajinkya M. Joglekar 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. l 123-118US01/P036776.USU1 2535 EXAMINER SILVERMAN, SETH ADAM ART UNIT PAPER NUMBER 2145 NOTIFICATION DATE DELIVERY MODE 12/28/2018 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): pairdocketing@ssiplaw.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte AJINKY AM. JOGLEKAR and BRADLEY C. PECK Appeal2018-000214 Application 13/913,324 Technology Center 2100 Before JOSEPH L. DIXON, CHARLES J. BOUDREAU, and JASON M. REPKO, Administrative Patent Judges. REPKO, Administrative Patent Judge. DECISION ON APPEAL Appeal2018-000214 Application 13/913,324 STATEMENT OF THE CASE Appellants 1 appeal under 35 U.S.C. Â§ 134(a) from the Examiner's rejection of claims 1, 3-7, 9-11, 13-17, 19-21, 23-27, 29-37, and 43--48. App. Br. 10-37. 2 Claims 2, 12, 22, 32, and 38--42 were canceled. The Examiner withdrew the rejections of claims 8, 18, and 28 in the Answer. Ans. 69. We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. THE INVENTION Appellants' invention relates to programming an implantable fluid- delivery device. Abstract. The device displays a graphical user interface with an axis for time and another for the fluid-delivery rate. Id. The heights of the graphical objects in a dosing program correspond to a vertical axis that represents therapeutic-agent-infusion rate values. Spec. ,r 85. Some displayed values are less than the maximum therapeutic-agent-infusion rate. Id. These objects can be small compared to the overall display area. Id. Such objects may be too small for the user to work with effectively. Id. To address this issue, the invention determines a maximum value of the fluid-delivery axis using a reference-rate value. Id. ,r,r 57, 86. For example, the reference-rate value may represent a particular dosing rate for a therapeutic agent. Id. ,r 57. A user may input a therapeutic-agent 1 According to Appellants, the real party in interest is Medtronic Inc. of Minneapolis, Minnesota, the assignee of record, and Medtronic plc of Dublin, Ireland, the ultimate parent entity of Medtronic Inc. App. Br. 3. 2 Throughout this opinion, we refer to the Final Rejection ("Final Act.") mailed December 29, 2016; the Appeal Brief ("App. Br.") filed May 30, 2017; the Examiner's Answer ("Ans.") mailed August 9, 2017; and the Reply Brief ("Reply Br.") filed October 5, 2017. 2 Appeal2018-000214 Application 13/913,324 concentration as a mass per unit of volume, e.g., in milligrams per milliliters. Id. ,r 57. The system uses the received therapeutic-agent concentration to determine a reference-rate value. Id. The interface then shows an infusion graph with a vertical axis scaled to correspond to the determined reference rate. Id. ,r 86. By displaying the graph in this way, the invention allows a user to determine and adjust the dosing parameters easily. Id. Claims 1, 11, 21, 3 1, and 3 5 are independent. Claim 1 is reproduced below with our emphasis on the limitation at issue: 1. A method comprising: receiving, by a device for programming a fluid delivery device, a therapeutic agent concentration, wherein the therapeutic agent concentration indicates a mass of a therapeutic agent per unit of volume of a fluid delivered by the fluid delivery device; determining, by the device for programming the fluid delivery device, a maximum rate value of a vertical axis for display via a user interface of the device based on the received therapeutic agent concentration, wherein the vertical axis represents rates of delivery of the fluid by the fluid delivery device, wherein the maximum rate value includes a mass value, wherein determining the maximum rate value of the vertical axis based on the received therapeutic agent concentration comprises determining the mass value of the maximum rate value as a percent of the mass value indicated by the therapeutic agent concentration; displaying, via the user interface, a horizontal axis and the vertical axis, wherein the horizontal axis represents time, and wherein the maximum rate value of the displayed vertical axis is determined to be less than a maximum therapeutic agent infusion rate; and displaying an indication of a therapy dosing program for delivery of the therapeutic agent to a patient relative to the horizontal axis and the vertical axis to represent a rate of delivery of the therapeutic agent via the fluid delivery device to the patient over time. 3 Appeal2018-000214 Application 13/913,324 THE EVIDENCE The Examiner relies on the following as evidence: Yiv et al. Drew et al. Alme et al. Chuang US 6,245,349 B 1 US 2010/0010646 Al US 2010/0185183 Al US 2010/0188427 Al THE REJECTIONS June 12, 2001 Jan. 14,2010 July 22, 2010 July 29, 2010 Claims 1, 3-5, 9-11, 13-15, 18-21, 23-25, 29-31, 34, 35, and43--48 stand rejected under 35 U.S.C. Â§ 103 as unpatentable over Alme, Chuang, and Drew. Final Act. 7-56. Claims 6, 7, 16, 17, 26, 27, 32, 33, 36, and 37 stand rejected under 35 U.S.C. Â§ 103 as unpatentable over Alme, Chuang, Drew, and Yiv. Final Act. 56-68. THE REJECTION OVER ALME, CHUANG, AND DREW The Examiner's Findings The Examiner finds that Alme teaches every limitation recited in claim 1 except for (1) determining a maximum rate value of a vertical axis by determining the mass value of the maximum rate value as a percent of the mass value and (2) a mass value indicated by the therapeutic-agent concentration. Final Act. 7-13. In concluding that the subject matter of claim 1 would have been obvious, the Examiner cites Chuang and Drew, respectively, as teaching these features. Id. at 10-13. Specifically, the Examiner concludes that it would have been obvious to use Chuang's maximum-rate-value determination for Alme's and Drew's data to arrive at the claimed invention. Ans. 69-71. 4 Appeal2018-000214 Application 13/913,324 Appellants ' Contentions Appellants argue that the cited references do not teach or suggest the recited maximum-rate-value determination. App. Br. 13-17. Appellants argue Drew does not determine a first mass value as a percent of a second, different mass value. Id. at 18. Appellants argue that Drew, like Alme, displays rates, not therapeutic-agent concentrations. Id. at 15. Appellants argue that Chuang merely determines a graph's upper and lower bounds using the displayed data. Id. at 16. So in Appellants' view, it would not have been obvious to determine a mass value of the maximum rate value as a percent of the mass value indicated by the therapeutic-agent concentration. Id. Issue UnderÂ§ 103, has the Examiner erred in rejecting independent claim 1 by finding that Alme, Chuang, and Drew would have taught or suggested "determining the maximum rate value of the vertical axis based on the received therapeutic agent concentration comprises determining the mass value of the maximum rate value as a percent of the mass value indicated by the therapeutic agent concentration," as recited in claim 1? Analysis Generally, claim 1 recites steps for programming a fluid-delivery device. For example, Figure 4A shows receiving a therapeutic-agent concentration of 10.0 mg/mL for morphine. Fig. 4A. Part of Figure 4A is reproduced below. 5 Appeal2018-000214 Application 13/913,324 Figure 4A shows a user interface for receiving a therapeutic-agent concentration 104 from the user. Spec. 116. In Figure 4A, therapeutic-agent concentration 104 represents the concentration at which implantable fluid-delivery system 10 (not pictured above) stores therapeutic agent 102. Spec. ,r 93. From therapeutic-agent concentration 104, processor 52 determines a reference rate value. Id. ,r 94. In one example, the reference rate value includes a mass value that is ten percent of the mass value of therapeutic-agent concentration 104. Id. In Figure 4A's example, processor 52 may determine a reference rate value that includes a mass value of one milligram (1 mg). Id. Using the determined reference rate value, processor 52 causes user interface 50 to display a maximum vertical-axis rate 122 of 1.000 milligrams per hour, shown in Figure 5B (below). Id. ,r 100. 6 Appeal2018-000214 Application 13/913,324 Figure SB shows a user interface for delivering a therapeutic agent at an infusion rate corresponding to graphical object 126's height for a time period corresponding to the object's width. As shown in Figure 5B above, processor 52 may cause the user interface to display zoom values 121, 123, 125. Id. ,r 104. These zoom values represent different maximum vertical-axis values. Id. Using the selected zoom values, processor 52 displays a different corresponding maximum vertical- axis value. Id. Although claim 1 also covers other embodiments, this disclosure nevertheless informs our understanding of one way to determine a mass value (e.g., 1 mg) of the maximum rate value (e.g., 1 mg/hr) as a percentage (e.g., 10%) of the mass value (e.g., 10 mg) indicated by the therapeutic- agent concentration (e.g., 10.0 mg/ml), which is the limitation at issue in claim 1. See, e.g., id. ,r,r 96, 100, 106. The Examiner finds that Alme' s system receives a therapeutic-agent concentration. Final Act. 7-8 (citing Alme ,r,r 97, 100, 101, Figs. 9-13). In particular, Alme's user enters a total dose of a drug in micrograms. 7 Appeal2018-000214 Application 13/913,324 Alme ,r 97. In the Examiner's view, a fluid containing a drug at a particular concentration is a drug per unit volume. Final Act. 7. Notably, Alme's interface only allows the user to enter the total dose in text box 202, not a concentration----e.g., a mass per unit volume. See Alme Fig. 9, cited in Final Act. 8. Part of Alme's Figure 9 is shown below . . ............. ~~i11:;t1~,,,,1~at~~ ....... Â·. l 2:{}Q-J {lv r;:~e tst<:, "" 1) , __ ioJ Aime's Figure 9 shows text boxes 202 and 203 for modifying the dosing program. Alme 1 98. So, at best, the Examiner has shown that the value received, as shown in text boxes 202 and 203, is implicitly based on some therapeutic-agent concentration. Final Act. 7-8. Nevertheless, the Examiner has not shown that Alme teaches or suggests the recited relationship between the maximum value and this received therapeutic-agent concentration. See id. Specifically, from the user input in Figure 9, Alme provides graph 220, which shows a pending dosing program. Alme ,r 99. Graph 220 is illustrated below in Alme's Figure 10. Id. 8 Appeal2018-000214 Application 13/913,324 ,,ts 40 Â·Â·Â·"Â·23:2 :M-0-40 Â·10------'Â·Â·-Â· -Â·-Â·Â·-Â·Â·----------------------~ 5 Aime's Fig. 10 shows a user interface with a therapy schedule based on user input received via the user interface of FIG. 9. Alme 199. The Examiner finds that, although Alme is silent on what the maximum value is for the vertical axis of graph 220 ( and similar graphs in Figures 11- 13 ), Figures 10-13 nonetheless show a maximum value without disclosing it as such. Ans. 69-70. Yet the limitation at issue does not simply call for using a maximum value of the underlying data, as the Examiner's reasoning suggests (see id.), but instead requires determining a maximum rate value of the vertical axis using percentages of the mass values of the concentration. Accordingly, we agree with Appellants that Chuang does not remedy the deficiency of Alme. App. Br. 16-17. Chuang teaches determining a maximum value data point that becomes the maximum value displayed on the vertical axis. See, e.g., Chuang ,r 58. Because Alme's data points are rates, applying Chuang's 9 Appeal2018-000214 Application 13/913,324 teaching to Alme merely would result in a maximum rate for the axis's maximum value. Reply Br. 5. The Examiner also has not shown that Drew, individually or in combination with Alme and Chuang, teaches or suggests the recited mass- value percentage. See App. Br. 13-17. Instead, Drew provides an interface similar to Alme' s. Compare Drew Fig. 19, with Alme Fig. 9. Like Alme, Drew teaches an input for the total desired daily dose in micrograms (text box40) and an average hourly rate (text box 42). See Drew Fig. 19. The Examiner finds that "Drew displays, on Figure 19, a ratio by displaying the maximum daily dosage, and displaying the hourly rate of the same." Ans. 70. In the Examiner's view, Drew's ratio, "as is well known, is another form of a percentage that expresses the total dosage by rate of distribution of that dosage." Id. Claim 1, however, requires a mass value that is the percent of another mass value. And Drew does not determine a mass value of the hourly dosage rate as a percent of a mass value of the total daily dose. Accord Reply Br. 6. Rather, Appellants point out, and we agree, Drew's total daily dose and the hourly dosage rate are merely proportional by a unit conversion. Id. On this record, we are persuaded that Drew does not cure the deficiencies of Alme and Chuang discussed above. Accordingly, we do not sustain the rejection of claim 1. For the same reasons, we also do not sustain the rejection of claims 3-5, 9, 10, 43, and 48, which depend from claim 1 and were rejected with the combination of Alme, Drew, and Chuang. Independent claims 11, 21, 31, and 3 5 also require determining a mass value of the maximum rate value as a percent of the mass value indicated by 10 Appeal2018-000214 Application 13/913,324 the received therapeutic-agent concentration. Thus, for the same reasons as for independent claim 1, we do not sustain the rejection of these claims or the corresponding dependent claims (13-15, 18-20, 23-25, 29-31, 34, and 44--47). THE REJECTION OVER ALME, CHUANG, DREW, AND YIV In the rejection of dependent claims 6, 7, 16, 17, 26, 27, 32, 33, 36, and 37, the Examiner did not rely on Yiv to teach the limitation missing from the combination of Alme, Chuang, and Drew. See Final Act. 56-68. Thus, Yiv does not cure the deficiency discussed in the previous section, and we do not sustain the rejections of dependent claims 6, 7, 16, 26, 27, 32, 33, 36, and 37 for the same reasons as for the corresponding independent claims. DECISION We reverse the Examiner's rejection of claims 1, 3-7, 9-11, 13-17, 19-21, 23-27, 29-37, and 43--48. REVERSED 11