2019006820 (P.T.A.B. Mar. 15, 2021)

GAMBRO LUNDIA AB

Patent Trials and Appeals BoardMar 15, 2021

2019006820 (P.T.A.B. Mar. 15, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/652,228 06/15/2015 John O'MAHONY 0405.000043US01 (PN1714) 6782 26813 7590 03/15/2021 MUETING RAASCH GROUP 111 WASHINGTON AVE. S., SUITE 700 MINNEAPOLIS, MN 55401 EXAMINER NGUYEN, NHAT HUY T ART UNIT PAPER NUMBER 2142 NOTIFICATION DATE DELIVERY MODE 03/15/2021 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): ptodocketing@mrgs.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte JOHN O’MAHONY and ANDREW WENGER ____________ Appeal 2019-006820 Application 14/652,228 Technology Center 2100 ____________ Before ELENI MANTIS MERCADER, NORMAN H. BEAMER, and GARTH D. BAER, Administrative Patent Judges. MANTIS MERCADER, Administrative Patent Judge. DECISION ON APPEAL Appeal 2019-006820 Application 14/652,228 2 STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s Final Rejection of claims 1–34, which constitute all the claims pending in this application. We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part and enter NEW GROUNDS OF REJECTION within the provisions of 37 C.F.R. § 41.50(b). THE INVENTION Appellant’s claimed invention is directed to “[e]xtracorporeal blood treatment systems and methods to use and modify/create treatment profiles for extracorporeal blood treatments” (Abstract). Independent claim 1, reproduced below, is representative of the subject matter on appeal: 1. An extracorporeal blood treatment system comprising: an extracorporeal blood control apparatus to perform an extracorporeal blood treatment, the extracorporeal blood control apparatus comprising one or more pumps; a display apparatus comprising a graphical user interface, wherein the graphical user interface is configured to depict a profile identifier region, a therapy type region, and a therapy set region; an input apparatus configured to allow a user to select a profile using the profile identifier region of the graphical user interface, wherein the profile comprises preset settings for an extracorporeal blood treatment; and 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Gambro Lundia AB as the real party in interest (Appeal Br. 2). Appeal 2019-006820 Application 14/652,228 3 a computing apparatus operatively coupled to the display apparatus and the input apparatus, wherein the computing apparatus is configured to: store a plurality of profiles, wherein each profile of the plurality of profiles comprises a preset therapy type of a plurality of different therapy types and a preset therapy set of a plurality of different therapy sets, each therapy set representing a replacement unit for use in performing a different therapy, wherein the replacement unit comprises at least one of a filtration unit and a flow tubing line and forms at least one flow circuit in operative association with the one or more pumps of the extracorporeal blood control apparatus, allow a user to use the input apparatus to select a profile of the plurality of profiles using a profile identifier region of a graphical user interface to configure the extracorporeal blood treatment system to perform the extracorporeal blood treatment according to the selected profile, and display on the graphical user interface the preset therapy type of the selected profile in a therapy type region and the preset therapy set of the selected profile in a therapy set region Appeal Br. 40 (Claims Appendix 1). REFERENCES The prior art relied upon by the Examiner in rejecting the claims on appeal is the following: Name Reference Date Manica US 5,679,245 Oct. 21, 1997 Sun US 2002/0022973 A1 Feb. 21, 2002 Setzer US 2008/0072896 A1 Mar. 27, 2008 Peters US 2010/0121246 A1 May 13, 2010 McTaggart US 2011/0238032 A1 Sept. 29, 2011 Scarpaci US 2013/0165847 A1 June 27, 2013 Appeal 2019-006820 Application 14/652,228 4 Smith US 9,241,958 B2 Jan. 26, 2016 Stewart US 9,690,909 B2 June 27, 2017 REJECTIONS The Examiner made the following rejections: Claims 1–4, 7, 8, 11–13, 15, 19, and 32–34 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, and Peters. Final Act. 4. Claims 5 and 6 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, Peters, and Sun. Final Act. 19. Claims 9 and 14 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, Peters, and McTaggart. Final Act. 21. Claim 10 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, Peters, and Smith. Final Act. 22. Claims 16–18, 20, 22–26, and 28–30 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, Peters, and Setzer. Final Act. 23. Claim 21 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, Peters, Setzer, McTaggart, and Smith. Final Act. 37. Claim 27 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, Peters, Setzer, and McTaggart. Final Act. 38. Claim 31 stands rejected under 35 U.S.C. § 103(a) as being unpatentable over Manica, Stewart, Peters, Setzer, and Scarpaci. Final Act. 39. Appeal 2019-006820 Application 14/652,228 5 ISSUES The issues are whether the Examiner erred in finding that the combination of Manica, Stewart, and Peters teaches or suggests the limitation of: 1. store a plurality of profiles, wherein each profile of the plurality of profiles comprises a preset therapy type of a plurality of different therapy types and a preset therapy set of a plurality of different therapy sets, each therapy set representing a replacement unit for use in performing a different therapy, wherein the replacement unit comprises at least one of a filtration unit and a flow tubing line and forms at least one flow circuit in operative association with the one or more pumps of the extracorporeal blood control apparatus, as recited in independent claim 1, and similarly recited in independent claims 16, 18, 19, 32, and 33; and 2. allowing a user to use the input apparatus to adjust the at least one preset alarm value of the at least one alarm limit of the plurality of alarm limits of the selected profile using the alarm region of the graphical user interface, as recited in dependent claim 13, and similarly recited in dependent claim 26. ANALYSIS We adopt the Examiner’s findings in the Answer and Final Office Action, and we add the following primarily for emphasis. We note that if Appellant failed to present arguments on a particular rejection, we will not unilaterally review those uncontested aspects of the rejection. See Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential); Hyatt v. Dudas, 551 F.3d 1307, 1313–14 (Fed. Cir. 2008) (The Board may treat arguments Appellant failed to make for a given ground of rejection as waived.). Appeal 2019-006820 Application 14/652,228 6 Claim 1 Appellant argues that the cited portions of Peters appear to be focused on changing flow rates and a setup of screen covering various setup tasks without any discussion of a profile that includes a preset therapy set representing a replacement unit comprising at least one of a filtration unit and a flow tubing line (Appeal Br. 24, citing Peters ¶¶ 52, 54, 57, Figs. 14A–B). Appellant contends that while “Peters does mention the term ‘tubing’” (Appeal Br. 25, citing Peters ¶ 54), “the term ‘tubing’ is described with reference to operator instructions provided by the control software” and “does not relate to a potentially-equivalent profile comprising a preset therapy set representing a replacement unit comprising at least one of a filtration unit and a flow tubing line” (Appeal Br. 25). We do not agree with Appellant’s argument. The test for obviousness is not whether the claimed invention is expressly suggested in any one or all of the references, but whether the claimed subject matter would have been obvious to those of ordinary skill in the art in light of the combined teachings of those references. See In re Keller, 642 F.2d 413, 425 (CCPA 1981). Nonobviousness cannot be established by attacking the references individually when the rejection is predicated upon a combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The Examiner finds, and we agree, that Manica teaches the claimed “preset therapy set,” in which [the] user selects a patient profile for whom treatment information is stored. Treatment information includes previously stored treatment Manica suggests plurality of therapy types such as SCUE [and] CVVH . . . [.] Manica also Appeal 2019-006820 Application 14/652,228 7 suggests different parameters such as types and rates of fluid can be changed or modified. Types and rates are used in different therapy as well (Final Act. 5, emphasis omitted, citing Manica 13:25–32, Fig. 4 step 204, 13:67, 13:50–55). The Examiner further finds, and we agree, that Peters teaches the claimed “wherein the replacement unit comprises at least one of a filtration unit and a flow tubing line and forms at least one flow circuit in operative association with the one or more pumps of the extracorporeal blood control apparatus,” because Peter’s “replacement unit includes flow rates for [the] filtration unit and one or more pumps” (Final Act. 6, emphasis omitted, citing Peters ¶ 52 line 6–9, Figs. 14A–B, ¶ 54). In other words, the combination of Peter’s replacement unit (having flow rates for the filtration unit and pumps) with Manica’s profiles (having preset therapy sets), along with Stewart’s profile storage, teaches or suggests the claimed limitation. With respect to Peter’s use of the term “tubing,” one skilled in the art would understand that “adjusting the replacement fluid flow rate to a suitable therapeutic level” via “apparatus manipulations” such as “replacement fluid bag and tubing installment and connections” (Peters ¶ 54), is a vital parameter that varies by therapy. See, for example, Peters ¶ 54, Manica 14:51–15:46 (describing operation of primary circuit 38 and associated pumps for various treatment protocols). Claims 13 and 26 Regarding dependent claim 13, Appellant argues that [the] cited portions of Stewart . . . fail to describe displaying at least one preset alarm value and allowing a user to use the input apparatus to adjust the at least one preset alarm value as would be required for a prima facie case of obviousness of dependent Appeal 2019-006820 Application 14/652,228 8 claim 13. Instead, column 17, lines 64-67 and Figure 7 of Stewart appears to be directed at the display of an alarm-not adjustment of an alarm value (Appeal Br. 26, emphasis omitted). Appellant contends that the Examiner’s logic, i.e., user can adjust parameters to comply with the hard alarm, does not remedy the deficiency in Stewart because, for example, any parameter that is adjusted to comply with the hard alarm cannot be reasonably equated to a preset alarm value as recited in dependent claim 13 (Appeal Br. 26). We agree with Appellant’s argument. The Examiner finds, and we agree, that Stewart teaches a “hard alarm” and “[u]ser[s] can adjust parameters to comply with the hard alarm” (Ans. 44, citing Stewart 17:64– 67, Fig. 7). However, “adjust[ing] parameters to comply with the hard alarm” is not the same as the claimed “adjust[ing] the at least one preset alarm value of the at least one alarm limit,” because in Stewart’s system alarm values are not changed, but instead satisfy “pre-programmed acceptable ranges” (Stewart 18:5–6) and do not appear to be one of the “program parameters” that can be modified (Stewart 17:51–53; see also Fig. 1 step 69). Regarding dependent claim 26, this claim is commensurate in scope to dependent claim 13, but the rejection of dependent claim 26 relies on Manica, Stewart, Peters, and Setzer. The Examiner’s findings regarding dependent claim 26 are identical to the findings regarding dependent claim 13. See Final Act. 35. Similarly, Appellant’s argument regarding dependent claim 26 is identical to the argument made regarding dependent claim 13. Likewise, our analysis above regarding dependent claim 13 applies to Appeal 2019-006820 Application 14/652,228 9 dependent claim 26, as the combination of Manica, Stewart, and Peters teaches or suggests the subject matter of dependent claim 26. Accordingly, we are constrained by the record to reverse the Examiner’s rejection of dependent claim 13, as well as dependent claim 26. NEW GROUNDS OF REJECTION Pursuant to our authority under 37 C.F.R. § 41.50(b), we enter new grounds of rejection and separately reject dependent claims 13 and 26 under pre-AIA 35 U.S.C. § 103(a) as obvious over the combination of Manica, Stewart, and Peters. We incorporate the Examiner’s rejection of dependent claim 13 for Stewart’s disclosure of all elements of the claim except as to the limitation allowing a user to use the input apparatus to adjust the at least one preset alarm value of the at least one alarm limit of the plurality of alarm limits of the selected profile using the alarm region of the graphical user interface. Similarly, we incorporate the Examiner’s rejection of dependent claim 26 for Stewart’s disclosure of all elements of the claim except as to the limitation allowing a user to use the input apparatus to adjust at least one preset alarm value of the plurality of alarm limits of the new profile using the alarm region of the graphical user interface. Regarding the limitation of dependent claim 13 shown above, we find that in addition to Manica’s preset values, which include “blood flow rate [and] pressures levels to be maintained in the primary and secondary circuits 38 and 74” (Manica 13:52–54), Manica’s alarm settings includes a “custom mode” in which “the operator can set a return blood pressure maximum Appeal 2019-006820 Application 14/652,228 10 above which an alarm condition is detected and an access pressure minimum below which an alarm condition is detected, while at the adjust flow step 226 shown in FIG. 4” (Manica 18:63–67). We further find that Manica thereafter teaches that [i]f the monitor processor 140 detects that the access pressure measured by the first pressure sensor 54 falls below the minimum pressure previously set and stored in control and monitor memories 123 and 142 or that the return pressure measured by the third pressure sensor 54 rises above the maximum pressure previously set and stored in memory, signals are sent to the control processor 122 via the dual ported memory 110 so that the control processor can send appropriate signals to cause the apparatus 30 to enter the safe state. The operator is notified of the situation via the display 114 and via an audible alarm (Manica 18:67–19:10, emphasis added). Thus, Manica’s custom mode allows for an adjustment of preset alarm values. It would have been obvious for one skilled in the art to have combined Manica’s adjustment of preset alarm values with Stewart’s and Peters’ user interface, in order to minimize human errors associated with modification of parameter data, as Stewart’s user interface would provide useful warnings as “soft” alarms. See Stewart, 18:7–23, Fig. 6. The same reasoning is applied in the rejection of dependent claim 26. We note the Patent Trial and Appeal Board is a review body, rather than a place of initial examination. We have rejected dependent claims 13 and 26 based on our authority under 37 C.F.R. § 41.50(b). We leave it to the Examiner to ascertain whether other claims should be rejected on similar grounds to those set forth herein or in combination with additional prior art. Appeal 2019-006820 Application 14/652,228 11 CONCLUSION The Examiner did not err in finding that the combination of Manica, Stewart, and Peters teaches or suggests the limitation of: store a plurality of profiles, wherein each profile of the plurality of profiles comprises a preset therapy type of a plurality of different therapy types and a preset therapy set of a plurality of different therapy sets, each therapy set representing a replacement unit for use in performing a different therapy, wherein the replacement unit comprises at least one of a filtration unit and a flow tubing line and forms at least one flow circuit in operative association with the one or more pumps of the extracorporeal blood control apparatus, as recited in independent claim 1, and similarly recited in independent claims 16, 18, 19, 32, and 33. The Examiner erred in finding that the combination of Manica, Stewart, and Peters teaches or suggests the limitation of allowing a user to use the input apparatus to adjust the at least one preset alarm value of the at least one alarm limit of the plurality of alarm limits of the selected profile using the alarm region of the graphical user interface, as recited in dependent claim 13, and similarly recited in dependent claim 26. Appeal 2019-006820 Application 14/652,228 12 DECISION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Ba sis Affirmed Reversed New Ground 1–4, 7, 8, 11–13, 15, 19, 32–34 103(a) Manica, Stewart, Peters 1–4, 7, 8, 11, 12, 15, 19, 32–34 13 13 5, 6 103(a) Manica, Stewart, Peters, Sun 5, 6 9, 14 103(a) Manica, Stewart, Peters, McTaggart 9, 14 10 103(a) Manica, Stewart, Peters, Smith 10 16–18, 20, 22– 26, 28–30 103(a) Manica, Stewart, Peters, Setzer 16–18, 20, 22– 25, 28–30 26 26 21 103(a) Manica, Stewart, Peters, Setzer, McTaggart, Smith 21 27 103(a) Manica, Stewart, Peters, Setzer, McTaggart 27 31 103(a) Manica, Stewart, Peters, Setzer, Scarpaci 31 Overall Outcome 1–12, 14– 25, 27–34 13, 26 13, 26 TIME PERIOD FOR RESPONSE 37 C.F.R. § 41.50(b) provides a “new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” Appeal 2019-006820 Application 14/652,228 13 37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new Evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner . . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same Record . . . . No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). See 37 C.F.R. § 41.50(f). AFFIRMED IN PART; 37 C.F.R. § 41.50(b)