ICU Medical, Inc.

Patent Trials and Appeals Board

Feb 11, 2022

2021000423 (P.T.A.B. Feb. 11, 2022)

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. 15/435,230 02/16/2017 John Arrizza ICUH.054C1 2754 20995 7590 02/11/2022 KNOBBE MARTENS OLSON & BEAR LLP 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 EXAMINER ST LEGER, GEOFFREY R ART UNIT PAPER NUMBER 2192 NOTIFICATION DATE DELIVERY MODE 02/11/2022 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): efiling@knobbe.com jayna.cartee@knobbe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JOHN ARRIZZA, JAMES R. SHULTS, THOMAS J. VACCARO, PATRICK A. WARD ____________________ Appeal 2021-000423 Application 15/435,230 Technology Center 2100 ____________________ Before ERIC S. FRAHM, BETH Z. SHAW, and MATTHEW J. McNEILL, Administrative Patent Judges. FRAHM, Administrative Patent Judge. DECISION ON APPEAL Appeal 2021-000423 Application 15/435,230 2 STATEMENT OF THE CASE1 Appellant2 appeals under 35 U.S.C. § 134 from a final rejection of claims 24-27, 29-35, and 37, which constitute all claims pending in this appeal. Claims 1-23, 28, and 36 have been canceled (see Appeal Br. 14, 15, 17). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. DISCLOSED AND CLAIMED INVENTION According to Appellant, the disclosed invention, entitled “Medical Device Update System” (see Title), “relates in general to medical devices” and more particularly, “to a novel system and method for updating software and configuration files in medical devices, such as infusion pumps” (Spec. ¶ 1). Claims 24 (a system) and 31 (an electronic method) are independent, and each pertain to updating software including a drug library for an infusion pump system. Claim 24, reproduced below, is illustrative of the claimed subject matter: 24. A system for updating software including a drug library of an infusion pump system, the system comprising: a first memory location configured to store a first drug library; a network communication interface configured to communicate with a server; 1 Throughout this Decision we refer to the Specification filed February 16, 2017 (“Spec.”); Appeal Brief filed May 15, 2020 (“Appeal Br.”); Reply Brief filed October 21, 2020 (Reply Br.); Final Office Action mailed August 15, 2019 (“Final Act.”); Advisory Action mailed January 8, 2020; and the Examiner’s Answer mailed August 21, 2020 (“Ans.”). 2 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42 (2018). “The word ‘applicant’ when used in this title refers to the inventor or all of the joint inventors, or to the person applying for a patent as provided in §§ 1.43, 1.45, or 1.46.” 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as ICU Medical, Inc. (Appeal Br. 3). Appeal 2021-000423 Application 15/435,230 3 a display configured to display a plurality of user interfaces; and a controller configured to: receive an update message from the server, said update message including a location of update data on the server; download, from the server, update data including a second drug library using a network operating system level interface after receipt of the update message, wherein the infusion pump system instead of the server is responsible for downloading the update data; store the downloaded update data including the second drug library locally in a communication subsystem memory; process a first command from a user to turn off an infusion pump; generate a first user interface in response to the first command, the first user interface comprising a first input corresponding to installation of the second drug library received from the server; determine that the first input indicates that a user has selected to proceed with the installation of the second drug library; and in response to the determination that the first input indicates that the user has selected to proceed with the installation of the second drug library: access the second drug library from the communication subsystem memory; install the second drug library in a second memory location based on the determination of the first input, the second memory location different than the first memory location, thereby maintaining both the first drug library and the second drug library; determine that the second drug library was successfully installed; set the second drug library as a current drug library based on the determination of successful installation of the second drug library; and Appeal 2021-000423 Application 15/435,230 4 erase the first drug library from the first memory location. Appeal Br. 14, Claims Appendix (emphasis added). EXAMINER’S REJECTION and APPELLANT’S CONTENTIONS Examiner’s Rejection The Examiner made the following rejection: Claims 24-27, 29-35, and 37 stand rejected under 35 U.S.C. § 103 as being unpatentable over Medfusion Syringe Infusion Pump Model 4000 Operator’s Manual, Software Version V1.1, pp. i-iv, 1-49 (September 2011)3 (hereinafter, “Medfusion”), Ju et al. (US 2011/0138185 A1; published June 9, 2011) (hereinafter, “Ju”), and Holland et al. (US 2005/0278194 A1; published Dec. 15, 2005) (hereinafter, “Holland”). Final Act. 3-10; Advisory Act. 2; Ans. 3-11. Appellant’s Principal Contentions With regard to claims 24 and 31, Appellant primarily contends: (1) Claim 24 recites a pull system, where the infusion pump (i.e., client), instead of the server, is responsible for downloading the update data (see Appeal Br. 8), and the Examiner has improperly interpreted the claim term “download” (see Reply Br. 2-3); and (2) Holland, and thus the combination, fails to teach or suggest a communication subsystem memory for storing downloaded update data, as recited in claims 24 and 31 (see Appeal Br. 9-11), because the Examiner has improperly interpreted the claim term “communication subsystem memory” (see Reply Br. 3-4). 3 See Notice of References Cited, Form PTO-892 mailed January 2, 2018. Appeal 2021-000423 Application 15/435,230 5 ISSUE Based on Appellant’s arguments, and the commensurate scope of independent claims 24 and 31, we select (i) claim 24 as representative of claims 24-27, 29-35, and 37, which are all rejected over the combination of Medfusion, Ju, and Holland. See 37 C.F.R. § 41.37(c)(1)(iv). Based on Appellant’s arguments in the Appeal Brief (see Appeal Br. 7-13) and the Reply Brief (see Reply Br. 2-4), the following principal issue is presented on appeal: Has Appellant shown the Examiner erred in rejecting claims 24-27, 29-35, and 37 under 35 U.S.C. § 103 because the collective teachings and suggestions of Medfusion, Ju, and Holland, taken with the knowledge of a person having ordinary skill in the art, do not support the conclusion of obviousness as to the subject matter of representative claim 24? ANALYSIS We have reviewed the Examiner’s rejections (Final Act. 3-10; Ans. 3-11) in light of Appellant’s arguments (Appeal Br. 7-13; Reply Br. 2-4) that the Examiner has erred, as well as the Examiner’s Advisory Action and response to Appellant’s arguments in the Appeal Brief (Ans. 11-19). With regard to independent claim 24, we agree with and adopt as our own the Examiner’s findings of facts and conclusions as set forth in the Final Action (Final Act. 3-10; Ans. 10-11); Advisory Action (Advisory Act. 2); and Answer (Ans. 11-19). On the record before us, Appellant has not shown that the Examiner erred in combining Medfusion, Ju, and Holland to teach or Appeal 2021-000423 Application 15/435,230 6 suggest the disputed limitations. We provide the following explanation for emphasis. With regard to claims 24 and 31, we agree with the Examiner (see Final Act. 3-7; Ans. 3-8) that (i) Medfusion teaches a system and electronic method for updating software including a drug library of an infusion pump that downloads data from a server; and (ii) Holland teaches a local communication subsystem memory. We also agree with the Examiner that Cohen et al. (US 2004/0139004 A1; published July 15, 2004) (hereinafter, “Cohen”) is evidence that it was known at the time of Appellant’s invention that data can be downloaded from a server to a client device upon the request of the client device (see Advisory Act. 2).4 Appellant’s contention that Cohen teaches away from the claimed invention (see Appeal Br. 9) is unpersuasive inasmuch as Cohen is not an applied reference in the rejection, but simply serves as extrinsic evidence supporting the Examiner’s interpretation of the term “download” and the function of downloading in a computing system environment. Appellant’s argument that claim 24 recites a pull system, where the infusion pump (i.e., client), instead of the server (e.g., a push system), is responsible for downloading the update data (see Appeal Br. 8), is not persuasive of Examiner error because such argument is not responsive to the Examiner’s rejection and is not commensurate in scope to the language of claim 24, which only requires downloading update data from a server where 4 Art can legitimately serve to document the knowledge that skilled artisans would bring to bear in reading the prior art identified as producing obviousness. Randall Mfg. v. Rea, 733 F.3d 1355, 1362-63 (Fed. Cir. 2013). Appeal 2021-000423 Application 15/435,230 7 the infusion pump system is responsible for the operation. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) (limitations not appearing in the claims cannot be relied upon for patentability). The Examiner has established that Medfusion downloads data from a server, and that the download operation is initiated or requested by the client device or infusion pump system, and not the server. Appellant’s contention that Holland fails to teach or suggest a communication subsystem memory for storing downloaded update data, as recited in claims 24 and 31 (see Appeal Br. 9-11), because the Examiner has improperly interpreted the claim term “communication subsystem memory” (see Reply Br. 3-4), are unpersuasive. Claim 24 recites a system having a memory location, a network communication interface, a display, a controller, and a communication subsystem memory used for local storage (presumably, in the infusion pump system), but is silent as to any communication subsystem or communication system. In light of the fact that claim 24 fails to divulge any “subsystem,” the Examiner has not unreasonably determined that Holland’s local cache memory 126A in Figure 4A teaches or suggests the communication subsystem memory set forth in claim 24 (see Final Act. 6; Ans. 7, 14-16). In view of the foregoing, Appellant has not sufficiently shown the Examiner erred in rejecting claims 24 and 31 for obviousness, and Appellant’s contentions that the combination fails to disclose or suggest the disputed limitations of claims 24 and 31 are not persuasive. Accordingly, we sustain the Examiner’s obviousness rejections of representative claim 24, as well as claims 25-27, 29-35, and 37 grouped therewith. Appeal 2021-000423 Application 15/435,230 8 CONCLUSION For the foregoing reasons, Appellant has not demonstrated any error in the rejection of independent claims 24 and 31. Accordingly, the Examiner’s obviousness rejection of claims 24-27, 29-35, and 37 over the combination of Medfusion, Ju, and Holland is sustained. In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 24-27, 29-35, 37 103 Medfusion, Ju, Holland 24-27, 29- 35, 37 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). See 37 C.F.R. §§ 41.50(f), 41.52(b). AFFIRMED