ICU Medical, Inc.

Patent Trials and Appeals Board

Jan 31, 2022

2021001464 (P.T.A.B. Jan. 31, 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. 15/164,251 05/25/2016 James D. Jacobson ICUH.081A 2080 20995 7590 01/31/2022 KNOBBE MARTENS OLSON & BEAR LLP 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 EXAMINER TRINH, HONG-VAN N ART UNIT PAPER NUMBER 3783 NOTIFICATION DATE DELIVERY MODE 01/31/2022 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 JAMES D. JACOBSON and ANATOLY S. BELKIN Appeal 2021-001464 Application 15/164,251 Technology Center 3700 Before JILL D. HILL, JEREMY M. PLENZLER, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 7-11.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies ICU Medical, Inc. as the real party in interest. Appeal Br. 2. 2 Claims 1-6 and 12-20 have been cancelled. Appeal Br. 6-7 (Claims App.). Appeal 2021-001464 Application 15/164,251 2 CLAIMED SUBJECT MATTER Appellant’s disclosure is directed to an infusion pump that is able to obtain drug libraries from different types of drug library editors (“DLEs”), e.g., from both “dedicated” DLEs and “enterprise” DLEs. See Spec. 1:14- 2:25. Appellant explains that, in systems used prior to Appellant’s invention, “one infusion pump can receive a drug library from an enterprise drug library editor, but not a dedicated drug library editor. Similarly, a different kind of infusion pump can receive a drug library from a dedicated drug library editor, but not an enterprise drug library editor.” Appeal Br. 2 (quoting Spec. 2:14-17). Method claim 7, reproduced below, is illustrative of the claimed subject matter. 1. A method of configuring one or more infusion pumps comprising: preparing a first drug library on a first drug library editor; preparing a second drug library on a second drug library editor; receiving a download message including an indicator, said indicator indicating a selection of an operational drug library; loading the first drug library or the second drug library into the infusion pump as the operational drug library based on the indicator in the download message; and delivering an infusion from the infusion pump in accordance with the operational drug library; wherein the first drug library editor is one of a dedicated drug library editor and an enterprise drug library editor, and the second drug library editor is the other of the one of the dedicated drug library editor and the enterprise drug library editor. Appeal Br. 6 (Claims App.). Appeal 2021-001464 Application 15/164,251 3 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Ford US 5,681,285 Oct. 28, 1997 Holland US 2005/0144043 A1 June 30, 2005 REJECTION Claims 7-11 are rejected under 35 U.S.C. § 103 as unpatentable over Holland and Ford. OPINION (Holland and Ford) Claim 7 requires that “the first drug library editor is one of a dedicated drug library editor and an enterprise drug library editor, and the second drug library editor is the other of the one of the dedicated drug library editor and the enterprise drug library editor.” Appeal Br. 6 (Claims App.) (emphasis added). Appellant’s Specification defines “dedicated” and “enterprise” drug library editors as follows. The dedicated drug library editor 120 as defined herein is a standalone drug library editor that is not networked to other information systems within a healthcare system. The dedicated drug library editor is operably connectable to and provides a drug library for a single type of infusion pump, typically a limited set of local infusion pumps such as one to fifteen infusion pumps in a single geographic location. The dedicated drug library editor is also limited in the functions it performs and typically only handles the creation, editing and downloading of a drug library to the pump. The enterprise drug library editor as defined herein is a drug library editor operably connectable to and providing drug libraries for a number of different types of infusion pumps, Appeal 2021-001464 Application 15/164,251 4 for example a multitude (more than fifteen) geographically dispersed pumps of various types (PCA, syringe, large volume parenteral, etc.). Spec. 5:15-25 (bolding omitted, emphasis added). The Examiner finds that Holland discloses many of the elements recited in claim 7, including the step of preparing a first drug library on a first drug library editor, wherein the first drug library editor is one of a dedicated drug library editor and an enterprise drug library editor. Final Act. 3. Based on bolding provided in the Examiner’s explanation, it is apparent that the Examiner finds Holland discloses the use of an enterprise drug library editor. See id. (citing Holland ¶ 148). The Examiner finds “Holland is silent regarding preparing a second drug library on a second drug library editor: wherein the second drug library editor is the other of the one of the dedicated drug library editor and the enterprise drug library editor.” Final Act. 3 (emphasis omitted). To address this deficiency in Holland’s teachings, the Examiner finds Ford discloses “a method of configuring one or more infusion pumps comprising: preparing a drug library (96, Ford) on a drug library editor (94, Ford) loading the drug library into the infusion pump as an operational drug [library].” Id. (citing Ford 16:26-30, Fig. 19a) (emphasis omitted). Based on bolding provided in the Examiner’s explanation, it is apparent that the Examiner finds Ford discloses the use of a dedicated drug library editor. See id. The Examiner reasons: It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method Holland to incorporate the teachings of Ford to incorporate preparing a second drug library on a second drug library editor: where the second drug library editor Appeal 2021-001464 Application 15/164,251 5 is the other of the one of the dedicated drug library editor and the enterprise drug library editor in order to load a customized drug library into a pump from an external computer source via a direct connection (Cols 10-11, lines 64-15, Ford) and it would also be beneficial if the network were down. Id. at 3-4 (emphasis omitted). Appellant first argues “Holland fails to teach or suggest any capability of an infusion pump being able to obtain drug libraries from different types of drug library editors, specifically enterprise and dedicated.” Appeal Br. 4. Similarly, Appellant states, “[w]hile Ford teaches an ability to create a customized drug library using a particular drug library editor, it also does not teach or suggest any capability of an infusion pump being able to obtain drug libraries from different types of drug library editors, specifically enterprise and dedicated.” Id. (emphasis added). Thus, Appellant contends Holland and Ford each teach only a single drug library editor. In a related argument, Appellant contends that “even if combinable, the improper combination of Ford/Holland still results in one particular drug library editor and an infusion pump capable of loading drug library created by only that particular drug library editor.” Id. In response, the Examiner explains that the proposed modification adds the drug library and drug library editor of Ford to the system of Holland, resulting in a system (and method) that uses first and second drug library editors as claimed. See Ans. 4. The Examiner has the better position on this point because the Final Office Action explicitly acknowledges that Holland fails to disclose two different types of drug library editors, and the proposed modification is made to address this deficiency. Final Act. 3-4 (“It would have been Appeal 2021-001464 Application 15/164,251 6 obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method Holland to incorporate the teachings of Ford to incorporate preparing a second drug library on a second drug library editor.”). Emphasis omitted. Appellant next asserts “[t]his is not a case of mere substitution. There are no teachings in either of these references that even suggest an infusion pump capable of operating two different drug libraries.” Appeal Br. 5. This argument is unavailing because it is merely a generic denial that the two cited references suggest the claimed invention. Appellant’s argument does not address the Examiner’s stated reasoning for making the proposed modification. Final Act. 4 (“it would also be beneficial if the network were down.”). Given that Appellant’s stated definition of a dedicated drug library editor includes the limitation that the editor not be networked to other information systems, i.e., it does not need a network connection (see Spec. 5:15-25), Appellant has not identified error in the Examiner’s reasoning. Appellant also argues “[Holland] and Ford fail to mention ‘enterprise’ or ‘dedicated’ in their respective disclosures. The Final Office Action fails to give any weight to these limitations and has not given any particular reason for ignoring the specific limitations.” Appeal Br. 5. In response, the Examiner refers to the description Appellant sets forth on page 1 of the Specification regarding dedicated and enterprise library editors and finds that paragraph 149 of Holland discloses a library editor meeting the definition of an enterprise drug library editor. Ans. 5. Based on the same disclosure in Appellant’s Specification, the Examiner Appeal 2021-001464 Application 15/164,251 7 finds Ford discloses a dedicated drug library editor. Id. (citing Ford 10:64- 11:4). The Examiner has the better position. Paragraph 149 of Holland describes the ability of a user to select one or more medical devices, such as infusers or pumps, and then launch or initiate drug library downloads via a network. The cited portion of Ford describes a pump connected to a PC via a cable, and the following paragraph in Ford describes storage of the drug library on a disk. See Ford 11:16-38. Ford states, “[o]nce the customized drug library has been constructed, computer interface 94 enables the user to download the customized drug library and supplementary configuration data into one or more drug infusion pumps 98 that are to be used in a particular medical facility for which the customized library was designed.” Id. 11:33- 38 (emphasis omitted). Thus, the Examiner has set forth a prima facie case that Holland and Ford disclose the above-noted limitations. Although Appellant’s Reply Brief states, “Applicant disagrees with all the assertions in the Examiner’s Answer” (Reply Br. 2), Appellant does not specifically address the Examiner’s findings regarding either Holland or Ford. Rather, Appellant’s argument appears to rest on the fact that Holland and Ford do not use the specific terms “dedicated drug library editor” and “enterprise drug library editor.” In re Neugebauer, 330 F. 2d 353, 356 n. 4 (CCPA 1964) (“In the construction of words, not the mere words, but the thing and the meaning, are to be inquired after.”). Appellant argues “[c]laim 7 recites the ‘indicator indicating a selection of an operational drug library.’ Since Holland fails to teach or suggest an infusion pump that is capable of operating with multiple drug Appeal 2021-001464 Application 15/164,251 8 libraries, Holland does not require a ‘selection’ between two libraries.” Appeal Br. 5. The Examiner replies that paragraph 149 of Holland discloses such an indicator. Ans. 6. Holland states, “[a]n alert or notice, in visual or audible form, that a drug library update has been received may be communicated to the infuser user interface.” Holland ¶ 149 (emphasis omitted). Holland further states, “[a] triggering event at step 342, including but not limited to the consent of a caregiver 114, causes the new drug library to be pulled from the cache memory 126A, which is associated with the interface 122 and pump 14, in step 344.” Id. (emphasis omitted). Holland discloses that the new drug library replaces the existing active drug library in the infuser when a triggering event (such as consent of the caregiver) occurs, and the infuser also reports which active drug library it is using. Id. Thus, contrary to Appellant’s argument, Holland discloses an infusion pump that is capable of operating with multiple drug libraries, and Holland does allow for a “selection” between two (old and new) libraries. Thus, the Examiner’s finding on this point is supported by a preponderance of the evidence. Further, as explained by the Examiner, the modified version of Holland’s system would continue to allow library selection, even after including the second drug library prepared on a second drug library editor as disclosed by Ford. See Ans. 6. In the Reply Brief, for the first time, Appellant argues that the Examiner’s proposed modification to the method disclosed by Holland “would change the principle of operation of Holland’s pump which is capable of using only one library.” Reply Br. 3. According to Appellant, Appeal 2021-001464 Application 15/164,251 9 “[a] different library (from Ford) cannot be added to Holland’s pump without changing the principle of operating the pump.” Id. Appellant’s argument does not apprise us of Examiner error. Appellant’s argument implies that the principle of operation of Holland’s method is to use only one drug library. Appellant’s argument directly contradicts the disclosure in paragraph 149 of Holland in which a new drug library is downloaded once consent of a user is given. Further, assuming for the purpose of argument that Holland’s method used only a single library, Appellant provides no explanation as to why this sole detail (the use of only one library) within the multi-step operation disclosed by Holland would amount to Holland’s “principle of operation.” We sustain the Examiner’s rejection of claim 7. Appellant does not make arguments for the patentability of claims 8- 11 aside from those discussed above regarding claim 7. See Appeal Br. 3-6. Accordingly, for the same reasons, we sustain the rejection of claims 8-11. CONCLUSION The Examiner’s rejections are affirmed. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § References/Basis Affirmed Reversed 7-11 103 Holland, Ford 7-11 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED