Roche Diagnostics Operations, Inc.Download PDFPatent Trials and Appeals BoardMay 3, 20212020003389 (P.T.A.B. May. 3, 2021) Copy Citation 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. 14/172,043 02/04/2014 Eric S. Carlsgaard 31575 US1 (15878A-125) 4873 98067 7590 05/03/2021 Harness Dickey (Roche) 5445 Corporate Drive, Suite 200 Troy, MI 48098-2683 EXAMINER FRITCHMAN, REBECCA M ART UNIT PAPER NUMBER 1797 NOTIFICATION DATE DELIVERY MODE 05/03/2021 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): pair_roche@firsttofile.com troymailroom@hdp.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte ERIC S. CALSGAARD, DAVID B. MARKISOHN, and MARK MEARS ____________ Appeal 2020-003389 Application 14/172,043 Technology Center 1700 ____________ Before JEFFREY T. SMITH, JENNIFER R. GUPTA, and JANE E. INGLESE, Administrative Patent Judges. INGLESE, Administrative Patent Judge. DECISION ON APPEAL Appellant1 requests review under 35 U.S.C. § 134(a) of the Examiner’s final rejection of claims 1–7 and 10–13.2 We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 “Appellant” refers to the “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies Roche Diabetes Care, Inc. as the real party in interest. Appeal Brief filed December 3, 2019 (“Appeal Br.”), 3. 2 Final Office Action entered June 19, 2019 (“Final Act.”), 1. Appeal 2020-003389 Application 14/172,043 2 CLAIMED SUBJECT MATTER Appellant claims a diabetes management system. Appeal Br. 7–8. Claim 1 illustrates the subject matter on appeal, and reads as follows: 1. A diabetes management system comprising: a handheld medical device that includes: a port configured to receive a test strip having a reaction site for receiving a sample of fluid from a patient; a blood glucose (bG) meter, cooperatively operable with a test strip inserted in the port, configured to measure glucose in a sample of fluid residing in the test strip and associate identifying information with the glucose measurement; a wireless transceiver cooperatively operable with the bG meter to communicate the glucose measurement and the identifying information via a wireless data link; a user interface that selectively instructs the handheld medical device to initiate a pairing procedure in response to input received from a user; and a first processor configured to: determine whether a test strip is received in the port; measure, in response to a determination that a test strip is received in the port, glucose in the sample of fluid on the test strip, determine, in response to a determination that a test strip is received in the port, whether an auto-send feature is enabled on the handheld medical device; and determine, in response to a determination that a test strip is received in the port, whether the handheld medical device is paired with a mobile computing device; and in response to a determination (i) that the auto-send feature is enabled and (ii) the handheld medical device is paired with the mobile computing device and (iii) receiving the glucose measurement from the bG meter, instruct the Appeal 2020-003389 Application 14/172,043 3 wireless transceiver to establish a wireless connection and communicate the glucose measurement and the identifying information to mobile computing device; the mobile computing device comprising a second processor configured to execute a diabetes management application stored on an associated memory, the diabetes management application configured to: process a plurality of glucose measurements and identifying information associated with each of the plurality of glucose measurements; and display, on a user display of the mobile computing device, a message indicative of at least one glucose measurement. Appeal Br. 15–16 (Claims Appendix) (emphasis added and spacing altered). REJECTION The Examiner maintains the rejection of claims 1–7 and 10–13 under 35 U.S.C. § 103 as unpatentable over OneTouch3 in view of Valdes4 and Elder5 in the Examiner’s Answer entered January 10, 2020 (“Ans.”). FACTUAL FINDINGS AND ANALYSIS Upon consideration of the evidence relied upon in this appeal and each of Appellant’s contentions, we affirm the Examiner’s rejection of claims 1–7 and 10–13 under 35 U.S.C. § 103 for reasons set forth in the Final Action, the Answer, and below. We review appealed rejections for reversible error based on the 3 OneTouch VerioSync: Blood Glucose Monitoring System –Owner’s Booklet (34 pgs). 4 Valdes et al., US 2011/0320130 Al, published December 29, 2011. 5 Elder et al., US 2014/0238874 Al, published August 28, 2014. Appeal 2020-003389 Application 14/172,043 4 arguments and evidence the Appellant provides. 37 C.F.R. § 41.37(c)(1)(iv); Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (explaining that even if the Examiner had failed to make a prima facie case, “it has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections”)). Appellant presents arguments directed to the subject matter of independent claim 1 only, to which we accordingly limit our discussion. Appeal Br. 10–14; 37 C.F.R. § 41.37(c)(1)(iv). OneTouch discloses a blood glucose monitoring system that includes a blood glucose meter. OneTouch pp. 1, 16. OneTouch provides instructions for using the system that involve an initial set-up process with the following steps: downloading the OneTouch Reveal app onto an Apple device, pairing the blood glucose meter with the Apple device using Bluetooth, and syncing the meter and the app. OneTouch pp. 18–27. OneTouch discloses that after this initial set-up process, the system can be used for blood glucose testing, which first involves inserting a test strip into a test strip port on the meter “to turn the meter on.” OneTouch pp. 26, 39. OneTouch discloses that after applying a blood sample to the test strip, a blood glucose result appears on the meter display, and the meter then syncs with the app to send the test result to the app via Bluetooth. OneTouch pp. 42, 45–46. OneTouch cautions not to remove the test strip from the port until the blood glucose result displays on the meter, or the meter will turn off. OneTouch p. 44. OneTouch also indicates that a test strip should not be inserted into the meter during transmission, because doing so “will cancel the transfer of all results.” OneTouch p. 47. Appeal 2020-003389 Application 14/172,043 5 The Examiner finds that the OneTouch System thus “reads on” the diabetes management system of claim 1, including ensuring that a test strip has been inserted in the port, because the OneTouch System “would not work if this were not the case.” Final Act. 3–4. The Examiner additionally relies on Elder “[i]f it is unclear to one of ordinary skill in the art . . . that the OneTouch System reads on . . . making sure a test strip was received in the port.” Final Act. 3–4. Elder discloses blood analyte meter 10 that includes processing system 140 having processing unit 120, and port 22 for receiving glucose test strip 24. Final Act. 4–5; Elder ¶ 16, Figs. 1A, 1B. Elder discloses that processing unit 120 receives a signal from test strip port 22 indicating that a test strip has been inserted into port 22. Elder ¶ 32. Appellant argues that “OneTouch does not teach or suggest that sending glucose measurements occurs in response to a determination that a test strip is inserted into a port of the meter.” Appeal Br. 11. Appellant argues that “sending of test results in [the] OneTouch meter is independent from (and not in response to) insertion of a test strip” because “Bluetooth can be turned on with or without a strip being inserted into the port of the device.” Id. Appellant argues that Valdes and Elder both do not cure this deficiency of OneTouch because neither reference teaches or suggests sending test results in response to a determination that a test strip is inserted into a port. Appeal Br. 11–12. Appellant’s arguments do not identify reversible error in the Examiner’s rejection, for reasons that follow. As discussed above, OneTouch explicitly discloses that testing blood glucose using OneTouch’s meter after an initial set-up process first involves Appeal 2020-003389 Application 14/172,043 6 inserting a test strip into a test strip port on the meter “to turn the meter on.” OneTouch p. 39. One of ordinary skill in the art reasonably would have understood from this disclosure that the remaining steps for testing blood glucose using OneTouch’s system occur as a result of, or in response to, inserting a test strip into the test strip port of OneTouch’s blood glucose meter. The ordinarily skilled artisan would have recognized that the meter would need to be turned on before the subsequent steps could be conducted, including the step of sending the glucose test result to the paired app. Contrary to Appellant’s arguments, one of ordinary skill in the art, therefore, would have understood that a glucose test result is sent from OneTouch’s meter to a paired app in response to a determination that a test strip has been inserted into the test strip port of the meter. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) ([A]n obviousness analysis “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for [an examiner] can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.”); see also In re Preda, 401 F. 2d 825, 826 (CCPA 1968) (“[I]t is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.”). Although OneTouch does not explicitly disclose the means for making this determination, Elder includes such disclosure. As discussed above, Elder discloses blood analyte meter 10 including processing unit 120 that receives a signal from test strip port 22 indicating that a test strip has been inserted into port 22. Elder ¶ 32. One of ordinary skill in the art would have recognized that a processing unit as disclosed in Elder would have been suitable as the means used in OneTouch’s meter to determine when a test Appeal 2020-003389 Application 14/172,043 7 strip has been inserted into OneTouch’s test strip port. The ordinarily skilled artisan would have recognized that a signal could be sent from OneTouch’s test strip port to a processing unit in OneTouch’s system as disclosed in Elder, and in response to such a signal, the processing unit could turn OneTouch’s meter on, and send instructions for carrying out the remaining steps in OneTouch’s process, including the step of sending the glucose test result to the paired app, as required by claim 1. As to Appellant’s argument that Valdes does not teach or suggest sending test results in response to a determination that a test strip is inserted into a port, the Examiner does not rely on Valdes for any such disclosure. Final Act. 3–4. Appellant’s argument, therefore, does not identify reversible error in the Examiner’s rejection because it does not address the basis for the Examiner’s reliance on Valdes, discussed below. Appellant argues that because “OneTouch teaches terminating any transmission of test results upon detecting insertion of a test strip,” the Examiner is not correct in finding that OneTouch teaches ensuring that a test strip has been inserted in the test strip port because the OneTouch System “would not work if this were not the case.” Appeal Br. 12. Appellant argues that “OneTouch teaches away from sending test results in a response to a determination that a test strip is inserted into a port of the meter” because “[r]ather than transmitting upon insertion of a test strip, OneTouch teaches terminating any transmission of test results when a test strip is inserted into a port of the meter.” Appeal Br. 13. Appellant argues that “the principle of operation of the OneTouch system would change if modified in the manner suggested by the examiner” because “the OneTouch system cancels data transmission upon detecting the insertion of a test strip.” Appeal 2020-003389 Application 14/172,043 8 Appeal Br. 13–14. Appellant’s arguments do not identify reversible error in the Examiner’s rejection, for reasons that follow. As discussed above, OneTouch discloses conducting blood glucose testing using OneTouch’s system by first inserting a test strip into a test strip port on the meter “to turn the meter on,” and then applying a blood sample to the test strip. OneTouch discloses that a blood glucose result then appears on the meter display, and the meter syncs with a paired app to send the test result to the app using Bluetooth. OneTouch explicitly cautions against removing the test strip from the port until the blood glucose result displays on the meter, because doing so will cause the meter to turn off. OneTouch p. 44. Contrary to Appellant’s arguments, OneTouch thus discloses turning on OneTouch’s meter by inserting a test strip into a test strip port in the meter, and leaving the test strip in the port until a blood glucose result appears on the meter’s display. Although OneTouch also indicates that a test strip should not be inserted into the meter during transmission of the blood glucose result from the meter to the paired app, because doing so “will cancel the transfer of all results,” one of ordinary skill in the art would have understood this disclosure to refer to a situation in which a test strip previously had been inserted into the test strip port of OneTouch’s meter to turn the meter on, blood had been applied to the test strip, and a blood glucose test result was being transmitted from the meter to the paired app. OneTouch indicates that in such a situation, the test strip should remain in the port during transmission of the test result to the app, because removing the strip during transfer of the test result terminates the transmission. OneTouch p. 47. Appeal 2020-003389 Application 14/172,043 9 Contrary to Appellant’s arguments, this disclosure does not teach away from, or change the operating principle of, OneTouch’s process, which involves sending a glucose test result to a paired app as a consequence of, or in response to, determining that a test strip has been inserted into a port of OneTouch’s meter, such as through use of a processing unit as disclosed in Elder (as discussed above). In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (“A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant.”). Appellant argues that “the examiner’s rationale for combining the teachings of Valdes with the OneTouch system are [sic] flawed” because “[t]he OneTouch system does not continuously detect or quantify glucose measurements.” Appeal Br. 12–13. As discussed above, however, the Examiner finds that the OneTouch System “reads on” the diabetes management system of claim 1. Nonetheless, the Examiner further relies on Valdes “[i]f it is unclear to one of ordinary skill in the art though that the OneTouch system reads on the diabetes management application” recited in claim 1. Final Act. 3. The Examiner finds that Valdes discloses a software application stored on a mobile computing device that receives data wirelessly from a sensor that substantially continuously measures glucose, and displays glucose measurements on the mobile computing device. Final Act. 3. In view of these disclosures in Valdes, the Examiner concludes that it would have been obvious to one of ordinary skill in the art to use a software application as disclosed in Valdes with the OneTouch system to allow transmission of raw Appeal 2020-003389 Application 14/172,043 10 or minimally processed glucose data for subsequent analysis at a remote computing device. Final Act. 4 (citing Valdes ¶ 4). Although Valdes disclosees a glucose sensor that substantially continuously measures glucose as Appellant argues, this disclosure is not the basis for the Examiner’s reliance on Valdes. Final Act. 3–4; Valdes ¶ 8. Rather, although OneTouch explicitly discloses pairing OneTouch’s blood glucose meter with an app on an Apple device, and syncing the meter with the app to wirelessly send glucose test results from the meter to the app, Valdes also discloses sending glucose measurements to an app stored on a mobile computing device and displaying the test results on the mobile device. Valdes ¶¶ 8, 9, 12, 14, 16. The Examiner relies on this disclosure in Valdes to further support the Examiner’s finding that a diabetes management application stored on a mobile computing device that receives glucose measurements from a glucose meter as recited in claim 1 was known in the art at the time of filing. Final Act. 3–4. Appellant’s arguments, therefore, do not identify reversible error in the Examiner’s rejection, which we accordingly sustain. CONCLUSION Claims 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–7, 10–13 103 OneTouch, Valdes, Elder 1–7, 10–13 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). AFFIRMED Copy with citationCopy as parenthetical citation