MEDTRONIC MINIMED, INC.

Patent Trials and Appeals Board

Feb 9, 2022

2021004027 (P.T.A.B. Feb. 9, 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. 15/444,252 02/27/2017 Eric Allan Larson 009.5033D1C1 5526 98412 7590 02/09/2022 LKGLOBAL (Medtronic Minimed) 7010 E Cochise Rd. Scottsdale, AZ 85253 EXAMINER STINSON, CHELSEA E. ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 02/09/2022 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): medtronic@lkglobal.com rs.patents.one@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ERIC ALLAN LARSON and RAJIV SHAH Appeal 2021-004027 Application 15/444,252 Technology Center 3700 Before BENJAMIN D. M. WOOD, BRETT C. MARTIN, and JEREMY M. PLENZLER, Administrative Patent Judges. WOOD, 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 1-20. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 “Appellant” refers to the applicant as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Medtronic Minimed, Inc. Appeal Br. 3. Appeal 2021-004027 Application 15/444,252 2 CLAIMED SUBJECT MATTER The claims are directed to packaging for medical devices, such as glucose sensors, in which the device is sealed inside a package tray with a gas-permeable sealing material to allow volatile substances to vent from inside the package. Spec. ¶¶ 2, 6. This prevents the volatile substances that would otherwise be trapped in the package from degrading the glucose oxidase enzyme used in some glucose sensors. Id. ¶ 21. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method for packaging a device, the method comprising: placing the device directly on a package tray; providing a cover having a periphery, wherein the cover is formed from a gas-permeable material at least along the periphery; sealing the device inside the package tray with the cover, resulting in a sealed package tray, wherein the gas-permeable material along the periphery of the cover is directly sealed to the package tray and wherein the gas-permeable material of the cover allows volatile substances to vent from the device inside the sealed package tray to outside the sealed package tray. REFERENCES Name Reference Date Dutchik US 5,590,778 Jan. 7, 1997 Hickey US 6,412,639 B1 July 2, 2002 McMichael US 2003/0159969 A1 Aug. 28, 2003 Miller US 2004/0016212 A1 Jan. 29, 2004 Yan US 2005/0268573 A1 Dec. 8, 2005 Shah US 7,725,148 B2 May 25, 2010 Appeal 2021-004027 Application 15/444,252 3 REJECTIONS Claims Rejected 35 U.S.C. § References 1, 8, 9, 11-13, 17, 18 103 Dutchik, McMichael 2-5, 14, 15, 20 103 Dutchik, McMichael, Shah 6 103 Dutchik, McMichael, Miller 7, 16 103 Dutchik, McMichael, Yan 10, 19 103 Dutchik, McMichael, Hickey OPINION Claims 1, 8, 9, 11-13, 17, and 18-§ 103-Dutch and McMichael Based on Appellant’s arguments (Appeal Br. 8-9), we select claim 1 as representative of the claims subject to this rejection, and decide the appeal of this rejection on the basis of claim 1 alone. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Dutchik teaches a method for packaging a device comprising placing the device directly on a package tray, providing a cover having a periphery, and sealing the device inside the package tray with the cover, wherein the cover allows volatile substances to vent from the device inside the sealed package tray to outside the sealed package tray. Final Act. 3-4 (citing Dutchik 7:19-20, 31-40, 9:27-31 Figs. 1-3). The Examiner acknowledges, however, that Dutchik does not expressly disclose that the cover is formed from a gas-permeable material at least along the periphery of the cover, and the periphery directly sealed to the package tray. Id. at 4. The Examiner therefore relies on McMichael to teach the missing limitations: the Examiner finds that McMichael teaches a medical-device package comprising a cover made of Tyvek®, which is gas-permeable (and therefore necessarily gas-permeable at least along its periphery, as required by claim 1). Id. (citing McMichael ¶ 28, Fig. 1). The Examiner determines that it would have been obvious to one of ordinary skill in the art to modify Appeal 2021-004027 Application 15/444,252 4 the cover used in Dutchik’s package so that it is entirely formed of Tyvek, as taught by McMichael, “in order to reduce the number of components of the package while still allowing volatile substance[s] to vent from the package.” Id. Appellant first argues that [n]either Dutchik nor McMichael discloses or suggests that a gas-permeable material of a cover allows volatile substances to vent from the device inside the sealed package tray to outside the sealed package tray, or the express step of venting volatile substances from the device inside the sealed package tray to outside the sealed package tray. Appeal Br. 8. This is incorrect. As the Examiner points out (Ans. 17), Dutchik teaches that its package allows the venting of sterilizing gases through the package’s Tyvek® microporous patches. Dutchik 9:27-31. Dutchik makes clear that the Tyvek® patches permit passage of gas “to and from” the packages. Id. at 9:32-33 (emphasis added). Appellant does not appear to dispute that Tyvek® is gas permeable; indeed, Appellant’s package uses Tyvek® to make the gas-permeable cover for its medical- device packages. Spec. ¶ 35, Fig. 2. Appellant also argues that “there is no teaching or suggestion in the cited references for making a combination including each claim limitation.” Appeal Br. 8. Appellant contends that “the Office has not provided reasoning that supports both how and why such combinations of references would have been made.” Id. at 9. To the extent Appellant contends that a reason to combine references must be found in the references themselves, Appellant is mistaken. While there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness, “the analysis need not seek out Appeal 2021-004027 Application 15/444,252 5 precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int'l. Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Further, contrary to Appellant’s assertion, the Examiner has provided a reason why one of ordinary skill in the art would have combined the teachings of Dutchik and McMichael: “to reduce the number of components of the package while still allowing volatile substance[s] to vent from the package.” Final Act. 4. Appellant has not addressed this reason, much less shown why it lacks rational underpinning. In sum, we are not persuaded that the Examiner erred in rejecting claim 1, and therefore sustain the Examiner’s rejection of claims 1, 8, 9, 11- 13, 17, and 18 as unpatentable over Dutchik and McMichael. Claims 2-5, 14, 15, and 20-§ 103-Dutchik, McMichael, and Shah Claims 2, 3, and 14 depend from claim 1 or 13 and further recite, in Appellant’s words, “that the device placed directly on the package tray comprises glucose oxidase enzyme, and that the gas-permeable material vents volatile substances that would otherwise degrade the glucose oxidase enzyme.” Appeal Br. 9. Claim 20, likewise, is drawn to a device comprising glucose oxidase enzyme in a package tray. Id. at 17 (Claims App.). Claims 4-5 and 15 ultimately depend from claim 1 or 13 and further recite (again, in Appellant’s words) “that the device comprises a plastic material and that the gas-permeable material vents volatile substances outgassed from the plastic material.” Id. at 9. The Examiner relies on Shah to teach a medical device comprising glucose oxidase enzyme and comprising a plastic material. See, e.g., Final Act. 8-10 (citing Shah 6:19-20, Fig. 4); see Ans. 18 (citing Shah 1:53). The Appeal 2021-004027 Application 15/444,252 6 Examiner determines that one of ordinary skill in the art would have used Dutchik’s package for glucose sensors because it was “known in the art that [glucose sensors] are commonly used for medical applications, specifically in monitoring blood glucose levels in a diabetic patient.” See, e.g., id. (citing Shah 1:8-30). Appellant responds that “there is no teaching in any of the cited references for venting volatile substances outgassed from plastic material in the device that would degrade the glucose oxidase enzyme.” Appeal Br. 10 (addressing claims 2-6,2 14, and 15); see id. at 11 (specifically addressing claim 20). Further, according to Appellant, “as no cited reference actually discloses or suggests packaging glucose oxidase enzyme, there is no acknowledgment that the glucose oxidase enzyme may be degraded by any outgassed volatile substances in a confined package.” Id. at 10. The Examiner responds that: [T]he office interprets the ethylene oxide gas as disclosed by Dutchik (Col. 1, ln 53) to be equivalent to volatile substances that would otherwise degrade the glucose oxidase enzyme since they are consistent with “gases chemicals, solvents, or the like” and “alcohol; ethanol; solvents; volatile (non)condensable materials; low-molecular-weight additives; reactive diluents; absorbed moisture; and the like” as disclosed in Para [0022] and [0034], respectively, [in] the instant application.” 2 Claim 6 depends from claim 1 and additionally recites “wherein the package tray [as opposed to the device itself, as recited in, e.g., claim 2] is formed at least in part from a plastic material; and the gas-permeable material vents volatile substances outgassed from the plastic material.” Appeal Br. 15 (Claims App.). The Examiner separately rejected claim 6 as unpatentable over Dutchik, McMichael, and Miller. Final Act. 13-14. As Appellant groups claim 6 with the claims rejected over Dutchik, McMichael, and Shah, we also consider claim 6 together with those claims. Appeal 2021-004027 Application 15/444,252 7 Ans. 18 (emphasis omitted). Appellant did not submit a Reply Brief, and therefore does not respond to these findings. Appellant’s arguments are not persuasive of Examiner error. First, while no single reference teaches packaging a device comprising glucose oxidase enzyme and a plastic material in a tray with a gas-permeable cover, the Examiner relies on the combination of Dutchik, McMichael, and Shah to teach the claimed device, not on any one of these references by itself. See In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references.”).3 As for Appellant’s argument that the cited references do not teach venting volatile substances outgassed from plastic material in the device that would degrade the glucose oxidase enzyme, our understanding of the Examiner’s position is that the requirements that the gas-permeable material vent volatile substances that would otherwise degrade the glucose oxidase enzyme (e.g., claim 2), or that it vent volatile substances outgassed from the plastic material (e.g., claim 4), are considered by the Examiner to be functional limitations. [W]here the Patent Office has reason to believe that a functional limitation asserted to be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent characteristic of the prior art, it possesses the authority to require the applicant to prove that the subject matter shown to be in the prior art does not possess the characteristic relied on. 3 While Appellant asserts that the Final Action “provides no rationale for making the specific combination,” (Appeal Br. 10) this is incorrect. See Final Act. 8. Appellant does not explain why this rationale lacks rational underpinning. Appeal 2021-004027 Application 15/444,252 8 In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997) (quoting In re Swinehart, 439 F.2d 210, 213 (CCPA 1971)). An Examiner can show a reason to believe that a prior-art reference inherently discloses a functional limitation by showing that the device is capable of performing the claimed function. See id. at 1479 (upholding the Board’s anticipation ruling based on “[t]he Board’s finding that the scaled-up version [of the oil-can top] of figure 5 of Harz would be capable of performing all of the functions recited in Schreiber’s claim 1”). We understand the Examiner’s position to be that if the Tyvek® material used in Dutchik’s package is capable of permitting the venting of ethylene oxide gas, it would also be capable of venting the gases identified in the Specification as outgassed from a glucose sensor or its packaging. We are not aware of anything in the record that contradicts this position. Accordingly, we sustain the Examiner’s rejection of claims 2-6, 14, 15, and 20 as unpatentable over Dutchik, McMichael, and Shah (or Miller, in the case of claim 6). Claims 7 and 16-§ 103-Dutchik, McMichael, and Yan Appellant does not respond to the Examiner’s rejection of claims 7 and 16, but apparently relies on arguments made in connection with claims 1 and 13, from which claims 7 and 16 depend, to support their patentability. Because we found these arguments unpersuasive, however, we sustain the Examiner’s rejection of claims 7 and 16 as unpatentable over Dutchik, McMichael, and Yan. Claims 10 and 19-§ 103-Dutchik, McMichael, and Hickey Claim 10 depends from claim 1 via claim 9, and additionally recites “sterilizing the device after sealing the device inside the package tray” (claim 9), and “wherein sterilizing the device comprises radiating the sealed Appeal 2021-004027 Application 15/444,252 9 package tray with sterilizing energy (claim 10).” Appeal Br. 15 (Claims App.). Claim 19 depends from claim 13 via claim 18, and contains similar additional limitations. Id. at 16. The Examiner relies on Hickey to teach the additional limitations of these claims. Final Act. 16 (citing Hickey 6:25-28, Figs. 1, 4). The Examiner determines that it would have been obvious to one of ordinary skill in the art to modify Dutchik and McMichael to include the step of sterilizing the device by radiating it with sterilizing energy as taught by Hickey “in order to reduce the amount of volatile substances that may be formed within the package.” Id. Appellant responds: Dutchik and McMichael expressly describe structures and processes providing for sterilization of medical instruments with ethylene oxide. Any permeable structures disclosed are disclosed as providing for permeation of a sterilization gas such as ethylene oxide. Replacement of the sterilization gas process with an irradiation process removes any motivation to include a permeable cover in the device. Therefore, Dutchik and McMichael teach against the use of irradiation to sterilize the instrument within the sealed package, as recited by claims 10 and 19. Appeal Br. 11 (emphasis added). The Examiner disagrees with Appellant’s analysis, stating that: [T]he office relies on the step of sterilizing the device with sterilizing energy taught by Hickey as an additional sterilizing step, not a replacement. The office maintains that it would be obvious to one of ordinary skill in the art to make such a modification since Hickey teaches more than one sterilization step, the first one being equivalent to that . . . disclosed by Dutchik. Ans. 18. Appeal 2021-004027 Application 15/444,252 10 We agree with Appellant. The prior art of record recognizes only one reason to use a gas-permeable cover for a medical-device package: To allow the passage of sterilizing gas into and out of the package. See Dutchik 1:45- 53, 63-67, 3:26-29, 5:30-55, 9:19-37; McMichael ¶¶ 27-28. We are not persuaded that it would have been obvious to one of ordinary skill in the art to use a gas-permeable package cover without taking advantageous of the gas-permeability to sterilize the product. We are also not persuaded by the Examiner’s explanation in the Answer. The Examiner’s suggestion in the Answer that one of ordinary skill in the art would have added an additional sterilizing step is inconsistent with the Examiner’s position in the Final Action, where the Examiner stated that the reason why one of ordinary skill in the art would have combined Hickey with Dutchik and McMichael is “to reduce the amount of volatile substances that may be formed within the package”-which is accomplished by eliminating the gas sterilization step altogether. Ans. 16. Moreover, Hickey uses two sterilization steps because the kit being sterilized comprises two separate portions, and each sterilizing step is for a separate portion of the kit. Hickey 4:28-31, 61-63, Figs. 1-4. The Dutchik package is not separated into two distinct portions, so Hickey would not have motivated one of ordinary skill in the art would to subject Dickey’s package to two separate sterilizations. Therefore, we do not sustain the Examiner’s rejection of claims 10 and 19 as unpatentable over Dutchik, McMichael, and Hickey. Appeal 2021-004027 Application 15/444,252 11 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 8, 9, 11- 13, 17, 18 103 Dutchik, McMichael 1, 8, 9, 11- 13, 17, 18 2-5, 14, 15, 20 103 Dutchik, McMichael, Shah 2-5, 14, 15, 20 6 103 Dutchik, McMichael, Miller 6 7, 16 103 Dutchik, McMichael, Yan 7, 16 10, 19 103 Dutchik, McMichael, Hickey 10, 19 Overall Outcome 1-9, 11-18, 20 10, 19 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED IN PART