Ex Parte Simpson et al

Patent Trial and Appeal BoardFeb 22, 2019

13780808 (P.T.A.B. Feb. 22, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/780,808 02/28/2013 68851 7590 02/26/2019 KNOBBE, MARTENS, OLSON & BEAR, LLP DEXCOM, INC. 2040 MAIN STREET FOURTEENTH FLOOR IRVINE, CA 92614 FIRST NAMED INVENTOR Peter C. Simpson 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 ATTORNEY DOCKET NO. CONFIRMATION NO. DEXCOM.238A 2685 EXAMINER WEARE, MEREDITH H ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 02/26/2019 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): j ayna.cartee@knobbe.com efiling@knobbe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PETER C. SIMPSON, JENNIFER BLACKWELL, and SEBASTIAN BOHM Appeal 2018-003038 1 Application 13/780,808 Technology Center 3700 Before JENNIFERD. BAHR, LEE L. STEPINA, and ARTHUR M. PESLAK, Administrative Patent Judges. STEPINA, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant appeals under 35 U.S.C. Â§ 134 from the Examiner's decision rejecting claims 1, 18, 20-23, and 26-28. 2 We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 Appellant (DexCom, Inc.) is listed in the Appeal Brief as the real party in interest. Appeal Br. 2. 2 Claims 2-17, 19, 24, 25, and 29-32 have been cancelled. Appeal Br. 17- 18 ( Claims App.). Appeal 2018-003038 Application 13/780,808 CLAIMED SUBJECT MATTER The claims are directed to a sensor for continuous analyte monitoring. Claim 1, reproduced below with emphasis added, is illustrative of the claimed subject matter: 1. A sensor device for measuring an analyte concentration in a host, comprising: a sensor unit comprising a sensor body, at least one electrode comprising an electroactive surface, and a membrane covering at least a portion of the at least one electrode, wherein the sensor body comprises a distal end, wherein the distal end is blunt, wherein the membrane comprises an enzyme configured to react with the analyte, wherein the sensor unit lacks a column strength necessary to be inserted alone through the host's skin without substantial buckling; a coating layer covering at least a portion of the membrane, wherein the coating layer is configured to prevent the membrane from peeling back when the sensor unit is advanced through tissue during sensor insertion, wherein the coating layer is configured to provide a column strength that allows the sensor body to be inserted through the host's skin without substantial buckling, wherein the coating layer comprises a coating material, wherein the coating material is a dissolvable or biodegradable material, wherein the coating layer forms a sensor tip; and a base spaced from the sensor body distal end and configured to support the sensor device on an exterior surface of the host's skin. Appeal Br. 17 (Claims App.). REFERENCES RELIED ON BY THE EXAMINER Hague Harris Kastanos Simpson US 2002/0072720 Al US 2006/0030833 Al US 2011/0073475 Al US 2011/0077490 Al 2 June 13, 2002 Feb.9,2006 Mar. 31, 2011 Mar. 31, 2011 Appeal 2018-003038 Application 13/780,808 THE REJECTIONS ON APPEAL 3 I. Claims 1, 18, 20-23, 26, and 27 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Simpson, Hague, and Kastanos. II. Claim 28 is rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Simpson, Hague, Kastanos, and Harris. III. Claim 1 is provisionally rejected on the ground of nonstatutory double-patenting over claim 25 of Application No. 14/962,972, Simpson, and Kastanos. IV. Claim 1 is provisionally rejected on the ground of nonstatutory double-patenting over claim 23 of Application No. 14/963,065,4 Simpson, and Kastanos. OPINION Rejection I Appellant argues the claims subject to the first ground of rejection, i.e., claims 1, 18, 20-23, 26, and 27, as a group. See Appeal Br. 9. We select claim 1 as representative of the group, and claims 18, 20-23, 26, and 27 stand or fall with claim 1. 37 C.F.R. Â§ 4I.37(c)(l)(iv). The Summary of the Claimed Subject Matter in the Appeal Brief refers to Figure 9 as depicting some of the elements recited in claim 1. Appeal Br. 6-7. We reproduce Appellant's Figure 9 below. 3 As claims 29--32 have been cancelled, the rejections of these claims under 35 U.S.C. Â§ 112, first and second paragraphs (Final Act. 2--4), have been withdrawn. Advisory Act. 2. 4 This Application was indicated as abandoned on October 11, 2017. 3 Appeal 2018-003038 Application 13/780,808 906\ 908 910 Appellant's Figure 9 depicts (as a cross-section) a host's skin penetrated by a sensor body 904 partially covered by a membrane 902 that is coated with hardening agent 900. Spec. ,r,r 91, 149 The Examiner finds that Simpson discloses many of the elements required by claim 1, but relies on Kastanos to teach a sensor device with a sensor body that lacks the column strength necessary to enable the sensor device to be inserted alone, without buckling, through a host's skin. See Final Act. 5-8 (citing Simpson ,r,r 156, 167, 185, Fig. 1; Kastanos ,r,r 6, 8, 44). 5 The Examiner also relies on Kastanos to teach a coating layer that is configured to provide enough column strength to allow the sensor body to be inserted through the host's skin without substantial buckling. See id. at 8 (citing Kastanos ,r,r 78, 83). The Examiner reasons that it would have been 5 The Examiner relies on Hague to teach elements of claim 1 that are not pertinent to Appellant's arguments. See Final Act. 6-7. 4 Appeal 2018-003038 Application 13/780,808 obvious to modify the sensor device of Simpson such that the sensor unit would, by itself, lack column strength to avoid substantial buckling during insertion through a host's skin and to also add a coating layer that provides the column strength necessary to insert the sensor body without substantial buckling "in order to provide sufficient structural support for direct, unassisted insertion of the sensor ... while improving comfort for the user and reducing damage to the surrounding tissue of the insertion site." Id. (citing Kastanos ,r,r 2, 42). We reproduce Figure 1 of Simpson below. 170 ( ' FIG. 1 '--- ... ----!JO ---~120 -//6 -/80 Figure 1 of Simpson is a schematic cross-section of skin 180 pierced by sensor body 120 having a support member 130 covered by membrane 140. Simpson ,r,r 121, 156. Appellant attacks the Examiner's rationale for modifying the device of Simpson, but does not traverse Examiner's determination that the 5 Appeal 2018-003038 Application 13/780,808 combination of the teachings of Simpson, Hague, and Kastanos, if made as proposed, would include all of the elements recited in claim 1. Specifically, Appellant asserts (i) Simpson teaches away from the Examiner's proposed modification, (ii) the proposed modification renders Simpson's device inoperable for its intended purpose, (iii) the proposed modification changes the principle of operation of Simpson's device, and (iv) the rationale for the proposed modification relies on improper hindsight by violating the express teachings in Simpson. See Appeal Br. 9--15. (i) Teaching Away Appellant contends that Simpson teaches away from any modification that would remove the column strength necessary for its sensor body to be inserted, alone, through the host's skin without substantial buckling. See Appeal Br. 11. In support of this argument, Appellant quotes the portion of Simpson's Abstract reproduced below. The in vivo portion may comprise a tissue piercing element 110 configured for piercing the skin 180 of the host and a sensor body 120 comprising a material or support member 130 that provides sufficient column strength to allow the sensor body to be pushable in a host tissue without substantial buckling. Appeal Br. 11-12 (quoting Simpson, Abstract). Based on this portion of Simpson's Abstract, Appellant states, "[a]s shown, Simpson expressly teaches away from a modification that would render the sensor body without the column strength necessary to be inserted alone through the host's skin without substantial buckling." Appeal Br. 12. In response, the Examiner refers to paragraphs 98 and 167 of Simpson, which teach that the sensor body may be embedded in a biodegradable coating that functions as a tissue piercing element (namely, a 6 Appeal 2018-003038 Application 13/780,808 needle) and that a tissue piercing element can be configured with column strength sufficient to avoid buckling. Ans. 3. In reply, Appellant reiterates that Simpson teaches away from reducing the column strength of the sensor body. Reply Br. 2-5. As for Simpson's discussion of a needle, Appellant contends that the needle described by Simpson does not qualify as a tissue piercing element. Id. at 5 ("Simpson never discloses that the sensor body is encapsulated or embedded within the tissue piercing element. This feature actually relates to the needle in Simpson"). Appellant further argues "the purpose of the needle is not to provide column strength, but rather 'to provide protection of the membrane during insertion of the sensor device."' Id. (quoting Simpson ,r 167). We disagree with Appellant's argument because the Examiner's proposed modification to Simpson provides a device with sufficient column strength to be insertable through a host's skin without substantial buckling, despite the fact that a subcomponent of the device, i.e., the sensor unit without its coating, lacks the column strength to perform this function. See Final Act. 8. In other words, we understand Simpson to teach that the ability to insert the sensor device through the skin is the characteristic that is most important, not that any particular portion of the sensor device provide this ability. See Simpson ,r 156 ("In the particular embodiment illustrated in FIG. 1, the sensor device 100 comprises an in vivo portion 160 (also referred to as a sensor unit) configured for insertion under the skin of the host and an ex vivo portion 170 configured to remain above the host's skin surface after sensor insertion."). Thus, we agree with the Examiner (Ans. 3) that Simpson does not criticize, discredit, or otherwise discourage the claimed solution. Indeed, the Examiner's proposed modification to add a coating appears to be 7 Appeal 2018-003038 Application 13/780,808 in accordance with at least one express teaching in Simpson. See Simpson ,r 167 ( discussing encapsulation in a biodegradable material). (ii) Inoperability Appellant next argues that the Examiner's proposed modification would cause the sensor body taught by Simpson to buckle, i.e., fail, when subjected to the resistance associated with penetrating tissue and skin. See Appeal Br. 12-13, Reply Br. 5---6. This argument is, in essence, a paraphrasing of Appellant's "teaching away" argument discussed above, and, for the same reasons, is unavailing. Specifically, the Examiner's proposed modification to the device in Simpson results in a sensor that can be inserted without substantial buckling. In support of the assertion that the proposed modification would render Simpson's device inoperable, Appellant states, "the bending characteristics of the planar substrate sensor of Kastanos are substantially different than the bending characteristics of the wire sensor of Simpson[, and s ]uch differences highlight that the proposed modification of such different types of sensors would render Simpson inoperable for its intended purpose." Appeal Br. 13. Aside from pointing out that the devices disclosed by Simpson and Kastanos have different shapes with allegedly different bending characteristics, Appellant provides no explanation as to why the teachings of Kastanos, as applied by the Examiner in the proposed modification, would render Simpson's device inoperable for its intended purpose. Accordingly, this argument does not apprise us of Examiner error. 8 Appeal 2018-003038 Application 13/780,808 (iii) Changing the Principle of Operation Appellant next contends that the proposed modification to Simpson's device changes its principle of operation, "namely that the sensor body of Simpson does not substantially buckle when inserted alone through the host's skin." Appeal Br. 14; see also Reply Br. 6-7. The Examiner disagrees, stating "[ t ]he intended purpose or principle of operation of Simpson is providing a sensor unit that is directly insertable without the use of a separate device, such as an applicator or introducer." Ans. 5 ( citing Simpson ,r 155). The Examiner has the better position on this point. We agree that the proposed modification does not change the principle of operation of the sensor device disclosed by Simpson because the modified sensor still functions as it did before the modification, even with respect to being inserted through a host's skin. The fact that a portion of any resistance encountered during insertion is being born by the coating the Examiner proposes to add does not change this principle. (iv) Impermissible Hindsight Appellant next contends that the Examiner applies impermissible hindsight reasoning in rejecting claim 1 because "the proposed modification ... violates the express teachings of Simpson by changing Simpson's sensor body, which has sufficient column strength to avoid substantial buckling, to a sensor body that lacks such column strength." Appeal Br. 15. Appellant's argument does not apprise us of Examiner error. As discussed above, the Examiner's proposed modification to the device disclosed by Simpson does not undermine teachings of Simpson. Further, 9 Appeal 2018-003038 Application 13/780,808 the Examiner's reasoning for modifying Simpson based on the teachings of Kastanos is supported by the express disclosure in Kastanos. See Kastanos We have considered all of Appellant's arguments contesting Rejection I, but find them unavailing. Accordingly, we sustain the rejection of claims 1, 18, 20-23, 26, and 27 as unpatentable over Simpson, Hague, and Kastanos. Rejection II Appellant makes no additional arguments in support of the patentability of claim 28. See Appeal Br. 16. Accordingly, we sustain Rejection II for the same reasons discussed above regarding Rejection I. Rejections III and IV The scope of claim 25 of Application No. 14/962,972 has changed since the notification date of the Final Office Action. Application No. 14/963,065 has been abandoned. Accordingly, we leave it to the Examiner to determine the propriety of Rejections III and IV. DECISION The Examiner's decision to reject claims 1, 18, 20-23, 26-28 is affirmed. 10 Appeal 2018-003038 Application 13/780,808 No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). See 37 C.F.R. Â§ 1.136(a)(l )(iv). AFFIRMED 11