DexCom, Inc.

Patent Trials and Appeals Board

Apr 1, 2022

2021004737 (P.T.A.B. Apr. 1, 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. 15/872,280 01/16/2018 Sebastian Bohm 0670-US02_0027 1012 183946 7590 04/01/2022 MOORE & VAN ALLEN PLLC for DexCom, Inc. ATTN: IP DEPARTMENT 100 North Tryon Street Suite 4700 Charlotte, NC 28202 EXAMINER WEARE, MEREDITH H ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 04/01/2022 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): Dexcom.pair@anaqua.com iplaw@mvalaw.com usptomail@mvalaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte SEBASTIAN BOHM, PRADNYA PRAKASH SAMANT, and JIONG ZOU Appeal 2021-004737 Application 15/872,280 Technology Center 3700 Before BRETT C. MARTIN, LISA M. GUIJT, and MICHAEL L. WOODS, Administrative Patent Judges. MARTIN, 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 1-7, 9, 11, 12, 19, 22-24, and 26-34, the only claims currently pending in the application. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Dexcom, Inc. Appeal Br. 3. Appeal 2021-004737 Application 15/872,280 2 CLAIMED SUBJECT MATTER The claims are directed “to systems and methods for measuring an analyte concentration in a host.” Spec. ¶ 2. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A sensor device for measuring an analyte concentration m a host, the sensor device comprising: a sensor unit comprising a sensor body, at least one electrode, and a membrane covering at least a portion of the at least one electrode; a tissue-piercing element comprising a dissolvable material that dissolves after insertion into the host, the tissue- piercing element abutting a distal end of and not fully encasing the sensor body and being capable of piercing tissue; and a mounting unit spaced from the sensor tip and configured to support the sensor device on an exterior surface of the host's skin, wherein the dissolvable material has a tensile strength of from about 20 MPa to about 90 MPa as measured by ASTM- D2370, or a Young's modulus of from about 1 GPa to about 10 GPa as measured by ASTM-D2370, or a combination thereof. Appeal Br. 28 (Claims App.). REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Zion US 2004/0202719 A1 Oct. 14, 2004 Fedder US 2013/0131482 A1 May 23, 2013 Lucisano US 2013/0197332 A1 Aug. 1, 2013 Simpson US 2015/0289788 A1 Oct. 15, 2015 Godden US 2017/0028184 A1 Feb. 2, 2017 REJECTIONS Claims 1-7, 9, 22-24, and 26-33 stand rejected under 35 U.S.C. § 103 as being unpatentable over Simpson and Godden or Fedder. Final Act. 3. Appeal 2021-004737 Application 15/872,280 3 Claims 11, 12, and 19 stand rejected under 35 U.S.C. § 103 as being unpatentable over Simpson, Godden or Fedder, and Zion. Final Act. 8. Claim 34 stands rejected under 35 U.S.C. § 103 as being unpatentable over Simpson, Godden or Fedder, and Lucisano. Final Act. 9. OPINION Tensile Strength The Examiner admits that Simpson is silent regarding the claimed tensile strength, but asserts that “Godden discloses a material [that] should have a sufficiently high elastic modulus and tensile strength to ensure successful insertion into skin . . . thereby indicating and/or suggesting the mechanical properties of the tissue-piercing element material, such as elastic modulus and tensile strength, provide a quality which can be optimized.” Final Act. 4. Appellant argues that in order to be optimizable, a variable must first be recognized as being a result-effective variable capable of such optimization. Reply Br. 3. Appellant correctly points out, however, that “Godden provides one of ordinary skill in the art with absolutely no description or suggestion that the properties recited in claim 1 could result from optimization,” and that “Godden provides neither an end point nor a range of end points.” Id. We agree with Appellant that “Godden does not discuss variability of the respective values or that varying those values alone could contribute to the ability of the microneedle array instrument of Godden to pierce skin.” Id. Accordingly, Godden fails to provide the threshold teaching of a result-effective variable necessary for the Examiner’s asserted optimization. As such we do not sustain the Examiner’s rejection over Simpson and Godden. Appeal 2021-004737 Application 15/872,280 4 As to Fedder, the Examiner finds it does explicitly teach the claimed tensile strength. Final Act. 4. The Examiner explains that although brain tissue is not the type of tissue utilized in Simpson’s analyte monitoring device, Fedder does not state that it has optimized its properties specifically or only for brain tissue. See Final Act. 4, see also Ans. 4-5. Appellant, however, points out that Fedder is described only for use with brain tissue (using tissue 60 times and “[t]he only specific tissue that Fedder mentions is brain tissue” (Reply Br. 5)), which “is 3 orders of magnitude softer than skin tissue.” Reply Br. 6. Appellant notes that “brain tissue has different properties as compared to the types of tissue that the claimed apparatus is configured to penetrate.” Reply Br. 5. Appellant further argues that “Fedder simply provides neither a description nor a suggestion that its device could be used to pierce skin” as would be required in both the disclosed analyte measuring device and Simpson’s analyte monitoring device, and that “the tensile strength values and Young’s modulus values listed in Fedder, cannot be combined with Simpson to render the instant claims obvious.” Id. Appellant also notes that, in general, “the lack of overlap between the Young’s modulus and tensile strength values of Simpson and Fedder…show a contradiction between the two references and counsels one of ordinary skill against combining the two references.” Reply Br. 6. Although we would not go so far as to call the references nonanalogous, we do agree that brain tissue and the types of tissue to be penetrated using the analyte devices at issue are dissimilar enough that one of ordinary skill in the art would not have looked to Fedder for modification of Simpson regarding properties such as tensile strength or Young’s modulus. We, therefore, do not sustain the Examiner’s rejection over Simson and Fedder. Appeal 2021-004737 Application 15/872,280 5 All of the Examiner’s rejections rely on either the combination of Simpson with Fedder or Godden. Accordingly, for the reasons stated above, we do not sustain the Examiner’s rejections. CONCLUSION The Examiner’s rejections are reversed. DECISION SUMMARY In summary: Claim(s) Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-7, 9, 22- 24, 26-33 103 Simpson, Godden 1-7, 9, 22- 24, 26-33 1-7, 9, 22- 24, 26-33 103 Simpson, Fedder 1-7, 9, 22- 24, 26-33 11, 12, 19 103 Simpson, Godden, Zion 11, 12, 19 11, 12, 19 103 Simpson, Fedder, Zion 11, 12, 19 34 103 Simpson, Godden, Lucisano 34 34 103 Simpson, Fedder, Lucisano 34 Overall Outcome 1-7, 9, 11, 12, 19, 22- 24, 26-34 REVERSED