Ex Parte Harris et alDownload PDFPatent Trial and Appeal BoardFeb 13, 201912113784 (P.T.A.B. Feb. 13, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/113,784 05/01/2008 21884 7590 02/14/2019 WELSH FLAXMAN & GITLER LLC 2000 DUKE STREET, SUITE 100 ALEXANDRIA, VA 22314 FIRST NAMED INVENTOR Jason L. Harris 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. END-6291USNP 1717 EXAMINER MARCETICH, ADAM M ART UNIT PAPER NUMBER 3781 MAIL DATE DELIVERY MODE 02/14/2019 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JASON L. HARRIS, MARKS. ZEINER, and MICHAEL J. STOKES Appeal2017-005446 Application 12/113,784 Technology Center 3700 Before GEORGE R. HOSKINS, MICHAEL L. WOODS, and SEAN P. O'HANLON, Administrative Patent Judges. WOODS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Jason L. Harris, Mark S. Zeiner, and Michael J. Stokes (collectively, "Appellants") appeal from the Examiner's rejection of claims 1, 3, 4, and 6- 15. Appeal Br. 3. We have jurisdiction over this appeal under 35 U.S.C. § 6(b). SUMMARY OF THE DECISION We REVERSE. Appeal2017-005446 Application 12/113,784 CLAIMED SUBJECT MATTER Appellants' invention relates to "a hybrid method for combining gastric volume reduction surgery with the application of a duodenal sleeve." Spec. 1 (Field of Invention). Claims 1 and 15 are the independent claims, and claim 1 is reproduced below with emphases added to particular limitations at issue in this appeal. 1. A method for treating a patient, comprising: creating at least one incision to gain access to a peritoneal cavity; performing a gastric volume reduction procedure; introducing a duodenal sleeve for transporting chyme exiting the stomach to prevent gastric contents in the form of chyme from interacting with at least a portion of a duodenum, the duodenal sleeve including a proximal opening and a distal opening, the step of introducing further includes anchoring the proximal opening to, or distal to, muscle in a pyloric portion of the stomach; and directing the chyme leaving the stomach inside the duodenal sleeve and bypassing the duodenum such that there is no mixing of chyme with bile until the chyme reaches a Jejunum. Appeal Br. 19 (Claims App.). THE REJECTIONS I. Claims 1, 3, 4, and 15 stand rejected under 35 U.S.C. § I03(a) as unpatentable over Gertner (US 2006/0074473 Al, published Apr. 6, 2006) and Levine (US 2005/0085923 Al, published Apr. 21, 2005). Final Act. 2. II. Claims 6-14 stand rejected under 35 U.S.C. § I03(a) as unpatentable over Gertner, Levine, and Harris (US 2008/0249566 Al, published Oct. 9, 2008). Final Act. 7. 2 Appeal2017-005446 Application 12/113,784 ANALYSIS Re} ection I: Gertner and Levine The issue before us is whether the Examiner's reasoning for combining Gertner with Levine is supported by the evidence. "[R ]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006), cited with approval in KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007). Examiner's Rejection In rejecting claims 1, 3, 4, and 15, the Examiner relies on Gertner for disclosing a method for reducing the volume of a stomach, including the steps of "creating at least one incision to gain access to a peritoneal cavity" and "performing a gastric volume reduction procedure." Final Act. 2-3 ( citations omitted). The Examiner acknowledges that "Gertner teaches the invention substantially as claimed ... with the exception of introducing a duodenal sleeve." Id. at 3 (emphasis added). To address the claimed "introducing a duodenal sleeve," the Examiner relies on Levine and asserts that Levine discloses a method for applying a sleeve. Id. ( citing Levine ,r,r 10, 91 ). In combining Gertner with Levine, the Examiner reasons, "[ o ]ne would be motivated to modify Gertner with the duodenal sleeve of Levine since Gertner explicitly calls for implanting the stent of Levine." Id. at 4 (citing Levine ,r 123 (emphasis added)). The Examiner further reasons, "it would have been obvious ... to modify Gertner with the duodenal sleeve of 3 Appeal2017-005446 Application 12/113,784 Levine in order to limit nutrient absorption with a device recognized by Gertner." Id. Appellants 'Argument Appellants argue, inter alia, that "Gertner does not explicitly call for implanting the stent of Levine in conjunction with gastric volume reduction." Appeal Br. 9. Appellants explain, "the disclosure of Gertner does not lead one to the conclusion presented by the Examiner but rather leads one skilled in the art to a completely different conclusion." Id. We agree. Our Analysis The Examiner asserts, "Gertner explicitly calls for implanting the stent of Levine," and reasons that, because of this disclosure, "[ o ]ne would be motivated to modify Gertner with the duodenal sleeve of Levine." Final Act. 4 ( citing Gertner ,r 123). The Examiner's reliance on Gertner, however, is misplaced. The cited paragraph within Gertner that the Examiner relies on discloses, In other embodiments, the devices and methods of this invention can assist in the implantation of devices such as stents, meshes, stitches, or tubes in the gastrointestinal tract. The major technical difficulty encountered in placing stents, tubes, and meshes inside the lumen of the gastrointestinal tract is that they tent to migrate because the walls of such devices do not adhere to slippery mucosa. A transgastric or trans intestinal fastener, implanted with the current instrumentation would solve this problem. Such a method would be particularly useful in the attachment of the stent part 4 Appeal2017-005446 Application 12/113,784 of the stent-sleeve system outlined in patent application WO 04049982. 1 Gertner ,r 123 (emphases added). Contrary to the rejection, the above disclosure does not teach, disclose, or suggest combining a duodenal sleeve with stomach reduction, as the rejection implies. See Final Act. 4. Rather, this disclosure merely describes a problem involving stents placed within a gastrointestinal tract, in that the stents may migrate due to the slippery mucosa within the tract's inner walls, and using a transgastric or transintestinal fastener, such as Gertner's anchor, would solve the migration problem. Gertner ,r 123. Stated differently, Gertner generally discloses "anchors ... used to pull the walls of [an] organ together." Gertner, (57). Paragraph 123 of Gertner suggests that these anchors may be used as fasteners to prevent stent migration. Id. ,r 123. Gertner does not suggest using Gertner's anchors for stomach reduction while also using a duodenal sleeve. In the Answer, the Examiner explains in the alternative that Gertner's goal is to treat obesity, generally, and "Gertner can be read more broadly as seeking a way to encourage malabsorption" of food. See Ans. 10. Specifically, the Examiner states, "Gertner generally seeks to inhibit absorption of nutrients, and recognizes two effective approaches for achieving this effect." Id. ( citing Gertner ,r 6 ( emphasis added)). The Examiner further explains that "[i]mplanting the stent-graft system of Levine would advance the goals of Gertner by interfering with absorption and mechanically restricting the effective volume of a patient's digestive tract." Id. (citing in-part Gertner ,r 6 (emphasis added)). 1 Levine and WO 04049982 appear to be related applications. 5 Appeal2017-005446 Application 12/113,784 We disagree with the Examiner's assertion that one of Gertner' s goals is to inhibit the absorption of nutrients. Id. The cited paragraph of Gertner discloses in full: Over the past four decades, there have been numerous surgical procedures and devices developed to treat the morbidly obese. In general, there are two physiologic aspects of all past and current procedures: malabsorption and mechanical restriction/volume reduction. Gertner ,r 6. This disclosure merely explains that the numerous surgical procedures used to treat obesity rely on malabsorption and mechanical restriction/volume reduction. Id. This disclosure does not identify the "goals of Gertner [as] interfering with absorption and mechanically restricting the effective volume of a patient's digestive tract." Ans. 10. More importantly, however, this disclosure does not support the Examiner's reasoning that it would have been obvious to add a duodenal sleeve, as described in Levine, with Gertner' s stomach reduction procedure. We find nothing in the Final Office Action or Answer that persuades us that it would have been obvious to combine Gertner' s stomach reduction procedure with Levine's duodenal sleeve procedure. Accordingly, we do not sustain the rejection of claims 1, 3, 4, and 15 as unpatentable over Gertner and Levine. Rejection II: Gertner, Levine, and Harris In rejecting dependent claims 6-14 as unpatentable over Gertner, Levine, and Harris, the Examiner relies on the same unsupported reasoning discussed above under Rejection I. See Final Act. 7. 6 Appeal2017-005446 Application 12/113,784 For the same reasons that we do not sustain Rejection I, we do not sustain the rejection of claims 6-14 as unpatentable over Gertner, Levine, and Harris. SUMMARY We reverse the rejection of claims 1, 3, 4, and 15 as unpatentable over Gertner and Levine. We reverse the rejection of claims 6-14 as unpatentable over Gertner, Levine, and Harris. REVERSED 7 Copy with citationCopy as parenthetical citation