Ex Parte Kagan et alDownload PDFPatent Trial and Appeal BoardFeb 19, 201310698148 (P.T.A.B. Feb. 19, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte JONATHAN KAGAN, JAMES BALLIRO, DAVID CARR-LOCKE, MITCHELL DANN, LEE GUTERMAN, SAYEED IKRAMUDDIN, JAMES LEARY, and RICHARD THOMAS __________ Appeal 2011-004773 Application 10/698,148 Technology Center 3700 __________ Before ERIC GRIMES, JEFFREY N. FREDMAN, and SHERIDAN K. SNEDDEN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method of treating obesity, which have been rejected for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The Specification discloses methods of treating obesity using “minimally invasive techniques for effectively reducing stomach volume, Appeal 2011-004773 Application 10/698,148 2 bypassing a portion of the stomach and/or small intestines and/or reducing nutrient absorption in the stomach and/or small intestines” (Spec. 3, ¶ 11). The “system may include an internal gastric sleeve. . . . When combined with a restrictive stoma, the sleeve functions as the pouch in a gastric bypass.” (Id. at 4-5, ¶ 15.) The Specification states that the “use of plications (folds) is often useful in overcoming the difficulties of coupling a fastener device to a hollow walled organ because the folds give the added strength of a double layer attachment point” (id. at 71, ¶ 356). “Another advantage is that the outermost wall of the gastrointestinal tract, the serosa, appears to heal well because when it is in contact with itself, such as within a fold, it tends to heal together” (id.). The Specification discloses that a fastener can also be driven through a single tissue layer, without folding (id. at 73, ¶ 361), and that an exemplary fastener has a curled portion that can be straightened out to lie essentially parallel to a post (which passes through the tissue); “[w]hen the curled portion . . . is released from the delivery device and allowed to expand, it then forms a cone shaped spring” that holds the fastener in place (id. at 72, ¶ 360). The Specification states that “[t]his particular geometry is intended to be exemplary and other geometries which increase the area of the portion of the fastener which bears the weight (force) of the dependent device and thereby helps resist pull-through” can be used (id.). The Specification states, for example, that “T-tag fasteners can be used to attach many of the structure[s] described herein. . . . T-tag fasteners are generally configured to Appeal 2011-004773 Application 10/698,148 3 flex at the juncture of the T and tail to allow delivery along the axis of the T through a minimal puncture diameter.” (Id. at 23, ¶ 164.) Claims 43-50, 52, 54-61, 72, and 73 are on appeal. Claims 43 and 52 are representative and read as follows: 43. A method of treating a patient, comprising the steps of: providing a gastrointestinal sleeve, having a proximal end, a distal end, and a lumen extending therethrough; transesophageally advancing the sleeve to position the proximal end adjacent an attachment site near the gastroesophageal junction; advancing the distal end through the stomach and into the intestine; and attaching the proximal end at the attachment site without creating a serosal to serosal bond, such that the sleeve is configured to deliver food from the esophagus directly into the intestine; wherein the attaching the proximal end step comprises anchoring at least one tissue anchor having a proximal end and a distal end, said anchoring comprising changing the distal end of the tissue anchor from a transversely reduced configuration used while passing transmurally through the attachment site to a transversely enlarged configuration used after passing transmurally through the attachment site, wherein the distal end of the tissue anchor includes a proximally facing surface which rests against a serosal surface to retain the sleeve, and wherein the enlarged configuration of the tissue anchor is transversely larger than any transverse portion of the tissue anchor when the tissue anchor is passing transmurally through the attachment site in the reduced configuration. 52. A method of treating a patient as in Claim 43, wherein the tissue anchor comprises a “T” tag. Appeal 2011-004773 Application 10/698,148 4 I. Issue The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103(a) as obvious based on Bessler,1 Taylor,2 and Moss3 (Answer 3). The Examiner finds that “Bessler discloses the claimed invention except for the attaching tissue anchors” (id. at 4) because Bessler’s sleeve is attached using a stent. The Examiner finds that Taylor teaches attaching a device using tissue anchors that pass transmurally through an attachment site without creating a serosal to serosal bond (id. at 4-5) and that Moss teaches surgical fasteners that have the transverse configurations recited in claim 43 (id. at 5). The Examiner concludes that it would have been obvious to modify Bessler by attaching its device without creating a serosal to serosal bond, as taught by Taylor, using the surgical fasteners taught by Moss because Moss teaches that its fasteners “provid[e] a means for tissue anchoring which substantially eliminates ancillary tissue damage and inaccurate placement” (id. at 6). Appellants contend that Bessler teaches only a nonpuncturing attachment system (Appeal Br. 9) and therefore it would not have been obvious to modify Bessler with the barbs of Taylor or the T-tags of Moss (id. at 10-11), and in fact Bessler teaches away from penetrating tissue attachment (id. at 12). Appellants also contend that they have provided 1 Bessler, US 2004/0039452, Feb. 26, 2004. 2 Taylor, US 6,254,642, July 3, 2001. 3 Moss, US 5,470,337, Nov. 28, 1995. Appeal 2011-004773 Application 10/698,148 5 evidence showing that a person of ordinary skill in the art would not have had a reasonable expectation of success in combining the references (id. at 11-12) as well as evidence of failure of others and unexpected results (id. at 13-14). The issues presented are: Does the evidence support the Examiner’s conclusion that it would have been obvious to combine the teachings of Bessler, Taylor, and Moss with a reasonable expectation of success? If so, have Appellants provided sufficient evidence to show that the claimed invention would not have been obvious, when Appellants’ evidence is weighed together with the prior art? Findings of Fact 1. Bessler discloses a method of treating obesity (Bessler 1, ¶ 6) in which “a device is inserted into a patient’s stomach endoscopically to separate ingested food from gastric fluids and, optionally, to separate ingested food in the duodenum from digestive enzymes” (id. at 1, ¶ 12). 2. “In one embodiment of the invention, a stent is inserted into a patient’s gastrointestinal tract to bypass the stomach. . . . Optionally the one- way-valve at the end of the stent can comprise a sleeve that extends through the stent, preferably into the duodenum or beyond.” (Id.) 3. “One end of the stent is intended to be positioned at or above the gastro-esophageal junction, and the other end is intended to be positioned in the duodenum or beyond” (id.). 4. Taylor discloses “an anti-reflux valve prosthesis system for treating gastroesophageal reflux disease” (Taylor, col. 2, ll. 19-21). Appeal 2011-004773 Application 10/698,148 6 5. Taylor discloses “perorally inserting [the] anti-reflux valve prosthesis down the lumen of the esophagus, to the gastroesophageal junction, where it is fixed in place” (id. at col. 2, ll. 23-25). 6. Taylor discloses that the prosthesis includes a tissue anchor array for fixing the prosthesis in the lumen of the esophagus (id. at col. 6, ll. 55- 57). In one embodiment, “the tissue anchor array 19 is comprised of barbed spikes 25 for piercing and engaging the lumen wall of the esophagus” (id. at col. 6, ll. 59-61). 7. Moss discloses that “[r]ecently, to avoid the time required to sew up a wound and tie the sutures, rapid fastening procedures have been developed, wherein an ‘H’ or ‘T’-shaped fastener is inserted into the tissue about the wound in lieu of a sewn stitch” (Moss, col. 1, ll. 27-31). 8. Moss discloses “a surgical fastener implantation device for quickly and accurately inserting and releasing either a ‘T’-shaped or ‘H’-shaped surgical fastener into a body” (id. at col. 3, ll. 33-36). 9. Moss discloses that its device “substantially eliminates ancillary tissue damage and the inaccurate placement commonly associated with the operation of prior art fastening devices” (id. at col. 4, ll. 17-19). Analysis Bessler discloses a method that meets the limitations of claim 43 except that Bessler’s sleeve is attached by way of a stent. Taylor discloses fixing an anti-reflux valve at the gastroesophageal junction using barbed spikes that pierce the wall of the esophagus. Moss provides an apparatus for inserting T-tags, which are an art-accepted alternative to sutures. Moss Appeal 2011-004773 Application 10/698,148 7 discloses that its device eliminates ancillary tissue damage and inaccurate placement when inserting T-tags. Based on these teachings, we agree with the Examiner that it would have been obvious to secure Bessler’s sleeve at the gastroesophageal junction using T-tags inserted using Moss’s device, in order to eliminate ancillary tissue damage in the securing process. Taylor provides evidence that securing a medical device at the gastroesophageal junction using methods that involve piercing the wall of the esophagus were known alternatives to using a stent as taught by Bessler. “When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). See also id. at 417 (“If a person of ordinary skill can implement a predictable variation [of a known work], § 103 likely bars its patentability.”). Appellants argue that Bessler only discloses a nonpuncturing attachment system (Appeal Br. 9) and the “use of sharpened barbs as disclosed in Taylor [is] therefore inconsistent with Bessler’s apparent intent of providing a non-penetrating less traumatic device for gastric bypass” (id. at 10). Appellants also argue that “[a] person of ordinary skill in the art attempting to practice the invention of Bessler would have no reason to include a penetrating fastener of the type disclosed in Moss any more than a penetrating fastener of the type disclosed in Taylor” (id. at 10-11). Appellants also argue that Bessler teaches away from penetrating tissue fasteners (id. at 12-13). Appeal 2011-004773 Application 10/698,148 8 These arguments are not persuasive. Bessler expresses “a need for less traumatic surgical or non-surgical techniques to treat obesity” (Bessler 1, ¶ 5). “Less traumatic,” in the context of Bessler’s disclosure, is relative to the “two primary surgical procedures used for achieving weight loss” (id. at 1, ¶ 4), which involve significant risk and many reported complications (see id. at 1, ¶ 5). A person of ordinary skill in the art would recognize that the method suggested by the cited references would be much less invasive than gastric bypass surgery (the result of which is illustrated in Figure 3 of Gannoe). In addition, Moss discloses that use of its device to insert T-tags substantially eliminates ancillary tissue damage. Appellants have not pointed to any disclosure in Bessler that would discourage a person of ordinary skill in the art from modifying Bessler by securing its sleeve using methods that involve even minimal tissue damage. Appellants also argue that the Examiner has not shown that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the cited references (Appeal Br. 11-12). Appellants cite the Thompson Declaration4 as evidence that “to Appellants’ knowledge, all methods of attaching a device to an attachment site near or at the gastroesophageal junction with the exception perhaps of esophageal stents in certain cancer patients, have generally resulted in failure” (id. at 11). Appellants also cite the Thompson Declaration as evidence of failure of 4 Declaration under 37 C.F.R. § 1.132 of Christopher Thompson dated Nov. 20, 2008 (Appeal Br. Evidence Appendix). Appeal 2011-004773 Application 10/698,148 9 others (id. at 13) and argue that “it was completely unexpected that Appellants’ claimed method . . . would achieve stable fixation” (id.). These arguments are also unpersuasive. Dr. Thompson declared that “to [his] knowledge, prior to the claimed invention, all methods of attaching a device to an attachment site near or at the gastroesophageal junction, with the exception perhaps of esophageal stents in certain cancer patients, have generally resulted in failure” (Thompson Declaration, ¶ 9). Dr. Thompson declared that he “was thus in fact extremely surprised that the methods claimed . . . have been very effective in safely, stably and securely attaching a device to an attachment site near the gastroesophageal junction, as evidenced by both animal trials as well as in human trials” (id.). Dr. Thompson concludes that he “would not have predicted the success of the claimed methods and devices from any of the teachings of Bessler, Taylor, or Gannoe” (id.). However, obviousness under § 103 is judged from the perspective of a hypothetical person of ordinary skill in the art, not from the perspective of any actual person working in the field. See In re Rouffet, 149 F.3d 1350, 1357 (Fed. Cir. 1998) (“Obviousness is determined from the vantage point of a hypothetical person having ordinary skill in the art.”). A person of ordinary skill in the art is presumed to be familiar with all of the relevant prior art. See id. (“The legal construct also presumes that all prior art references are available to this hypothetical skilled artisan.”). In this case, although Dr. Thompson was not aware of successful attachment of a device near or at the gastroesophageal junction, a hypothetical person of ordinary skill in the art would have been aware of Appeal 2011-004773 Application 10/698,148 10 Bessler’s disclosure of attachment using a stent “at or above the gastro- esophageal junction” (Bessler 1, ¶ 12), and Taylor’s disclosure that prior art surgically implantable anti-reflux valves were fixed at the gastroesophageal junction using, e.g., suturing (Taylor, col. 1, ll. 41-62), as well as its disclosure of an anti-reflux valve fixed at the gastroesophageal junction using barbed spikes (id. at col. 6, ll. 55-61). A person of ordinary skill in the art therefore would have been aware of multiple disclosures in the art of attaching a medical device at or near the gastroesophageal junction. Those disclosures are entitled to a presumption of enablement. See In re Antor Media Corp., 689 F.3d 1282, 1288 (Fed. Cir. 2012) (“[A] prior art printed publication cited by an examiner is presumptively enabling barring any showing to the contrary by a patent applicant.”). Appellants have cited no persuasive evidence, either in the Thompson Declaration or elsewhere, to show that despite the disclosures of Bessler and Taylor, a person of ordinary skill in the art would not have been aware of successful attempts to attach a medical device at or near the gastroesophageal junction. Given Dr. Thompson’s apparent lack of awareness of the examples cited by Bessler and Taylor of medical devices attached at or near the gastroesophageal junction, we find that Dr. Taylor’s statement that he was surprised at the success of the claimed method, as well as his statement that he would not have predicted success in combining the references, to be entitled to very little weight as evidence of the position of a hypothetical person of ordinary skill in the art who was familiar with all of the relevant prior art. We therefore do not find the Thompson Declaration to be Appeal 2011-004773 Application 10/698,148 11 persuasive evidence demonstrating the nonobviousness of the claimed method. We affirm the rejection of claim 43 as obvious based on Bessler, Taylor, and Moss. The claims were not argued separately, so claims 44-50, 52, 54-61, 72, and 73 fall with claim 43. 37 C.F.R. § 41.37(c)(1)(vii). Conclusion of Law The evidence supports the Examiner’s conclusion that it would have been obvious to combine the teachings of Bessler, Taylor, and Moss with a reasonable expectation of success. Appellants have not provided evidence of nonobviousness that outweighs the evidence of obviousness provided by the prior art. II. The Examiner has rejected all of the claims on appeal under 35 U.S.C. § 103(a) as obvious based on Gannoe,5 Taylor, and Moss (Answer 6). The Examiner finds that “Gannoe discloses a method for treating obesity and providing a lengthy sleeve and support tissue anchor with a temp or permanent cuff by suture transesophageally to an attachment site near the gastroesophageal junction” (id.). The Examiner relies on Taylor and Moss for the same teachings discussed previously (id. at 7-8) and concludes that it would have been obvious to attach Gannoe’s device using Moss’ fastening anchors (id. at 8). Appellants argue that “Gannoe discloses methods and devices for creating a tissue ring such as in the upper stomach. . . . This results in a 5 Gannoe et al., US 2004/0082963 A1, Apr. 29, 2004. Appeal 2011-004773 Application 10/698,148 12 permanent serosa to serosa scar tissue bond to reinforce and hold a tissue plication in place.” (Appeal Br. 14.) Appellants argue that “the Examiner cannot merely pick out Gannoe’s sleeve while ignoring the permanently tissue altering plication anchoring system” (id. at 15). We agree with Appellants that the Examiner’s rejection depends on picking out the optional tissue sleeve disclosed by Gannoe while ignoring its teachings directed to a method of creating tissue plications. “It is impermissible within the framework of section 103 to pick and choose from any one reference only so much of it as will support a given position, to the exclusion of other parts necessary to the full appreciation of what such reference fairly suggests to one of ordinary skill in the art.” In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986). Gannoe discloses “methods and apparatus for the transoral, or endoscopic, restriction of a hollow body organ, such as the creation of a small stomach pouch” (Gannoe 1, ¶ 8). “The end result of the procedure is the formation of a variety of organ divisions or plications that serve as barriers or ‘partitions’ or ‘pouches’ that are substantially sealed off from the majority of the organ cavity” (id. at 1-2, ¶ 8). Thus, Gannoe’s disclosed methods depend on creating plications or “tissue rings” from layers of the stomach wall (see id. at 3-4, ¶ 33). Although Gannoe discloses that its methods can also include “placement of an optional bypass conduit” (id. at 4, ¶ 35), the Examiner’s rejection depends on the use of that optional component to the exclusion of the rest of what is disclosed by Gannoe. We therefore agree with Appellants that the rejection based on Gannoe does not take into consideration what the Appeal 2011-004773 Application 10/698,148 13 reference as a whole fairly suggests to a person of ordinary skill in the art. See Hedges, 783 F.2d at 1041. The rejection based on Gannoe, Taylor, and Moss is reversed. SUMMARY We affirm the rejection of claims 43-50, 52, 54-61, 72, and 73 under 35 U.S.C. § 103(a) based on Bessler, Taylor, and Moss. We reverse the rejection under 35 U.S.C. § 103(a) based on Gannoe, Taylor, and Moss. 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). AFFIRMED lp Copy with citationCopy as parenthetical citation