Ex Parte Saadat et alDownload PDFPatent Trial and Appeal BoardOct 4, 201210898683 (P.T.A.B. Oct. 4, 2012) Copy Citation 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. 10/898,683 07/23/2004 Vahid Saadat USGINZ02800 2870 7590 10/05/2012 USGI Medical, Inc. 1140 Calle Cordillera San Clemente, CA 92673 EXAMINER NGUYEN, TUAN VAN ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 10/05/2012 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 AND TRIAL APPEAL BOARD __________ Ex parte VAHID SAADAT and DESMOND BIRKETT __________ Appeal 2011-012097 Application 10/898,683 Technology Center 3700 __________ Before DEMETRA J. MILLS, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for achieving prolonged maintenance of gastrointestinal tissue folds. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2011-012097 Application 10/898,683 2 Statement of the Case “The present invention relates to methods and apparatus for achieving prolonged maintenance of gastrointestinal („GI‟) tissue folds by forming, securing and promoting healing of the folds. More particularly, the present invention provides methods and apparatus for remodeling the tissue folds to facilitate their prolonged maintenance” (Spec. 1 ¶ 0001). The Claims Claims 16-22, 24-30, and 32-35 are on appeal. Claim 16 is representative and reads as follows: 16. A method for achieving prolonged maintenance of gastrointestinal tissue folds, the method comprising: injuring at least a first region of tissue to be approximated against a second region of tissue; removing at least a portion of injured tissue from the first region to be approximated; contacting the first region of tissue against the second region of tissue to promote healing between the first and second regions of tissue; and deploying an anchor assembly comprising a pair of tissue anchors connected by a suture through the first region of tissue and the second region of tissue to secure the first region of tissue to the second region of tissue. The issue The Examiner rejected claims 16-22, 24-30, and 32-35 under 35 U.S.C. § 103(a) as obvious over Deem 1 (Ans. 3-5). The Examiner finds that Deem teaches “a method for performing gastric reduction, the method comprising: forming anterior and posterior 1 Deem et al., US 6,558,400 B2, issued May 6, 2003. Appeal 2011-012097 Application 10/898,683 3 tissue folds within a patient‟s stomach (col. 10, lines 29-37 and lead line 24 of Figs. 8A-8B)” (Ans. 3). The Examiner finds that Deem teaches injuring “tissue disposed between the anterior and posterior tissue folds; approximating the anterior and posterior tissue folds such that the approximated tissue folds contact one another in a region of injured or removed tissue, thereby promoting healing between the at least two tissue folds” (id.). The Examiner finds that Deem teaches that “stapler 172 is used to forms [sic] the lumen 26 of Figs. 8A and 8B and the side surface of septum 184 of stapler 172 includes „a cutting, abrading, scoring, heating, freezing, chemically damaging, or s[o]me other damaging surface to tissue” (id.). Appellants contend that “the only tissue injuring process described by Deem is performed by a particular embodiment of the stapling unit (172), and is performed only during a portion of the process in which first and second portions of the stomach are brought into apposition . . . prior to staple deployment” (App. Br. 13). Appellants also contend that “the only anchor deployment process described by Deem is performed by deploying the anchors (80) into tissue prior to drawing a suture (82) tight to bring the opposing surfaces into apposition” (id.). Appellants contend that “[n]owhere is there any description, suggestion, or hint of a method that would include both injuring tissue and deploying an anchor assembly - which is what is recited in claim 16. Nor is there any obvious manner by which these method steps would be combined” (id.). Appeal 2011-012097 Application 10/898,683 4 The issue with respect to this rejection is: Does the evidence of record support the Examiner‟s conclusion that Deem renders claims 16 and 26 obvious? Findings of Fact 1. Deem teaches that “an endoscopic stapler preferably brings two regions of tissue into apposition and may then apply a fastening element, e.g., staples, clips, tags, screws, etc., into the two regions of tissue to affix them together” (Deem, col. 4, ll. 21-26). 2. Figure 8B of Deem is reproduced below: Figure 8B shows “a superior view of a modified stomach maintained by a fastening staple” (Deem, col. 5, ll. 44-45). Appeal 2011-012097 Application 10/898,683 5 3. Deem teaches that: FIG. 8A shows the cross sectioned superior view of FIG. 1B with the addition of staple 160 maintaining junction 24. The figure shows an example of how, e.g., an endoscopically applied stapler, may be used to retain and hold junction 24 to form modified lumen 26. FIG. 8B shows a close-up view of the junction 24 and staple 160 which was applied from within lumen 26. (Deem, col. 10, ll. 32-38.) 4. Deem teaches that as “the tissue is held to unit 172, septum 184 may be withdrawn . . . . Removal of septum 184 may then bring the first and second portions of tissue into contact apposition. The side surfaces 188 of septum 184 may incorporate a cutting, abrading, scoring, heating, freezing, chemically damaging, or some other damaging surface to tissue” (Deem, col. 11, ll. 33-41). 5. Deem teaches that this “damage may encourage a more vigorous healing response and a more permanent fixation between the damaged tissue once stapled or affixed together” (Deem, col. 11, ll. 43-46). 6. Deem teaches that “[a]fter removal of septum 184, the staples loaded within staple enclosure 176 may be fired through staple slots 180 to affix the tissue” (Deem, col. 11, ll. 47-49). 7. Deem teaches an embodiment where after “anchors 80 have been fastened, suture 82 may be drawn through each of the anchors 80, preferably in a zig-zag manner, and then suture 82 may be drawn tight to bring the opposing surfaces of interior lining 74 together in apposition along dye marks 72 to form the modified lumen” (Deem, col. 9, ll. 11-16). Appeal 2011-012097 Application 10/898,683 6 8. Deem teaches that as “pusher sleeve 456 advances, it may also push or urge elastic ring 458 distally along inner tube 452 until ring 458 is pushed entirely off the distal end of inner tube 452 and onto a portion of lining tissue 466” (Deem, col. 19, ll. 18-21). 9. Figures 27A-D are reproduced below: Appeal 2011-012097 Application 10/898,683 7 “FIGS. 27A to 27D show the device . . . inserted into a stomach to draw or cinch up lining tissue to reduce a volume of the stomach” (Deem, col. 6, ll. 47-49). 10. Deem teaches that “[d]evice 450 may then be removed from stomach 460 . . . thereby leaving lining tissue 466 with elastic ring 458. After time . . . pressure necrosis may cause lining tissue 466 and ring 458 to simply fall off from the rest of interior surface 464 to be passed normally through the rest of the patient‟s body” (Deem, col. 19, ll. 22-27). 11. Deem teaches that as “bougie 40 is advanced down to pylorus 76, distal balloon 52 may be inflated through inflation tip 50, thus securing the device” (Deem, col. 8, ll. 33-35). Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.” Id. at 417. Analysis Claim 16 Deem teaches that “an endoscopic stapler preferably brings two regions of tissue into apposition and may then apply a fastening element, e.g., staples, clips, tags, screws, etc., into the two regions of tissue to affix them together” (Deem, col. 4, ll. 21-26; FF 1). Deem specifically teaches an example where “the tissue is held to unit 172, septum 184 may be withdrawn . . . . Removal of septum 184 may then Appeal 2011-012097 Application 10/898,683 8 bring the first and second portions of tissue into contact apposition. The side surfaces 188 of septum 184 may incorporate a cutting, abrading, scoring, heating, freezing, chemically damaging, or some other damaging surface to tissue” (Deem, col. 11, ll. 33-41; FF 4). The Examiner finds that during “the process of abrading, cutting the tissue, some of the tissue will be removed or shed, thus, Deem et al. discloses the step of removing injured tissue” (Ans. 4). Deem teaches that this “damage may encourage a more vigorous healing response and a more permanent fixation between the damaged tissue once stapled or affixed together” (Deem, col. 11, ll. 43-46; FF 5). While the embodiment of figures 8 and 9 relies upon the use of a stapler, Deem teaches a separate embodiment where after “anchors 80 have been fastened, suture 82 may be drawn through each of the anchors 80, preferably in a zig-zag manner, and then suture 82 may be drawn tight to bring the opposing surfaces of interior lining 74 together in apposition along dye marks 72 to form the modified lumen” (Deem, col. 9, ll. 11-16; FF 7). Applying the KSR standard of obviousness to the findings of fact, we conclude that the person of ordinary skill and creativity would have predictably recognized that when Deem teaches that the stapler affixes two regions of tissue in apposition using a “fastening element” where the “fastening element” may be selected from a nonexclusive list of components (FF 1), and Deem separately teaches affixing two regions of tissue using anchors and a suture (FF 7), the ordinary artisan would have found it obvious to use the anchors and suture as a fastening element in the stapler embodiment. Such a combination is merely a “predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417. Appeal 2011-012097 Application 10/898,683 9 Appellants contend that “the only tissue injuring process described by Deem is performed by a particular embodiment of the stapling unit (172), and is performed only during a portion of the process in which first and second portions of the stomach are brought into apposition . . . prior to staple deployment” (App. Br. 13). Appellants also contend that “the only anchor deployment process described by Deem is performed by deploying the anchors (80) into tissue prior to drawing a suture (82) tight to bring the opposing surfaces into apposition” (id.). Appellants contend that “[n]owhere is there any description, suggestion, or hint of a method that would include both injuring tissue and deploying an anchor assembly - which is what is recited in claim 16. Nor is there any obvious manner by which these method steps would be combined” (id.). We are not persuaded. Deem teaches that the regions placed in apposition may be joined by a variety of different fastening elements, including “e.g., staples, clips, tags, screws, etc., into the two regions of tissue to affix them together” (Deem, col. 4, ll. 24-26; FF 1). Deem also teaches an additional mode of fastening where “suture 82 may be drawn through each of the anchors 80, preferably in a zig-zag manner, and then suture 82 may be drawn tight to bring the opposing surfaces of interior lining 74 together in apposition along dye marks 72 to form the modified lumen” (Deem, col. 9, ll. 11-16; FF 7). In Icon, the Court found that an inventor considering a hinge and latch mechanism for portable computers would naturally look to references employing other “housings, hinges, latches, springs, etc.,” which in that case came from areas such as “a desktop telephone directory, a piano lid, a kitchen cabinet, a washing Appeal 2011-012097 Application 10/898,683 10 machine cabinet, a wooden furniture cabinet, or a two-part housing for storing audio cassettes.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1380 (Fed. Cir. 2007) (citing In re Paulsen, 30 F.3d 1475, 1481 (Fed.Cir. 1994). The instant situation is similar to that of Icon and Paulsen, since in the instant case an ordinary practitioner considering different fastening elements to join two tissue regions would have reasonably considered all of the different attachment mechanisms disclosed by Deem, which includes the use of anchors and sutures (FF 7). Claim 26 Appellants contend that “claim 26 recites a method including the step of „shapelocking the device.‟ The Office Action does not identify any teaching in the Deem patent corresponding with this limitation in its rejection of claim 26” (App. Br. 16). The Examiner finds that in “col. 8, lines 2-54, Deem et al. disclose a marking device or Bougie 40 preferably be used at the beginning of the procedure and using a distal balloon 52 to securing the device before delivering of the die [sic dye]. The step of securing the Bougie 40 is interpreted as shape-locking the device” (Ans. 8). We find the Examiner has the better position. While the Specification does not directly define the term “shape-lockable,” the Specification does state that “[o]ne or more of the tools optionally may be steerable or shape- lockable/rigidizable” (Spec. 4 ¶ 0016). Thus, we interpret shape-lockable to be equivalent to “rigidizable,” so that the term is reasonably interpreted as broadly requiring that the tool may be secured in a rigid form. Deem teaches Appeal 2011-012097 Application 10/898,683 11 that after balloon 52 is inflated, the bougie is secured to a particular location, which securing reasonably makes the bougie “rigid” relative to its previous unsecured state (FF 11). Because claim 26 is of the open “comprising” format, the first two steps of claim 26 may reasonably refer to the insertion and securement of the bougie 40, with the remaining steps referring to the formation of anchored tissue folds as discussed above regarding claim 16. Conclusion of Law The evidence of record supports the Examiner‟s conclusion that Deem renders claims 16 and 26 obvious. SUMMARY In summary, we affirm the rejection of claims 16 and 26 under 35 U.S.C. § 103(a) as obvious over Deem. Pursuant to 37 C.F.R. § 41.37(c)(1), we also affirm the rejection of claims 17-22, 24, 25, 27-30, and 32-35 as these claims were not argued separately. 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 cdc Copy with citationCopy as parenthetical citation