Ex Parte Ebersole et alDownload PDFPatent Trial and Appeal BoardSep 26, 201712572352 (P.T.A.B. Sep. 26, 2017) 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. 12/572,352 10/02/2009 Garrett Ebersole H-US-00894 CIP 2 3723 (203-546 50855 7590 Covidien LP 60 Middletown Avenue Mailstop 54, Legal Dept. North Haven, CT 06473 09/28/2017 EXAMINER ORKIN, ALEXANDER J ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 09/28/2017 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): SurgicalUS@covidien.com medtronic_mitg-si_docketing@cardinal-ip.com mail @ cdfslaw. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GARRETT EBERSOLE, MARWA CHOUDHURY, RONALD OSTAPOFF, BRIAN NENTWICK, and RICHARD P. STEVENSON1 Appeal 2016-008133 Application 12/572,352 Technology Center 3700 Before ERIC B. GRIMES, TAWEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. NEWMAN, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134 involves claims to a reinforcing material comprising a buttress. The Examiner entered final rejections for anticipation and obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellants state “the real party in interest is the assignee of this patent application, Covidien LP. The ultimate parent of Covidien LP is Medtronic, pic.” App. Br. 1. Appeal 2016-008133 Application 12/572,352 STATEMENT OF THE CASE Background The present disclosure relates to articles of polymeric materials in tape, ribbon, sheet, and/or film configurations. These polymeric materials may be formed so that they possess no orientation or multi-directional orientation, which may enhance the integrity of the polymeric material when multidirectional forces are applied thereto. The polymeric materials of the present disclosure may be utilized in numerous applications including, in embodiments, as surgical buttresses or reinforcing tapes for staple or suture lines. Spec. 1:12-18. “While buttresses may be used in conjunction with stapling devices or sutures to enhance sealing of wounds, materials possessing a unidirectional orientation as described above may crack or tear with the application of small amounts of force.” Id. at 2:23 to 3:3. “Thus, it would be advantageous to provide a material for use with existing wound closure methods to enhance the sealing of a wound. Such materials may be utilized in conjunction with a surgical stapling device as well as sutures and other wound closure methods.” Id. at 3:7—10. The Claims Claims 1—7 and 9-15 are on appeal. Final Act. I.2 Claim 1 is illustrative and reads as follows: 1. A reinforcing material comprising a buttress made from a polymeric film which possesses no orientation or a multi-directional orientation and includes at least one of glycolide, lactide, dioxanone, trimethylene carbonate, and 2 Examiner’s Final Action, mailed September 10, 2015. 2 Appeal 2016-008133 Application 12/572,352 caprolactone, wherein the buttress comprises etched portions which extend parallel and continuously along an entire length of the buttress to increase a surface area of the reinforcing material. Appeal Br. 11 (Claims Appendix). The following rejections are before us to review: Claims 1—3, 5, 6, 9-11, 14, and 15 are rejected under 35 U.S.C. § 102(e) as anticipated by Bergin.3 Final Act. 2. Claim 12 is rejected under 35 U.S.C. § 103(a) as obvious over Bergin in view of McNiven.4 5Id. at 6. Claims 1—7, 9—11, and 13—15s are rejected under 35 U.S.C. § 102(e) as anticipated by O’Brien.6 Id. at 4. Claim 12 is rejected under 35 U.S.C. § 103(a) as obvious over O’Brien in view of McNiven. Id. at 6. I The Examiner has rejected claims 1—3, 5, 6, 9—11, 14, and 15 as anticipated by Bergin. The Examiner finds Bergin discloses all of the limitations of claim 1. Final Act. 2—3.7 Specific to the issues on appeal, the 3 US 2007/0118229 Al, published May 24, 2007 (“Bergin”). 4 US 7,989,018 B2, issued Aug. 2, 2011 (“McNiven”). 5 Although the Final Action lists claim 16 among the rejected claims, Appellants cancelled claim 16. App. Br. 12. 6 US 2007/0112421 Al, published May 17, 2007 (“O’Brien”). 7 In the Answer, the Examiner states: The Product-by-Process interpretations in both the rejection of claims 1—3, 5, 6, 9-11, 14, and 15 under 35 U.S.C. § 102(e) as being anticipated over U.S. Patent Publication 2007/0118229 to Bergin et al and the rejection of claims 1—7, 9-11 and 13—16 3 Appeal 2016-008133 Application 12/572,352 Examiner finds Bergin discloses “a reinforcing material [an article] comprising a buttress.” Id. The issue in this rejection is whether a preponderance of the evidence supports the Examiner’s finding that Bergin anticipates the rejected claims. Among other arguments, Appellants argue Bergin “describes ‘ [a]n intramedullary implant for mounting within an intramedullary canal of a bone. However, nowhere does Bergin disclose or suggest a buttress.” App. Br. 3^4. Appellants argue the Examiner’s interpretation of “buttress” is unreasonably broad in light of the Specification. Id. at 4. Appellants argue the Specification defines “buttress” as follows: In embodiments, the polymeric materials may be utilized to form buttresses or similar materials for use in conjunction with wound closure devices such as staplers and sutures to enhance wound closure. The term “buttress” as used herein includes a device, such as a pledget* * * * * * * [8], which provides support (i.e., mechanical) to the suture or staple line, and also to the surrounding tissue. under 35 U.S.C. § 102(e) as being anticipated over U.S. Patent Publication 2007/0112421 to O'Brien et al have been withdrawn. However, both Bergin and O’Brien rejections still stand based on anticipating the limitations without only depending on the product by process interpretation as argued in the office action filed 09/10/2016 and in the response to arguments below. Ans. 2—3. We restrict our analysis to the Examiner’s findings accordingly. 8 A pledget is “a small flat absorbent pad used to medicate, protect, or absorb drainage from a wound or sore.” The American Heritage Dictionary of Medicine (2nd ed.). Boston, MA: Houghton Mifflin. 4 Appeal 2016-008133 Application 12/572,352 App. Br. 4—5, citing Spec. 6:5—9 (emphasis in brief). Appellants argue that in light of this disclosure, the skilled artisan would recognize that Bergin’s intramedullary implant is not a buttress. Id. at 5. The Examiner responds that “[t]he claim limitation of ‘buttress’ does not positively recite that it will be used with a suture or staple line. Therefore it can be read as a ‘supportive structure’ to surrounding tissue.” Ans. 4. The Examiner states that Bergin “discloses an article ‘200’ that can act as a buttress that will be supportive to surrounding tissue as seen in figure 6.” Id. at 4. The Examiner further states that Bergin discloses embodiments with “bone engaging features” and devices used for “stabilizations which can further read on a buttress function that ‘supports surrounding tissue.’” Id. In reply, Appellants argue that “the claims must be given the broadest reasonable interpretation consistent with the specification,” citing In re Am. Acad. ofSci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Reply Br. 2. According to Appellants, the skilled artisan “would recognize that the recited films are used as buttresses or similar materials used with wound closure devices [which] Bergin does not disclose.” Id. at 3. Principles of Law “The protocol of giving claims their broadest reasonable interpretation during examination does not include giving claims a legally incorrect interpretation. This protocol is solely an examination expedient, not a rule of claim construction.” In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir. 2009). 5 Appeal 2016-008133 Application 12/572,352 Analysis We agree with Appellants that Bergin’s reinforcing material does not meet the limitations of the claims on appeal. Bergin discloses “[a]n intramedullary implant for mounting within an intramedullary canal of bone.” Bergin Abstract. Bergin, which pertains to components of prostheses for orthopedic surgery (see Abstract) discloses that a “stem” is one of three parts of a replacement joint used for shoulder or hip surgery. Id. | 5. Figure 6, which the Examiner relies on to show that the reinforcing article “can act as a buttress that will be supportive to surrounding tissue” (Ans. 4) is disclosed by Bergin as “a side plan view of fixation points of the stem” and as showing that “the fit obtained inside the intramedullary canal will be stable three-point fixation.” Id. 35/70. Bergin’s stem is therefore disclosed for use in bone fixation and not to stabilize a wound closure. The Examiner has not pointed us to any other disclosures in Bergin supporting the Examiner’s interpretation. We are not persuaded by the Examiner’s reasoning that “buttress” requires a positive recitation in the claim that it will be used with a suture or staple line (Ans. 4). Rather, we agree with Appellants that, under the holding of American Academy, the claims are to be given the broadest reasonable interpretation consistent with the specification as understood by the ordinarily skilled artisan (App. Br. 4, American Academy, 367 F.3d at 1364). As shown in the passage quoted by Appellants above, “buttress” would have been understood by the skilled artisan to mean a device that provides support to a suture or staple line and its surrounding tissue, not a device to be fixed within bone. We therefore reverse the rejection under 35 U.S.C. § 102(e). 6 Appeal 2016-008133 Application 12/572,352 II The Examiner has rejected claim 12 over Bergin in view of McNiven. Final Act. 6. This rejection relies upon the underlying anticipation rejection over Bergin. Having reversed the Bergin rejection for the reasons given above, we necessarily reverse the obviousness rejection based on Bergin and McNiven, as the Examiner does not rely upon McNiven to address the “buttress” limitation of independent claim 1. III The Examiner has rejected claims 1—7, 9-11, and 13—15 as anticipated by O’Brien. The Examiner finds O’Brien discloses all of the limitations of claim 1. Final Act. 4. Specific to the issues on appeal, the Examiner finds O’Brien discloses “a reinforcing material [an article] comprising a buttress.” Id. The issue in this rejection is whether a preponderance of the evidence supports the Examiner’s finding that O’Brien anticipates the rejected claims. Among other arguments, Appellants argue O’Brien “has not been shown to have described a reinforcing material including ‘a buttress . . .’ as recited in amended claim 1.” App. Br. 6. Rather, Appellants argue, O’Brien “describes a medical device, such as a stent, for treating a body lumen” that is not “the recited buttresses.” Id. Appellants incorporate their reasoning as applied to the Bergin rejection above with respect to the interpretation of “buttress” by the ordinarily skilled artisan in light of the Specification. Id. 7 Appeal 2016-008133 Application 12/572,352 The Examiner responds that “O’Brien teaches an article ‘50’ that can support surrounding tissue as seen in figure 9, lOa-d, and paragraph 36, 41 in that they contact the surrounding the vessel upon expansion.” Ans. 4. In reply, Appellants reiterate that “the Office’s interpretation of the claims ignores the recitations of both a buttress and/or a film. . . . O’Brien’s stents are neither.” Reply Br. 3. We agree with Appellants that O’Brien’s stent does not meet the limitations of the claims on appeal. O’Brien discloses “medical devices, such as stents, for providing a medical treatment to an area of a patient, such as a body lumen.” O’Brien Abstract. O’Brien discloses its invention as: A medical device is described comprising: a stent having at least a first strut, wherein the first strut comprises an outer surface configured to engage a body lumen when the stent is expanded, an inner surface opposite the outer surface, and at least one side surface extending between the outer surface and the inner surface; a coating disposed on a portion of at least one strut surface; and at least a first groove disposed in the coating and situated along the at least one strut surface. Id. 14. Figure 9, which the Examiner relies on to show that the stent can support surrounding tissue (Ans. 4), discloses “cross-sectional views of various groove arrangements on an exemplary strut.” Id. 131. Figures 10a— d, similarly relied upon the Examiner, disclose “a top view, partially in section, of the stent in an unexpanded state within a body lumen,” followed by views depicting positioning and expansion of the stent within the lumen. Id. 1131-34. O’Brien’s stent is therefore disclosed for use in a body lumen such as a blood vessel and not to stabilize a wound closure. The Examiner has not 8 Appeal 2016-008133 Application 12/572,352 pointed us to any other disclosures in O’Brien supporting the Examiner’s interpretation. As above, we are persuaded by Appellants that “buttress” would have been understood by the skilled artisan to mean a device that provides support to a suture or staple line and its surrounding tissue, not a device to be affixed within a body lumen. We therefore reverse the rejection under 35 U.S.C. § 102(e). IV The Examiner has rejected claim 12 over O’Brien in view of McNiven. Final Act. 6. This rejection relies upon the underlying anticipation rejection over O’Brien. Having reversed the O’Brien rejection for the reasons given above, we necessarily reverse the obviousness rejection based on O’Brien and McNiven, as the Examiner does not rely upon McNiven to address the “buttress” limitation of independent claim 1. SUMMARY We reverse the rejection of claims 1—3, 5, 6, 9-11, 14, and 15 under 35 U.S.C. § 102(e) as anticipated by Bergin. We reverse the rejection of claim 12 under 35 U.S.C. § 103(a) as obvious over Bergin in view of McNiven. We reverse the rejection of claims 1—7, 9-11, and 13—15 under 35 U.S.C. § 102(e) as anticipated by O’Brien. We reverse the rejection of claim 12 under 35 U.S.C. § 103(a) as obvious over O’Brien in view of McNiven. REVERSED 9 Copy with citationCopy as parenthetical citation