Ex Parte Bell et al

Patent Trial and Appeal BoardAug 22, 2016

13443266 (P.T.A.B. Aug. 22, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/443,266 04/10/2012 Stephen Graham Bell 24955 7590 08/24/2016 ROGITZ & AS SOCIA TES Jeanne Gahagan 750B STREET SUITE 3120 SAN DIEGO, CA 92101 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. 1208.010 5594 EXAMINER HOUSTON, ELIZABETH ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 08/24/2016 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): Noelle@rogitz.com eofficeaction@appcoll.com J ohn@rogitz.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte STEPHEN GRAHAM BELL and GIUSEPPE AMAT0 1 Appeal2014-005685 Application 13/443,266 Technology Center 3700 Before JOHN C. KERINS, BRANDON J. WARNER, and AMANDA F. WIEKER, Administrative Patent Judges. WIEKER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Stephen Graham Bell and Giuseppe Amato ("Appellants") appeal under 35 U.S.C. Â§ 134(a) from the Examiner's November 21, 2013 non-final rejection of claims 1-3, 26, 27, and 30-43 ("Non-Final Act."). We have jurisdiction over the appeal under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 According to Appellants, the Real Party in Interest is Insightra Medical, Inc. Appeal Br. 2. Appeal2014-005685 Application 13/443,266 CLAIMED SUBJECT MATTER The invention concerns hernia repair implants. Spec. 1. Claim 1 is illustrative of the subject matter on appeal, and recites: 1. Hernia repair implant comprising: a first layer made of mesh for facing a body structure having a hernia defect to cover the defect while promoting tissue growth into the first layer from the body structure; a second layer opposed to the first layer and made of anti- adhesion material to prevent growth of tissue into the second layer from body structures contacting the second layer; at least a first elongated fixation strap having a first end connected to at least one of the first or second layers at a first radial distance and a second end opposed to the first end and disposed radially distant from periphery of the first layer, the first elongated fixation strap having a configuration in which the first elongated fixation strap extends lengthwise away from and coplanar with one of the first and second layers to which the fixation strap is connected; and at least a first elongated centering strap having a first end connected to at least one of the first or second layers at a second radial distance, the second radial distance being fhrther from the periphery of the first layer than the first radial distance at which the first end of the first elongated fixation strap is connected, the first elongated centering strap having a configuration in which the first elongated centering strap extends lengthwise away from and coplanar with one of the first and second layers to which the centering strap is connected. Appeal Br. 7 (Claims App.) (emphases added). Independent claim 43 similarly requires fixation and centering straps that "extend[] lengthwise coplanar with" a plane defined by an implant's major surface. Id. at 10 (Claims App.). 2 Appeal2014-005685 Application 13/443,266 REJECTIONS The claims stand rejected as follows: I. Claims 1-3, 26, 27, and 30-43 under 35 U.S.C. Â§ 112, first paragraph, as failing to comply with the written description requirement. II. Claims 1-3, 37-39, and 43 under 35 U.S.C. Â§ 102(b) as anticipated by Crawley (US 2009/0240267 Al, pub. Sept. 24, 2009). III. Claims 26, 27, 31, 32, 34, 36, and 40 under 35 U.S.C. Â§ 103(a) as unpatentable over Crawley. IV. Claim 30 under 35 U.S.C. Â§ 103(a) as unpatentable over Crawley and Criscuolo (US 2011/0130774 Al, pub. June 2, 2011). V. Claims 33 and 35 under 35 U.S.C. Â§ 103(a) as unpatentable over Crawley and Browning (US 2008/0200751 Al, pub. Aug. 21, 2008). 2 VI. Claim 41under35 U.S.C. Â§ 103(a) as unpatentable over Crawley and Darios (US 7,404,819 Bl, iss. July 29, 2008). VII. Claim 42 under 35 U.S.C. Â§ 103(a) as unpatentable over Crawley and Anderson (US 2004/0039453 Al, pub. Feb. 26, 2004). 2 The Examiner's rejection lists incorrectly the publication number for Browning. Non-Final Act. 9. The Examiner provides the correct publication number in the Answer. Ans. 3. 3 Appeal2014-005685 Application 13/443,266 ANALYSIS Written Description - Claims 1-3, 26, 27, and 30-43 Appellants argue claims 1-3, 26, 27, and 30-43 as a group. Appeal Br. 4; Reply Br. 1-2. We treat claim 1 as representative, and claims 2, 3, 26, 27, and 30-43 stand or fall with claim 1. 37 C.F.R. Â§ 41.37(c)(iv). The Examiner finds that the originally filed Specification does not provide adequate written descriptive support for a fixation strap and a centering strap, each of which "extends lengthwise away from and coplanar with one of the first and second layers," as claimed. Non-Final Act 4. Appellants contend that Figure 4 and Figure 6 "plainly and unambiguously show[] to the skilled artisan exactly what is claimed." Appeal Br. 4. Specifically, Appellants argue that Figure 4 depicts fixation strap 40 "extending away from the edge of the layer to which the strap is connected, and thus [strap 40] is coplanar with the layer." Id.; see also Reply Br. 2. Appellants also argue that Figure 6 depicts "all straps lying flat against the mesh body, meaning that at least the bottom of the surfaces of each strap touch and thus are coplanar with the mesh body." Appeal Br. 4; see also Reply Br. 1-2 ("[I]f two things lie in the same plane (as the bottom surface of the strap and [the] top surface of the layer do), then they are coplanar."). To satisfy the written description requirement of 35 U.S.C. Â§ 112, first paragraph, Appellants' Specification "must 'clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed' ... [by] reasonably convey[ing] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." 4 Appeal2014-005685 Application 13/443,266 Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en bane) (citation omitted). Appellants do not direct us to any textual portion of the Specification that provides support for the "coplanar" arrangement reflected in the claims, and we find none. Further, we find that Figures 4 and 6, to which Appellants direct our attention, do not provide adequate written descriptive support sufficient to demonstrate that the inventor had possession of the claimed subject matter as of the filing date of this application. During examination, "claims ... are to be given their broadest reasonable interpretation consistent with the specification," and "claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Bond, 910 F.2d 831, 833 (Fed. Cir. 1990). Therefore, the words of the claim must be given their plain meaning unless the plain meaning is inconsistent with the specification. In re Zietz, 893 F.2d 319, 321 (Fed. Cir. 1989). An appropriate definition of "coplanar," in the context of the claim language, is "lying or acting in the same plane." See Ans. 3 (providing Merriam-Webster Dictionary definition); see also Merriam-Webster Dictionary, accessed at http://www.merriam-webster.com/dictionary/coplanar, last viewed Aug. 16, 2016. Appellants provide neither evidence nor argument to support a different construction of this term and, as noted above, Appellants' Specification provides no guidance as to the meaning of this term in the context of the disclosed invention. With this interpretation in mind, we tum to Figures 4 and 6, which Appellants contend provide support for the disputed claim limitations. Figure 4 depicts centering straps 34 extending perpendicularly outward from 5 Appeal2014-005685 Application 13/443,266 mesh implant 26, in an arrangement that plainly is not "coplanar," as claimed and construed. See Spec., Fig. 4; see also Ans. 5. Furthermore, although fixation straps 40 are depicted as generally extending outward from implant 26, both the implant and straps are shown to be curved and undulating. See Spec., Fig. 4; see also Ans. 5. As such, this Figure alone does not provide sufficient clarity such that a person of ordinary skill in the art would recognize that the inventor had possession of a fixation strap that, as a whole, lays in the same plane as one layer of the implant. See Ans. 5. Figure 6 depicts a plan view of mesh implant 48 with centering straps 44 and fixation straps 46. Spec. 5, 13-14. We are unpersuaded by Appellants' argument that Figure 6 depicts "all straps lying flat against the mesh body, meaning that at least the bottom of the surfaces of each strap touch and thus are coplanar with the mesh body." Appeal Br. 4; see also Reply Br. 1-2. As noted by the Examiner, Figure 6 is presented in two dimensions, and lacks any depiction of the critical third dimension. Ans. 4-- 5. Accordingly, Figure 6 alone does not depict a view of the connection between the implant and the straps that would permit a person of ordinary skill in the art to determine whether the straps are located immediately adjacent the implant's surface, e.g., "flat against the mesh body," as argued by Appellants, or spaced therefrom. Furthermore, even if it were clear from Figure 6 that the straps lay flat against the implant, this would not establish that the straps and implant are coplanar, as construed. Such a showing would establish only that the surfaces of the strap and implant lay in abutting planes. See, e.g., Reply Br. 1-2 ("[I]f two things lie in the same plane (as the bottom swface of the strap and [the] top swface of the layer do), then 6 Appeal2014-005685 Application 13/443,266 they are coplanar.") (emphases added). This does not establish that the objects themselves lay in the same plane, i.e., are coplanar, as claimed. Finally, Appellants' Figures 4 and 6 depict implants 26 and 48, respectively, without depicting first and second layers, as claimed. Spec., Figs. 4, 6. Indeed, the Specification discloses that the implants "may be a single layer or have a multilayer construction." See and compare id. at 8 (discussing Figures 2-5), 13 (stating that the Figure 6 implant is "such as the one shown in Figures 2-5"), with Reply Br. 2 (arguing that the implant shown in Figure 4 is "made of the claimed layers"). Therefore, although the implants depicted in Figures 4 and 6 may comprise multiple layers, they do not necessarily contain multiple layers and do not necessarily contain the specific layers claimed. As such, we are unpersuaded by Appellants' argument that "element 40 in figure 4 plainly is extending away from the edge of the layer to which the strap is connected, and thus is coplanar with the layer," because it is unclear what "layer" is referenced. Appeal Br. 4. For these reasons, we affirm the Examiner's rejection of claims 1-3, 26, 27, and 30-43 as failing to comply with the written description requirement of 35 U.S.C. Â§ 112, first paragraph. Anticipation by Crawley- Claims 1-3, 3 7-3 9, and 43 and Obviousness over Crawley, Alone or in Combination with Additional Prior Art- Claims 26, 27, 30-36, and 40-42 As discussed above, independent claims 1 and 43 recite fixation and centering straps that are "coplanar" with one layer of an implant, or with a plane defined by an implant's major surface. Appeal Br. 7, 10 (Claims App.). The Examiner finds that Crawley discloses a hernia repair implant comprising first and second layers, fixation straps (outer elements 12), and 7 Appeal2014-005685 Application 13/443,266 centering straps (inner elements 12), wherein the fixation and centering straps are "configured to extend 'coplanar' as shown in FIG. 5B," when optional bundling means 18 either are not provided or are dissolved. Non- Final Act. 5---6. Appellants contend that Crawley's elements 12 are not coplanar with one of the implant's layers. Appeal Br. 4--6. Appellants contend that these elements are "angled up and away" from the implant. Id. at 5---6. We agree with Appellants that Crawley does not depict fixation and centering straps that are coplanar with the implant. Crawley discloses that when bundling means 18 dissolves or absorbs, it "will release the hollow members [12] to allow them to better conform to the shape of the defect into which they were inserted." Crawley i-f 36. Crawley's Figure 5B depicts elements 12 unrestrained by bundling means 18 and shows that these elements are capable of extending toward implant 52. Id., Fig. 5B. Crawley does not establish, however, that elements 12 would lay in the same plane as implant 52, as required by the broadest reasonable interpretation of the term "coplanar," as discussed above. See supra at 7 (finding the "coplanar" limitations unsupported by the Specification). Consequently, we cannot affirm the Examiner's rejection of claims 1 or 43, or the rejections of claims 2, 3, 26, 27, and 30-42, which claims depend from claim 1, as anticipated or obvious over the asserted prior art. We reverse these rejections. DECISION The Examiner's rejection of claims 1-3, 26, 27, and 30-43 as failing to comply with the written description requirement of 35 U.S.C. Â§ 112, first paragraph is AFFIRMED; 8 Appeal2014-005685 Application 13/443,266 the Examiner's rejection of claims 1-3, 37-39, and 43 as anticipated by Crawley under 35 U.S.C. Â§ 102(b) is REVERSED; and the Examiner's rejections of claims 26, 27, 30-36, and 40-42 as unpatentable under 35 U.S.C. Â§ 103(a) are REVERSED. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. Â§ 1.136(a). AFFIRMED 9