Ex Parte McKinsey et alDownload PDFPatent Trial and Appeal BoardMay 7, 201312195762 (P.T.A.B. May. 7, 2013) Copy Citation UNITED STATES PATENT AND TRADEMARKOFFICE 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. 12/195,762 08/21/2008 James F. McKinsey 12730/407 (PA-5967-RFB) 9086 48003 7590 05/07/2013 BRINKS HOFER GILSON & LIONE/CHICAGO/COOK PO BOX 10395 CHICAGO, IL 60610 EXAMINER SCHALL, MATTHEWWAYNE ART UNIT PAPER NUMBER 3738 MAIL DATE DELIVERY MODE 05/07/2013 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 JAMES F. MCKINSEY, SHYAM SV KUPPURATHANAM, and MATTHEW S. WANINGER __________ Appeal 2012-001030 Application 12/195,762 Technology Center 3700 __________ Before DEMETRA J. MILLS, LORA M. GREEN, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to an implantable graft. The Examiner rejected the claims as failing the written description requirement, as anticipated and as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2012-001030 Application 12/195,762 2 Statement of the Case Background The Specification teaches that “[a]neurysms occur in blood vessels in locations where, due to age, disease or genetic predisposition, the blood vessel strength or resiliency is insufficient” (Spec. 1, ll. 11-13). “The present disclosure provides for a variable yarn density textile graft for bridging a defect in a main vessel near one or more branch vessels” (Spec. 4, ll. 19-20). The Claims Claims 1-20 are on appeal. Claim 1 is representative and reads as follows: 1. An implantable graft comprising: a main graft body forming a lumen with a proximal end and a distal end; where at least a portion of the lumen is defined by a woven fabric comprising yarns aligned in a first direction interwoven with yarns aligned in a second direction; where the woven fabric further comprises a main portion and at least one reduced yarn density region disposed between the proximal and distal end; where, although at least some yarns traverse the reduced yarn density region, the reduced yarn density region is defined by having a lower yarn density than the main portion; and where both the main portion and the reduced yarn density region are substantially impermeable to fluid flow. The issues A. The Examiner rejected claims 1-20 under 35 U.S.C. § 112, first paragraph as failing to comply with the written description requirement (Ans. 4). Appeal 2012-001030 Application 12/195,762 3 B. The Examiner rejected claims 1, 2, 5-8, 14-17, and 19 under 35 U.S.C. § 102(b) as anticipated by Greenhalgh1 (Ans. 5-8). C. The Examiner rejected claims 3, 4, and 9-11 under 35 U.S.C. § 103(a) as obvious over Greenhalgh (Ans. 8-11). D. The Examiner rejected claims 12, 13, and 18 under 35 U.S.C. § 103(a) as obvious over Greenhalgh and Rakos2 (Ans. 11-12). E. The Examiner rejected claim 20 under 35 U.S.C. § 103(a) as obvious over Greenhalgh and Quadri3 (Ans. 12-13). A. 35 U.S.C. § 112, first paragraph - written description The Examiner finds that “[t]here is no support in the disclosure for the additional claim limitation of ‘the main portion and the reduced yarn density region are substantially impermeable to fluid flow’” (Ans. 4). The Examiner finds that “[s]imply stating holes may be created in the region to provide blood flow does not require the region to be substantially impermeable and this does not support the newly added claim limitation. The material could be semi-permeable or permeable and the added holes are used to increase the blood flow” (id. at 13). Appellants contend that “key to whether a claim limitation has adequate support is not whether the specification provides a literal basis for the claim, but what the specification demonstrated to those of ordinary skill in the art” (App. Br. 11). Appellants contend that “the device must be 1 Greenhalgh, E., US 2002/0052649 A1, published May 2, 2002. 2 Rakos et al., US 2005/0240261 A1, published Oct. 27, 2005. 3 Quadri, A., US 2005/0154444 A1, published Jul. 14, 2005. Appeal 2012-001030 Application 12/195,762 4 substantially impermeable to fluid flow to work for its intended purpose and one of ordinary skill in the art would know this” (App. Br. 11). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion that the claims lack descriptive support for the limitation “where both the main portion and the reduced yarn density region are substantially impermeable to fluid flow”? Findings of Fact The following findings of fact (“FF”) are supported by a preponderance of the evidence of record. 1. The Specification teaches “[v]ariable yarn density textile grafts include any prosthesis that is introduced temporarily or permanently into the body for the prophylaxis or therapy of a medical condition” (Spec. 6, ll. 25- 27). 2. The Specification teaches that the “reduced yarn density regions may be perforated, preferably in situ, to establish fenestrations providing blood flow to the real arteries 222, 223” (Spec. 7, ll. 13-15). 3. The Specification teaches that “[f]ollowing proper positioning of the graft, the guide wire may be used to poke through and perforate the reduced yarn density region. In some examples, an inflatable balloon may be used to enhance perforation of the reduced yarn density region to further enable blood flow through the fenestration” (Spec. 7, ll. 21-25). 4. The Specification teaches that a “reduced yarn density region variable weave the may permit a tighter fit between a bridge stent and a fenestration, thereby decreasing any fluid leakage about the circumference of the fenestration” (Spec. 9, ll. 26-28). Appeal 2012-001030 Application 12/195,762 5 Principles of Law “[I]t is the specification itself that must demonstrate possession. And while the description requirement does not demand any particular form of disclosure, ... or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Analysis While the Examiner is correct that the specific language of the claims was not disclosed ipsis verbis in the Specification, ipsis verbis support is not required. Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed. Cir. 1996). Here, the Specification clearly requires fenestrations (i.e. added perforations) in order to permit fluid flow through the weave (FF 2-4). That is, the weave is not permeable to fluid until fenestrations are established, such as by perforating the reduced yarn density section (FF2). We therefore agree with Appellants that the Specification inherently provides descriptive support for the concept of an “impermeable” weave. Conclusion of Law The evidence of record does not support the Examiner’s conclusion that the claims lack descriptive support for the limitation “where both the main portion and the reduced yarn density region are substantially impermeable to fluid flow.” B. 35 U.S.C. § 102(b) over Greenhalgh The Examiner finds that: Greenhalgh discloses an implantable graft comprising: a main graft body forming a lumen with a proximal end and a Appeal 2012-001030 Application 12/195,762 6 distal end; where at least a portion of the lumen is defined by a woven fabric comprising yarns aligned in a first direction interwoven with yarns aligned in a second direction; where the woven fabric further comprises a main portion and at least one reduced yarn density region disposed between the proximal and distal end; and where, although at least some yarns traverse the reduced yarn density region, the reduced yarn density region is defined by having a lower yarn density than the main portion (Ans. 5). The Examiner finds that “the main portion and the reduced yarn density region will be substantially impermeable to fluid flow after tissue ingrowth has occurred. Additionally and/or alternatively, Figures 4-5 disclose alternative embodiments of the graft material that contains regions of higher and lower yarn density and also do not have any fluid permeable regions” (id.). The issue with respect to this rejection is: Does the evidence of record support the Examiner’s conclusion Greenhalgh anticipates claim 1? Findings of Fact 5. Figure 1 of Greenhalgh is reproduced below: “FIG. 1 shows a vascular stent graft 10 typically used to treat a vascular aneurysm 12 in an artery 14. . . . At each end of substrate 18 are attachment Appeal 2012-001030 Application 12/195,762 7 regions 22 engage able with the living tissue of the artery” (Greenhalgh 2 ¶¶ 0023-0025). 6. Greenhalgh teaches that because “the substrate 18 between the attachment regions 22 must remain substantially hemostatic, however, the attachment regions 22 of higher permeability are confined to relatively narrow bands . . . . This length should provide adequate attachment and sealing of the graft to the artery without resulting in unacceptable levels of leakage” (Greenhalgh 2 ¶ 0026). 7. Greenhalgh teaches that “the regions 22 of higher permeability may be formed by changing the density of the weave in these regions, i.e., weaving fewer filamentary members per unit area” (Greenhalgh 2 ¶ 0028). 8. Figure 4 is reproduced below: “As shown in FIG. 4, a means for promoting growth of living animal tissue across attachment regions 22 to attach and seal the graft to the vessel also includes creating a textured surface 23 having increased surface area” (Greenhalgh 3 ¶ 0032). 9. Greenhalgh teaches that: Appeal 2012-001030 Application 12/195,762 8 the textured surface 23 having increased surface area may also be formed over region 22 by weaving or knitting textured filamentary members 31 under varying tension, using low tension where the fabric is to be bulkier and have a higher surface area and high tension to stretch the yarns and remove the bulk and reduce the surface area available for attachment to the living animal tissue. (Greenhalgh 3 ¶ 0033.) 10. Greenhalgh teaches that an advantage in “using increased surface area to form the regions to promote living animal tissue ingrowth is that the hemostatic properties of the graft are maintained throughout the entire length of the graft, i.e., there are no regions of high permeability which may leak initially after the graft is implanted” (Greenhalgh 3 ¶ 0035). Principles of Law “A single prior art reference that discloses, either expressly or inherently, each limitation of a claim invalidates that claim by anticipation.” Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375 (Fed. Cir. 2005). Analysis The Examiner’s rejection identifies two different embodiments which the Examiner finds anticipate claim 1, the graft of figure 1 and the graft of figure 4. Regarding the figure 1 embodiment, Appellants contend that the “reference numerals 22 designate these porous high permeability regions at the ends of the graft, and not between the ends of the graft as clearly recited by the claims” (App. Br. 15). Appellants also contend that “although Greenhalgh discloses other regions of the graft are substantially Appeal 2012-001030 Application 12/195,762 9 impermeable, the areas of reduced density are, to the absolute contrary, porous and have a ‘substantially higher permeability’” (App. Br. 15). While we are not persuaded by Appellants’ argument regarding the location of the reduced density regions, we agree with Appellants that Greenhalgh clearly discloses that the regions in the graft in figure 1 are permeable, specifically Greenhalgh teaches that “attachment regions 22 of higher permeability are confined to relatively narrow bands . . . . This length should provide adequate attachment and sealing of the graft to the artery without resulting in unacceptable levels of leakage” (Greenhalgh 2 ¶ 0026; FF 6). For this reason, the embodiment in figure 1 does not anticipate the claimed invention. Appellants contend that with “regard to Figure 4 of this embodiment, Greenhalgh does not discuss whether this region 22 has a greater or lesser yarn density, but only that it has increased surface area, for example by creating loops on the surface. The Examiner has not shown that the increased surface are of Greenhalgh equates with increased or decreased density.” (App. Br. 16.) The Examiner responds that “Greenhalgh very clearly discloses altering the density of portions of the device in paragraph [0033]. Increasing the number of threads and/or loops increases the density” (Ans. 14). The Examiner also finds that “‘the main portion’ and the ‘reduced yarn density region’ are vague and can be located at any portion between the ends of the prior art invention” (id.). We find that Appellants have the better position. Claim 1 requires a woven fabric which “comprises a main portion and at least one reduced yarn Appeal 2012-001030 Application 12/195,762 10 density region.” The claim requires that the reduced density must be in the woven fabric, and does not address the surface area requirement. Greenhalgh teaches that the textured surface 23 having increased surface area may also be formed over region 22 by weaving or knitting textured filamentary members 31 under varying tension, using low tension where the fabric is to be bulkier and have a higher surface area and high tension to stretch the yarns and remove the bulk and reduce the surface area available for attachment to the living animal tissue. (Greenhalgh 3 ¶ 0033; FF 9.) While Greenhalgh teaches that textured surface 23 may include additional weaving, the Examiner has not established that the region 23 necessarily has a higher yarn density than region 18 in figure 4. That is, increased surface area of the yarn is not necessarily equivalent to increased density, but rather describes how the yarn is woven, not the amount of yarn incorporated per unit area. “Inherency . . . may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). Conclusion of Law The evidence of record does not support the Examiner’s conclusion Greenhalgh anticipates claim 1. C-E. 35 U.S.C. § 103(a) rejections Each of these rejections relies upon the underlying anticipation rejection over Greenhalgh. Having reversed the rejection of claim 1 over Appeal 2012-001030 Application 12/195,762 11 Greenhalgh above, we necessarily reverse these obviousness rejections, which do not suggest the reduced yarn densities as required by claim 1. SUMMARY In summary, we reverse the rejection of claims 1-20 under 35 U.S.C. § 112, first paragraph as failing to comply with the written description requirement. We reverse the rejection of claims 1, 2, 5-8, 14-17, and 19 under 35 U.S.C. § 102(b) as anticipated by Greenhalgh. We reverse the rejection of claims 3, 4, and 9-11 under 35 U.S.C. § 103(a) as obvious over Greenhalgh. We reverse the rejection of claims 12, 13, and 18 under 35 U.S.C. § 103(a) as obvious over Greenhalgh and Rakos. We reverse the rejection of claim 20 under 35 U.S.C. § 103(a) as obvious over Greenhalgh and Quadri. REVERSED cdc Copy with citationCopy as parenthetical citation