Ex Parte Edelman et alDownload PDFPatent Trial and Appeal BoardSep 22, 201612434856 (P.T.A.B. Sep. 22, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/434,856 0510412009 11050 7590 09/26/2016 SEAGER, TUFTE & WICKHEM, LLP 100 South 5th Street Suite 600 Minneapolis, MN 55402 FIRST NAMED INVENTOR Peter EDELMAN 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. 2001.1242101 2145 EXAMINER TCHERKASSKAYA, OLGA V ART UNIT PAPER NUMBER 1615 NOTIFICATION DATE DELIVERY MODE 09/26/2016 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): BSC.USPTO@stwiplaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PETER EDELMAN and AFSAR ALI 1 Appeal2015-002837 Application 12/434,856 Technology Center 1600 Before DONALD E. ADAMS, TA WEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. CHANG, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to an intravascular medical device comprising a coating layer, a method of forming a coating layer on a medical device, and a method of treating an intravascular site comprising said medical device, which have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1 Appellants identify the Real Party in Interest as Boston Scientific Scimed, Inc. (Appeal Br. 1.) 1 Appeal2015-002837 Application 12/434,856 STATEMENT OF THE CASE According to the Specification, "the present invention provides an intravascular medical device comprising a coating layer disposed on a substrate associated with a medical device," where "[a]t least a portion of the coating layer is partitioned into a plurality of discontinuous members" having "a size less than the luminal diameter of an arteriole." (Spec. i-fi-f l 0- 12.) Further according to the Specification, as the coating layer on the medical device degrades, any fragmentation of the coating layer will preferentially occur in a predetermined fashion by detachment of the discontinuous members. Because of their size, the detached discontinuous members may avoid causing embolisms in blood vessels downstream of the medical device. (Id. at i-f 12.) Claims 1-28 are on appeal. Claims 1 and 16 are illustrative and reproduced below: 1. An intravascular medical device comprising: a coating layer disposed on a substrate associated with the medical device; wherein at least a portion of the coating layer comprises a plurality of discontinuous bioresorbable members that define a preferential pattern of fragmentation upon degradation of the coating layer, and wherein the discontinuous bioresorbable members have a size less than the luminal diameter of an arteriole. 16. A method of forming a coating layer on a medical device, compnsmg: disposing a coating layer on a substrate associated with the medical device; and excavating portions of the coating layer to form a plurality of discontinuous bioresorbable members in the coating layer, wherein the discontinuous bioresorbable members define a preferential pattern of fragmentation upon degradation of the coating 2 Appeal2015-002837 Application 12/434,856 layer, and wherein the discontinuous bioresorbable members have a size less than the luminal diameter of an arteriole. (Appeal Br. 7, 9 (Claims App'x).) The Examiner rejects claims 1-15 and 23-28 under 35 U.S.C. § 103(a) as being unpatentable over Nolting,2 Campbell,3 Mills,4 Wilkinson,5 and Weber. 6 (Ans. 2.) The Examiner rejects claims 16-22 under 35 U.S.C. § 103(a) as being unpatentable over Mills, Weber, and Nolting. (Id.) DISCUSSION Issue The Examiner has rejected claims 1-15 and 23-28 under 35 U.S.C. § 103(a) as being unpatentable over Nolting, Campbell, Mills, Wilkinson, and Weber and rejected claims 16-22 under 35 U.S.C. § 103(a) as being unpatentable over Mills, Weber, and Nolting. Because similar issues are dispositive for these rejections, we discuss them together. With respect to claims 1-15 and 23-28, the Examiner finds that (1) Nolting discloses "a concept of an intravascular medical devices comprising a coating layer ... disposed on a supporting member and said coating layer comprises a plurality of members ... that can be used (e.g.,) to bind other 2 Nolting et al., US 2003/0028240 Al, published Feb. 6, 2003. 3 Campbell, US 2005/0055078 Al, published Mar. 10, 2005. 4 Christopher A. Mills et al., Transparent micro- and nanopatterned poly(lactic acid) for biomedical applications, 7 6A J. BIOMEDICAL MATERIALS RESEARCH PART A 781 (2006). 5 C.D.W. Wilkinson et al., The use of materials patterned on a nano- and micro-metric scale in cellular engineering, 19 MATERIALS SCIENCE AND ENGINEERING C 263 (2002). 6 Weber et al., US 2005/0208100 Al, published Sep. 22, 2005. 3 Appeal2015-002837 Application 12/434,856 components to the device"; (2) Campbell teaches "implantable medical devices ... comprising separate biodegradable coatings ... on a plurality of identical stent segments placed end-to-end''; (3) Mills discloses "a concept of micro- or nano-patterned biocompatible and/or biodegradable surfaces ... on implantable medical devices, wherein discontinue[ ous] elements on said surfaces might be smaller than the luminal diameter of an arteriole ... and/or less than red blood cell"; (4) Weber teaches "implantable medical devices ... comprising coatings with a plurality of separated holes . . . that can be filled with a specific drug/compound ... for controlled drug delivery" and further teaches that "said structures can be obtained by well- known technique that involves formation of a first coating comprising a plurality of discontinuous bioresorbable members"; and (5) Wilkinson teaches "medical implantable devices comprising nano-patterned biodegradable coatings that comprise discontinuous members ... for controlling cell adhesion." (Ans. 4--5 (emphasis original).) The Examiner concludes that it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize a micro/nano-patterned biodegradable coatings taught by Campbell, Mills, Wilkinson and Weber in medical devices taught by Nolting, because it would provide such functions of implantable devices as (1) controlling cell adhesion on a surface of said devices; (2) controlling degradation rate of the coating layers; (3) minimize harmful byproducts during the biodegradation; (4) can be prepared by well-known techniques providing precise control of pattern dimensions; and ( 5) might provide multi-drug controlled release. (Id. at 5.) With respect to claims 16-22, the Examiner finds that (1) Mills discloses "a method of making a micro-patterned layer for implantable 4 Appeal2015-002837 Application 12/434,856 medical devices[] that includes ... disposing a layer on a substrate, e.g., forming ... biocompatible/biodegradable surface(s); and ... excavating portions of said layer to form a plurality of bioresorable members having a size of less than the luminal diameter of an arteriole ... and/or ... red blood cell"; (2) Weber teaches "a method of making a coating comprising spaced polymeric anchoring elements ... adhered to the substrate of the implantable medical devices ... that are further used to form drug reservoirs within the multilayer coating on said medical device"; and (3) Nolting teaches "a method of making a coating layer on a medical device, employing (i) the coating layer comprising a heat-bondable material and (ii) the step of excavating comprises heating a coating layer and/or substrate to initiate the formation of heat bonds." (Id. at 7-8.) The Examiner concludes that it would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize heat bonded coatings taught by Nolting in the method of making a patterned coating layer(s) on a medical device as taught by Mills and Weber, because Nolting teaches that heat-bonded coatings provide secure adhesion of coatings to coverings, sufficient flexibility to the intra vascular device, and [allows minimization of] embolization during the device functioning. It also would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize an energy beam for providing a localized polymeric melt of heat-bondable material without harming peripheral supplements. (Id. at 8.) Appellants contend that the cited references do not disclose "[t]he claimed structure of 'discontinous bioresorbable members hav[ing] a size less than the luminal diameter of an arteriole' on a substrate associated with a[] ... medical device." (Appeal Br. 2 (brackets original); see also id. at 5.) Appellants further contend that there is no reason to modify the prior art to 5 Appeal2015-002837 Application 12/434,856 include the claimed "discontinuous bioresorbable members hav[ing] a size less than the luminal diameter of an arteriole." (Id. at 5---6.) The issue with respect to this rejection is whether the evidence of record supports the Examiner's findings that claims 1-15 and 23-28 are obvious over Nolting, Campbell, Mills, Wilkinson, and Weber and that claims 16-22 are obvious over Mills, Weber, and Nolting. Analysis The Specification defines "discontinuous members" as "discrete portions of a coating layer that are defined by gaps extending through the full thickness of the coating layer." (Spec. i-f 11.) We agree with Appellants that the Examiner has not shown that the prior art disclose a coating layer comprising "a plurality of discontinuous bioresorbable members." The Examiner agrees that Nolting does not teach "discontinuous members [of a coating] that are bioresorbable." (Final Act. 4.) The Examiner also agrees that iviills is silent regarding bioresorbable members of a coating being "discontinuous ... , i.e., separated by gap and revealing [underlying] coating/substrate." (Id. at 5.) Thus, it appears that the Examiner relies Campbell, Wilkinson, and/or Weber to suggest a coating comprising "discontinuous bioresorbable members." In response to Appellants' arguments regarding "discontinuous bioresorbable members," the Examiner first points to Figure 1 of Campbell (Ans. 4), which is reproduced below: 6 Appeal2015-002837 Application 12/434,856 FIG.1 Fig. 1 of Campbell shows a stent delivery system made in accordance with Campbell's invention. (Campbell i-f 19.) The Examiner appears to point to slough coating 125 as a coating comprising "discontinuous members." We agree with Appellants, however, that Campbell's Fig. 1 does not disclose such a coating. (Reply Br. 2-3.) Although there appears to be "gaps" between the elements labeled 125 (slough coating), this is because the slough coating is deposited upon a stent 120 (i.e., substrate) comprising a number of disparate segments. (Campbell i-f 30.) That is, it is the stent substrate in Campbell's Fig. 1, rather than the slough coating, that is discontinuous. The Examiner also has not shown that Wilkinson disclose a "coating" comprising discontinuous members. The Examiner argues that "Wilkinson teaches ... nanopatteming of the surfaces of biodegradable materials in medical implantable devices." (Final Act. 6; see also Ans. 5.) The Examiner does not explain, however, why such modification of the substrate without creation of a separate layer should be considered a "coating." Finally, the Examiner relies on Fig. 5 in Weber as showing a plurality of discontinuous bioresorbable members. (Ans. 5.) Weber's Figure 5A is reproduced below: 7 Appeal2015-002837 Application 12/434,856 Fig. 5A Weber's Fig. 5A depicts "a metallic or ceramic region 100 ... with multiple regions 103 (e.g., dots) of disintegrable material ... [created], for example, .. by laying down a polymer layer and removing part of it ... using laser ablation .... " (Weber i-f 83.) Weber further discloses that the a coating is subsequently provided over the structure in Fig. 5A before the disintegrable material regions 103 are removed to create "enclosed pockets" that are then filled with a therapeutic agent. (Id.) We are not convinced that regions of disintegrable material on top of a substrate constitute a coating per se. Assuming that they do, however, the Examiner has not shown that these regions "define a preferential pattern of fragmentation upon degradation of the coating layer." The Examiner argues that this limitation is an intended use and that the limitation is met so long as the prior art structure is "capable of performing the intended use." (Ans. 6.) To the extent the Examiner is arguing that the phrase at issue is non-limiting, we disagree because "defin[ing] a preferential pattern of fragmentation upon degradation of the coating layer" is an affirmative functional limitation. Neither has the Examiner shown that the disintegrable material regions 103 of Weber's Fig. 5A are either explicitly or inherently capable of defining such a preferential pattern of fragmentation. Instead, the Examiner states only that the alleged discontinuous bioresorbable members of the coating disclosed in the prior art are "arranged in a special pattern." (Id.) We find that this is not sufficient to establish a prima facie case. 8 Appeal2015-002837 Application 12/434,856 Finally, we also agree with Appellants that the Examiner has not sufficiently articulated a reason to combine or modify the cited art to arrive at the claimed invention. (Appeal Br. 3.) For instance, with respect to the reason to combine Nolting, Campbell, Mills, Weber, and Wilkinson, the Examiner essentially recites the benefits disclosed for the invention of each prior art reference. (Ans. 5.) The Examiner provides no articulated reasoning, however, as to why a particular benefit disclosed in one reference (e.g., the ability to control cell adhesion by nanoembossing a surface, as disclosed in Mills) would be relevant or desirable for purposes of the invention of another reference (e.g., the stent-graft assembly of Nolting). KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ("[R]ejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness."). In sum, the Examiner has not shown that the cited references suggest a coating layer comprising "a plurality of discontinuous bioresorbable members" that "define a preferential pattern of fragmentation upon degradation of the coating layer." Because each claim on appeal recite these limitations (Appeal Br. 7-10 (Claims App'x)), and because the Examiner has also failed to provide articulated reasoning for combining and/ or modifying the cited references to arrive at the claimed invention, we reverse the Examiner's rejection of claims 1-28. 9 Appeal2015-002837 Application 12/434,856 SUMMARY For the reasons above, we reverse the Examiner's decision rejecting claims 1-2 8. REVERSED 10 Copy with citationCopy as parenthetical citation