Ex Parte Weber et al

Patent Trial and Appeal BoardNov 30, 2012

11900779 (P.T.A.B. Nov. 30, 2012)

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. 11/900,779 09/12/2007 Jan Weber 04-0185US1 (4010.147) 4470 27774 7590 11/30/2012 MAYER & WILLIAMS PC 251 NORTH AVENUE WEST Suite 201 WESTFIELD, NJ 07090 EXAMINER BARHAM, BETHANY P ART UNIT PAPER NUMBER 1615 MAIL DATE DELIVERY MODE 11/30/2012 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 TRIAL AND APPEAL BOARD __________ Ex parte JAN WEBER, THOMAS J. HOLMAN, GRAIG L. KVEEN __________ Appeal 2011-013348 Application 11/900,779 Technology Center 1600 __________ Before TONI R. SCHEINER, FRANCISCO C. PRATS, and ERICA A. FRANKLIN, Administrative Patent Judges. FRANKLIN, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to medical devices having a composite region. The Patent Examiner rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE Claims 1, 4-6, 9, 10, 14-18 and 21-23 are on appeal. Claims 1, 14 and 18 are representative and read as follows: Appeal 2011-013348 Application 11/900,779 2 1. A medical device comprising at least one composite region, said composite region comprising carbon particles and a polymer, wherein said medical device comprises a stent having two ends, an interior surface and an exterior surface, wherein said composite region comprises a first layer comprising said polymer and a therapeutic agent and a second layer comprising said carbon particles, wherein the first layer is disposed over at least a portion of the exterior surface of the stent and the second layer is disposed over at least a portion of the interior surface of the stent. 14. A medical device comprising at least one composite region, said composite region comprising carbon particles and a polymer, wherein said medical device comprises a stent having two ends, an interior surface and an exterior surface, wherein said composite region comprises a first layer comprising said polymer and a therapeutic agent and a second layer comprising said carbon particles, wherein the first layer covers the entire exterior surface of the stent and the second layer covers the entire interior surface of the stent. 18. The medical device of claim 1, wherein the first layer is a film comprising styrene-isobutylene copolymer that is perforated with holes. The Examiner rejected the claims as follows: • claims 1, 4-6, 9-10 and 14-18 under 35 U.S.C. §102(b) as anticipated by Holman; 1 • claims 1, 4-6, 9-10 and 14-18 under 35 U.S.C. §102(b) as anticipated by Ranade; 2 • claims 1, 4-6, 9-10, 14-18 and 21 under 35 U.S.C. § 103(a) as unpatentable over Weber; 3 1 Patent Application Publication No. US 2006/0136042 A1by Thomas J. Holman et al., published Jun. 22, 2006. 2 Patent Application Publication No. US 2006/0093642 A1 by Shrirang V. Ranade, published May 4, 2006. 3 Patent Application Publication No. US 2005/0074479 A1 by Jan Weber et al., published Apr. 7, 2005. Appeal 2011-013348 Application 11/900,779 3 • claims 1, 4-6, 9-10, 14-18 and 20-23 under 35 U.S.C. § 103(a) as unpatentable over Weber, Atanasoska, 4 or Asgari; 5 and • claims 1, 4-6, 9-10, 14-18 and 20-23 under 35 U.S.C. § 103(a) as unpatentable over Ranade or Holman and Atanasoska or Asgari. ANTICIPATION I. Holman The Examiner found that Holman taught a stent comprising a framework and carbon nanotubes, wherein: the carbon nanotubes can be affixed to the stent with SIBS, a triblock copolymer of styrene and isobutylene; the carbon nanotube layer can be disposed within the interior of the framework; and a drug such as paclitaxel can be combined with SIBS polymer as an external coating for the stent. (Ans. 5.) The Examiner also found that Holman‟s figures 9 and 13 show the SIBS layer on the exterior of the stent. (Id. at 5-6.) Appellants contend that Holman did not teach a SIBS layer on the exterior of the stent. (App. Br. 4.) Appellants assert that Holman figures 9 and 13 instead reveal “a carbon nanotube sheet portion 40 on the exterior surface.” (Id.) Appellants assert that Holman‟s teaching that in some embodiments the agent is placed on the stent in the form of a coating, which may include at least one therapeutic agent and at least one polymer agent also does not provide this limitation because Holman did not identify which 4 Patent Application Publication No. US 2007/0067882 A1 by Liliana Atanasoska et al., published Mar. 22, 2007. 5 Patent Application Publication No. US 2006/0167147 A1 by Soheil Asgari, published Jul. 27, 2006. Appeal 2011-013348 Application 11/900,779 4 surfaces of the stent are covered. (Id.; Reply Br. 4.) Appellants assert that “[i]nstead, a carbon nanotube sheet portion 40 is disposed on the exterior surface of the stent.” (App. Br. 4.) After considering all of the evidence and the arguments, we find that the Examiner correctly found that Holman disclosed a SIBS sheet on the exterior surface of the stent. Holman‟s figure 9 is reproduced below: Holman figure 9 “is a cross-sectional view of a stent with a SIBS sheet used in applying carbon nanotube sheets.” (Holman [0040].) Holman states that, “As shown in FIG. 9 a SIBS sheet 65 may be used in applying one or more carbon nanotube sheets 40 to the stent framework 50.” (Holman [0060].) Thus, we find that figure 9 shows the SIBS sheet 65 on both the exterior and interior surfaces of the stent framework. (Id. at [0040] and [0060].) We also find that figure 9 shows a carbon nanotube sheet 40 on the exterior surface of the stent, in that it is located exterior to the SIBS sheet that is used to apply the nanotube sheet to the exterior surface of the stent framework. In other words, Holman depicts both layers on the exterior surface of the stent. Additionally, Appellants acknowledge that Holman disclosed that a therapeutic agent may be placed on the stent in the form of a coating which may also include at least one polymer agent. (App. Br. 4.) However, Appeal 2011-013348 Application 11/900,779 5 Appellants assert that Holman did not identify which surface(s) of the stent are coated. (Id., Reply Br. 4.) According to Appellants, “there is no teaching that this coating is disposed over at least a portion of the exterior surface of the stent as claimed in claim 1, much less covering the entire exterior surface of the stent as claimed in claim 14.” (App. Br. 4.)(emphasis added.) We are not persuaded by Appellants‟ argument. As the Examiner correctly found (Ans. 11) Holman taught that the therapeutic agent may be applied to the stent, and “may be on the surface of the stent….” (Holman [0016].) Upon our review of Holman, we do not find any language excluding the exterior surface of the stent from among the potential surfaces to be coated with the therapeutic agent and polymer. Thus, we find that a skilled artisan would have understood Holman‟s teachings to apply a therapeutic agent to the surface of a stent and that the agent may be placed on the stent in the form of a coating to include applying such coating to either a portion or all of the exterior surface of the stent. In the Reply Brief, Appellants further assert that Holman did not “describe in combination a device in which a first layer comprising a polymer and a therapeutic agent is disposed over at least a portion of the exterior surface of a stent and a second layer comprising carbon particles is disposed over at least a portion of the interior surface of a stent, as claimed.” (Reply Br. 4.) Determining whether a prior art reference anticipates a claimed invention is “not constrained to proceed example-by-example....” Net MoneyIN, Inc. v. VeriSign, Inc. 545 F.3d 1359, 1369 n.5 (Fed. Cir. 2008).Rather, such review requires “looking at the reference as a whole, Appeal 2011-013348 Application 11/900,779 6 [and] conclud[ing] whether or not that reference discloses all elements of the claimed invention arranged as in the claim.” Id. Here, we find that the Examiner has combined disclosures that are “directly related to each other” by Holman‟s teaching. See id at 1371. Holman disclosed that its stent comprised a framework, a carbon nanotube sheet, and optionally, a therapeutic agent including a polymer agent. The remainder of Holman‟s disclosure taught how the latter components may be arranged on the former framework. These disclosures included a teaching that the stent framework may be coated with a therapeutic agent including a polymer agent. As discussed, we found that a skilled artisan would have understood that such a coating may be applied to the exterior surface of the stent. Further, as the Examiner correctly found, and Appellants have not disputed, Holman taught that the carbon nanotube layer could be disposed within the interior of the stent framework. (Ans. 5; Holman Fig. 10.) Thus, we agree with the Examiner that Holman, as a whole, anticipated the claimed invention. Accordingly, we affirm the anticipation rejection of claims 1, 4-6, 9- 10 and 14-17 over Holman. Appellants separately argue the rejection of claim 18, asserting that Holman did not teach that the first layer is a film comprising styrene- isobutylene copolymer that is perforated with holes. (App. Br. 5.) The Examiner responds by saying that this claim limitation is met by Holman‟s teaching that the stent includes a plurality of interconnected struts and that the agent is placed on the strut in the form of a coating which may include the recited polymer (SIBS), and further that this coating may be applied in strips. (Ans. 12.) Appeal 2011-013348 Application 11/900,779 7 According to the Examiner, such an arrangement would naturally result in a coating with holes. (Ans. 12.) We find that Appellants have the better position. In particular, we do not find that the Examiner has established that a coating comprising SIBS copolymer applied on a plurality of interconnected struts provided a coating that is “perforated with holes,” as required by claim 18. Accordingly, we reverse the anticipation of claim 18 over Holman. II. Ranade The Examiner found that Ranade taught an article such as a stent having a porous drug delivery coating comprising a solution of active agent, carbon nanotubes, and a carrier such as SIBS, if desired. (Ans. 6.) The Examiner found that Ranade disclosed paclitaxel as a therapeutic agent. (Id.) Additionally, the Examiner found that Ranade‟s figure 4 shows a stent with a polymer coating containing nanotubes on the inside and a polymer coating containing bioactive agent on the exterior of the stent. (Id.) Appellants contend that Ranade “Fig. 4 and its associated discussion reveals a stent 12 with nothing disposed on its interior surface, and a mixture of nanotubes 11, polymer matrix 41 and bioactive agent 14 disposed on its exterior surface.” (App. Br. 5.) According to Appellants, Ranade does not teach a first and second layer as recited in the claimed invention. (Id.) After considering the evidence and argument, we find that Ranade disclosed a stent having carbon nanotubes on its interior surface. As the Examiner correctly found, Ranade disclosed a polymer matrix 41 that may include bioactive agent 14 and nanotubes 11. (Ans. 6, 13; Ranade [0049].) Ranade taught that this polymer matrix is on the exterior of stent 12, and that it “may also be coated on the inside of stent 12….” (Id.) Appeal 2011-013348 Application 11/900,779 8 (emphasis added.) Thus, Ranade taught a first layer and a second layer, as recited by the claimed invention, rather than being limited to a single layer of material, as asserted by Appellants. (See Reply Br. 5.) Accordingly, we affirm the rejection of claims 1, 4-6, 9-10 and 14-17 as anticipated by Ranade. Appellants separately argue that Ranade does not anticipate claim 18 by asserting that the reference does not teach that the first layer is a film comprising styrene-isobutylene copolymer that is perforated with holes. (App. Br. 5.) However, as the Examiner correctly found, Ranade taught that the “incorporation of nanotubes into the polymer coating leads „to the in-situ formation of pores (also referred to herein as voids)‟” (Ans. 13; Ranade [0035].) Appellants have not established otherwise by merely asserting that “voids due to the introduction of nanotubes do not constitute „a film … that is perforated with holes‟ as claimed.” (Reply Br. 6.) In particular, Appellants have not referred to a Specification description of the disputed claim language that distinguishes Ranade‟s coating having voids from a film that is perforated with holes. Accordingly, we affirm the rejection of claim 18 as anticipated by Ranade. OBVIOUSNESS I. Weber The Examiner‟s position is that Weber taught medical implants such as stents comprising a layer or layers of bucky paper, which is an entangled mat of nanotubes, to deliver therapeutic agents, such as paclitaxel. (Ans. 7.) The Examiner found that Weber taught that layers of polymer coating, e.g. Appeal 2011-013348 Application 11/900,779 9 SIBS, can be applied in addition to the layers of bucky paper onto the medical device. (Id.) The Examiner also found that Weber taught that the bucky paper and/or SIBS can be coated on the interior and/or the exterior of the stent, and may or may not contain a therapeutic agent. (Id.) The Examiner concluded that it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have rearranged Weber‟s disclosed layers of bucky paper and polymers with therapeutic agents around the stent exterior and interior because Weber disclosed stents with bucky paper on the interior and also stents with SIBS polymer and active layer on the exterior. (Id. at 8-9.) The Examiner reasoned that rearranging known coating layers on a stent would be obvious to a skilled artisan and would yield predictable results. (Id. at 9.) Appellants contend that the portions of Weber relied upon by the Examiner are directed to embodiments where the polymer and therapeutic agent are positioned between the bucky paper and the implant, rather than embodiments having the first and second layers recited by the claimed invention. (App. Br. 6-7.) We are not persuaded by Appellants‟ contention, as Weber disclosed (a) an embodiment wherein bucky paper was rolled and inserted into a stent, whereby the bucky paper covered the entire inside surface of the stent and folded back over the stent to also cover the exterior of the stent (Ans. 14; Weber [0052-53] and Fig. 11) and (b) an embodiment wherein a mixed polymer/drug or SIBS/drug coating was applied to the exterior of the stent (Ans. 14; Weber [0043-52]). As the Examiner soundly reasoned (Ans. 14) it would have been within the skill of an ordinary artisan to predictably rearrange the known elements in these embodiments such that the interior of Appeal 2011-013348 Application 11/900,779 10 the stent maintained the bucky paper covering while the exterior of the stent comprised a polymer/drug coating. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416-7(2007)(When an invention „“simply arranges old elements with each performing the same function it had been known to perform‟ and yields no more than one would expect form such an arrangement, the combination is obvious. … If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”). In the Reply Brief, Appellants further contend that Weber‟s teachings relied upon by the Examiner pertain to implants and medical devices such as balloon catheters and do “not teach a polymer/drug or SIBS/drug coated on the exterior of a stent as urged by the Examiner.” (Reply Br. 7.) This argument is not persuasive as Weber disclosed that: (a) its “[p]referred medical devices for use in conjunction with the present invention include… vascular stents …[and] cerebral stents” (Weber [0029]); (b) the medical implant may be a stent (id. at Claim 4). Accordingly, we affirm the obviousness rejection of claims 1, 4-6, 9- 10, 14-17 and 21over Weber. Appellants separately argue the obviousness rejection of claim 18 by asserting that Weber did not teach or suggest that the exterior layer comprises styrene-isobutylene copolymer that is perforated with holes. (App. Br. 7.) According to Appellants, the disclosure in Weber of “a stable porous polymer like… SIBS” referred to “a barrier layer disposed over a therapeutic coating and thus does not constitute a first layer comprising a polymer (styrene-isobutylene copolymer) and a therapeutic agent,” which is the film that the claimed invention requires to be perforated with holes. (Reply Br. 7, citing Weber [0048].) Appeal 2011-013348 Application 11/900,779 11 We agree with Appellants. The instant Specification explains that “SIBS can be continuous, textured and discontinuous or perforated with holes.” (Spec. [0083].) While Weber taught that the barrier layer may comprise porous SIBS, the Examiner has not established that Weber taught or suggested using a porous SIBS in the exterior layer comprising the therapeutic agent. Accordingly, we reverse the obviousness rejection of claim 18 over Weber. II. Weber and Atanasoska or Asgari Appellants contend that the “[d]eficiencies in Weber are pointed out above [and that] Atanasoska and Asgari, which are cited for their teachings regarding cationic surfactants, do not make up for these deficiencies.” (Reply Br. 8; App. Br. 8.) Consequently, for the reasons discussed regarding the obviousness rejection over Weber, we affirm the rejection of claims 1, 4-6, 9-10, 14-17 and 21-23 as obvious over the combination of Weber, Atanasoska or Asgari. Appellants further assert that none of Weber, Atanasoska or Asgari teach or suggest the limitation recited in claim18 “wherein the first layer is a film comprising styrene-isobutylene copolymer that is perforated with holes.” (App. Br. 7.) The Examiner again relied on Weber as teaching this limitation. Consequently, for the reasons discussed regarding the obviousness rejection over Weber, we reverse the rejection of claim 18 as obvious over the combination of Weber, Atanasoska or Asgari. III. Ranade or Holman and Atanasoska or Asgari Appellants contend that the “[d]eficiencies in Ranade and Holman are pointed out above” and that “Atanasoska and Asgari, which are cited for Appeal 2011-013348 Application 11/900,779 12 their teachings regarding cationic surfactants, do not make up for these deficiencies.” (App. Br. 8; Reply Br. 8.) Consequently, for the reasons discussed regarding the anticipation rejections, we affirm the rejection of claims 1, 4-6, 9-10, 14-18 and 21-23 as obvious over the combination of Ranade, Atanasoska or Asgari. SUMMARY We affirm the rejection of claims 1, 4-6, 9-10 and 14-17 under 35 U.S.C. §102(b) as anticipated by Holman; we reverse the rejection of claim 18 under 35 U.S.C. §102(b) as anticipated by Holman; we affirm the rejection of claims 1, 4-6, 9-10 and 14-18 under 35 U.S.C. §102(b) as anticipated by Ranade; we affirm the rejection of claims 1, 4-6, 9-10, 14-17 and 21 under 35 U.S.C. § 103(a) as unpatentable over Weber; we reverse the rejection of claim 18 under 35 U.S.C. § 103(a) as unpatentable over Weber; we affirm the rejection of claims 1, 4-6, 9-10, 14-17 and 21-23 under 35 U.S.C. § 103(a) as unpatentable over Weber, Atanasoska, or Asgari; we reverse the rejection of claim 18 under 35 U.S.C. § 103(a) as unpatentable over Weber, Atanasoska, or Asgari; and we affirm the rejection of claims 1, 4-6, 9-10, 14-18 and 21-23 under 35 U.S.C. § 103(a) as unpatentable over Ranade or Holman and Atanasoska or Asgari. Appeal 2011-013348 Application 11/900,779 13 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 alw