Ex Parte SundarDownload PDFBoard of Patent Appeals and InterferencesJan 25, 201210413827 (B.P.A.I. Jan. 25, 2012) 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. 10/413,827 04/15/2003 Rangarajan Sundar PA905CIP(2650/112) 4503 7590 01/25/2012 Michael J. Jaro MEDTRONIC AVE 3576 Unocal Place Santa Rosa, CA 95403 EXAMINER HOUSTON, ELIZABETH ART UNIT PAPER NUMBER 3731 MAIL DATE DELIVERY MODE 01/25/2012 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 BOARD OF PATENT APPEALS AND INTERFERENCES ____________________ Ex parte RANGARAJAN SUNDAR ____________________ Appeal 2009-012109 Application 10/413,827 Technology Center 3700 ____________________ Before: STEFAN STAICOVICI, PHILLIP J. KAUFFMAN, and MICHAEL L. HOELTER, Administrative Patent Judges. KAUFFMAN, Administrative Patent Judge. DECISION ON APPEAL Appeal 2009-012109 Application 10/413,827 2 STATEMENT OF CASE Appellant seeks review of the Examiner’s rejection of claims 6-10 and 28 under 35 U.S.C. § 103(a) as unpatentable over Verhoeven (US 2005/0251250 A1; pub. Nov. 10, 2005), and claims 1-5 and 27 as unpatentable over Verhoeven and Dinh (US 5,697,967; iss. Dec. 16, 1997). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appellant’s claimed invention “relates to a stent delivery system and device having a coating.” Spec. 1, para. [0002]. Independent claim 6, reproduced below, is representative (emphasis added): 6. A stent device comprising: a body; and at least one coating disposed on the body, the coating having an average surface roughness of less than 75 nanometers. CONTENTIONS AND ISSUES Appellant argues claims 6-8, 10, and 28 as a group, and we select independent claim 6 as representative. App. Br. 9-13; see 37 C.F.R. § 41.37(c)(1)(vii). Appellant argues claims 1-3, 5, and 27 as a group, and we select independent claim 1 as representative. App. Br. 14-16. Because the limitation at issue (the average surface roughness of the stent coating) is contained in both claims 1 and 6, we analyze claim 6, and our analysis is equally applicable to claim 1. Appellant presents separate arguments for claims 4 and 9. App. Br. 13, 15-16. It is uncontested that Verhoeven discloses the stent of independent claim 6, except the coating having an average surface roughness of less than 75 nanometers. Ans. 3-4; App. Br. 9-16; Reply Br. 5-9. It is uncontested that Verhoeven discloses that low surface roughness is preferable, and that a substantially uniform coating having a low surface roughness can prevent Appeal 2009-012109 Application 10/413,827 3 complications such as blood clotting. Ans. 5; App. Br. 10, 14 (conceding that Verhoeven discloses that low surface roughness may be desirable, and not contesting the benefit of low surface roughness). The Examiner concluded that because the claimed range lacks criticality, modification of Verhoeven’s surface roughness to meet the claimed range would have been an obvious matter of design choice. Ans. 3. Appellant argues that Verhoeven does not disclose a stent coating having an average surface roughness of less than 75 nanometers, and that the Specification discloses “dramatic and surprising results.” App. Br. 9-16; Reply Br. 5-9. Regarding claims 4 and 9, Appellant additionally argues that Verhoeven does not disclose a coating having a thickness of 1 to 150 nanometers and an average surface roughness of less than 75 nanometers. App. Br. 13, 15-16. This appeal presents the following issues: Does Verhoeven disclose or render obvious a stent coating having an average surface roughness of less than 75 nanometers? Has Appellant demonstrated the criticality of the average surface roughness range of claim 6? Would a stent coating having a thickness of 1 to 150 nanometers and an average surface roughness of less than 75 nanometers, as in claims 4 and 9, have been obvious in view of Verhoeven? ANALYSIS Claims 1-3, 5-8, 10, 27, and 28 We are unpersuaded by Appellant’s arguments that Verhoeven does not disclose a stent coating having an average surface roughness of less than 75 nanometers. Appeal 2009-012109 Application 10/413,827 4 First, Appellant argues that Verhoeven discloses relative surface roughness and RMS surface roughness, but does not disclose average surface roughness within the claimed range. App. Br. 10-12; Reply Br. 6-7. This argument is unresponsive. The Examiner did not find that Verhoeven discloses surface roughness in terms of average surface roughness. Ans. 3. Second, Appellant contends that Verhoeven’s coating thickness is independent of, and unrelated to, relative roughness, and that “at most” Verhoeven discloses that the uncoated surface of the stent is visually rougher than the coated surface. App. Br. 12-13 (citing Verhoeven, paras. [0013], [0039], [0042]). Appellant’s characterization is inaccurate. Verhoeven discloses a direct relationship between coating thickness and relative surface roughness.1 See Verhoeven, paras. [0012], [0041]-[0042]. Further, Verhoeven discloses more than the uncoated surface of the stent being visually rougher than the coated surface. See, e.g., Verhoeven , para. [0011] (disclosing a uniform coating thickness of 0.1 micrometers with a relative standard deviation of no greater than about 10 percent). Third, Appellant calculates that Verhoeven’s example of a dry coating thickness of 4 micrometers at a relative surface roughness of about 10 percent results in an RMS surface roughness of 400 nanometers.2 App. Br. 10. Appellant then contends that, assuming that RMS roughness is equivalent to average surface roughness, Verhoeven discloses an average 1 Verhoeven defines relative roughness as 100 x Rq (RMS roughness) divided by the thickness of the coating (T), and consequently thickness is directly related to relative roughness. 2 Appellant performs this calculation using Verhoeven’s formula that relative roughness (RMS) equals 100 x Rq / T, where T is the thickness of the coating. Verhoeven paras. [0012], [0042]. Appeal 2009-012109 Application 10/413,827 5 surface roughness of 400 nanometer, over five times higher than the claimed range of less than 75 nanometers. Id. As the Examiner correctly points out (Ans. 4), Appellant’s calculation based on Verhoeven’s disclosure of a coating thickness of 4 micrometers ignores Verhoeven’s additional disclosure of a dry coating thickness of 0.1 micrometers (100 nanometers). To explain why Appellant performed the calculation using Verhoeven’s stent coating thickness of 4 micrometers instead of 0.1 micrometers, Appellant argues that the thickness of 4 micrometers is “a reasonable measure of what can be expected” with Verhoeven’s method. App. Br. 11. Verhoeven discloses a stent coating thickness of 0.1 micrometers (Verhoeven paras. [0011], [0020]), and Appellant fails to present a convincing reason for ignoring this explicit disclosure in an issued patent. A coating thickness of 0.1 micrometers and a relative surface roughness of 10 percent results in a RMS surface roughness of 10 nanometers.3 Further, the Examiner found, and Appellant does not contest, that surface roughness expressed in terms of RMS is generally equal to or slightly higher than average surface roughness. Ans. 5. Consequently, Verhoeven’s disclosure of a RMS surface roughness of 10 nanometers is equal to or great than an average surface roughness of 10 nanometers, within the range of less than 75 nanometers called for in claim 6. Because the Examiner found (Ans. 4), and we agree, that Verhoeven discloses a coating having an average surface roughness within the claimed range of less than 75 nanometers, claim 6 is anticipated by Verhoeven. Consequently, we affirm the rejection of claims 1-3, 5-8, 10, 27, and 28 on this basis. See In re 3 Calculated using the formula at Verhoeven, para. [0042]. Appeal 2009-012109 Application 10/413,827 6 Fracalossi, 681 F.2d 792, 794 (CCPA 1982) (anticipation is the epitome of obviousness). Even if Verhoeven did not disclose a coating having an average surface roughness as called for in claim 6, we conclude that such would have been obvious in view of Verhoeven. Appellant argues that the burden did not shift to Appellant because the Examiner did not establish that Verhoeven and the subject matter of claim 6 are substantially the same. App. Br. 12-13 (citing as support for this standard to Ex Parte Phillips, 28 USPQ2d 1302 (BPAI 1993). We disagree. First, routine Board decisions, such as Phillips, are not binding on the Board.4 Second, because it is uncontested that the only difference between the prior art (Verhoeven) and the subject matter of claim 6 is a difference in the range of a particular variable (average surface roughness), the Examiner has established a prima facie case of obviousness. See, e.g., In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). Consequently, Appellant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range. In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Appellant argues that the Specification describes the “dramatic and surprising end result” of decreasing average surface roughness from 142 and 77 nanometers for existing stents, to 2.35 and 16.3 nanometers for the claimed stent. App. Br. 12 (citing Spec., para. [0041]5). To the extent that 4 See Board of Patent Appeals and Interferences Standard Operating Procedure 2 (Revision 7) Publication of Opinions and Binding Precedent (Mar. 23, 2008) (available at http://www.uspto.gov/web/offices/dcom/bpai/ sop2.pdf). 5 Based on the content of the argument, it appears Appellant intends to refer to paragraph [0039] of the Specification, not paragraph [0041]. Appeal 2009-012109 Application 10/413,827 7 this is an argument that the claimed range of an average roughness of less than 75 nanometers is critical, we are unpersuaded by this evidence. This evidence relates to an average surface roughness of 2.35 and 16.3 nanometers while, in contrast, claim 6 calls for a coating having an average surface roughness of less than 75 nanometers. Consequently, Appellant’s argument is not commensurate in scope with claim 6. Appellant has not demonstrated the criticality of the claimed range of less than 75 nanometers. Appellant also asserts that the Examiner’s conclusion of obviousness is based on an erroneous finding of fact. Ans. 4-5; Reply Br. 7-8. Specifically, Appellant asserts that a relative roughness of 0 percent is a physical impossibility, and consequently, the Examiner’s finding that Verhoeven’s disclosure of a relative surface roughness of “at most 25 percent” is disclosure of a relative surface roughness range of 0 to 25 percent is in error. Our analysis, as well as the Examiner’s, is not based on a finding that Verhoeven discloses a relative surface roughness of 0 percent; rather, the analysis is based upon a finding that Verhoeven discloses a relative roughness for a stent coating of 10 percent, a fact conceded by Appellant. Ans. 4; App. Br. 10; Verhoeven para. [0010], [0020]). Thus, the subject matter of claims 1-3, 5-8, 10, 27, and 28 was obvious over Verhoeven. Claims 4 and 9 Claims 4 and 9, which depend from independent claims 1 and 6, respectively, each call for a coating thickness of 1 to 150 nanometers and an average surface roughness of less than 75 nanometers. Appellant argues that Verhoeven discloses relative roughness of about 10 percent so that a coating with a thickness of 1 nanometer would have a RMS roughness of 100 nanometers, which exceeds the range called for in Appeal 2009-012109 Application 10/413,827 8 claims 4 and 9. App. Br. 13, 15-16. As explained in the analysis of claim 6, supra, Appellant does not contest the Examiner’s finding that surface roughness expressed in terms of RMS is generally equal to or slightly higher than average surface roughness. Ans. 5. Consequently, Verhoeven’s disclosure of a RMS surface roughness of 100 nanometers is equal to or slightly higher than an average surface roughness of 100 nanometers. Because it is uncontested that the only different between the prior art (Verhoeven) and the claimed subject matter is the range of a particular variable (average surface roughness), the Examiner has established a prima facie case of obviousness. See In re Peterson, 315 F.3d at 1329; see also Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985) (a prima facie case of obviousness exists when the claimed range and the prior art range do not overlap but are close enough such that one skilled in the art would have expected them to have the same properties). Consequently, Appellant must show that the particular range is critical. As explained in the analysis of claim 6 supra, Appellant has not met this burden because Appellant’s evidence is not commensurate in scope with the claimed subject matter. Accordingly, we sustain the rejection of claims 4 and 9. CONCLUSIONS Verhoeven discloses or renders obvious a stent coating having an average surface roughness of less than 75 nanometers as called for in claim 6. Appellant has not demonstrated the criticality of the surface roughness range of claim 6. Appeal 2009-012109 Application 10/413,827 9 A stent coating having a thickness of 1 to 150 nanometers and an average surface roughness of less than 75 nanometers as called for in claims 4 and 9 would have been obvious in view of Verhoeven. DECISION We affirm the Examiner’s decision to reject 1-10, 27, and 28. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED nlk Copy with citationCopy as parenthetical citation