Ex Parte SaffranDownload PDFPatent Trial and Appeal BoardDec 10, 201411052204 (P.T.A.B. Dec. 10, 2014) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte BRUCE N. SAFFRAN ____________ Appeal 2012-006638 Application 11/052,204 Technology Center 1600 ____________ Before DONALD E. ADAMS, ULRIKE W. JENKS, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL1 This appeal under 35 U.S.C. § 134 involves claims 1–3, 5–7, 10, 21, 25–27, 30–37, 40, 49, 52, and 53 (Br. 3).2 Examiner entered a rejection under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 The Real Party in Interest is Appellant, Bruce N. Saffran (Br. 2). 2 Claims 4, 8, 9, 11–20, 28, 29, 38, 39, 41–48, 50, and 51 stand withdrawn from consideration (Br. 3). Appeal 2012-006638 Application 11/052,204 2 STATEMENT OF THE CASE The claims are directed to an implantable medical device, a method of making an implantable medical device, and a method for catalyzing a physiological reaction in vivo. Claim 1 is representative and is reproduced in the Claims Appendix of Appellant’s Brief. Claims 1–3, 5–7, 10, 21, 25–27, 30–37, 40, 49, 52, and 53 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Ornberg,3 Wang,4 Lee,5 and Whitehead.6 ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. An embodiment of Wang’s invention is directed to “a coating of nanomagnetic particles . . . that have the ability to deflect electromagnetic fields while remaining electrically non-conductive,” wherein the coating may be placed on a “guide wire, catheter, stent, and the like” (Wang ¶ 270; Ans. 5). FF 2. Examiner finds that Wang’s stent may be coated with a composition comprising nanomagnetic particles and silane (Ans. 5; see generally Wang ¶ 190). FF 3. Wang suggests a coating comprising a receptor material, wherein the receptor material may be “affinity recognition molecules,” such as 3 Ornberg et al., US 7,004,976 B2, issued Feb. 28, 2006. 4 Wang et al., US 2004/0210289 A1, published Oct. 21, 2004. 5 Lee et al., US 2002/0115081 A1, published Aug. 22, 2002. 6 Whitehead et al., US 4,698,302, issued Oct. 6, 1987. Appeal 2012-006638 Application 11/052,204 3 “antibodies, enzymes, specific binding proteins, nucleic acid molecules, and receptors” (Wang ¶¶ 785 and 797; Ans. 7). FF 4. Examiner finds that Wang fails to suggest “the type of metal used as a substrate [as] instantly claimed or [the] use [of] a photocatalyst, such as light as a stimulator” (Ans. 5). FF 5. Ornberg “relates to biomaterials[, e.g., a stent,] modified with non- proteinaceous catalysts for the dismutation of superoxide” (Ornberg, col. 1, ll. 15–32). FF 6. Ornberg defines the term “biomaterial” as including, inter alia, “metals such as stainless steel, tantalum, titanium, nitinol, gold, platinum, . . . iridium, silver, . . . [and] tungsten” (Ornberg, col. 8, ll. 2–7; Ans. 5). FF 7. Notwithstanding Examiner’s finding to the contrary, Ornberg suggests that the term “‘biomaterial’ is not meant to encompass drugs and biologically active molecules such as . . . enzymes, enzyme substrates, enzyme inhibitors, or enzyme receptor substrates” (Ornberg, col. 8, ll. 29–35 (emphasis added); see also id. at ll. 36–45 (“The term ‘non-proteinaceous catalysts . . . explicitly excludes a superoxide dismutase enzyme obtained from any species”); Cf. Ans. 5). FF 8. Examiner finds that Ornberg suggests the “use [of] silane as a linker with tantalum disks” (Ans. 5; see Ornberg, col. 87, l. 5). FF 9. Examiner finds that Ornberg suggests “a method of surface covalent conjugation effected by a photo-chemical reaction, see column 49, lines 15- 32 and Example 23” (Ans. 5). FF 10. Examiner finds that the combination of Wang and Ornberg fail to suggest the use of silane “to bind . . . enzymes or enzyme substrates to the metal substrate of the stent” (Ans. 5). Appeal 2012-006638 Application 11/052,204 4 FF 11. Lee suggests the “[u]se of a long-term sustained release implant . . . that . . . is constructed and arranged to deliver therapeutic levels of the active ingredient for at least 30 days, and preferably 60 days” (Lee ¶ 203; see genrally Ans. 6). FF 12. Lee suggests that “the substrate[, e.g., stent,] may be coated with a compound[, such as amino silanes and amino-reactive silanes,] to enhance binding of the [nucleic acid] probe to the substrate” (Lee ¶¶ 236 and 232 (“[a] probe with a nucleic acid sequence” (emphasis added)); see Ans. 6; see also Lee ¶ 156 (“Other forms of the polymeric matrix for containing the nucleic acids of the invention include . . . stents”); Lee ¶ 158 (“In general, the nucleic acids of the invention are delivered using the bioerodible implant by way of diffusion, or more preferably, by degradation of the polymeric matrix”)). FF 13. Examiner finds that Wang, Ornberg, and Lee fail to suggest “that the moiety attached to the surface of the substrate is capable of multiple reactions with different substrates” and relies on Whitehead to make up for this deficiency in the combination of Wang, Ornberg, and Lee (Ans. 6). FF 14. Whitehead “relates to magnetically responsive particles and to their use in systems in which the separation of certain molecules from the surrounding medium is necessary or desirable” (Whitehead, col. 1, l. 66–col. 2, l. 2). FF 15. Whitehead suggests that The magnetic particles of this invention are suitable for use in immobilized enzyme systems, particularly where enzyme recycling is desired. Enzymatic reactions are preferably carried out by dispersing enzyme-coupled magnetic particles in a reaction mixture containing substrate(s), allowing the enzymatic reaction to occur, magnetically separating the Appeal 2012-006638 Application 11/052,204 5 enzyme-coupled magnetic particle from the reaction mixture containing product(s) and unreacted substrate(s) and, if desired, redispersing the particles in fresh substrate(s) thereby reusing enzyme. (Whitehead, col. 10, ll. 3–13; see also id. at col. 16, ll. 39–60; Ans. 6.) FF 16. Whitehead’s Table II reproduced below, Examiner finds that Whitehead’s Table II “specifically lists 9 different enzymes and their corresponding plural reactants” (Ans. 13–14). ANALYSIS Based on the combination of Wang, Ornberg, Lee, and Whitehead, Examiner concludes that, at the time Appellant’s invention was made, it would have been prima facie obvious to (a) “use the metals of Ornberg . . . to coat the stent of Wang . . . because Ornberg . . . teach that the metals are biocompatible” (Ans. 5); (b) use “the photo-chemical reaction described by Ornberg . . . in the stent of Wang . . . to determine the presence of a reaction with the substrate and the target and the rate of reactions occurring” (Ans. 5); (c) use “silane to bind agents to the stent since it is conventionally used in the art for that purpose,” as suggested by Wang, Ornberg, and Lee (see Ans. 6); and (d) “use an enzyme for multiple reactions, as described by Whitehead . . ., to facilitate ease of separation of unbound analyte . . . and to conserve enzyme” (Ans. 6). We are not persuaded. Appeal 2012-006638 Application 11/052,204 6 Taken in combination, Wang, Ornberg, and Lee suggest an implantable medical device, e.g., a stent, having a coating (FF 1–3, 5, 11, and 12). While Wang suggests that the stent may comprise an enzyme coating, Ornberg expressly discloses that the coating is not an enzyme (FF 3; Cf. FF 7). As for Lee, Examiner failed to establish an evidentiary basis on this record to support a conclusion that an enzyme, or other moiety within the scope of Appellant’s claimed invention, that may be attached to Lee’s bioerodable device, would remain attached to the surface after the first reaction, as is required by Appellant’s claimed invention (see FF 11–12; Cf. Appellant’s independent claims 1, 52, and 53). Therefore, at best, the combination of Wang, Ornberg, and Lee suggests Wang’s stent with Ornberg’s metal, a silane, and an enzyme within the scope of Wang (FF 1– 12). The combination of Wang, Ornberg, and Lee, however, fails to suggest “that the moiety attached to the surface of the substrate[, in this case, an implantable medical device, e.g., a stent,] is capable of multiple reactions with different substrates” (FF 13). Examiner relies on Whitehead to make up for this deficiency (id.). Whitehead “relates to magnetically responsive particles and to their use in systems in which the separation of certain molecules from the surrounding medium is necessary or desirable” (FF 14 (emphasis added)). In essence, Whitehead suggests “dispersing enzyme- coupled magnetic particles in a reaction mixture containing substrate(s), allowing the enzymatic reaction to occur, magnetically separating the enzyme-coupled magnetic particle from the reaction mixture containing product(s) and unreacted substrate(s) and, if desired, redispersing the particles in fresh substrate(s) thereby reusing enzyme” (FF 15 (emphasis Appeal 2012-006638 Application 11/052,204 7 added); Cf. Br. 15 (“The claims on appeal . . . relate to an implantable medical device for placement adjacent a biological tissue or fluid in vivo. No disclosure has been found in Whitehead actually relating to in vivo reuse of anything, nor does the . . . [Examiner] point to where such disclosure can be found”)). Examiner failed to articulate a reason why a person of ordinary skill in this art would have found a “stent,” as suggested by Ornberg, Wang, and Lee, to represent a system “in which the separation of certain molecules from the surrounding medium is necessary or desirable” as that phrase is used in the context of Whitehead (FF 14; see also FF 15; see Br. 16). In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (“there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.”). Nevertheless, we recognize Examiner’s reference to Whitehead’s Table II (FF 16). According to Examiner, this table “specifically lists 9 different enzymes and their corresponding plural reactants” (id.). We are not persuaded. Whitehead’s Table II contains two columns (see id.). The left column is a list of 10 enzymes. The right column lists: (a) the reactant, e.g., substrate, for the particular enzyme identified in the left column and (b) the corresponding product resulting from the reaction of the enzyme with the reactant (see id.). Notwithstanding Examiner’s assertion to the contrary, only one of the enzymes, glucoamylase, identified in Whitehead’s Table II is disclosed to have more than one reactant, e.g., substrate, starch and dextrin (see id.). Examiner failed to explain why: (a) a person of ordinary skill in this art would coat a stent suggested by the combination of Ornberg, Wang, and Lee with glucoamylase or (b) a person of ordinary skill in this art would Appeal 2012-006638 Application 11/052,204 8 consider glucoamylase (i) representative of all enzymes that may act on more than one substrate and (ii) find utility as a coating on a stent. See In re Kahn, 441 F.3d at 988. To be complete, we recognize Examiner’s finding that the combination of Wang and Ornberg fails to suggest the use of silane “to bind . . . enzymes or enzyme substrates to the metal substrate of the stent” and reliance on Lee to make up for this deficiency (FF 10 and 12; Ans. 6; Cf. FF 2 and 8). Notwithstanding Examiner’s assertion to the contrary, Lee’s only mention of silane is in the context of binding nucleic acid to a stent (FF 12). Examiner failed to establish an evidentiary basis on this record to support a conclusion that (a) Lee’s nucleic acid is an enzyme, as used in the context of Examiner’s rejection and/or (b) silane can, in fact, be used to bind enzymes or a moiety that is capable of catalyzing a first reaction upon contacting a first substrate in the biological tissue or fluid and at least a second reaction upon contacting a second substrate as is required by Appellant’s claimed invention. In sum, Examiner has, at best, established that various components of Appellant’s claimed invention were known in the art at the time of Appellant’s claimed invention. A conclusion of obviousness, however, [R]equires more than a mere showing that the prior art includes separate references covering each separate limitation in a claim under examination. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). Rather, obviousness requires the additional showing that a person of ordinary skill at the time of the invention would have selected and combined those prior art elements in the normal course of research and development to yield the claimed invention. Id. at 421, 127 S.Ct. 1727. Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). Appeal 2012-006638 Application 11/052,204 9 CONCLUSION OF LAW The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1–3, 5–7, 10, 21, 25–27, 30–37, 40, 49, 52, and 53 under 35 U.S.C. § 103(a) as unpatentable over the combination of Ornberg, Wang, Lee, and Whitehead is reversed. REVERSED cdc Copy with citationCopy as parenthetical citation