Ex Parte Whitcher et al

Patent Trial and Appeal BoardNov 21, 2012

11180165 (P.T.A.B. Nov. 21, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte FORREST D. WHITCHER and MAKOTO TAKEUCHI __________ Appeal 2011-013405 Application 11,180,165 Technology Center 3700 __________ Before ERIC GRIMES, ERICA A. FRANKLIN, and JACQUELINE WRIGHT BONILLA, Administrative Patent Judges. Opinion for the Board filed by Administrative Patent Judge GRIMES. Opinion Dissenting-in-part filed by Administrative Patent Judge BONILLA. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to stents. The Examiner has rejected the claims as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. Appeal 2011-0113405 Application 11/180,165 2 STATEMENT OF THE CASE The Specification discloses that, in “using vapor deposition techniques for the formation of medical devices” (Spec. 5:9-10), “nanocrystalline structures can be formed by depositing an amorphous layer of desired material onto a substrate” (id. at 10:1-2) and aging at temperatures well below typical annealing temperatures (id. at 9:13) “to form nanometer sized crystals” (id. at 10:2-3). The Specification discloses that a “medical device with a nanocrystalline structure is useful because of its enhanced mechanical properties, for instance fatigue resistance and corrosion resistance” (id. at 9:22-24). Claims 30, 33-35, and 48-51 are on appeal. Claims 30 and 48 are representative and read as follows: 30. An implantable medical device comprising one or more biocompatible metallic members arranged to form a radially deformable tubular member, at least one of the biocompatible metallic members consisting of a biocompatible metal having a morphology defined by grain sizes having a maximum dimension of between 1 nanometer and 10 nanometers, wherein said device is a stent. 48. A stent consisting of a tubular member comprising a plurality of slots, the tubular member comprising nitinol having a morphology defined by grain sizes having a maximum dimension of between 1 nanometer and 10 nanometers. The claims stand rejected as follows: • Claims 30, 33-35, and 48-51 under 35 U.S.C. § 102(b) in view of Roth;1 1 Roth, US 6,096,175, Aug. 1, 2000. Appeal 2011-0113405 Application 11/180,165 3 • Claims 30, 33-35, and 48-51 under 35 U.S.C. § 103(a) in view of Roth and Brown;2 and • Claims 30 and 33-35 under 35 U.S.C. § 102(b), or alternatively under 35 U.S.C. § 103(a), in view of Burrell.3 I. The Examiner has rejected claims 30, 33-35, and 48-51 as anticipated by Roth. The Examiner finds that Roth discloses stents made by the same methods described in the Specification (Answer 4). The Examiner finds that, although “Roth is silent regarding the claimed grain size” (id. at 5), it “is inherent that a thin film stent formed by the same method and from the same materials would inherently have the same claimed grain size” (id.). Appellants argue that Roth does not disclose aging at a temperature well below the annealing temperature, as described in the Specification for producing the claimed nanocrystalline structure (Appeal Br. 3). Appellants argue that Roth instead discloses an annealing step after the deposition of the metal layer and therefore the Examiner has not provided evidence of inherency of the claimed grain size (id.). We agree with Appellants that the Examiner has not adequately shown that Roth inherently discloses a “biocompatible metal having a morphology defined by grain sizes having a maximum dimension of between 1 nanometer and 10 nanometers,” as recited in claim 1. “Inherency … may not be established by probabilities or possibilities. The mere fact that 2 Brown et al., US 3,660,177, May 2, 1972. 3 Burrell et al., US 5,454,886, Oct. 3, 1995 Appeal 2011-0113405 Application 11/180,165 4 a certain thing may result from a given set of circumstances is not sufficient.” In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). The Specification discloses that “nanocrystalline structures can be formed by depositing an amorphous layer of desired material onto a substrate or target” and aging the amorphous layer to form nanometer-sized crystals (Spec. 10:1-3). The Specification states that the aging conditions are “well below typical annealing temperatures, such as about or near room temperature” (id. at 9:13-14). The Examiner reasons that “the step of ‘aging’ is optional. Nowhere in the specification does [it] state that the aging step must be done to achieve the claimed grain size.” (Answer 7.) The Examiner cites Example 1 of the Specification as disclosing that “no aging step is required to produce a grain size of less than 10 nanometers” (id.). We do not find the Examiner’s reasoning adequate to show that the claimed grain size would be inherent in the prior art product. The Specification states that “aging techniques can be used to form nanometer sized crystals” (Spec. 10:1-2). Although the Specification’s “can be used” language leaves open the possibility of using other techniques to form nanometer-sized crystals, no such techniques are described in the Specification and the Examiner has not provided evidence showing that nanometer-sized crystals form under the conditions disclosed by Roth. In addition, although Example 1 of the Specification does not expressly describe an aging step, the Examiner has not pointed to any disclosure in Roth of a process for stent fabrication that matches the procedure described in the Specification’s Example 1. Notably, Roth Appeal 2011-0113405 Application 11/180,165 5 discloses that annealing of the nitinol stent is the desired process (Roth, col. 6, ll. 9-16) and that standard annealing methods typically require “a period of several minutes at temperatures around 500° centigrade” (id. at col. 7, ll. 60-63). Thus, the Examiner has not persuasively shown that Roth discloses a process that is similar enough to the process set forth in Example 1 to support a finding of inherency. We therefore reverse the rejection of claims 30, 33-35, and 48-51 as anticipated by Roth. II. The Examiner has rejected claims 30, 33-35, and 48-51 as obvious in view of Roth and Brown. The Examiner relies on Roth as discussed above. As an alternative to his inherency reasoning, the Examiner finds that Brown discloses that, “with nickel-based alloys (such as the Nitinol material of Roth), a smaller grain size improves fatigue and strength properties” (Answer 5-6). The Examiner concludes that “it would have been obvious to one having ordinary skill in the art [of] vapor deposition and sputtering to have reduced the grain size including the claimed range when making a thin film stent to reduce the risk of stent strut breaking” (id. at 5). Appellants contend that Brown “does not disclose or suggest the claimed grain sizes … [but] instead discloses grain sizes of ASTM 10-13, which correspond to an average grain dimension of between about 4 and 11 micrometers, much greater in size than … claimed” (Appeal Br. 4). Appellants argue that Brown “would not have given one having ordinary skill in the art any reason to modify Roth to have the claimed grain sizes” (id.). Appeal 2011-0113405 Application 11/180,165 6 We agree with Appellants that the Examiner has not adequately explained how Roth and Brown would have made obvious the claimed stents. Brown discloses that, in a study of “certain nickel-base alloys as a function of heat treatment, it was determined that ultra-fine grain sizes can provide vastly improved fatigue and strength properties” in gas turbine engines (Brown, col. 2, ll. 35-43). Brown discloses that the “grain sizes of ASTM 10 (0.0002 inch diameter) or finer display superior fatigue and tensile strength properties” (id. at col. 3, ll. 44-47). A diameter of 2 x 10-4 inch is equal to 5 x 10-6 meter,4 or 5000 nanometers. Thus, the ASTM 10 grain size suggested by Brown is larger than the claimed grain size of between 1-10 nanometers by about three orders of magnitude. In view of this significant size difference, we agree with Appellants that the Examiner has not persuasively shown that the combination of Roth and Brown would have made obvious the grain sizes of the claimed stents. Thus, we reverse the rejection of claims 30, 33-35, and 48-51 as being obvious in view of Roth and Brown. III. The Examiner has rejected claims 30 and 33-35 as anticipated by, or alternatively as obvious in view of, Burrell. The Examiner finds that Burrell discloses “a method of forming an anti-microbial coating having a grain size of about 10-60 nm which has been interpreted to include less than 10 nm on implantable devices” (Answer 6). 4 We take official notice that 1 inch equals 2.54 centimeters (or 2.54 x 10-2 meter). Thus, 0.0002 inch = (0.0002)(2.54 x 10-2) = 5.08 x 10-6 meter. Appeal 2011-0113405 Application 11/180,165 7 Appellants argue that “the coating of Burrell cannot be construed to be, by itself, the claimed ‘at least one of the biocompatible metallic members’ where ‘one or more biocompatible metallic members [are] arranged to form a radially deformable tubular member.’” (Appeal Br. 4). Claim 30 recites “one or more biocompatible metallic members arranged to form a radially deformable tubular member … [and] consisting of a biocompatible metal having a morphology defined by grain sizes having a maximum dimension of between 1 nanometer and 10 nanometers.” Burrell discloses “methods of forming anti-microbial coatings and powders of biocompatible metals which provide a sustained release of anti-microbial metal species when in contact with body fluids or body tissues” (Burrell, col. 1, ll. 11-14). Burrell discloses that an “anti-microbial coating … is deposited as a thin metallic film on one or more surfaces of a medical device by vapour deposition techniques” (id. at col. 8, ll. 10-13) and that the deposited metallic film can have grains with a size of about 10 to 60 nanometers (id. at col. 12, ll. 41-42). The Examiner reasons that “a coating does qualify as ‘one or more biocompatible metallic members’” (Answer 9). We disagree with the Examiner’s claim interpretation. “[T]he PTO applies to the verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by ... the applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). Appeal 2011-0113405 Application 11/180,165 8 Here, the language of claim 30 itself supports the conclusion that the “biocompatible metallic member” is a structural component, because the member(s) must be “arranged to form a radially deformable tubular member” (claim 30, emphasis added). A coating is applied to a preexisting structure but a coating by itself cannot be arranged to form a structure. The Specification’s use of the term “member” is also consistent with interpreting it to require a structural component. The Specification discloses that “the medical devices … have at least one or more metallic members. These members have discrete dimensions and shapes as desired for particular medical devices” (Spec.10:12-14). Unlike the Specification’s “members,” a coating cannot have a discrete shape – it has only the shape of the structure that it coats. The Specification also discloses that a stent can be formed from a helical pattern of wire, or “[i]ndividual rings or circular members can be linked together such as by struts, sutures, welding or interlacing or locking of the rings to form a tubular stent” (id. at 10:27-11:2). The Specification thus equates “circular members” with “rings,” which are structural components. Thus, when the term “biocompatible metallic member” is interpreted as used in the claims and in view of the disclosure in the Specification, one of ordinary skill in the art would understand it to refer to a structural member of a stent. Thus, the Examiner’s interpretation of the term “biocompatible metallic member” to include a coating on a structural member is unreasonably broad. The fact that, as our dissenting colleague points out, the Specification refers to coatings does not change our conclusion. The description of coatings is relevant to, for example, claim Appeal 2011-0113405 Application 11/180,165 9 50, which is directed to a “tubular member comprising nitinol” (claim 48, emphasis added) that “further comprises a radiopaque coating” (claim 50) but does not suggest that a coating is itself a metallic member. Thus, we reverse the rejection of claims 30 and 33-35 as anticipated by Burrell. SUMMARY We reverse all of the rejections on appeal. REVERSED lp Appeal 2011-0113405 Application 11/180,165 10 BONILLA, Administrative Patent Judge, dissenting-in-part I respectfully dissent regarding the rejection of claims 30 and 33-35 as obvious over Burrell. In short, I would affirm the rejection under 35 U.S.C. § 103(a), and adopt the reasoning of the Examiner, as stated on page 9 of the Answer. I agree that a coating, such as the metal anti-microbial coating described in Burrell (Burrell, col. 8, ll. 8-55, in particular see ll. 45-47) having a grain size of “about 10-60 nm” (id. at col. 12, ll. 14-42), qualifies as a biocompatible metallic member as recited in claim 30. Claim 30 recites a device comprising “one or more biocompatible metallic members arranged to form a radially deformable tubular member.” An ordinary artisan reading Burrell would have known that a catheter, orthopedic pen, shunt, “and the like” such as a stent, for example (id. at col. 7, ll. 51-55), could have been metallic (id. at ll. 65-66), radially deformable, and tubular in shape. Burrell describes coating such a first biocompatible metallic member with a second biocompatible metallic member, i.e., a coating consisting of a metal having a relevant grain size, as recited in the “consisting of …” phrase in the claim. The first biocompatible metallic member (e.g., stent or portion of a stent) and the second biocompatible metallic member (a coating consisting of a metal having a grain size of 10 nm) together—i.e., “one or more biocompatible metallic members”—would be “arranged to form a radially deformable tubular member” as recited in claim 30. My colleagues question whether a “member” as recited in claim 30 encompasses a coating. “[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the Appeal 2011-0113405 Application 11/180,165 11 specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). The instant Specification does not preclude a “member” from being a coating. In fact, the Specification describes “depositing a biocompatible metallic layer on a substrate” in what appears to be a coating process (Spec. 3, ll. 1-6; 6, ll. 22-24; 10, ll. 1-3). The fact that the Specification also describes removing the metallic layer from a substrate and using the layer to form medical device embodiments (id. at 3, ll. 8-10; 10, l. 29 – 11, l. 2) does not dictate that a coating as described in Burrell, e.g., one acting as a second biocompatible metallic member layered onto a first biocompatible metallic member, cannot be a “member.” As noted above, a coating member, along with the member it coats, would be “arranged to form a radially deformable tubular member” as required in claim 30. Moreover, like the member it coats, the coating member would have a “discrete dimension[] and shape[] as desired” for the particular medical device (Spec. 10, ll. 12-14). I note that the Specification describes “the deposition of multiple layers for the further improvement of desired medical device properties,” where the “the deposited metallic layer 115 is optionally coated with a layer 116 of a radiopaque material such as platinum or tantalum to impart radiopacity to the medical device” (id. at 15, ll. 19-22, 27-29; see also 16, ll. 5-10). Thus, a broadest reasonable reading of the Specification indicates that a “biocompatible metallic member” may encompass a metal coating.