Ex Parte GoodinDownload PDFPatent Trials and Appeals BoardJan 27, 201511854894 - (D) (P.T.A.B. Jan. 27, 2015) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte RICHARD GOODIN ____________ Appeal 2012-004880 Application 11/854,894 Technology Center 3700 ____________ Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal1 under 35 U.S.C. § 134 involving claims directed to a balloon catheter. The Patent Examiner rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant states that the Real Party in Interest is Boston Scientific Scimed, Inc. (App. Br. 3.) Appeal 2012-004880 Application 11/854,894 2 STATEMENT OF THE CASE Claims 1–3 and 7–14 are on appeal, and can be found in the Appendix of the Appeal Brief (App. Br. 9–10). Claim 1 is representative of the claims on appeal, and reads as follows: 1. A balloon catheter, comprising: an elongate shaft having a distal region defining a distal end, a shaft lumen extending through the elongate shaft to the distal end; a balloon disposed about the distal region of the elongate shaft; a guidewire port disposed within the distal region of the elongate shaft proximal of the balloon; a tubular member defining a guidewire lumen disposed within the shaft lumen, the tubular member extending from the guidewire port to within a proximal end of a coil extending through the balloon, the coil having a coil interior and a coil exterior, an exterior of the tubular member being attached to the interior of the coil; and a polymer coating disposed on the coil interior; wherein a distal end of the tubular member is fixedly attached to the proximal end of the coil such that the tubular member and the coil provide a fluid-tight passage through the balloon. The Examiner rejects the claims as follows: I. claims 1–3, 7, 8, 10–12, and 14 under 35 U.S.C. § 103(a) as unpatentable over Estrada2 in view of Barlow;3 and II. claims 9 and 13 under 35 U.S.C. § 103(a) as unpatentable over Estrada in view of Barlow and further in view of Speck.4 2 Edward A. Estrada et al., US 6,193,686 B1, issued Feb. 27, 2001. 3 Edward A. Barlow et al., US 5,112,304, issued May 12, 1992. 4 Marc L. Speck, US 2004/0002728 Al, published Jan. 1, 2004. Appeal 2012-004880 Application 11/854,894 3 I. The Issue: Obviousness over Estrada and Barlow According to the Examiner, “Estrada is relied upon for disclosing all the structural components of the claimed balloon catheter, including a tubular member and coil forming a secondary guidewire lumen.” (Ans. 7; see also FF 3 below.) The Examiner acknowledges that Estrada’s “coil (42) is disposed between layers (43 and 44) of the tube (34), [therefore,] Estrada fails to connect the portion of the tube (34) defining the ‘tubular member’ to the proximal end of the coil (42).” (Ans. 5; see also FF 3.) The Examiner finds that Barlow’s catheter [I]ncludes a coil (38) coated with a polymer (40) forming a portion of a guidewire lumen passing through the balloon. The guidewire lumen includes a tubular member (20) forming the proximal portion of the guidewire lumen (22). Barlow teaches that another way to connect a tubular member and coil to form a fluid-tight passage for a guidewire through a balloon can be configured so that the distal end of the tubular member is fixed within the proximal end of the coil (location 42). (Ans. 5; see below FF 2.) The Examiner explains that Barlow is “relied upon for teaching an alternate way to form a fluid-tight connection between a tubular member and coil of a guidewire lumen.” (Ans. 7; see also FF 2.) 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 modify the connection of the tubular member and coil of the secondary guidewire lumen of the Estrada device so that the exterior surface of the distal end of the tubular member is fixed within the interior of the proximal end coil, as taught by Barlow, as this modification merely involves the combination of known elements according to known methods to obtain the predictable result of forming a fluidtight guidewire lumen comprising a coil. (Ans. 5–6.) App App Exam prov to th Find (Bar eal 2012-0 lication 11 Does the iner’s con ides the lim e interior o ings of Fa 1. Fi FI balloon a proxim inflation tube 20 The guid connects structure low, col. 3 04880 /854,894 preponde clusion th itation of f the coil” ct g. 1 of Ba G. 1 illust catheter 10 al end 14 /deflation secures int ewire pas between t 26 , ll. 31–54 rance of th at the com “an exter ? rlow, repro rates a per , the prese with guide port 18. . . o one end sage 22, in he guidew .) 4 e evidenc bination o ior of the t duced bel spective v nt inventi wire entry . The pro of the guid ternal to t ire entry p e of record f Estrada ubular me ow, shows iew of a m on, includi port 16 a ximal end ewire ent he catheter ort 16 and support t in view of mber bein a balloon ultilumen ng a hub 1 nd an of the cat ry port 16 tube 20, the ballo he Barlow g attached catheter. 2 at heter . . . . on App App secti (Bar eal 2012-0 lication 11 2. Fi on of the b Fig. 5, re An embe material such as b tensione the elast spring 3 which is elastome which is about po material heat fusi low, col. 3 04880 /854,894 g. 5 of Ba alloon por produced dded sprin 40 which y heat fus d to a pred omeric ma 8 in the ela coaxial, in ric materi secured a int 58 of t 40 contain on or adhe , l. 59 to c rlow, repro tion of the above, illu g 38 is em connects t ion or adh etermined terial prov stomeric m cludes a b al 50 and o bout point he embedd ing the gu sively. ol. 4, l. 4; 5 duced bel catheter: strates the bedded o o the cathe esively. T degree pr iding a me aterial. A raided fib uter elasto 54 of the ed spring idewire pa see also A ow, shows inflated b r fused int ter tube 2 he spring ior to bein mory for balloon er 48 betw meric ma catheter tu 38 and ela ssage 22, ns. 5.) a detailed alloon. o elastome 0 at point can be g embedde the embed structure 2 een an inn terial 52, be 20 and stomeric such as by cross- ric 44, d in ded 6, er App App (Estr repro eal 2012-0 lication 11 3. Fi Fig. 1 sh Th tubular m guidewir lumen su the infla extremit extremit extremit compon provides is provid fluorosc ada, col. 5 4. Es duced abo Th 13 prefe 04880 /854,894 g. 1 of Est ows: e guidewi ember 34 e 36 suita ch as the table ballo y of the in y of the ba y of the ou ents are pr a flexible ed on the opic locati , l. 57 to c trada also ve. e inner tu rably inclu rada, repro re lumen which is ble for adv coronary a on 15 is se ner tubula lloon is se ter tubula eferably b yet sealed exterior of on of the b ol. 6, l. 5; shows a c bular mem des a helic 6 duced bel 18 extends configured ancement rteries. . . alingly se r member alingly se r member onded by l bond. A the inner alloon du see also A oil within ber 34 of al coil 42 ow, show through th to slidabl through a . The dist cured to th 34 and the cured to th 33. These aser bondi mid-balloo tubular me ring the pr ns. 5.) the shaft, the distal s of high st s a balloon e inner y receive patient’s b al extremi e distal proximal e distal catheter ng which n marker mber 34 f ocedure. shown in F haft sectio rength mat catheter. a ody ty of 39 or ig 1, n erial Appeal 2012-004880 Application 11/854,894 7 and most preferably is a ribboned material. The coil 42 is disposed between two layers of polymeric material, an inner layer 43 and an outer layer 44. The inner layer 43 is preferably formed of lubricous [sic] material or have a lubricious inner surface. . . . The outer layer 44 is preferably compatible with the material of the balloon 15 and the outer tubular member 33 so that they can be readily bonded by fusion bonding. (Estrada col. 6, ll. 26–38.) Principles of Law “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Analysis We adopt the fact finding and analysis of the Examiner (Ans. 4–7). Barlow shows a tubular member defining the guidewire lumen (see element 20, FF 1–2), a coil extending through the balloon (see element 38, FF 2; see also Ans. 5), and a polymer coating on the coil (FF 2; see also Ans. 5). Additionally, we note that Barlow’s balloon catheter has the balloon disposed about the distal region of the shaft (FF 1–2, see element 26), and provides a guidewire port that is positioned at the proximal end of the shaft and is also proximal to the balloon (FF 1, see element 16). As recognized by the Examiner, Barlow teaches spring 38 that “is embedded or fused into elastomeric material 40 which connects to the catheter tube 20 at point 44, such as by heat fusion or adhesively.” (FF 2; see also Ans. 5.) Appellant contends that the combination as proposed by the Examiner would render Estrada’s balloon catheter unsuitable for the intended purpose, because “the balloon will be unable to sustain an inflated condition, thereby Appeal 2012-004880 Application 11/854,894 8 altering the principle of operation of the device and rendering it unsuitable for its intended use.” (Br. 6–7.) We recognize, but are not persuaded, by Appellant’s contention that the combination of references would necessarily result in a construct that would not function as a balloon catheter. The combination of familiar elements does not necessarily require the wholesale substitution of entire elements as suggested by Appellant (Br. 6–7). The obviousness inquiry does not ask “whether the references could be physically combined but whether the claimed inventions are rendered obvious by the teachings of the prior art as a whole.” In re Etter, 756 F.2d 852, 859 (Fed. Cir. 1985) (en banc). Here, the Examiner is relying on Barlow “for teaching an alternate way to form a fluid-tight connection between a tubular member and coil of a guidewire lumen.” (Ans. 7; see also FF 2.) Estrada disclosed sandwiching a helical coil between an outer and inner layer. (FF 4.) Estrada specifically recognizes that “[t]he outer layer 44 is preferably compatible with the material of . . . the outer tubular member 33 so that they can be readily bonded by fusion bonding.” (Id.) The Examiner rejects the claims “based on a modification attachment of the components of Estrada that form the secondary guidewire lumen (18) in light of Barlow’s disclosure.” (Ans. 7.) In other words, the Examiner finds it obvious to apply “an alternate way to form a fluid-tight connection between a tubular member and coil of a guidewire lumen. Barlow discloses that it is known to dispose the exterior of the distal end of the tubular member within the proximal end of the coil.” (Id.) Here, Estrada disclosed sandwiching the coil between two layers, of which one can be bonded or fused to the outer tubular member (FF 4), while Barlow disclosed that the coil can be either embedded or fused to the Appeal 2012-004880 Application 11/854,894 9 material that attaches to the catheter tube (FF 2). We agree with the Examiner’s position that one of ordinary skill in the art would recognize that these attachment methods would be interchangeable. Accordingly, we agree with the Examiner that taken as a whole the references suggest all the elements as presently claimed (see FF 1–4). Appellant’s arguments do not persuade us that the preponderance of the evidence fails to support the Examiner’s prima facie case of obviousness. As Appellant does not argue the claims separately, we focus our analysis on claim 1, and claims 2, 3, 7, 8, 10–12, and 14 fall with that claim. 37 C.F.R. § 41.37 (c)(1). II. The Issue: Obviousness over Estrada, Barlow and Speck Appellant contends that Speck does not remedy the shortcomings of Estrada and Barlow. (Br. 7.) Appellant provides no further arguments with respect to the combination of Estrada, Barlow, and Speck; accordingly, Appellant has waived arguments directed to this combination of references. We therefore affirm that rejection as well. See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“In the event of such a waiver, the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections.”). Appeal 2012-004880 Application 11/854,894 10 SUMMARY We affirm the rejection of claims 1–3, 7, 8, 10–12, and 14 under 35 U.S.C. § 103(a) as unpatentable over Estrada and Barlow. We affirm the rejection of claims 9 and 13 under 35 U.S.C. § 103(a) as unpatentable over Estrada, Barlow, and Speck. TIME PERIOD FOR RESPONSE 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 cdc Copy with citationCopy as parenthetical citation