Ex Parte Ye et alDownload PDFBoard of Patent Appeals and InterferencesApr 1, 200909945225 (B.P.A.I. Apr. 1, 2009) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte TING TINA YE and GREGORY E. MIRIGIAN __________ Appeal 2008-6320 Application 09/945,225 Technology Center 3700 __________ Decided:1 April 1, 2009 __________ Before TONI R. SCHEINER, DONALD E. ADAMS, and JEFFREY N. FREDMAN, Administrative Patent Judges. FREDMAN, Administrative Patent Judge. DECISION ON APPEAL 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, begins to run from the decided date shown on this page of the decision. The time period does not run from the Mail Date (paper delivery) or Notification Date (electronic delivery). Appeal 2008-6320 Application 09/945,225 This is an appeal under 35 U.S.C. § 134 involving a claim to an intravascular catheter. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Statement of the Case Background “Intravascular catheters are used in a wide variety of relatively non- invasive medical procedures” (Spec. 1, ll. 11-12). The Specification teaches that “[i]n order for the catheter to navigate a patient's tortuous vascular system, it is desirable that intravascular catheters be very flexible, particularly near the distal end” (Spec. 2, ll. 2-4). The Claim Claims 1-21 are on appeal. Independent claim 1 is representative and reads as follows: 1. An intravascular catheter, comprising: an elongate shaft having a proximal end, a distal end, and a distal tip having a shapable length that is shapeable by thermoforming techniques, the elongate shaft including: an inner liner; a second layer disposed over the inner liner, the second layer including a first segment and a second segment, the first segment extending to a distal terminus and the second segment extending from the distal terminus to a radiopaque marker band disposed proximal of the distal end of the shaft, wherein the distal terminus is set back from the distal end of the shaft a distance equal to or greater than the shapable length; a third layer disposed over the second layer; and a fourth layer disposed over the third layer, the fourth layer including a proximal end and a distal end. 2 Appeal 2008-6320 Application 09/945,225 The prior art The Examiner relies on the following prior art references to show unpatentability: Nita et al. US Patent 5,951,539 Sep. 14, 1999 Samson et al. US Patent 6,090,099 Jul. 18, 2000 The issues A. The Examiner rejected claim 1 under 35 U.S.C. § 102(e) as anticipated by Samson (Final Rej. 2-3). B. The Examiner rejected claims 1-5, 7-10, 12, and 13 under 35 U.S.C. § 103(a) as being obvious over Samson (Final Rej. 3-4). C. The Examiner rejected claims 1-21 under 35 U.S.C. § 103(a) as being obvious over Samson and Nita (Final Rej. 4-5). A. 35 U.S.C. § 102(e) over Samson The Examiner found that Samson . . . discloses a catheter comprising an elongated shaft, having a proximal end, a distal end and a distal tip, wherein the shaft includes an inner liner, a second layer disposed on the inner layer, a third layer disposed on the second layer and a fourth layer disposed on the third layer and wherein the first segment extends to a distal terminus and the second segment extending from the distal terminus to a radiopaque marker disposed proximal of the distal end of the shaft. (Final Rej. 2.) Appellants contend that the “limitation that the tip is ‘shapable’ means that it can be shaped, but is not necessarily shaped. This limitation describes a structural characteristic of the product, not a process step” (App. Br. 9). 3 Appeal 2008-6320 Application 09/945,225 “Appellants do assert that their product differs structurally from the product of the prior art” (App. Br. 10). Appellants contend that the “recited claim element of a ‘shapeable length that is shapeable by thermoforming techniques’ has been expressly ignored by the Examiner . . . . The phrase clearly does not recite how the catheter was formed, and is not a product by process recitation. Therefore, a prima facie position has not been established” (App. Br. 11). In view of these conflicting positions, we frame the anticipation issue before us as follows: Did the Examiner err in finding that the catheter of Samson comprises a “distal tip having a shapeable length that is shapeable by thermoforming techniques”? Findings of Fact (FF) 1. Samson teaches “a catheter section made up, desirably, of an outer tubing component and at least one inner stiffener component placed coaxially within that outer tubing component. Between the at least one inner stiffener component and the outer tubing component is a metallic braided tubing member” (Samson, col. 4, ll. 33-38). 4 Appeal 2008-6320 Application 09/945,225 2. Samson teaches a catheter of Figure 2 as reproduced below: Figure 2 shows “fragmentary cross-sections of catheter sections” (Samson, col. 4, l.l. 65-66). 3. Samson teaches that a “catheter body or section (200) has a pair of inner tubing stiffener members (202 and 204), an optional lubricious sheath (206), and the outer polymeric layer (208)” (Samson, col. 5, ll. 59- 61). 4. Samson teaches that the catheter also comprises “a pair of radio-opaque bands, the proximal band is (210) and the distal band is (212.)” (Samson, col. 5, ll. 62-63). 5. Samson teaches that the catheter also comprises a “braided tubing member (214). The inner tubing stiffening members or inner stiffening tubing sections (202 and 204) desirably are simple sections of tubing which have been cut to length for placement in the catheter section” (Samson, col. 5, ll. 65-67). 5 Appeal 2008-6320 Application 09/945,225 6. Samson teaches that a catheter “must be sufficiently flexible at the distal end to allow passage of the catheter tip through the loops and increasingly smaller blood vessels” (Samson, col. 1, ll. 40-42). 7. The distal tip of the catheter of Samson shown in Figure 2 is composed of the lubricious sheath 206 and the stiffener member 202 (FF 2- 3). 8. Samson teaches that the “‘lubricious sheath’ (206) may be of any of a variety of lubricious polymers, e.g., polytetrafluoroethylene, FEP, or other fluorocarbon polymers or polysulfones” (Samson, col. 6, ll. 16-20). 9. Samson teaches that the “inner stiffener members sections, or layers (202 and 204) may be of a wide variety of materials but preferably are LLDPE or LDPE, perhaps containing a small amount of ethylene vinyl acetate (EVA)” (Samson, col. 6, ll. 11-15). 10. Figure 2 of the Specification is reproduced below: “Figure 2 is an enlarged view of a shaft of the intravascular catheter” (Spec. 4, l. 11). 11. The Specification teaches that “[s]haft 12 comprises multiple layers including an inner liner 24” (Spec. 5, l. 13). 6 Appeal 2008-6320 Application 09/945,225 12. The Specification teaches that “[p]referably, inner liner 24 comprises polytetrafluoroethylene (PTFE) . . . inner liner 24 may comprise materials including . . . fluorinated ethylene proprylene (FEP) . . . polysu[l]fone” (Spec. 5, ll. 13-21). 13. The Specification teaches that “fourth layer 44 may be comprised of materials similar to those disclosed above, including polymers and metals” (Spec. 8, ll. 5-7). The Specification teaches polymers including “polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC)” (Spec. 5, ll. 18-19). 14. The Specification teaches that “[a]t distal end 48, the preferred material is a low durometer polymer (e.g., PEBAX 2533) to maintain a soft, atraumatic tip” (Spec. 8, ll. 11-12). Principles of Law “A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987). Analysis of whether a claim is patentable over the prior art under 35 U.S.C. § 102 begins with a determination of the scope of the claim. We determine the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction in light of the specification as it would be interpreted by one of ordinary skill in the art. In re Am. Acad. Of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). The properly interpreted claim must then be compared with the prior art. 7 Appeal 2008-6320 Application 09/945,225 “It is well settled that a prior art reference may anticipate when the claim limitations not expressly found in that reference are nonetheless inherent in it. Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002) (citations and internal quotation marks omitted). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks omitted). “[A] prima facie case of anticipation [may be] based on inherency.” In re King, 801 F.2d 1324, 1327 (Fed. Cir. 1986). Once a prima facie case of anticipation has been established, the burden shifts to the Appellant to prove that the prior art product does not necessarily or inherently possess the characteristics of the claimed product. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product.”). See also In re Spada, 911 F.2d 705, 708-09 (Fed. Cir. 1990). Analysis Samson teaches an intravascular catheter with an elongate shaft (FF 1- 2) which includes an inner liner, lubricious sheath 206 (FF 2-3), a second layer that is set back from the distal end of the shaft which is the inner tube 8 Appeal 2008-6320 Application 09/945,225 stiffening layer 204, (FF 2-3), a third layer comprising a braided tubing member 214 (FF 5) and a fourth layer comprising stiffening layer 202 which extends to the distal end of the shaft (FF 2-5). Samson teaches that the distal tip is flexible and is composed of layers 202 and 206 (FF 6-7). The dispute centers on whether the distal tip is “shapeable by thermoforming techniques” (Claim 1). Claim 1 and the Specification do not require any particular degree of “shapeability” (FF 10-11). We agree with Appellants that the “shapeable” limitation is not a product by process limitation (App. Br. 8). We agree with Appellants that the “word ‘shapeable’ should be understood as meaning ‘capable of being shaped’. Thus, it is a material property of a portion of the recited device” (Reply Br. 4). However, the catheter of Samson is structurally identical to the catheter of claim 1, including all of the claimed layers (FF 2-5, 10). Additionally, Samson teaches that the first of the two layers which compose the distal end, the lubricious sheath 206, can be composed of polytetrafluoroethylene (FF 8). This is identical to the material identified as preferred by the Specification for the inner layer (FF 12). Samson teaches that the second layer of the distal end may be composed of a variety of materials, including LLDPE or LDPE (FF 9). While the Specification prefers PEBAX 2533 (FF 14), the Specification states that “fourth layer 44 may be comprised of materials similar to those disclosed above, including polymers and metals” (Spec. 8, ll. 5-7; FF 13). One of those materials listed above in the Specification is polyethylene, which is the material taught by Samson (FF 9, 13). 9 Appeal 2008-6320 Application 09/945,225 Since Samson is structurally identical to Appellants catheter, and may be composed of virtually identical materials to those disclosed by Appellants, the only question is whether the distal tip is “shapeable by thermoforming techniques” (Claim 1). The Examiner has reasonably established a prima facie case of unpatentability at least based on inherency, thereby shifting to Appellants the burden of proving that the distal tip of Samson would not have been “shapeable.” See In re Best, 562 F.2d 1252, 1255 (CCPA 1977)(“Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products”) (footnote omitted). On this record, Appellants have proffered no such proof. We are not persuaded by Appellants’ argument that regarding the distal terminus of Samson that “[n]o such sections are included in the catheter as shown” (Reply Br. 6). In fact, Samson clearly shows a distal region composed of the inner lubricious layer and the outermost layer which is distal to the second layer (FF 2). This region is the “shapeable length” of the Samson catheter. We agree with Appellants that “a portion of the catheter, and not just disassembled components” must be shapeable (Reply Br. 7). However, the region of Samson identified above represents a portion of the catheter and that portion is reasonably interpreted as inherently satisfying the “shapeable” limitation since it is composed of the materials identical to those disclosed in the Specification for the distal tip (FF 8-9, 11-14). 10 Appeal 2008-6320 Application 09/945,225 Conclusion of Law The Examiner did not err in finding that the catheter of Samson comprises a “distal tip having a shapeable length that is shapeable by thermoforming techniques.” B. 35 U.S.C. § 103(a) over Samson The Examiner rejected claims 1-5, 7-10, 12, and 13 under 35 U.S.C. § 103(a) as being obvious over Samson (Final Rej. 3-4). Claims 2, 5, 7-10, 12, and 13 depend from claim 1. As we have affirmed the rejection of claim 1 over Samson, and Appellants do not identify how Samson fails to teach the dependent claim limitations, we also affirm the rejections of these claims as well. Appellants separately argue claims 3 and 4, but the argument is that Samson does not teach that “the shape of the distal tip can be heat set . . .[or] that the shape of the distal tip can be heat set by steam” (App. Br. 11). We are not convinced by these arguments for the reasons already discussed, that based upon the evidence of record the distal tip of Samson inherently satisfies these functional recitations. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product . . .Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its 11 Appeal 2008-6320 Application 09/945,225 fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.”). C. 35 U.S.C. § 103(a) over Samson and Nita The Examiner rejected claims 1-21 under 35 U.S.C. § 103(a) as being obvious over Samson and Nita (Final Rej. 4-5). As above, claims 2 and 5-13 depend from claim 1. Claims 14 is argued using the same argument as claim 1, which was addressed above. Claims 15 and 18-21 depend from claim 14 and are not separately argued. Appellants rely upon the same argument regarding the “shapeability” of the distal tip to overcome the obviousness case over Samson and Nita. We note that Nita teaches and prefers the use of PEBAX in the outer polymeric layer (Nita, col. 12, l. 63 to col. 13, l. 1). As we have affirmed the rejection of claim 1 over Samson, and Appellants do not identify how Samson and Nita fail to teach any other limitations of independent claim 14 or any of the dependent claim limitations, we also affirm the rejections of these claims. As above, Appellants separately argue claims 3, 4, 16, and 17, but the argument is that “these thermoforming, heat set, and heat set by steam features are neither disclosed nor suggested in either reference” (App. Br. 13). We are not convinced by these arguments for the reasons already discussed, that the distal tip of Samson inherently satisfies these functional recitations. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (“Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not 12 Appeal 2008-6320 Application 09/945,225 necessarily or inherently possess the characteristics of his claimed product . . .Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on ‘prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products.”). SUMMARY In summary, we affirm the rejection of claim 1 under 35 U.S.C. § 102(e) over Samson. We affirm the rejection of claim 1, 3, and 4 under 35 U.S.C. § 103(a) over Samson. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2, 5, 7-10, 12, and 13 as these claims were not argued separately. We affirm the rejection of claims 1, 3, 4, 14, 16, and 17 under 35 U.S.C. § 103(a) over Samson and Nita. Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2, 5-13, 15, and 18-21 as these claims were not argued separately No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006). AFFIRMED cdc CROMPTON, SEAGER & TUFTE, LLC 1221 NICOLLET AVENUE SUITE 800 MINNEAPOLIS MN 55403-2420 13 Copy with citationCopy as parenthetical citation