Ex Parte Connors et alDownload PDFPatent Trial and Appeal BoardSep 29, 201510831813 (P.T.A.B. Sep. 29, 2015) 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. 10/831,813 04/26/2004 John J. Connors III 8627/211 (PA-5406-RFB) 1646 48004 7590 09/29/2015 BGL/Cook - Indianapolis BRINKS GILSON & LIONE CAPITAL CENTER, SUITE 1100 201 NORTH ILLINOIS STREET INDIANAPOLIS, IN 46204-4220 EXAMINER HOUSTON, ELIZABETH ART UNIT PAPER NUMBER 3773 MAIL DATE DELIVERY MODE 09/29/2015 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 PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte JOHN J. CONNORS, III, CHRISTOPHER G. DIXON, and RAY LEONARD, II ____________________ Appeal 2013-003068 Application 10/831,813 Technology Center 3700 ____________________ Before ANNETTE R. REIMERS, MICHAEL L. WOODS, and JAMES J. MAYBERRY, Administrative Patent Judges. WOODS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE John J. Connors, III et al. (“Appellantsâ€) seek our review under 35 U.S.C. § 134 of the final rejection of claims 1–10, 14, 16–26, and 30–36. Br. 2. Claims 11–13, 15, and 27–29 have been cancelled. Id. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appeal 2013-003068 Application 10/831,813 2 CLAIMED SUBJECT MATTER Appellants’ invention is directed to a “sheath having a plurality of distal segments that are of decreasing durometer.†Spec. para 2. Claims 1, 22, and 34 are the independent claims and claims 1 and 22 are reproduced below, with emphasis added on particular limitations at issue in this appeal. 1. A flexible, kink-resistant introducer sheath, said sheath having a proximal end and a distal end, comprising: an inner tube having a passageway extending longitudinally therethrough, said passageway having a substantially uniform diameter; a coil comprising a plurality of turns positioned longitudinally around said inner tube, said turns having a predetermined spacing therebetween; and an outer tube positioned longitudinally around said coil and said inner tube and connected to said inner tube through the spaces between said turns, said outer tube comprising a plurality of tube segments aligned in order of decreasing durometer from said proximal end to said distal end, said plurality of segments comprising a major segment of higher durometer comprising at least about 75% of the length of the outer tube, and at least three minor segments of lower durometer, wherein none of said minor segments exceeds about 5 cm in length. 22. A sheath and catheter assembly, comprising: a sheath having a proximal end and a distal end, said sheath comprising: an inner tube having a passageway extending longitudinally therethrough, said passageway having a substantially uniform diameter; a coil comprising a plurality of turns positioned longitudinally around said inner tube, said turns having a predetermined spacing therebetween; and an outer tube positioned longitudinally around said coil and connected to said inner tube through the spaces between said turns, said outer tube comprising a plurality of tube segments, said segments aligned in order of decreasing durometer toward said distal end; and Appeal 2013-003068 Application 10/831,813 3 a catheter having an open proximal end, an open tapered distal end, and a passageway extending longitudinally therethrough between said open proximal end and said open distal end, said catheter sized for insertion into said inner tube passageway, and further sized such that at least said tapered distal end portion extends beyond the distal end of said sheath when said catheter is inserted into said inner tube passageway; said tapered catheter distal end is dimensioned relative to said sheath distal end such that a generally smooth profile of said assembly is defined thereby, said catheter having an outer diameter that is 0.0005 to 0.004 inch (0.013 to 0.10 mm) less than said diameter of said inner tube passageway. Br. 20 and 22, Claims App. THE REJECTIONS I. Claims 1–10, 14, 16–20, and 34–36 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Parker (US 2002/0032408 A1, published Mar. 14, 2002) and Nita (US 5,951,539, issued Sept. 14, 1999). Final Act. 2 (dated July 19, 2011); see also id. at 2–4 (indicating that claims 34–36 are included in the rejection, despite not being listed in the initial statement of rejected claims). II. Claims 22, 23, 26, and 33 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Parker and Pinchuk (US 4,960,410, issued Oct. 2, 1990). Final Act. 5. III. Claims 30–32 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Parker, Pinchuk, and Nita. Final Act. 6–7. IV. Claim 21 stands rejected under 35 U.S.C. § 103(a) as unpatentable over Parker, Nita, and Chow (US 6,171,296 B1, issued Jan. 9, 2001). Final Act. 7. V. Claims 24 and 25 stand rejected under 35 U.S.C. § 103(a) as Appeal 2013-003068 Application 10/831,813 4 unpatentable over Parker, Pinchuk, and Chow. Final Act. 8. ANALYSIS Rejection I: Claims 1–10, 14, 16–20, and 34–36 In contesting the rejection, Appellants do not present separate arguments for claims 2–10, 14, 16–20, and 34–36 apart from those presented for claim 1. See Br. 12. Accordingly, claims 2–10, 14, 16–20, and 34–36 stand or fall with claim 1. In rejecting claim 1, the Examiner relies on Parker for teaching a sheath comprising, inter alia, inner tube 20, coil 14 positioned longitudinally around the inner tube, and outer tube 18 with two discrete longitudinal segments “aligned in order of decreasing durometer from said proximal end (30) to said distal end (28).†Final Act. 2–3 (citing Parker, Fig. 3 and paras. 31, 34). The Examiner finds that “Parker teaches the claimed invention [with the exception of the claimed] three minor segments.†Id. at 3. With respect to the claimed “at least three minor segments of lower durometer, wherein none of said minor segments exceeds about 5 cm in length,†the Examiner relies on Nita for teaching three minor segments 242, 244, 246 “each with a length of about 5 cm . . . for the purpose of kink resistance and flexibility.†Id. (citing Nita, col. 8, ll. 5–7; col. 14, ll. 36–56). In combining Parker with Nita, the Examiner concludes that “[i]t would have been obvious to one of ordinary skill in the art to combine length and durometers of the device of Nita with the sheath of Parker, as Nita navigates successfully through the vasculature because the most distal tip gradually getting softer.†Id. Appeal 2013-003068 Application 10/831,813 5 In contesting the rejection, Appellants argue that “Nita undesirably teaches the use of dual, or stacked, reinforcing members, and the formation of regions of double thickness to achieve the durometer differences between the segments.†Br. 8. Appellants further assert, “the teachings of Nita run counter to (i.e., teach away from) the expressed desire in the present application to maintain as small a wall thickness as possible.†Id. at 10. According to Appellants, “[s]hort of hindsight, a skilled artisan would have no basis to arrive at the claimed structure from the teachings of the references . . . [and] the Examiner has not met her burden of establishing a prima facie case of obviousness of claim 1.†Id. at 12. We are not persuaded by Appellants’ argument, as it is not probative of Examiner error. In particular, Appellants’ argument concentrates on Nita’s “stacked, reinforcing members†without specifically identifying error in the Examiner’s findings or reasoning. In rejecting claim 1, the Examiner simply relies on Nita for teaching “three minor segments ([242, 244, 246]) each with a length of about 5 cm and the total length of the device being of about 70-100 cm . . . for the purpose of kink resistance and flexibility.†Final Act. 3 (citing Nita, col. 8, ll. 5–7, and col. 14, ll. 36–56). As correctly explained by the Examiner, “the double winding portion of Nita is not relied upon in making the combination nor does the teaching of this portion negate the teaching of Nita to provide multiple segments of varying durometer to increase flexibility toward the distal end.†Ans. 11–12. For the foregoing reasons, we are not apprised of error in the Examiner’s rejection of claim 1, and claims 2–10, 14, 16–20, and 34–36, which fall with claim 1. Appeal 2013-003068 Application 10/831,813 6 Rejection II: Claims 22, 23, 26, and 33 Claims 22, 23, and 26 In contesting the rejection, Appellants do not present separate arguments for claim 26 apart from those presented for claim 22. See Br. 13– 18. Accordingly, claim 26 stands or falls with claim 22. In rejecting claim 22, the Examiner finds that Parker teaches a sheath and catheter assembly comprising, inter alia, sheath 40 and catheter 48, where catheter 48 has “a tapered distal end.†Id. at 5–6 (citing Parker, Figs. 3, 5, and paras. 31, 36). Figure 5 of Parker is reproduced below: Figure 5 depicts Parker’s medical device 10, including catheter 38, catheter shaft 40, and occluder 48, which has an enlarged tip 50 engageable with valve seat 46 to seal distal end 42 of tube 11. Parker paras. 36 and 37. The Examiner further finds that Parker does not disclose a “catheter having an outer diameter that is 0.0005 to 0.004 inches less than the diameter of the inner tube passageway,†but concludes that: It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a small tolerance (see Parker para. 40), since it has been held that where the general conditions of a claim are disclosed in the prior art, Appeal 2013-003068 Application 10/831,813 7 discovering the optimum or workable ranges involves only routine skill in the art. Final Act. 6 (citing In re Aller, 220 F.2d 454, 456 (CCPA 1955)). The Examiner further finds that Parker does not teach “that the catheter has an open proximal and distal end,†and instead relies on Pinchuk for teaching “a catheter with open ends . . . for the purpose of injecting fluids or monitoring blood pressure.†Id. (citing Pinchuk, Fig. 3, and col. 2, ll. 8 and 9). The Examiner concludes that “[i]t would have been obvious to one of ordinary skill in the art at the time the invention was made to use the open catheter of Pinchuk with the device of Parker as this aids in injecting fluids or monitoring blood pressure in the patient.†Id. (citing Pinchuk, col. 2, ll. 8 and 9). In contesting the rejection of claim 22, Appellants present several arguments, which we address separately, below. First, Appellants argue that Parker’s occluder 48 cannot be construed as the claimed “catheter,†as it “does not have a tapered distal end.†Br. 14; see also id. at 16 (“The occluder of Fig[ure] 5 of Parker does not constitute a tapered distal end as claimed.â€) We are not persuaded by Appellants’ first argument. As can be seen clearly in Parker’s Figure 5, reproduced above, “catheter†48 has a tapered distal end, as called for in the claims, which—in Parker’s disclosure—is used to engage valve seat 46. See Parker para. 37. Second, Appellants argue that “as recited in the claims, the assembly can access hard-to-reach target areas in a manner that minimizes the possibility of inadvertent dislodgement or otherwise knocking off loose plaque particles.†Br. 14 (citing Spec. 11, ll. 19–22). Appellants assert, “[n]either of the cited references, either individually or in combination, Appeal 2013-003068 Application 10/831,813 8 teaches or suggests a structure capable of accomplishing this feature.†Id. Appellants rely on the particular language of claim 22, which recites, “said catheter having an outer diameter that is 0.0005 to 0.004 inch . . . less than said diameter of said inner tube passageway.†Id. at 15; id. at 22, Claims App. With respect to claim 23, Appellants further point out, “this relationship was even more narrowly recited as 0.001 to 0.003 inch less than the diameter of the inner tube passageway.†Id. at 15. We are not persuaded by Appellants’ second argument, as it is not commensurate with the scope of claim 22 (or claim 23). In particular, neither claim 22 nor claim 23 recites structure that requires accessing “hard- to-reach target areas†in a manner that minimizes “inadvertent dislodgment†of loose plaque particles. See Adv. Act. 2 (dated Oct. 24, 2011) (“Again[,] the applicant argues limitations that are not in the claims, including accessing ‘hard-to-reach target areas.’â€) With respect to the claimed diameters, Appellants’ argument does not point out error in the Examiner’s determination that it would have been obvious to modify Parker to include the claimed diameters (or tolerances). See Final Act. 6 (citing Parker para. 40). As correctly explained by the Examiner, “Parker as modified by Pinchuk teaches the structure as necessitated in the claims.†Ans. 12. Third, Appellants argue that Parker “does not teach a dimension of his occluder relative to the sheath that defines a generally smooth profile.†Br. 16 (emphasis omitted, emphasis added). Appellants further explain, “Parker teaches away from the claimed structure, as the leading end of the assembly of Parker . . . has [a] ledge-type profile that is distinguish[able] by the claimed structure.†Id. Appeal 2013-003068 Application 10/831,813 9 We are not persuaded by Appellants’ third argument, as it is premised on an overly narrow interpretation of the relevant claim limitation. The relevant claim limitation simply recites, “said tapered catheter distal end is dimensioned relative to said sheath distal end such that a generally smooth profile of said assembly is defined thereby.†Br. 22, Claims App. (emphasis added). Importantly, this claim limitation does not preclude the presence of a “ledge-type profile†between the catheter and sheath, as Appellants’ assert. See id. at 16. Moreover, we note that our interpretation is consistent with Appellants’ Specification, as Figure 7 of Appellants’ Specification depicts a similar “ledge-type†profile between catheter 50 and the distal end of sheath 13, and the Specification explains that the assembly “provides a smooth transition†as long as the claimed diameter difference between the catheter and inner tube passageway is met—which the Examiner explains is obvious to achieve. See Spec. para. 36; id. at para. 42 (“Having a diameter difference in this range is also advantageous because it provides a smooth transition between the catheter and the sheathâ€); see also Final Act. 6 (“It would have been obvious . . . to have a small toleranceâ€) (citing Parker, para. 40). Further, we are not persuaded by Appellants’ argument that “Parker teaches away from the claimed structure,†as Appellants fail to identify any disclosure in Parker that criticizes, discredits, or discourages the Examiner’s proposed modification. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) (“The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed . . . .â€) Appeal 2013-003068 Application 10/831,813 10 Fourth, Appellants assert that “[t]he dimensions from Parker cited by the Examiner are not only non-analogous to the proper dimensions of the claimed assembly, but are taken from an apparatus that has little in common with the claimed assembly.†Br. 16 (emphasis added). We are not persuaded by Appellants’ fourth argument. As correctly explained by the Examiner, The device of Parker is suitable in small vessels . . . and the device of Pinchuck [sic] is used in vessels . . . . Those of ordinary skill in the art would not take the teaching of being used in vessels to exclude “small vessels†and would certainly have the ability to modify the size of Pinchuck’s [sic] device depending on what size vessels they wanted to use the device on. These references are in the same field of endeavor and are proper to combine. Ans. 12 (citing Parker paras. 9, 10, and Pinchuk, col. 3, ll. 15). Fifth, Appellants argue that “the Examiner has not articulated a reason that would have prompted one skilled in the art to modify Parker with Pinchuk as proposed.†Br. 17. We are not persuaded by Appellants’ fifth argument, as it fails to identify error in the Examiner’s reasoning that “[i]t would have been obvious . . . to use the open catheter of Pinchuk with the device of Parker as this aids in injecting fluids or monitoring blood pressure in the patient.†Final Act. 6 (citing Pinchuk, col. 2, ll. 8 and 9). For the foregoing reasons, we are not apprised of error in the Examiner’s rejection of claim 22 or claim 23, and claim 26, which falls with claim 22. Appeal 2013-003068 Application 10/831,813 11 Claim 33 Claim 33 depends from claim 22 and further recites, “wherein said tapered distal end of said catheter has a curved configuration, said curved configuration corresponding to a vascular pattern at a target site within the anatomy of a patient for facilitating insertion of the catheter into said target site.†Br. 23, Claims App. In rejecting claim 33, the Examiner finds that Parker’s distal end of catheter 48 “has a curved configuration (the curve at the tip).†Final Act. 6; see also Parker, Fig. 5. In contesting the rejection of claim 33, Appellants argue, “the tapered distal end of the catheter has a curved configuration [and that this] structure is neither taught nor suggested in the cited combination.†Br. 18. We are not persuaded by Appellants’ argument, as it appears to be premised on an overly narrow interpretation of the claim. Further, Appellants’ argument fails to precisely explain why the Examiner’s finding—that the curved tip of Parker’s catheter 48 meets the relevant limitation—is somehow in error. See Br. 18; Final Act. 6; Parker, Fig. 5. Upon reviewing the Specification, we note that Appellants do not provide a special definition for the claimed term “curved configuration†that would support a narrower claim construction. See, e.g., Spec. paras. 38 and 39. We further note that the curved tip of Parker’s occluder 48 appears to “correspond[] to a vascular pattern at a target site within the anatomy of a patient for facilitating insertion of the catheter into said target site,†as called for in claim 33 and as found by the Examiner. To the extent that Appellants believe the claim should be interpreted to require the specific structure depicted in Appellants’ Figures 6 and 7, we remind Appellants that although Appeal 2013-003068 Application 10/831,813 12 the claims are interpreted in light of the Specification, limitations from the Specification must not be read into the claims. In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). For the foregoing reasons, we are not apprised of error in the Examiner’s rejection of claim 33. Rejections III, IV, and V: Claims 21, 24, 25, and 30–32 Appellants do not present separate arguments for any of claims 21, 24, 25, or 30–32, apart from the presented, supra. Br. 18. Accordingly, and for the same reasons discussed above, we are not apprised of error in the Examiner’s rejections of claims 21, 24, 25, and 30–32. SUMMARY The Examiner’s decision to reject claims 1–10, 14, 16–20, and 34–36 under 35 U.S.C. § 103(a) as unpatentable over Parker and Nita is affirmed. The Examiner’s decision to reject claims 22, 23, 26, and 33 under 35 U.S.C. § 103(a) as unpatentable over Parker and Pinchuk is affirmed. The Examiner’s decision to reject claims 30–32 under 35 U.S.C. § 103(a) as unpatentable over Parker, Pinchuk, and Nita is affirmed. The Examiner’s decision to reject claim 21 under 35 U.S.C. § 103(a) as unpatentable over Parker, Nita, and Chow is affirmed. The Examiner’s decision to reject claims 24 and 25 under 35 U.S.C. § 103(a) as unpatentable over Parker, Pinchuk, and Chow is affirmed. 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). Appeal 2013-003068 Application 10/831,813 13 AFFIRMED hh Copy with citationCopy as parenthetical citation