Ex Parte Rome et al

Patent Trial and Appeal BoardDec 10, 2015

11021769 (P.T.A.B. Dec. 10, 2015)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 111021,769 12/21/2004 GuyT. Rome 34284 7590 12/14/2015 Rutan & Tucker, LLP. 611 ANTON BL VD SUITE 1400 COST A MESA, CA 92626 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 101672.0033P 4172 EXAMINER MCEVOY, THOMAS M ART UNIT PAPER NUMBER 3731 NOTIFICATION DATE DELIVERY MODE 12/14/2015 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address( es): patents@rutan.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GUY T. ROME and WILLIAM R. BARRON Appeal2013-004814 Application 11/021, 7 69 Technology Center 3700 Before KEN B. BARRETT, GEORGE R. HOSKINS, and FREDERICK C. LANEY, Administrative Patent Judges. HOSKINS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Guy T. Rome and William R. Barron ("Appellants") 1 appeal under 35 U.S.C. Â§ 134 from the Examiner's decision rejecting claims 1-3 and 10- 16 in this application. The Board has jurisdiction over the appeal under 35 U.S.C. Â§ 6(b). We AFFIRM-IN-PART. 1 The Appeal Brief identifies C.R. Bard, Inc. as the real party in interest. Appeal Br. 3. Appeal2013-004814 Application 11/021,769 CLAIMED SUBJECT MATTER Claim 1 is the sole independent claim on appeal: 1. A tissue tunneler for tunneling a catheter subcutaneously under a patient's skin from a first incision point to a second incision point, the catheter including at least one lumen, the tissue tunneler comprising: an elongated body comprising a tapered distal end to facilitate insertion of the tunneler into a body tissue and minimize trauma to the patient, the elongated body capable of creating a subcutaneous tunnel while minimizing trauma to the patient, and a proximal end including a barb having an expanding cross-sectional area in a proximal direction; an oversleeve slidably disposed over the elongated body; and an expansion mechanism slidably disposed about the barb, the expansion mechanism including an expandable sleeve having a smooth outer surface and a tab extending radially outward from the sleeve to engage an inner surface of the oversleeve following insertion of the barb and expandable sleeve into the catheter lumen. Appeal Br. 31 (Claims App.). REJECTIONS ON APPEAL Claims 1, 11, and 13-15 are rejected under 35 U.S.C. Â§ 102(e) as anticipated by Schweikert (US 2005/0027282 Al, pub. Feb. 3, 2005). Claims 1-3, 11, and 13-15 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Baessler (US 5,647,627, iss. July 15, 1997) and Lavender (US 5,988,719, iss. Nov. 23, 1999). Claims 10, 12, and 16 are rejected under 35 U.S.C. Â§ 103(a) as unpatentable over Baessler, Lavender, and Fields (US 4,746,158, iss. May 24, 1988). 2 Appeal2013-004814 Application 11/021,769 ANALYSIS A. Anticipation Re} ection based on Schweikert Claims 1, 11, and 13 Appellants argue claims 1, 11, and 13 as a group are not anticipated by Schweikert. Appeal Br. 6-11. We select claim 1 to decide the appeal of the anticipation rejection of these claims, with claims 11 and 13 standing or falling with claim 1. See 37 C.F.R. Â§ 41.37(c)(l)(iv). The Examiner cites the catheter tunneler of Schweikert's Figure 8 as anticipating claim 1. Final Act. 2-3. The Examiner finds the claimed "elongated body" corresponds to trocar 410, which includes the claimed "barb" at beveled portion 416. Id. at 2; Schweikert i-f 47. The Examiner finds the claimed "oversleeve" corresponds to slider 440. Final Act. 2; Schweikert i-f 50. The Examiner finds the claimed "expansion mechanism including an expandable sleeve" corresponds to adapter 420, which includes expandable legs 434a, 434b and the claimed "tab" at bumps 450. Final Act. 2-3; Ans. 8-9; Schweikert i-f 50. Appellants argue the Examiner errs in finding Schweikert's adapter 420 forms an expansion mechanism including an expandable sleeve, as recited in claim 1. Appeal Br. 7; Reply Br. 4---6. According to Appellants, legs 434a and 434b are compressed to restrain a catheter within passageway 438, and compression cannot reasonably be considered an expansion mechanism or an expandable sleeve. Appeal Br. 7. Appellants further argue Schweikert lacks any agency, means, or assembly of parts by which an expansion is accomplished. Reply Br. 4--5. These arguments are not persuasive. Schweikert's catheter tunneler holds a catheter in place by movement of oversleeve 440 in a proximal 3 Appeal2013-004814 Application 11/021,769 direction, to compress legs 434a and 434b around a catheter within passageway 438. Schweikert i-f 50. The Examiner finds that because legs 434a, 434b can thereby contract, they must also allow expansion. 2 Ans. 8. Indeed, Schweikert indicates legs 434a and 434b "separate from each other as well as move away from the longitudinal axis ... into an unbiased position," when oversleeve 440 is moved in a distal direction to permit the catheter to be removed from passageway 438. Schweikert i-fi-139, 51. Thus, the Examiner's finding that Schweikert's adapter 420, including legs 434a and 434b, is an expansion mechanism including an expandable sleeve is supported by a preponderance of the evidence. Appellants also argue the Examiner errs in finding Schweikert's tab 450 "extend[ s] radially outward from the sleeve to engage an inner surface of the oversleeve," as recited in claim 1. Appeal Br. 8. Appellants assert the Examiner identifies the expandable sleeve as legs 434a and 434b, and assert bumps 450 are not part of and do not extend radially outward from the legs. Id. Appellants also assert bumps 450 "are primarily designed to prevent movement" of oversleeve 440, not to engage its inner surface. Id. These arguments are not persuasive. The Examiner finds the claimed "expandable sleeve" in Schweikert corresponds to the entire adapter 420, not (as Appellants suggest) just the distal portion including legs 434a and 434b. Final Act. 2; Ans. 8-9. Tab 450 clearly extends radially outward from sleeve 420. Schweikert, Fig. 8. Moreover, the Examiner's finding that tab 450 engages the inner surface of oversleeve 440 when the oversleeve 2 Appellants assert the Examiner finds Schweikert discloses an expansion mechanism because a person could manually force legs 434a and 434b apart. Reply Br. 4---6. We are unable to locate any such finding by the Examiner. 4 Appeal2013-004814 Application 11/021,769 moves over the tab to be installed on sleeve 420 is supported by a preponderance of evidence. See Final Act. 2-3 (citing Schweikert i-fi-1 32, 51 ); see also Schweikert i1 50. Appellants suggest "[ m ]erely sliding past a surface," such as the interaction between tab 450 and oversleeve 440 in Schweikert, does not constitute an "engaging" as recited in claim 1. Reply Br. 9-10. Appellants argue the claimed engagement requires an "interlock," as exemplified by the Specification's notch 42 locking onto tab 26. Id. We firstly reject this argument on procedural grounds, because it was presented for the first time in the Reply Brief without establishing good cause. See 37 C.F.R. Â§ 41.41 (b )(2 ). We secondly determine the argument is unpersuasive, because the Appellants' Specification indicates a tab "engages" an oversleeve even if there is no notch in the oversleeve to interlock the two components together. Spec. i-fi-f 12, 67-68. Appellants moreover argue the Examiner errs in finding Schweikert's tab 450 "engage[s] an inner surface of the oversleeve [ 440]/ollowing insertion of the barb[416] and expandable sleeve [420] into the catheter lumen," as recited in claim 1 (emphasis added). Appeal Br. 8-10; Reply Br. 6-11. Appellants point out Schweikert holds a catheter within passageway 438 of sleeve 420, and Schweikert does not disclose either barb 416 or sleeve 420 being inserted into a catheter. Appeal Br. 8. The Examiner responds that a catheter is not a positively recited structure within claim 1, and the claim "embrace[ s] any conceivable catheter which the invention could tunnel." Ans. 9. According to the Examiner, "[in ]numerable catheters can be envisioned which closely fit over the oversleeve [ 440] and barb [ 416] of Schweikert yet have some portion in the 5 Appeal2013-004814 Application 11/021,769 catheter lumen which allows gripping by the expandable sleeve 420 (e.g. nipples for inner fluid channels, inner coaxial dual catheters, etc.)." Id. Such a catheter, the Examiner reasons, would allow oversleeve 440 and barb 416 to be placed into the catheter lumen, and further allow oversleeve 440 to slide over tab 450 for sleeve 420 to grip an internal feature of the catheter. Id. The Examiner finds oversleeve 440 can still be slid back and forth by a user, even though it may be covered by the catheter, because "catheters often have flexible outer walls" which would permit such operation. Id. Appellants reply that the Examiner's analysis "improperly us[ es] hindsight and speculation to invent a catheter that is not disclosed" and does not actually exist. Reply Br. 7-8. Further according to Appellants, if barb 416 and sleeve 420 were inserted into a catheter as proposed by the Examiner, Schweikert's device would be unable to function for its intended purpose. Appeal Br. 9-10; Reply Br. 10-11. In particular, Appellants contend that if a catheter were to cover oversleeve 440, then oversleeve 440 would be inaccessible and unusable to compress legs 434a and 434b. Reply Br. 10-11. Appellants also contend that the Examiner's catheter, which would "closely fit over" oversleeve 440 and barb 416 (Ans. 9), could not satisfy the claim requirement for tab 450 to "engage an inner surface of the oversleeve [ 440] following insertion" into the catheter. Reply Br. 8-9. We will assume for purposes of this decision that the phrase "following insertion ... " is a functional limitation of claim 1, and not a mere intended use. Even with that assumption, we are not persuaded of Examiner error in finding Schweikert's tab 450 is capable of engaging an inner surface of oversleeve 440 following insertion of sleeve 420 and barb 416 (nested 6 Appeal2013-004814 Application 11/021,769 within tapered portion 432 of sleeve 420) into a catheter lumen. In particular, we are not persuaded of Examiner error in finding that "catheters often have flexible outer walls" which would permit an operator to grip and slide oversleeve 440 within the catheter by squeezing the catheter wall, despite the "close[] fit" of the catheter over oversleeve 440. Ans. 9. Such flexibility is not inconsistent with distal movement of oversleeve 440 over tab 450 to engage the tab, thereby meeting the disputed limitation of claim 1, or proximal movement of oversleeve 440 to compress legs 434a, 434b. Appellants additionally argue the Examiner errs in finding oversleeve 440 is "slidably disposed over" elongated body 410, as recited in claim 1. Appeal Br. 10-11; Reply Br. 11. According to Appellants, oversleeve 440 is slidably disposed over only sleeve 420, not body 410. Appeal Br. 1 O; Reply Br. 11. Further, Appellants assert, when elongated body 410 is properly positioned within sleeve 420, barb 416 rests within tapered portion 432, so that body 410 is not located inside the area of oversleeve 440. Appeal Br. 10-11. These arguments are not persuasive. Rather, we agree with the Examiner that oversleeve 440 is slidably disposed over sleeve 420, and elongated body 410 may be slid within sleeve 420, so that oversleeve 440 is "indirectly slidably disposed over" body 410. Ans. 10. In particular, during insertion of body 410 into sleeve 420 so that barb 416 rests within tapered portion 432, the entire extent of body 410 passes through the area of oversleeve 440. Claim 1 does not specify that the recited arrangement must be met at any particular time, or that there is direct sliding contact between oversleeve 440 and body 410, and we may not import examples from the Specification into the claim. See In re Omeprazole Patent Litigation, 483 7 Appeal2013-004814 Application 11/021,769 F.3d 1364, 1372 (Fed. Cir. 2007); In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993). For the foregoing reasons, we sustain the rejection of claims 1, 11, and 13 as anticipated by Schweikert. Claims 14 and 15 Claim 14 depends from claim 1 to recite "the expandable sleeve has a tubular body with an inner lumen including a gradually decreasing diameter from a proximal end of the tubular body to a distal end thereof," and claim 15 depends from claim 14. Appeal Br. 32 (Claims App.). Appellants argue the Examiner errs in finding Schweikert's sleeve 420 has the gradually decreasing diameter recited in claim 14. Appeal Br. 11; Reply Br. 12. For the following reasons, we agree. To support the challenged finding, the Examiner cites Schweikert's Figures 8 and 9. Final Act. 3; Ans. 10. Figure 8 shows an inner lumen of sleeve 420 having a ribbed 437 profile at its proximal end 426, transitioning to a relatively long middle portion with a constant diameter, which leads to a decreasing diameter portion 432 at distal end 424. Schweikert i-fi-1 48--49. Such a structure is not a gradually decreasing diameter from the proximal end to the distal end, as claimed. Figure 9, as Appellants point out, is a different embodiment from Figure 8 and is therefore not pertinent to the anticipation rejection which relies on the Figure 8 embodiment. Reply Br. 12. For the foregoing reasons, we do not sustain the rejection of claim 14 and its dependent claim 15 as anticipated by Schweikert. 8 Appeal2013-004814 Application 11/021,769 B. Obviousness Rejection based on Baessler and Lavender Appellants argue the Examiner errs in finding the combination of Baessler's pipe puller 10 and Lavender's pipe pulling device 10 would be "capable of creating a subcutaneous tunnel while minimizing trauma to the patient," as required by claim 1. Appeal Br. 18-21; Reply Br. 16. For the following reasons, we agree. Baessler discloses laying a pipe underground by using a vehicle (such as a tractor) to pull a ripper R to open a trench in the earth, and further pull pipe puller 10 via chain 15 to lay a pipe in the trench created by ripper R. Baessler, Figs. 1-3, 1:18-24, 3:20-23, 3:45-51. It is readily apparent that the use of ripper R creates a trench, not the claimed tunnel, 3 and further would not minimize trauma if used to insert a catheter in a patient. Lavender's pipe pulling device 10 is operated by laying a cable through an already-created tunnel in the earth, and then attaching the cable to opening 94 of pulling eye 92 to pull device 10 (and an attached pipe) through the tunnel. Lavender, Figs. 1-2, 2:66-3:1, 3:46-48. The Examiner determines it would have been obvious to dispense with the chain of Baessler and the cable of Lavender, so that the resulting device would be capable of creating a subcutaneous tunnel while minimizing trauma to the patient. Final Act. 8; Ans. 11-12. However, the Examiner does not adequately articulate any reason why it would have been obvious to modify the references by dispensing with their pulling mechanisms to result in a device having an elongated body capable of creating a subcutaneous tunnel while minimizing trauma. Final Act. 8; Ans. 11-12. It is not 3 See Appeal Br. 18 ("Tunneling involves going underneath the surface without disrupting the surface, i.e., subcutaneously. (See e.g., Instant Specification, i-f [0088])."). 9 Appeal2013-004814 Application 11/021,769 apparent from the references themselves, which rely on pulling (not pushing) mechanisms to lay pipe, how such a modified device could be used to create a tunnel, or how such a tunneling operation would be conducted without substantial trauma. See Final Act. 5 (Examiner's proposed modification utilizing Lavender's pulling eye 92 as the leading end of the tunneler). For the foregoing reasons, we do not sustain the rejection of claim 1 and claims 2, 3, 11, and 13-15 depending therefrom as unpatentab le over Baessler and Lavender. C. Obviousness Rejection based on Baessler, Lavender, and Fields The Examiner relies on Fields as disclosing the proximal end tip of dependent claims 10 and 12, and a circular tab with a diameter greater than the outer diameter of the tubular body as recited in dependent claim 16. Final Act. 7. Thus, Fields does not cure the deficiencies noted above in combining Baessler and Lavender concerning independent claim 1, and we therefore do not sustain the rejection of claims 10, 12, and 16. DECISION The rejection of claims 1, 11, and 13-15 as anticipated by Schweikert is affirmed as to claims 1, 11, and 13, and reversed as to claims 14 and 15. The rejection of claims 1-3, 11, and 13-15 as unpatentable over Baessler and Lavender is reversed. The rejection of claims 10, 12, and 16 as unpatentable over Baessler, Lavender, and Fields is reversed. No time period for taking any subsequent action in connection with this appeal may be extended, under 37 C.F.R. Â§ 1.136(a)(l)(iv). 10 Appeal2013-004814 Application 11/021,769 mls AFFIRMED-fN-P ART 11