Ex Parte Nishtala et alDownload PDFPatent Trial and Appeal BoardAug 21, 201813662278 (P.T.A.B. Aug. 21, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/662,278 10/26/2012 Vasu Nishtala 34284 7590 08/23/2018 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. 101674.0006P2 9581 EXAMINER MARCETICH, ADAM M ART UNIT PAPER NUMBER 3761 NOTIFICATION DATE DELIVERY MODE 08/23/2018 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 V ASU NISHTALA, MICHAEL O'GRADY, and ROBERT YOUNG 1 Appeal2017-010499 Application 13/662,278 Technology Center 3700 Before DANIELS. SONG, JAMES P. CAL VE, and BRANDON J. WARNER, Administrative Patent Judges. CAL VE, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134(a) from the Office Action finally rejecting claims 1-20. Appeal Br. 4. We have jurisdiction under 35 U.S.C. § 6(b ). We AFFIRM. 1 C.R. Bard, Inc. is identified as the real party in interest (Appeal Br. 4) and also is the applicant pursuant to 37 C.F.R. § 1.46. Appeal2017-010499 Application 13/662,278 CLAIMED SUBJECT MATTER Claim 1, the sole independent claim on appeal, is reproduced below. 1. A catheter apparatus, comprising: a container including: a proximal end section; a distal end section; and a middle section connecting the proximal end section to the distal end section, the middle section including a plurality of pleats along a collapsible section, the collapsible section having a first expanded length and a second collapsed length less than the first expanded length; an introduction member, separate from the container, and coupled to the distal end section of the container; a conduit positioned within the container, the conduit including: a proximal end fixed to the proximal end section; a distal end slidably positioned with respect to the container at the distal end section; and a coating disposed on an outer surface thereof; and a wetting fluid disposed within the container. Appeal Br. 19 (Claims App.). REJECTIONS Claims 1-12 and 16 are rejected under 35 U.S.C. § I03(a) as unpatentable over Bonner, Jr. (US 3,894,540, iss. July 15, 1975) ("Bonner"), Nestenborg (US 2005/0043715 Al, pub. Feb. 24, 2005), and Kavanagh (US 2003/0018302 Al, pub. Jan. 23, 2003). Claims 13-15 are rejected under 35 U.S.C. § I03(a) as unpatentable over Bonner, Nestenborg, Kavanagh, and Morris (US 5,848,691, iss. Dec. 15, 1998). 2 Appeal2017-010499 Application 13/662,278 Claims 17-20 are rejected under 35 U.S.C. § I03(a) as unpatentable over Bonner, Nestenborg, Kavanagh, and Moulis (US 2002/0132013 Al, pub. Sept. 19, 2002). ANALYSIS Claims 1-12 and 16 Rejected Over Bonner, Nestenborg, and Kavanagh Appellants argue claims 1, 2, 4--12, and 16 as a group. Appeal Br. 10-15. We select claim 1 as representative. 37 C.F.R. § 4I.37(c)(l)(iv). We address Appellants' separate arguments for claim 3 below. Claims 1, 2, 4--12, and 16 The Examiner finds that Bonner teaches a catheter as recited in claim 1, having a container (protective sheath 20), conduit 10, and a wetting fluid (lubrication medium) in seal cap 23, but lacks express disclosure of a coating on an outer surface of conduit 10 and wetting fluid in container 20. Final Act. 2-3. The Examiner finds that Nestenborg discloses a catheter assembly comprising a container (receptacle/bag 2 or wetting fluid container 350), a conduit ( catheter 3) within the container, a hydrophilic coating disposed on an outer surface of catheter 3, and wetting fluid 360 in container 2, 350. Id. at 3--4. The Examine determines it would have been obvious to include the coating and wetting fluid ofNestenborg to automatically hydrate and lubricate the entire length of the catheter of Bonner, rather than limiting lubricant to sealing cap 23 as Bonner teaches. Id. at 4; Ans. 13-14. The Examiner relies on Kavanagh to teach a self-lubricating catheter 10 with a container (pouch 11 ), conduit ( urinary catheter 15), wetting fluid 52 in the container ( chamber 24) and an introduction member (introducer 30) separate from container 11 to protect the catheter tip. Final Act. 4. 3 Appeal2017-010499 Application 13/662,278 The Examiner determines a skilled artisan would have been motivated to use a separate introduction member made of a soft elastomeric material, as taught by Kavanagh, on the catheter of Bonner and Nestenborg to prevent contamination and irritation as the catheter is introduced. Id. at 5. Appellants argue that the combination of Bonner and Nestenborg is not obvious because it would require substantial reconstruction and redesign of Bonner to retain N estenborg' s wetting fluid in the container of Bonner at the telescoping overlap 16 of telescoping tubes 13, 15 because Bonner does not disclose telescoping tubes 13, 15 or protective sheath 20 being connected in a fluid impermeable manner. Appeal Br. 10, 11. Appellants argue that the Examiner has not provided a reason why a skilled artisan would combine Bonner and Nestenborg absent hindsight. Id. at 11. In particular, Appellants argue that the Examiner has not provided a reason why including the coating and wetting fluid ofNestenborg on Bonner "to automatically lubricate the entirety of the catheter" would improve the function of the Bonner device, which already applies a bactericidal ointment and lubricant via a sealing cap. Id. at 12. Appellants argue that a skilled artisan would have been motivated, to increase the lubricant already in Bonner if more lubrication was desired, rather than redesigning Bonner to seal during telescoping action plus adding an expensive coating to the catheter and water to the container. Id. at 12-13. The Examiner's reason for modifying Bonner to include a coating and wetting fluid of N estenborg is supported by a rational underpinning based on the teachings ofNestenborg that it is well-known to coat the outer surface of a catheter with a hydrophilic coating to lubricate and facilitate insertion into the urethra. Nestenborg ,r,r 3, 56. Nestenborg teaches to wet the catheter to activate the coating before insertion into a patient's urethra. Id. ,r,r 3, 63. 4 Appeal2017-010499 Application 13/662,278 To accomplish this objective, Nestenborg places a hydrophilic coating on urinary catheter 3 and places catheter 3 within a container (receptacle/bag 2 or container 250/350/450) into which a wetting fluid is released or placed. Id. ,r,r 63-72. In the former case, wetting fluid is released into the receptacle to activate catheter 3 before inserting it into a patient. Id. ,r,r 63-70. In the latter case, wetting fluid is added during production and the catheter is then maintained in an activated, ready-to-use condition as the hydrophilic surface layer is preserved in a wetted state within the receptacle. ,r,r 71-72. The Examiner proposes to improve Bonner's catheter by employing the techniques taught by Nestenborg for similar benefits. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) ("if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill"). Final Act. 4; Ans. 14. The presence of a rational underpinning obviates Appellants' hindsight argument. See In re Cree, Inc., 818 F.3d 694, 702 n.3 (Fed. Cir. 2016) (hindsight argument is of no moment where the Examiner provides a sufficient, non-hindsight reason to combine the references). The proposed modification is compatible with Bonner's use of cap 23 "to cover, seal and lubricate the dilator 22." Bonner, 2:54--55. Lubrication of an outer surface of dilator 22 via outer cap 23 does not lubricate catheter 10, as Appellants recognize. Appeal Br. 13. Dilator 22 is inserted into the urethra and catheter 10 slides inside of dilator 22 into the urethra. Bonner, 2:55---68, Figs. 2, 3. Rather than adding lubricant to a small outer cap 23 to try to lubricate catheter 10 as it passes inside of dilator 22 (Appeal Br. 12), the Examiner proposes to wet the entire catheter as N estenborg teaches. 5 Appeal2017-010499 Application 13/662,278 Therefore, Bonner's use of a small amount of lubricant to facilitate insertion of dilator 22 and prevent infection is improved by N estenborg' s total lubricate of catheter 10 for insertion into a urethra. The Examiner's proposed modification of Bonner based on teachings ofNestenborg meets this need of Bonner and is supported by a rational underpinning. Similarly, Bonner's teaching to apply a bactericidal jelly or lubricant to surfaces of telescoping protective tubes 13, 15 prior to enclosing these tubes within a protective sheath 20 (id. at 5:47-55; Final Act. 4; Appeal Br. 12) does not ameliorate the need to apply a hydrophilic coating to the outer surface of the catheter and activate the coating with a wetting fluid as Nestenborg teaches. Nor does modification of Bonner's catheter assembly require major redesign and reconstruction of telescoping tubes 13, 15 as Appellants argue. Reply Br. 4. The Examiner is not proposing to contain wetting fluid within telescoping tubes 13, 15 as Appellants allege. Appeal Br. 11. Instead, the Examiner proposes to place wetting fluid in protective sheath 20 of Bonner, much like wetting fluid container 350 illustrated in Figure 3 ofNestenborg. See Final Act. 2--4; Ans. 13-15. As the Examiner points out, this container volume is much larger than cap 23 and therefore can contain more wetting fluid to activate the coating on the catheter. Ans. 13-14. Protective sheath 20 is secured at one end to tube 13 and at the other end to tube 15. Bonner, 2:40--45. Even if a fluid-tight seal is required by the claims and protective sheath 20 lacks such a seal with the catheter, Nestenborg teaches such seals. Nestenborg ,r,r 61-72, Fig. 1-3. After wetting, fluid can be drained prior to the catheter's use, and the wetting fluid container can be removed or retained in place during use as desired. Id. A person of ordinary skill also is a person of ordinary creativity. KSR, 550 U.S. at 421; see Reply Br. 4--6. 6 Appeal2017-010499 Application 13/662,278 Appellants also argue that Bonner already discloses a sealing cap to cover, seal, and lubricate the dilator and prevent contamination so a skilled artisan would have no motivation to look to Kavanagh for a dilator to avoid contamination and improve patient comfort. Appeal Br. 14--15. Again, the Examiner has provided a reason for using Kavanagh' s separate dilator and the reason is supported by a rational underpinning where Kavanagh teaches that a separate introduction member (introducer 30) can be made of a soft elastomeric material that reduces irritation when it is inserted into a patient's urethra in addition to protecting the catheter tip from contamination. 2 Final Act. 5; Ans. 15-16; see Kavanagh ,r,r 2, 9, 24. Thus, we sustain the rejection of claims 1, 2, 4--12, and 16. Claim 3 Claim 3 depends from claim 1 and recites "wherein the introduction member includes a tip that extends through an opening in the container distal end section." Appeal Br. 19 (Claims App.). The Examiner finds that Bonner shows dilator 22 extending through a distal opening in protective sheath 20, which corresponds to the container. Final Act. 6. In particular, Figures 2 and 3 of Bonner show a reduced-diameter dilator 22 passing through an opening in a distal end of protective sheath 20. Ans. 16. 2 Kavanagh also provides an indication of the redesign required if a skilled artisan wanted to add lubricant to Bonner's dilator 22 to lubricate the entire catheter 10, as Appellants argue would have been obvious to do instead of the modification proposed by the Examiner. Appeal Br. 12. The flowable lubricant 52 must be placed in a much larger chamber 24, and a user must squeeze grip members 41, 42 as catheter 15 advances through chamber 24 to apply the lubricant to catheter 15. Kavanagh ,r 32, Fig. 3. In contrast to Kavanagh's design, the Examiner proposes to use Bonner's existing design and simply fill outer protective sheath 20 with a saline solution that activates a hydrophilic coating on Bonner's catheter 10 as taught by Nestenborg. 7 Appeal2017-010499 Application 13/662,278 Appellants argue that claim 3 requires the tip of the introduction member to extend through an opening in the container distal end section, and Appellants disclose this feature as introduction member 60 connected to a distal end 50 of container 20 and "disposed partially within the container 20 and partially outside of the container, such that an introducer tip 70 extends through the opening in the distal end section 50 of the container 20." Appeal Br. 16. Appellants argue that introduction member 60 is shown in Figure 1 in dashed lines extending through an opening of container 20. Appellants also argue that neither Bonner or Nestenborg teach "an introduction member separate from the container" so it would be impossible for them to disclose a tip of an introduction member extending through an opening in the container as claimed, and Kavanagh does not cure this deficiency. Id. at 16-17. We agree with the Examiner that Figures 2 and 3 of Bonner illustrate dilator 22, which corresponds to the claimed introduction member tip, as a reduced-diameter section located at a distal end of protective tube 13, which, corresponds to the claimed introduction member 60, which extends partially within and partially outside of protective sheath 20. Bonner's dilator 22 is disposed at a distal end of protective tube 13, like the claimed tip 70 of the claimed introduction member 60. Final Act. 6; Ans. 16. As modified by Kavanagh's teachings, Bonner's dilator 22 is separate from protective sheath 20. Spec. ,r 24, Fig. 1; Bonner, Figs. 1, 2. Because Bonner's protective tube 13 is disposed partially within and partially outside protective sheath 20 and dilator 22 is disposed at a distal end of protective tube, dilator also extends through an opening in protective sheath 20 as claimed and as interpreted in light of Appellants' Specification. See Spec. ,r 24, Fig. 1. Thus, we sustain the rejection of claim 3. 8 Appeal2017-010499 Application 13/662,278 Claims 13-15 Rejected Over Bonner, Nestenborg, Kavanagh, and Morris Appellants argue that claims 13-15 are patentable at least because they depend from claim 1, which is patentable. Appeal Br. 1 7. Because we sustain the rejection of claim 1 as unpatentable over Bonner, Nestenborg, and Kavanagh as discussed above, this argument is not persuasive and we also sustain the rejection of claims 13-15. Claims 17-20 Rejected Over Bonner, Nestenborg, Kavanagh, and Moulis Appellants argue that claims 17-20 are patentable at least because they depend from claim 1, which is patentable. Id. at 18. Because we sustain the rejection of claim 1 as unpatentable over Bonner, Nestenborg, and Kavanagh as discussed above, this argument is not persuasive and we also sustain the rejection of claims 17-20. DECISION We affirm the rejections of claims 1-20. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 9 Copy with citationCopy as parenthetical citation