Ex Parte Griswold et al

Patent Trials and Appeals BoardFeb 15, 2019

13482883 - (D) (P.T.A.B. Feb. 15, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/482,883 05/29/2012 80584 7590 Medtronic, Inc. 710 Medtronic Parkway MS: LC340 Minneapolis, MN 55432 02/20/2019 FIRST NAMED INVENTOR Erik C. Griswold 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. P0041214.USU2/llll-384 3472 EXAMINER WEARE, MEREDITH H ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 02/20/2019 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): pairdocketing@ssiplaw.com rs.patents.five@medtronic.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ERIK C. GRISWOLD, JAMES CAL VIN ALLAN, RUDOLPH A. BEASLEY, WILLIAM J. HAVEL, JON D. SCHELL, DON H. TRAN, and STEVEN L. WALDHAUSER Appeal2018-006006 Application 13/482,883 1 Technology Center 3700 Before MICHAEL C. ASTORINO, BRADLEY B. BAY AT, and TARA L. HUTCHINGS, Administrative Patent Judges. ASTORINO, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. Â§ 134(a), the Appellants appeal from the Examiner's decision rejecting claims 1-22. We have jurisdiction over the appeal under 35 U.S.C. Â§ 6(b). We REVERSE. 1 According to the Appellants, "[ t ]he Real Party in Interest is Medtronic, Inc. of Minneapolis, Minnesota, the assignee of record, and Medtronic plc of Dublin, Ireland, the ultimate parent entity of Medtronic, Inc." Appeal Br. 3. Appeal2018-006006 Application 13/482,883 STATEMENT OF THE CASE Subject Matter on Appeal The technical field of the Appellants' invention "relates to delivery and deployment techniques for implantable medical devices." Spec. ,r 2. Claims 1 and 16 are the independent claims on appeal. Claim 1, reproduced below, is illustrative of the subject matter on appeal. 1. A kit for intravascular implantation of an implantable medical device within a patient, the kit comprising: an elongated outer sheath forming an inner lumen with a distal opening and a proximal opening, the outer sheath sized to traverse a vasculature of the patient; an elongated inner sheath with a tapered distal end, wherein the tapered distal end is configured to substantially fill the inner lumen of the outer sheath and close-off the distal opening of the outer sheath, wherein the inner sheath is slidable within the inner lumen of the outer sheath, wherein the inner sheath is selectably removable from the inner lumen of the outer sheath by sliding the inner sheath out of the proximal opening of the outer sheath; and an elongated deployment receptacle including a deployment bay at a distal end of the deployment receptacle and a proximal portion, wherein the deployment receptacle is slidable within the inner lumen of the outer sheath when the inner sheath is not within the inner lumen of the outer sheath, wherein the deployment bay is configured to carry the implantable medical device through the inner lumen of the outer sheath and facilitate deployment of the implantable medical device out of the distal opening of the outer sheath, wherein the deployment bay includes a proximal wall that limits proximal movement of the implantable medical device relative to the elongated deployment receptacle while the implantable medical device is carried within the deployment bay, wherein a transverse cross section of the proximal portion is smaller than a transverse cross section of the deployment bay. 2 Appeal2018-006006 Application 13/482,883 Rejections The Examiner maintains the following rejections under (pre-AIA) 35 U.S.C. Â§ I03(a): claims 1-3 and 9 as unpatentable over Boyle '902 2, Boyle '537 3, and Zhang4; 5 claims 4 and 5 as unpatentable over Boyle '902, Boyle '537, Zhang, and Rafiee6; claims 6-8 as unpatentable over Boyle '902, Boyle '537, Zhang, and Benjamin 7; claims 10, 14, and 15 as unpatentable over Boyle '902, Boyle '537, Zhang, and Griswold8; claim 10 as unpatentable over Boyle '902, Boyle '537, Zhang, and Jacobson9; claims 11-13 as unpatentable over Boyle '902, Boyle '537, Zhang, and VanTassel 10 ; 2 Boyle et al. (US 6,679,902 Bl, iss. Jan. 20, 2004) ("Boyle '902"). 3 Boyle et al. (US 2003/0004537 Al, pub. Jan. 2, 2003) ("Boyle '537"). 4 Zhang et al. (US 6,120,480, iss. Sept. 19, 2000) ("Zhang"). 5 In the Final Office Action, the Examiner twice addresses claim 17 as unpatentable over Boyle '902, Boyle '537, and Zhang. Final Act. 3, 19; see Appeal Br. 6, n.48 ( acknowledging "there does not appear to be any differences between these two rejections"). In the Answer, the Examiner addresses claim 17 once. Ans. 14. We follow the Examiner's approach in the Answer. 6 Rafiee et al. (US 2009/0192601 Al, pub. July 30, 2009) ("Rafiee"). 7 Benjamin et al. (US 2010/0004730 Al, pub. Jan. 7, 2010) ("Benjamin"). 8 Griswold et al. (US 2011/0251662 Al, pub. Oct. 13, 2011) ("Griswold"). 9 Jacobson (US 2007/0088418 Al, pub. Apr. 19, 2007). 10 VanTassel et al. (US 6,645,143 B2, iss. Nov. 11, 2003) ("VanTassel"). 3 Appeal2018-006006 Application 13/482,883 claims 14 and 15 as unpatentable over Boyle '902, Boyle '537, Zhang, and Altman 11 ; claims 16 and 18 as unpatentable over Boyle '902 and Boyle '537; claim 17 as unpatentable over Boyle '902, Boyle '537, and Zhang; claims 19 and 20 as unpatentable over Boyle '902, Boyle '537, and VanTassel; claims 21 and 22 as unpatentable over Boyle '902, Boyle '537, and Griswold; and claims 21 and 22 as unpatentable over Boyle '902, Boyle '537, and Jacobson. ANALYSIS Independent Claim 1 and Dependent Claims 2-15 Independent claim 1 calls for a kit comprising an elongated deployment receptacle including a deployment bay at a distal end and a proximal portion, "wherein a transverse cross section of the proximal portion is smaller than a transverse cross section of the deployment bay." Appeal Br., Claims App. The Examiner finds that Boyle '902 teaches a low profile delivery sheath having a proximal portion and a deployment bay at a distal end. Final Act. 3--4. As for the latter, the Examiner specifically finds that the deployment bay reads on "necked down section 44 and/or bearing surface 54 11 Altman (US 2002/0120250 Al, pub. Aug. 29, 2002). 4 Appeal2018-006006 Application 13/482,883 of the cylindrical cavity 50." Id.; see Boyle '902, col. 5, 11. 14--23, 47-55. The Examiner finds that Boyle '902 fails to "teach a transverse cross section of the proximal portion is smaller than a transverse cross section of the deployment bay." Final Act. 4. Indeed, the transverse cross section of Boyle '902's proximal portion is larger than a transverse cross section of the deployment bay. See Boyle '902, Figs. 1, 4. To remedy this deficiency, the Examiner turns to the teachings of Boyle '537. 12 Final Act. 4. The Examiner finds that Boyle '537 teaches a sheath where a transverse cross section of tubular member 7 4 is smaller than a transverse cross section than housing portion 62. See id. ( citing Boyle '537, Figs. 4--5). The Examiner determines that it would have been obvious to one of ordinary skill in the art to modify the proximal portion of Boyle '902's sheath to have a smaller transverse cross section than the deployment bay, as taught by Boyle '537. See id. at 4--5. The Examiner explains this modification to be "a simple substitution of one known, sufficiently pushable proximal portion of a delivery sheath for another to yield no more than predictable results." Ans. 3 (emphasis added). 13 Further, the Examiner explains that proposed substitution is not to make the deployment bay at the distal end of the Boyle '902's sheath larger. See id. at 6. 12 The Examiner does not rely on Zhang's teachings to further modify Boyle '902's sheath to meet the claimed subject matter particular to the elongated deployment receptacle. See Final Act. 5---6. 13 The Examiner withdrew "the alternate rejection based on the smaller diameter proximal portion being a mere matter of design choice." Ans. 6; see Final Act. 5. 5 Appeal2018-006006 Application 13/482,883 The basis for the Examiner's simple substitution is that the relative size of the proximal and distal portions of Boyle '902's sheath may be swapped because a change in elasticity of the material presumably would maintain the required stiffness for pushability. See id. at 3. In support of this substitution, the Examiner finds that Boyle '902's sheath requires a proximal portion that is "sufficiently stiff to provide good pushability within a guiding catheter" and that Boyle '537's sheath teaches a proximal portion that is similar in that it provides "a sufficiently high column strength." Id. at 2-3; see Boyle '902, col. 3, 11. 27-37; Boyle '537 ,r,r 19, 56. The Appellants argue, among other things, that the Examiner fails to show that substituting the material and transverse cross section of the proximal portion of Boyle '537's sheath for the material and transverse cross section of the proximal portion of Boyle '902's sheath would be adequate to maintain the required pushability for Boyle '902 sheath. See Reply Br. 7- 13. The Appellants' argument is persuasive. The Examiner presumes that the stiffness for the proximal portion of Boyle '537's sheath is acceptable for the proximal portion of Boyle '902's sheath. See Ans. 3. However, the Examiner's presumption appears to be based more on speculation than being adequately supported by evidence and technical reasoning. For example, the Examiner fails to compare the stiffness (i.e., elasticity) of the materials for the proximal portions of Boyle '902's and Boyle '537's sheaths. As pointed out by the Appellants: the proximal portion of Boyle '902's sheath may be made of any suitable bio-compatible polymer possessing a relatively high modulus of elasticity, e.g., high density polyethylene (HDPE), high 6 Appeal2018-006006 Application 13/482,883 density polypropylene, PeBax 72D (Reply Br. 7, n.2 ( citing Boyle '902, col. 5, 11. 7-11 ), n.4); the distal portion of Boyle '902's sheath includes a material having a low modulus of elasticity, e.g., PeBax 40b and polyolefin (id. at 7, n.5 ( citing Boyle '902, col. 5, 1. 66 - col. 6, 1. 8)); the proximal portion of Boyle '537's sheath is made of low elastic material, e.g., PeBax 40D, cross-linked HDPE, polyolefin, polyamide (id. at 7, n.3 (citing Boyle '537 i-f 51); see Boyle '537 i-f 56); and the material of the distal portion of Boyle '902's sheath and the proximal portion of Boyle '537's sheath is not a relatively high modulus of elasticity (see Reply Br. 7-8). On this record, the Examiner's substitution fails to recognize that the proposed change in material for the proximal portion of Boyle '902's sheath is to a material that lacks a relatively high modulus of elasticity. And, the Examiner fails to adequately show how a change in material for the proximal portion of Boyle '902's sheath to have a low elastic material would have resulted in the required pushability for Boyle '902 sheath. Further, the Examiner fails to adequately analogize how the elasticity or stiffness of the materials for the proximal portions of Boyle '902's and Boyle '537's sheaths relates to: the elasticity or stiffness of the distal portions of Boyle '902's and Boyle '537's sheaths; the actual dimensions of the proximal and distal portions of Boyle '902's and Boyle '537's sheaths; and functions of Boyle '902's and Boyle '537's sheaths generally, and/or the proximal and distal portions, specifically. See id. at 7-13; see, e.g., 7 Appeal2018-006006 Application 13/482,883 Boyle '902, col. 4, 1. 64- col. 5, 1. 7 (suggesting relative size of the proximal portion's wall thickness and lumen affects good pushability). Thus, we do not sustain the Examiner's rejection of independent claim 1 as unpatentable over Boyle '902, Boyle '537, and Zhang. The Examiner does not rely on the art of record in a manner that cures the deficiency in the rejection of claim 1 discussed above. Accordingly, on the record before us, we also do not sustain the rejections of claims 2-15, which depend either directly or indirectly from independent claim 1. Independent Claim 16 and Dependent Claims 17-22 Independent claim 16 recites "[a] method for intra vascular implantation of an implantable medical device within a patient" that includes a step of "inserting an elongated deployment receptacle, including a deployment bay at a distal end of the deployment receptacle and a proximal portion, ... wherein a transverse cross section of the proximal portion is smaller than a transverse cross section of the deployment bay." Appeal Br., Claims App. The Examiner's rejection of claim 16 is based on the same inadequately supported findings and reasoning discussed above with regard to the rejection of claim 1. See Final Act. 18-19; Ans. 3, 6. Thus, we do not sustain the Examiner's rejection of independent claim 16 as unpatentable over Boyle '902 and Boyle '537. The Examiner does not rely on the art of record in a manner that cures the deficiency in the rejection of claim 16. Accordingly, on the record before us, we also do not sustain the rejections of claims 17-22, which depend either directly or indirectly from independent claim 16. 8 Appeal2018-006006 Application 13/482,883 DECISION We REVERSE the Examiner's decision rejecting claims 1-22. REVERSED 9